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

Loyd V Allen, Claudia C Okeke
International Journal of Pharmaceutical Compounding 2008, 12 (3): 252-7
This article 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 disussed in Chapter 797.

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