AST, Inc. products

The GENiSYS® R system is designed for aseptic fill-finish applications, providing automated capabilities that ensure compliance with stringent cGMP requirements. It's capable of processing a variety of ready-to-fill vial, syringe, and cartridge formats, making it suitable for both clinical and small-batch commercial production. The modular design allows for customization to meet specific application needs without the risk and cost of full customization. Built-in features include environmental monitoring and advanced options such as in-process fill weight control and electronic batch record reporting. The system is integrated with isolator-barrier technologies, including RABS or aseptic isolators, for enhanced sterility assurance and seamless in-situ bio-decontamination. Efficient changeover and the capability to maximize product yield through minimized waste further enhance its utility in small-batch processing.

The ASEPTiCell represents a cutting-edge solution in aseptic processing, designed for handling small to medium batch sizes of injectable drug products. This advanced system integrates standard process modules with robotic technology to create a highly adaptable filling and finishing setup for vials, syringes, and cartridges. It is engineered to maintain compliance with the stringent cGMP standards by offering features such as environmental monitoring, in-process fill weight control, and comprehensive electronic batch record reporting. The system is also equipped to perform quick changeovers, reducing downtime significantly, and has integrated capabilities for automated lyophilization loading and unloading. It includes isolator-barrier technologies to provide a controlled aseptic environment, which can be further enhanced with hydrogen peroxide-based bio-decontamination. Its modular design allows customization to fit specific application needs without incurring substantial costs or risks.