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.
Consistent High-Quality Sealing
Proper application of the vial cap is critical to container closure integrity, sterility and stability of the drug product within the vial. The Vial Sealing System monitors critical parameters such as applied force prior to forming the seal on the aluminum skirt to ensure proper stopper compression during the sealing process. The system utilizes a free-spinning disk design that has been optimized to minimize the generation of particles during the sealing process and to form a pharmaceutically aesthetic seal.
Vial Sealing Process
The vials or bottles are manually placed on the machine by the operator. Once placed, the sealing process is initiated, and the sealing head moves down to compress the vial stopper until the closed-loop compression force feedback confirms the operator programmed compression setting is achieved. With the stopper compressed the vial is rotated and the free-spinning disk gently forms the aluminum skirt of the cap around the neck of the vial. This sealing process maintains the compression of the rubber stopper, generates fewer particles and provides a pharmaceutically aesthetic seal without the witness marks common to jaw style crimpers.
Advanced Vial Sealing 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
- Uniform vial sealing using a sealing disk provides a repeatable quality overseal that eliminates the common challenges of jaw style crimping
- 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
- Multi-product aseptic filling facilities
- Filling and assembly of custom devices and containers
- Personalized medicine
- Engineering runs