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The WFI Distillation Still Machine from TianSure is engineered to produce high-purity, pyrogen-free Water for Injection (WFI) required for sterile pharmaceutical manufacturing. Designed according to GMP and international pharmacopeia standards (USP/EP), the equipment ensures reliable, validated WFI production for critical pharmaceutical processes.
Description
Working Principle
Pre-treated feed water enters the distillation still, where it is heated to generate pure steam. During the distillation process, pyrogens, microorganisms and dissolved impurities are effectively separated from the vapor phase. The generated pure steam then condenses into Water for Injection. Continuous venting of non-condensable gases ensures consistent WFI quality. The distilled WFI is transferred to sanitary storage tanks and distributed through a hygienic loop to maintain microbiological safety.
Main Features
• Distillation still machine designed for pharmaceutical WFI production
• Produces pyrogen-free Water for Injection compliant with GMP, USP and EP
• 316L stainless steel construction with sanitary internal polishing or electropolishing
• Proven distillation design for effective pyrogen and impurity removal
• Automatic operation with PLC + HMI control and data recording
• Online monitoring of conductivity, temperature and critical parameters
• Compatible with hot WFI storage and 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 sterile filling operations
• GMP clean utility systems in pharmaceutical plants
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