Critical Environments Columns
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Risk Assessment Of Objectionable Microorganisms In Nonsterile Pharmaceuticals
4/19/2019
This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.
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Cleaning, Sanitizing, Sterilizing, Or Wishing It Away: What Are We Doing To Control Bioburden?
4/12/2019
Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA) — a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.
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Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals
4/5/2019
This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.
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“What, You Call That A RABS?” 7 (Real-Life) Aseptic Filling Blunders To Avoid
This article is based upon the authors' travels over the last 10 years, looking at aseptic filling operations and seeing what was described to be “a RABS” by the various owners. Some of these are actually amusing, and they illustrate what happens when “hands-on” engineering meets the needs of operations while the compliance department is asleep at the wheel.