News|Articles|May 15, 2016
- Pharmaceutical Technology-05-15-2016
- Volume 2016 eBook
- Issue 2
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.
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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
about 10 years ago
Measuring and Removing Genotoxic Impuritiesabout 10 years ago
Qualification and Validation of Single-Use Shipping Systemsabout 10 years ago
Revised ISO Cleanroom Standards Improve Air Cleanliness Classificationabout 10 years ago
Lessons Learned Accelerate Vaccine Developmentabout 10 years ago
Protecting the Product and the Patientabout 10 years ago
Deconstructing the Regulatory SpiralAdvertisement
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