浅谈制药企业纯化水储存及分配系统设计要点

Discussion on Design Points of Purified Water Storage and Distribution System in Pharmaceutical Companies

纯化水是一种非常关键的辅料,既可作为工艺原料参与整个生产工艺过程,也可作为器具用水用于清洁。纯化水直接影响药品的成品质量,其重要性不言而喻。因此无论是从药品生产质量规范的角度,还是从良好工程管理规范的角度出发,企业都须证明其纯化水系统能够始终如一地提供达到质量标准的纯化水。基于质量源于设计的理念,本文分析和阐述了纯化水储存及分配系统选型设计时需要重点考虑的要点。

Purified water is a crucial auxiliary material,which could be used as a process raw material to participate in the entire production process,as well as a tool for cleaning,directly affecting the quality of finished pharmaceutical products,the importance is self-evident.Therefore,whether from the perspective of drug production quality standards or good engineering management practices,enterprises must prove that the purified water system could consistently provide purified water that meets quality standards.Based on the concept of quality by design,on the key points to be considered in the selection and design of purified water storage and distribution system were analyzed and elaborated.