Mulder Kyle, Gonzales Ben A
Technical Safety Services, LLC, Portland Oregon.
Technical Safety Services, Inc., Berkeley, California.
Int J Pharm Compd. 2019 Jul-Aug;23(4):271-278.
In pharmaceutical compounding, effective contamination control is based on a complete understanding of the impact, sources, mechanisms, and prevention of adulterants in the compounding suite. Only then do the multiple facets of designing, constructing, maintaining, cleaning, using, and monitoring controlled environments make sense. This article presents an overview of the types of contaminants likely to compromise the potency and for their eradication. The information provided also applies to the contamination of other sites such as surgery suites, hallways, bathrooms, and the home setting. In a series of upcoming articles, the importance of compounding techniques, primary and secondary engineering controls, personal protective equipment, environmental monitoring, cleaning processes, hazardous-drug considerations, and certification of the compounding suite will be discussed in detail.
在药物配制过程中,有效的污染控制基于对配制区域内掺假物质的影响、来源、机制及预防措施的全面理解。只有这样,设计、建造、维护、清洁、使用和监测受控环境的多个方面才有意义。本文概述了可能影响药效的污染物类型及其消除方法。所提供的信息也适用于其他场所的污染,如手术室、走廊、浴室和家庭环境。在接下来的一系列文章中,将详细讨论配制技术、一级和二级工程控制、个人防护设备、环境监测、清洁流程、危险药物注意事项以及配制区域认证的重要性。