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An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.
The polymeric nature of single-use systems creates the potential for extractables and leachables to impact the production of drug products. The qualification of single-use systems is, therefore, different and more challenging than stainless-steel systems.
BioPharm International spoke with Andrew Bulpin, head of process solutions for MilliporeSigma; Danny Hower, extractables & leachables supervisor, SGS; Dr. Dujuan Lu, extractables & leachables technical client manager, SGS; Helene Pora, vice-president, technical communication and regulatory strategy, Pall Biotech; Eric Isberg, director of Life Sciences at Entegris; and experts from the Bio-Process Systems Alliance (BPSA) Technical Committee, about the challenges and procedures involved in the qualification of single-use systems.
eBook: Single-Use Systems
When referring to this article, please cite it as S. Haigney, "Qualification of Single-Use Systems," BioPharm International Single-Use Systems eBook (June 2018).