Moody Colleen A, Eckel Stephen F, Amerine Lindsey B
University of North Carolina (UNC) Hospitals, Chapel Hill, NC, USA.
UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA.
J Pharm Technol. 2016 Apr;32(2):47-53. doi: 10.1177/8755122515607537. Epub 2015 Oct 5.
Microbial contamination of compounded medications is a serious concern within hospital pharmacies as it can lead to severe patient injury. The United States Pharmacopeia <797> mandates that pharmacy personnel responsible for preparing compounded sterile preparations must annually demonstrate competency in aseptic technique by performing a media-fill challenge test. The purpose of this study is to evaluate the sensitivity of a commonly used media-fill test through proper and improper compounding techniques. Two aseptically trained pharmacy technicians performed media-fill challenge testing by carrying out 5 separate manipulations 5 times each for a total of 25 trials. Sterile vials, syringes, and intravenous bags were prepared. The first manipulation followed best-practice aseptic technique and sterile compounding procedures. Each of the following 4 manipulations removed one aspect of best-practice aseptic technique. The prepared products were incubated at 20°C to 25°C. A positive result for microbial contamination is indicated by visible turbidity within the vials, syringes, and intravenous bags at the following check points: 24 hours, 72 hours, 7 days, 14 days, 21 days, and >30 days. Twenty-five trials, each containing 10 distinct admixtures, resulted in a total of 250 compounded preparations. No single preparation showed signs of turbidity, sedimentation, or visible microbial growth at any of the 6 checkpoints yielding a 0% contamination rate. However, the positive controls inoculated with bacteria did have positive microbial growth results. A more sensitive test needs to be developed to provide assurances that all poor aseptic practices are detected in compounding personnel.
医院药房中，复方制剂的微生物污染是一个严重问题，因为它可能导致患者受到严重伤害。美国药典<797>规定，负责制备复方无菌制剂的药房人员必须每年通过进行培养基灌装挑战试验来证明其在无菌技术方面的能力。本研究的目的是通过正确和不正确的配制技术来评估常用培养基灌装试验的敏感性。两名经过无菌培训的药房技术人员通过每次进行5次单独操作，共进行25次试验，来进行培养基灌装挑战试验。制备了无菌小瓶、注射器和静脉输液袋。第一次操作遵循最佳实践无菌技术和无菌配制程序。接下来的4次操作每次都去除最佳实践无菌技术的一个方面。制备的产品在20°C至25°C下孵育。在以下检查点，小瓶、注射器和静脉输液袋内出现可见浑浊表明微生物污染呈阳性结果：24小时、72小时、7天、14天、21天和>30天。25次试验，每次包含10种不同的混合物，共产生250份复方制剂。在6个检查点中的任何一个，没有一份制剂出现浑浊、沉淀或可见微生物生长的迹象，污染率为0%。然而，接种细菌的阳性对照确实有阳性微生物生长结果。需要开发一种更敏感的试验，以确保在配制人员中检测到所有不良无菌操作。
