High-throughput aseptic isolator for syringes and vials filling
Streamline your aseptic filling process with a high-speed solution engineered to handle both vials and syringes, ensuring seamless integration into your production line while maintaining stringent sterility standards.
Processes and Fills Vials and Syringes Aseptically
The HELIOS High-throughput Aseptic Isolator, from Comecer, is engineered for precise filling and calibration of vials and syringes in aseptic conditions. Designed for pharmaceutical and radiopharmaceutical production centers, it supports applications such as producing radiolabeled tracers, sterile injectables, and monoclonal antibodies. This automated system can process batch sizes effectively with an average speed of one unit every 75 seconds. Integration into existing production lines is seamless, featuring an invisible conveying system and magnetic transport for precise movement. HELIOS operates under cGMP guidelines, equipped with Class A laminar flow, and offers comprehensive sterilization and leak testing. Constructed with options for lead shielding and equipped with a HEPA filtration system, it supports strict contamination control measures. Maintenance is streamlined through its easy-clean design and features such as a semi-automatic Bubble Point Test. Tailored engineering options allow for customization to meet specific operational needs while adhering to stringent industry compliance.
Benefits
- Ensures product safety by maintaining aseptic conditions with Class A laminar flow.
- Increases production speed by processing vials and syringes every 75 seconds.
- Minimizes contamination risks through integrated sterilization and leak testing features.
- Saves space with a compact design suitable for both small labs and large facilities.
- Simplifies format changes between vials and syringes, enhancing operational flexibility.
- Applications
- Syringes,Vials,Aseptic products,Radiopharmaceuticals,Biopharmaceuticals,Pharmaceuticals
- End products
- Aseptic vaccines,Sterile injectables,Monoclonal antibodies,Lyophilized drug vials,Radiolabeled tracers,Pre-filled syringes
- Steps before
- Preparation of vials and syringes,Calibration (in the pass-through ionization chamber),Loading materials into the introduction chamber
- Steps after
- Leak testing,Shielded storage,Extraction,Sterilization cycle with VPHP,Packing
- Input ingredients
- vials,syringes,radioactive fluids
- Output ingredients
- filled vials,filled syringes
- Market info
- Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.
- Batch size
- 50 syringes or vials per cycle
- Dispensing speed
- 1 syringe/vial every 75 seconds
- Automation
- Fully automatic system
- Filtration system
- HEPA H14 absolute filtering cartridge
- Leak test
- Automatic for main chamber and pre-chamber
- Shielding
- 75 or 100 mm of lead shielding
- Sterilization cycle
- VPHP cycle available
- Particle counter
- Integrated option
- Cleanroom Classification
- Full area Class A laminar flow
- Automation Level
- Fully automatic
- Batch Size
- 50 syringes or vials
- Batch Operation Time
- Average speed of 1 syringe/vial every 75 seconds
- Integration Level
- Multi-format handling (vials and syringes)
- Changeover Time
- Easy change of formats
- Cleaning Method
- Complete cleanability for aseptic area
- Conveying System
- Invisible conveying system with magnetic transport
- Cycle Steps
- Dispensing,calibration,discharge,extraction
- Flexibility
- Hybrid batch capability (vials and syringes)
- Aseptic Process
- GMP Class A laminar flow
- Testing Features
- Bubble Point Test,leak test
- Particle Counter
- Integrated option
- Sterilization Cycle
- VPHP sterilisation
- GMP Compliance
- Yes
- CGMP Guidelines
- Yes
- Class A Laminar Flow
- Yes
- Air Quality Class B “At rest” (EEC-cGMP)
- Yes
- ISO 9001
- Certified
- ISO 13485
- Certified Quality System
- ISO 45001
- Health and Safety Management System
- ISO 14001,ISO 50001
- Environmental and Energetic Management System
- Machine footprint
- Compact design
- Design
- Compact and essential
- Shielding
- 75 or 100 mm lead
- Discharge method
- Shielded container and extraction
- Conveying system
- Invisible magnetic transport
- Control panel type
- Operator panel for parameter monitoring
- Integration possibilities
- IIoT platform integration with Illuminate™ MI
- Lead shielding options
- 75 or 100 mm
- Material handling
- Invisible conveying system with magnetic transport
- Glove port configuration
- Handling gloves equipped