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CONTENTS Vol.14 No.4 December 16-31, 2018

Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Prabhat Prakash

Effective implementation of the recently launched MSME Support and Outreach Programme could prove to be the catalyst for the sector's progress | P26

New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet )

P31: Automation Fair 2018 links people, machines, data into a connected future

P62: Endotoxins: A P36: SCHOTT Glass: Aiming high

danger to pharmaceutical and medical device manufacturing industries

Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis

P34: INTERVIEW P58: K2VITAL Abhishek Bansal Co-Founder & CEO, Shadowfax

DELTA Vitamin K2-7: For bone and heart health

P71: Analytical techniques with a place in the oral solid dosage formulation toolkit

Automation solutions for PHARMA industry www.br-automation.com

Manager Bhadresh Valia

Express Pharma® Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar

Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

December 16-31, 2018

EDITOR’S NOTE

Will quality trip or lift us up in 2019?

s we wind up one year and gear up for the next, I wonder how CEOs of pharmaceutical companies would rate 2018. If there was one learning from this year that will shape strategy for the next, it should be that investments in quality need to be continuous, consistent and comprehensive. Unfortunately, this is easier said than done. The pharma industry across the world, but more so in economies such as India, seems to be caught in a vicious circle of driving down costs, yet keeping up with technology. All governments, not just in India, are capping the prices of medical and devices, so margins are slimming rapidly. And quality is the first casualty in a cost-cutting drive. Which is bad news as current FDA inspection trends, reportedly discussed at the 13th FDA Inspection Summit in October, point to increasing scrutiny. Excerpts of these talks have gone viral on various pharma focussed WhatsApp groups and while experts caution that these are not official statements from the FDA, they do reflect current FDA inspection trends. Pharma companies in India should note that five new record sets are apparently being requested for inspections: a data integrity compliance plan, an inventory list of cGXP computerised systems along with validations, a list and copies of computer system validation and data-integrity related SOPs along with policies that the site trained their employees on, recent change controls related to validated systems and 18 months of CAPAs involving validated systems or any keyword search with ‘data’. Investigators are asking for USB thumb drives for information instead of paper copies so they can review electronically. All this will add to the cost of ensuring quality. Industry insiders estimate that quality-related costs in many organisations are already as high as 15-20 per cent of sales revenue. This escalates to 40 per cent in some companies. The vicious cycle, also discussed at the Summit, starts when the company gets into trouble with regulators (483s, Warning Letters, product recalls, etc.) The company hires several employees in quality related functions and expensive consultants to address the shortcomings . The company then spends millions

EXPRESS PHARMA

December 16-31, 2018

If 2018 was defined by Ayushman Bharat, what will define 2019?

to address the quality concerns flagged by regulators, as well as countless hours to raise their compliance standards. The company gets a ‘clean bill’ from regulators. And all is well for some time. But then the management decides it’s time for a cost-cutting drive as profit margins are thinning and shareholders and promoters want to see returns. After a review of options to cut corners, the management decides that “too much money is being spent on quality,” “we're doing fine now.” Therefore the management decides to reduce headcount, opts out of infrastructure updates in quality related functions, and pat themselves on the back for the resulting 'savings'. But at the next inspection, the company gets another 483 and finds itself in a vicious loop, going back to square one. We have quite a few examples of this cycle being played out in India, and while its somewhat comforting to know that its not restricted to India, that doesn’t quite solve the problem. Companies assumed that hiring consultants who are ex-employees of global regulators would guarantee a clean chit during inspections. Some of these companies replied to observations from the US FDA expressing surprise that their ex-FDA consultants had not found the same problem as the current inspectors. The US FDA declined to accept the reasoning of its own ex-FDA staffers over the current inspectors, citing constant changes in the inspection protocols, and that it provided new training to their employees. So anyone who is ex-FDA ‘was not considered to represent the agency or their current thinking/ regulations.’ Yes, some companies are managing to pull themselves out of this black hole, but it’s a slippery slope. And there are no short cuts. 2019 will be about finding long-term solutions to these niggling issues. Or, finally throwing in the towel and/or diversifying deeper into easier, less regulated and less price controlled portfolios like OTC and nutraceuticals. And to add to the cauldron, we have a general election coming up! So interesting times ahead for sure. Express Pharma wishes all our readers all the best for 2019! VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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Effective implementation of the recently launched MSME Support and Outreach Programme could prove to be the catalyst for the sector's progress By Swati Rana

the Modi government recently launched the MSME Support and Outreach Programme to boost the growth of the sector in India. Under the programme, the government has made various announcements and deliverables that focus on access to credit, access to market, hand holding and facilitation support measures etc. for the MSME sector.

The 12 point agenda With the launch of the programme, the government has also announced 12 point agenda for MSMEs. In its announcement, Prime Minister Narendra Modi said, â€œTo resolve the issue of cash cycle in MSMEs, all companies with a turnover more than `500 crores, must now compulsorily be brought on the Trade Receivables e-Discounting System (TReDS). Joining this portal will enable entrepre-

neurs to access credit from banks, based on their upcoming receivables.â€? 1) Launch of 59-minute loan portal to enable easy access to credit for MSMEs. In principle approval of loans upto `1 crore through the portal. Portal link through GST portal. 2) Two per cent interest subvention for all GST registered MSMEs, on fresh or incremental loans. Increase in interest rebate from three

to five per cent for exporters who receive loans in the pre-shipment and post-shipment period. 3) Companies with turnover more than `500 crores to be compulsorily brought on the Trade Receivables e-Discounting System (TReDS) to enable entrepreneurs to access credit, based on upcoming receivables. 4) Central Public Sector Undertaking (CPSUs) units to

make mandatory procurement of 25 per cent instead of 205 from MSMEs. 5) CPSUs to make mandatory procurement of three per cent from women entrepreneurs out of 25 per cent mandatory procurement. 6) CPSUs to compulsorily be part of Public Procurement Portal GeM- Government e-Marketplace. CPSUs to get their vendors registered on GeM portal. 7) 20 hubs and 100 spokes in

Bhavin Mehta,

Chandrajit Banerjee,

Dinesh Dua,

Eshwar Reddy,

S R Vaidya,

Director, Kilitch Drugs (India)

Director General, CII

Chairman,Pharmexcil

Executive Director, BDMA(I)

Chairman, MSME Committee, IDMA

26 EXPRESS PHARMA December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

the form of Toolrooms for Technological Upgradation to be established across the country with a fund allotment of ` 6000 crores. 8) Clusters for pharma MSMEs to be supported with 70 per cent Government of India assistance. 9) Only one annual return to be filed for eight labour laws and 10 Union regulations to simplify government procedures. 10) Computerised random allotment for visits to firms by Inspectors to simplify government procedures. 11) Environment clearance and consent to establish unit to be merged into a single consent. Return to be accepted on the basis of self-certification. 12) Ordinance has been promulgated to enable entrepreneurs to correct the minor violations under the Companies Act through simple procedures rather than to approach Courts.

A welcome move The industry is very positive about this move and believes that it would be instrumental in reviving the sector’s progress and dealing with its bottlenecks. The industry stakeholders have already begun to take steps to implment this programme effectively. Eshwara Reddy, DCGI has urged the pharma companies in Aurangabad, Pune and Baddi to share their units details for an intervention by Department of Pharmaceutical. In his letter, he stated, “As you are aware PM has launched a historic MSME support and outreach programme on November 2, 2018 to strengthen the ecosystem for MSMEs by providing easy access to credit marketing and coverage of employees under social security schemes. Three districts namely Aurangabad, Pune in Maharashtra and Baddi in Himachal Pradesh which has concentration of pharma industries have been identified for trageted sectoral interventions by the DoP.” SR Vaidya, Chairman, MSME Committee, IDMA further informs, “On the basis of the performance in the above mentioned regions, the same will be

EXPRESS PHARMA

December 16-31, 2018

extended to other districts in the country where there is a pharma nucleus.”

Benefits of MSME support and Outreach programme Chandrajit Banerjee, Director General, CII says, “The progres-

sive 12-point agenda for MSME announced by Prime Minister addresses the right pain points for the small enterprises sector which provides livelihood to millions of households in the country. The online portal launched for providing credit in less than

an hour is a visionary initiative to make funds available to the sector at a time when it is facing a major liquidity crunch. Coupled with increase in interest rate subvention, it will provide muchneeded impetus to the sector. The 12 steps would strengthen

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CPHI & P-MEC INDIA 2018 SPECIAL

for growth of the overall economy. We compliment Prime Minister on a comprehensive and strategic program to revitalise MSMEs as a dynamic engine of inclusive growth.” “The Modi government’s announcement to provide loan of Rs 1 crore in an hour to the MSMEs will definitely boost the industry. Lack of adequate funds has always been a bottleneck for this section. Easy access to the loans will help not only in the operations of the sector but also provide capital to its R&D centres, where SMEs can play a strong role. The current government is emphasising in faster introduction of generic drugs into the market which will also benefit the Indian pharmaceutical companies going forward, opined Mehta.” Dua highlights, “Speedy loan approval & disbursal will help the industry immensely for which the rate of interest needs to be brought down to about five to six per cent P.A. GST registered MSME to get two per cent rebate for loan up to `1 Crore is an excellent decision. Interest subvention for preshipment for exports from three to five per cent will also help exporting units in SME sector. SME cash flow will get corrected to some extent to (TReDS). With launch of Ayushman, sourcing of pharma products by PSU sector from MSME will up to 25 per cent and will massively help matters. Women entrepreneurs in pharma industry will help them through by 3 per cent sourcing by govt. as mandatory. Govt. e-market place will get greatly expanded for SME’s through Ayushman. Although it is yet to be established as to how much SME in pharma industry will benefit from Rs. 6,000 Crores package for upgradation of MSME but it seems that MSEM sector in pharma will benefit significantly. Ease of doing business specifically for pharma company in India is a short in the arm very significantly but details of this scheme are yet awaited. Self certification of environment clearance, if implemented in letter & spirit, will be a great relief. Filing of one annual return instead of 8 state &

28 EXPRESS PHARMA December 16-31, 2018

PHARMA MSMEs: THE STORY SO FAR

he MSME sector is one of the major generators of employment and a significant contributor to the overall growth of the country’s economy. Dinesh Dua, Chairman, Pharmexcil throws more light on the current scenario of the sector and informs, “The MSME sector contributes `20 lakhs crores to Goods & Services, contributing to 40 per cent of GDP of India. Similarly, in India pharma industry about 60 per cent of the manufacturing is contributed by MSME’s within an annual turnover of approximately `60,000 crores or $9 billion which is an integral part of predominantly formulations and to an extent API industry more so for intermediates. The industry is extremely fragmented with approximately 24,000 units in MSME’s sector accounting for 70 per cent of production by volume and 50 per cent by value on ex factory basis. Pharma Exports of $ 20 billion and domestic is $18 billion. SMEs contribute to almost 90 per cent to domestic formulation and about 50 per cent to exports.” P Eshwar Reddy, Executive Director, BDMA also empasises that SMEs in India have a crucial role in creating employment, providing support services , and undertaking contract manufacturing for big units in their respective sectors and points out that major manufacturers of APIs are from small, medium and large units depending on products, technology, scale of operations and so on. But, they have been struggling for quite some time because of various reasons. Bhavin Mehta, Director, Kilitch Drugs (India) elaborates on some of them and says, “Major challenges faced by the SMEs are lack of proper industrial infrastructure, compliance with environmental laws, Regulatory stringencies. Besides financial constraints, the SME segment is also challenged to make its presence known amongst its global competitors. One big challenge faced by SMEs include the lack of awareness about regulatory compliance of various regions, stringent quality norms, ever changing technology in the drug making procedures, meeting international standards requirements.” Dua points out that pharma SMEs are currently are facing the same crises as overall SME sector post demonetisation & GST. Lack of financing options, particularly from PSBs and NBFCs, more so post RBI structures, has almost taken SME industry to a point of extinction and unless immediate and expedient measures are taken, 50 per cent of SMEs may not survive.” Vaidya also says, “SMEs contribute 35-40 per cent in terms of production, with a turnover of about `70,000 crores and above in the pharma sector. Despite such significant contribution to manufacturing output and about 40 per cent to exports, the SME sector in India has been allocated only 8 to 10 per cent of the total credit flow by the country’s banking and financial institutions leaving a large funding gap. Since the credit flow to SME sector is cumbersome, venture funds and NBFCs have used this opportunity by opting for innovating funding models and rating frameworks to lend to this sector.” Vaidya adds to this information and states, “There were more than 15,000 manufacturers but over a period of time and due to the repercussions of the implementation of Schedule M, the numbers has considerably diminished owing to non availability of capital to be infused into the operations. Now, there are around 7000 SMEs in India now and many of them have been started by pharmacy graduates. ”

10 central govt. for taxes labour will ease MSME productivity very significantly. He says, “In our considered opinion besides exports incentives like MAI and a lot of significant help to SME industry in particular facilitated through Pharmexcil, a part of Ministry of Commerce as also various schemes by DoP will help SME in pharma industry to do well besides 12 points of change by PM.

Steps to tap its true potential Thus the programme comes as a much needed respite for an

industry. This, in turn, will help the pharma sector leverage the innovative opportunities in the generics pharma market, both domestic and globally. Speaking on the opportunities, Dua says, “In spite of all constraints, there are several opportunities available in SME sector in pharma such as tax deduction to promote R&D upto 200 per cent of the investment. However, much more is needed to promote R&D on the lines of western countries, China, Japan, and Oceania. To name a few: cluster development programmes for effluent treatment plants (ETP),

tech upgradation and QMS; Credit link upgradation system should be vigorously pursued and offered to the industry.” But he is als optimistic about the sector’s future in times to come as there are some steps being taken to revive the growth in the sector. He points out that while the Prime Minister of India, Narendra Modi has recently rolled out an excellent package for SME which will also benefit pharma sector; several large companies are incentivising their Top and Senior Management to become entrepreneurs through captive consumption

thereby avoiding their capexes whilst helping ‘SME sector started by professionals’ to get credit through ‘Buy Back’ arrangements which is doing very well in Andhra and Telangana regions. But, a lot more needs to be done by top 100 pharma companies in India to leverage such entrepreneurial help. The Government of India has also initiated various necessary steps to support to SMEs, especially in building better infrastructure through various incentives and facilities. There is a steep increase in the cost of land, machinery and equipment and the project cost for upgradation works out to about `4 to 5 crores. Hence, Department of Pharmaceuticals has stepped in to support and recently announced the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) to provide interest subvention for soft loans of `4 crores at six per cent for GMP compliant, medium scale, bulk drug and formulation manufacturing facilities and extended it to SSIs. Another scheme introduced earlier for SSIs, called the Credit-Linked Capital Subsidy Scheme (CLCSS) for extending soft loans of `1 crore.

Effective implementation: Key to progress Thus, while there are efforts being taken to revive the growth in the sector. However, success would depend on their implementation. As Reddy says, “Conceptually, the schemes are good but the implementation is often not as per expectations. So. the government needs to focus and work on the proper implementation of the MSME programme and scheme launch from time to time for the upliftment of the sector, then only these programmes will be successful and sector will grow.” But, the sector is hopeful of a turnround in its fortunes. With the implementation of the recently announced scheme, it will take a quantum jump and add to the current 12 per cent P.A. CAGR growth of pharma in India. swati.rana@expressindia.com

CPHI & P-MEC INDIA 2018 SPECIAL

Evaluation And Optimization Of Coating Process Parameters For Instacoattm Sfc In Perforated Pan

he traditional Sugar Coating Process is a multistage with much skill dependency and is typically very time consuming. INSTACOAT™ SFC is the most advanced ready-to-use sugar coating formulation which can be sprayed and well suited for all types of coating equipment (Conventional, Perforated and Continuous). The aim of the present study was to evaluate and optimize the critical coating process parameters of INSTACOAT™ SFC in a perforated pan coater. Experimental Method Multivitamin Tablets were

used as the substrate for the sugar coating process. A 48 inch diameter perforated pan coater equipped with a spraytech, 1.5 mm nozzle was used for the coating process . InstacoatTMSFC was applied to the desired weight gain(approx. 68 per cent) over the seal coated multivitamin tablets at 25 per cent solids level. Instacoat Universal coating seal coat was applied to 3 per cent weight gain at an 11 per cent solids level. A final polishing coat of Instaglow formulation was applied. All the critical process parameters (Product Temperature, Spray Rate, Pan RPM, and Atomising

Air Pressure etc.) were studied and optimised. Coated tablets were evaluated for final appearance and DT. Results and Discussion The coating process parameters were well optimised in the 48’’ perforated pan coaterr (Table no. 1). Multivitamin tablets were successfully coated using InstacoatTM SFC and the coated tablets achieved very smooth finish in significantly less time as compared to manual conventional sugar coating. The coating process was completed without any process concerns and nil coating defects. The physical characteristics and dis-

integration time of the coated tablets were found to be well within the specifications. InstacoatTM SFC coated tablets showed excellent coating weight uniformity and glossy finish.

Conclusion The coating process results demonstrated that InstacoatTMSFC provided a well optimised coating process in a perforated pan. The InstacoatTMSFC based scientific coating process helped to achieve process time savings of approx.36 per cent when compared with the customers inhouse sugar coating process.

The coating finish was also more uniform. The reproducibility of the coating process was good and demonstrated on three consecutive batches. InstacoatTM SFC is the most advanced sugar coating formulation designed to simplify the sugar coating process, improve process efficiency and overall product quality. Trial Protocol designed by: Sanjay Negi/Sunil Jagdale Trials executed by: Sunil Jagdale Contact details Email: info@idealcures.co.in

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EXPRESS PHARMA

December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

Automation Fair 2018 links people, machines,data into a connected future Renewed commitment to its Connected Enterprise platform defined Rockwell Automation's 27th Automation Fair held in Philadelphia recently. India is the second most important growth market for the company in the APAC region. Most of the growth could come from pharma firms striving to digitise and secure their data to avoid data integrity concerns, reports Viveka Roychowdhury

he recently concluded 27 th Automation Fair (AF) set the stage for Rockwell Automation (RA) to unveil its new look and brand promise: Expanding Human Possibility. As Blake Moret, Chairman and CEO, RA put it, itâ€™s about â€œturning data into insights that unlock productivity. The new Rockwell Automation brand emphasises the central role that people play in advanced manu-

EXPRESS PHARMA

December 16-31, 2018

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Enabling the adaptive machine. Like no other transport system.

CPHI & P-MEC INDIA 2018 SPECIAL

facturing and underscores our focus on ways we maximise performance, advance innovation and drive growth.” A good example of such a solution was the launch of FactoryTalk InnovationSuite, the first offering integrating technologies from RA and PTC since their strategic partnership this June, when the former made a $1 billion equity investment in the latter for a 8.4 per cent stake. The new suite delivers complete visibility of operations and systems status from one source of information inside the organisation. (See release: http://www.expressbpd.com/pha rma/latest-updates/rockwellautomation-and-ptc-collaborate/407129/) The software suite which enables companies to optimise their operations and enhance productivity by providing decision makers with improved data and insights, has immense applications in the life sciences sector, one of the five focus sectors of RA. The Connected Enterprise Industries Pavilion had a life sciences section, demonstrating how RA solutions combined with other technologies (like the GE Healthcare –Xcellerex XDR bioreactor featured in the booth) allow life sciences organisations to use knowledge-driven operations to improve speed to market, increase visibility into production and better monitor regulatory compliance. The three day AF, spread over 50 exhibits, hands-on labs and technical sessions also had booths that spotlighted themes like the connected enterprise, smart devices, smart systems, safety and security, data analytics and augmented reality. In addition, there were breakaway sessions on topics like fostering leadership through STEM, as well as sector specific forums designed as a meeting place for RA personnel, their partner network companies a well as current and prospective customers. As in previous editions, clients, vendors, distributors

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Blake Moret, Chairman & CEO, Rockwell Automation gives the keynote at Automation Perspectives, kick-starting the 27th Automation Fair in Philadelphia

ber 7, the Asia Pacific region clocked a 9.7 per cent organic growth in the quarter, with China up double digits. In line with these stats, India is the second most important growth market after China in the APAC region, according to Moret. Company executives indicated that biopharma is the fastest growing segment within life sciences but this is admittedly on a much smaller base than RA's other focus areas like oil and gas, so its easier to grow double digits,. But as Joe Sousa, President, Asia Pacific, Rockwell Automation pointed out the growth is also because of the changing dynamics of the

Automation Fair Hands-On Labs, where fair attendees get firsthand experience with Rockwell Automation products during 90 minute handson labs

The three day AF, spread over 50 exhibits,had hands-on labs and technical sessions

and RA personnel trooped in for deep dives into the latest technologies and solutions from RA and its partner network, all geared towards deepening RA's commitment to the connected enterprise using data analytics and augmented reality.

Asia Pacific strategy The Asia Pacific region is clearly a growth driver for the Fortune 500 company which

reported fiscal year 2017 global sales at $6.3 billion. For the 12-month period ending September 2018, the Asia Pacific region had a sales growth of 7.7 per cent, just marginally second to the EMEA region (7.8 per cent). Within the Asia Pacific region, China is the biggest market for RA, followed by India. According to the company's Q4 results for fiscal year 2018 released on Novem-

industry. For e.g., single dose manufacturing has a higher automation intensity and the packaging, which is an area that RA participates heavily in. As facilities are being upgraded or new greenfield facilities are being built, the environmental controls are a strong area for RA. Company officials also revealed that pharma companies are consulting RA beyond the traditional blending and packaging of pharma products, and looking for creating a safe, secure and consistent environment. For instance, pharma companies are approaching RA for their cyber security assessments, to help them refine the cyber security plans. Spelling out the role of India, John Watts, Regional Marketing Director, Asia Pacific at Rockwell said, “In the Asia Pacific region, after China,

India represents the greatest growth potential for RA as a region.” While India was primarily a sales office for RA, the country also contributed to a couple of global functions like a remote engineering centre and a global engineering centre. Approximately 300 engineers across the Noida and Pune sites, support global project execution, with another 200 engineers in the design centre in Bangalore, a part of a network of global design centres, who are involved in new product design, product certification, product life cycle redesign, etc. The AF did feature a few examples of life sciences companies from India who have deployed automation solutions from RA. For e.g., Piyush Rao, Deputy General Manager, Process Engineering, Fresenius Kabi Oncology made a presentation as part of RA's Process Solutions User Group meetings held prior to AF. He spoke how his facility implemented a PlantPAx DCS to reduce manual intervention and provide a scalable platform for future expansion and automation. Once in place, they found that not only did it help them meet initial goals, it also helped them improve reliability, safety and quality, and delivered the benefits of centralised control of automated equipment. Similarly, during the Life Sciences Forum, Mumbaibased Manish Kumar Singh, Associate Director – Regional Automation (Asia Pacific Consumer Supply Chain), Consumer Products Division, Johnson & Johnson, spoke on shop floor digitisation using an advanced batch system during the life sciences forum at AF. He pointed out how RA's solution allowed J&J to make the shop floor more millennial friendly, while meeting business objectives of reducing batch sizes of consumer products. While life sciences companies in India are at various stages of the learning curve as far as automation is concerned, Chandramouli KL, ManagerTechnology and Strategic

CPHI & P-MEC INDIA 2018 SPECIAL

Alliance at Rockwell Automation India sees increasing interest. According to him, with data integrity becoming an issue with various global regulators, more pharma companies in India have started investments in automation and connected enterprise systems in the recent past, to address these challenges. Contrasting the life sciences sector to the other four focus areas of RA, Watts commented that life sciences in general is ahead of industries as it is a very regulated sector. â€œ(Life sciences companies in) India are ramping up very fast because they have to meet the

Pharma firms are consulting RA beyond traditional blending and packaging of pharma products, and looking to create a safe, secure and consistent environment regulatory requirements (of various regulators). They realised now that the way to do that is to digitalise and get control of your data. All these companies want to be global brands. If you want to sell globally, you have to have uniform quality and production standards. If the company has a global regulator coming to the plant, and they don't understand the system, the company could end up spending a lot of time and money getting it approved. So it is in the company's best interests to use proven systems because a) you spend much less money getting

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approval and b) you still drive up productivity and efficiency as you deploy.â€? Illustrating the comprehensive nature of RA's solutions, Chandramouli pointed out that RA's serialisation and track and trace solutions are de-

signed to support a company's export requirements across countries, making it easy to export to multiple countries with differing serialisation regulations. While company officials could not share the percentage growth they are

expecting specifically from the life sciences sector in India, Watts said that with all the focus industries, they want to grow at least one or two times more than the market. Company executives spoke of plans to hire another 150 engineers

over the next five years at the Bangalore design centre, taking the total strength to 350, a clear sign that RA would like to see more aggressive growth from the country. viveka.r@expressindia.com

CPhI & P-MEC INDIA 2018 SPECIAL

I N T E R V I E W

In the near future we plan to expand by signing with more players in the pharma sector Most pharma products come with a limited shelf-life as they are environment sensitive. Shadowfax, crowd sources delivery platform, is using technology to provide a solution for this challenge with 45 minutes hyper local deliveries, same day heavy shipment deliveries and express logistics pan-India. Abhishek Bansal, Co-Founder & CEO, Shadowfax share more details about his company with Usha Sharma Tell us about Shadowfax and its ongoing activities. Shadowfax is India's largest crowd sources delivery platform. Using our advanced state of the art technology we are completely disrupting the way businesses look at logistics and supply chain. We've three prime offerings right now, namely - NOW, INSTA & CONNECT wherein we enable businesses to carry out 45 min hyper local deliveries, same day heavy shipment deliveries and express logistics pan-India respectively. How do you partner with online and offline pharmacy stores and what are the regulatory requirements you adhere to before joining hands with them? We partner with many online and offline pharmacies and help them in movement of goods from the wholesaler to retailer and also the last mile to the end consumer. In terms of regulatory requirements we partner with these pharmacies and procure the necessary approvals wherever

34 EXPRESS PHARMA December 16-31, 2018

required. Is the less than 90-minutes delivery also happening in the medicine segment? Yes, it is pretty much happening and growing at a rapid pace. With penetration of internet and shift in consumer behaviour, we've observed that this segment is one of the fastest growing ones and also helps brands immensely increase the

customer delight quotient and thus increase their popularity. What is your opinion on the role of IOT in the pharma industry? What role will it play in bridging the gap between manufacturers and suppliers and removing the inefficiencies across the supply chain? Most pharma products come with a limited shelf-life in a

controlled environment. The environment sensitive products, especially those susceptible to temperature variations and sunlight exposures, may degenerate immediately with fluctuations in the environment. The IOT helps in tracing the environmental benchmarks at all times and making a real time info regarding packages / shipments / lots available to

CPhI & P-MEC INDIA 2018 SPECIAL

the manufacturers and suppliers. This helps in maximising controls, reducing costs and minimising damages. The IOT of course covers the logistics issues of determining the real time location of package / shipment, estimated delivery time and lags if any, thereby improving the tractability and trace-ability of the package. What are the challanges faced with implementation of IOT in the pharma supply chain and how is it dealt with? Like other sectors, the first challenge is to get the pharma supply chain to adopt IOT. With changing

We aren't worried much about the competition and firmly believe that the markets will always choose the best solution

the best solution. What is your market presence in India for the pharma sector and how do you plan to expand it? Shadowfax has made its presence felt in the delivery

sector in the pharma industry as we deliver for a number of major players in the industry. We use LCV and bikes to ensure safe and on time delivery of the products. In the near future we plan to expand by signing with more

players in the pharma sector. Tell us the company's business strategies for next three to five years? We as a company plan to invest strongly in technology and cost optimisation

solutions which we are rolling out to our business partners, thereby giving them a never seen before level of transparency, convenience and trust. u.sharma@expressindia.com

CSIR-Indian Institute of Chemical Technology (Under Ministry of Science & Technology, Govt. of India) Tarnaka, Uppal Road, Hyderabad â€“ 500007, Telangana, INDIA CSIR-Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad, a constituent laboratory of Council of Scientific & Industrial Research (CSIR) is a leading research Institute in the area of chemical sciences. The core strength of institute lies in Organic Chemistry, and it continues to excel in this field for over seven decades. The institute is proud in celebrating its Platinum Jubliee, in the year 2018. The R&D efforts during these years have resulted in the development of several innovative processes for a variety of products necessary for human welfare such as drugs, agrochemicals, food and drugs, APIs and intermediates, organic coatings, polymers, catalysis, adhesives, fluorine products, renewable & nonrenewable energy and many more. More than 150 technologies developed by CSIR-IICT are now in commercial production. One of the main strengths of CSIRIICT is its rich pool of scientists and research scholars numbering over 700 which creates the right ambience for generating knowledge and translational research for industry and society. This institute has active collaborations with several countries including France, Germany, UK, Switzerland, Italy, USA, Australia, Japan, Korea etc., and several students have been benefitted from various exchange visits and postdoctoral programmes.

mindsets, awareness building and a positive costbenefit analysis the hesitations can be tackled. The other challenge is to train people on the use of a new technology but that can be easily tackled with training and continuous usage. In the Indian market whom do you deem as comeptiotrs and how do you deal with them in a healthy manner? We tend to focus on the first principle and build our solutions from the bottom. We aren't worried much about the competition and firmly believe that the markets will always choose

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CSIR-IICT provides knowledge based services for physio, chemical and thermal characterisation of heterogeneous and homogeneous catalysis, custom synthesis, molecular modelling for drug design, combinatorial libraries, drug master files, chemical finger printing, invitro & invivo entomological/toxicological/pharmacological screening of bioactive molecules, basic/design engineering packages for pilot plant and commercial plant for upscaling processes, process simulation, optimisation, control, process safety and reaction engineering. It has state of art facilities like National Molbank, HTS for chemical library generation & screening, LC-MS, NMR (upto 700 MHz), Laser Raman, Ultrafast Laser spectroscopy, Fluorescence correlation spectroscopy, Automated synthesizer, XRD, SEM, TEM, AFM, ESCA, etc. CSIR- IICT encourages Public Private Partnership to undertake Innovative research by providing expertise and infrastructure.

