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Pharmaceutical Technology

Pharmaceutical Technology-05-15-2016
Volume2016 eBook
Issue 2
Pages: s31-s35

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

Author(s):

James P. Agalloco

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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Articles in this issue
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Measuring and Removing Genotoxic Impurities
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Qualification and Validation of Single-Use Shipping Systems
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The Evolution of Planning, Design, and Engineering—Flexibility Takes Center Stage
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Revised ISO Cleanroom Standards Improve Air Cleanliness Classification
Lessons-Learned-Accelerate-Vaccine.jpg
Lessons Learned Accelerate Vaccine Development
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Protecting the Product and the Patient
Deconstructing-the-Regulatory.jpg
Deconstructing the Regulatory Spiral
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Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations

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