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Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 7: Microbial Contamination Risk Levels, 12-Hour Use, and Immediate Use

Author(s):  Allen Loyd V Jr, Okeke Claudia C

Issue:  May/Jun 2008 - Pain Management
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Abstract:  This articles discusses the types of contamination that may occur when compounding personnel prepare, handle, or store sterile preparations, as discussed in United States Pharmacopeia Chapter <797> Pharmaceutical Compounding—Sterile Preparations. Contamination may be microbial, physical, or chemical, and all these are possible when sterile preparations are made. Microbial contamination may be fungal or bacterial. The most frequently identified microbial organisms in sterile preparations are spores and endotoxins. Chemical and physical contamination includes foreign objects, chemicals, physical matter, nonsterile components or objects, and airborne particles, objects, or matter from environments with uncontrolled air quality. Thorough knowledge of the possible sources of contamination can help in implementing the steps and processes to avoid contamination. The purpose of this article is to review the contamination risk level categories as discussed in Chapter <797>.

Related Keywords: Claudia C. Okeke, PhD, RPh, United States Pharmacopeia Chapter <797>, USP, microbial contamination, sterile preparations, standards, compounding risk levels, beyond-use dates, engineering controls, air quality, aseptic technique, Loyd V. Allen, Jr, PhD, RPh


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