Water for Injection
Cold WFI Generation System Membrane-Based Technology
Energy-efficient alternative to conventional distillation
Consistent WFI quality aligned with USP, EP, WHO, and global pharmacopeial requirements
The GM Water Cold WFI Generation System is an advanced, membrane-based solution engineered to produce Water for Injection (WFI) using non-thermal purification technologies. Designed as an energy-efficient alternative to conventional distillation, the system delivers consistent WFI quality while meeting modern pharmaceutical expectations for sustainability, reliability, and compliance.
The system utilizes a multi-barrier membrane purification approach, typically integrating high-efficiency Reverse Osmosis (RO), Electrodeionization (EDI), and Ultra-filtration (Post UF) technologies to ensure effective control of chemical, microbial, and endotoxin contaminants. This layered design provides robust assurance of WFI quality aligned with USP, EP, WHO, and global pharmacopeial requirements under defined operating conditions.
A key advantage of Cold WFI technology is its significantly reduced energy consumption compared to thermal distillation systems. By eliminating steam generation and high-temperature processes, the system lowers utility demand, operational costs, and environmental impact—making it an ideal choice for modern pharmaceutical facilities.
The Cold WFI system is compact, skid-mounted, and fully automated, enabling easy installation, optimized footprint, and operator-friendly operation. A PLC-based control system with HMI manages all critical parameters, including conductivity, TOC (optional), flow, pressure, and temperature. Integrated alarms, interlocks, and data logging support controlled operation and inspection readiness. An optional 21 CFR Part 11–compliant automation package is available for validated environments.
Engineered with GMP-compliant hygienic design principles, all product-contact components are constructed in SS 316L, featuring orbital welding, sanitary fittings, and dead-leg–minimized piping. The system is designed to support hot water and chemical sanitization, ensuring effective microbial control, system integrity, and long-term reliability.
With robust engineering, high-quality components, and validation-ready documentation, the GM Water Cold WFI Generation System delivers:
- Consistent WFI quality meeting global pharmacopeial standards
- Dependable performance with minimal operational intervention
- Lower total cost of ownership through energy and utility savings
- Safe and compliant pharmaceutical manufacturing support worldwide
Advanced membrane-based technology delivers WFI quality water with significantly reduced energy consumption compared to conventional thermal distillation systems.
Designed to produce Water for Injection in alignment with USP, EP, WHO, and global pharmacopeial requirements under validated operating conditions.
Integrated purification stages including RO, EDI, and final polishing provide multiple barriers against chemical, microbial, and endotoxin contamination.
PLC-based control system with real-time monitoring, alarms, interlocks, and data logging. 21 CFR Part 11–compliant automation package available.
Reduced utilities, chemical-free operation, and optimized recovery contribute to a lower total cost of ownership.
Supplied with comprehensive DQ, IQ, OQ documentation to support qualification and regulatory inspections.
System in Action
Watch our PW generation system in operation
Cold WFI Generation System Membrane-Based Technology
Complete demonstration of our 3000 LPH PW generation system in operation
Why membrane-based WFI is the future of pharmaceutical water
| Parameter | Cold WFI (Membrane) | Traditional Distillation |
|---|---|---|
| Energy Consumption | Significantly Lower | Very High |
| Start-up Time | Fast (< 1 hour) | Slow (4-6 hours) |
| Carbon Footprint | Low | High |
| Operating Cost | Lower TCO | Higher TCO |
| Steam Requirement | None | Required |
| Scalability | Excellent | Limited |
| Validation Complexity | Moderate | Moderate |
| Technology | Multi-barrier membrane (RO + EDI + Post UF) |
| Capacity Range | 200 LPH to 5,000 LPH |
| Output Quality | Conductivity < 1.3 µS/cm @ 25°C |
| Endotoxin Level | < 0.25 EU/mL |
| TOC Level | < 500 ppb |
| Microbial Quality | < 10 CFU/100mL |
| Energy Consumption | 60-70% lower than distillation |
| Construction | SS 316L with orbital welding, sanitary fittings |
| Sanitization | Hot water and chemical sanitization supported |
| Automation | PLC + HMI, 21 CFR Part 11 optional |
| Compliance | USP, EP, WHO, IP standards |
| Documentation | DQ, IQ, OQ support included |
For Custom Specifications do get in touch with us at support@gmwater.in
Multi-Barrier Process Flow
Layered purification for robust WFI quality assurance
Pre-treatment
Feed water conditioning and filtration
High-Efficiency RO
Reverse osmosis for salt reduction
EDI Polishing
Electrodeionization for ion removal
Post UF
Ultrafiltration for endotoxin control
Storage & Loop
Hot storage and distribution
- Lower Operating Costs
Significantly reduced energy consumption compared to thermal distillation systems
- Pharmacopeia Compliant
Meets USP, EP, WHO, and global pharmacopeial requirements for Water for Injection
- Sustainability
Lower utility demand and environmental impact—ideal for modern pharmaceutical facilities
- High Reliability
Multi-barrier approach ensures consistent quality with robust assurance
Ready to Upgrade to Cold WFI Technology?
Lower energy costs, reduced environmental impact, and consistent pharmacopeia-compliant WFI quality