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The Clean Utility WFI Water Solution from TianSure is engineered to serve as a core clean utility in pharmaceutical and biopharmaceutical manufacturing facilities. Designed according to GMP and international pharmacopeia standards (USP/EP), the solution integrates WFI generation, hot storage and sanitary distribution to provide a reliable and validated Water for Injection supply for sterile production processes.
Description
System Scope & Working Principle
The clean utility WFI solution typically includes pre-treatment, WFI generation (multi-effect distillation), hot WFI storage tanks and a continuous sanitary distribution loop. Pre-treated feed 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 system components are designed with hygienic principles to ensure stable water quality and regulatory compliance.
Main Features
• Integrated clean utility solution for pharmaceutical WFI systems
• Produces pyrogen-free Water for Injection compliant with GMP, USP and EP
• 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 microbial control
• PLC + HMI automatic control with real-time monitoring and data recording
• Modular design for easy expansion and integration with plant utilities
• Turnkey project execution with full documentation: URS, DQ, IQ, OQ, PQ, FAT, SAT
Applications
• Pharmaceutical Water for Injection (WFI) clean utility systems
• Injectable and parenteral drug manufacturing plants
• Biopharmaceutical and vaccine production facilities
• Aseptic processing and sterile filling lines
• GMP clean utility infrastructure in pharmaceutical factories
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