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Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.
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 managing quality and extractables and leachables (E&L) in single-use systems.
eBook: Single-Use Systems
When referring to this article, please cite it as S. Haigney, "Managing Quality in Single-Use Systems," BioPharm International Single-Use Systems eBook (June 2018).