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配制基础:实施美国药典第797章药物配制-无菌制剂的注意事项,第15部分:人员培训、清洁与着装

Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 15: personnel training, cleansing, and garbing.

作者信息

Okeke Claudia C, Allen Loyd V

机构信息

claumek PharmaScience, Rockville, Maryland.

出版信息

Int J Pharm Compd. 2009 Sep-Oct;11(5):420-6.

PMID:23966526
Abstract

Proper cleansing techniques must be followed by compounding personnel, the purpose of which is to eliminate microbial residues that could contaminate compounded sterile preparations. Personnel must be highly competent and motivated to perform the aseptic manipulations of compounding sterile preparations, ingredients, and devices without mistake. For personnel to achieve the level of competency and the motivation required for properly compounded sterile preparations, they must be thoroughly trained not only on compounding procedures, but on all aspects of cleansing and garbing. This article discusses the requirements provided within the United States Pharmcopeia concerning personnel training, cleansing, and garbing, as well as a discussion on good compounding practices as they relate to each of these issues.

摘要

调配人员必须遵循适当的清洁技术,其目的是消除可能污染无菌调配制剂的微生物残留。人员必须具备高超的能力且有积极性,无误地对无菌制剂、成分和器械进行无菌操作。为使人员达到正确调配无菌制剂所需的能力水平和积极性,他们不仅必须在调配程序方面接受全面培训,还必须在清洁和着装的各个方面接受培训。本文讨论了美国药典中有关人员培训、清洁和着装的要求,以及与这些问题相关的良好调配规范。

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