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.

AT-Closed Vial®_filling_2

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
AT-Closed Vial®_filling_2

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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