Contact details: Director CSIR-Indian Institute of Chemical Technology Tarnaka, Hyderabad â€“ 500 007, Telangana, INDIA Telephone: +91-40-2719-3030 : Fax: +91-40-2719-0387 Email: director@iict.res.in Website: www.iictindia.org

An Institute with Industrial Outlook and Academic Ambiance

CPhI & P-MEC INDIA 2018 SPECIAL

SCHOTTGlass: Aiming high With the increasing demand for glass tubing, SCHOTT Glass India is investing in a new unit at its existing manufacturing site at Jambusar, Gujarat. Besides, the company also aims to expand its presence in China. Thus it is on an accelerated growth path. By Usha Sharma Partnering progress

ver the years, there is a growing role and significance of the Indian pharmaceutical industry in the global pharma markets. Similarly, we have also seen several global players investing or partnering with Indian firms, as a result of the ruling government’s industry-friendly policies. One such instance is of German-origin glass tubing manufacturing specialist company Schott’s investment of approximately ` 180 crore through its Indian subsidiary SCHOTT Glass India to set up a new pharma tubing tank facility at its existing manufacturing site in Jambusar district, Gujarat. The Jambusar plant currently is a production hub for SCHOTT pharma tubing for Asia, and through its 100 per cent subsidiary in India, has one manufacturing site in Jambusar, and sales offices in Mumbai and Pune. Construction of the new facility is ongoing and it is expected to commence commercial production by early 2020. However, the company has been present in India for around two decades and it started its business operations in 1998 by acquiring a company producing pharma tubing in Jambusar. Recalling the initial days with the company 20 years ago, Dr Patrick Markschlaeger, Executive Vice President, SCHOTT, Business Unit Tubing highlights, “We started our journey in India by bringing in our best technologies to turn the existing site into a worldclass manufacturing site. For us, there couldn’t have been a better place than Gujarat in terms of work atmosphere, infrastructure and access to raw materials, including energy.” Since then, it has grown from strength to strength and the new facility in Jambusar is the

36 EXPRESS PHARMA December 16-31, 2018

Dr Patrick Markschlaeger, Executive Vice President, SCHOTT, Business Unit Tubing

most recent feather in its cap.

Government impetus It also explains why they chose to set up their new manufacturing facility as well at Jambusar. Markschlaeger says, “The state government has been very supportive of the pharma industry in Gujarat, which is evident from the growth of the sector in the state.” He further elaborates, “With the introduction of the Goods and Services Tax (GST) last year, things have become more streamlined, and Gujarat has become even more lucrative as a manufacturing hub. In fact, according to the Indian Drug Manufacturers’ Association (IDMA), Gujarat contributes to around 33 per cent of the national pharma production, and

this share is expected to move up to 40 per cent by 2020. We feel encouraged by the current Indian government’s ‘Make in India’ and ‘Vibrant Gujarat’ initiatives that are supporting companies like ours to strive for better infrastructure and ease of doing business.”

The company’s recent business expansion plans also support the government’s ‘Make in India’ campaign and ‘Vibrant Gujarat’ initiatives, as the company's new facility will generate more investment and employment in the state. Markschlaeger informs, “We currently have around 350 employees and 100 contract workers working at the plant in Jambusar. The new tank will provide jobs for at least 70 additional local workers.” Moreover, the upcoming facility will play a key role in the company’s plans to tap the Asian markets. The company is very gung ho on growth as it believes that there are tremendous opportunities for growth in this segment and industry reports confirm this fact. As per a market research report by Grand View Research, the global pharma glass packaging market size was estimated at $12.84 billion in 2016. It is projected to witness a CAGR of 6.3 per cent from 2017 to 2025 and India is one of the key markets for pharma glass packaging markets in Asia. These numbers reveal that there is a huge requirement for the glass tubing in the pharma sector, and Schott Tubing has a major role in meeting these requirements. Markschlaeger informs, “In general, SCHOTT Tubing has a significant market share in the global pharma tubing sector, in which India has a vital role to play.” The company’s presence of nearly two decades in India has established it as a trusted partner for major pharma companies and helped it grow despite the entry of other solutions. But, how do they plan to continue being a leader in this space? So, which are the prod-

ucts and solutions that provide the company with a competitive edge over its peers and how are they right to meet the constantly evolving demands of the pharma industry?

An eclectic product portfolio For ages, the Indian pharma packaging market was dominated by the glass packaging, which has also witnessed considerable competition from plastic manufacturers over the years. So, how has SCHOTT ensured that its clientele continues to prefer their glass solutions? Why should they choose glass packaging over plastic solutions? Markschlaeger answers these questions and says, “An unmatched combination of our high-quality production standards, truly global footprint and technological expertise has established SCHOTT as a market leader, globally as well as in India.” He further elaborates on a few of their renowned and widely-used products, “When it comes to choosing a suitable primary packaging for drugs, pharma companies have relied on FIOLAX pharma containers for over 100 years. This type I borosilicate glass features high hydrolytic resistance, hence preserving the efficacy of medicine and reducing the risk of a potential drug/container interaction. It is because of its specifications that borosilicate glass is used to package a number of drugs including highly sensitive drug formulations.” Thus, its existing products and their quality have continued to keep their clientele happy and content. Moreover, it has adopted newer technologies from Germany to meet the growing demands of the Indian market.

CPhI & P-MEC INDIA 2018 SPECIAL

Markschlaeger points out, “India serves as an ideal example for Industry 4.0 - the current trend of automation and data exchange in manufacturing technologies. The Indian plant showcases main elements of a ‘smart factory’ through path-

SCHOTT has captured significant market presence in India, and with its recent ` 180 crore investment at Jambusar, it intends to increase it production capacity by 50 per cent breaking technologies like- perfeXion. For example, last year, SCHOTT implemented perfeXion in Jambusar — the new era of quality processing to achieve exceptional quality control standards for its FIOLAX pharma glass tubing. perfeXion uses state-of-the-art cameras and lasers to pinpoint potential defects along the production line. By harnessing big data, we have moved from a statistical sample-based quality-control process to 100 per cent inspection of each FIOLAX tube.” SCHOTT’s pharma packaging experts also see a few trends in the primary packaging industry itself. For example, an increase in formulations with sensitive and complex molecule structures, e.g. biotech drugs, which require innovative packaging solutions to ensure drug stability. Another trend shaping the industry is the move from hospital to home care to enable patients to self-

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administer the drugs in an environment they feel most comfortable in. Such patterns require the containers and subsequently the tubing to have highly accurate dimensions, especially regarding the inside diameter. We achieve this

through perfeXion, which allowed us to step into a new era of quality processing.”

Growth strategies for India With these products, the company has captured significant

market presence in India, and with its recent ` 180 crore investment at Jambusar, it intends to increase it production capacity by 50 per cent. The increased capacity will not only cater to the increasing domestic demands but also to the

need for high-quality pharma glass tubing in other Asian markets. Markschlaeger explains about the features of the new facility and its advantages, “With an additional tank facility, SCHOTT will also build new

CPhI & P-MEC INDIA 2018 SPECIAL

construction for energy supply, workshops and warehouse. Additionally, there will be an expansion of storage for energy, engineering and logistics infrastructure within the plant. With our production capacity set to increase by another 50 per cent through the new plant, we look forward to the coming years for catering to the industry’s increasing requirements (both domestic and international) for quality pharma packaging glass material. As part of the production network within SCHOTT’s Tubing business unit, the new tank will be built and equipped with all latest state-of-the-art machinery as used in all other tubing factories worldwide.” However, glass manufacturing is a process which requires continuous power supply. And hence the design of its new facility also has a provision for solar power generation to meet its requirements and complement electric power supply. Commenting on the company’s investments on solar power panels, Markschlaeger says, “It involves heavy investment but the state government is encouraging companies to do so and it will add value to our facility as well. It will help us in fulfilling the customers need without any interruption.” Summing up the company’s expansion plans for the Indian market by this year end, he says, “For pharma tube production, the Jambusar plant is considered as a manufacturing hub for its demands in the fastgrowing Asian markets. This is a big advantage for our India activities in terms of investment, lead time and availability of a trained workforce.”

Going forward While it is fortifying its presence and foothold in the Indian market, SCHOTT has also signed an investment agreement to build a production site in China to further meet local needs there. Thus, the company has an ambitious growth plan in place, and is on an accelerated path to progress. u.sharma@expressindia.com

38 EXPRESS PHARMA December 16-31, 2018

How perfeXion & FIOLAX really work?

ERFEXION, process control and integrated data management system works as an integrated network for real-time collection and evaluation of the data. More than 100,000 data tags per minute are collected in this system.All this generates valuable data for controlling and stabilising the tubing production process.Talking more about the features of perfeXion, Markschlaeger says,“We now offer an improved product with superior auditability and traceability for the pharma industry.This also allows us to customise the specification of the glass tubing according to specific needs of the container format. perfeXion uses state-of-the-art cameras and lasers to pinpoint potential defects along the production line. SCHOTT also offers pharma glass tubing products and services to its regional and international customers. Its main product, FIOLAX borosilicate glass tubing, has grown to become the gold standard ‘raw material’for glass containers in the global pharma industry. Revealing more about the concept of FIOLAX tubing, he highlights,“Our main product, FIOLAX borosilicate glass tubing, has grown since 1911 to become the gold standard ‘raw material' for glass containers in the global pharma industry. Known for unmatched quality, our packaging material is the first preference for most of India's leading pharma companies.Thanks to its high hydrolytic resistance, FIOLAX neutral glass tubing preserves the efficacy of medicine and reduces the risk of interaction with packaging to a minimum.” FIOLAX is used to manufacture high-quality vials, syringes, ampoules and cartridges, which are then filled with injectable drugs.

CPHI & P-MEC INDIA 2018 SPECIAL

I N T E R V I E W

â€œWe plan to set up our first international manufacturing facility in USâ€? Ideal Cures, mumbai-based manufacturer and exporter of pharma excipients and coating solutions has grown from strength to strength since its inception. It is now fortifying its global presence by setting up its first international manufacturing facility in the US. Suresh Pareek, Managing Director, Ideal Cures divulges the company's growth plans with Usha Sharma The industry is looking for tailor-made solutions and products, so how do you handle such requirements? Outsourcing is here to stay. Various branches of the industry have asked for outsourcing or tailor made solutions which led to establishment of BPO, call centers, property management services, house-keeping, and maintenance services. The reason for this is that it allows the company to maintain its competitiveness by focusing on their core business and outsource certain operations

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CPHI & P-MEC INDIA 2018 SPECIAL

launched Instacoat QD and Instacoat T2F, what have been the industry responses to these products? We launched two new products at the 2nd FDD Conclave held in June 2018, at Hyderabad and the response for both the products at the conclave itself was overwhelming. More than hundred customers have shown interest for both these products and are interacting and working on solutions that these products will provide. INSTACOAT QD is quick disintegrating films which release contents of the tablet in 15-20 secs. The products are designed to provide a remarkable reduction in coating time and energy. INSTACOAT T2f is another product specifically designed to meet

the restrictions in regulated markets. These products are completely free of talc and TiO 2 and have already started receiving good response from customers in Europe and Americas.

that are complex to handle. As the pharma industry grew it also looked at outsourcing certain operations so that they could focus on their core strength of manufacturing and R&D and also look at more complex formulations. In this process, pharma industry always looks for small scale and medium scale enterprises to provide them with tailor made solutions. We at Ideal Cures,

40 EXPRESS PHARMA December 16-31, 2018

decided to provide specialised solutions in excipients by focusing on products relating to film coating and drug delivery. We provide these solutions by constantly communicating with the industry professionals at various levels, through various industry forums and round table discussions. Our approach has always been to be able to add value by offering to be a dependable solution provider to

the industry. We provide products which save time that are environment friendly and cost efficient. Best example of this is our product INSTACOAT 4g where we provided high productivity coatings products which saved 50-60 percent time and energy thereby reducing carbon emissions. Recently, the company has

What all products you offer to the Indian as well as international market? We offer wide INSTACOAT range of film coating materials for both Indian and international market including immediate release coatings, quick dissolving coatings INSTACOAT QD, moisture barrier coatings, high productivity coatings, enteric coatings for target delivery and easy solubility, neutral spheres for drug delivery -ESPHERES, cooling compounds for taste masking and enhancing palatability- ECOCOOL, sugar

coatings- INSTACOAT SFC, polymers â€“ECOPOL , flavored, natural color coatings, and Coatings free of Talc and TiO2 of INSTACOAT T2f. The company has established its presence in the Indian market, how do you plan to expand your international business? Ideal Cures has had a decade of continuous expansion right from our first office in Milan, Italy in 2009, followed by an application lab in Turkey and Israel in 2013, office in Barcelona, Spain in 2015, and then US in 2016. Simultaneously, we have also expanded our list of agents and distributors in over 30 countries. And now Ideal Cures plans to set up its first international manufacturing facility in US - All these years we have serviced our clients through manufacturing facilities in India. We have not done any manufacturing outside India. The primary reason of opening of the US office two years back was to eventually set up a manufacturing facility. We have been actively looking for a good manufacturing location in the US and have now zeroed on the eastern coast to set up our first international manufacturing facility. We are excited. We have estimated a $7.5.million investment and expect the facility to go on commercial manufacturing in April 2020. We are also is in the process of expanding our office by recruiting more people in the US. Our main focus for the US facility would be to serve our existing customers in US, target new customers and offer them value added services and support them in their endeavor to increase production and reduce cost. Did the industry get the clear definition of novel inactive ingredients excipients from the US FDA? Novel excipient can be a material which has not been used till date for the products meant for human consumption and for this purpose the

CPHI & P-MEC INDIA 2018 SPECIAL

guidelines for clinical, safety and toxicity are available from FDA. Another way of novelty is to present a formulation using approved excipients, where the IID limits of the components can be considered for support. Yes, the clarity prevails for the Novel inactive ingredients as per US FDA norms. Though it looks like a NCE if the novel inactive ingredient needs to be approved due to complexities and detail study involved. USP-NF Excipient Biological Safety Evaluation Guidelines <1074> provides guidance on conducting a safety assessment of a novel excipient. In the US, the FDA has also issued guidance on non-clinical studies for new excipients. Tell us about the complexities and challenges associated with the US FDA Inactive Ingredient Database (IID) I personally feel the guidance from IID data is helpful to select and quantify the materials in our formulations. However, there is some complexity, if the formulator is also using the same components in the product then the control on the quantity may not be possible and a conflict may arise. Additionally the database gives multiple products with varying quantities of the same ingredients and the value may vary many folds (from 2 to 200 mg). In a situation like this, it may be prudent to specify the maximum permissible usage for different routes in the quarterly updates. Why IPEC disagrees with the FDA's claim on the use of excipients that does not have precedence in the same route of delivery should always be viewed as high risk and subject to ANDA refusal? US FDA considers the novel excipients as good as a NCE, a very elaborate and costly study programme is defined to be carried out. The material gets the entry into IIG database depending upon its use in a product as ANDA. There have been moves by IPEC and independent US agencies to

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evolve the wayout, whereas the FDA adopts ICH standards and guidelines for the detailed studies. Partly the high risk part as envisaged by US FDA looks logical if the route of delivery is different especially parenteral and nasal routes.

Give us a brief update on the company's corporate plans for next financial year Ideal Cures has always taken an initiative to cater to formulatorsâ€™ specific needs whether it is related to film coating or specialty excipients.

Next financial year will mostly be devoted to setup of the manufacturing unit in US and also in development of new products which will meet the requirement of the US market for pharma, nutra and OTC products. This we will achieve

by working closely with the R&D companies in US. Another focus of the company will be to provide faster product deliveries to the customers in North-East India through our Sikkim plant. u.sharma@expressindia.com

CPHI & P-MEC INDIA 2018 SPECIAL

Development and optimisation Of Ti02 free Instanute formulations T

itanium dioxide (TiO2) is the most widely used white pigment in pharmaceutical/nutraceutical coating formulations. It has high brightness and a very high refractive index. Apart from producing a white colour in liquids, paste or as coatings on solids, TiO2 is also an effective opacifier. High Opacity is a fundamental requirement of most pharma coating systems. However there has been recent suggestions that titanium dioxide (TiO2) is a potential carcinogen. Hence many pharmaceutical companies are now avoiding use of titanium dioxide in their pharma and nutra products. Alternative opacifiers which are non-toxic, economical and safe for consumption are available. The aim of the study was to develop an optimised Instanute IR ready-mix formulation containing alternative opacifiers to titanium dioxide.

Table No.3. Opacity Data

Suresh Pareek

Sanjay Negi

Sr.NO.

Formulation

Opacity Value

Instanute IR containing TiO2

97.28

Trial- I

85.55

Trial- II

93.64

calcium carbonate (15 per cent and 25 per cent), were used. Coating suspensions were

Experimental method A series of Instanute IR ready formulated coating systems using alternative opacifiers to Ti02 were used in this study in which DM water was used for coating suspension preparation. An experimental plan was constructed concentration of

Figure 1 (Coated Tablets)

Table No. 1. Core Tablets and Coating Formulation Details

Table No. 2. Coating Process Parameters

A) Placebo Tablet Details

Sr. No. Parameter

Trial - I

Trial - II

Coater Type

Conventional

Pan size(cm)

Lot Size (g)

754

Inlet Temp. (Â°C)

Product Bed Temp. (Â°C)

40-42

40 to 43

Spray rate (g/min)

0.4 to 0.5

Placebo Tablet dimensions

12 mm round Biconvex tablets, plain on both sides.

B) Coating Formulation Details Product Name

INSTANUTE IR Trial I

Color

White

Solids Level (%w/w)

42 EXPRESS PHARMA December 16-31, 2018

Trial II

prepared at 15 per cent solids content. Viscosities of suspensions were measured using a Brookfield viscometer. Coating trials were executed in a conventional coating pan using yellow core tablets at five per cent weight gain. The critical coating process parameters i.e. product bed temperature, spray rate, pan speed and per cent weight gain were optimised. Instanute IR film coating opacity was determined by measuring the contrast ratio of the coatings on opacity charts using a Datacolor 500 reflectance spectrophotometer. Result and Discussion: Instanute IR film coating opacity was determined by measurement of the the ratio of coatings on black and white backgrounds using a Data color 500 reflectance spectrophotometer and found to be adequate compared to the film containing Titanium dioxide. The opacity of modified Instanute IR coatings was assessed and found to be satisfactory. These new Instanute IR formulations provide a good alternative to typical titanium dioxide based coatings for pharma and nutra products exhibiting good hiding properties. Trial Protocol designed by: Sanjay Negi/Rupali Bhadale/Vaishali Jamnik Trials executed by: Rupali Bhadale/Vaishali Jamnik Contact details Email: info@idealcures.co.in

CPHI & P-MEC INDIA 2018 SPECIAL

DuPont hosts 'Health by Design' Symposium in Mumbai,Hyderabad Industry experts gave insights on what they expect from excipient manufacturers By Usha Sharma

uPont organised ‘Health by Design' symposium in Mumbai and Hyderabad, with the aim of updating the pharma industry about the latest trends and innovations in drug delivery development and enhance productivity. The event connected industry experts from different stages of development to discuss pressing topics such as selection of the right technology partner, how to transform

current drug development processes and more. Chief Guest Shirish Dabhade, retired Assistant Commissioner, Maharashtra FDA, kicked off the day by tapping into his more than 21 years' experience, reflecting on the time in the late 80s and 90s when time-consuming and laborious manual and semi-manual tableting techniques were used. He highlighted the role of advanced technologies and increasing

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dependency on artificial intelligence (AI) in pushing current pharma boundaries, emphasising the necessity of having a skilled staff to optimise the use of new technology. He also briefly touched on more recent innovations, like derma patches and microneedle patches, pointing out how such innovations are improving healthcare in India by offering patient-centric dosage forms that are virtually pain-free, improve com-

pliance and effectiveness of medication. Two of DuPont Nutrition & Health’s top executives in the South Asia region – Prashant Chitgopekar, Deputy General Manager, and Sangesh Torne, Application Development Manager—presented on discovering new possibilities to improve productivity and differentiation in the marketplace. Chitgopekar discussed the challenges faced by generic-pro-

ducing companies and how they have impacted their bottom line, including lower sales growth, lower profitability and value proposition challenges. To help offset the decreasing return on high investments in R&D, he suggested ways by which companies could increase returns on innovation. He challenged attendees to focus on three specific avenues—continuous manufacturing, productivity and differentiation – to ex-

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CPHI & P-MEC INDIA 2018 SPECIAL

pand their footprint both globally and domestically by stretching the pharma product lifecycle to overcome current market challenges. Taking over from Chitgopekar, Torne emphasised the need to increase productivity by utilising the functionality of a continuous manufacturing process. He focused on the benefits of a continuous process, including fewer process steps, less time and improved process robustness, as well as shared insights on methods to help minimise the pains of switching to the process. While highlighting the advantages of process innovations like Moisture Activated Dry Granulation (MADG) in the wet granulation process, he explained how various excipients in the combined DuPont + Dow+ FMC portfolio could reduce the number of steps and time taken in the production cycle, thus helping companies transition from batch to continuous manufacturing. These products are designed with solubility and controlled release methods for wet granulation process in mind. Up next, Gopeshkumar Singh, Application Development Manager, South Asia, DuPont Nutrition and Health, shared techniques to help formulators solve bioavailability challenges. Briefing about the challenges faced by the industry in hydroxypropyl methylcellulose (HPMC) process, he discussed novel excipients in DuPontâ€™s portfolio for bioavailability, immediate release and controlled release purposes to help increase the solubility of APIs, simplify processes and improve patient compliance. Singh emphasised the rising demand for novel excipients and explained that this demand could be met by tailormade HPMC. Tejas Gunjikar, Application Development Leader, South Asia, DuPont Nutrition and Health, started his presentation by asking the audience to list the challenges they face during regulatory

44 EXPRESS PHARMA December 16-31, 2018

Panelists at Mumbai (from L-R): Raviraj Pillai, Senior Director and Site Head, Pharmaceutical Development, Abbott, Pramod Kharwade, General Manager, Formulations, Glenmark, Viveka Roychowdhury, Editor, Express Pharma, Preeti Raut, Vice President, Formulation Development, Cipla, Savindu Kudrigikar, Business Head, South Asia, DuPont Nutrition and Health, Sandhya Shenoy, Associate Vice President, R&D, FDC, Sanjay Sharma, Head Technology Transfer, Lupin

Panelists at Hyderabad (from L-R): Dr Venkata Ramana Reddy S, AGM - R&D, Formulations, Suven Life Sciences, Seshnath Chauhan, Director - Global Sourcing (SCM), DRL, Viveka Roychowdhury, Editor, Express Pharma, Dr Rajeev Singh Raghuvanshi, Senior Vice President & Head, BRaIN, IPDO, DRL, Dr Pavan Bhat, Executive Vice President,Technical Operations - R&D, Natco Pharma and Savindu Kudrigikar, Business Head, South Asia, DuPont Nutrition and Health

Shirish Dabhade, retired Assistant Commissioner, Maharashtra FDA was the Chief Guest at the Mumbai edition

filling. A common pain point that emerged was the need for bridging documents, and the fact that the Inactive Ingredients Database (IID) changes every three months. He shared tips on navigating ingredient database challenges for successful filling, including insights into US FDA's expectations from pharma companies before ANDA filing and approval. Concluding his presentation, he mentioned how DuPont is able to assist client pharma companies in preparing bridging documents, and urged attendees to provide not just the data, but the justification and context of use of a particular excipient as well. Besides these scientific, power packed sessions, the audience also had a lot to gain from the panel discussion, moderated by Viveka Roychowdhury, Editor, Express Pharma and Express Healthcare. Among the topics discussed were industry trends, technology and process innovations that provide speed to market and flexibility in oral solid dosage formulation. The panel comprised Pramod Kharwade, General Manager, Formulations, Glenmark; Preeti Raut, Vice President, Formulation Development, Cipla; Raviraj Pillai, Senior Director and Site Head, Pharmaceutical Development, Abbott; Sandhya Shenoy, Associate Vice President, R&D, FDC; and Sanjay Sharma, Head Technology Transfer, Lupin. Explaining the dynamics of the business, Sharma shared that on certain occasions the business scenario changes over the years from its initial development process to its last mile. As cost plays a key role in the decision making process, choosing the right excipients at the right time becomes crucial. Concurring with this view, Shenoy said that companies tend to resist change, whether it be new technologies or novel excipients, as they become worried about

CPHI & P-MEC INDIA 2018 SPECIAL

how these changes would impact regulatory compliance. She explained how choosing the right partner is a key decision to be taken at the early stages of product development to ensure smooth formulation processes that adhere to regulatory standards. She also suggested that vendors or excipients manufacturers should get their novel developments approved and validated by regulators before launching them. This would increase uptake of these technologies as the industry would then be assured that the new technologies are compliant with norms. She also stated that lack of evidence by vendors has created a hurdle in the process of continuous manufacturing and gave an example of how her company had to modify one of its products to conform to IP, thoughthe initial product was USP complaint and more effective. In the same vein, Raut noted how pharma companies historically take longer to understand newer technologies and suggested that whenever such developments happen, vendors or excipient manufacturers should provide an update to pharma companies. Kharwade pointed out that pharma companies would not see value in making huge investments in novel technology unless they had a basket of products that could benefit from this investment. Justifying the decision, he said that while the return on investment may not be accomplished with a single product in such a dynamic and competitive market, it could be made more viable across various products. Pillai opined that the focus should be on identifying an unmet patient need, rather than simply using a novel excipient as a differentiator.He significantly remarked that an unmet patient need could be fulfilled by process modification, rather than a change in excipients or technologies. Each panelist then shared their experiences in selecting excipients and technologies, and their insights while dealing with regulatory changes. The experts also suggested that excipient manufacturers should first understand the needs of pharma companies and then develop their products accordingly. While at the symposium, DuPont unveiled the new brand identity of the mega merger of DuPont, Dow Chemicals and FMC Corporation. Savindu Kudrigikar, Business Head, South Asia, DuPont Nutrition and Health,

gave a brief overview of the expanded business portfolio after the merger. She also mentioned the role of their channel partners, Signet and Colorcon, in welding DuPont's global presence with their deep local expertise. Kudrigikar shared more on the merger following the event, stating, “The alliance between DuPont, heritage Dow and FMC will give our customers access to the largest pharma portfolio on the market, consisting of solutions, expertise and research from three industry-leading innovators. We will continue to expand our offerings together to ensure our customers are equipped with a supplier’s partner that offers solutions for each of their unique formulation needs.” The panelists in the Hyderabad edition were Dr Rajeev Singh Raghuvanshi, Senior Vice President & Head, BRaIN, IPDO, DRL; Dr Pavan Bhat, Executive Vice President,Technical Operations - R&D, Natco Pharma; Dr. Venkata Ramana Reddy S, AGM R&D, Formulations, Suven Life Sciences, and Seshnath Chauhan, Director - Global Sourcing (SCM), DRL. In the course of the panel discussion in Hyderabad, Bhat noted that excipient manufacturers are collaborating with pharma industry and regulators to introduce new excipients which are functional and help address challenges faced in drug development. Giving his views, Raghuvanshi commented that the value delivered by excipients will be the foremost consideration. Speaking about the adoption of new technologies, Reddy said that process time and sometimes the number of steps would reduce due to some co-processed and ready made excipients, mentioning some examples like direct compressible polymers for matrix system. As the SCM expert on the panel, Chauhan from DRL spoke about how pharma companies can derisk their supply chains. Summing up the discussion, Roychowdhury concluded that developing innovative excipients delivering proven value in terms of higher quality, efficacy improvement, cost reduction, and time to market is the need of the hour. In her closing remarks, Kudrigikar gave an overview of the range of solutions from DuPont, appreciated the discussion and thanked the attendees for their time and insights.

