The WFI cold production system is a fully membrane-based process for generating Water for Injection (WFI) at ambient temperature ("cold") – without a conventional distillation stage. Following pretreatment, RO/EDI , a degassing system , and final ultrafiltration for endotoxin and microbiological control are performed. Compared to traditional "hot WFI" distillation plants, steam generation is eliminated, significantly reducing energy consumption and plant size.
 The generated WFI is routed via hygienically designed distribution and return systems and, depending on the design, can be stored and distributed at either a cold or temperature-controlled level.


 Application
 The system is designed to produce Water for Injection (WFI) quality according to monograph 0169 at ambient temperature (“cold”) and is intended for pharmaceutical production lines, e.g.:

 
 Injections
 
 Infusions
 
 sterile cleaning


 System structure
 1) Pretreatment

 
 softening
 
 Activated charcoal
 
 Particle filter

 2) Membrane-based WFI generation

 
 Reverse osmosis (RO)
 
 Electrode Ionization (EDI)
 
 Degassing system (DGS)
 
 Ultrafiltration (UF) for endotoxin and microbiological control

 3) Operation & Distribution

 
 Hygienic distribution and return systems
 
 Cleaning concepts and monitoring according to design


 Special features / characteristics

 
 Membrane-based method (“Cold WFI”) permitted according to European Pharmacopoeia Monograph 0169 and United States Pharmacopeia (USP).
 
 Energy and space requirements reduced compared to distillation systems – operating costs significantly lower
 
 Modular skid design for 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.

 Technical data
 Capacity (typical range): 1 – 15 m³/h (customer-specific)
 Material: AISI 316L (product contact), electropolished surface
 Conductivity of product water: ≤ ~1.1 µS/cm at 20 °C according to Ph. Eur. Monograph 0169
 TOC: ≤ 0.5 ppm / ≤ 500 ppb (typical)
 Operating temperature: Ambient temperature; Pretreatment of drinking water for softening; Operation with integrated buffer tank in the system

 contact
 For information on design, capacity, distribution/storage concept and documentation scope (DQ/IQ/OQ), please use the contact form below.

 Modular design & extensions
 DGS – Membrane water degassing
 ULTRATEC – Ultrafiltration
 PW generator – ultrapure water system
 Drinking water transfer station – Functional preparation of drinking water
 Loop return – monitoring/control unit
 Loop distribution station – media distribution
 Distillation plant (WFI) – Multi-stage distillation plant