BioPharm June eBook: Single-Use Systems

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Page 18 of 46

18 BioPharm International eBook June 2018 Single-Use Systems Qualification Qualif cation of Single-Use Systems 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. T he 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 sys- tems is, therefore, different and more chal- lenging 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 pro- cedures involved in the qualification of single-use systems. SINGLE-USE VERSUS STAINLESS-STEEL BioPharm: What challenges are specific to the qualifi- cation of single-use systems compared with stainless- steel? How are these challenges addressed? B u l p i n ( M i l l i p o r e S i g m a ) : T h e k e y d i f f e r e n c e b et we e n si ng le - u se s y ste m s a nd st a i n le ss - ste e l i s t he mate r ia l of con st r uc t ion. St a i n le ss - ste e l equipment has been a critical component within SUSAN HAIGNEY Victor Correia/

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