ISO 22519:2019 纯净水和用于注射前处理和生产系统的水

标准编号：ISO 22519:2019

中文名称：纯净水和用于注射前处理和生产系统的水

英文名称：Purified water and water for injection pretreatment and production systems

发布日期：2019-06

标准范围

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.

标准预览图