The new ISPE D/A/CH handbook "Production of Water for Injection Purposes Without Distillation" is available

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The appearance of the new European monograph on the production of Water for Injections (Water for Injection, WFI) is the result of discussions, analyses, and conversations.

In this monograph, in the Production section, membrane processes for the production of WFI are now listed as an equivalent alternative to distillation methods. Until now, WFI in Europe had to be produced by final distillation.

Distillation is a very safe method for producing WFI and is therefore regarded worldwide as the gold standard for WFI production.

With the development of new manufacturing methods in water treatment, the industry has called for these new processes to be approved for WFI production in order to reduce costs.

The new WFI monograph of the European Pharmacopoeia (Ph. Eur.) has now achieved harmonization of the pharmacopoeias of Europe, the USA, and Japan.

These pharmacopoeias now permit the recognized production of WFI without distillation.

To produce WFI in a compliant and reliable manner, suitable plant design and appropriate monitoring of process technology are required.

The current requirements from authorities still contain ambiguities and raise questions.

The interdisciplinary expert team from the ISPE D/A/CH Community of Practice (CoP) for Pharmaceutical Water & Steam has now created a guideline in the form of a manual, in German.

This provides an overview of the regulatory requirements and answers open questions regarding membrane-based WFI production from the experts' perspective.

The document provides planners, operators, equipment manufacturers, pharmaceutical manufacturers, and regulatory representatives with a practical guide that considers both regulatory compliance and technical and operational feasibility.

An excerpt from the manual can be viewed here: https://ispe-dach.org/das-water-for-injection-wfi-handbuch/

The order form is also available there.