USP CHAPTER 51 Chapter 51, Antimicrobial Effectiveness Testing of the United States Pharmacopeia, has been in existence for quite some time. In fact it was known previously as the preservative effectiveness test.

USP Chapter 51-AET is used to determine the preservative adequacy of an unused product formulation. In-use testing is performed to determine what happens to the microbial content of a formulation after use by a consumer. Consumers will do a a lot of weird stuff during use that cannot be predicted by performing a USP Chapter 51- AET.

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THINKING ABOUT USP CHAPTER <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS by David A. Porter, Ph.D.

Chapter <51> Background Material USP chapter <51> Antimicrobial Effectiveness Testing is designed to determine whether a product containing an antimicrobial agent is adequately preserved. Given the toxic nature of such agents, the lowest amount possible that achieves this level of antimicrobial efficacy should be used.

USP <51> Criteria for Fungal Organisms Started by Microbugge in General: Hello all, I'm wondering if the group has an opinion about why the USP <51> test criteria for fungal organisms in each product...

I would refer you to USP <1115> Bioburden control in Non-sterile Pharmaceutical Product for a discussion of the hierarchy of microbial contamination risk. The pharmaceutical ingredients, water system, and process equipment cleaning and storage are much greater sources of contamination.

CU October 9 2023Date of This Update: October 9, 2023

In terms of <72> I disagree with the title change from sterility to contamination testing (sterility testing but not contamination is a specification in USP monographs), reducing the suitability test inoculum level from <100 to <10 cfu so it differs from <72> and Ph. Eur. 2.6.27 so companies may have to requalify their test methods to comply with the compendial test methods, and the ...

INTRODUCTION Welcome to the PMF training module covering the SOP “Performance Verification of Autoclaves”. The version in this training module has been updated and is available at