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As a professional WFI Generator Manufacturer, TianSure focuses on the design and manufacture of Water for Injection (WFI) generators for pharmaceutical and biopharmaceutical manufacturing. Our WFI generators are engineered in strict compliance with GMP and international pharmacopeia standards (USP/EP), ensuring reliable production of pyrogen-free WFI for sterile processes.
Description
Manufacturing Scope & Working Principle
TianSure WFI generators are typically based on validated distillation technology, such as multi-effect water distillers. Pre-treated feed water is evaporated to generate pure steam, which then condenses into Water for Injection. Pyrogens, microorganisms and impurities are effectively removed during the distillation process. Continuous venting of non-condensable gases ensures stable and consistent WFI quality suitable for pharmaceutical use.
Main Features
• Professional manufacturer of pharmaceutical WFI generators
• Produces pyrogen-free Water for Injection compliant with GMP, USP and EP
• Proven multi-effect distillation technology for reliable performance
• 316L stainless steel construction with sanitary polishing or electropolishing
• Automatic operation with PLC + HMI control and data recording
• Continuous monitoring of conductivity, temperature and critical parameters
• Custom engineering based on user URS and project requirements
• Complete validation documentation: URS, DQ, IQ, OQ, PQ, FAT, SAT
Applications
• Pharmaceutical Water for Injection (WFI) generation systems
• Injectable and parenteral drug manufacturing plants
• Biopharmaceutical and vaccine production facilities
• Aseptic processing and sterile filling operations
• GMP clean utility systems in pharmaceutical factories
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