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The WFI Plant for Injectable Production from TianSure is engineered to provide a reliable supply of pyrogen-free Water for Injection (WFI) required in sterile injectable drug manufacturing. Designed in strict accordance with GMP and international pharmacopeia standards (USP/EP), the plant supports safe, consistent and validated injectable production processes.
Description
System Scope & Working Principle
The WFI plant typically includes feed water pre-treatment, WFI generation by distillation, hot WFI storage tanks and a continuous sanitary distribution loop. Pre-treated water is distilled to produce pure steam, which condenses into pyrogen-free WFI. The WFI is stored at elevated temperature and continuously circulated to prevent microbial growth. All system components are hygienically designed to ensure consistent water quality throughout injectable production.
Main Features
• WFI plant designed specifically for injectable and parenteral production
• Produces pyrogen-free Water for Injection compliant with GMP, USP and EP
• Proven distillation technology for reliable WFI generation
• 316L stainless steel tanks and piping with sanitary polishing or electropolishing
• Hot WFI storage and continuous circulation for microbiological control
• PLC + HMI automatic control with real-time monitoring and data recording
• Designed for integration with injection preparation and filling lines
• Complete validation documentation: URS, DQ, IQ, OQ, PQ, FAT, SAT
Applications
• Sterile injectable and parenteral drug manufacturing
• Large-volume and small-volume injections
• Biopharmaceutical injectable products
• Aseptic processing and filling operations
• GMP clean utility systems in pharmaceutical plants
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