BioPharm June eBook: Single-Use Systems

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24 BioPharm International eBook June 2018 Single-Use Systems Quality Leonardo da\ Managing Quality in Single-Use Systems Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment. B ioPharm International spoke with Andrew B u lpi n, he ad of pro c e s s s olut ion s 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. REGULATORY EXPECTATIONS BioPharm: What are the regulatory expectations for the qualification of single-use systems? How do these expectations compare between the United States and Europe? Hower and Lu (SGS): The US Code of Federal Regulations (21 CFR 211.65) (1) states that equipment shall be constructed so that surfaces that contact compo- nents, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product. As for elemental impurities, the testing lim- its and methods shall be compliant to United States Pharmacopeia (USP) <232> (2) and International Council for Harmonization (ICH) Q3D (3). USP also published USP <665> and <1665> drafts on Pharmacopeial Forum (PF) 43 (4, 5) in 2017 on polymeric components and sys- tems used in the manufacturing of pharmaceutical and SUSAN HAIGNEY

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