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The Pharmaceutical WFI Generation System from TianSure is engineered to supply high-purity, pyrogen-free Water for Injection (WFI) required for sterile pharmaceutical manufacturing. Designed in strict accordance with GMP and pharmacopeia standards (USP/EP), the system provides reliable and validated WFI production for critical pharmaceutical processes.
Description
Working Principle
Pre-treated feed water is introduced into the WFI generation unit, typically a multi-effect water distiller or equivalent distillation technology. The water is heated to generate pure steam, which then condenses to form WFI. Through controlled distillation and continuous removal of non-condensable gases and impurities, pyrogens and contaminants are effectively eliminated. The produced WFI is transferred to a hot storage tank and distributed through a sanitary loop, usually maintained at elevated temperature to prevent microbial growth.
Main Features
• Pharmaceutical-grade WFI generation compliant with GMP requirements
• Produces pyrogen-free Water for Injection meeting USP and EP standards
• Proven distillation technology for reliable and validated WFI production
• 316L stainless steel construction with sanitary polishing or electropolishing
• Automatic operation with PLC + HMI control and data recording
• Continuous monitoring of conductivity, temperature and key parameters
• Easy integration with WFI storage and hot distribution systems
• Complete validation documentation: URS, DQ, IQ, OQ, PQ, FAT, SAT
Applications
• Water for Injection (WFI) production for sterile pharmaceuticals
• Injectable and parenteral drug manufacturing
• Biopharmaceutical and vaccine production facilities
• Aseptic processing and filling lines
• GMP clean utility systems in pharmaceutical plants
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