
- BioPharm International-06-15-2018
- Volume 2018 eBook
- Issue 2
Qualification 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.
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.
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Article Details
BioPharm International
eBook: Single-Use Systems
Vol. 31
June 2018
Pages: 18-23
Citation
When referring to this article, please cite it as S. Haigney, "Qualification of Single-Use Systems," BioPharm International Single-Use Systems eBook (June 2018).
Articles in this issue
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Considering Silicone Tubing and Assembliesover 7 years ago
Managing Quality in Single-Use Systemsover 7 years ago
Comparing the Supply Lifecycle of Bioreactorsover 7 years ago
Assurance of Supplyover 7 years ago
Biosimilars and Biobetters Strategies and Challengesover 7 years ago
An Integrated Approach to Shipping Liquid in Single-Use Systemsover 7 years ago
Single-Use Boosts Fill/Finish in Commercial BiomanufacturingNewsletter
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