Abstract

Summary of Quality-Control Testing for Sterile and Nonsterile Compounded Preparations, Part 2: Microbiological Testing

Author(s): Allen Loyd V Jr

Issue: Jul/Aug 2019 - Volume 23, Number 4

Page(s): 299-303

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Abstract

This 2-part series discusses quality-control and quality-assurance issues along with physical and chemical analytical methods and microbiological testing related to both sterile and nonsterile compounded preparations. This second part covers microbiological testing, including sterility, bacterial endotoxins, preservative effectiveness, and microbial limit testing, along with continuous quality improvement, sample selection and requirements, out-of-specification results, and cost factors associated with testing.

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