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.
• For cGMP manufacturing
• Built upon specification
• For isolator or RABS installation
• Tool-less format change
• 100% IPC of weight
• Automated vial loading
• Single-use material only
• High filling accuracy
• CFR 21 part 11 compliant
The AT-Closed Vial® technology PX Filling Line addresses the needs of the high-speed commercial manufacturing of novel biopharmaceutical products, including cell therapy, gene therapy products, exosomes, as well as the related products as starting material, viral vectors, plasmid DNA.
The high versatility of the process is achieved thanks to the tool-less format change, use of the ready-to-fill AT-Closed Vial® and single-use product path.