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The Pyrogen-Free Water Distillation System from TianSure is engineered to produce high-purity, pyrogen-free Water for Injection (WFI) required for sterile pharmaceutical manufacturing. Designed in accordance with GMP and international pharmacopeia standards (USP/EP), the system provides reliable and validated removal of pyrogens and contaminants through proven distillation technology
Description
Working Principle
Pre-treated feed water enters the distillation system and 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 to form Water for Injection. Continuous venting of non-condensable gases and optimized internal design ensure stable production of pyrogen-free WFI suitable for pharmaceutical use.
Main Features
• Distillation-based system for effective pyrogen removal
• Produces pyrogen-free Water for Injection compliant with GMP, USP and EP
• 316L stainless steel construction with sanitary internal polishing or electropolishing
• Proven design ensuring consistent and validated WFI quality
• Automatic operation with PLC + HMI control and data recording
• Online monitoring of conductivity, temperature and critical parameters
• Designed for integration with hot WFI storage and distribution loops
• Complete validation documentation: URS, DQ, IQ, OQ, PQ, FAT, SAT
Applications
• Pharmaceutical Water for Injection (WFI) production
• 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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