Automated filling machine Crystal™ PX

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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 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 Automated vial loading Single-use material only High filling accuracy CFR 21 part 11 compliant Perfect for 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. 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.