纯化水、注射用水预处理及生产系统

[中文适用范围]： 本文件为评估基于膜的注射水 (WFI) 生成系统的设计、操作和性能提供了基准。 本文件适用于新系统的设计。 本文件涵盖以下主题： ——基于膜的注射用水生成系统的原理； ——基于膜的注射用水生成系统的工艺设计、建造、操作和维护； ——控制基于膜的注射水生成系统参数。 本文件不涵盖以下主题： ——验证； ——蒸馏。 [外文原描述]： This document provides a benchmark for evaluation of the design, operation and performance of water for injection (WFI) generation systems based on membranes. This document is applicable to the design of new systems. This document covers the following topics: — principles of membrane-based WFI generation systems; — process design, construction, operation and maintenance of membrane-based WFI generation systems; — controlling membrane-based WFI generation system parameters. This document does not cover the following topics: — validation; — distillation.