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u.sharma@expressindia.com

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CPhI & P-MEC INDIA 2018 SPECIAL

I N T E R V I E W

We are proud of that fact that many pharma OEMs and end-users have placed their trust in B&R Praveen Vaidya, Manager - Key Accounts, B&R Industrial Automation, in an interaction with Express Pharma, speaks on his company's offerings for the pharma sector, their the innovations they plan to showcase at P-MEC 2018 B&R is an innovative automation provider, could you shed light on the key innovations you will be showcasing at P-MEC 2018? At this yearâ€™s P-MEC 2018, we will be showcasing our machine and factory automation solutions as well as Industrial IoT solutions, enabling pharma industry with seamless integration, universal scalability and complying with stringent regulations and standards. Visitors to our stall in Hall 10, Stall 10.A29 at India Expo Centre, Noida, Delhi will get a chance to understand and experience various modular and flexible hardware and software solutions for pharma machines and factories. Our solutions on display would be Secure Remote Maintenance, Vision system and Hypervisor, which enable machine builders with an integrated automation system. Could you please provide more details of these products along with their applications in pharma industry? Pharma industry is heading towards adopting industrial IoT-based approaches. Keeping this in mind, we are displaying our latest solutions in P-MEC 2018, where OEMs and end-users can experience them. Like consumer goods,

46 EXPRESS PHARMA December 16-31, 2018

pharma machines and systems are being sold in all corners of the world. However, for OEMs, having customers around the world comes with its share of new challenges such as efficient and quick maintenance during downtimes. To avoid travel costs, OEMs are increasingly relying on remote maintenance. Our Secure Remote Maintenance makes diagnosing and maintaining machinery and equipment easier than ever. The user is able to access information about system hardware and software from anywhere in the world. The industry is experiencing an increased usage of vision system not just for final inspection, but also at multiple points throughout the production and packaging process in food and pharma, where quality control is of extreme importance. B&R unites the worlds of automation and vision. Since the hardware is fully integrated in the automation system, the cameras can be synchronised to machine functions with microsecond precision. Conventionally, vision needs PC-based systems with a generalpurpose operating systems and higher processing power whereas automation system work on controllers with a real time operating system.

Together with integrated machine vision and hypervisor, B&R helps in delivering a perfect solution for OEMs. B&R Hypervisor allows multiple operating systems to run in parallel on a single device. The operating systems can communicate with each other via a virtual network. Hypervisor is a software, which allows Windows or Linux to run alongside B&Râ€™s own real-time operating system. This reduces the cost for the OEMs and enhances performance as it makes it possible to combine

a controller and HMI PC in one device. With the hypervisor, an industrial PC can also be used as an edge controller, which serves as a controller and simultaneously transmits pre-processed data to higher-level systems via secured vendor independent OPC UA. How fast pharma OEMs or end-users can integrate your solutions and experience the benefits? We believe in a single tool for all products. Over decades, our Automation Studio has

been the single powerful programming tool for all our hardware, which supports IEC61131, C and C++ programming languages. Through its sustainable and efficient approach to software development it helps our customers to reduce engineering costs and time to market even with ever increasing product complexity. B&R mapp Technology is revolutionising the development of application software in the field of automation. These modular software blocks simplify the development of new programmes and reduce the development time for new machines and systems by an average of 67 per cent. With mapp Technology, software developers are able to configure more and programme less. In competitive and regulated environment, how does B&R automation helps industry to achieve compliances and improve documentation? Our automated solutions directly addresses all regulations prescribed by 21 CFR Part 11. mapp Technology provides customers various technology libraries that support all FDA criteria for electronic records and

CPhI & P-MEC INDIA 2018 SPECIAL

signatures. Data security, data integrity, traceability and electronic signatures are a few basic requirements of 21 CFR Part 11. B&R thoroughly addresses these requirements of security by restrictive access to data through mapp Technology. It allows different levels for access control so users can only access data that is at their assigned level, with user actions being logged with a timestamp and username. The data can be exported as an encrypted PDF. It has the ability to retrace actions performed on a machine that can also be of great service to its manufacturer in event of warranty claims. Pharma companies demand ability to log operations performed by users seamlessly without the risk of being tampered with. Our mapp Audit component serves as a quick and easy way to implement and customise necessary audit trail functionality. mapp Audit runs directly in B&R automation system. With B&R, system manufacturers and end users benefit from maximum security without having to implement organisational measures to prevent tampering on the control system. Could you highlight some of your successful implementations and case studies? We are proud of that fact that many pharma OEMs and end-users have placed their trust in B&R. Our wide range of solutions have helped them significantly enhance productivity and flexibility of their machines and facilities. From blister packaging to fillers and cappers, from cartoning to case packers or palletizers and roboticsâ€“ B&R provides the best automation solutions for pharma machines and factories. Recently, we partnered with a leading pharma packaging equipment provider to develop a high-speed robotic transfer system, which is capable of achieving a rate of

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900 blisters and 300 cartons per minute. With mapp Technology, our customer could drastically reduce programming effort and the robot was effortlessly incorporated and perfectly synchronised with the

machine automation. In another factory of a renowned player in the Food & Beverage market, with our factory automation solution APROL PDA (Process Data Acquisition), our customer was able to get a holistic view

of various losses such as material, time and energy. APROL offers process data acquisition, energy monitoring and condition monitoring in a single system. APROL not only provides a huge cost benefit for the

factory operators but also offers an integrated firewall, which takes care of data security and avoid unauthorised access to the system. EP News Bureau

CPhI & P-MEC INDIA 2018 SPECIAL

Testing for pyrogens: Acore product safety issue The article from Regulatory Management and BioM Division of Merck provides insights on the significance of Monocyte Activation Test (MAT) for detection of pyrogens

ever is one of the cardinal signs of inflammation and very often is related to bacterial or viral invasion of the human body. As far back as 100 years ago (Hort and Penfold, 1912) it had been realised that substances released from dead bacteria may cause fever. These substances were termed pyrogens, i.e., fever inducing substances (Kluger, 1991; Moltz, 1993). Whenever they enter the human body or come into contact with the human blood stream, the host’s innate defense mechanisms, carried by macrophages, monocytes, dendritic cells, and neutrophils, spring into action (Derijk et al., 1993). This can lead to severe signs of inflammation, shock, multi-organ failure, and sometimes even death (Hartung et al., 1997; Dinarello, 2000; Beutler et al., 2003). During production or usage of pharma, biotherapeutics and medical devices, pyrogen contamination can occur. These pyrogenic substances have the potential to induce life threatening fever in humans. To ensure patient safety, the affected industries must test that their concentration does not exceed certain limits. The most frequently applied methods to detect pyrogens in the pharma industry have been the Rabbit Pyrogen Test (RPT) and Bacterial Endotoxin Test (BET), also known as Limulus Amoebocyte Lysate (LAL) test. However, both are limited in the product types they can test (see table below) and in the range of pyrogens for which they are suitable. For example, the LAL test can only detect the lipopolysaccharides (LPS) of Gram-negative bacteria, otherwise known as endotoxins. They form the most common

48 EXPRESS PHARMA December 16-31, 2018

TABLE SHOW LIMITATION OF RABBIT AND LAL TEST Rabbit Test (RPT) LALTest

Rabbit Test (RPT) LALTest

Cytostatic drugs

Blood products

Sedatives

Lipids

Analgesics

Cell therapeutics

Cytokines

Proteins

Test (MAT) was introduced into: ◗ Chapter 2.6.30 of the European Pharmacopoeia in 2010 as an alternative ◗ An FDA Guidance for Industry in 2012 (Pyrogen and Endotoxins Testing)

MAT system for a wider spectrum of detectable pyrogens

Antibiotics

Pyrogens constitute a heterogeneous group of contaminants comprising microbial and non-microbial substances. Data demonstrating that the MAT is capable of covering a much wider range of pyrogens relevant to hu-

Chemotherapeutics Proteins

TABLE 2

has since proved the MAT reaches further: while LAL tests detect only the LPS of gram-negative bacteria, MAT also covers pyrogens originating from gram-positive bacteria, yeasts, molds and viruses. Its spectrum includes: ◗ Endotoxins (lipopolysaccharides, LPS) ◗ Lipoteichoic acid (LTA) ◗ Bacterial DNA (CpG-motif) ◗ Synthetic Toll-like receptor (TLR)-agonists ◗ Lipoproteins ◗ Endogenous pyrogens ◗ Particles from packaging, rubber, plastic, organic dust

The MAT detects non-endotoxin pyrogens that the rabbit and LAL tests don’t – five cases:

TABLE 3 Batch

LAL test

Rabbit test

Fever in patients

Whole Blood pyrogen test IL-1 (pg/ml)

Il-6(pg/ml)

negative

egative

8.5

28.0

negative

Positive

Yes

142.6

654.4

negative

Yes

421.5

9,444.0

Cut off :

32.6

127.6

but not the only class of pyrogens. Both tests are based on immune reactions of animals, rather than humans, and bring with them a high level of

animal consumption (rabbits or horseshoe crabs). To overcome the limitations of the rabbit and LAL test, the Monocyte Activation

mans were not included in the (predominantly LPS focused) validation studies of the past years. However, extensive clinical and scientific research

1. Life-saving drug A major pharma company received many reports of adverse drug reactions (redness, shivering, fever) for a life-saving drug containing a substance produced by fermentation. The batches responsible had passed LAL and rabbit tests without a detectable response. It became clear that an unknown NEP contamination was impairing patient safety. The MAT was introduced as a testing system for batch release in accordance with FDA. Consequently, it was possible to improve the production process. As shown in the timeline below, adverse drug reactions had decreased to zero a few years later. 2. Human serum albumin An experimental study tested pyrogen contaminated batches of human serum albumin (HSA) for clinical use. The influence of NEPs was investigated by blocking LPS with Polymyxin B, which revealed that all three contami-

CPhI & P-MEC INDIA 2018 SPECIAL

nated batches contained significant concentrations of NEPs which could only be detected using the whole blood MAT. The authors concluded that only the whole blood MAT is qualified to ensure consumer safety when it comes to non-endotoxin pyrogenic contaminations.

LAL test. The authors concluded that an LAL test is insufficient to quantify potentially hazardous pyrogenic contaminations of dialysis tubing. Many biofilm-creating bacteria are Gram-positive so cannot be detected by LAL

tests. As we have seen in all the above five case studies will different products MAT is able to detect heterogenous group of pyrogens which can cause adverse reactions in humans.

Benefits of moving to MAT 1. Greater product safety: Detects a wide spectrum of pyrogens (including NEPs) 2. Highly compactible: Allows testing of wider range of pharmaceutical products 3. Invitro test: Involves

no animal consumption and mimics innate immune reactions in humans 4. Reliable test: Easy to perform, robust test system 5. Regulatory recognition: Introduced into EP and in an FDA guidance for industry

3. Infusion solution An infusion solution containing gelatin caused fever reactions in hospital patients. The manufacturer withdrew the incriminated batches from the market and re-investigated them using both LAL (the release criterion of this parenteral) and rabbit tests. The manufacturer blinded the batches and sent them to the responsible national control authority for analysis using the whole blood MAT in parallel with blinded, non-incriminated control batches. The fever causing substances were identified as NEPs. Check the results in Table 3 4. Dialysate A global recall was issued for an icodextrin-containing dialysate after patients complained about abdominal pain, nausea, vomiting, diarrhea and fever. The incriminated batches passed the LAL and rabbit tests. An ex vivo pyrogen test was then performed using human peripheral blood mononuclear cells (PBMCs) from healthy donors after exposure to the test substance. The samples led to increased cytokine release, suggesting the presence of NEPs. Further analysis showed peptidoglycan to be the main contaminant. An investigation of the production process revealed that the gram-positive bacterium Alicyclobacillus acidocaldarius was the source. 5. Dialysis Tubing Biofilm contamination within silicone dialysis tubing is a significant patient safety concern. An analysis of tube scrapings showed that the MAT detected greater amounts of pyrogens than the

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CPhI & P-MEC INDIA 2018 SPECIAL

In vitro pyrogen testing: Key to progress The article provides insight on how in vitro pyrogen test such as Monocyte Activation Test like based on human cells offers a valuable alternative to the rabbit pyrogen test

dverse reactions to parenteral preparations have been described as early as the late 19 th century, frequently termed ‘injection fever’. The first fever-causing agents, ‘pyrogens’, were identified in 1912 by Hort and Penfold, who were also the first to design a pyrogen test based on injection of material into rabbits. At that time, the pyrogenic agent was identified as endotoxins included in preparations of gram-negative bacteria. Interestingly, it was shown that live and dead microorganisms presented the same pyrogenic potential. Pyrogens, a heterogeneous group of fever inducing contaminants, comprises microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by gram-negative bacteria, lipoteichoic acid (LTA) from gram-positive bacteria, bacterial DNA (CpGmotive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. In the following years, it became more and more clear that sterility is not necessarily equal to apyrogenicity, which led to the inclusion of a pyrogen test in the 12 th edition of the United States Pharmacopoeia (USP) in 1942. The high number of pyrogen tests on rabbits and the variable sensitivity of that test system (e.g. by development of pyrogen tolerance in rabbits after repeated injections) made development of alternative tests necessary. The first and most successful of these new tests was the bacterial endotoxin test based on the

50 EXPRESS PHARMA December 16-31, 2018

The high number of pyrogen tests on rabbits and the variable sensitivity of that test system (e.g. by development of pyrogen tolerance in rabbits after repeated injections) made development of alternative tests necessary lysate of amoebocytes from the blood of horseshoe crabs, which became commercially available in the 1970s and has been widely used as a replacement for the rabbit pyrogen test. On the other hand, quality control for the presence of pyrogens is getting more and more complicated, as production processes (e.g. biotechnology and cell therapy products) bring new risks of various contaminants (i.e. non-endotoxin pyrogens) entering the final product, like viruses from animal-based raw materials or gram-positive bacteria from contaminations. Non-endotoxin pyrogens (NEPs) are undetectable by the bacterial endotoxin test, and there is therefore a risk of overlooking a NEP contamination. Drugs that are purported to be sterile must also be free from pyrogens to prevent patients from febrile reactions. (e.g. European GMP – Annex 1; FDA Guidance for industry – Sterile Drug Product produced by aseptic Processing – Current Good Manufacturing Practice). Parenteral preparations must be ‘pyrogen-free’ because administration of pyrogens may lead to lifethreatening fever in some patients. The severity of the adverse reaction depends on the concentration and biologi-

cal activity of the respective pyrogen. It is therefore necessary to test these products for the full range of pyrogens to ensure patient safety. Contamination with pyrogens in pharma products, biotherapeutics and on medical devices can also lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices. the Rabbit Pyrogen Test, RPT, (EP 2.6.8, USP 151) and the Bacterial Endotoxin Test (Limulus Amebocyte Lysate, LAL, EP 2.6.14, USP 85). Both methods feature limitations in the scope of their application. RPT is not suitable for products such as radiotherapeutics, chemotherapeutics, analgesics, steroids, cytokines, dopamine and immunosuppressive agents while LAL cannot be applied to drugs that interfere with the clotting system, cell therapy products, endotoxin-binding plasma components or products containing glucans to name a few. Furthermore, LAL, unlike RPT, detects only endotoxins from gram-negative bacteria as the mechanism of action does not reflect the inflammatory response of a mammalian organism but instead is based on the clotting reaction of the haemolymph of the horseshoe crab. Inability to detect non-

endotoxin pyrogen contaminants precludes the BET/LAL method from being a complete in vitro alternative to the RPT. As the limitation of being unable to detect all pyrogens by BET/LAL methods and in case of any doubt of the presence of non-endotoxin contaminants, the laboratory was required to use the rabbit test. During the last 30 years, the willingness to consider the animal pain and suffering has increased significantly and consequently the pressure to reduce animal testing has also increased. The publication of ‘The Principles of Humane Experimental Technique’ by W.M.S. Russel and R.L. Burch in 1959 marks the birth of the principle of the ‘Three Rs’ (Replacement, Reduction and Refinement). In terms of ethics, this concept has influenced regulations in many countries: 1 In the US, the Animal Welfare Act was enacted in 1966 and the FDA has been promoting initiatives to reduce animal testing (e.g. "Advancing regulatory science for public health", Oct. 2010). 2 In Japan, animal experimentation is also regulated by laws, but is more based on a self-regulation system due to the combination of Buddhist and Christian assumptions.

3 In Europe, the ‘Three Rs’ have been present in EU legislation in spirit since 1986 when the first EU legislation for the protection of animals used for experimentation and other scientific purposes was adopted. Then, the Directive 2010/63/EU, described the principle of the ‘Three Rs’ for the first time and made it a firm legal requirement. According to this law, if an in vivo test can be replaced by a validated in vitro test, it is an obligation to change to an in vitro test. Currently there are four methods that can currently be described for pyrogen and endotoxin detection. They are differentiated by: 1 - Their target: either pyrogens (i.e. endotoxins and non-endotoxin pyrogens) or endotoxins only 2 - The use or no use of animals. Endotoxin tests can detect contamination of Gram-negative bacteria, but when performing an endotoxin test, the pyrogenic activity of a preparation in humans may be underestimated due to non-endotoxin contaminants. Therefore, endotoxin tests may mostly be used for raw materials, production water and in-process testing. On the other hand, pyrogen tests detect the whole range of pyrogens (including both endotoxins and NEPs). They are designed to predict the pyrogen activity of a preparation in human and are therefore used as quality control for final products In 2016, due to the increase in production of more and more complex products, the general chapter for endotoxin

CPhI & P-MEC INDIA 2018 SPECIAL

testing in the European Pharmacopoeia (Chapter 5.1.10) introduced the necessity for an evaluation of the product, production process and raw materials with respect to the risk for pyrogens that are non-detectable by the bacterial endotoxin test. A non-animal in-vitro alternative that would be capable of detecting both endotoxin and non-endotoxin contamination appeared to be a perfect solution. In this context, the in vitro pyrogen test based on human cells offers a valuable alternative to the rabbit pyrogen test. Since January 2010, the Monocyte Activation Test has been described as a compendial method for Pyrogen Detection in the European

MAT is described as a compendial method for pyrogen detection in European Pharmacopeia Pharmacopeia (Chapter 2.6.30) and since the 2016 revision, recommendations have been given to replace tests on rabbits with the Monocyte Activation Test, wherever possible and after product specific validation (EP 2.6.8, Rev. July 2016). The Monocyte Activation Test (MAT) (EP 2.6.30, FDA Q&A June 2012) was developed on the principle of the human immune system response: when challenged by the pyrogens entering the body or coming into contact with the blood stream, the hostâ€™s innate immune defense mechanisms cause the monocytes/macrophages to produce prostaglandins and pro-inflammatory cytokines such as interleukin-1 (IL-1), interleukin-6 (IL-6) and tu-

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December 16-31, 2018

mour necrosis factor-a (TNFa). The initiated pro-inflammatory signaling pathway can cause fever resulting in severe inflammation, organ-failure and even death. Mimicking this biological response, sources of monocytes deter-

mines pyrogenicity of the tested sample by measuring the Interleukin-6 production in an immunological assay (ELISA). MAT detects both gram-positive (non-endotoxin) and gram-negative (endotoxin) contamination

alongside other biological (virus, fungi) and non-biological pyrogens.

Benefits of moving to MAT 1. MAT allows detection of a broad range of pyrogens

2. MAT allows testing of a wide range of products 3. MAT is an in vitro method 4. MAT is supported by regulations and guidelines 5. MAT is robust and sensitive method

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CPhI & P-MEC INDIA 2018 SPECIAL

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Mack Universal brings innovation with technology to transform businesses Manoj Choudhari - Director, Mack Universal speaks on his company’s offerings for the pharma sector, its strategies for market penetration and more, in an interview with Express Pharma

Tell us about your company and its offerings for the life sciences sector? Who are your major pharma clients? Mack Universal started in 2012 which is the sister concern of Mack Pharmatech. It is a wellestablished organisation since 1999, with business transactions in India as well as globally. Mack Universal is one of the leading multifaceted business conglomerates in India and is engaged in supplying a wide range of activities that touch the most basic and far advanced aspects of everyday life in pharma, food, chemicals and other similar industries. We deal with a varied temperature range of muffle furnaces. Our company continues to maintain or exceed the standards that are demanded by the best companies in the world. We employ dedicated individuals that identify and exploit the right opportunities. We are a professionally managed company that believes in profitable, sustainable and enjoyable long-term relationships with all the key stakeholders – including employees, customers, shareholders, suppliers, etc. Our dynamic sales and service team understands that successful partnerships with our clients depend on consistently delivering beyond expectations. Our

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have consistently shown faith on us and have placed repeat orders, which is a testimony of our capabilities. Some of our reputed clients include Mylan Laboratories, Sanofi, Ipca Laboratories, Apotex Pharmachem, Wockhardt, Mylan – Zambia International, and Keva Pharmaceuticals – Nepal.

customer profile along with our high-end team supports the management to achieve the three word business strategy; ‘Insight - Vision Solutions’. With eight regional locations for service strategically positioned as required, Mack Universal is poised to effectively support your project needs, wherever they may be. We have followed a clientcentric approach all the time to fulfill the requirement of our clients which results in a repertoire of satisfied clientele. Our customers

What are your current focus areas for the pharma/biotech industry? One of the most rapidly changing environments is the technology environment. Any company who has the skill set to work with the latest technology can serve their clients the best. Mack Universal shines in these areas as it has always bought in innovation with the help of technology to transform businesses, and change the way they did in the past. Currently, we are focussing on pharma, chemical plants, universities and petrochem industries, research institutes and other industries. Muffle furnaces are used in many areas such as quality control analysis, combustion, heat treatment, preheating, melting, oxidation, metallurgical research and sample production. Are there any plans to launch or showcase any new products at CPhI India 2018?

CPhI & P-MEC INDIA 2018 SPECIAL

Yes, it is our pleasure to introduce a new version of the model MT-1200-7 SS case with in association with Turkey-based TETRA ISI SYSTEMLERI’s MAGMATHERM furnace body and Indian-based control system. Magmatherm furnaces are high quality products. They have been produced for heavy duty conditions. Unique mechanical design provides long life and unique PID Control Unit provides reliability and ergonomics. ◗ Chamber walls are made up of insulating fire bricks

MACK UNIVERSAL expanded with new a dedicated plant in Sinnar MIDC with 5500 sq ft area. Since the last five years, Mack Universal has received a very good response from

pharma companies. We are in touch with top pharma companies in India and abroad and has been able to get repeated business from them. Mack Universal plan a

growth policy as market penetration, based on this vision we have already developed a muffle furnace with additional technology like latest control system with printing facility, service

plays an importaant role in the pharma industry based on this we extend warranty/service of the equipment to increase confidence on Mack Universal.

www.glatt.com

Process & Plant Engineering

Since the last five years, Mack Universal has received a very good response from pharma companies against mechanical abrasion and thermal aging and deformation. ◗ Half buried heaters are on two sides and the top is in quartz tubes. ◗ Modular inner body; replacement and fully renewing the furnace ◗ Standard chimney with fan ◗ Extraction of oxidising gases which occur during the burning process and homogenous heating. ◗ Adjustable foot screw We would request all visitors to take a moment to discover the new version at CPhI P-MEC 2018, Stand 12, C-04. We are committed to clients satisfaction and welcome their feedback! We’ll do all we can to create a positive experience. What is the company’s growth strategy for the next three years?

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MEET THE EXPERTS @ P-MEC India India Expo Centre, Greater Noida, Delhi NCR, India, 12 - 14 December, 2018 Stand no. 9.A03, Hall 9

Glatt. Integrated Process Solutions.

CPHI & P-MEC INDIA 2018 SPECIAL

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‘Globally, there is a growing respect for the quality of Indian product’ Founded in 1996, Ami Polymer is a leading manufacturer of biopharmaceuticals grade elastomer tubings, reinforced hoses, gaskets as well as extrude, moulded components – supplying to industries as varied as pharmaceuticals, biotech, food processing, plastics, and medical industries, among others. In an interview with Express Pharma, Alpesh Gandhi, Managing Director, Ami Polymer, throws light on a wide range of matters that have defined the company’s growth including its emphasis on obtaining the best of global quality certifications, and the impact of the government policies. Excerpts from the interview Please brief us about Ami Polymer’s spread of operations. Our head office is in Mira Road, off Mumbai and our manufacturing site is at Silvassa, Gujarat. We have branch offices in Mumbai, Goa, Indore, Roorkee, Baddi, Sikkim, Baroda, Ahmedabad, Hyderabad, Vishakhapatnam, Bengaluru and Chennai. We also have an office in New York, US; and a direct presence in Bangladesh, Germany, Iran, Switzerland, Dubai, Slovenia, and Spain. Currently, our employee strength is more than 275. Which industries do you target with your products? Our products are specially made to suit the pharmaceuticals, biotech, food processing, plastics, and medical industries, though we also cater to a number of other sectors, such as steel, engineering, aerospace, textile, solar and steel. How have the policies of the present government impacted your business? We have seen a huge growth thanks to the pro-business policies of the Narendra Modi government, especially

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in the exports segment. That’s because the government has taken plenty of initiatives to promote exports. The Skill India scheme has also benefited us immensely. We generally undertake campus recruitment from the ITIs (Indian Technical Institutes). Previously, we rarely used to get good technically skilled people from these institutes, but today there is an abundance of job aspirants who are appropriately skilled. This is a result of close association between the institutes and the industry. The government has been proactive in supporting the formation of committees, comprising representatives of both the industry and the institutes, for developing course curricula. These

committees fine-tune courseware according to the needs of the industry, and this is what helps us to recruit people with the right skills. How has the Goods and Services Tax (GST) affected your business? It’s a great relief for those having pan-India operations to treat all regions across India as a single market, and not having to pay taxes separately for different regions. It’s a boon for those doing legitimate business, as transactions have become easier. GST has not only emboldened those who are doing legitimate business, but has also helped increase their number, because only those coming under the GST bracket, are entitled to get credit for business transactions. Manipulations

have come down drastically.

studies on products.

