AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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M1 Filling Station
Description
The Crystal™ M1 Filling Station is a tabletop aseptic filling system, de-risking your manual fill & finish operation.
The Crystal™ M1 Filling Station operates with the AT-Closed Vial®, remaining functionally closed throughout the filling process, significantly reducing the contamination risks typically associated with the manual fill & finish.
The system consists of the filling unit with its dosing system, precision balance, laser re-sealing unit and a capping tool.
Installed in a Biosafety Cabinet or an isolator, the system provides flexibility and ease of switch to the AT-Closed Vial® technology.
Features
- Up to 200 AT-Closed Vial® per hour
- 0,1 ml to 50 ml filling
- At your site in 6 weeks
- Installed and qualified in 1 day
- Easy validation
- For standard biosafety cabinet
- High filling accuracy
- Single-use material only
- Toolless format change
- Reproducible scalable process
Functioning principle
Using the M1 Filling Station, the AT-Closed Vial® are individually filled through the stopper, laser re-sealed and capped, while being manually transferred between the process stations within the critical area.
To prepare the batch, the bulk product is connected to the AT-Filling Kit™, the dosing system and laser control unit are calibrated. For practical and ergonomic process, the AT-Closed Vial® can be provided in AT-CryoBox™, accompanied with AT-Cap™ in rigid support.
One by one, the vials are installed on the base of the filling tool. By manipulation of the lever, the piercing step with the spear-point needle is initiated. The product is safely injected in the vial, while being completely isolated from the surrounding environment.
Next, the AT-Closed Vial® is manually transferred to the laser re-sealing cabinet. Just 1 second laser shot is enough to re-close the filled vial, without any impact on the product. To complete the process, the capping tool is used to place a snap fit AT-Cap™ on the vial.
The AT-CryoBox™ with processed vials is then extracted from the critical area.
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