Immediate Use Compounding Sterile Products (CSP)- Need of Alternative Sterility Testing Method- A Review

Author(s):  Rajagopal Kumaravelrajan, Venkatesan Suba

Issue:  Sep/Oct 2025 - Volume 29, Number 5
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Abstract:  Immediate-use compounded sterile preparations (CSPs) pose significant sterility testing challenges because of short beyond-use dating. Traditional sterility tests, as outlined in USP <71>, require long incubation periods. USP Chapter <797> provides guidelines emphasizing aseptic technique, environmental controls, and validated sterility testing methods. Alternative rapid sterility testing methods, such as those which use cytometric or ATP bioluminescence principles, may obtain faster results and proving suitable for immediate-use CSPs, though they require rigorous validation. This review discusses the sterility testing challenges specific to immediate-use CSPs, examines USP <797> requirements, and compares traditional and alternative testing approaches. It highlights the need for validated rapid methods to enhance sterility testing procedures to improve patient safety in sterile compounding.

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL

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