How do you manage to cope with the ever-changing and demanding customer expectations? Since we are increasing our focus on the export market, we are trying to win customers who will go only for world-class products. So we keep enhancing the quality of our products, and this is possible by upgrading our manufacturing equipment consistently with the latest technology enhancements happening globally. The other way to ensure the quality that customer demands, is to obtain the best of global quality certifications, which we have been managing quite successfully and consistently. Our certifications include DMF #26201 (Drug Master File) for manufacturing silicon tubes and hoses accredited by US FDA; Clean Room of Class 10000 Certified Facility; NSF-51 Certification on platinum cured silicone resin; TUV Nord Certified ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007; and TOXICON Lab (USA) based E&L Study, USP Class 87, ISO 10993 biocompatibility

In the recent past, there have been cases where Indian companies had got into trouble over certification issues denting the image of our country abroad. How does the world look at the quality of the products leaving Indian shores? The world today looks at India in a very positive way. There is a growing respect for Indian products in the US and the other parts of the world. Indian companies have worked hard to earn this respect. For instance, India has the highest number of US FDA-compliant plants today. What are your expectations from the Indian market, at a time when a series of elections, including the Lok Sabha elections are round the corner? It all depends on the policies of the government, like the GST, which have been a boon to those doing legitimate business. We hope such probusiness policies will continue, and we will get consistently motivated. What was your revenue for

CPHI & P-MEC INDIA 2018 SPECIAL

the last financial year, and how much growth do you expect this year? In the last financial year, we achieved a ` 36-crore revenue, and we are targeting to achieve a revenue of ` 155 crore by the year 2022. What’s your share of business from the exports and domestic markets? Presently, exports account for only about 15 per cent of our business, and we hope to increase this percentage to about 50 per cent within the next five years. Focusing on exports, what are the key demand drivers for your products? Our product and plant certifications. In the export market, buyers are much more stringent with quality parameters of the product they intend to buy. Which new regions are you eyeing in the export market? While we look forward to consolidating our position in the markets that we are already present, we are looking at new regions like East Asia, Russia and China. Won’t language be a barrier in the East Asian countries? Also, what’s your modus operandi for starting off your business in new regions? Language barriers are taken care of by English translators. In newer regions, we generally start by appointing local agencies who help us choose local channel partners after which our people visit the region. If the progress is good in a particular region, then we set up our offices and employ staff for these offices. How big is the role of IT systems in your business operations? One of the major reasons for our growth is that we have been using the best of IT solutions, and keep

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upgrading them. Since long, we have been using Microsoft Dynamics NAV ERP solution for operations, and SAP for Customer Relationship Management (CRM), The processes are getting faster, hassle-free.

How much do you focus on R&D for product quality enhancements? We have a full-fledged R&D team that indulge in a lot of reverse engineering and develop applications after understanding customer

requirements and demands perfectly, before developing the product. The R&D team has also been instrumental in developing a number of import substitutes. This way, we save on import duties; are able to do customisation

faster, and remain costcompetitive. Our emphasis on R&D also ensures that we don’t have to keep inventories for long, and our products are always of international standards. EP News Bureau

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‘A foray into the US and European markets is our goal now’ Mack Pharmatech is a Nashik-based leading manufacturer of pharma and laboratory equipment for the past 20 years. Dr Kiran Badgujar, Director, Mack Pharmatech, shares insights on the company’s growth strategy, challenges and the road map ahead with Express Pharma. Excerpts of the interview Could you tell us about the growth journey of your company so far? In 1999, Manoj Chaudhari, Partner, Mack Pharmatech and I started a service-based business. Both of us share an engineering background. At the moment, Mack Pharmatech is one of the top brands in the pharmaceutical and laboratory equipment industry, supplying to major pharma companies such as Aurobindo Pharmaceuticals, Dr Reddy’s Laboratories, and Cipla, to list a few. Mack Pharmatech is the first Indian company to have acquired the European CE Certification. All our products are CE marked. Since 2005, we have been supplying to Hungary’s Sun Pharmaceutical Industries. We have worked our way up from the absolute ground level. We do not believe in copy-paste when it comes to technology. We develop our own products. Starting out as two individuals, today we have an employee-strength of 200. We have a pan-India presence of service stations. As a company policy, we offer jobs to those who are in need and treat them as part of our extended family. We can say it with pride that our attrition rate continues to remain low. The Indian pharma’s sunrise segment, generics experienced certain challenges in the past. What is the current outlook for this segment? Our observation is that the overall pharma sector itself

56 EXPRESS PHARMA December 16-31, 2018

remains a booming industry right now. Since 2008, the sector has seen fast growth. For instance, in Himachal Pradesh, the pharma sector has the biggest share in economic growth rate, which influences other ancillary industries too. The same growth story is being witnessed in Gujarat for the last five years, especially due to the supportive role played by the government. Earlier, Hyderabad has been the main hub of the pharma industry in the south. Similarly, cities such as Visakhapatnam are also into

the competition. With the splitting of the state of Andhra Pradesh and Telangana, the market has become even more competitive. The state governments of Andhra and Telangana are focussing on the pharma sector. In the future too, the industry would continue to lead the Indian economy. The last four to five years was a slag period. Due to the changes in infrastructure policies, a lot of companies were taken over. However, in the past three years, we remain competitive in areas such as Haridwar, Dehradun,

Baddi and Parwanoo. This also includes areas of the north-east like Guwahati and Sikkim, where pharma companies are opening new plants. So many new companies are coming up. The response to Indian products has been quite favourable globally. Considering that we remain directly connected with the owner of the companies. The global demand has been extremely good. The technical knowledge that Indians possess is quite good. The whole global perspective towards India had completely changed with genuinely good suppliers offering at the best pricing. While countries like Germany and Italy offer good quality, the pricing is three times more. Smaller countries remain happy as they are selling at twice the price. Considering all these factors the market remains booming.

Bangladesh and South Asian countries like Malaysia. In addition, we have a presence in Ghana, Turkey, South Africa, Uzbekistan. We are working with channel partners in all these countries.

Could you tell us about the business model? Do you conduct direct sales and distribution or have channel partners? Our experience with a channel partner has not been so good. So we have adopted a centralised control model. We control the sales and service from our headquarters at Nashik. We have a business presence in all the states of India. In fact, 95 per cent of the Southern market has been covered by us already.

Do you manufacture products from the groundup or your company sources components from China? We manufacture from the ground up. Our suppliers too are based in India. The whole manufacturing ecosystem has developed in India. India remains a leading nation when it comes to manufacturing and this can definitely be stated about the pharma sector. When it comes to capsule or tablet making machines, Indian companies are amongst the top manufacturers in the world.

Currently, in which countries do you have a presence? We have a presence in

Any business plans overseas? Currently, we are focussing on the South Asian and the Middle East markets. Our major focus is on Malaysia. Incidentally, in countries like Malaysia, Indian companies face stiff competition from other Indian companies operating in that market. When it comes to product quality as well as pricing, India remains the best option. In the future, newer markets are bound to open up. We haven’t conducted any exhibition for the European market so far. However, our next target is to securely entry into the European as well as the US markets.

What are the challenges faced by Indian

CPHI & P-MEC INDIA 2018 SPECIAL

manufacturers like you? Matching the quality standards and quality control up to the maximum level with European companies such as those from Germany is the biggest challenge. The government needs to introduce newer schemes to promote exports to create a strong branding push for the products manufactured in India. The message must go out strongly through international trade expositions that products made in India stand for quality. Innovative products manufactured in India too need to be promoted at such global pharma exhibitions. Do you see the government being supportive on this front? Yes, we have high hopes from the present government at the Centre. It has been heartening to see the way the Modi government is promoting India at the global level. Yes, we are hopeful. What has been the impact of GST on business and product pricing? With GST, things have become simpler from the procedural standpoint. Many laborious processes have become simpler and seamless after the implementation. About four to five per cent drop in product prices can also be witnessed. The GST rate of many products that earlier was 28 per cent has been brought down to 18 per cent. This has given a two-way benefitâ€”to suppliers as well as buyers. As a result of these changes, sales too have improved dramatically since the GST implementation. Any expansion plans of your company? We are looking at expanding our global footprint. When it comes to targeting export destinations, the key challenge we face is identifying the right distributor with deep knowledge of the market. Currently, we are

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participating in about five international exhibitions. We plan to participate in 10 exhibitions by next year. At the moment, we are participating in trade exhibitions in Thailand, Indonesia, Nepal and

Bangladesh. By next year, we will be focussing on entering the markets such as Turkey, Central America and Germany (Frankfurt). As mentioned earlier, a foray into the US and European markets is our goal now.

Any innovations that you plan to introduce on the product side? We introduce regular product upgrades. We plan to launch star-ratings, something along the lines of electronic white goods in terms of power

efficiency. Also, recently we introduced biometric. The machines designed are totally controlled by the software and can be easily operated from any area with good internet connectivity. EP News Bureau

CPHI & P-MEC INDIA 2018 SPECIAL

K2VITAL DELTAVitamin K2-7: For bone and heart health Jim Beakey, KAPPA, elaborates how protected, microencapsulated K2VITAL DELTA is the solution to bone and heart health supplement formulations that use beneficial minerals

2VITAL DELTA vitamin K2 MK-7 is important for all people throughout life, and can influence healthy ageing. Strong bones and a clean, flexible cardiovascular system are vital to vibrant, healthy living as people get older. Vitamin K2 holds the key. K2 is an essential fat-soluble vitamin - just like vitamins A or D. Vitamin K2 activates osteocalcin proteins which incorporate calcium into bone. Without K2, calcium and vitamin D3 cannot optimally support bone health. K2 also activates matrix Gla proteins (MGP) which bind excess calcium in the body. This prevents excess calcium from making its way to the heart and circulatory system. Calcification of arteries and vessels is a risk factor for disease, and can impact quality of life as people age. Unfortunately, standard unprotected vitamin K2-7 is not stable in formulations that have high alkaline content or include minerals such as calcium or magnesium salts. Protected, microencapsulated K2VITAL DELTA is the solution to bone and heart health supplement formulations that use beneficial minerals.

Childhood bone growth influences healthy ageing Calcium, vitamins K2 and D3 are the three vital nutrients for bone health, representing The Bone Health Triangle. If one part of the triangle is missing then optimal bone health is inhibited. Vitamin D3 ensures an efficient uptake of calcium through the intestines into the bloodstream,

58 EXPRESS PHARMA December 16-31, 2018

ance tips in favour of the cells that break down bone, and old bone is removed faster than it is replaced. Bone mass begins to decrease more rapidly. Bones become more porous, brittle and weaker. The risk for fractures increases and the body’s ability to mend broken bones decreases. Additionally, bad habits like smoking or drinking can also negatively affect bone health. Both can cause calcium loss in bones. The risk of developing bone-weakening diseases like osteopenia and osteoporosis increase during this time frame. Fortunately, studies show that even during this period, bone health can still be ‘actively managed,’ and new bone mass can be built. Exercise is one method, supplementation of vitamin K2-7 is another. and K2 activates the osteocalcin proteins that integrate calcium into bone. Without K2, calcium cannot properly support bone growth. K2 is particularly important in childhood and adolescence when bones grow rapidly. Childhood years also have a significant influence on how we age later in life. Peak Bone Mass (PBM) is reached somewhere around age 20 when bones are strongest and most dense. Bone mass then begins a natural and steady decline, and the decline is more pronounced for women following menopause – increasing the risk of bone diseases like osteoporosis. Starting the adult years with a high PBM provides insurance for when the natural decline in bone density begins. By having a higher bone mass

when we are young, we lessen the effects of bone degeneration later in life. One study demonstrated that a 10 per cent increase in peak bone mass may reduce the risk of osteoporotic fracture risk later in life by 50 per cent1.

Vitamin K2 in late adulthood Late adulthood is the time when many people begin to think about delaying the onset of aging, and when changes in bone metabolism accelerate. Bones undergo a natural cycle of disassembly and regeneration about every seven years. Specialised cells called osteoblasts and osteoclasts build-up and remove old bone. When we are young, new bone is created faster than old bone is taken away. By about the age of 40, however, the bal-

Exercise and K2VITAL DELTA: Better bone health Several studies demonstrate that bones can continue to grow and adapt in response to physical training after PBM is reached 2. Exercise training helps make bones stronger and more dense, in as little as three months, and these benefits have been observed in populations well into their 70s and 80s. Vitamin K2 supplementation, along with calcium and vitamin D3, also provide ‘bone insurance’ for late adulthood. Clinical studies demonstrate that vitamin K2 supports bone growth 3, reduces bone fracture risk 4, 5 and inhibits the age-related decline of bone mineral density compared to a control group in an ageing population 6. Vitamin K2-7

bone health supplements that includes calcium however, should include protected K2-7 to ensure shelf-life stability and K2 potency.

K2-7 and cardiovascular health Calcium is vital for strong bones, but it also introduces risk. Too much calcium in the body can have a negative effect on the heart by making arteries more ridged, less flexible, and less able to meet the demands physical activity. In the worst cases, calcified arteries or calcium plaque build-up are risk factors for cardiovascular disease and heart attack. Excess calcium can become incorporated into soft tissues like the arteries and vessels of the circulatory system. Arteries and vessels can lose flexibility, limiting their ability to expand outward.

CPHI & P-MEC INDIA 2018 SPECIAL

The heart must work harder to push blood through narrower vessels. Calcium deposits and fatty lipids can also build-up within arteries and vessels, creating blockages and compounding the risk. Calcification builds over decades, affecting as many as 1 in three adults7. Fortunately, K2-7 also activates matrix Gla proteins (MGP) which bind excess calcium in blood to prevent deposit in vessels and arteries. This plays a preventative role in maintaining heart health. Vitamin K2 can also reverse existing calcification and restore flexibility to vessels and arteries 8. K2 regulates calcium by transporting it to where it is needed (bones) and away from where it is harmful (heart).

The K2VITAL DELTA opportunity The essential bone, heart and

to transition along with consumers from one life stage to the next in a wide range of product formulations and dosage formats.

References

circulatory system benefits of K2VITAL DELTA create commercial opportunities for virtually all consumer types and up to 11 market categories. Vitamin K2 complements four of the five top-selling ingredients, including calcium, omega-3, magnesium and multivitamin blend. Pro-

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tected, microencapsulated K2VITAL DELTA ensures shelf-life stability and K2 potency in formulations that include mineral salts. DELTA holds a first-of-its-kind drug import license for vitamin K2 for the Indian market, and a drug import license. K2VITAL is the perfect ingredient

1.Cummings, S.R., et al., Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet, 1993. 341(8837): p. 72-5. 2.Cheng, S., et al., Bone mineral density and physical activity in 50-60-year-old women. Bone Miner, 1991. 12(2): p. 123-32. 3.Huang, Z.B., et al., Does vitamin K2 play a role in the prevention and treatment of osteoporosis for postmenopausal women: a meta-analysis of randomized controlled trials. Osteoporos Int, 2015. 26(3): p. 1175-86. 4.Kaneki, M., et al., Japanese fermented soybean food as the major determinant of the large geographic difference in circulating levels of vitamin K2: possi-

ble implications for hip-fracture risk. Nutrition, 2001. 17(4): p. 315-21. 5.Yaegashi, Y., et al., Association of hip fracture incidence and intake of calcium, magnesium, vitamin D, and vitamin K. Eur J Epidemiol, 2008. 23(3): p. 21925. 6.Knapen, M.H., et al., Threeyear low-dose menaquinone-7 supplementation helps decrease bone loss in healthy postmenopausal women. Osteoporos Int, 2013. 24(9): p. 2499-507. 7.Rocha-Singh, K.J., T. Zeller, and M.R. Jaff, Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv, 2014. 83(6): p. E212-20. 8.Knapen, M.H., et al., Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women. A double-blind randomised clinical trial. Thromb Haemost, 2015. 113(5): p. 1135-44.

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CPHI & P-MEC INDIA 2018 SPECIAL

HPLC or HP-TLC ? There is a choice now…. LC and HP-TLC are both liquid chromatography techniques and can often analyse, the same samples. In such situations, HP-TLC nowadays can be the method of choice, for numerous practical reasons. An insight by Rakesh Ranjan, Asst Manager Sales, Anchrom Enterprises India

t is well established that HPLC (LC) is an excellent technique with high scientific merit but low practicality and HP-TLC is a very practical technique. In the 1970s, all liquid chromatography in the pharmacopeias was TLC until LC was developed as a better method for quantification. LC now rules the chromatography roost, especially in combination with MS. Instrumental TLC could not keep pace with LC, due to lack of a universally acceptable methodology. Then in December 2015, USP made HP-TLC an official technique and described a SOP in its Chapter 203. Until that moment, most analysts incorrectly assumed that instrumental TLC was HP-TLC. Only instrumentation cannot be enough. In fact, instrumentation is tailored to meet the method parameters requirements. Most analysts overlook the fact that HP-TLC is an entirely new technique because

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they think they know TLC or Instrumental TLC. Anyone who does that, not only underestimates HP-TLC but fails to utilise a new powerful official method for their routine and research analysis, which is very cost and time effective. Both are precious commodities. LC is one of the (if not THE) slowest techniques in any lab and therefore requires perpetual repeat purchases, as variety and or number of samples increases. On top of it, its very expensive to clean up samples before LC analysis. Cost per analysis and maintenance costs are high.

The new USP (Chapter 203) / EP (Chapter 2.8.25) require control over all the variables in the HP-TLC procedure. The USP/EP HP-TLC SOP have a very simple sample preparation, fixed size of HPTLC plate (20x10 cm), fixed application pattern of samples (band size, distances from bottom and side edges, no. of samples/plates), development in 20x10 twin trough chamber, up-to 70mm, chamber saturation – 20 minutes, layer at 33% Rh etc. All data must be auditable. Data documentation and evaluation by Image analyser or Scanner (in process). LC and HP-TLC are both liquid chromatography techniques and can often analyse, the same samples. In such situations, HP-TLC nowadays can be the method of choice, for numerous practical reasons. When high resolution and ultra-high precision is required, LC methods will be the choice. In other cases, HPTLC could be the better alternative.

The most popular detector in chromatography i.e. MS is also easily hyphenated with HP-TLC. In fact, HPTLC-MS and HPTLC-MS-MS has unique advantages such as WYSIWYG (what you “see” is what you get) i.e. only the selected fraction from the chromatographed plate goes into MS or elution of fractions at same Rf from all samples or very high output. It takes less than 3 minutes to obtain a MS from HP-TLC fraction. A reaction mixture can be directly applied, separated and MS of fractions obtained, all in an hour! One fundamental limitation of LC is that it can analyse only a single sample at a time while HP-TLC analyses a hundred samples in parallel. Imagine a 2-lane road vs. a 50-lane highway! Another basic limitation is that only those samples can be analysed for which the LC System has been arduously made ready. This makes LC usability very rigid. HP-TLC on the other hand, retains the samples on the layer i.e. the plate and so the HP-TLC instrument is not committed to any sample. Just like in case of a balance or centrifuge. LC is excellent when dedi-

cated to just one analysis whereas HP-TLC is an “analysis on demand” technique. Once samples are ready for chromatography HP-TLC results can be had in the next 90 minutes, without affecting other people’s on-going analysis! There is no instrumental set-up time. “Chromatogram” in LC refers to instrumental output in the shape of peaks, while in HP-TLC it could be peaks as well as visual images and also in-situ bio-assays or effect directed analysis. The exposed and stationary “HP-TLC chromatograms” can be measured repeatedly under different parameters and made amenable to different detection modes. Post chromatography derivatisation is a simple, very powerful but routine method in HP-TLC and applicable to every sample. Hundreds of derivatisation reagents are available for specificity or sensitivity or create “fingerprints”. In LC, derivatisation is cumbersome, expensive and a last resort. UV and Infra-Red Spectrophotometers do not cost the same, although both are similar in function. It is, therefore, not logical to expect both LC and HP-TLC to have the same ini-

CPHI & P-MEC INDIA 2018 SPECIAL

tial price. Even the Government of India Purchase Manual says â€œpurchase price is less important that total price in lifetimeâ€?. HP-TLC entry level system has many functions such as UV-Vis-Fluorescence, spectrum recording, fraction collection, post chromatography derivatisation, micro-preparative capability etc. while entry level LC usually has only a UV-Vis detector. Besides several nonchromatography accessories are essential to run a LC. HP-TLC works at room temperature-pressure and so has no wear and tear. High and ultra-high pressure in LC requires a very high maintenance and life of LC is half of HP-TLC. Running cost of analysis by HP-TLC is extremely low, as

HP-TLC works at room temperature-pressure and so has no wear and tear. High and ultra-high pressure in LC requires a very high maintenance and life of LC is half of HP-TLC

even 20 samples can be analysed on a 20x10 cm plate with 20ml of solvent within an hour. Similar analysis by LC consumes litres of solvent, re-

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duces column life and would take a day. Westerners prefer high consumption, as a boost to their rich economy. LC is a high consumption method.

Westerners prefer LC because it is fully automatic while in HPTLC, the individual steps are automated. A person has to physically move the plate from one step to the next. Machines are cheap and labour expensive in the West but the opposite is true in India.

All in all, now chromatographers have a newly made official technique i.e. HPTLC which can significantly speed up analysis, reduce costs while complying with all the cGLP and other regulatory requirements, in pharma, API, Q.C. and R&D labs.

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December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

Endotoxins: Adanger to pharmaceutical and medical device manufacturing industries Berkshire (USA) gives an insight on clean-room wipers which are instrumental in solving the problem of Endotoxin Pharmaceutical and medical device manufacturing personnel must cope with endotoxins — a contamination source unique to their industries. Endotoxins, also known as pyrogens, originate from dead (!) gram negative bacteria. When this strain of bacteria are killed by antibacterial reagents (say phenolic or quaternary ammonium compounds), radiation, steam sterilisation, etc. the cell wall detritus that is released is toxic to humans. Yes, the bacteria are dead, but the material that they shed are deadly. That material - the endotoxins - if introduced into the body can cause fevers; hence the name pyrogens, meaning fever-producing. So pharmaceutical and medical device companies are faced with a difficult problem: Kill the bacteria, but also remove the dead bacteria.

protocols and environmental monitoring, the outcomes can be disastrous. While many cleaning procedures focus on kill rate and eradicating harmful living microorganisms with antibacterial reagents such as phenolic, quaternary ammonium solutions, radiation, and other forms of sterilisation; there is a hidden menace still lurking on the surface that you cannot see. Enter pyrogens, fever inducing endotoxins left behind from dead gram-negative bacteria. While disinfectants excel at rendering the bacteria as non-viable, the byproducts that they shed, can be deadly. Regulated industries are faced with a difficult task: Kill the bacteria, but also remove the dead bacteria. Using wipes that are not tested and validated for low endotoxins levels can exacerbate the situation and can often contribute to endotoxin contamination. Endotoxin testing is done using the Limulus Amebocyte Lysate (LAL) test method for the detection of endotoxins in the quality assurance of injectable drugs and medical devices.

Enter wipers Clean-room wipers are instrumental in solving this problem. If wipers are wetted with antibacterial agents, the bacteria are rendered non-viable. But just as important, the wipers entrap the dead bacteria and remove them from the wiped surfaces. This removal process is compounded when the treated surfaces are wiped with fresh wipers wetted with WFI (water for injection, itself filtered to remove any endotoxins) to remove the antibacterial solutions. A perceptive reader would point out that the wipers must also be low in endotoxins. Very true. Wipers are tested for endotoxin content to ensure that

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Low endotoxin wipes to the rescue they don't add significant amounts of pyrogens to the wiped surfaces to become part of the problem. It is worth noting that electronics and semiconductor manufacturers, which also utilise cleanrooms, do not concern themselves with endotoxins, since their products do not find their way into the human body. Endotoxins are primarily important to the health

care industries. As an example, medical device manufacturers are VERY concerned about endotoxins, because their products are meant to enter the body, either for diagnostic or remedial purposes. For further information on this, please see the Berkshire Technical Brief “Medical Device Contamination”. Need a low endotoxing wipe? Take a look at the Berk-

shire Low Endotoxin Wipes:

Low endotoxin wipes Low Endotoxin Cleanroom wipes engineered clean to meet the exacting standards of the pharmaceutical, healthcare, and medical device industries. Endotoxins pose a substantial risk to regulated industries. If not properly addressed within your cleaning

Our new line of Low Endotoxin wipes are lot-to-lot tested to ensure they meet or exceed the requirements set by USP & FDA standards based on the maximum allowable thresholds for endotoxins across key regulated industries. When used with antibacterial agents, our wipes excel at entrapping the dead bacteria from the surface when the proper wiping techniques are used. In addition, we

CPHI & P-MEC INDIA 2018 SPECIAL

recommend using WFI (water for injection) in conjunction with a low endotoxin wipe for effective removal of disinfectant solutions and endotoxins after surface disinfection has taken place to ensure you have neutralised the threat of endotoxins in your environment.

Contact person: Pang Yew Loong - S.E.A. Sales Manager Distributed in India by: Yogi Kripa Medi Chem

APPLICATIONS

Berkshire products are available in India by: Yogi Kripa Medi Chem, Ujjagar Chambers, 1st Floor, Next to Deonar Bus Depot, Deonar, Mumbai-88 Tel: +91.22.62364748 /49 www.yogikripa.com

◗ Injectables ◗ Implantable devices ◗ Instruments and tools ◗ Surgical kits

INDUSTRIES

◗ Pharmaceutical manufacturing ◗ Medical dxevice ◗ Biotechnology ◗ Biologics ◗ Healthcare / Surgical Suite ◗ Other key EPA, FDA regulated industries

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Anchal Gupta (Director) Email: anchal.gupta@yogikripa.com

Ref: https://www.berkshire.com/lear ning-center/endotoxins-pharmacutical-medical-device-danger

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December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

Refrigerated warehouse makes every doorway count New facility’s doors separate ambient, refrigerated and freezer storage to reduce energy consumption while optimising uptime. An insight by Gandhi Automations

andhi Automations is one of the leading diversified suppliers to the pharma sector, serving pan India customer accounts in more than 23 cities. Clean room doors (Prime Clean Reset) are designed for inside applications requiring limitation of leak flow. The perfect sealing properties of Prime Clean Reset provide environmental control and protect the inside environment against draughts, dust and dirt. Clean room doors provided by us also has self- repairing system. One of the most imperative aspects of clean rooms is the door you choose for clean room facility. Time for which door is open will play a critical factor in avoiding dirt, temperature, humidity etc. Opening and closure of door has to quick enough to isolate the two areas.

