Flexible Small-Batch Filling & Closing Machine - (GENiSYS™ c20)

Sterile Made Simple.

GENiSYS c20 is a compact combination filling system for automated aseptic processing of nested, ready-to-fill vials, syringes, and cartridges.  GENiSYS c20 provides all the automated features of larger scale filling systems in a compact footprint, making it ideal for use in small scale filling applications, R&D process development, niche product manufacturing, clinical filling, and compounding pharmacies.

Advantages of Restricted Access Barrier System (RABS)

Along with designing filling machines for isolators to prevent contamination, we also offer machines that are used with RABS or Restricted Access Barrier System. Because isolators can have its drawbacks, such as making interventions more difficult, RABS offer an alternative that ensures a sterile environment and makes interventions a possibility.  

GENiSYS c20 is designed for use within a Restricted Access Barrier System (RABS) or Laminar Air Flow (LAF) cabinet and ideal for labs and clean rooms with minimal available space.  AST’s meticulous attention to aseptic design, selection of the materials and surfaces has been done to ensure that the system meets cGMP standards for aseptic processing.

Applications include:

  • Clinical materials manufacturing
  • R&D and drug process development
  • Stability studies
  • Small batch commercial manufacturing
  • Compounding pharmacies

Benefits

  • Ideal for flexible small batch production
  • Compact footprint minimizes lab or cleanroom space
  • Automated processing of pre-sterilized syringes, vials and cartridges
  • Highly accurate product dosing
  • Fast and easy change-over between batches
  • Automated fill weight measurement and control
  • Multiple syringe and cartridge stoppering options
  • Intuitive operator interfaces and controls

The GENiSYS c20 is a highly flexible filling system for filling and stoppering pre-sterilized syringes, vials and cartridges on a single compact machine.  The system is integrated with advanced features to ensure that each container is handled with care and to ensure the machine consistently produces the highest quality products.

Integrated In-Process Control (IPC) System

GENiSYS c20 can be integrated with peristaltic or rotary piston pumps for accurate and gentle product dosing. The design of the dosing system was carefully considered to minimize product waste and is the only compact multi-format filling system available with an integrated In-Process Control (IPC) system that can automatically weigh the volume of the dosed container. The IPC system can perform statistical to 100% weighing of each container filled. The pumps integrated with the IPC system minimize product waste common to the beginning and end of batch operations.

GENiSYS c20 offers the most flexible stoppering options available for plugging and closing vials, syringes and cartridges in a compact filling system.  Its unique design allows for syringe and cartridges pistons to be inserted using vacuum or vent-tube options, and vials can be fully or partially stoppered.  By offering conventional stoppering processes at a bench-scale GENiSYS c20 makes tech transfer and scale-up simple and straight forward.

Technical Information

Dimensions (LxWxH)

1830mm x 622mm x 1672mm

Containers:

Pre-sterilized vials, syringes and cartridges

Vial Sizes:

2mL to 50mL (ISO 2R – 50R)

Syringe Sizes:

0.5mL to 20mL

Cartridge Sizes:

3mL

Production Rate:

Up to 1200 units per hour

Dispense Options:

Peristaltic & Rotary Piston

Filling Volume:

0.1mL to 100mL

Filling Accuracy:

Up to ±0.5%

Electrical Utilities:

110/220VAC – 50/60Hz.

Power Consumption:

Max. 1200W

Vacuum Utilities:

6 SCFM @ 925mbar

Weight:

Approx. 250kg

Available Options:

  • In-process fill weight verification (IPC)
  • Viable and non-viable environmental monitoring
  • Electronic Batch Reporting (EBR)
  • LAF or RABS integration

Click here to view AST GENiSYS Brochure

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