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The 316L Stainless Steel Pure Steam Generator from TianSure is engineered to provide high-purity, pyrogen-free steam for critical sterilization processes in pharmaceutical and biopharmaceutical manufacturing. All water- and steam-contact parts are constructed from 316L stainless steel with sanitary internal polishing to ensure full compliance with GMP clean utility requirements.
Description
Working Principle
Purified Water or Water for Injection (WFI) is fed into the pure steam generator and heated by plant steam or electric heaters. The generated steam rises through the evaporation section and passes through a high-efficiency separator and demister to remove entrained droplets, particles and impurities. Only dry, clean pure steam exits the generator and is supplied to SIP systems and other sterilization points, ensuring consistent steam quality and hygienic operation.
Main Features
• Full 316L stainless steel construction for water- and steam-contact parts
• Produces clean, pyrogen-free pure steam compliant with GMP standards
• High-efficiency separation and demisting for dry steam output
• Stable pressure and temperature control for reliable sterilization cycles
• Sanitary design suitable for SIP and aseptic processing environments
• Siemens PLC + HMI automatic control with alarms and data recording
• Easy integration with CIP/SIP systems, autoclaves and process equipment
• Complete validation documentation: URS, DQ, IQ, OQ, PQ available
Applications
• SIP sterilization of pharmaceutical tanks and vessels
• Sterilization of process piping and distribution loops
• Autoclaves and aseptic processing equipment
• Biopharmaceutical and vaccine manufacturing facilities
• GMP cleanrooms and sterile production areas
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