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The GMP Pure Steam Generation System from TianSure is engineered to provide clean, pyrogen-free steam for critical sterilization processes in pharmaceutical and biopharmaceutical manufacturing. Designed in accordance with GMP and clean utility guidelines, the system ensures reliable pure steam supply for SIP and aseptic production environments.
Description
Working Principle
Purified Water or Water for Injection (WFI) is supplied to the pure steam generator and heated by plant steam or electric heating elements. The generated steam passes through a high-efficiency separator and demister to remove entrained droplets, particles and impurities. Only dry, high-purity steam is delivered to the distribution system. The entire process is designed to maintain consistent steam quality and hygienic operation under GMP conditions.
Main Features
• GMP-compliant pure steam generation system
• Produces clean, pyrogen-free steam for SIP and aseptic processing
• 316L stainless steel water- and steam-contact parts with sanitary polishing
• High-efficiency separation and demisting for dry steam output
• Stable pressure and temperature control for reliable sterilization cycles
• 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 clean utility loops
• Aseptic processing equipment and skids
• Biopharmaceutical and vaccine manufacturing facilities
• GMP cleanrooms and sterile production areas
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