浅谈制药设备的清洁验证

A Brief Discussion on Cleaning and Verification of Pharmaceutical Equipment

在生产过程中,作为特别商品的药物,它是被用来作为人类疾病预防,治疗和诊断的物品。其作用是对人的生理功能进行调节,并注明功效、用法及剂量。因此必须在每一次生产或每一次更换药品后进行生产设备的彻底清洁,以防止药品间的污染和交叉污染。本文首先阐述了《药品生产质量管理规范》对设备清洁验证的要求,接着分析了制药设备的清洁验证,最后介绍了总有机碳分析在制药设备清洁验证中的应用。

In the process of production,as a special commodity,drug is used as an article for the prevention,treatment and diagnosis of human diseases.Its function is to regulate the physiological function of human beings and indicate the efficacy,usage and dosage.Therefore,the production equipment must be thoroughly cleaned after each production or every replacement of medicines so as to prevent contamination and cross contamination between medicines.This paper first expounds the requirements of equipment cleaning and verification of ＂Standard for quality management of drug production＂,then analyzes the cleaning and verification of pharmaceutical equipment,and finally introduces the application of total organic carbon analysis in the cleaning and verification of pharmaceutical equipment.