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AST will unveil its multi-format robotic filling system, the GENiSYS R, at INTERPHEX.
AST Inc.’s GENiSYS R is its latest multi-format robotic filling system designed specifically for cell, gene, and regenerative applications. The system can be configured to process all ready-to-use, nested, vial, syringe, and cartridge formats for clinical and small batch commercial applications. The use of reliable robotics enables a complete system changeover in as little as thirty minutes, according to the company.
The system is integrated with isolator-barrier technologies to fully enclose and control the aseptic environment for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic condition during production. With isolator integrated systems, the system is completely compatible with repeated in-situbio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.
An in-process control system allows for 100% fill-weight inspection with minimal reduction in processing speeds to minimize or even eliminate improperly filled containers and minimize product hold-up at the end of the batch. In addition, the ASTView electronic batch record system provides a complete record of the dispensed material.
Source: AST Inc.