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Decontamination Technology: The Missing Element

Author(s):  Rahe Hank

Issue:  May/Jun 2013 - Volume 17, Number 3
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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.

Related Keywords: Hank Rahe, BSIM, MSE, compounded sterile preparations, drug safety, environmental contamination, sterility assurance level, aseptic technique, air quality standards, United States Pharmacopeia Chapter <1211>, primary engineering controls, packaging, disinfectants, sterilants, disinfection, sterilization, decontamination

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

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