Membrane-Based WFI System
Product Overview: The Membrane-Based WFI System is designed for pharma 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 pharma 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, 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.
FAQ:
1.Question: Which process do you adopt ?
Answer:Usually we will be according to what your raw water quality
and your requested water requirement .
2. Question:Can you customize For me?
Answer :Yes. We can manufacture according your requirement , we can
even design appearance of equipment .
3.Question: What standards is the Pharmaceutical Purified Water
System ?
Answer: Usually there are five standards in this pharmaceutical
industry , FDA,cGMP ,GMP ,USP, Japanese .
4.Question:How long is the Delivery time ?
Answer: Usually the delivery time is 35 -40 Days .
