Rahe Hank
Containment Technologies Group, Inc., Indianapolis, Indiana 46203, USA.
Int J Pharm Compd. 2013 May-Jun;17(3):193-9.
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.
了解适用于无菌制剂配制的去污技术及其在实现配制制剂可接受的无菌保证水平方面的作用至关重要。为患者提供安全的制剂需要构成可接受无菌保证水平的关键要素。这些关键要素包括制剂成分及其配制环境的去污、无菌技术以及配制环境适当的空气质量。本文探讨了适用于无菌制剂的无菌保证概念。