64 EXPRESS PHARMA December 16-31, 2018

At Gandhi Automations, we provide clean room high speed doors specifically designed for above purpose. Our clean room high speed doors are best suited for pharma industries where you need to have controlled environment. The opening and closing of door is fast enough to separate two areas. In the high-volume, 24/7 facility, turns in the cooler happen twice a day and, in the freezer, inventory turns occur every day and a half. With traffic streaming in and out of the building through 47 dock doors, losing a single high-traffic door could severely jeopardize deliveries. Prime Freeze High Speed Doors are a perfect solution where cold storage with negative temperatures to as low as – 22°F is required. The curtain is made of reinforced PVC

One of the most imperative aspects of clean rooms is the door you choose for clean room facility

vinyl with heated side guides. Optionally a special and innovative insulated flexible curtain is also available. High Speed Freezer Doors are the solution when temperature

control is critical and where forklift traffic is high. “If a cooler door is down, that could be detrimental to our operation,” says warehouse manager, who notes that a single inoperable door could cost 30 per cent of shipping capacity. “We cannot afford to lose an opening. We are hard on things, and that’s why we need durable doors.” High-speed freezer duo not only helps maintain temperature but also in human safety. high-speed freezer doors have a revolutionary soft bottom edge and sensor combine to ensure operator safety at all times. High-speed freezer duo doors curated by Gandhi Automations are sturdy, dependable and an ideal fit for maintaining temperature control. To prevent ice formation during intensive cooling, the highspeed freezer duo doors have

a functionality of partial and full opening. Its intelligent dual curtain technology - simultaneous open-and-close operation has blower/dryer to maintain temperature balance. Fast door speed also reduces the likelihood of panel collisions with tall-mast forklifts. In the event of a collision, the self-repairing system automatically resets the panel back into its guide without human intervention. To avoid accidental contact with door panels, an LED safety light system along the door columns warns employees when the door is about to close and when it is actually closing. Two photo eyes, (cells) a dual-pneumatic reversing edge and threshold warning lights will reverse the descending door panel if an employee is in the doorway.

CPHI & P-MEC INDIA 2018 SPECIAL

NEOMACHINE MFG CO: Aleader in automatic coating technology

olkata-based NEOMACHINE MFG Co was started in 1973 with an objective of manufacturing quality pharmaceutical machinery. For a decade, the company catered to the requirements of the Indian pharma companies in injectables, liquid, tablet, capsule and ointment sections machinery. NEOMACHINE started the process of developing an automatic coating machine for tablets. After, two years of research and development, the first NEOCOTA Automatic Coating System was manufactured in 1984.

During the last three decades, NEOMACHINE had manufactured and marketed more than 600 machines, out of which 100 machines were exported to the different countries like the US, Australia, China, Jordan, Yemen, the UAE, Uganda, Kenya, Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh, Bolivia, Nepal, Myanmar, Nigeria etc. and also going to export to Sri Lanka and Vietnam shortly. NEOMACHINE, a professionally managed organisation now have two manufacturing Units. During the last three decades, NEOMACHINE had manufactured and marketed

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more than 600 machines units in Kolkata, which are equipped with state-of-the-art equipment like fabrication, machining, assembling, finishing and other related jobs. The company has been strictly following all the quality control guidelines during manufacturing. The bought-out items are inspected at the manufacturersâ€™ works periodically. The company has got a dedicated team of engineers for providing erection and commissioning and prompt after-sales service to the clients. The in-house R&D facility is abreast with latest technology up-gradation and developments

in â€˜coating technology. This helps in continuous improvement of the product. We have developed in our R&D Machine called MINIMAX where coating can be started from 50 Gms.-150 Gms. & 150 Gms-250 Gms. NEOMACHINE also provides DQ/IQ /OQ/ documents for automatic coating system and are in the process of getting CE certification. NEOMACHINE being a single product company manufacturing only automatic coating system for coating of pharma tablets, pellets and gems products, have gained vast experiences in latest coating technology as well as validation and qualification of

coating equipment to qualify for the audit of various national and international agencies. The latest models of NEOCOTA are having all the constructional features for validation and qualification. The equipment are supplied with all the necessary documents for proper validation during installation and commissioning as well as trial production. Over the years, the company has gained vast experiences in manufacturing 'Automatic Coating System' by interacting with various Indian and multinational pharma and confectionery units based in India and abroad.

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December 16-31, 2018

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The United Engineering Company: Serving the pharma industry for the last five decades T

HE UNITED ENGINEERING COMPANY (UEC) with the brand name ‘UNITED’ is known for being the pioneer and commander in packaging machinery manufacturing in India. UEC, which was started in the year 1963 by GD Roy, has attained high reputation in providing machines and services of highest standards since the beginning. With the founder’s innovative ideas and unmatched leadership quali-

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery etc ties, UEC crossed various boundaries in different fields of work. Initiating the business with

solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and

has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for

its customers. With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others. The company has also expanded its footprints abroad in a large way. Today, ‘UNITED’ machines are exported to more than 21 coun-

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Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India. Board line: 0120-6651500. Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com

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IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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CPHI & P-MEC INDIA 2018 SPECIAL

tries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, the UAE, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others. UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘UNITED’ machines provide technically advanced solution for its cus-

been an active participant in numerous social events which help in uplifting the quality of living

of the deprived. With almost every pharma formulation manufacturer be-

ing an ‘UNITED’ machine user coupled with more than 50 years experience, UEC

commits in becoming better than the best in the near future.

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers tomers. Presently, UEC is having its head office in Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having its marketing and sales office in Mumbai to cater to the eastern part of the nation and overseas. The company has also set up well equipped service shop in Mumbai to service its clients. The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development and continuous value additions to the pharma packaging industry. Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service. UEC is equally focussed on being a corporate citizen. It has never shirked the responsibility of the society and has always

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December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

I N T E R V I E W

'Technology exchange will help us serve our home market' Sunil Saraf, Director, Remi Elektrotechnik talks about the company's future growth prospects in an interaction with Express Pharma

Tell us about the USP of REMI? Urge for innovative products, supplying excellent quality and exclusive products at reasonable prices has been the main USP of Remi, ever since its inception. Our R&D team is always on its toes and is driven for constant innovations and quality enhancement. Remi was the first manufacturer of certain unique products such as table top centrifuges, laboratory and magnetic stirrers, high speed (20,000 RPM) centrifuges, refrigerated centrifuges, blood bank centrifuges for component separation, mixers and shakers and biggest top entry agitator for fluid mixing in India. Tell us about your manufacturing capacity and capabilities Our manufacturing facility is located in Vasai (Palghar). The facility is spread across an area of 65,000 sq ft. which houses all different departments like design and development, fabrication, powder coating, assembly lines, quality assurance, packaging and dispatch. The installed capacity is more than 6000 units per month. We also have a dedicated test room to simulate different environment conditions to type test our products internally. How do you assure quality, sustainability and affordability of your product in the global and domestic market?

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Over the past six decades we have faced intense competition from many companies. However we have been able to sustain ourselves due to the unchallenged quality of our products, prompt technical services and more over wide range of products including laboratory and magnetic stirrers, bench stop and floor standing centrifuges in refrigerated and nonrefrigerated versions, shakers and mixers, incubators, stability chambers, cold cabinets, deep freezers, walkin chambers etc. Our products meet the requirements of global regulators like US FDA. Instruments like incubators, stability chambers, freezers, walk in stability chambers, cold rooms etc are supplied with proprietary “REMI datasoft” software which comply with the requirements of 21CFR part 11.

We, at Remi, are focussing on a two-pronged approach for the next five years, technological up gradation and global market expansion with our existing range of products

According to you, what steps should the government take to ease exports and what are your initiatives to achieve this? We truly appreciate the efforts taken by the Government of India for encouraging, Make in India concept and its development. Moreover, there is further scope to encourage indigenous companies, to export more Make in India products by extending export incentives etc. Being a global exporter of laboratory and blood bank instruments, it is imperative for REMI to get its

products and processes certified by international bodies. All REMI products have certifications recognised by international organisations such as ISO-13485 : 2016. ISO 9001-2015: Certifications for design, manufacturing and supply of laboratory and blood banking instruments, CE Marking: Important conformity standards in EU, all Remi products carry CE mark adhering conformity. Our manufacturing facilities adhere to WHO GMP GUIDELINES. What is the company’s road map for the next five years? We, at Remi, are focussing on a two-pronged approach for the next five years, technological up gradation and global market expansion with our existing range of products. Market expansion will ensure a global reach to strengthen and grow our market in the world and technology exchange will help us serve our home market and extended markets with the best products. Our historic and successful past has helped us to gather profound insights on the customers need in the segment that we are operating. We introduce a new product or upgrade our existing product based on our customer feedback. We see a lot of business opportunities in healthcare and medical devices market. EP News Bureau

CPHI & P-MEC INDIA 2018 SPECIAL

Disintegration testing of dosage forms Aditya Marfatia, Director, Electrolab and Dr Namita Varde,Application Scientist, Electrolab provide an insight on disintegration testing focussing on the transition from bath to bathless disintegration Disintegration testing of immediate release (IR) dosage forms such as tablets (coated, uncoated, buccal and sublingual) and capsules (soft and hard gelatin) allow companies to take critical go/no-go decisions early on during product development. In addition, it is a vital quality control test to ensure batch-to-batch reproducibility, thus facilitating batch release. This test is performed to make certain that the tablet/capsule disintegrates in the time specified in the individual monograph. Disintegration process occurs in two stages: i) tablet disintegra-

Aditya Marfatia, Director, Electrolab

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tion into granules; and ii) deaggregation of granules. Disintegration of an IR dosage form remains a prerequisite for API dissolution, subsequently followed by absorption and concurrent bioavailability. The USP has a dedicated general chapter on disintegration testing <701>, which is harmonised with the texts of the European Pharmacopoeia (EP) and/or Japanese Pharmacopoeia (JP). Disintegration testing was first mentioned in 1907 in Swiss Pharmacopoeia, which stated that the dosage form should dissolve or disintegrate post a short time after being

Dr Namita Varde, Application Scientist, Electrolab

placed in cold water. A disintegration test for tablets was later incorporated in the same pharmacopoeia in 1933. It stated that the test was to be conducted with a tablet placed in a 100 mL Erlenmeyer flask containing 50 mL of water at 37 Â°C that was to be swirled periodically. In 1948, the British Pharmacopoeia (BP) adopted disintegration testing of tablets based on observing disintegration behavior in test tubes. A specific disintegration testing apparatus was used for eight years by the US Army Medical Department laboratories, which later formed the

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December 16-31, 2018

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basis for the compendial basket-rack assembly apparatus. The basket-rack assembly apparatus was first adopted by the USP in 1950, which is the apparatus currently used to perform majority of disintegration testing of orally administered dosage forms.

Disintegration apparatus The basket-rack assembly is of two types: i) Apparatus A- for tablets/capsules measuring less than 18 mm in length; and ii) Apparatus Bfor tablets/capsules measuring more than 18 mm. The apparatus consists of a basket-rack assembly, a beaker for the immersion fluid (water or media specified in the individual monograph), a heater to heat the fluid to 37 °C and a device to lower or raise the basket in the immersion fluid. The basket-rack assembly in Apparatus A consists of 6 open-ended transparent tubes having a length of 77.5 ± 2.5 mm each, an inner diameter of 20.7 – 23 mm each and a wall 1 – 2.8 mm thick. Apparatus B consists of three large open ended tubes with an inner diameter of 32 – 34.6 mm each. The thickness of the wire should be 0.57 – 0.66 mm for apparatus A, whereas for apparatus B, it should be 0.60 – 0.66 mm according to EP and BP and 1/4 inch by the Dietary Supplements chapter of the USP. The design of the basket-rack assembly can be varied, provided the specification for the tubes and screen mesh size are maintained.

Figure 1: Disintegration Apparatus A (left) and Apparatus B (right) as per the USP guidelines

Figure 2: Disintegration tester Model EDI-2SA & screenshot taken from iDT-6

Evolution of disintegration testers Traditional disintegration testers consisted of a basketrack assembly, an immersion vessel, a water bath and a device to mechanically lower and raise the basket-rack assembly. A technician was required to manually lower the basketrack assembly before the test, feed the test duration and further monitor the basket for tablet disintegration, to stop the test accordingly. In recent years, automation has hit disintegration testing. The current disintegration testers can

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automatically lower and raise the basket-rack assembly into and from the immersion fluid and can determine the exact duration of tablet disintegration as well. A major transition is observed presently in the pharma industry in the utilisation of bathless disintegration testers in place of water bath disintegration testers. In bathless disintegration tester, a common or individual water bath is not present. Instead, there are temperature probes stationed in the immersion fluid itself, which can directly be used to measure the testing temperature. Some testers have temperature probes attached to the basket-rack assembly instead of being immersed in the beaker. In such cases, temperature fluctuations may occur as a result of the continuous vertical movement of the basket-rack assembly into/out of the beaker. Moreover, when the basket is parked outside, the temperature may not be logged prior to starting the test and starting the test prematurely when the temperature has not reached to USP specifications, can lead to inaccurate and variable data. As a consequence, positioning of the temperature probe in the basket-rack assembly may not be optimal. The bathless heating saves time, electricity and water. From a drug testing standpoint, the 483’s that can be observed during bath disintegration testing include water quality concerns in terms of microbial/fungal contamination, cleaning cycle validation, etc. In order to reduce the regulatory burden, the shift towards bathless disintegration testers was vital. Bathless disintegration testing is at present a well established and proven technique.

ets in this model allows for unobstructed visualisation of the tablet disintegration process. EDI-2SA is a semi-automatic bathless disintegration tester fully compliant with USP, IP, BP and EP specifications. The customers of Model EDI-2SA have expressed satisfaction post transitioning into this bathless tester. Bathless heating feature of this tester facilitates better water management. Attainment of media temperature is 30 per cent faster compared to water bath disintegration testers. Individual heating of beakers facilitates testing of products at two different temperatures. This tester offers disintegration time registration for individual tablets, which means the disintegration time for individual basket tube can be registered. It provides multilevel user securities. The green illumination from bottom for active arm offers better visibility of the disintegration process. In addition, this tester has an individual motor and timer with external temperature probe for each basket. It has a unique camless drive, an ergonomically designed and magnetically coupled basket for easy loading. The basket parks out from the immersion fluid beaker post test completion. This is advantageous for routine quality control testing of dosage forms with known disintegration times. Product data can be fed manually into the tester with an optional splash resistant keyboard. For data collection and analysis, the test results can be printed directly. This tester can also be integrated with the biometric kloudface system. In addition, it can also be integrated with iDT, which allows for photo/video recording of the tablet disintegration process.

Key features of EDI-2SA

fig-2 EDi2sa with idt and icons

EDI-2SA is the first bathless disintegration tester in the world, which does not utilise any foreign objects for attaining temperature, which remain in contact with the immersion fluid. In addition, the absence of water bath or heating jack-

References 1. <701> Disintegration chapter - USP 2. Gousous et al, Oral Solid Dosage Form Disintegration Testing - The Forgotten Test, Journal of Pharmaceutical Sciences, 104:2664-2675, 2015

CPHI & P-MEC INDIA 2018 SPECIAL

Analytical techniques with a place in the oral solid dosage formulation toolkit Stuart Wakefield, Regional Manager-Middle East and India, Malvern Panalytical in this article gives an insight on the steps involved in moving from a drug substance to a successful oral solid dosage (OSD) form, and at the analytical technologies that can be helpful

ver the past two decades the empirical processes which once characterised pharmaceutical development have steadily given way to the more systematic, knowledge-led approach enshrined in Quality by Design (QbD). A QbD strategy builds quality into a product from the outset through the development of a detailed understanding of the factors that influence clinical efficacy, and of an effective control strategy for manufacture, based on the mitigation of risk. The starting point for pharma product formulation is an identified, active drug substance. The goal of formulation development is to incorporate this substance in a product and to develop a manufacturing process that will deliver that product securely and consistently.

product are the variables that directly impact clinical efficacy and quality, in other words those that impact the QTPP. So, for example, a CQA for an OSD might be dose uniformity, since this impacts the amount of drug delivered with each tablet, and the efficacy of the product. ◗ Determining the CQAs of the drug substance and excipients: These are different from the CQAs for the finished product. For example, while the disintegration characteristics of a tablet might impact how quickly drug substance particles are released from the tablet matrix, it could be the size of those particles that influences the rate of dissolution of the drug, and consequently bioavailability.

◗ Selecting an appropriate manufacturing process: Once the formulation is de-

fined then attention shifts to identifying how to make the product consistently, as efficiently as possible. ◗ Defining a control strategy: The final element of pharma development is to identify which variables must be controlled during manufacture to ensure that the defined quality targets are met. Timely and efficient monitoring and control technologies are required for successful implementation. QbD wraps around all of these steps and influences the rigor and approach that is taken in tackling them. For example, a QbD approach to investigating the CQAs of the drug product might extend to developing functional relation-

Characterising the drug substance

The regulatory framework and QbD ICH Q8(R2) provides detailed guidance about pharma development and suggests that the following steps represent a minimal requirement for success: ◗ Defining the quality target product profile (QTPP): Developing the QTPP requires consideration of how the drug substance will be delivered, the form the pharma product will take, the strength of the drug, its bioavailability, and how stability will be maintained within the manufactured product. ◗ Identifying the critical quality attributes (CQAs) of the product: The CQAs of a

ships between these CQAs and critical material attributes (CMAs) and process parameters (CPPs Implementing a QbD approach demands a greater understanding than more empirical approaches and is therefore associated with the more secure demonstration of risk mitigation. Manufacturers that adopt this approach are therefore permitted the freedom of changing operating conditions within the defined design space: a valuable prize. In summary though, the fundamental steps involved in pharma development are identical with or without QbD. Focussing on the information required to drive these steps helps to identify analytical strategies that can support the formulation work flow.

Figure 1: Automated imaging is an efficient technique for differentiating polymorphs of a drug substance

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In the early stages of formulation, the focus lies on the drug substance itself and how to deliver its therapeutic effect to the patient. The pharmacological profile of a drug substance can be influenced by both biological and physicochemical properties. Understanding the impact of these properties helps with the development of a detailed specification for the drug substance and other aspects of the QTPP such as the quantity of drug substance in each tablet. ICH Q6A is helpful in identifying which tests are required to securely characterise the drug substance in an IND or NDA situation and suggests that the specifications for the

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drug substance might relate to: ◗ Physical properties such as pH, refractive index, melting point ◗ Particle size ◗ Polymorphic form/amorphous content ◗ Chiral identity ◗ Water content ◗ Inorganic impurity levels ◗ Microbial content Many of these properties can influence the performance of the product in a number of ways and will therefore go on to be identified as CQAs for the drug. For example, particle size can affect the dissolution, solubility or bioavailability of the drug in a tablet and also, perhaps less obviously, impact the processability of a tablet blend. For the majority of pharma applications, the need for particle size information, and particle size control, is efficiently met by laser diffraction. Other critical drug properties, such as polymorphic form, are less readily characterised. Many drugs exist in multiple crystal forms. If a certain polymorph is identified as having desirable characteristics, then the presence of others may have a detrimental effect on the product. Manual microscopy is one technique for differentiating crystal forms, but it can be both time-consuming and subject to operator variability.

Figure 2: Raman spectra for polymorphs A (orange line) and B (red line). Between 1120 – 1300 cm-1 the spectra are clearly different enabling the reliable classification of particles that are closely similar in morphological form

Case study: Using MDRS to differentiate drug substance polymorphs The technique of MDRS (Morphological Directed Raman Spectroscopy ), as its name suggests involves using morphological data to guide the efficient application of Raman spectroscopy, which in turn provides chemical identification. The technique is implemented using an automated imaging system with spectroscopy capabilities, such as the Morphologi M4ID, Malvern Panalytical. Figure 1 shows images of two different polymorphic forms of a drug substance, measured using a Morphologi M4-ID. Polymorph A and B have distinctly different morphologies; the former has a

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Figure 3: Triple detector GPC/SEC reliably and directly measures the absolute MW of polymeric excipients for controlled release, providing data that supports identification of a suitable candidate for the any specific formulation

square-like crystalline form and the latter a needle-like structure. Automated imaging, which can gather tens of thousands of particle images in just minutes, therefore delivers relatively reliable differentiation between the two polymorphs. By applying size and shape classification it is possible to identify individual particles as polymorph A or B with a high degree of accuracy. However, the sample images below exemplify a small population of particles that may be

less securely classified on the basis of size and shape alone. Different crystal structures produce different Raman spectra so bringing spectroscopy to bear, to characterise particles that are not clearly one polymorph, or the other, provides confirmatory data. Figure 2 shows the Raman spectra for polymorph A and B. For the most part the spectra are closely similar and overlay one another. However, there are clear differences within the 1120 – 1300 cm-1 re-

gion. Focussing analysis in this region allows reliable differentiation between particles of closely similar morphology.

Introducing excipients Once a detailed profile of the drug substance has been developed, the next step is to identify the excipients that are required to successfully formulate the drug substance within a tablet. The role of excipients varies considerably depending on the drug substance and the required clinical effect. In some

instances, controlled release agents are incorporated to tailor the rate at which the drug substance is released in vivo. In others, excipients enhance the handling characteristics of the tablet blend, by improving bulk properties such as powder flow, bulk density or compressibility. An excipient may therefore directly influence the QTPP and be associated with a product CQA such as rate of drug substance release. Alternatively, the impact on the QTPP may be less straightforward. By altering the bulk properties of the blend, a poorly specified excipient may compromise manufacturing performance and lead to the production of sub-standard products, tablets with poor mechanical properties that are unstable and/or

For the majority of pharma applications, the need for particle size information, and particle size control, is efficiently met by laser diffraction have an inconsistent disintegration profile, for example. Assessing the potential for excipients to impact processability is therefore important. In summary the choice of each excipient and its grade is guided by the need to: ◗ Identify any product CQAs that may be impacted by the excipient, either directly or indirectly, and select a material that will deliver the performance set out in the QTPP. ◗ Understand how the CMAs of the excipient, such as molecular weight (MW) or parti-

CPHI & P-MEC INDIA 2018 SPECIAL

cle size, affect the product CQA. ◗ Establish specifications and acceptance criteria for an excipient that will ensure it performs successfully within the formulation. The following case studies illustrate how gel permeation chromatography/size exclusion chromatography (GPC/SEC) and laser diffraction particle size analysis can be helpful in building the understanding necessary to identify an appropriate excipient and grade.

Table 1: Comparison of Mw data reported using Triple Detection and conventional GPC/SEC. Data reported by the TDA system include the molecular size (Rg(w) and Rh(w)) and intrinsic viscosity (ηw)

Case study: Selecting an excipient for controlled drug release [1] Polymers such as Hypromellose (Hydroxypropyl Methylcellulose, HPMC) and its derivatives are commonly used

Triple detection also provides molecular size and intrinsic viscosity data which can be used to quantify important structural features of a polymer such as the degree of cross linking or chain branching as controlled drug release agents. The grade of the polymer used directly affects the release profile of the drug substance making it a CQA. The effective use of these materials relies on understanding the polymeric characteristics that define performance which are MW, MW distribution and

Figure 4: Particle size distribution data highlights the ability of laser diffraction to precisely determine the amount of fines in lactose grades containing coarse and fine material

polymer. Figure 3 shows MW distribution data for four samples of HPMC and the derivative excipient Hypromellose acetate succinate (HPMCAS) measured with a triple detector GPC/SEC system - Viscotek TDAMax, Malvern Panalytical. In addition, the contrast between the MW data generated with the triple detector array with that produced using just a single RI detector is also shown indicating the substantial, and variable, inaccuracies that can be introduced by relying on calibration of the system with a standard. Triple detection also provides molecular size and intrinsic viscosity data which can be used to quantify important structural features of a polymer such as the degree of cross linking or chain branching. These features also contribute to the functionality of the polymer excipient within a tablet blend and can be investigated to provide additional information on which to base excipient grade choice.

Case study: Selecting excipient grade

Figure 5: Measurements of the particle shape of the drug substance reveal that blending results in a reduction in elongation that is suggestive of particle chipping (from reference [2]).

chain structure. Multi-detector GPC/SEC can be used to measure these properties. GPC/SEC is a two-step process. The first step involves separation of a solution of the polymeric sample, on the basis of hydrodynamic volume, using a packed column.

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The second is analysis of the resulting size fractionated eluent stream using one or more detectors. Conventional GPC/SEC systems employ only a single refractive index (RI) to measure concentration and rely on calibration curves to generate relative (to a stan-

dard) MW data. In contrast, the use of a detector array that additionally incorporates a light scattering and viscometer detector enables the measurement of absolute MW without any requirement for calibration and provides structural information about the

Lactose is a prime example of an excipient that is most usually added to a formulation simply to provide bulk and enable accurate dosing. Choice of lactose grade is therefore governed not by any direct impact on functionality but rather by the effect of the lactose on processability. The particle size and particle size distribution of the lactose impact powder flowability, compressibility, and the likelihood of segregation and are therefore often identified as CMAs. Laser diffraction is an ensemble particle sizing technique that measures the particle size of either wet and dry samples containing particles in the size range 0.01 μm to 3500 μm. Figure 4 illustrates the use of laser diffraction to measure the particle size distribution of different lactose blends, some of which contain very small amounts of fines. These data were measured using the Mastersizer 3000, Malvern Panalytical.

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CPHI & P-MEC INDIA 2018 SPECIAL

Making the product, bringing the API and excipient together After formulation has progressed through the characterisation of individual ingredients the focus of the workflow shifts to bringing the drug substance and excipients together. At this stage it is essential to ensure that the individual ingredients within a formulation remain in the required state, after they have been combined. In most cases, it is the fine drug substance particles that are most susceptible to changes, and indeed of most interest, because of the potential for impacting the QTPP. Changes in particle size, shape or polymorphic form may all occur during mixing and processing. Being able to isolate and characterise the drug substance within the blend is therefore crucial.

sistent manufacture of products that meet the defined specification. In- or on-line Process Analytical Technology (PAT) can be helpful here in delivering timely monitoring and the necessary control. For example, real time particle sizing during granulation or milling helps analysts determine that particles meet a size specification that will deliver desirable process performance and ensure that the final tablet meets the QTPP.

Figure 6: An in-line particle sizing probe allows real-time continuous monitoring of a wet granulation process

Case study: Monitoring process induced changes in an API [2] The ability of MDRS to detect changes in individual components within a multi-component blend enables an assessment of any changes to the drug substance induced by processing. In this case study, an investigation was carried out to assess the impact of processing on the morphology of a drug substance within a tablet blend, with the goal being to understand if blending caused particle break-up. Data were obtained for the blending of the drug substance with three different excipients: lactose, microcrystalline cellulose (MCC) and a mixture of lactose and MCC. Figure 5 shows how the elongation of the drug substance particles changes, as a result of blending. Elongation is a shape parameter defined by the formula (1 â€“ width/length). Needle-like particles will have an elongation close to 1, whereas regular-shaped particles, such as spheres, will have an elongation ratio of close to 0. In this case blending clearly had a marked impact on elongation

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December 16-31, 2018

Figure 7: The distance between the tablet and the spray nozzle impacts the delivered droplet size, and consequently the quality of the applied coating

which is lower in, all of the blended samples, suggesting that the drug substance particles become less needle-like in shape as a result of this processing step. Detecting this particle breakage mechanism is important, since it can increase the amount of drug substance fines in the blend. This may lead to an increase in processing problems, such as the risk of adhesion to equipment surfaces during subsequent

stages of the process, and, ultimately, impact dose content uniformity and bioavailability.

Optimising the manufacturing process Once there is a secure understanding of how to formulate the excipients and drug substance within the laboratory environment, the manufacturing process becomes a primary focus. In tableting processes the first step is often granulation. Granulation

of a tableting blend helps to reduce the risk of segregation and can improve the processability of the blend. Milling and lubrication of the resulting granules produces an optimised, homogeneous feed for the tablet press. Spray coating of the tablet is usually the final production step. Measuring and controlling the properties that impact the CQAs of the product, at each stage of the manufacturing process, safeguards the con-

Case study: Monitoring the evolution of particle size during wet granulation High shear wet granulation offers a number of advantages relative to alternative granulation techniques [3] and is often selected for tablet manufacture. In this unit operation a granulating liquid is used to bind the particles together in a high shear mixer. Particle size measurements can be used to control granulation to a desirable endpoint and also to compare the trajectory of granulation processes at different scales. In-line particle sizing probes such as the Parsum IPP70 (Malvern Panalytical) use spatial partial velocimetry [3] to measure particle size in real-time and have proven application as PAT for granulation monitoring. A key feature is the robust nature of the probes which enables continuous, reliable particle size measurement in the moist, fouling environment of the granulator. Figure 6 shows the evolution of granule size during a high shear wet granulation process, measured using an inline Parsum probe. Changes in granule size at each stage of the process are clearly evident and the granulation is efficiently tracked through to a defined endpoint.

