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Basics of Sterile Compounding: Contamination Control

Author(s):  Akers Michael J

Issue:  May/Jun 2015 - Volume 19, Number 3
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Abstract:  There are serious consequences if contamination control is not enforced and contaminated products/preparations are released to the market. The greatest risk of microbial contamination is exposure of sterile (also termed “critical”) sites to potential sources of contamination. Contamination control basically involves at least fourteen entities to control or that help to determine the extent (quality) of control. Some of these entities are covered in this article; others will be covered in subsequent articles by the author.

Related Keywords: Michael J. Akers, PhD, microbial contamination, contamination risks, cleanroom facilities, endotoxins, pyrogens, air cleanliness classifications, disinfectants, antiseptics, sanitizing agents, sanitization, environmental controls, environmental monitoring systems, United States Pharmacopeia Chapter <797>, USP, viable particles, particulates, microorganisms

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS

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