AST GENiSYS - Model R - Aseptic Small Batch Filling and Closing Machine
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.
GENiSYS R Automated cGMP Aseptic Small Batch Processing – Clinical and Small-Batch Commercial
GENiSYS R can be configured with advanced system features and capabilities to tailor the equipment for each unique application. The system meets the highest standards for aseptic processing by providing features such as environmental monitoring, multiple product dispense system options, in-process fill weight control, and electronic batch record reporting.
Aseptic Barrier Technologies
GENiSYS R is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions 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 conditions during production. With isolator integrated systems, the GENiSYS R is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.
Maximize Product Yield
Eliminating waste is the key to successful small-batch processing. Necessary operations such as pump calibration, in-process fill weight checks and residual product hold-up in the fluid path all contribute to product rejects. The GENiSYS R’s 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 – resulting in maximize product yield. In addition, the ASTView Electronic Batch Record (EBR) system provides a complete record of the dispensed material.
- Machine Model : GENiSYS® R20
- Standard System Dimensions (LxWxH)
- (SABO-MTO-FCM-VSM) : 4225mm x 1400mm x 2405mm
- [166" x 55" x 95"]
- Containers : Pre-sterilized vials, syringes, and cartridges
- (Note: Tooling for non-standard/custom container formats available)
- Vial Sizes : 2mL to 50mL (ISO 2R – 50R)
- Syringe Sizes : 0.5mL to 50mL
- Cartridge Sizes : 1mL to 20mL
- Production Rate : Up to 20upm
- Dispense Options : Peristaltic & Rotary Piston
- Filling Accuracy : Up to ±0.5%
- Vial Closing Methods : Serum or Lyo stopper options
- Vial Sealing Methods : Crimp or Press-fit capping options
- Syringe / Cartridge Closing Method : Vacuum, Vent-Tube and Vent/Vac Combo
- Barrier System : Restricted Access Barrier System (RABS) or Isolator
- Materials of Construction : Pharmaceutical grade stainless steel, plastics, and elastomers
- Human-Machine Interface (HMI) : ASTView on a 21" color touchscreen
- Module Options : Manual Bag Opening (MBO)
- Semi-Automatic Bag Opening (SABO)
- Automatic Bag Opening (ABO)
- Manual Tub Opening (MTO)
- Automatic Tub Opening (ATO)
- Lyophilization Prep / De-Nesting Module (LPM)
- Vial Sealing Module (VSM)
- Available Options : In-process fill weight verification (IPC) and automated dynamic pump calibration
- Viable and non-viable environmental monitoring (EM)
- Electronic Batch Report (EBR) system
- Pre- & post-fill container purging with inert gas