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Article: Guide To Irradiation And Sterilization Validation Of Single-Use Bioprocess Systems
By The Irradiation and Sterilization Subcommittee of the Bio-Process Systems Alliance
Single-use bioprocess manufacturing systems increasingly are being implemented by the biopharmaceutical industry based on safety, time, and cost-reduction benefits. These disposable systems are used to process or contain fluids ranging from culture media, additives, and buffers, to bulk intermediates and final formulations. In many cases microbial control or sterility is required to ensure product purity and safety. Radiation sterilization is a common means of microbial control and sterilization applied to single-use systems. The standard methods for validating radiation sterilization are not widely understood in the pharmaceutical industry, which has historically relied on moist heat (steam) for sterilization of stainless steel bioprocess systems.
Reprinted with permission from BioProcess International
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