The First M-WFI System for Japan

Die erste M-WFI Anlage für Japan

The First M-WFI System for Japan

This system has a capacity of 500 l/h and will soon be installed in Japan at our customer Topsystem. This marks a significant milestone for us and the Japanese market, as it will be the first system for cold WFI production in Japan.

Although the cold production of WFI (Water for Injection) was already approved in Japan before the implementation of ANNEX 1 of the European Pharmacopoeia, there has not yet been a membrane-based WFI production system on the Japanese market.

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Ultrafiltration plays a crucial role in cold WFI production, which we have placed particular focus on: We use highly robust ceramic modules that can be continuously treated with ozone.

This patented process ensures a stable and reliable production method while providing enhanced patient protection. In addition to the option of hot water sanitization for the entire system, the ozonation of the ultrafiltration unit serves as another key measure to ensure continuous microbial inactivation.

An additional benefit of this approach is that ozone can be recirculated through the system, extending beyond ultrafiltration to the softening stage of water pretreatment, ensuring constant microbial reduction throughout the process.

A detailed comparison of membrane-based WFI production and traditional distillation can be found in our two-part blog post on our website.

Service and Maintenance in Japan

Furthermore, as part of our service & maintenance concept, we will be using Water Expert SmartGlasses. With real-time video and audio transmission, on-site technicians can receive optimal support and guidance from our Help Desk experts.

This allows for quick and efficient troubleshooting, preventing production downtimes or quality deviations before they occur.

We sincerely thank Topsystem from Japan for their collaboration and trust.

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