Sterilization of Compounded Parenteral Products: Verification of Autoclaves
Author(s): Rahe Hank
Issue: Mar/Apr 2013 - Volume 17, Number 2
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Page(s): 94-98
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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