PRODUCTS
The GENiSYS® C: Precision Filling, Maximum Yield for High-Value Liquid Pharmaceuticals
In the Know
Capabilities
- Tested, standardized modules configurable for clinical-to-commercial processing needs
- Universal RTU container processing capabilities, including cryovials
- cGMP technology across all modules
- Ergonomic design for operator-driven processes
- Scalable solutions for easy validation and efficient technology transfer
- Product stewardship measures for quality control and high-value products
- Full ramp-up support, including qualification services and full documentation packages
- Responsive, 24/7 aftermarket support throughout the life of your equipment
- Isolator or RABS configuration
- Compact, Integrated configuration for a smaller operational footprint
- Processes up to 10 units per minute
- Configurable, recipe-driven production
- Toolless change parts
- Processes vials, syringes, and cartridges on the same line with minimal changeover time between formats
- Press-fit cap and screw-capping for cryovials available
- Peristaltic and rotary piston pump options
- ASTView, a centralized HMI for intuitive operation and data retention, and an optional EBR system for 21 CFR Part 11 Compliance
- For syringes and cartridges, Piston insertion for options for the full scope of drug product properties and sensitivities
The GENiSYS C utilizes precisely designed robotics and automation in a quality-by-design approach specifically designed for the demands and specifications of sterile injectable products. Features include:
- Reduced human interventions
- Intuitive design with minimal points of failure
- Gentle container handling
- Robotic configurations available
- EM suite design, including optional automated plate handling
Lead time and machine changeover requirements are crucial to the time-to-market equation for pharmaceutical manufacturers. The built-in philosophy at AST approaches fill-line configurations in an adaptable way that prioritizes customer’s specifications. Like grabbing the right tools from a toolbox, AST’s modular approach enables our team to capture the majority of requirements with our existing modular solutions, which allows very rapid configuration, delivery, validation, and launch of an operation.
The available modules on the GENiSYS® C are:
- SABO – Semi-Automatic Bag Opening scrollable
- ABO – Automatic Bag Opening
- MTO – Manual Tub Opening
- ATO – Automatic Tub Opening
- FCM – Fill / Close Module
- VSM – Vial Sealing Module (also available in a linear configuration)
- OFM – Outfeed module
Interactive Diagram of GENiSYS® C | Click a Hotspot
Semi-Automated Bag Opening with hygienic trash removal and no touch transfer into Grade A space.
Robotic tub handling with seal removal and staging with minimal particle generation.
Automated, Recipe-driven filling and closing of containers with in-line quality controls and reject sorting. Press fit caps and screw cap available.
Outfeed or Finishing with cGMP, low-particle vial sealing.
You've seen the GENiSYS® C in motion...
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Meeting Industry Needs | Applications
The advancements in patient-centered modalities for the treatment of rare and complex diseases continue to grow. The fragility and unique properties of these liquid pharmaceuticals require the highest standards of quality, spotlighting the importance of strategies for maximum yield and agile or decentralized manufacturing operations. AST’s GENiSYS® C leverages flexible, modular technology to meet the majority of customer requirements. From breakthrough cell and gene therapies to specialized vaccines to biologics, these individual and targeted products represent the leading edge of medical science.
Use Cases
A global cell and gene leader looking to expand its facility and production portfolio partnered with AST on an Isolated GENiSYS® C for AAV production.
Download the Case Study
