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Safe Concepts for the Cold Production Process of WFI
Water for Injection (WFI): Customized Solutions for the Highest Purity Requirements
Water for Injection (WFI) sets the highest purity standards for pharmaceutical water treatment. It is used, among other applications, in the production of medicines that are directly injected into the body, requiring extremely low concentrations of microorganisms, endotoxins, ions, and other dissolved substances.
EnviroFALK PharmaWaterSystems GmbH provides specialized WFI systems that utilize advanced membrane technologies to achieve the required purity levels and ensure consistent quality. These systems offer an efficient and safe solution for companies that require a reliable source of WFI.
Mature Concepts with Additional Qualification Measures
To ensure microbial quality, our system design proactively reduces harmful influences and integrates numerous preventative measures against microbial growth:
- Optionally, a UV unit with a wavelength of 254 nm for reducing microorganisms.
- High flow rates prevent stagnant water, even during standby phases.
- A minimized number of removable connections is an integral part of a well-thought-out and robust Hygienic Design.
- The system is made entirely of stainless steel AISI 316L.
- A variety of fully automated sanitization concepts are available to our customers in compliance with EMA requirements.
Rely on mature system concepts with Hygienic Design to successfully retain microorganisms and endotoxins.
- In compliance with all EMA and Ph. Eur. requirements
- Ultrafiltration with 6,000 Dalton, whale by whale with automated integrity test
- Aseptic connections according to DIN 11864
- Reynolds numbers > 10,000 even during standby phases
- Online TOC measurement, optionally for feed water
- Automatic pressure differential measurements
Sanitization concepts for cold-produced WFI
Preventive sanitization is essential for the cold production, storage and distribution of WFI (water for injection). Regular hot water sanitization at > 70 °C is effective against microbial growth. Depending on the feed water and system technology, further measures may be necessary:
- UV irradiation to directly kill microorganisms
- Cooling the water to inhibit growth
- Chemical sanitization, e.g. as part of maintenance
Sanitization during storage and distribution
The following strategies are available for cold storage and distribution:
- Continuous ozonization of the storage tank and regular ozonization of the distribution system
- Alternatively: UV irradiation + cooling of the water combined with regular hot water sanitization (> 70 °C) or pressurized hot water sanitization (> 121 °C)
- The option of chemical sanitization should also be available here
Service
We offer services ranging from the smallest spare part to full-scale plant maintenance. Contact us to learn more about our comprehensive support services!
Trade Fairs & Events
When it comes to solutions for your water treatment, experience genuine enthusiasm in a personal conversation at our trade fairs and events. Get to know us!
References
Many of our customers are leading companies in their industry that have trusted EnviroFALK water treatment systems for years. See for yourself!
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Customers & Solutions
Polymun relies on sustainable pharmaceutical water treatment with cold WFI technology.
Polymun modernisiert seine Pharmawasseraufbereitung mit innovativer Kalt-WFI-Technologie und setzt damit neue Maßstäbe für Energieeffizienz, Nachhaltigkeit und Versorgungssicherheit in der biopharmazeutischen Produktion. Gemeinsam mit EnviroFALK entstand eine zukunftsfähige Lösung für höchste Wasserqualität bei deutlich reduziertem Energieverbrauch. mehr lesen
Membrane-based WFI plant for a modern pharmaceutical site in southern Germany
A globally operating pharmaceutical customer has specified a new, membrane-based WFI system for its southern German site. This will be integrated into an existing building, in which a new laboratory area for the accompanying manufacturing process is being built in parallel. mehr lesen
Pure Media Systems for the New Production Facility of Allergopharma
EnviroFALK PharmaWaterSystems delivers everything. Receive a comprehensive production line that is fully aligned in terms of functionality and quality.When... mehr lesen
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