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

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