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The Distilled Water for Injection Equipment 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 equipment provides reliable and validated WFI production for critical pharmaceutical processes.
Description
Working Principle
Pre-treated feed water enters the distillation unit, where it is heated to generate pure steam. During the distillation process, pyrogens, microorganisms and dissolved impurities are effectively removed. The generated pure steam condenses to form Water for Injection. Non-condensable gases are continuously vented to maintain product quality. The distilled WFI is then transferred to a sanitary storage tank and distributed through a hygienic loop, typically maintained at elevated temperature to prevent microbial growth.
Main Features
• Distillation-based WFI generation for reliable pyrogen removal
• Produces Water for Injection compliant with GMP, USP and EP standards
• 316L stainless steel construction with sanitary internal polishing or electropolishing
• Continuous removal of non-condensable gases for consistent water quality
• Automatic operation with PLC + HMI control and data recording
• Online monitoring of conductivity, temperature and key parameters
• Designed for integration 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 filling operations
• GMP clean utility systems in pharmaceutical plants
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