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Basics of Water For Injection Production

The production of water for injection (WFI) is a critical process operation for any pharmaceutical manufacturing facility requiring this quality of water. The processes used are to ensure the water is treated correctly and all contaminants are stripped out, leaving WFI quality water.

WFI is produced predominantly via distillation; this is a requirement of the European Pharmacopoeia. Other such pharmacopoeias, like United States Pharmacopeia (USP) and Japanese Pharmacopoeia (JP), allow the use of membrane technology through reverse osmosis and ultrafiltration to attain WFI quality water.

The production of WFI by membrane technology is not thought to be as effective as distillation due to inherent risks of membrane processes, their ease of bacterial and chemical contamination and loss of integrity. The water is also processed at ambient temperatures, as opposed to those elevated temperatures witnessed during distillation.


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By Dave Forte, Process Engineer, Water Group at Pharmatec Procip Ltd

Dave Forte graduated from the University of Wales in Swansea with a MEng (Hons) degree in Chemical Engineering. He currently holds the position of Water System Process Engineer with Pharmatec Procip Ltd, specialising in the design of critical pure water and steam systems.

He has been responsible for the design of water systems (supplied and installed) within AstraZeneca, GlaxoSmithKline, Rhodia-Chirex and Boots PLC, as well as conducting numerous design studies and system audits.

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Dave Forte
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