The system is based on a fully membrane-based purification process: After pretreatment (softening, activated carbon, particle filter), an RO/EDI stage follows, along with a degassing system and a final ultrafiltration for endotoxin and microbiological control. Unlike traditional distillation plants ("Hot WFI"), this process does not require steam generation, thus significantly reducing energy consumption and plant size.
The generated WFI is routed through hygienically designed distribution and return systems and can be stored and distributed either cold or at a temperature.Special features / characteristics:
- Membrane-based method (“Cold WFI”) permitted according to European Pharmacopoeia Monograph 0169 and United States Pharmacopeia (USP).
- Energy and space requirements are reduced compared to distillation systems – operating costs are significantly lower.
- Modular skid design, easy integration and expansion.
- High-precision process and quality monitoring (conductivity, TOC, CFU, endotoxins)
- Validatable documentation (DQ/IQ/OQ) for pharmaceutical use
👉 Advantage:
Efficient, GMP-compliant WFI production without distillation – reduces energy and investment costs while maintaining water quality.
WFI cold generation system
The system is designed for the potential production of Water for Injection (WFI) quality according to monograph 0169 at ambient temperature (“cold”), without a conventional distillation stage. It is designed for pharmaceutical production lines (injections, infusions, sterile purification).
The process using reverse osmosis (RO), degassing (DGS), electrode ionization (EDI) and ultrafiltration (UF) with appropriate cleaning concepts and monitoring replaced the thermal process.