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Abstract:  The most recent changes to Chapter <797> of the United States Pharmacopeia–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 revisions 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.

Related Keywords: Eric S. Kastango, MBA, RPh, FASHP, USP, United States Pharmacopeia Chapter <797>, sterile preparations, cleanroom, air quality, microbes, microbial contamination, air sampling devices, device specifications

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, TECHNOLOGY, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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