The Container Closing System was designed with cGMP in mind. Its compact, aseptic design provides complete compatibility with cleanrooms, bio-safety cabinets, laminar airflow hoods, and aseptic isolator environments.
Given the systems process versatility and the range of container sizes the system can handle, the Container Closing System is the ideal tool for any small-batch closing machine for pre-filled syringes and cartridges.
Vacuum & Vent-Tube Process Flexibility
The syringe and cartridge closing process is electronically controlled to precisely position the piston into the syringe or cartridge under optimized conditions every time. The vacuum insertion process utilizes AST's patented multi-stage vacuum insertion method with a mechanical assist and is an ideal option for processing silicone-free syringes and cartridges commonly used in biologic applications. Changing over the machine for vent-tube or mechanical piston insertion is as easy as simply changing out a few format parts.
Pre-Filled Syringe & Cartridge Closing Process
After the filled syringe or cartridge is manually placed onto a support, the piston is placed onto the insertion pin and retained with a vacuum. Once positioned, the machine will insert the vent-tube into the syringe or place the vacuum block on to the flange of the container. For vent-tube, the piston is inserted into the syringe, and after placement, the pin and tube are removed from the closed container. For vacuum insertion, the syringe is evacuated with a vacuum and the piston is inserted to the programmed recipe depth. The vacuum system has the added advantage of AST’s multi-stage insertion process and servo assist for ensuring the piston is consistently placed into the correct position.
Advanced System Features:
- ASTView high-resolution interface provides intelligent and intuitive control of the system for creating unique recipes and real-time process monitoring
- Motion control system provides accurate and repeatable placement of the closure into the pre-filled syringe or cartridge
- Process flexibility allows the user to perform vacuum or vent-tube insertion process on the same machine with only format part changes
- 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 airflow hood
- Clinical trial materials manufacturing
- Filling of toxic and cytotoxic materials
- Compounding pharmacies
- Stability studies
- Engineering runs