AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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PX Filling Line
Description
The Crystal™ PX Filling Line platform enables high-speed fill & finish operations.
Providing 100% in-process control (IPC), full GMP compliance and sterility assurance. Operating with the AT-Closed Vial®, these aseptic filling lines offer flexible capacity, depending on the configuration, up to 180 vials/min.
Custom-built according to user requirement specification, the PX Filling Line can be supplied with a safety barrier for high-class cleanroom, closed Restricted-Access Barrier System (RABS), in isolator with H2O2 decontamination.
Features
- For cGMP manufacturing
- Built upon specification
- For isolator or RABS installation
- Filling from 0,1 ml to 50 ml
- Tool-less format change
- 100% IPC of weight
- Up to 10.800 vials/hour
- Automated vial loading
- Single-use material only
- High filling accuracy
- CFR 21 part 11 compliant
Functioning principle
The AT-Closed Vial® technology PX Filling Line consists of the vial loading unit, the weighting and acceptance stations for in-process control, the filling unit, the laser re-sealing and capping units and the conveying system, critical operations being performed in ISO 5 conditions.
Ready-to-fill AT-Closed Vial® in trays are automatically loaded on the filing line. After being individually weight-checked and identified, they are transferred to the filling unit.
The filling unit is equipped with several needles, simultaneously filling through the stopper a group of vials. Transferred to the laser re-sealing station, this group of vials is re-closed with 1 second laser shot on the stopper surface.
The vials are then individually capped and transferred to the exit weighting station, where the last acceptance controls are conducted.
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