News|Articles|May 15, 2016

Pharmaceutical Technology

  • Pharmaceutical Technology-05-15-2016
  • Volume 2016 eBook
  • Issue 2

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

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

over 9 years ago

Measuring and Removing Genotoxic Impurities

over 9 years ago

Qualification and Validation of Single-Use Shipping Systems

over 9 years ago

The Evolution of Planning, Design, and Engineering—Flexibility Takes Center Stage

over 9 years ago

Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

over 9 years ago

Lessons Learned Accelerate Vaccine Development

over 9 years ago

Protecting the Product and the Patient

over 9 years ago

Deconstructing the Regulatory Spiral

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