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The WFI Generator Turnkey Solution from TianSure is engineered to deliver a complete, ready-to-operate Water for Injection (WFI) system for pharmaceutical and biopharmaceutical facilities. As a one-stop solution provider, TianSure covers the full project lifecycle—from engineering design and equipment manufacturing to installation, commissioning and validation—ensuring full GMP and pharmacopeia compliance (USP/EP).
Description
Turnkey Scope & Working Principle
The turnkey WFI generator solution typically includes feed water pre-treatment, WFI generation using multi-effect distillation, hot WFI storage tanks and a continuous sanitary distribution loop. Pre-treated water is distilled to generate pure steam, which condenses into pyrogen-free WFI. The WFI is stored at elevated temperature and continuously circulated to prevent microbial growth. All systems are designed, installed and validated as an integrated clean utility package.
Main Features
• Complete turnkey solution for pharmaceutical WFI generator systems
• GMP-compliant design meeting USP and EP requirements
• Proven multi-effect distillation technology for reliable WFI generation
• 316L stainless steel tanks and piping with sanitary polishing or electropolishing
• Hot WFI storage and continuous circulation for microbiological control
• PLC + HMI automatic control with monitoring, alarms and data recording
• Single-responsibility EPC execution reducing project risk
• Full project documentation and validation support: URS, DQ, IQ, OQ, PQ, FAT, SAT
Applications
• Pharmaceutical Water for Injection (WFI) systems
• Injectable and parenteral drug manufacturing plants
• Biopharmaceutical and vaccine production facilities
• Aseptic processing and sterile filling operations
• GMP clean utility infrastructure projects
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