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The 316L Stainless Steel WFI System from TianSure is engineered to produce and distribute high-purity, pyrogen-free Water for Injection (WFI) for pharmaceutical and biopharmaceutical manufacturing. All product-contact parts are fabricated from 316L stainless steel with sanitary internal polishing or electropolishing to ensure full compliance with GMP and pharmacopeia requirements.
Description
Working Principle
Pre-treated feed water is introduced into the WFI generation unit, typically a multi-effect water distiller. Through controlled distillation, feed water is evaporated to produce pure steam, which then condenses into WFI. Pyrogens, microorganisms and impurities are effectively removed during the distillation process. The produced WFI is collected in a 316L stainless steel storage tank and circulated through a hot distribution loop, usually maintained at elevated temperature to prevent microbial growth and ensure water quality stability
Main Feature
• Full 316L stainless steel construction for all WFI-contact parts
• Produces pyrogen-free Water for Injection compliant with GMP, USP and EP
• Proven distillation technology for reliable and validated WFI production
• Sanitary internal surface finish with optional electropolishing
• Automatic operation with PLC + HMI control and data recording
• Continuous monitoring of conductivity, temperature and critical 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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