Water4Injection

Online water quality and integrity control in membrane-based Water for Injections production systems.

Since the release of the revised Ph. Eur. Monograph 0169 in 2017, water for injection (WFI) can be produced with alternative methods to distillation, including more energy and cost efficient multistage membrane based processes. Although membrane-based products for WFI applications exist in USA and slowly developing in Europe, there are currently no systems on the market, which are able to fulfil high-level requirements for safety, quality control and generally robustness. The major current limitation of the membrane based WFI systems is its microbial safety. The risks of microbial contamination and proliferation are induced by biofouling, common in reverse osmosis systems. The standard WFI monitoring methods such as heterotrophic plate count require days to receive results, and are not able to provide the necessary level of security to customers. This leads to the currently low acceptance of the membrane based WFI (cold WFI) production.

IEC FHNW, BWT and BNovate collaborate on the further development of the WFI system evaluation and monitoring methods. The Innosuise funded collaborative project has a goal to bring on the market a cold WFI system with real-time process monitoring, which satisfies the high quality requirements of the European Pharmaceutical Industry.