Bench-Top Syringe & Cartridge Closing System
AST’s Container Filling System (CFS) is a bench-top, semi-automatic machine used for the filling of pre-filled syringes and cartridges, and the filling and stoppering of vials and bottles. The system is designed to meet the demanding requirements for small batch processing of sterile injectable products.
The Container Filling System was designed with cGMP in mind. Its compact, aseptic design provides complete compatibility with cleanrooms, bio-safety cabinets, laminar air flow hoods and aseptic isolator environments.
The system’s versatility, features and compact size make it ideally suited for labs and cGMP small batch filling applications.
Consistent & Accurate Container Filling
The Container Filling System is integrated with an advanced product dispense system that provides consistent and accurate product dispensing. The integrated peristaltic pump provides accurate dispensing with minimal product shear while using a pre-sterilized single-use fluid path. When integrated with an electronic weigh scale, the system can fill the container while measuring the dispensed material and providing automatic fill adjustments to the pump as required. The system’s electronically controlled axis inserts the filling needle into the container and slowly lifts to minimize shear, foaming or product agitation.
Bench-Top Container Filling Process
The empty container is manually placed on the support at the center of the machine. For vial filling, a serum or lyo stopper is placed on a support stand immediately adjacent to the container support. Once positioned, the system will automatically transfer the container to the electronic weigh scale and record the tare weight of the container. With the container on the balance, the filling needle will go into the container and dispense the product as it slowly lifts from the inside of the container. Once the filling cycle is complete, the final fill volume is recorded and any fill adjustments are automatically performed. The system will transfer the container back to the center support. For vials the system will pick and place the previously placed stopper onto the vial and the operator will manually remove it from the machine. Syringes and cartridges will be removed manually and closed on the Container Closing System (CCS).
Advanced System Features:
- ASTView high resolution interface provides intelligent and intuitive control of the system for creating unique recipes and real-time process monitoring
- Dispense system provides accurate and repeatable container filling with automatic volumetric monitoring and adjustment
- Process flexibility allows the system to fill a wide array of containers with materials of various sensitivity and viscosity ranges
- Electronic Batch Report (EBR) System records critical process information that can be used to create a 21 CFR Part 11 compliant batch report to simplify the technology transfer or regulatory filing processes
- Compact design makes the system ideally suited for aseptic isolators, biological safety cabinets or laminar air flow hood
- Clinical trial materials manufacturing
- Filling of toxic and cytotoxic materials
- Multi-product aseptic filling facilities
- R&D, pre-clinical and drug process development
- Personalized medicine
- System can be integrated with multiple aseptic barrier options
- Can be configured with multiple pump options including rotary piston for accurate product dosing
- Ability to process a wide range of vials and vial finishes
- Programmable filling needle motion
- Historical process data accessible with Excel
- Simple format parts allow for fast and easy change-over between batches
- Intuitive operator interfaces and controls
- Optional weigh cell integration automates pump calibration and fill weight measurement for statistical sampling or 100% In-Process Weight Check with minimal reduction in processing speeds
- Standard line options available with quick delivery
- Compact footprint allows for placement within an isolator, biological safety cabinet or LAF, and minimizes lab or cleanroom space
*Figures are typical. Actual performance results and technical parameters may vary depending upon application requirements.
**Subject to change without notice.