AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
More
We use cookies to offer you the best experience on our site. You can find out more about the cookies we use or disable them in the Cookie settings
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
Crystal™ 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.
Loading...