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The Injection Liquid Preparation System from TianSure is engineered for the preparation of sterile injectable solutions under GMP conditions. It is suitable for injections, IV solutions and other parenteral products, providing reliable mixing, precise control and validated hygienic performance throughout the preparation process.
Description
Working Principle
Purified Water or Water for Injection (WFI) and raw materials are introduced into the preparation tank through sanitary connections. Mixing is performed in a closed system using a suitable agitator to ensure uniform dissolution and homogeneity. Prior to production, CIP and SIP are carried out to achieve validated cleanliness and sterility. After preparation, the injectable solution is transferred through sterile filtration to buffer tanks or directly to aseptic filling lines.
Main Features
• GMP-compliant injection liquid preparation system
• 316L stainless steel product-contact parts with sanitary polishing or electropolishing
• Closed-system mixing for sterile and aseptic processing
• Integrated CIP/SIP system for validated cleaning and sterilization
• Sterile filtration and hygienic transfer design
• Accurate temperature control with heating and cooling jackets (optional)
• Siemens PLC + HMI automatic control with alarm and data recording
• Complete validation documentation: URS, DQ, IQ, OQ, PQ
Applications
• Injectable solutions and parenteral products
• Large-volume and small-volume injections
• IV fluids and infusion solutions
• Biopharmaceutical sterile formulations
• Aseptic preparation prior to filling and lyophilization
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