Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations

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Pharmaceutical TechnologyPharmaceutical Technology-05-15-2016
Volume 2016 eBook
Issue 2
Pages: s31-s35

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

USP requirements for the absence of “objectionable organisms” are well intended, but may often result in the need for subjective, and unrealistic, determinations. This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

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Pharmaceutical Technology’s 2016 Bioprocessing and Sterile Manufacturing eBook

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