ISO 22519:2023Published

Membrane-based generation of water for injection (WFI)

Production d'eau pour préparations injectables (EPPI) utilisant des membranes

Abstract / scope

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.

Life cycle

Replaces

ISO 22519:2019WithdrawnPurified water and water for injection pretreatment and production systemsInternational Standard · Published 29 May 2019 · ISO/TC 282