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