17.04.2023
Cold production of WFI according to EP.
EnviroFALK PharmaWaterSystems GmbH

Cold production of WFI according to EP.

According to all EMA and Ph. Eur. requirements
Ozonizable ceramic ultrafiltration
Aseptic connections according to DIN 11864
Reynolds numbers > 10,000 even in standby phases
Performance regulation: 10-100%

Safe concepts for the cold manufacturing process

In addition to the production of WFI by distillation, we also offer you the generation of WFI by membrane processes: Our systems have two reverse osmosis membrane stages with downstream electrodeionization and ultrafiltration.

To ensure the microbial quality, the Letzner system design reduces harmful influences from the outset and integrates numerous preventive measures against microbial growth:

Two UV lamps with different wavelengths ensure a reduction of microorganisms and the degradation of nutrients.

A high flow rate prevents standing water even in standby phases.

A minimized number of exclusively used aseptic connections are an integral part of a sophisticated and robust hygienic design.

The design is completely made of AISI 316L grade stainless steel.

For the ultrafiltration ozonizable ceramic modules are used in a patented procedure, further we use stand hollow-fibre UF modules.

Different, fully automatic sanitization concepts are available to our customers following EMA requirements

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EnviroFALK PharmaWaterSystems GmbH