Semi-Automatic Vial Sealing for Small Batch Processing
AST's Vial Sealing System (VSS) is a benchtop, semi-automatic machine used for sealing or capping pharmaceutical vials and bottles with aluminum caps. The VSS provides complete and precise control of the container sealing or capping operations to ensure the highest quality vial seal. The system’s versatility allows for processing of a wide range of vial or bottle sizes and finishes, and is ideal for small batch processing of sterile pharmaceutical and biotechnology products.
The Container Closing 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.
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 air flow hood
- Clinical trial materials manufacturing
- Multi-product aseptic filling facilities
- Filling and assembly of custom devices and containers
- Personalized medicine
- Engineering runs
- System can be integrated with multiple aseptic barrier options
- Ability to process a wide range of vials and vial finishes
- Closed loop feedback for compression force improves Container Closure Integrity (CCI)
- Consistent, high quality seal process that generates few particles
- Historical process data accessible with Excel
- Simple format parts allow for fast and easy change-over between batches
- Intuitive operator interfaces and controls
- Programmable compression force and crimping speed allows for automatic sealing head adjustment
- 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
|Dimensions (LxWxH)||775mm x 500mm x 640mm [31" x 20" x 25"]|
|Weight||73 kg [160 lbs.]|
|Containers:||Vials, Bottles & Cartridges|
|Finish Size:||8mm, 13mm, 20mm, 32mm|
|Sizes (Dia./Height):||Ø12mm-47mm / 35mm-100mm|
|Other Container Options||Tooling for non-standard/custom container formats|
|Aluminum Seal / Cap Type:||DIN standard with or without flip-top|
|Sealing Method:||Disc Style|
|Production Rate:||Up to 10 cycles per minute|
|Electrical Utilities:||110/220VAC – 60/50Hz.|
|Clean Air Utilities:||Clean dry air 7 bar, 0.5L/min free air|
|Materials of Construction:||Pharmaceutical grade stainless steel, plastics and elastomers|
|Human-Machine Interface (HMI)||ASTView on a 10" color touchscreen|
*Figures are typical. Actual performance results and technical parameters may vary depending upon application requirements.
**Subject to change without notice.