Membrane-based WFI system for a modern pharmaceutical site in southern Germany

A globally operating pharmaceutical client specified a new membrane-based WFI system for its site in southern Germany. This system is being integrated into an existing building, where a new laboratory area for accompanying production is being developed in parallel.

The laboratory area spans four floors, which are predominantly supplied with cold and hot WFI. The supply is provided via subloops with integrated heat exchangers, ensuring temperature-stable delivery. The actual WFI generation system as well as the storage and distribution system are located in the basement.

The new WFI system is fed with softened water provided by the customer. Already at the inlet, UV disinfection with 800 J/m² at 254 nm ensures the required microbiological safety. The actual generation is carried out using a state-of-the-art membrane combination of reverse osmosis, membrane degassing, electrodeionization, and final ultrafiltration with a cut-off of 6,000 Dalton and automatic integrity testing.

A special feature of this project is the flexible thermal sanitization capability of the system. While typically only complete generation units can be thermally treated, in this case even the reverse osmosis as the first membrane barrier can be thermally sanitized independently and separately. This enables an exceptionally high level of microbiological safety and process control.

The cold-generated WFI is permanently stored in a 5 m³ tank with continuous ozonation. A sterile pump supplies the four laboratory levels with up to 10 m³/h. The dosed ozone is reliably degraded immediately before use by a UV unit (254 nm, 1,250 J/m²) down to the detection limit of < 5 ppb.

Since absolute ozone-free conditions are required during production, the ozone level reduced after UV disinfection is continuously monitored. In addition, the system automatically switches to the storage tank every hour and verifies the required ozone concentration of 80 ppb. For complete ozonation of the loop system, the UV unit is switched off and the ozone concentration in the return line is monitored.

The combination of modern membrane technology, an intelligent ozone strategy, and highly flexible thermal sanitization results in an extremely safe and reliable WFI system. Sectional thermal treatment enables microbiologically stable operation while maintaining high system availability.

Continuous monitoring of ozone levels, safe degradation during production, and automatic validation of tank concentration ensure maximum transparency and safety. At the same time, the energy-efficient membrane-based WFI generation supports sustainable production processes.

The complete membrane-based WFI system, including storage and distribution, underwent a comprehensive Factory Acceptance Test (FAT) at the main EnviroFALK PharmaWaterSystems site in Leverkusen. All key operational functions were successfully tested together with the customer.

Final installation as well as the qualification phases Installation Qualification (IQ), Operational Qualification (OQ), and the Site Acceptance Test (SAT) will take place shortly at the customer’s site.