Introduction:

     The pre-filled syringe filling and stoppering production line is used for the sterile filling of RTU pre-filled 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 external environment, prevent drug pollution, improve efficiency in the drug production links, and make the clinical use of drugs more convenient.

Performance:

  High precision: high-precision ceramic plunger pump is adopted to accurately control the filling volume to ensure accurate drug dosage.

Efficiency: meet the production needs of different customers, and cover the capacity of medium and low  speed, medium and high speed, and high speed, etc.

Sterile operation: during the filling and stoppering process, the equipment can maintain a sterile environment, effectively prevent microbial contamination, and ensure the safety and effectiveness of drugs 

Intelligent control: automatic monitoring and adjustment of equipment operation, and easy to operate. 

Wide application: suitable for filling a variety of drugs, and applicable to a variety of RTU packaging materials;

Regulatory requirements conformance: meet GMP, FDA 21CFR part 11 and other regulatory requirements to ensure the legality and compliance of the production process.

Easy integration: easy to integrate with other front and rear end equipment such as packaging production line, liquid formulation system and detection system to form a complete production system and improve production efficiency.

Modular design: by replacing change parts, it can be applicable to various forms of packaging materials of different sizes, and work stations are reserved for a number of optional functions, so that the equipment can be upgraded in the future.

Easy maintenance and repair: designed to be easy to disassemble and clean, reducing the difficulty and cost of maintenance and repair.

Flexible production mode: support a variety of production modes, such as single batch production, continuous production, etc., to meet different production needs.

Intelligent: filling volume and stoppering depth can be adjusted on the touch screen, and each ceramic pump is controlled by a separate servo motor, and the filling accuracy of a single pump is adjustable and highly stable.

Safety: the stopper missing detection sensor is used to detect whether there is missing stopper in the stopper taking plate, to ensure that the stoppering is 100% completed. It also has the alarms of stoppering and filling overload protection, out-of-limit air speed of dust particle, other abnormal conditions, etc.

Traceability: can record key data and information in the production process for easy traceability and quality control to ensure the safety and effectiveness of drugs.

A variety of filling systems are available to cope with incorrect liquid characteristics, such as metal plunger pumps, ceramic plunger pumps, peristaltic pumps, linear peristaltic pumps, time-pressure methods, etc. These filling systems can be configured independently or together.

Optional configuration： 

• Nitrogen filling system is configured to meet the antioxidant process requirements during filling and storage of liquid medicine;
• The vacuum filling and stoppering mode is applicable to multiple types of rubber stoppers, and the stoppering mode causes no damage;
• The laminar flow can be expanded, and the exposed areas of products and packaging materials are protected under class A clean environment;
• An online PMS monitoring system is adopted to monitor the sterile production environment in real time with data traceability;
• It can be configured with an online sterilization plunger pump to achieve CIP/SIP of the filling system.