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Quality Control: Rapid Sterility Testing for Compounding Pharmacies

Author(s):  Taylor Andrew

Issue:  Jul/Aug 2020 - Volume 24, Number 4
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Abstract:  Rapid sterility testing offers numerous benefits compared to a traditional sterility test, most notably shortened incubation times and reduced subjectivity in results analysis. The wait for traditional sterility results introduces unnecessary risks into the production process in the event of contamination, additional storage requirements, merchandise hold times, and delays to market. Various available technologies deliver quality-control results in just a number of days or hours, allowing stakeholders to quickly confirm the presence or absence of microbial contamination.

Related Keywords: Andrew Taylor, MS, rapid sterility testing, rapid microbiological methods, bioburden testing, rapid environmental monitoring, United States Pharmacopeia Chapter <71>, USP, test incubation time, quality-control testing, microbial contamination, growth-based methods, non-growth-based methods, U.S. Food and Drug Administration, FDA, United States Pharmacopeia Chapter <1223>, validation parameters


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