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The High-Purity WFI Distillation Line from TianSure is engineered for the production of ultra-pure, pyrogen-free Water for Injection (WFI) required in pharmaceutical and biopharmaceutical manufacturing. Designed in strict accordance with GMP and international pharmacopeia standards (USP/EP), the distillation line provides reliable, continuous and validated WFI production for sterile processes.
Description
System Scope & Working Principle
The high-purity WFI distillation line typically includes feed water pre-treatment, multi-effect water distillation units, non-condensable gas removal, hot WFI storage tanks and a continuous sanitary distribution loop. Pre-treated water is evaporated to generate pure steam, which then condenses into WFI. Through controlled multi-effect distillation and continuous venting of impurities, pyrogens and microorganisms are effectively removed. The produced WFI is stored at elevated temperature and continuously circulated to maintain microbiological safety and water quality stability.
Main Features
• High-purity WFI distillation line designed for pharmaceutical applications
• Produces pyrogen-free Water for Injection compliant with GMP, USP and EP
• Energy-efficient multi-effect distillation technology
• 316L stainless steel construction with sanitary polishing or electropolishing
• Continuous removal of non-condensable gases for consistent WFI quality
• Hot WFI storage and continuous circulation for microbial control
• PLC + HMI automatic control with real-time monitoring and data recording
• Modular design for easy integration with clean utility systems
• Complete validation documentation: URS, DQ, IQ, OQ, PQ, FAT, SAT
Applications
• Pharmaceutical Water for Injection (WFI) production lines
• Injectable and parenteral drug manufacturing
• Biopharmaceutical and vaccine production facilities
• Aseptic processing and sterile filling operations
• GMP clean utility systems in pharmaceutical plants
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