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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Articles in this issue

over 9 years ago

Article

Measuring and Removing Genotoxic Impurities

over 9 years ago

Article

Qualification and Validation of Single-Use Shipping Systems

over 9 years ago

Article

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

over 9 years ago

Article

Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

over 9 years ago

Article

Lessons Learned Accelerate Vaccine Development

over 9 years ago

Article

Protecting the Product and the Patient

over 9 years ago

Article

Deconstructing the Regulatory Spiral

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