AST GENiSYS - Model C -Advanced and Compact Filling and Closing System
AST's GENiSYS C is designed as an advanced, compact solution for the automated filling and closing of vials, syringes, and cartridges. This system is ideal for small-scale applications, including research and development, process development, and niche manufacturing, fulfilling cGMP requirements for clinical and small-batch commercial manufacturing. Its compact footprint incorporates features found in larger machines, making it suitable for operations with limited space. The system is versatile, capable of handling nested, ready-to-use, and custom containers, and includes advanced capabilities like in-process weighing, electronic batch recording, and environmental monitoring. Designed for use in restricted spaces, it operates within Laminar Airflow Hoods, RABS, and aseptic isolators. The GENiSYS C prioritizes product yield through 100% fill weight inspection and real-time data capture, reducing waste significantly. Configurations can include peristaltic and rotary piston pumps, inert gas purging, and vacuum technology, making it a comprehensive tool for aseptic processing.
AST’s GENiSYS® C is an advanced and compact filling and closing system for automated processing of nested, custom and ready-to-use vials, syringes, and cartridges. With many features typically found in large scale filling machines, the GENiSYS C’s compact footprint makes this system ideal for use in small scale filling applications, including R&D, process development, engineering runs, niche product manufacturing, and even cGMP clinical and small-batch commercial manufacturing.
Trusted Partner for Maximum Product Yield
Maximize Product Yield
Eliminating waste is the key to successful small-batch processing. Necessary operations such as pump calibration, on-going fill volume checks and residual product hold-up in the fluid path all contribute to wasted product material. The GENiSYS® C in-process control system allows for 100% fill weight inspection and real-time filling directly on the electronic weigh scale to eliminate improperly filled containers and minimize product hold-up at the end of the batch in order to maximize product yield. Couple this with ASTView Electronic Batch Record (EBR) system and you are able to have a complete record of the dispensed product.
- Automated processing of ready-to-fill vials, syringes and cartridges
- Up to 20 containers per minute
- Fast and easy change-over with tool-less change parts
- High accuracy product dosing
- Optional fully integrated in-process weight check system
- Multiple syringe and cartridge stoppering options
- Viable & non-viable environmental monitoring
- LAF, RABS or Isolator Configuration
- High-resolution color touchscreen interface
- Optional Electronic Batch Reporting (EBR) System
- 21 CFR Part 11 compliant
- IQ/OQ and GAMP documentation available
- Machine Model : GENiSYS® C10GENiSYS® C20
- System Dimensions
- (LxWxH) : 1800mm x 625mm x 1725mm
- [71" x 25" x 68"]
- 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
- (Note: Options available for sizes not listed)
- Production Rate : Up to 10upmUp to 20upm
- Dispense Options : Peristaltic & Rotary Piston
- Filling Accuracy : Up to ±0.5% (varies with fill volume)
- Vial Closing Methods : Serum or Lyo stopper options
- Vial Sealing Methods :
- Press-fit capping; crimping available with optional Vial Sealing Module
- Syringe / Cartridge Closing Method : Vacuum, Vent-Tube and Vent/Vac Combo
- Barrier System : Laminar Airflow Hood (LAF)
- Materials of Construction : Pharmaceutical grade stainless steel, plastics, and elastomers
- Human-Machine Interface (HMI) : ASTView on a 10" color touchscreen
- 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
- Extended Laminar Airflow (LAF) Hood