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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
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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.

Related Keywords: Loyd V. Allen Jr., PhD, RPh, compounded sterile preparations, microbiological testing, sterility testing, bacterial endotoxins, sample selection, sample preparation, preservative effectiveness, microbial limit testing, out of specification results, homogeneity, solubility, sterilization, continuous quality improvement

Related Categories: EXCIPIENTS, STERILE PREPARATIONS, QUALITY CONTROL

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