Ligugnana Roberto
Around Lab News.
Int J Pharm Compd. 2017 May-Jun;21(3):182-190.
Chapter <797> issued by the United States Pharmacopeial Convention, Inc. is the standard for sterile compounding. It is designed to reduce the number of patient infections due to contaminated pharmaceutical preparation. This regulation applies to all staff who prepare compounded sterile preparations and all places where they are produced, including hospitals, clinics, pharmacies, and physician's offices. This article provides the history of environmental microbiology and provides a discussion on environmental microbiology sampling of air for pharmaceutical sterile compounding.
美国药典委员会发布的第<797>章是无菌配制的标准。其目的是减少因药品制剂污染导致的患者感染数量。本规定适用于所有配制无菌制剂的工作人员以及他们生产制剂的所有场所,包括医院、诊所、药房和医生办公室。本文介绍了环境微生物学的历史,并对药品无菌配制的空气环境微生物采样进行了讨论。