Introduction:
The RTU (Ready-to-Use) Prefilled Syringe/Vial/Cartridge Filling Machine is used for the sterile filling of RTU prefilled syringe, RTU vial, RTU cartridge, etc, can automatically complete unpacking, filling, stoppering and other process steps, and widely used in pharmaceutical, cosmetic medicine, medical and other industries. It can accurately fill small doses of drugs, such as vaccines and biological products, antithrombotic drugs,cosmetic medicine products, etc. into containers to ensure precise dosage. In addition, it can effectively isolate the equipment from the exteral environment, prevent drug pollution, improve efficiency in the drug producion links, and make the clinical use of drugs more convenient.
Features:
Exceptional Precision: Incorporates a high-accuracy ceramic plunger pump for reliable and consistent dosing performance.
High Productivity: Supports medium to high-speed production, easily adapting to varying output requirements.
Full Aseptic Assurance: Maintains sterility throughout filling and stoppering to prevent product contamination.
Intelligent Control System: Features automated monitoring and an intuitive interface for streamlined operation.
Broad Compatibility: Works with diverse drug formulations and Ready-to-Use (RTU) container systems.
Regulatory Compliance: Meets cGMP, FDA 21 CFR Part 11, and other international regulatory standards.
Seamless Integration: Interfaces efficiently with upstream and downstream production equipment.
Modular Structure: Allows flexible reconfiguration and upgrades for different container formats.
Easy Maintenance: Designed for quick disassembly and cleaning, reducing downtime and cost.
Operational Flexibility: Capable of both batch and continuous production modes.
Smart Adjustment: Enables servo-driven fine-tuning of filling volume and stopper insertion depth.
Enhanced Safety: Includes missing stopper detection and multi-level overload protection.
Complete Traceability: Logs critical process data for quality control and batch tracking.
Wide Adaptability: Accommodates multiple filling technologies to suit different liquid characteristics.
Optional Configurations:
1.A nitrogen filling system is available to meet antioxidant requirements during the filling and storage of liquid medicines. The vacuum filling and stoppering process is compatible with various rubber stopper types and ensures stopper integrity without damage.
2.The laminar flow coverage can be expanded to ensure that product and packaging material exposure areas remain under a Class A clean environment. An online PMS (Particle Monitoring System) is included for real-time sterile environment monitoring with full data traceability.
3.An online sterilizable plunger pump can be equipped to enable Clean-in-Place (CIP) and Sterilize-in-Place (SIP) of the filling system.
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