ABSTRACT
Understanding decontamination technology as it applies to compounding sterile preparations and its role in achieving an acceptable level of sterility assurance in compounded preparations is essential. Delivering safe preparations to patients requires the key elements that make up an acceptable sterility-assurance level. Those key elements are decontamination of the preparation components and the environment in which they are compounded, aseptic technique, and proper air quality of the compounding environment. This article explores the concept of sterility assurance as it applies to sterile preparations.
Subject(s)
Decontamination/methods , Drug Compounding/standards , Drug Contamination/prevention & control , SterilizationABSTRACT
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.
