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

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.