Membrane-Based WFI System
Product Overview: The Membrane-Based WFI System is designed for pharmaceutical Water for Injection production using double-pass RO, EDI and ultrafiltration technology. It provides stable water quality, lower energy consumption and GMP-compliant operation for modern pharmaceutical manufacturing.
Applications
This system is widely used in pharmaceutical manufacturing, biotechnology production, sterile preparation, laboratory research and medical industries where high-purity Water for Injection is required for injection, cleaning and process water applications.
Process Flow
Pretreatment → Double Pass RO → EDI → Ultrafiltration (UF) → Storage Tank → Distribution Loop (SS316L) → Point of Use
Technical Parameters
| Item | Specification |
|---|
| Capacity | 100–10,000 L/H |
| Conductivity | ≤1.1 μS/cm @25°C |
| TOC | ≤500 ppb |
| Endotoxin | ≤0.25 EU/ml |
| Bacteria | <10 CFU/100 ml |
| Material | SS316L, internal Ra<0.4 μm |
| Control System | PLC + HMI, Siemens or Schneider optional |
Configuration List
The system includes multimedia filter, activated carbon filter, water softener, double-pass RO membranes, EDI module, ultrafiltration membrane for endotoxin removal, sanitary pumps, UV sterilizer, ozone system, SS316L storage tank and automatic PLC control system.
Project Cases
Our membrane-based WFI systems have been applied in pharmaceutical factories in Southeast Asia, the Middle East and Europe, helping customers achieve stable WFI production, GMP validation and continuous operation.
Certifications & Standards
The system is designed according to GMP, FDA, USP, EP and WHO requirements. Optional IQ/OQ/PQ validation support and complete documentation can be provided for audit and compliance needs.
FAQ
Q: Is membrane-based WFI acceptable under GMP?
A: Yes. It can be accepted with proper system design, validation and water quality control strategy.
Q: What are the advantages compared with distillation?
A: Lower energy consumption, compact design, faster startup and flexible operation.
Q: Can the system be customized?
A: Yes. Capacity, materials, control system and validation documents can be customized.