本文件规定了纯化水（PW）和注射用水（WFI）预处理和基于膜的生产系统的设计、材料选择、施工和操作。 由于可能有许多不同类型的给水，因此介绍了不同的部件和配置。提供了一个决策矩阵，为不同类型的给水提供指导。 本文件不包括 -根据系统选择适当的药典水定义:例如PW、WFI或其他； -产生PW/WFI的热过程； -环路、存储和分配； -纯蒸汽的产生和分配； -实验室水系统和 -验证。

This document specifies design, materials selection, construction and operation of Purified Water (PW) and Water for Injection (WFI) pretreatment and membrane-based production systems. As many different types of feed water are possible, different components and configurations are presented. A decision matrix is provided to give guidance for the different types of feed water. This document excludes — selection of the appropriate compendial water definition per system: e.g. PW, WFI or other; — thermal process for generation of PW/WFI; — loops, storage and distribution; — pure steam generation and distribution; — laboratory water systems and — validation.