Product Description
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. It can automatically complete unpacking, filling, stoppering and other process steps. It is widely used for vaccines, biological products, antithrombotic drugs, and cosmetic medicine products.
Key Features
- High Precision: High-precision ceramic plunger pump for accurate dosage control.
- Sterile Operation: Maintains a sterile environment to prevent contamination.
- Intelligent Control: Automatic monitoring and PLC control for seamless production.
- Regulatory Compliance: Meets GMP and FDA 21CFR part 11 requirements.
- Modular Design: Adaptable to various packaging materials and easy upgrades.
Frequently Asked Questions
1. What is the filling accuracy of the prefilled syringe line?
The system is equipped with high-precision ceramic plunger pumps, achieving a filling accuracy of up to 99%.
2. Does the equipment comply with international standards?
Yes, it fully complies with GMP, FDA 21CFR part 11, and other stringent pharmaceutical regulatory requirements.
3. What is the production capacity of this machine?
The capacity is customizable based on the number of filling heads (2-10), ranging from 2,000 to 30,000 vials per hour.
4. Can it handle different sizes of syringes and vials?
Yes, it is designed for 1ml-20ml RTU pre-filled syringes, vials, and cartridges with adjustable modes.
5. Is an isolator system available?
Optional isolator and PMS online monitoring systems are available to ensure a sterile Class A clean environment.