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药品配制中的主要工程控制,第1部分:单向气流工作站、无菌配制隔离器和无菌配制密闭隔离器

Primary Engineering Controls in Pharmaceutical Compounding, Part 1: Unidirectional-airflow Workstations, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators.

作者信息

Mulder Kyle

机构信息

Technical Safety Services, LLC, Portland Oregon.

出版信息

Int J Pharm Compd. 2019 Nov-Dec;23(6):447-452.

Abstract

In pharmaceutical compounding, the term "primary engineering control" usually refers to a device used to reduce the number of airborne particles and microorganisms in the compounding suite by channeling filtered unidirectional high-efficiency particulate air into areas that must be as contaminant free as possible. In this article, which is the first in a 2-part series, several types of primary engineering controls (unidirectional-airflow workstations, compounding aseptic isolators, compounding aseptic containment isolators) used to achieve that goal are discussed, as is laminar airflow in those units and the use of casters and hydraulic lifts. In part 2, several classes of biosafety cabinets used for that purpose in compounding are examined.

摘要

在药物配制中,“一级工程控制”一词通常指的是一种装置,该装置通过将经过过滤的单向高效微粒空气导入必须尽可能无污染物的区域,来减少配制间空气中的微粒和微生物数量。本文是一个两部分系列文章中的第一篇,文中讨论了用于实现该目标的几种类型的一级工程控制(单向气流工作站、无菌配制隔离器、无菌配制密闭隔离器),以及这些装置中的层流气流、脚轮和液压升降机的使用。在第二部分中,将对用于药物配制的几类生物安全柜进行研究。

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