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

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.

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.