Automated aseptic filling and closing system for vials and syringes
Optimize small-batch production with precision filling and sterile sealing designed for diverse liquid pharmaceuticals, ensuring compliance and seamless integration into high-stakes development environments.
Fills and Seals Liquid Vials, Syringes, and Cartridges
The GENiSYS® C from AST is a compact aseptic filling and closing system specifically engineered for small-batch production of vials, syringes, and cartridges. This system excels in providing precise and flexible filling for a wide range of pharmaceutical and biologic applications, including mRNA vaccines and monoclonal antibodies. It integrates advanced features such as in-process weighing, viable and non-viable environmental monitoring, and inert gas purging to ensure sterile conditions and product integrity. Capable of processing up to 20 containers per minute with high filling accuracy of up to ±0.5%, GENiSYS® C supports both peristaltic and rotary piston pump dispensing options. Designed to operate within laminar airflow hoods, RABS, or isolator systems, it adheres to cGMP standards and is 21 CFR Part 11 compliant, supporting your regulatory requirements. Customizable configurations and user-friendly interface streamline operations, making it an essential tool for pharmaceutical manufacturers, biologics producers, and contract manufacturing organizations seeking to optimize their aseptic filling processes.
Benefits
- Enhances product yield by minimizing waste through real-time filling and in-process control.
- Supports diverse pharmaceutical applications with flexible filling options for nested and custom containers.
- Meets stringent regulatory standards through 21 CFR Part 11 compliance and GMP adherence.
- Facilitates rapid changeovers and process customization to adapt quickly to varying production needs.
- Ensures sterile operations in compact spaces with integration into LAF, RABS, or isolator environments.
- Applications
- Personalized medicine,Compounding pharmacies,Orphan drug development,Vaccine development,Drug development,Bio-similars,Cell and gene therapy,Custom devices and containers,Biologics manufacturing
- End products
- Patient-specific compounded medications,Car-t cell therapies,Personalized cancer vaccines,Specialized dosing vials,Orphan drug formulations,Monoclonal antibodies,Biosimilar insulin,Custom medical syringes,Mrna vaccines,Viral vector-based gene therapies
- Steps before
- Preparation of nested,pre-sterilized containers,Setup of laminar airflow hood or isolator,Configuring pump calibration
- Steps after
- Vial sealing,Syringe and cartridge stoppering,Environmental monitoring,Electronic batch record generation
- Input ingredients
- nested vials,ready-to-use vials,custom vials,nested syringes,ready-to-use syringes,custom syringes,nested cartridges,ready-to-use cartridges,custom cartridges,toxic materials,cytotoxic materials
- Output ingredients
- filled vials,filled syringes,filled cartridges,assembled devices and containers,dispensed product
- Market info
- AST is known for its expertise in designing and manufacturing customized engineered-to-order equipment for industrial applications, renowned for precision engineering, innovation, and reliable solutions tailored to meet unique customer specifications and industry standards.
- Machine Model
- GENiSYS®C10,GENiSYS®C20
- System Dimensions (LxWxH)
- 1800mm x 625mm x 1725mm [71" x 25" x 68"]
- Production Rate
- Up to 10upm,Up to 20upm
- Filling Accuracy
- Up to ±0.5%
- Automation
- Servo-Driven Motion control
- Filling Method
- Peristaltic,Rotary Piston
- Container Types
- Pre-sterilized vials,syringes,and cartridges
- Vial Sizes
- 2mL to 50mL (ISO 2R – 50R)
- Syringe Sizes
- 0.5mL to 50mL
- Cartridge Sizes
- 1mL to 20mL
- Filling Volume
- 1 ml – 50 mL
- Vial Closing Methods
- Serum or Lyo stopper options
- Vial Sealing Methods
- Press-fit capping
- Crimping available
- Syringe / Cartridge Closing Method
- Vacuum,Vent-Tube and Vent/Vac Combo
- Materials of Construction
- Pharmaceutical grade stainless steel,plastics,and elastomers
- Human-Machine Interface (HMI)
- ASTView on a 10" color touchscreen
- In-process Weight Verification
- IPC and automated dynamic pump calibration
- Environmental Monitoring
- Viable and non-viable
- Batch Documentation
- Electronic Batch Report (EBR) system
- Barrier System
- Laminar Airflow Hood (LAF),RABS or Isolator
- Automation level
- PLC / SCADA
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP / SIP available
- Cleaning method
- CIP
- Changeover time
- Fast and easy with tool-less change parts
- Energy efficiency
- Optimized for small-batch processing
- Cleaning method
- Manual / Automated
- Air incorporation control
- Integrated
- Machine footprint
- 1800mm x 625mm x 1725mm [71" x 25" x 68"]
- Container type
- Pre-sterilized vials,syringes,and cartridges
- Vial Sizes
- 2mL to 50mL (ISO 2R – 50R)
- Syringe Sizes
- 0.5mL to 50mL
- Cartridge Sizes
- 1mL to 20mL
- Materials of Construction
- Pharmaceutical grade stainless steel,plastics,and elastomers
- Compact footprint
- Advanced compact design for small scale use
- Control panel type
- 10" ASTView color touchscreen
- Discharge method
- Servo-driven motion control for accurate repeatable filling