CoP Pharma Water and steam
The aim of the CoP “Pharma Water and Steam” is to network experts from the pharmaceutical industry. We provide a platform for the discussion of specialist topics and the exchange of experiences. In addition, this group is actively participating in future revisions of ISPE’s international baseline guides on “Pharma Water and Steam”. We offer annual presentations, practice guides or technical discussions on topics related to “water and steam”. The content and focus are determined by the participants. Through communication with other global CoP’s, experiences are regularly shared.
Water for Injection
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.
In recent decades, with the development of new manufacturing methods in water treatment, there has been a demand from the industry to use these new processes for WFI generation as well, thereby reducing 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.
This is one reason that there is not yet a common understanding.
The interdisciplinary team of experts of the ISPE D/A/CH Community of Practice (rCoP) for pharmaceutical water and steam has produced a guideline in the form of a 110-page manual (d) for understanding.
This will provide an overview of the regulatory requirements, and open questions regarding membrane-based manufacturing of WFI will be answered from the experts’ perspective. Planners, operators, equipment manufacturers, drug manufacturers, and government officials are provided with a practical guide that addresses regulatory compliance as well as technical and operational feasibility.
Special topics of the working group
- Plant engineering and design
- Maintenance and servicing
- Construction materials
- Technologies of production and distribution
- Compliance and quality
- Commissioning and qualification
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Endress + Hauser
Merck Serono SA
BWT Aqua AG
GMP Assistance GmbH