Mixon William, Roth Abby
The Compounding Pharmacy, Hickory, North Carolina.
Azzur Labs, Schnecksville, Pennsylvania.
Int J Pharm Compd. 2017 May-Jun;21(3):193-203.
Compounding pharmacists must ensure that the sterile preparations they dispense are free of microbiologic contamination. Working in a cleanroom under controlled conditions (proper differential air pressure, temperature, and humidity; acceptable levels of viable and nonviable airborne particles and surface counts, etc.) and testing the efficacy of cleaning and disinfecting practices via environmental monitoring (viable-air and surface testing, glove-fingertip-thumb testing, etc.) are essential to preparing contamination-free medications. Sterile-compounding pharmacists must understand how to monitor their cleanroom environment and, if they perform testing in house, to interpret the results of simple microbiologic tests (a skill helpful even when tests are outsourced to a contract laboratory). In this article, which pertains to 503A sterile compounding, and is based on the current version of United States Pharmacopeia (USP) Chapter <797>, basic concepts in microbiology and the microbial tests that can be performed and interpreted in house and those that must be outsourced are discussed. Streamlining communication with contract laboratory personnel is reviewed. Requirements for an inhouse microbiology laboratory are presented, and the advantages and disadvantages of inhouse and outsourced testing are examined. A list of suggested reading is provided for easy reference. In a subsequent article, environmental monitoring and analysis will be addressed in detail.
配制药剂师必须确保他们配发的无菌制剂不受微生物污染。在受控条件下的洁净室中工作（适当的压差、温度和湿度；可接受水平的活菌和非活菌空气颗粒及表面计数等），并通过环境监测（活菌空气和表面检测、手套指尖拇指检测等）来测试清洁和消毒措施的效果，对于制备无污染药物至关重要。无菌配制药剂师必须了解如何监测他们的洁净室环境，并且如果他们在内部进行检测，要能够解读简单微生物检测的结果（即使检测外包给合同实验室，这项技能也很有帮助）。在本文中，涉及503A无菌配制，且基于美国药典（USP）第<797>章的当前版本，讨论了微生物学的基本概念以及可在内部进行并解读的微生物检测以及必须外包的检测。还回顾了与合同实验室人员简化沟通的方法。介绍了内部微生物实验室的要求，并探讨了内部检测和外包检测的优缺点。提供了一份推荐阅读清单以供方便参考。在后续文章中，将详细讨论环境监测与分析。
