ISO 22519:2019

Purified water and water for injection pretreatment and production systems

Scope

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.