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The GENiSYS® C: Precision Fill-Finish, Maximum Yield for High-Value Liquid Pharmaceuticals

AST’s GENiSYS® C is an advanced and compact pharmaceutical filling machine for the automated processing of nested, custom, and ready-to-use vials, syringes, and cartridges.  With many features typically found in large-scale filling systems, the GENiSYS® C’s compact footprint makes this system ideal for small-scale filling and closing applications, including R&D, process development, engineering runs, and cGMP clinical and commercial manufacturing for high-value parenteral products like ATMPs.

Offering 100 percent integration with barrier and decontamination technology, the GENiSYS® C is a flexible, scalable solution designed for the evolving product and pipeline demands of today’s fill-finish market.

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 20 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 
  • 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

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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-capping available.

Outfeed or Finishing  with cGMP, low-particle vial sealing.

You’ve seen the GENiSYS® C in action…
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Meeting Industry Needs | Applications

Firefly patient and doctor in a hospital with iv drip; selective focus
A patient-centered solution

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.

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Technology built for compliance
AST technology has been at the forefront of many of the regulatory trends and guidelines we see in the pharmaceutical manufacturing industry today. Global and domestic regulatory standards continue to work towards harmonization, as exemplified in the revised Annex 1, and these robust quality standards require high-performing, highly repeatable technologies. The GENiSYS® C is process-optimized for cGMP fill-finish production of RTU and custom containers, prioritizing critical zone protection by observing proper aseptic principles for processing and air handling, including First Air.
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Compact, automated process solutions for every stage of drug development.
Process-based configuration is utilized across the GENiSYS® C, starting with the choice of container. From there, container handling, fluid paths, pump methods, fill and close protocols, continuous environmental monitoring, and finishing can all be built around product and facility parameters, leveraging a suite of proven technologies and modular solutions.  With advancements in product dispensing technologies, IPC protocols, zero-waste filling methods, and barrier solutions, AST’s machines employ a comprehensive approach to risk management and product quality, from drug discovery to commercial production.
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Use Cases

Empowering viral vector production

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.

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FAQs

Can this system process specialty formats?
The GENiSYS® C offers universal processing of nested, custom, and ready-to-use vials, syringes, and cartridges. It can also process specialty format applications including screw capping and IV bags with minimal change parts.
No, no additional program control is necessary.  This system features ASTView®, which is a centralized program for operations and data-recording. It offers complete integration with other line technologies including barrier, decontamination, and glove testing platforms.

Yes, AST offers full aftermarket and project ramp-up support, including training and services for the full Commissioning, Qualification, and Validation (CQV) process through AST Academy. Services include IQ/OQ documentation and activities.

Yes, this system offers both statistical and 100 percent in-process weight checks, in addition to Augmented IPC, which executes 100 percent IPC while remaining in a statistical sample mode for minimal effect on machine speed.

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