DIGITAL TRANSFORMATION
↙ Adoption of AI in validation and other processes, including data collection and management, can result in valuable predictive qualities within a manufacturing facility.
Data and AI Accelerate Digital Transformation in Pharma MELISSA GRIFFEN, CONTRIBUTING EDITOR TOP THREE TAKEAWAYS 1. Manufacturers must focus on replacing paper with data through digital transformation.
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2. Starting small is the way to approach digital transformation, keeping the end state in mind.
s the name implies, “Pharma 4.0” is Industry 4.0 applied to pharmaceutical manufacturing, which is the addition of cyber-physical systems to computerize manufacturing while focusing on the human element. The concept has been gaining traction in recent years and was a common theme in the 2021 Parenteral Drug Administration (PDA) Annual Meeting. The four pillars of Pharma 4.0, as explained by Gilad Langer, Industry Practice Lead at Tulip Interfaces, a digital technology provider, are: • Resources • Information Systems • Organization and Processes • Culture These pillars focus on digitization, digitalization, and the human element. Further, Pharma 4.0 allows for the democratization of technology. In other words, what once was available only to experts is now available to the general workforce. The shift to this democratization can be eased through the new generations entering the field, who are all but raised on technology, making them what Langer called “digitally native.” Yet, the pharmaceutical industry is not
3. Artificial Intelligence will allow for robust real-time processes and predictive qualities.
taking full advantage of these advancements. One of the main facets of the Resources pillar is digital transformation which centers on real-time data and information to increase productivity, enable machine operators to do their jobs more efficiently, and further allow the use of predictive technologies, augmented reality (AR) and virtual reality (VR), Big Data, artificial intelligence (AI), and machine learning (ML). It allows for connectivity through integrated systems, equipment, people, and other software systems; real-time visibility into operations; transparency for quicker reaction time; and, at its highest levels, predictability and self-optimization in that the system can predict the outcome of a batch or machine’s performance and self-correct. In this kind of environment, apps, smart sensors, or the Industrial Internet of Things (IIoT) are used as a means of first capturing the data from the floor, which is then transferred to the cloud, available for use. (For more on predictive maintenance, see pp. 41.)
Replacing documents with data Thus, a focus of digital transformation is replacing the use of paper as a means of data collection. Paper is cumbersome and July/August 2021 • Healthcare Packaging | 33
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