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Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Microbial air-sampling equipment, part 1: meeting United States pharmacopeia chapter 797 standards
1Clinical IQ, LLC, Florham Park, New Jersey.
Abstract:
The most recent changes to Chapter 797 of the United States Pharmcopeia-National Formulary initiated an intense controversy about the frequency of cleanroom air sampling that is required to prevent the contamination of sterile preparations. For compounders who must purchase an air sampler to use in the cleanroom, choices abound. Included in this article are a review of United States Pharmacopeia-National Formulary requirements that pertain to air sampling, a discussion of how recent revision to Chapter 797 affect air sampling and patient safety, and, for easy reference, a table that features specifications for various models of microbial air samplers.

