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

Pharmaceutical Technology, Pharmaceutical 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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