Case study: Optimising spray coating Water-based solutions or suspensions containing an appropriate polymeric excipient are often used to impart a final coating to a tablet. These

CPHI & P-MEC INDIA 2018 SPECIAL

coatings are typically delivered using a pressurised spraying process with the aim of rapidly and uniformly coating the tablet with a coating of controlled thickness. The quality of the finished coating is highly dependent on the droplet size of the sprayed coating which impacts transfer efficiency (TE), coating uniformity and finish. Droplet size must therefore be optimised and controlled during the spray coating process. CPPs for this step may include the viscosity of the coating formulation, the distance of the spray nozzle from the tablet and the pressure at which spraying takes place. Figure 7 shows how the delivered particle size distribution of droplets of a spray coating solution varies as a function of distance from the spray nozzle (become larger as the distance between the tablet and the nozzle is increased). These data were measured using a Spraytec from Malvern Panalytical, an instrument designed specifically for the real-time particle sizing of sprays. The data presented in Figure 8 shows how particle size distribution varies as a function of spray pressure, across the range 30 – 200 bar. These results

automated imaging, MDRS and GPC/SEC can be applied within the context of modern formulation practice to rapidly advance to full-scale manufacture.

References

Figure 8: Increasing spraying pressures decreases the size of droplets produced during a spray coating process

quantify the extent to which droplet size decreases with increasing pressure. For this particular coating and nozzle, the median size at 30 bar is 42 μm but reduces to 28 μm at 200 bar.

Conclusion In recent decades formulation has become an increasingly

systematic, knowledge-driven process. Successful formulation relies on developing a detailed scientific understanding of the behavior of individual components within a drug product, and of the how constituent elements can be brought together to meet pharmacological targets, both in

the laboratory and into commercial manufacture. The widespread adoption of QbD reinforces this trend and intensifies the requirement for analytical techniques that can deliver the information needed in a timely and efficient way. The use of analytical techniques such as laser diffraction particle size analysis,

1. Chen R.,“ Characterization of Hypromellose Acetate Succinate by Size Exclusion Chromatography (SEC) Using Viscotek Triple Detector”, International Journal of Polymer Analysis and Characterisation,14:7,617-630 2. Gamble, J et al “Monitoring process induced attrition of drug substance particles within formulated blends,” International Journal of Pharmaceutics 470 (2014) 77-87 3. ‘Real time particle sizing for granulation control’ Malvern Instruments white paper. Available for download at: http://www.malvern.com/en/support/resource-center/Whitepapers/WP130226RealTimeParticleForGranulat.aspx Contact details Malvern Panalytical Naimex House, A-8 Mohan Co-operative Industrial Estate, Mathura Road, New Delhi – 110044 Tel : 011-30810244 Fax : 011-26950011 Email : delhi@aimil.com

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regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph. Preferably in colour, postcard size and with a good contrast.

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December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

Preserve the patients’eyes,not the drug P

reservatives are necessary evils in the conventional three piece multi dose eye drop vial, as the ambient non-sterile as well as the left over drop exposed to ambience environment renters in the vial from the same path as that of the drug flow path contaminating the liquid inside. Preservatives are added, as mandated, to prevent the growth of microbial contaminants and biodegradation in the formulations. Thus, preservatives have become a key component in ophthalmic formulations to keep the sterility of the product, widely used preservatives are: ◗ Benzalkonium chloride (BAC/BAK), ◗ Stabilised Oxychloro Complex (SOC)

TABLE 1

Owing to the potential adverse effects of ophthalmic preservatives, there is an increasing need for preservative-free ophthalmic products among the consumers

the solution that provides the benefits of the medication without the ill effects of any preservatives. The state-of-the-art patented pure flow technology prevents bacterial contamination and avoids the need of preservatives in the formulation. Benefits major of these preservative-free multi dose formulations are listed in Table 2. Working of the preservative free system in can be better understood correlating the below process shown in Table 3. On squeezing the bottle the liquid flows out of the bottle through a defined path dispensing uniform dosage (❏) Contaminated air (❏) or contaminated liquid from atmosphere cannot flow back into

the bottle due to the presence of non-return valve in the nozzle. (❏) Air compensation happens by entry of ambient air or liquid from ambient atmosphere through the aperture provided on the side of the bottle, through the continous silicon membrane which allows only gases to flow through, arresting the microbes. (❏) The functioning of the system can be summarised in a nutshell in four simple steps as mentioned in Table 4. In Novelia bottles main functions are achieved by Valve system: which opens to deliver accurate drop and closes to avoid any backflow Venting system: which allows only the filtered sterile air to enter the device after drop delivery due to the presence

Functioning of the Preservative-free system in a nutshell

◗ SofZia Though preservatives help keep the formulation sterile over the course of multiple uses, various studies have proved that preservatives used in long term therapy induces ocular toxicity and causes harmful effects to your eyes such as Tear film instability, Conjunctival inflammation, Ocular discomfort, Corneal Surface impairment and more mentioned in Table 1. Novelia,’ a technology from France, brought in India for the first time by Kilitch Healthcare India Limited, is

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December 16-31, 2018

TABLE 3

CPHI & P-MEC INDIA 2018 SPECIAL

of silicone membrane.

Major challenge test done to prove the ability of above functions: ◗ To challenge the valve system tightness to micro organisms with vaccum in the container. ◗ To challenge the ability of venting system to protect content against contamination ingress. ◗ To challenge the ability of Novelia bottle to keep the contents sterile even after repetative contact of the tip of the device with contamination. ◗ To challenge the ability to keep contents sterile during a three-month treatment and to check that Novelia bottles has the same functioning after three months of use. ◗ To challenge the compatability between the Novelia silicon parts and our formulations.

Conclusion Novelia bottles pass in all the above challenge test, demonstrating that the different technical functions of Novelia are able to protect content against contamination. FAQs Does preservative help to keep the drop efficacy? Preservatives are added to formulations to prevent decomposition of drug content due to microbial growth. In traditional eye dropper bottle, as external ambient nonsterile air comes in contact with the drug, inducing microbial growth, preservatives are added. It is myth to say that preservatives help to keep the drop efficacy.

In Novelia technology does the efficacy of the product remains same even after one month of opening the cap? In Novelia technology, ambiant non sterile air passes through the homogenous silicone membrane, blocking any potential bacteria and only allowing gasses to flow through, hence the product remains

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December 16-31, 2018

sterile and efficient all throughout its shelf life even after opening. Preservatives have no effect on efficacy of drug, so drops even after one month will be sterile and as efficient as first drop.

Does the residual drop on the tip of the bottle get wasted? In Novelia technology during instillation even if there is a residual drop remaining on the tip of the bottle, it does not get wasted for the follow-

ing reasons: ◗ On closing of the bottle with the cap, the drop remains sterile as the inner surface of the cap and the top of the bottle contains silver ions which avoids any bacteria growth

◗ When it is squeezed for a second time, this residual drop will be part of the new drop.

Contact details info@kilitchhealthare.com

CPHI & P-MEC INDIA 2018 SPECIAL

Ion Exchange introduces INDION LAB-Q series of products for High PurityWater They are compatible with multiple clinical analysers with different water dispensing capacities, developed by blending highly advanced technologies (RO, UV, UF and DI) and maintain international standards

on Exchange (India) has introduced INDION LAB-Q Water maker series of products that provide high purity water for multiple diagnostic applications in line with Clinical Laboratory Reagent Water (CLRW) and American Society for Testing and Materials (ASTM) standards. Ion Exchange, a pioneer of water treatment in India, with a legacy spanning over five decades offers complete solutions for water, waste water management, solid waste management and now waste to energy. Tap water has many contaminants and should not be used directly in laboratories or for scientific purposes. Impurities, elements or compounds in amounts as small as one part per trillion, can significantly influence results in many clinical research experiments. Heavy metals and dissolved organics, commonly found in tap water, are particularly damaging to the results in life science research. Some analytical techniques such as High Performance Liquid Chromatography (HPLC) which use detector base lines for calibration require ultra pure water completely free of any impurity so that the results remain uninfluenced. The water must especially be free of any elements that are being measured. INDION LAB-Q units are compatible with multiple clinical analysers with different water dispensing capacities. The products are developed by blending highly advanced technologies (RO, UV, UF and DI) and are manufactured in India

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while maintaining international standards. INDION LAB-Q series is available in the following variants: 1. INDION LAB-Q ULTRA â€“ Type I Water Maker: LAB-Q ULTRA is a multipurpose water purification unit which can produce Ultrapure Type I and Type II water directly from tap water. LAB-Q ULTRA produces pyrogen and DNAseRNase free water with very low

Total Organic Carbon (TOC) content thus meeting the requirements of liquid chromatography and all spectroscopy methods, in addition to microbiological and molecular biology applications. 2. INDION LAB-Q SMART Type II Water Maker: Pure water produced by LAB-Q SMART complies with the requirements of ISO 3686 and corresponding ASTM standards. LAB-Q SMART pro-

duces water with very low organic carbon content. This Type II water can be used as feed for Type I water, clinical analyzers, flame spectrometry electrochemistry, sample dilution, media â€“ buffer preparation and radioimmunoassay. 3. INDION LAB-Q Water Maker - Type III Water Maker: Lab Q water maker provides cost effective continuous uninterrupted water supply for clinical analyzers. Analyzers are

traditionally fed by water stills or bottled water. LAB-Q Water Maker provides a fit and forget solution reducing energy consumption and providing ease of logistics. Different standards of purity are required for different applications. The LAB-Q series of products provide unmatched superior quality water that perfectly complements the requisite laboratory procedure or appliance.

CPHI & P-MEC INDIA 2018 SPECIAL

Metal detectable silicone rubber: Aunique solution to multiple industries Nikunj Thakkar, Asst Manager – R&D, Ami Polymer, gives an insight on the advantage of metal detectable silicone which has become a unique solution to avoid contamination in production line

roduct quality is a matter of bigger concern in pharmaceutical, food and beverage industry. Major processing steps involve the dynamic movement of silicone rubber parts. Silicone is most preferred choice for sealing application in food and pharma industry. There was a risk of silicone rubber particles getting mixed into the products during the production process, due to natural wear and tear. This kind of contamination can cause serious quality problems during the production and it may affect the reputation of the company.

Scope of metal detectable silicone rubber To ensure that the product is free from contamination, the idea of metal detectable silicone arose. As the name suggests, metal detectable silicone rubber is a unique solution to avoid contamination in production line. Metal detector devices can detect silicone-based products made from this unique formulation. During mass production, if the device generates any signal of metal presence in product due to failure of seal or abrasion of gaskets, the line can be stopped immediately. Due to the safety and cost-effective solution, metal detector silicone rubber products are becoming the best solution for pharma, food and beverage industry.

FDA approved metal detectable silicone rubber: A challenge Designing formulation as per food and pharma regulatory compliances is really a challenging task for rubber formulators. To maintain food properties along with metal detectable formula is a matter of expertise, which is required to be placed for balancing both properties. Few silicone products are used in food and pharma product contact applications with the following required compliance:

FDA approved metal detectable silicone rubber and its applications

The above mentioned products can be traceable through X ray devices. Any small segment of rubber contamination with drug products can be traced through devices and defected products can be separated due to this innovation. The market of metal detectable silicone is growing and many industries are waiting to taste fruits of this development. Polymer industries are developing multiple application of this formulation and we expect that conventional silicones will be soon replaced with metal detectable silicones. Contact details Ami Polymer # +91 82389 22236 research@amipolymer.com

Silicone Diaphragms FOOD/PHARMA grade, platinum cured silicone is widely accepted in pharmaceutical and biotech applications and is often used throughout the plant. Like all of our diaphragm materials, our silicone diaphragms meet USP Class VI and FDA 21 CFR 177.2600 standards.

Features and benefits ◗ All diaphragms meet USP VI standard and are FDA CFR 177.2600 compliant ◗ Meets the standards for quality, purity, lack of toxicity, strength and consistency

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Clean room high speed doors a necessity I

f your business entity requires a designated area for clean manufacturing, Gandhi Automations offers a variety of energy efficient clean room high speed doors. These are suitable for even busy openings in a controlled environment with a guarantee to protect from airborne contaminants. Cleanroom space is a worthwhile investment for a firm as it assures improved quality in production which interprets to a better financial yield. High speed doors for such rooms have multiple benefits such as stabilising the pressure levels as well as reducing air leakage out of the room. This feature has been revolutionary in the industrial process finding application in production of medical equipment and its packaging, pharmaceutical industry, manufacture of computers and electronics, food processing and even in the manufacture of military technology.

Best choice of clean room high speed doors Once the nature of production for a product is understood one needs an experienced partner to guide in making an informed choice of high speed clean room doors. At Gandhi Automations, esteemed clients are given top priority, walking them through different products in order to pick out clean room doors that will serve them better. One of the key considerations to make is the overall time the door will take to close once opened. The objective here is to isolate the external environment to avoid entry of dust, humidity and altering the internal temperature of your cleanroom. The door then has to be designed to facilitate high speed open-

80 EXPRESS PHARMA December 16-31, 2018

ing and closure to serve the stated function. The doors meet unmatched quality standards both in the local and international market hence providing and sustaining a controlled environment in any given clean room.

Top features of our high speed clean room doors Gandhi Automations carefully designs its doors incorporating emerging technological trends in order to give a superior high speed door that will have extended durability once installed. Such features entail: ◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off : +91 22 66720200 / 66720300(200 Lines) Fax : +91 22 66720201 Email : sales@geapl.co.in Website : www.geapl.co.in

CPHI & P-MEC INDIA 2018 SPECIAL

Cole Parmer: Preferred partner to scientific and engineering community since 2006 in India The company’s close association with the pharmaceutical industry has enabled them to develop products and solutions to meet industry’s stringent requirements for testing and manufacturing

ith over 60 years in the Industry, ColeParmer is a leading manufacturer and supplier of fluid handling, environmental testing, electrochemistry, general laboratory equipment and consumable supplies. The company’s close association with the pharmaceutical industry has enabled them to develop products and solutions to meet industry’s stringent requirements for testing and manufacturing. Their application knowledge and expertise combined with in-depth understanding of customers’ needs enables them to provide integrated solutions that address their customer’s requirements. Cole-Parmer today is seen as a substantial, superior value, one-stop package of innovative products, quality service and technical support. Cole-Parmer has established a strong presence in the last 12 years in the Indian pharma and biotech markets. For biopharma product development, ColeParmer is proficient in providing custom solutions and scale-up assistance from R&D to pilot and to manufacturing. Carrying on the strong foundation, the company aims at continuous growth and therefore is meticulously investing in enhancing its product portfolio. It has added many renowned brands in the last three years to strengthen it’s Pharma portfolio – Techne, Jenway, Stuart, Electrothermal, Argos Technologies, Kinesis, Vaplock, Traceable, and Ismatec to name a few. Cole-Parmer offers complete solution from research to process applications. Whether it’s a lab set-up or scale-up, the company has wide range of products and services to offer. In

the bioprocess research and manufacturing space, ColeParmer is the most trusted choice for their Masterflex Peristaltic Pumps and fully validated pharma tubing. Other key application areas, in which end-toend customised solutions are most looked for are aseptic fluid transfer, including a wide range of single-use products such as bioprocess bags and liners, manifolds, and EZ Top container closures. The company has also very rapidly expanded its offerings in safety and cleanroom consumables. Cole-Parmer is amongst very few companies who manufacture pharmaceutical latex gloves, specifically made for pharmaceutical applications addressing related stringent regulatory concerns. The company today has an extensive range of latex and nitrile gloves for various pharma applications like research, cleanroom, oncology, chemical handling, and delicate object handling etc., provided with complete validation sup-

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swabs etc, meeting requirements of cleanroom environment. Range of plasticware and labware is also added to the consumables portfolio, for customers to get complete solution for their cell culture and research applications. Another recent addition to the portfolio is chromatography end-to-end solutions, which includes HPLC and GC columns, protein separation columns, fittings, Vaplock solvent delivery and waste systems, SGE micro syringes, D2 & HC lamps and vast range of AccuStandard standards. The company is also known for vast range of lab equipment and essentials, which include stirrers and mixers, baths and circulators, melting point apparatus, spectrophotometers, reaction stations, cell culture solutions, temperature products, and data loggers, to name a few. In addition to Cole-Parmer’s portfolio of proprietary and industry-leading brands, the company is renowned for offering exceptional service and technical support. Customers rely on the company's team of trained and experienced application experts for help in selecting the right product for their application, troubleshooting existing equipment, and solving regulatory compliance issues. It all adds up to a promise that Cole-Parmer as ‘Scientific Experts’ works to fulfil every day: delivering solutions customers trust and therefore is considered as preferred partner for end-to-end solution to the scientific community. port including factory audit, making it a reliable choice for the customers. Cleanroom range also in-

cludes apparels, microfiber wipers, goggles, chairs, shoes, and cleanroom supplies like mats, paper, mops, rollers, and

For more details visit ColeParmer.in, or contact at 022-6139-4444 / response@coleparmer.in

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Virosil Pharma: ASwiss eco-friendly disinfectant Virosil Pharma effectively protects critical surfaces that come in contact with pharma products

anosil Biotech, a Mumbai based company is the first company to pioneer the novel concept of ecofriendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with Silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine based disinfectants have been feared. Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, SunPharma, J&J, Abbott, Serum Institute,

Dr Reddy’s, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, Reliance Life Sciences, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Virosil Pharma effectively

protects critical surfaces that come in contact with pharma products. Manufacturing, filling, packing and storage areas; Instruments, equipment, water tanks and pipelines – can now be pathogen free. What’s more, there’s no need to re-wash disinfected surfaces or instruments since

H2O2-based Virosil Pharma safely decomposes into water and oxygen. The formulation has been tested in various reputed institutions in Switzerland, France, Germany, Australia and India.

MIC determination Method Based on modi-

fied BSEN1276 (antifungal), BSEN 1650(antibacterial) Objective To determine the minimum inhibitory concentration (MIC) of Virosil against standard microbial cultures. Test organisms 1) Escherichia coli ATCC10536

RESULTS TABLE 1- COUNT OF STANDARD CULTURE INOCULUM USED Standard Culture

CFU/ml

Log Value

S. aureus

400000000

8.6020

P aerugilosa

380000000

8.5797

E coli

370000000

8.5682

C.albicans

99000000

7.9956

A niger

88000

4.9444

RESULTS TABLE2- MICROBIAL COUNTS POST DISINFECTANT EXPOSURE IN CFU/ML Microbial Counts in CFU/ml

Microbial Counts in Log Values

Log Reductions

Virosil 5%

Test Organism 3 mins

15mins

30 mins

3 mins

15mins

30 mins

3 mins

15mins

30 mins

3 mins

15mins

30 mins

S. aureus

37000

1000

4.0338

5.6020

6.9030

4.5682

1.6989

99.99

99.9997

99.9999

P aerugilosa

75000

<10

<103.7047

>8.5797

4.8750

<1.0000

99.9802

>99.999

E coli

42000

<10

3.9449

>8.5682

4.6232

<1.0000

99.9886

>99.999

C albicans

<10

>7.9956

<1.0000

>99.999

A niger

<10

3.9444

>4.9444

1.0000

<1.0000

99.9886

>99.99

Highlighted values indicate MIC achieved as > 5 log reduction in Bacterial counts (BSEN 1650), > 4 log reduction in fungal counts (BSEN 1276)

82 EXPRESS PHARMA December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

2) Staphylococcus aureus A TCC6538 3) Pseudomonas aeruginosa ATCC9027 4) Candida albicans ATCC 10231 5) Aspergillus nigerATCC 16404

and against five different standard microbial respectively. The criteria for passing the MIC was chosen as > 5 log reduction in Bacterial counts (BSEN 1650) > 4 log reduction in Fungal counts (BSEN 1276)

Inference 1.) The minimum inhibitory concentration of the disinfectant sample Virosil was determined at different concentration â€“ contact time combination

2) Virosil was effective in inhibiting all bacterial and fungal cultures under study, at a contact time of 15 minutes and concentration of 5 per cent.

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Virosil was effective in inhibiting all bacterial and fungal cultures under study

Disinfecting biofilms using Virosil Pharma Virosil Pharma not only successfully penetrates biofilms and eliminates bacteria but also maintains a long residual level of disinfection in water tanks and pipelines. Using Virosil Pharma overcomes the disruption problem because it is absolutely safe to leave it in the water. Better still, the longer itâ€™s in the water, the better the results since it will attack the biofilms which har-

bour most of the bacteria populations. The company also offers a customised disinfection audit on its website; www.sanosilbiotech.com For further information and samples, please contact: Dev Gupta, CEO, Sanosil Biotech, Warden House, 1st floor, Sir PM Road, Fort, Mumbai 400 001 Tel No 022 22872295 / 43112700 / +919820016292 email: info@sanosilbiotech.com

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Tofflon Mini KUFill launches advanced solution for injectable manufacturing The product was launched considering the need of R&D, clinical trial etc

s the global pharmaceutical industry is experiencing a dynamic change, especially for biotech industry, in recent years many pharma companies are shifting the focus from small molecules to large molecule biologics and are more focussed in manufacturing of potent injectables. Tofflon recently introduced a unique Vial/PFS filling machine MiniKUFill to global market by considering the need of R&D, clinical trial and mainly small scale injectable manufacturing. This MiniKU-

84 EXPRESS PHARMA December 16-31, 2018

Fill have added advantages over conventional vial/PFS filling machine. Conventional vial filling machine is available in the market, which are suitable for massive commercial scale manufacturing and not suitable for manufacturing small batch capacity injections. This may lead to increase in manufacturing cost, wastage of utility and more human intervention due to continuous monitoring. Also, it is required to maintain clean room condition for all injectable manufacturing. In

case of toxic and oncology drugs, it is required to use the isolator to ensure operator safety and to avoid human intervention, maintenance of isolator for conventional vial filling machine resulting in high operation cost. Considering the above manufacturing challenges of small scale injectable manufacturing Minikufill provides more advanced solutions. The key benefits of MiniKUFill ◗ It is highly suitable for RTU

(Ready to use) nested vials/PFS and Cartridge. ◗ Quick scale up and easy changeover of recipes ◗ Available in combo vial/PFS/ cartridge options with minimum change parts ◗ Compact design occupies less space than conventional filling machine and product manufactured faster to market. ◗ Less operation cost and usage of utility. ◗ Customised design suitable for integration of lyophiliser for lyophilised injection manu-

facturing. ◗ Integrated with RABS or Isolator based product properties. ◗ In compliance to cGMP and FDA guidelines. Tofflon MiniKUFill is a plug and play type design with quick installation and faster production. It offers flexible process solutions at lower risk of contamination in aseptic manufacturing. Due to compact design, it is highly recommended for R&D use, clinical trials and for small scale production of injectable.

CPHI & P-MEC INDIA 2018 SPECIAL

Domino Printing Sciences receives ‘Supply Chain Excellence’accolade The awards were presented following a detailed review of each entrant’s citation by groups of judges, who visit each factory in turn to inspect processes, and interview management and staff

omino Printing Sciences, the global leader in the development and manufacturing of coding, marking and printing technologies, has received the ‘Supply Chain Excellence’ accolade at the prestigious annual Manufacturer MX Awards. Celebrating the best of British manufacturing, the event was held in Liverpool on November 16, 2018 and was organised by The Manufacturer Magazine in partnership with the Institute of Mechanical Engineers. The Manufacturer MX

Awards are universally acknowledged as the gold standard for bench-marking performance across a range of manufacturing categories, among companies of all sizes. The awards are presented following a detailed review of each entrant’s citation by groups of judges, who visit each factory in turn to inspect processes, and interview management and staff. Domino had been shortlisted and they are proud of the fact that after winning the supply chain excellence award last

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year they won the Operational Excellence category against

some very tough competition. Domino was elected as winners against brands like Jaguar Land rover, BMW Mini, Leyland Trucks and Philips Avent. In addition Domino won in this category against the overall ‘factory of the year’ winner Accolade Wines. The process is rigorous and judged by experienced people from the industry and from organisations like IMechE and the Royal Academy of Engineering. “We are delighted to receive this particular award

against some very tough competition,” says Carl Haycock, UK Printer Operations Director. “It recognises the investment that we have made in our supply chain, our people and our manufacturing processes to ensure we deliver the best possible experience for our customers. Our ability to deliver high quality, highly customised products to worldwide customers in short lead times is something we are rightly proud of.” EP News Bureau

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December 16-31, 2018

CPHI & P-MEC INDIA 2018 SPECIAL

Top performance does not have to be expensive

hlmann Pac-Systeme is a global leader in pharmaceutical packaging. With over 10,000 installations in nearly 100 countries, Uhlmann has been a trusted partner to the global pharmaceutical industry for 70 years. To complement its global reach, Uhlmann acquired Jinzhou Wonder Packing Machinery Co in northeast China in 2011. Established in 1998, the company now has nearly 190 employees working on the development, production, and sale of blister machines, car-

tively addresses the needs of global pharma companies for reliable packaging machines at an attractive price. Hundreds of these valuefor-money Wonder machines are in service in the pharmaceutical sector in China, the US, Algeria, Indonesia, India, as well as in many other countries.

BLISTER LINE eBL 350

toners and four-side sealed sachet machines. After acquiring Wonder, Uhlmann deputed a team of experienced design, production

and testing engineers to Jhinzhou. Over the initial years they developed and validated the first eBL 350. Designed in Ger-

THE EASY BLISTER MACHINE eB 350 Highlights ◗ GMP-compliant cantilever design for easy cleaning with pharmaceutical requirements ◗ German engineering for high-quality design ◗ Suitable for thermoforming and cold-forming foils ◗ Servo technology and easy handling for quick format changeovers ◗ Easy, intuitive operating system with central touchscreen ◗ Flexible line configuration with compatible cartoner solutions

Cartoner eC 250

CARTONER eC 250

86 EXPRESS PHARMA December 16-31, 2018

many and manufactured in China, these ensure optimum TCO benefits for customers. The Wonder portfolio effec-

Contact details Uhlmann India +91 91 4600 3482 sales@uhlmann.in

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NISSO HPC - A Japanese Excipient HPC -

HYDROXY PROPYL CELLULOSE

A Powerful binder & disintegrating facilitator

Cellulose based- Non interfering Provides good stability Suitable for high dose formulations For Direct Compression process Easy disintegration Available in many grades to suit your formulation requirements Distributed by Gangwal

angwal

December 16-31, 2018

Chemicals – leaders in Pharmaceutical Excipient

Contact for more information Gangwal Chemicals Pvt. Ltd. :

706-707, Quantum Tower, Rambagh Lane, Behind State Bank Of India, Malad (west), Mumbai - 400064 Tel.: +91 22 2888 9000, Fax: +91 22 2883 5347, Email: info@gangwalchem.com, Web.: www.gangwalchem.com

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

EMERGING AS THE MOST PREFERRED PRIMARY PACKAGING SOLUTIONS PROVIDER FOR THE PHARMA INDUSTRY. CALENDER

Uniworth Enterprises LLP with it's location at Ahmedabad, INDIA, is ideally suited to cater efﬁciently to the Indian market and with ICD facility and excellent connectivity by road to Nhava Sheva port, Mumbai, can also service the export market with minimum time lag between production and export.

