The Water for Injection (WFI) Manual


The appearance of the new European monograph on the production of Water for Injection (WFI) is the result of discussions, analyses and talks. In this monograph, membrane processes for the production of WFI are now included in the production section, as an equivalent alternative to distillation processes. To date, WFI had to be final distilled in Europe. Distillation represents a very safe process for the production of WFI and is therefore seen worldwide as the gold standard for WFI production.

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Water for Injection, abbreviated WFI, is water of special quality and requirements. The production, as well as the specification is described in the monograph of the same name.

With the development of new production methods in water treatment, the demand arose in the past decades to use these new processes also for WFI production in the pharmaceutical industry and thus to reduce costs. With the new WFI monograph of the Ph. Eur. In parallel, the pharmacopoeias of Europe, the USA and Japan have now been harmonized to a large extent.
These pharmacopoeias now allow the recognized preparation of WFIs without distillation.

Nevertheless, in order to be able to produce WFI compliantly and reliably, a suitable plant design and appropriate monitoring of the process technology are required. The currently existing specifications on the part of the authorities still contain ambiguities and raise questions.
Therefore, there is no uniform understanding yet.

The interdisciplinary team of experts of the ISPE D/A/CH Community of Practice (CoP) for Pharma Water and Steam has prepared a guideline in the form of a 110-page manual (d) for understanding.

The WFI Handbook provides an overview of the regulatory requirements. Open questions regarding membrane-based production of WFI will be answered by experts. Planners, operators, equipment manufacturers, drug manufacturers, and government officials are provided with a practical guide in the WFI Handbook that addresses regulatory compliance as well as technical and operational feasibility.

This is the german version of the handbook.

Additional information

Weight 0.3 kg