Water for Injection (WFI) has traditionally been made for the pharmaceutical industry using distillation methods, boiling feedwater using plant steam, and condensing it using cooling water. While this tried-and-true method is still available using Paul Mueller Company’s Multiple Effect Stills and Single Effect Stills, changes in the European Pharmacopoeia have opened the door to other equivalent methods for WFI production.
To offer our customers options for producing WFI, Paul Mueller Company is introducing our new membrane-based WFI skids. Our approach is a set of modular skids with a single control screen that purifies water from your incoming potable water source to WFI.
The skids combine softeners, carbon filters, reverse osmosis (RO), deionization (CDI), ultrafiltration (UF), and ultraviolet light (UV) for purification, linking these processes into a single control package on modular skids to fit your room layout. Mueller’s membrane-based WFI system was developed for the pharmaceutical market with standard hot water sanitizable RO membranes, in-skid water recycling, UV sanitized carbon filters, fusion welded polypropylene tubing for the softener skid, and polished stainless steel tubing for the RO, and UF skids.
An advantage of our membrane-based WFI skid is that it is produced at ambient temperature. You can match your production and distribution temperature, avoid additional heating or cooling of the loop water, and save costly utilities, creating a more sustainable solution! Additionally, with membrane-based WFI generation, no plant steam or coolant is required for WFI production!
With our consistent commitment to quality and our approach of using off-the-shelf non-proprietary components for ease of maintenance, these fully tested and integrated skids give you the ease of installation, operation, and service.
Skids are provided with our full pharmaceutical documentation package, including:
- P&ID (Piping and Instrumentation Diagram)
- General arrangement drawing
- Electrical schematics
- Material test reports and surface finish certs for sanitary components
- USP Class VI elastomers for sanitary components
- Calibration certificates
- Sanitary weld records
- Component manuals
- Cut sheets
- Full bill of materials
- Functional specifications
- Software design specification
- Factory acceptance testing (FAT)
- Site acceptance testing (SAT)