化学合成原料药生产设备清洗的关键因素探讨  

Discussion on Key Factors in Equipment Cleaning for Synthetic APIs

作　　者：王庆[1] 朱建伟[1] WANG Qing;ZHU Jianwei(Cell Engineering and Antibody Drug Engineering Research Center, School of Pharmacy, Shanghai JiaoTong University, Shanghai 200240)

机构地区：[1]上海交通大学药学院细胞工程与抗体药物工程研究中心,上海200240

出　　处：《中国医药工业杂志》2019年第3期260-269,共10页Chinese Journal of Pharmaceuticals

摘　　要：本文根据国外法规及相关行业指导原则,结合实际工作经验,对化学合成原料药生产过程中设备清洗需要考虑的因素进行综述和探讨。本文介绍了清洁可接受水平、清洗方法、清洁验证等重要概念及方法,并通过具体实例讨论了化学合成原料药生产设备清洗的关键因素,为化学合成原料药生产设备清洗提供参考。According to foreign regulations, relevant industry guidelines and practical experience, the factors that need to be considered in equipment cleaning during the production of chemical synthetic active pharmaceutical ingredient (API) are reviewed and discussed. This paper introduces some important concepts and methods, such as cleaning acceptable level, cleaning method and cleaning validation, and discusses the key factors of cleaning equipment for chemical synthetic APIs through specific examples, which can provide references for cleaning equipment for APIs.

关 键 词：化学合成原料药 设备清洗 允许日接触剂量 清洗方法 淋洗取样 擦拭取样 

分 类 号：TQ460[化学工程—制药化工]