Ÿ Dust Free & Fully Air Conditioned Factory Ÿ Fully Equipped Analytical Lab

SLITTER COATING LINE

Ÿ Producing 60 Micron PVC Film by Direct

Calendering without Stretching. Ÿ ISO 9001:2015 & ISO 15378:2017

Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area

LAMINATOR

Ÿ 6000 Sq. Mtr. Built-up Area

WE PACKAGE GOOD HEALTH. Corp. Oﬀ: 804, Siddhi Vinayak Tower B off. S.G. Highway, Makarba, Ahmedabad -380051 Factory: Chharodi - Sanand (Gujarat) +91 -9726430369 / 7433966038 info@uniworthllp.com • www.uniworthllp.com EXPRESS PHARMA

December 16-31, 2018

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Ami Polymer Pvt. Ltd.

Visit us @!

“Sealing Expert in Silicone” TUV Nord Certified ISO 9001:2015, 14001:2015 & BS OHSAS18001:2007 & Clean Room Class 10000 Certified Manufacturing facility

12 TO 14 DEC - 2018 GREATER NOIDA, DELHI NCR

STALL# E-19 HALL# 09

Silicone Customized Products

T PARTITION GASKETS

SILICONE HOPPER GASKETS

PARTITION GASKETS

Silicone Tubes SILICONE TIRES/BANDS

SILICONE TIPS

SILICONE DUST CUP (D & B TOOLING)

ANTISTATIC GASKET

MEDICAL & SURGICAL COMPONENTS

SILICONE MOUTHPIECE

BELLOW FOR ISOLATOR

SILICONE CORK

SILICONE SUCTION CUP

Silicone Molded Sifter Sieves

Silicone Inflatable Seals & Gaskets

BUTTERFLY VALVES GASKETS IN SILICONE/FKM/EPDM

SILICONE WASHER

Thermoplastic Elastomer Tube Bi - Layer Thermoplastic Elastomer Tube Silicone Hose with Polyester Braiding

Tri-Clover Gaskets (Silicone / FKM / EPDM / PTFE)

Silicone Bellows

www.amipolymer.com | mktg@amipolymer.com

Cold Chamber

Various size & capacity of chambers available on request.

December 16-31, 2018

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Taste TasteSensing SensingSystem System TS-5000Z TS-5000Z Taste was one of the most difficult areas to evaluate, relying mostly on the human tongue in sensory test

Developed in

Japan Available in

Now with the development TS-5000Z, taste of food, beverage, and medicine can be measured and visualized

India

Objective taste analysis system for any drug dosage form Best use for formulation R&D, searching best masking agent Machine available for Demonstration and Sample Testing

Hydrocarbon Gel SAMIC J-BASE

CHARACTERISTICS - Gelled liquid paraffin using 5~10% of synthetic chemical resin - Less change in consistency(hardness) by varying temperature - Insoluble in water - Color less - JPE(Japanese Pharmaceutical Excipients)

Exported By :

APPLICATION - General external, dental and oral medicine - Alternative for petroleum jelly

S. Zhaveri Pharmakem Pvt. Ltd. 308/310, Shiv Smriti Chambers, 49 Dr. Annie Besant Road, Mumbai - 400 018. India. T. - 91-22-4367 6666 | F. - 91-22-6660 7758 E. - info@szhaveri.net | W. - www.szhaveri.com EXPRESS PHARMA

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“TECHNOPTIONS” group … emerging .. beyond technology ... METAL MET AL DETECT DETECTOR OR PHARMACEUTICAL METAL DETECTION SYSTEM for .. TABLET / CAPLETS / SOFT and HARD GELATIN CAPSULES / POWDER / GRANULES etc.

Visit us at:

::COMBI COMBI:: :: DEDUSTER DEDUSTER METAL MET AL DETECT DETECTOR OR

Exclusive Representation in INDIA:

12/13/ /13/14 14 Dece December mber 2018 HALL 12 / STALL C02

December 16-31, 2018

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International standards:  FDA compliant  ISO2000-9001  ISO14001  OHSAS18001  ISO15378  HACCP

Aluminum Tubes for Pharmaceutical Products: • Optimal hygienic packaging. • UV light and oxygen barrier for active ingredients. • Perfect protection from external influences and UV rays.

NEW! Now offering higher volumes up to 120ml.

Aluminum Tubes Since 1967, LAGEENTUBES has been offering tailor-made, cutting edge aluminum packaging tube solutions for the leading pharmaceutical companies in over 30 countries across the globe. Providing the best quality aluminum tubes in the West, LAGEENTUBES caters the Indian pharmaceutical up-market industry that wants to grow their business in the Western world. In addition to aluminum tubes, LAGEENTUBES offers a wide range of plastic tubes for the cosmetic market. Come visit us - Booth No. 8.R01 CPHI India, December 12-14, India Expo Centre, Greater Noida, Delhi NCR

Germany: Philipp M. Eckardt pme@handelsagentur-eckardt.de

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Regd. Office: F-331, 1st Floor, Dreams Mall, L.B.S. Marg, Station Road, Bhandup, Mumbai - 400 078. Email: jetorders@jetspray.in, jetspray.innovations@gmail.com, Website: www.jetspray.in Tel.: 022 41205328, 022 21660056, What'sapp Mobile: 09323520869

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ADVANTAGES OF

PRE-PREPARED TROLLEY System over BUCKET TROLLEY System Today´s Cleaning Innovative Pre-prepared

3 No Heavy buckets 3 No Cross-contamination 3 > 50% less consumption of water and chemicals 3 High on ergonomics 3 Sustainable 3 Microfiber technologie 3 Small footprint of trolley´s

The pre-prepared method is exactly what it says – every mop and cloth required for that days’ cleaning is prepared in advance with the correct amount of water and customers validated disinfectant.

another pre-prepared mop is placed on the frame for use in the next room/area/surface. The used mop is then placed into a

B902 / 903 / 904, O2 Galleria, Minerava Industrial Estate, Mulund (West), Mumbai - 400 080 Cell : +91-8976610332 Website: www.vileda-professional.com l Email: prasad.crg@fhp-ww.com

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SPECIAL STATIC CURRENT PASSABLE SIEVE

CADMILL SCREEN

Z TYPE SIFTER SIEVE

S.L.E. TECHNOLOGY, TRIANGULAR GRATER, SPHERICAL GRATER CO-MILL SCREEN

F.B.E. DRYER SIEVES

ADVANCED SIEVES AND PERFORATED SCREENS TESTING KIT

MULTIMILL SCREEN

315, Tantia Jogani Industrial Esate, J. R. Boricha Marg, Opp. Kasturba Hospital, Mahalaxmi, Mumbai - 400 011. Phone: 022-23000008, 022 23000149

E-mail: at lantoent@ gmail.com

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TEST SEIVES

tlanto.ne t: www.a Visit us a

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Pride in Every action To widen our offerings and horizons through innovation & technology, we have extended our hands for Technical Collaboration for mutual benefits to enable us spearhead in Turnkey, Single window Solution to Customers. We are associated with companies like - Loedige GmbH, MPE USA, CSP ireland, RML Engineering, New Zealand.

Agency Division Bectochem Consultants and Engineers Pvt. Ltd.

FLEXIBLE WALL BARRIER TECHNOLOGY

Modern Process Equipment (MPE), USA - Chainvey

Flexible containment integrated with Sifter

Flexible containment integrated with Multi Mill

• Flexible wall barrier technology ideal for containment processes/dust free operations. • Available in MOC PU, PE and PVC anti-static for better compatibility with various solvents, SS scaffolding and Base tray for glovebag positioning & fitting. • Bespoke design and can be integrated with new and existing equipment/ process. • Ergonomic studies for better process understanding. • More visibility due to the transperent/ optical clarity of the glovebag. • System can be static / under negative pressure or positive pressure with AHU. • WIP (wash in place) arrangement for cleaning of the system. • Wide range of equipment can be integrated by using containment technology. • Applications: In API Industry - Weigh balance, reactor charging, Centrfiuge, Nustche filter, Multi Mill, Sifter & Pack off can be integrated with flexible containment system. In Formualtion R & D - High shear mixer, FBD, Blender, compression machine, auto coater, Blister pack can be integrated with Flexible containment system. • Possible OEL validation can be perfomed in Flexible isolator .

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GL Filtration Limited - World Leader in Solid- Liquid Seperation

Efficient Agitator System Metal Detector from Viscojet, Germany and Separator

Industrial & Chemical Compactor

Contained Tablet Press

Bectochem Consultants and Engineers Pvt. Ltd. Building 5C/204, Mittal Estate, Andheri-Kurla Road. Andheri(E), Mumbai-400059, India Tel: (91) 22-39277900/ 28500008/ 657018999 Fax: (91) 22-28506785 Email: fitz@bectochem.com Website:www.bectochem.com

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HVA

Technologies Private Ltd.

HVAC Clean Rooms Clean Room Equipments BMS & Electrical Regd ofď€ ce: F-62,Dreams The Mall, L.B.S Road, Bhandup(w), Mumbai-400 078 Corp. Off.: HVAX House, Bata Compound, Opp Viviana Mall, Khopat, Thane (W)- 400 601, India.Tel.: 022-21721115/16, Email: info@hvax.in Web: www.hvax.in

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OsmoPRO® Multi-Sample

Pharmaceutical Applications

Micro-Osmometer Introducing OsmoPRO, the newest member of the Advanced family of freezing point osmometers. OsmoPRO features a convenient carousel design for easy loading of up to 20 samples and requires only a small 20 μL sample volume. Featuring intuitive touchscreen operation.

NASAL

ORAL

TOPICAL

The One Point Source for Tamper Evident Sprayers

* Enhanced Data Management * Built in Quality Control * Efficient sample processing * Ethernet and multiple usb ports * Bulit-in barcode scanner * Industry leading accuracy FEATURES

127, Bussa Udyog Bhavan T.J Road, Sewri, Mumbai 400015. INDIA Tel. +91 22 24166630 Email: support@rosalina.in

Tamper Evident

Sterilizable

Tablet Applicators

Accurate dosage delivery

Cream Applicators

Available in different dosages

Tablet Containers

SANTAPET POLYMERS LIMITED Office: 8 Sheriff Devji Street, 1st Floor, Mumbai - 400 003. India Tel.: +91-22-23420381 l 66151691 Fax: +91-22-23441578 Email: suraj@santapetpolymers.com l Website: www.santapetpolymers.com

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For almost 40 years, Domino has been a leading global producer of innovative printing, coding and marking solutions for the Pharmaceutical and healthcare industries.This equates to extensive experience in serialization support. Our technology enables manufacturers and CMOâ€™s to comply with the validation requirements of Good Manufacturing Practice (GMP) and emerging global legislative standards, such as the DQSA, helping to secure the supply chain from Product to Pallet.

Trust the experts. Contact Domino to discuss your serialization needs.

Visit us @ Pmec Hall No. 14 Stall No. A46

Domino Printech India LLP Corporate office- Plot No. 167, HSIDC, Udyog Vihar, Phase I, Gurgaon122016, Haryana, India Tel: +91 124 488 6100, marketing@dominoindia.com

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through innovation, since 1986.

GAYLORD PHARMA SYSTEMS GAYLORD PHARMA SYSTEMS Pharmaceutical Equipment & Machinery for Tablets, Capsules, Liquids, Ointments, Food & Beverages, Chemicals, Bulk Drugs, Gaylord is catering infrastructure supplies for Pharmaceutical and allied industries for over Three Decades. Facilities for many of the most popular brands in all the dosage forms were set up by us. Over the years, we have been working on several innovations on our machines based on customer needs and feedback. One such Product is our “Work Horse”, The Triple Rotary Tablet Press. Three compression points give 33 % more tablets per rotation than conventional Double Rotary Machines. These are suitable for making TRILAYER Tablets.

Tablet Tools (Dies & Punches) of any Type,Size & Specifications for any Application

For Tablet Coating, we oﬀer conventional Coating Systems (Pans) as well as Automated Fully Programmable “Autocoaters”. These are oﬀered as Small Units for Laboratory and R&D use or Large ones for Industrial applications routinely.

RSE

ORKHO

THE W

The One and Only

Colloid Mill

TRIPLE ROTARY

TABLET PRESS Very Small Foot Print Can be as small as 4’5” x 4’5”

Gaylord Coater

CONSUMABLES, SPARES, SERVICE & TURN KEY PROJECTS, WORLDWIDE Corporate Oﬃce Tel. : +91 22 2686 5341/2/3. Telefax : +91 22 26861131

107, Acme Industrial Park, I.B. Patel Road, Goregaon (E), Mumbai 400 063. E-mail : info@gaylordpharmasystems.com. Web : www.gaylordpharmasystems.com

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EXPRESS PHARMA IS O 9 0 0 1 :2 0 0 8

Manufacturers of Laboratory Equipments WALK IN STABILITY CHAMBER AS PER ICH GUIDLINES : At 25°c At 30°c At 40°c

> > >

: : :

RH = 60% RH = 65% RH = 75%

PRODUCT RANGE - Stability Chambers - Plant Growth Chambers - Lab. Refrigerators - Lab. Precision Ovens - Autoclaves - Cryo Baths - Furnace(1500°c)

Stability Chamber

Deep Freezer

- Walk in Chambers - Humidity Chambers - Shaker Water Baths - Lab. Drying Ovens - Vacuum Ovens - BOD Incubators - Tray Dryer Ovens

Precision Oven

- Photo Stability Chambers - Seed Germinators - Multi Cell Ageing Ovens - Heavy Duty Ovens - Deep Freezers(-20°c/-40°c) - Muffle Furnace(1200°c)

HIGH Temperature Oven

www.tempoinstruments.com | E-mail : enquiry@tempo.net.in

B.O.D Incubator

| Contact : 09820464003

Tempo Instruments Pvt. Ltd. 10-11, Prospect Chamber Annex, 317-21, Dr. D.N. Road, Fort, Mumbai - 400001. Website : www.tempoinstruments.com | E-mail : enquiry@tempo.net.in

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TURNKEY CLEANROOM SOLUTIONS

CLEANROOM HVAC & ELECTRICALS

CLEANROOM WALL, CEILING & DOOR

CLEANROOM UTILITIES & VALIDATION

Static Pass box

Dynamic Pass box

Sampling Booth

Horizontal LAF

Laminar Air Flow

Bio-Safety Cabinet

Air Showers

Mobile LAF

CLEANROOM EQUIPMENT & FURNITURE

Pharmintech Turnkey Solutions Pvt. Ltd. Address : A-417, Tower-II, Lodha Supremus, Wagle Estate, Thane West - 400604, India.

Contact : +91-22-4971 9996

Email : sales@pharmintech.net

www.pharmintech.net

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To Advertise in

Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Rajesh Bhatkal 09821313017 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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CPHI & P-MEC INDIA 2018 SPECIAL

Arrest dust at source with Fabtech’s de-dusting tunnels D

ust plays havoc with clean conditions and results in expensive maintenance. Preventing the infiltration of dust at the point of entry of raw material with Fabtech’s De-dusting Tunnels results in substantial cost savings. Specialised manufacturing in industries like pharma, biotech, food and beverages, even semiconductors, defence and aerospace mandate sterile/clean environments where foreign particulate matters have a negative impact on product quality and yield. A significant challenge that needs to be addressed is contaminant entry from the outside through raw material containers, canisters, sacks and bags brought into the facility. Fabtech’s De-Dusting Tunnels are used to remove the loose particles and dust that accumulate on raw material containers even before they are brought into the warehouse prior to sam-

pling. This offers a significant reduction in dust levels, ensuring product quality and improved yield. These tunnels are a single

pass fully automated system with sliding doors at entrance and exit of the system. Containers are moved through an endless conveyor and through com-

binations of rotary moving brush in X and Y axis which scrub and detach non-viable particles from the container. Containers are subjected to high-ve-

locity air, and loose particles are collected in a tray while airborne particles are retained in a series of filters. Fabtech pioneered De-dusting Tunnels and ever since we have upgraded and innovated the product through continuous customer feedback. We continually add new features to address evolving requirements. Our Dedusting system is increasingly becoming a part of the standard project design layout. Fabtech’s de-dusting system is GMP compliant, reliable, automated, mechanised system, delivers consistent performance and is easy to maintain. It offers more consistent performance over human manual cleaning, is predictable, reduces dependence on manpower and saves costs. Add-on features like synchronisation with continuous sampling system make it an online integrated system with proper data storage and tracking.

The Life Engineering imperative From India to the world

ne of the biggest issues worldwide, especially in emerging and developing markets, is access to affordable medicines. Often, countries chasing development goals focus on economic growth and improved trade numbers, leaving a large number of human development goals on the backburner. Sanitation, waste management, transport, connectivity are all well-known victims of this economic pursuit. Equally devastating and not quite as well-

known is the developing world’s lack of pharmaceutical infrastructure. Unable to manufacture medicine locally, these countries end up importing medicine from developed markets, making these medicines prohibitively expensive for those in need. This is where India’s Fabtech is trying to make a difference across emerging geographies in West Asia, South America and Africa. Fabtech works with governments and private enter-

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prise in these markets to build indigenous pharmaceutical and biotech capability in regions that need it the most. They offer the complete spectrum of start to finish solutions feasibility studies, scoping project requirements, building project plans, executing those projects to building commercially viable plants that ensure medicines reach the market – and the local population – in the shortest possible period. Fabtech calls this their Life

Engineering philosophy. They believe that even though as an engineering company they are but a small piece of the life sciences ecosystem, the work they do positively impacts lives across the world. Having worked in India with generics, biosimilars and vaccine manufacturers and innovators, Fabtech leverages this experience and acts as a bridge to their customers in emerging markets. And Fabtech uses their global reach to help leverage part-

nerships across the world, seamlessly dovetailing manufacturing infrastructure with the know-how to optimise manufacturing processes for your product portfolio. Everybody at Fabtech believes they are agents of positive change working to evolve the life sciences landscape; building indigenous capability in regions that have none to ensure that everyone, wherever they are in the world, has the same access to life-saving drugs at reasonable prices.

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OPTIMAImmuFill makes debut appearance at Compamed The institute was established with a clear objective to serve the society of the region through scientific inventions and excelled in both basic and applied research areas of chemistry and chemical technologies

he new OPTIMA ImmuFill made its debut appearance at Compamed. This machine dispenses (ancillary) reagents into bottles, topping off the range of products for manufacturing and packaging complete ELISA test kits.

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The subject of web converting for products such as transdermal patches and orally disintegrating films (ODFs) also met with great interest and was one of the reasons for Optima Life Scienceâ€™s highly positive verdict on the trade fair.

An avantgarde product The OPTIMA ImmuFill was specifically designed for filling bottles with (ancillary) reagents. The rotary transfer machine dispenses the liquids in bottles of varying diameter and depth. As small batches are often produced in the diagnostics

industry, it is essential that formats can be changed quickly. The machine only requires very few format parts, allowing the format to be changed in under 30 minutes. One special feature is the integrated robot which inserts the bottles together with their

caps into the star wheel. Only the robotâ€™s vacuum cup needs to be switched when changing formats, which can be done particularly quickly and easily with a plug-in coupling. In addition, two, four, ten, and one-hundred-millilitre bottles can be processed on one wheel.

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The OPTIMA ImmuFill consists largely of aluminum components and is altogether a lot cheaper than machines from the pharmaceuticals industry, which predominantly uses stainless steel. Making the machine compact was also a key consideration. Occupying an area of three square metres, the machine is perfect for both smaller production spaces and for laboratories. The system complements the modular OPTIMA ImmuCoat machine platform, which covers the entire process of coating microtiter plates. Every process step required can be integrated into this platform. For instance, it includes incubators in which the microtiter plates are stored between the individual process steps. Also in the portfolio is the OPTIMA ImmuPouch machine, which packages the plates in three-side pouches and seals them. The OPTIMA Life Science machine range therefore covers the whole range of functions required for manufacturing and packaging complete test kits, including reagents. Synergies within the Optima Packaging Group were systematically harnessed to design the OPTIMA ImmuFill, a process that saw Optima Life Science draw on the specific expertise of R+E Automation.

with high throughput for mass production. As a member of the COMEDCO alliance, Optima Life Science also offers complete solutions for TDS and ODF products. As well as the OPTIMA TDC 125, this includes manufacturing and coating the films for active substances. Both are done together with Oatema in Dormagen, which, as a devel-

opment partner, can also provide support as required with its own laboratory.

Optima Life Scienceâ€™s verdict on the trade fair Optima Life Science came away from Compamed 2018 extremely satisfied. The excellent quality of contacts more than made up for the slight decrease in visitor

numbers. This year, Optima Life Science received a particularly high number of prospective clients from the diagnostics industry thanks to the new OPTIMA ImmuFill machine and the complete solution for ELISA test kits. And the company from SchwĂ¤bisch Hall had every reason to be happy with how the trade fair went, with

70 per cent of inquiries relating to specific projects and 70 per cent of inquiries coming from new contacts. Contact details OPTIMA Packaging Group Jan Deininger, Editor +49 (0)791 / 506-1472 jan.deininger@optima-packaging.com www.optima-packaging.com

Web converting for transdermal patches and ODF products Fair visitors were also very interested in the subject of web converting, especially the OPTIMA TDC 125. This is the ideal type of machine for new products and business areas in the field of transdermal patches (TDPs) and orally dissolving films (ODFs), which are manufactured in runs ranging from laboratory scale down to smaller batches. All production and packaging processes can be validated and later transferred to larger production machines as required. The scalable machine is suited to manufacturing product samples for clinical tests, for market launches, and for subsequent production. In its simplest form, the system works intermittently, but it can also be operated continuously

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Anew perspective on flow enhancement in solid oral dosage formulation – Advantages of an unique glidant material TRI-CAFOS 200-7 Compromised powder flow can lead to lack of dosage uniformity which can even cause a rejection of a batch of a finished product. Daniel Zakowiecki, Innovation and Application Development Manager, Marek Lachmann, Innovation and Application Development Manager and Tobias Hess, Head of Innovation and Application Development, Budenheim

rocessing of powders of various physical properties takes place in almost every stage of a pharma production and it does not matter whether the final dosage form is solid, liquid or suspension. Materials are sieved, mixed, conveyed through different pieces of equipment and therefore maintaining sufficient powder flow throughout the entire production process is crucial to avoid problems connected with clogging, air entrapment and/or uneven die-feeding. Compromised powder flow can lead to lack of dosage uniformity which can even cause a rejection of a batch of a finished product [1,2]. Modern technologies such as direct compression and especially the relatively new concept of continuous pharma manufacturing are increasingly used in pharma production and brought about new challenges. Good powder flow determines processability and a stable manufacturing process, therefore an appropriate product quality[2]. In the field of pharma technology the issue of flow regulation has been becoming more and more significant as a high number of drug substances entering the market show poor flow properties. Application of flow control agents (glidants) can facilitate powder flow and provides a good alternative to time and energy consuming granulation processes. Various glidant materials including talc, colloidal silicon dioxide or magnesium oxide are commonly

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Daniel Zakowiecki

Marek Lachmann

Tobias Hess

Fig. 1. SEM picture of TRI-CAFOS® 200-7 under magnification of 11 kX

used [3] whilst tribasic calcium phosphate (hydroxyapatite) is less frequently used as a glidant. High quality tribasic calcium phosphate glidant (TRI CAFOS 200 7) which is produced be the German company Budenheim,

has a number of unique features which are outlined in this article. Apart from powder flow enhancement it provides the advantage of substantially reduced dust formation. Thus, save handling of the material is

facilitated and the overall health hazard is reduced. It should be emphasised that TRI-CAFOS 200-7 fulfils all requirement of the monograph for tribasic calcium phosphate of the United States Pharmacopoeia

(USP/NF) and for calcium phosphate (tricalcii phosphas) of the European Pharmacopoeia (Ph.Eur.). The bulk TRI-CAFOS 200-7 powder consists of agglomerates having a particle size of around four micrometers (Fig. 1). Share forces involved in mixing process break up the agglomerates into smaller particles (also visible in the Fig. 1) which cover crystals of host particles and govern flowability of powder mixtures [4]. The bulk density of 200 g/dm3 is significantly higher than for the most commonly used glidants. Decreased dust formation and general handling advantages are the result of the increased bulk density as well as a specific particle structure(Fig. 1). The first part of the article [5] introduced TRI-CAFOS 200-7 and its application in powder flow enhancement as well as presented the possibility of use it in a direct compression of tablets containing two model drugs: ibuprofen and metamizole sodium monohydrate. The results proved a good performance of the material and presented TRI-CAFOS 200-7 as an excellent alternative for more commonly used glidants such as silicon dioxide or talk. The second part of the article focuses on the major advantage of TRI-CAFOS 200-7 – significantly reduced dust formation. Moreover, it presents and explains the prospect of the use in continuous manufacturing, the new concept for pharma industry [6].

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Fig. 3. Comparison of a dust formation from two glidant materials: TRI-CAFOS® 200-7 and hydrophilic silicon dioxide

Fig. 2. SP3 automatic sedimentation dust measuring instrument

Dust formation from Glidant materials- A major advantage of TRI-CAFOS 200-7 The dust formation from two glidant materials: hydrophilic silicon dioxide and tribasic calcium phosphate (TRI CAFOS 200 7) was measured using a SP3 automatic sedimentation dust-measuring instrument (Lorenz Messgerätebau, Kaltenburg-Lindau, Germany) (Fig. 2). A sample of glidant material was placed into the funnel of the apparatus and dropped by opening the valve. The laser attenuation was recorded over a period of 60 seconds. Relative dust formation was calculated from the obscuration of the laser beam without sample in relation to the obscuration

of the laser beam after dust formation using equation: Where: MV = measured

value / Ö0 = laser intensity without sample / Öt = laser intensity at time point t / K = Extinction coefficient / d = path length of the laser / Ct = concentration of dust particles. The dust value indicates the ratio of the dust from a sample remaining airborne after a sedimentation time of 30 seconds. Overall dust formation is obtained by integrating the relative attenuations of the laser beam over the time from zero to thirty seconds after the sample drop. The results of analysis shown in Fig. 3 demonstrate that dust formation from colloidal silicon dioxide is profoundly higher than from the tribasic calcium phosphate glidant TRI-CAFOS 200-7. Hydrophilic silicone dioxide releases larger amounts of dust after sample drop and shows a much slower settling rate than TRI-CAFOS 200-7. The dust values shown in Fig. 4 provide an indicator of the settling rate of the airborne materi-

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Fig. 4. Comparison of dust value (left) and integrated attenuation value (right) of two glidant materials: TRICAFOS® 200-7 and hydrophilic silicon dioxide

als. It can be observed that double the amount of dust stays airborne 30 seconds after release in the case of hydrophilic silicon dioxide. While the dust value provides an indicator for the settling rate it is not a measure of the overall dust that the operator might get exposed to during the initial handling of the material. Integrated attenuation value provides a more accurate picture (Fig. 4). In this case TRICAFOS 200-7 was chosen as reference and it can be observed that the overall dust formation from the tribasic calcium phosphate glidant is considerably lower than the other glidant material. Close to four times more dust is produced by the same sample mass

of hydrophilic colloidal silicon dioxide.

