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Sterilization of Compounded Parenteral Products: Verification of Autoclaves

Author(s):  Rahe Hank

Issue:  Mar/Apr 2013 - Volume 17, Number 2
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Abstract:  This article discusses the basic principles for verification of a sterilization process and provides a recommended approach to assure that autoclaves deliver the sterility-assured levels required for patient safety. Included is a summary of the protocol and verification (validation) results of a previously published case study involving autoclaves. To assure the sterility of compounded preparations, a verification procedure must be in place.

Related Keywords: Hank Rahe, BSIM, MSE, United States Pharmacopeia Chapter <1211>, USP, compounded sterile preparations, sterility assurance levels, sterilization, autoclaving, autoclaves, microbial contamination, documentation, verification, standards

Related Categories: STERILE PREPARATIONS, SUPPORT, TECHNOLOGY, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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