Water for Injection System (WFI Generation System)
Water for injection (WFI) is pharmaceutical-grade water that complies with the requirements specified in the relevant pharmacopoeia.
- Qualified feed water is pressurized by a multistage pump and enters the condenser, where the first heat exchange stage begins. The feed water then passes through each preheater. In the condenser and preheaters, feed water is heated by secondary steam, distilled water, and industrial steam condensate, helping recover process heat and improve energy use.
- After preheating, the feed water enters the water distributor of the first-effect evaporator. It is sprayed into the heating tubes and flows along the inner tube wall as a thin film. This falling-film evaporation process supports efficient heat transfer and stable steam generation.
- The secondary steam containing water droplets enters the steam-water separation device from the lower part of the heating tubes. After separation, the pure steam moves to the next effect as heating steam, while the unevaporated feed water continues to the next stage. This process is repeated through the multi-effect evaporation system.
- The pure steam from the final effect is combined with the condensed water from each stage, except the first effect. After cooling and removal of non-condensable gases, the resulting distilled water becomes Water for Injection. Depending on the model, the system can include a continuous discharge device for non-condensable gases.
- At the outlet, online conductivity monitoring checks the quality of the produced water. Qualified distilled water is delivered as WFI, while unqualified water is discharged, helping protect downstream pharmaceutical processes and maintain reliable water quality control.
- Pharmaceutical manufacturing and formulation
- Laboratory research and quality control testing
- Sterilization and cleaning of medical instruments and equipment
- Biotechnology development and experimental processes
- Aseptic filling and packaging operations
- Cooling tower and HVAC system maintenance
- Any process requiring high-purity water
- Electrical Conductivity: ≤2μS/cm
- Electrical Resistivity: ≥0.5MΩ•cm
- Microbial Count: ≤10CFU/100ml
- Endotoxin: ≤0.25EU/ml
- Heavy Metal Content: ≤0.5μg/ml
- Ammonia: ≤0.3μg/ml
- pH Value: 6.5~8.5
Note: Each pharmaceutical water system is custom-designed to meet the user requirement specification (URS) provided by the client. All photos and videos featured are from actual WEMAC projects.
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Single-Loop CirculationWhen the conductivity exceeds the predefined threshold, the purified water system redirects the water back to the intermediate tank to maintain water quality before entering the next stage.
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Dual Supply ConfigurationIf the conductivity remains within acceptable limits, the water is delayed and sent to the purified water storage tank, ensuring consistent quality without premature transfer.
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RO Membrane FlushingUses first-pass permeate to flush the reverse osmosis membranes. The intermediate tank acts as both the starting and return point for the cleaning cycle.
- Double Tube Sheet Design: The external preheater, condenser, and first-effect evaporator adopt a double tube sheet structure. The inner tube sheet expansion and external welding process help prevent cross-contamination and support hygienic WFI production.
- Three-Stage Separation: The system uses falling-film evaporation, gravity separation, and spiral-flow separation to remove entrained water droplets from secondary steam, helping improve steam purity and WFI quality.
- SS316L Contact Parts: All parts in contact with feed water, Water for Injection, and secondary pure steam are made of SS316L, supporting pharmaceutical-grade hygiene and long-term corrosion resistance.
- Efficient Thermal Insulation: The evaporator, preheater, and condenser use aluminum silicate needle-punched blanket insulation, which is lightweight, stable, and highly effective for heat preservation.
- Polished Stainless Steel Surfaces: Internal and external surfaces are electrochemically polished to maintain stainless steel smoothness and improve cleanability. The external surface can also be sandblasted according to project requirements.
- Energy-Saving Operation: Secondary steam is reused step by step across multiple effects, helping improve the utilization of industrial steam and reduce energy consumption. As the number of effects increases, the energy-saving effect becomes more significant, while cooling water consumption is greatly reduced. The five-effect still uses only a small amount of cooling water, and the six-effect still requires no cooling water.
- REduced Welding in Piping: Stainless steel pipes are directly bent where possible to reduce welding points, helping improve hygienic design and lower contamination risks.
- High-Quality Welding Process: Pipeline and fitting welds can use argon-shielded automatic welding with single-side welding and double-side forming. After welding, electrochemical polishing helps improve weld quality and cleanability.
- Validation Documentation Support: Endoscopic inspection photos, weld maps, pressure test reports, pickling and passivation reports, and system design documents can be provided to support project validation and quality review.
- Automatic Control System: The system adopts HMI + PLC fully automatic control, with a simple operating interface, multiple communication options, and at least three user authority levels for controlled operation.
- Online Monitoring: Conductivity, temperature, flow, and other key parameters can be monitored online. A paperless recorder or paper recorder can be selected to record and print critical process data.
- Compliance-Ready Data Control: The control system can be configured with electronic signatures, electronic records, and audit trail functions to meet GAMP 5 and 21 CFR Part 11 requirements.
- Project-Specific Configuration: The water for injection (WFI) generation system can be configured according to your production capacity, water quality requirements, validation needs, and clean utility layout. Contact our team to discuss a suitable WFI generation solution for your facility.



