Technical note Demonstrating column robustness through simulated transport testing Astrea Bioseparations performed transportation testing using an Evolve®D pre-packed chromatography column to evaluate the impact of simulated shipping and handling conditions on column integrity and chromatographic performance. Testing included vibration, shock, drop, and handling simulations representative of global air freight, sea, and road transport. Column performance assessments conducted before and after simulation testing demonstrated minimal variation in key chromatographic parameters, confirming maintained packing integrity, operational robustness, and suitability for shipment using Astrea Bioseparations’ dedicated transport packaging solutions.
Introduction Pre-packed chromatography columns are offered as part of Astrea Bioseparations’ extensive column product range. Designed for direct integration, these columns are supplied ready-for-use with certified performance to meet customer’s acceptance criteria. Maintaining column integrity is critical to ensuring consistent chromatographic performance upon arrival. Transportation by sea, air, or road can expose the packed column to vibration, shock and impact stresses. ISTA transportation testing allows assessment of these effects on the packed bed integrity and column performance criteria by evaluating column efficiency before and after the simulated testing procedures.
Demonstrating packed bed integrity and column performance using simulated transportation effects Astrea Bioseparations’ dispatched a pre-packed Evolve®D 35 cm chromatography column packed with an agarosebased resin to an accredited independent testing facility for ISTA transportation testing. The International Safe Transit Association (ISTA) protocols are industry standard protocols designed to simulate the environmental and mechanical stresses encountered during transportation and handling.
250 mm (2.5-19.6 L)
300 mm (3.5-28.3 L)
350 mm (4.8-38.5 L)
Testing conditions are designed to challenge the shipping configuration of the packaged product and packaging integrity during transportation, and includes: • Controlled vibration testing • Shock and impact events to represent potential handling incidents during loading and unloading • Compression and movement assessments to evaluate packaging protection during transit
Impact of transportation on packed bed performance By evaluating chromatographic performance before and after ISTA testing, the study can be used to assess the impact of transportation conditions on packed bed integrity, confirming maintained packing quality and operational performance following simulated shipment. Bed stability and packing integrity are considered maintained when the following performance characteristics remain uncompromised: • Column efficiency and plate count • Peak shape and degree of symmetry • Pressure-flow characteristics
450 mm (8.0-63.6 L)
600 mm (14.1-113.1 L)