ISO/TC 282/WG 3 - Water systems for biopharma industries

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.