Continuous manufacturing Over the last years the concept of continuous manufacturing has become increasingly popular in pharmaceutical industry. Continuous production offers various advantages in comparison to batch manufacturing including increased productivity, reduction of overall waste and decreased energy consumption which lead to cut down total costs of production. Additionally, time to market can be significantly shortened by omitting scale up phase [7,8]. In the study performed by Lachman et al. [6] colloidal silicon dioxide and tribasic calcium phosphate glidant, TRI-CAFOS

200-7, were tested with regards to their feeding properties and their performance in a continuous blending with the model drug substance – ibuprofen. Ibuprofen S380 (Strides Shasun, Karnataka, India) was introduced to the blending process from a K-Tron KT20 gravimetric feeder (Coperion K-Tron, NJ, USA). To achieve a 1 per cent w/w addition of the glidant to the drug substance a Brabender MT-S HYD gravimetric feeder (Brabender Technologie GmbH&Co.KG, Duisburg, Germany) was used. Blending was carried out using a Modulo Mix continuous blender (Hosokawa, Doetinchem, Netherlands). The binary mixtures (blends) were tested on the FT4

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Powder Rheometer (Freeman Technology, Tewkesbury, UK) with respect to their flow properties. Fig. 5 shows the basic flow energy (BFE) of powders blended with various mixer speeds and with different feed rate. Notably mixing with TRICAFOS 200-7 resulted in lower BFE while the blends have a higher bulk density, indicating improved powder flow. Fig.6 shows values of the flow function (FF) of ibuprofen blends. Normally higher FF values indicate easy flowing material, whereas lower ones more difficult flow. One can immediately noticed significantly higher value of ibuprofen and TRICAFOS 200-7 mixtures proving much better flow properties in comparison with blends with silicon dioxide. Fig. 5. Basic flow energy [mJ] of Ibuprofen blended with TRI-CAFOS® 200-7 (TCP) and hydrophilic silicon dioxide (SiO2)

Summary In the presented article some advantages of TRICAFOS 200-7 in comparison to the most commonly used glidant, hydrophilic silicon dioxide, were highlighted. First of all, owing to relatively high bulk density and a special particle structure, TRI-CAFOS 200-7 offers the great advantage to form only a fraction of the dust generated by other glidant materials. Higher density and decreased dust formation facilitates handling of the material as well as decreases exposition of operators to dust during powders processing. With the advent of new, challenging technologies the flow behaviour and the possibility to enhance it have been become a crucial issue. For e.g, the use of the most widely used glidant colloidal silicon dioxide in continuous processing is challenging because of its low bulk density, resulting in poor feeding properties. In opposite, TRI-CAFOS 200-7 shows improved feeding characteristics and excellent potential to be used in continuous manufacturing process.

References [1] Howard SA, Lai JW. Flow properties of solids. In: Encyclopaedia of Pharmaceutical Technology (edited

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Fig. 6. Flow function of Ibuprofen blended with TRI-CAFOS® 200-7 (TCP) and hydrophilic silicon dioxide (SiO2) by Swarbrick J). Informa Health Care, New York 2007, p. 3275-96 [2] Staniforth J. Powder Flow, in: Pharmaceutics, the Science of Dosage Form Design, 2nd ed. (edited by Aulton ME). Churchill Livingstone, London 2001, p. 197-210 [3] Rowe RC, et al. Handbook of Pharmaceutical Excipients, 6th ed. (edited Quinn RS). Pharmaceutical Press, London 2009 [4] Hess T, et al. Flow enhancement of poorly flowable APIs using a

novel tricalcium phosphate based glidant. Poster presented at AAPS Annual Meeting and Exposition, 2016 November 13-17, Denver, CO, USA [5] Lachmann M, et al. A new perspective on flow enhancement in solid oral dosage formulation – advantages of an unique glidant material TRI-CAFOS® 200-7 (Part 1). Express Pharma, Goa Pharma Summit Special, November 2018 [6] Lachmann M, et al. Flow en-

hancement of ibuprofen powder with two glidant types in a continuous blending process. Poster presented at 11th PBP World Meeting, 2018 March 19-22, Granada, Spain [7] Schaber SD, et al. Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study. Ind. Eng. Chem. Res., 2011; 50, 10083–92 [8] Aigner I, et al. Methodology for economic and technical comparison of continuous and batch processes to

enhance early stage decision-making, in: Continuous Manufacturing of Pharmaceuticals (edited by Kleinebudde P, Johannes Khinast J, Rantanen J). John Wiley & Sons Ltd., Hoboken 2017, p.485-505

Contact E-mail: sanjay.purohit @budenheim.com Webpage: www.budenheim.com

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AI ShieldTM Innovative Thermal Protection Protect your investment - Reduce AI Failure

orthington Industries and its Indonesian distributor, PT Lunar Chemplast introduced the new cryogenic refrigerator with the AI ShieldTM technology at the INDO 2018 exhibition to improve livestock conception and farmer productivity. Some farmers would repeat insemination up to three times without the cow con-

ceiving, losing both valuable money and time. A major contributing factor for low conception rates is the AI service providers who lift the semen holding canister out of the liquid nitrogen refrigerator tank and expose the bull semen to ambient temperature. Working in collaboration with the Gatesâ€™ foundation, the American organisation Global Good carried out stud-

ies that brought about the AI ShieldTM technology to protect bull semen during the AI service. The invented and patented technology, produced by Worthington Industries, reduces AI failures by protecting frozen bull semen from adverse temperature fluctuations common in removing the canister from traditional cryogenic refrigerators that reduces conception rates by up to 60 per cent. The innovative thermal protection guards' temperature swings to maintain semen viability, higher conception rates and increased cattle productivity. Scientific experiments on semen fertility have shown that semen cells are damaged even within

five seconds of exposure, significantly reducing fertility. The advanced technology provide an adsorbent in the canister wall. This temperature graph demonstrates the significant improvement in temperature stability with the AI ShieldTM technology compared to the standard canister. There are three temperature readinging in each canister; top middle and bottom. This graph shows that the viability of the semen after the canister is exposed to room temperature forty times. With the AI ShieldTM canister the viability of the semen is basically unchanged compared to the standard canister. Currently, there are two

inseminator models with the AI ShieldTM technology; the AIS3 with six canisters and the AIS1.5 with three canisters. AI ShieldTM technology maintains the semen/embryo viability resulting in higher conception rates and enabling the farmer to be more productive. Worthington Industries is a global, diversified, metals manufacturing company, which acquired the global assets of Taylor-Whartonâ€™s CryoScience business, including the manufacturing facility in Theodore, Alabama, in December 2015. Worthington Industries continues manufacturing cold chain storage and transportation equipment used in biobanking, fertility, genetic therapy and animal husbandry, among others. For more information contact: PT Lunar Chemplast: Lunar@indo.net.id

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DATAINTEGRITY: Alearning curve (genesis and cure) Rashida Najmi, Sr VP Global Quality, Regulatory and Pharmacovigilance, Piramal Enterprises provides insights on the measures needed to avoid occurrence of data integrity issues at pharma companies

ata Integrity - these two words, in the recent past have impacted companies, personnel and investors- damaging the perception of ‘Brand India’. Having pursued my career as a quality professional for over three decades and having closely tracked the regulatory space, I would like to present my views on this challenge that ‘Brand India’ is facing, and the steep learning curve that India based firms are going through, as they seek to overcome this challenge. Over the past few years I have observed a change in mindset, with Indian firms willing to acknowledge the problem, a crucial first step before developing a solution. I would like to state that these are my views only and respectfully acknowledge that there could be alternate perspectives on this issue. India is not yet at the finish line, but in my view, in a better position than before. The views captured here are not only centered on India but apply to the pharma industry in general. India plays a leading role in pharma imports to the West, supporting the entire drug value chain: from discovery through development, commercial manufacturing of New Chemical Entities, and finally life cycle management and supply of generic drugs. India has also been instrumental in improving affordability and accessibility of medicines, world-wide. The dependence on Indian pharmaceutical firms, especially the US, places the US regulatory agency–FDA in the onerous position of ensuring that all medicines from India, meant for public consumption in US are safe and efficacious

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as claimed. Let us also not forget that the FDA bases a lot of its decisions on the data that a company submits: therefore, when there is doubt on any data observed by the FDA during a site audit, it leads to the whole dossier being questioned. I have had some candid discussions with FDA inspectors over the years, and can vouch that there is little interest in identifying data integrity concerns if they do not exist. But, in my personal experience, the agency will like you to earn their trust: they will put you at scrutiny at first until they are confident about your company’s quality culture, ethics, systems, and personnel. When the noise around ‘Data Integrity Issue in India’ reached a crescendo in 2014, some of the firms in India went into ‘denial mode’, with a view that the FDA have been unfair and were ‘targeting’ the said firms. I did not (and do not) subscribe to this view. Based on my discussions with the regulatory agency, it is my belief that FDA was interested in ensuring that the right protocols were being followed, and their initial experience in India, did not provide them with that comfort. Things have changed a lot since then, and I am pleased to see that both, the companies, and the regulators are working together to address this issue. The results in the past year have demonstrated the significant strides the Indian life sciences industry has made towards compliance and quality. The concern around data integrity at most companies not only on the ones based out of India - is intermingled with the cultural background of

personnel on the shop floor, lack of awareness on the regulations around data security, and finally, a lack of design control to prevent such issues. In geographies with monarchial legacy, people are used to following orders without questioning if they are right. In countries where the personnel come from this lineage, the cultural values dictate that saying ‘no’ to their manager is considered disrespectful, and hence such companies thrive on the value system of the leader. Hence, there is a real concern in companies that culturally fit the description above, and where management choose to cut corners to achieve business goals. In addition, some of these companies have low tolerance for people that voice their concerns, and that prevents employees from owning up to errors and resorting to data manipulation to save their jobs. Let us look at some other practices – all of us who have studied in the eastern world can relate to some of the practices followed by us when we were in school. There is a rough book and then there is a fair copy. During live lectures, notes are taken in a rough book as it may have corrections and mistakes. The notes are then copied again in

the fair book excluding the mistakes such that the fair copy is clean. The fair copy is submitted for endorsement by the teacher and grades are allocated for neatness. Employees who grew up with this concept struggle with concomitant recording and they write on a sheet of paper or back side of label etc., and then later transcribe onto a batch record. The intent at times is not to change the data but to enter the data ‘neatly’; however this is not acceptable within the ALCOA principles. In certain countries, there is a trend of asking one’s team member to do one’s own work by delegation. This goes to the extent of delegating authority to use one’s password at workplace without knowing the implication of this act. Managers reveal their password to their juniors to perform electronic reviews and approval. The realisation that this is the equivalent of giving someone else the authority to sign your bank checks comes in much later. The fact is that your password stands for your signature and is legally binding and represents ‘you’- any issues that come up will need to be hence addressed by ‘you’. Language barrier add an additional layer of complexity to the data integrity situation. English not being the native language, employees are sometimes not eloquent enough to address questions to the satisfaction of the regulatory inspector. Several instances of data integrity concerns reported globally have similar causes. Let us look at a few: 1. Lack of willingness to spend on compliance needs. Eventually, ends up spending ten times the amount to hire

international consultants for remediation once the firm is in data integrity turmoil. 2. Resource constraints leading to inadequate staffing in quality divisions. 3. Lack of independence of quality division. Many firms have their quality control reporting into operations. Quality control is the final safety net for the product before it steps out and most patient safety decisions by QA are based on the data that QC generates. 4. Quality is the responsibility of Quality function and not a company-wide culture 5. Lack of top management commitment to quality. 6. Lack of interest from the leadership on regulatory inspections, its readiness and its outcome. 7. Quality function is pushed to take decisions in favour of meeting business numbers instead of compliance 8. Quality is not a collective responsibility in the organisation 9. Not spending in hiring a competent quality team. Your quality leaders must understand regulations well as they will interpret and execute the standards as expected. 10. Build lots of circles of policing and reviews rather than invest in building a culture of compliance and integrity. 11. Common culture of backdating like meeting agenda, meeting minutes, circulars, secretarial papers etc slowly seeps into the company’s culture and eventually into quality system documents as well. 12. Low spend on electronic system and automation, which are key to real time

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recording and data integrity. 13. Low tolerance to accept shop floor errors. Our research has shown that firms that run into issues of warning letter and import bans weaken their brand, lose investor and customer confidence, and hence take a significant hit to their market share and revenues. It also takes a long time (if at all) to regain the trust that is lost, with investors, customers and regulators. It is our view that companies look at their internal structures, systems, people and culture to address the issues above. The time spent is worth the benefit that can be achieved. How do we avoid occurrence of data integrity issues? First and foremost is ‘Quality Ownership’ at all levels in the company from Chairman, Board and CEO to the shop floor personnel. The Head of Quality cannot by himself/ herself drive data integrity or the quality culture. Senior Management must ensure that quality team is not pressurised to take steps that compromise Quality and Compliance for business needs. The time spent by top leaders in quality reviews, in discussing quality issues if any, sets the tone on how leadership views quality and compliance, which then cascades all the way down leading to a healthy quality culture. At Piramal, for example, our CEO emphasises that quality is a collective responsibility and incorporates quality into the goals of all employees within the organisation. Another crucial aspect is autonomy of quality function and its independence from business. The Head of Quality must be empowered to push back, as needed, when he/she feels that compliance may be compromised, without the fear of business impact. It is important to hire a competent quality leader and team who can hold custody for quality and orchestrate your quality band so that it is synchronous and does not miss a beat. I feel that it is important to have a

strong in house quality group rather than external consultants. Consultants can play a key role in identifying gaps in your quality structure, but I would not recommend that you transfer ownership of quality in your company to a consultant. I would highly recommend doing what is right for the longer term, than because it is dictated by regulatory guidance. If you do the right thing it will be acceptable by all regulatory standards. This brings me to the quality culture and quality health. Your company

long term benefits. Inculcate a practice of preserving the original copy with the right explanation if there is a need to reproduce. Do not share your password. When your staff observe such practices from leaders it automatically flows down to the shop floor. Respecting your quality division and resourcing it appropriately is important. Most of the times, role played by the quality team is not acknowledge by most companies unless there is a citation of non-compliance. Acknowledge them when everything is

fied, investigated and resolved promptly. Inculcate into your leaders the need to make rounds into the shop floor while it is in operation: this build connections with personnel, respect, and also make the leaders aware of the ongoing challenges in a manufacturing environment. All organizations that strive for a strong quality track record must also budget sufficiently for compliance. The cost of poor compliance is onerous and sucks you into a whirlpool of issues. Spending what is legitimate is impor-

First and foremost is ‘Quality Ownership’ at all levels in the company from Chairman, Board and CEO to the shop floor personnel. The Head of Quality cannot drive data integrity or the quality culture alone should have a culture of compliance and continuous improvement. This is a key role of company’s quality group and will put you ahead of any regulatory mandate as and when they are released with exception of specific ones that come as a regulation due to knowledge of FDA on a global level. Embrace a culture of accepting mistakes and allow people to own up to their errors. This will prevent manipulation due to fear of retribution. I recommend that this be explicitly communicated to operators, chemists, and technical teams. This will be your answer to preventing several on the floor data alterations. Do also keep in mind that it is important to provide adequate training on data integrity (ALCOA) to all concerned. As an organisation, abandon any practice which is not acceptable to integrity of data. Say goodbye to backdating signatures even for administrative documents. Delays may occur but not compromising the process will bring

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going right because they are doing their job well with support from other functions. Your quality team are torch bearers that collectively drive quality in the right direction. It is essential to have a high performing and competent quality team. Do not micromanage, but hire right, train right, and then empower them to drive the culture. Procedures and systems within the organisation must not be overly complicated. Strive to have simple and easy to execute systems. Make your forms user friendly. Include visual management and mistake proofing in your forms whether paper based or electronic. Provide prompt and easy detection of error so that investigation can be prompt. I am a strong believer of a concurrent batch review by quality and quality on floor. Phase your batch record at logical cut-offs and have QA presence on shop floor to review it phase by phase. This helps fixing issues in parallel and enables faster batch release. Concerns if any on data integrity can be identi-

tant to keep up your compliance with the latest requirement. Invest on IT tools for compliance, helps constant reminders for outstanding items and timely closure, and has data integrity controls. Most importantly, make your employees aware of importance of person based IT access and its significance. Do not neglect your compliance dashboard in rush to put batches out of the door. Keep healthy traction on investigation, aberration closures, internal audits, annual product reviews, management meetings etc. This is a silent killer and once derailed is difficult to recover and may tempt people on data integrity manipulation for no real reasons. The most imperative in my opinion is judging your company’s quality health. It should not be left to feeling or sense. Convert this intangible parameter to a tangible measurement. This is highly essential to channelise your effort and time towards the site that needs it the most. Develop internal tool to measure this. Run several trials to validate,

so that it is not misdirecting. For quality leads, responsible for several facilities, this will serve as an important tool to prioritise their band width. A focused audit and remediation on data integrity for a particular site based on this knowledge could be a plan of action. Keep close watch on the regulatory landscape. In past few years it has been extremely dynamic. Do not miss tracking all the draft guidance to enable proactive compliance. A lot has and is happening on data integrity requirement as well recently, requiring involvement of management and extending data integrity governance on the suppliers. Be proactive while recruiting and assessing personnel. A culture of integrity begins with the right hire. Conduct extensive reference and back ground checks for key roles. Introduce them to your data integrity policy and bring up awareness during induction and on boarding. Do not be tolerant to individuals who may have compromised compliance, however good they are otherwise. Set the right precedence. We have a white paper in our organisation which explains the steps to be taken by the facility if they identify perceived data integrity concerns. There is an option to go for forensic inspection by a third party for data integrity issues as well. It is crucial to address concerns early and prevent them from taking root. Institute reward or recognition for people who demonstrate your company values. At Piramal, we have a top level award for a person who practices our values in his/her work life. I wish to conclude my thoughts here, and sincerely hope that these will provide with some pointers as you strive to build a culture of data integrity within your organisation. Let us aim to move the needle of Quality from “Compliance to Culture”. rashida.najmi@piramal.com

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CLSIR to CSIR-IICT@ 75: The Journey through 1944-2018 The Institute was established with a clear objective to serve the society of the region through scientific inventions. Over the years it excelled both in basic and applied research areas of chemistry & chemical technologies and gained global stature. The Institute entered into the 75th Year in the service of Nation and the inauguration of the Year long Platinum Jubilee Events was celebrated on August 5, 2018 Formative Years CSIR-Indian Institute of Chemical Technology, a premier Institute working in the areas of Chemistry and Chemical Technology entered 75th year of its glorious services to the nation and celebrated the inauguration of year long Platinum Jubilee events on August 5, 2018. The seed for the institute was sown with a Farman (order) from the Nizam of the erstwhile Hyderabad state in 1944 as Central Laboratories for Scientific & Industrial Research (CLSIR). The Foundation stone of the main campus was laid in 1949 and inaugurated on January 2, 1954, by Late Pandit Jawaharlal Nehru, the first Prime Minister of India. In 1956, CSIR took over CLSIR and renamed as Regional Research Laboratory (RRL), to cater to the scientific and industrial needs of the region. Keeping in view of its global presence, RRL was rechristened as Indian Institute of Chemical Technology in 1989.

Core strength The Institute was established with a clear objective to serve the society of the region through scientific inventions and excelled in both basic and applied research areas of chemistry & chemical technologies. CSIR-IICT houses state-of-art pilot plant facilities to undertake industrial projects on a “concept to commercialization” mode. It is a great team work involving chemical and design engineering groups

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Dr S Chandrasekhar Director, CSIR-Indian Institute of Chemical Technology

towards successful implementation of projects up scaling from gram scale to pilot plant and finally commercialisation.

Areas of Research Initially, the institute focussed on pesticides, coal, ceramics, oils and fats, adhesives and polymers, natural products and medicinal chemistry. Diverse technologies were developed and successfully transferred to small and large scale industries. Later on as per the needs of Indian and International clients, attention was directed to pharma, energy, materials and other sectors of higher priority. In the formative years concentrated on pesticide research and later diverted its energies to cater to the

pharma sector and developed several technologies for life saving generic drugs. Worth mentioning is the technology for AZT (anti-HIV), a cost effective process development for ‘AZT’, the first curative and most expensive drug in the disease treatment and management of AIDS was introduced in the manufacture of Azidothymidine (AZT). It was developed indigenously for the first time, bringing down the costs in the world market. A new and highly cost-effective route for azido thymidine, a crucial intermediate for AZT, was also developed from D-xylose. More recently CSIR-IICT developed process for the prostaglandin based drug, misoprostol that is used to prevent gastric ulcers, treat mis-

carriage, induce labour and induce abortion. Gradually switching the gears, many of the erstwhile departmental activities were directed towards need of the hour: from the generic drugs to new non-infringing routes, new products and processes, green technologies, New Drug Discovery, product and process patents and leads. This paradigm shift gave CSIR-IICT new leads in drug discovery and some of them are under various stages of development currently. The pesticides research resulted in technologies that were commercialised by several industries, while, the activities threw light on bio-pesticides, pheromones/kairomones. The research activities include the development of intermediates and process routes for pesticides, besides the design of NCEs as crop protection chemicals. The scientists are well trained in synthesising complex natural products proteins, peptides, steroids, besides expertise in asymmetric synthesis, development of new reagents, synthesis of scaffolds and libraries for drug discovery. Thus, organic synthesis evolved into application oriented synthesis. A Chemical Biology group with modern facilities was nurtured to complement the activities of drug discovery, both in target identification and evaluation. To strengthen the drug discovery, a National Mol Bank facility has been established, which can store 2 million synthetic or natural compounds for ex-

tended periods in inert atmosphere for further screening. Understanding the pressing needs of discovery research, chemical biology and pharmacology departments were strengthened with the establishment of state-of-the art facilities along with animal house for clinical trials. The oils and fats department evolved into a Center for Excellence in Lipid Science & Technology. The degumming of Rice Bran Oil technology developed by the institute caters the oil industries in the production of more than four lakhs tonne per annum in India. The research activities thus have diversified into the development of nutracueticals and biofuel, etc. The catalysis group at CSIR-IICT is an excellent blend of scientists with expertise in physical and inorganic chemistry, besides organometallic chemistry. The group has made tremendous strides in the development of new catalysts for the pharma, agro and food products. The processes/technologies for pyrazinamide, triphenylphosphine, the catalysts for waste plastics to fuel oil, catalytic desulfurisation, solid acids/bases for the synthesis of fine chemicals are noteworthy. These activities have steadily transformed into the research on materials, nanomaterials, biomass to value added products and others.

Strategic sector Furthermore, the research in the strategic sector resulted in

CPHI & P-MEC INDIA 2018 SPECIAL

the establishment of a unique facility in the development of fluoro-organics, fluorinated fine chemicals and materials for pharma and commodity sectors. This research group is one of its kind in the country. CSIR-IICT developed and commercialised indigenous process technologies for several important fluorochemicals. The major technologies include ozone friendly refrigerant 1,1,1,2-tetrafluoroethane (HFC134a), fire suppressant 2H-heptaflulropropane, fine chemicals: 2,4-dichlorofluorobenzene, 2,2,2-trifluoroethanol, trifluoroacetic acid etc. Efforts are on in the development of technologies for new generation refrigerants HFO-123yf & HFO1234ze and fluoromonomers: vinylidene fluoride, trifluoroethylene and 1,3-hexafluorobutadiene. The synthetic aviation lubricants are one of the most important contributions of CSIR-IICT – to the world of Science & Technology. The activities of polymer and functional materials group include the areas of surface coatings, adhesives and biomaterials,

composites and waste utilisation and other allied areas. Recently, CSIR-IICT has developed and delivered a proto-type version of portable single-sided Nuclear Magnetic Resonance (NMR) device to DRDO-ASL, for strategic defense applications. This concept is parallel to clinical-MRI and the device allows step-bystep systematic depth profiling up to 25 cm at microscopic spatial resolution of objects of any size, which otherwise is not possible with the conventional NMR methods. The portable NMR system could successfully identify pre-generated faults across the composite objects. It has been tested for the sub-scale models of advanced missiles and the approach is particularly useful for testing the readiness of the missiles which are under prolonged storage. The success has formed basis for developing devices for large objects and onsite defense applications. Research in the field of energy has shifted from coal to the development of materials for solar energy, batteries,

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electrolytes, green energy. The research focus is aimed at the development of technologies for third generation solar cells such DSSC, OPV, OIHSC by the use of new and efficient material or organic molecules.

Societal sector The new membrane technology has been developed for the treatment of contaminated ground and surface water to convert into potable drinking water in rural areas. CSIRIICT and Mathri Aquatech together developed an indigenous atmospheric water generator (AWG) which harvests moisture from the atmosphere to generate potable water. The device is very useful for production of drinking water at locations where there is no raw water available for treatment or purification. Another initiative under this category has been the ‘WASTE to WEALTH’, wherein organic solid waste is treated to generate Bioenergy using ‘Anaerobic Gas lift Reactor Technology’ partnering with M/S Ahuja Engineering

Services. Herein kitchen waste is utilised to create clean cooking fuel to replace LPG consumption. The Akshaya Patra Foundation at Bellary and Hubli (Karnataka), Ahmedabad and Surat (Gujarat) are currently using this technology. CSIR-IICT canteen runs on this fuel.

Infrastructure The analytical support for the institute emanates from the centers of NMR, Mass, Xray; SEM/TEM/AFM/ESCA and so on. The NMR, MASS and X-Ray centres are recognized as the National Centers. The scientists of these centres not only facilitate analytical services but also engage in high-class research in their respective fields. CSIR-IICT library houses one of the largest/oldest collections of books/journals as well as subscribes to several online scientific journals.

Networking/collaborations The institute forged collaborations with several pharma, agro and fragrance industries from

within India and abroad which generated IP and revenues to the tune of millions of dollars. In addition, CSIR-IICT established cross country collaborations with academic institutions i.e., IICT-Indo-French (CNRSRennes), IICT-RMIT (Australia), IICT-NIMS (Japan) and others. The CSIR-IICT offers excellent support to start up companies and presently houses number of such pharma companies nurturing them as incubators.

Human resources The Human Resource policy looks into the talent search, appointment of the young scientists, mentoring and giving them opportunity to upgrade skills, including the development of leadership skills. The institute has the largest contingent of research students, whose enthusiastic activities every year results in several high quality publications in journals of international repute. Visit www.iictindia.org for further details

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CPHI & P-MEC INDIA 2018 SPECIAL

I N T E R V I E W

‘We have been growing at the rate of approximately 35 per cent annually’ Ravi Thakur, Director, Pharmintech Turnkey Solutions and Pravin Shetty, Director, Pharmintech Turnkey Solutions talk about their company’s offerings for the pharma sector and their growth plans Tell us about your company and its offering’s for the lifescience sector? Who are your major pharma clients? Pharmintech Turnkey Solutions is a knowledge driven enterprise and hence we keep ourselves updated with the current industry requirements. Our innovative design are helping companies to reduce the capital cost and upgrading their facilities to the current standards. Our inhouse design and manufacturing enable us to deliver the system timely. We offer complete solutions from design to build under one roof for the complete facility ◗ Clean room partitions and doors ◗ Clean room HVAC ◗ Clean room equipment [Pass box, LAF, Bio Safety, Air Showers Etc.] ◗ Clean room validation ◗ Complete range of SS furnitures We have and are working

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Ravi Thakur, Director, Pharmintech Turnkey Solutions

Pravin Shetty, Director, Pharmintech Turnkey Solutions

for reputed pharma companies on regular basis which includes, Wockhardt, Alembic, Centaur, Torrent, Bioplus, Recipharm, Lupin, Kopran, Sava Global and many more.

industries are the major suppliers to the world and hence face a global challenge in terms of product pricing. Pharmintech current focus is providing the industry with sustainable designs with better energy recovery solutions making the overall cost of the final product competitive without compromising on the

What are your current focus areas for pharma/biotech industry? Indian pharma and biotech

quality.

complete new design.

Are there any plans to launch or showcase any new products at CPHI / PMEC India 2018? We always look forward towards CPHI/PMec exhibitions with great enthusiasm and shall display our new offerings too. We are displaying few of our products like LAF and pass box with

What is the company’s growth strategy for the next three years? With the line of products and our pre and after sales service provided by us, we have been growing at the rate of approximately 35 per cent annually and we wish to maintain this consistency in the coming years too.

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