Cold WFI production has been approved in Europe since 2017. EnviroFALK PharmaWaterSystems GmbH has successfully commissioned several plants (production, storage and distribution) of this type in Germany and abroad. Great importance was always attached to exact compliance with EMEA specifications and a risk-minimizing design and safe manufacturing process, so that the economic and reliable production of this medium was guaranteed for the plant operator. The following aspects, among others, were taken into account:

- Safe water pre-treatment depending on the feed water quality.

- Robust process technology: two-stage RO, membrane degassing, EDI and ultra-filtration.

- Special focus: the last barrier against germs and endotoxins - ultrafiltration. A separate patent for the ozonization of ceramic ultrafiltration was implemented here.

- Hygienic design: turbulence in all pipelines, diaphragm valves from the feed water inlet, aseptic TC connections (11864-3), etc.

- Comprehensive, application-specific monitoring right from the incoming feed water: TOC, conductivity, residual hardness and the ozone content before softening and reverse osmosis.

- A resilient sanitization system: the entire system is hot water sanitizable, the ultrafiltration and parts of the pre-treatment can also be ozonized.