Water4Injection, FHNW School of Life Sciences

Since the release of the revised Ph. Eur. Monograph 0169 in 2017, water for injection (WFI) can be produced with methods other than distillation, including more energy and cost-efficient multistage membrane processes. Although membrane-based products for WFI applications exist in the USA and are developing in Europe, there are currently no systems on the market that can fulfil high-level requirements for safety, quality control and generally robustness.

The current limitation of membrane based WFI systems is microbial safety: the risk of microbial contamination and proliferation are induced by biofouling, which is common in reverse osmosis systems. 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.

The FHNW School of Life Sciences, BWT and BNovate collaborated on system evaluation and monitoring methods for membrane based WFI systems. The goal of this Innosuise funded project is to bring a cold WFI system with real-time process monitoring on the market, to satisfy the high quality requirements of the European pharmaceutical industry.