Aseptic small / medium batch filling and closing system
Ensure sterility in drug production by seamlessly integrating a versatile system that adapts to diverse container formats, delivering consistent aseptic filling and closing for small to medium batches.
Processes and Seals Aseptic Liquid Batches
The ASEPTiCell® from AST is an advanced aseptic fill-finish system tailored for small to medium batch production demands in pharmaceutical and biotech industries. It integrates robotic automation and modular systems, allowing efficient processing of ready-to-use vials, syringes, and cartridges. The ASEPTiCell® features in-process weight verification and environmental monitoring to ensure compliance with stringent cGMP requirements. Designed for applications including biologics, vaccines, and toxic materials, the system supports production of products like monoclonal antibodies and mRNA vaccines. With a compact footprint, it offers flexible module configurations, including lyophilization and isolator-barrier options, enhancing sterility and operational efficiency. Automated decontamination with hydrogen peroxide and rapid changeover capability further optimize production workflows. Compliant with pharmaceutical-grade material standards, the ASEPTiCell® is engineered for enhanced operational integration and ease of maintenance.
Benefits
- Ensures sterility and compliance with cGMP standards, enhancing product safety.
- Reduces production downtime with fast 30-minute changeovers between batches.
- Enhances operational efficiency via automated in-process weight verification and environmental monitoring.
- Provides flexibility with modular design, accommodating a range of batch sizes and container formats.
- Minimizes contamination risks through integrated aseptic barrier systems and automated decontamination processes.
- Applications
- Biologics,Proteins,Toxic and cytotoxic materials,Vaccine development,Orphan drugs,Bio-similars,Cell and gene therapy,Pharmaceuticals
- End products
- Car-t cell therapy drugs,Insulin,Monoclonal antibodies,Chemotherapy drugs,Antibody-drug conjugates,Mrna vaccines,Nusinersen,Rituximab biosimilars
- Steps before
- Container Preparation,Nested Container Loading,Sterilization,Aseptic Transfer
- Steps after
- Sealing,Lyophilization,Inspection,Packaging
- Input ingredients
- pre-sterilized vials,pre-sterilized syringes,pre-sterilized cartridges
- Output ingredients
- filled vials,filled syringes,filled cartridges,closed vials,sealed vials,closed syringes,closed cartridges
- 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
- ASEPTiCell®
- System Dimensions
- 6603mm x 1700mm x 2000mm
- Containers
- 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
- Production Rate
- Up to 100 units per minute
- Dispense Options
- Peristaltic,Rotary Piston
- Filling Accuracy
- Up to ±0.5%
- Vial Closing Methods
- Serum or Lyo stopper options
- Vial Sealing Methods
- Crimp or Press-fit capping options
- Syringe / Cartridge Closing Method
- Vacuum,Vent-Tube,,Vent/Vac Combo
- Barrier System
- Fully Integrated Restricted Access Barrier System (RABS) or Isolator
- Materials of Construction
- Pharmaceutical grade stainless steel,plastics,and elastomers
- Human-Machine Interface (HMI)
- ASTView on a 21" color touchscreen
- Module Options
- Semi-Automatic (SABO) or Automatic (ABO) Bag Opening,Automatic Tub Opening (ATO),Automatic Fill/Close (FCM),Lyophilization Prep / De-Nesting Module (LPM),Vial Sealing Module (VSM)
- Standard Options
- In-process fill weight verification (IPC) with automatic line purging and dynamic pump calibration,Viable and non-viable environmental monitoring (EM),Electronic Batch Reporting (EBR),Pre-,Post Fill Container Gas Purging
- Compact footprint
- Yes
- Changeover time
- As little as 30 minutes
- Automation
- Robotics and advanced system features
- Environmental Monitoring
- Viable and non-viable
- In-Process Weight Check
- Statistical sampling or 100% with minimal speed reduction
- Compression force
- Programmable force with automatic adjustment
- Inert Gas Purging
- Capable during filling
- Batch vs. continuous operation
- Small,Medium Batch
- Changeover time
- As little as 30 minutes
- Automation level
- Automated
- CIP/SIP
- SIP with hydrogen peroxide
- Cleaning method
- In-situ bio-decontamination
- Lyophilizer integration
- Automated lyo loading,unloading
- Aseptic Barrier System
- RABS / Isolator
- Configuration
- Flexible,Modular
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Compact footprint
- 6603mm x 1700mm x 2000mm
- Control panel type
- ASTView on a 21" color touchscreen
- Container type
- Pre-sterilized vials,syringes,and cartridges
- Modular system design
- Semi-Automatic or Automatic modules available
- Discharge method
- Automated filling and closing
- Control panel type
- ASTView on a 21" color touchscreen
- Integration possibilities
- Advanced robotic fill/finish integration
- Modular system design
- Customizable with various modules like Semi-Automatic Bag Opening,Automatic Filling,Closing
- System configuration
- Flexible configuration with customizable modules
- Aseptic barrier options
- Restricted Access Barrier System (RABS) or Isolator with VHP