Lab headspace analyzer for small volume parenterals
Enhance your quality control with precise gas concentration measurements in sterile pharmaceuticals, ensuring product integrity through non-destructive headspace analysis about your different vial, syringe, or ampoule packaging forms.
Measures Headspace Gas Concentrations in Sterile Containers
The NEO HSX Series from WILCO AG offers advanced headspace analysis for sterile pharmaceutical containers, utilizing laser absorption spectroscopy to accurately measure oxygen and carbon dioxide levels non-destructively. Key for ensuring container closure integrity, it’s designed for use with vials, syringes, and ampoules in lab-scale operations. What sets the NEO HSX apart is its precision, achieving up to 50% lower standard deviation with its fourth-generation laser technology. The system supports both manual and robot-assisted inspections, offering flexibility in sample handling. Ideal for pharmaceutical manufacturers, it integrates seamlessly into R&D and quality control processes while ensuring compliance with ISO Class 7 environments and 21 CFR Part 11 standards. The intuitive MAVIS operation system with customizable widgets enhances user interaction, and the system features a guided suitability test to secure operator-independent results.
Benefits
- Enhances quality assurance with precise, non-destructive headspace analysis.
- Minimizes operator error through intuitive guidance and automated processes.
- Boosts productivity by facilitating easy method transfer to high-speed production.
- Ensures regulatory compliance with 21 CFR Part 11 and ISO Class 7 standards.
- Offers flexible sample handling to accommodate diverse pharmaceutical packaging.
- Applications
- Bfs bottles,Syringes,Iv bags,Bfs cards,Vials,Ampoules,Sterile pharmaceuticals,Small volume parenterals,Large volume parenterals
- End products
- Insulin vials,Vaccines,Sterile ampoules,Monoclonal antibodies,Injectable antibiotics,Pre-filled syringes,Ophthalmic solutions,Infusion bags,Saline solution iv bags,Contrast media
- Steps before
- Sample Preparation,Container Filling,Package Sealing
- Steps after
- Quality Control,Data Analysis,Final Product Packaging
- Input ingredients
- small volume parenterals,large volume parenterals,BFS cards,BFS bottles,IV bags,vials,ampoules,syringes,aerosol cans,steel cans,pharmaceutical packaging
- Output ingredients
- inspected vials,inspected syringes,inspected ampoules,inspected BFS cards,inspected BFS bottles,inspected IV bags,leak-tested aerosol cans,leak-tested steel cans
- Market info
- Measurement Accuracy
- Up to 50% higher precision
- Automation
- Intuitive MAVIS operation system
- Measurement Types
- Non-destructive O2 and CO2 laser absorption spectroscopy
- Sample Types
- Vials 1 - 100 ml,ampoules 1 - 20 ml,syringes 0.5 - 10 ml
- Standard Deviation
- 50% lower compared to previous generation
- Laser Heads
- 4th generation
- NEO HSX DUO with two lasers,NEO HSX ONE with one laser
- Operator Guidance
- Support by LED status bar and guided system
- Environment Compatibility
- ISO Class 7 environments
- Data Compliance
- 21 CFR part 11 compliance
- Connectivity
- OPC UA server connectivity
- Sample Holders
- Exchangeable with position monitoring
- Operations Mode
- GMP testing and development mode
- Power Backup
- Integrated UPS for prevention of data loss
- Automation level
- Manual / PLC / SCADA
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Batch vs. continuous operation
- Batch / Inline Continuous
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- GMP Compliance
- Yes
- 21 CFR Part 11
- Compliant
- ISO Class 7
- Certified
- USP 1207
- Compliant
- ASTM F2338
- Compliant
- Machine footprint
- Compact
- Sample holder type
- Exchangeable,position monitored
- Control panel type
- MAVIS operation system,12.1" color display
- Shield for environmental protection
- Available
- Size range of containers
- Vials
- Control panel type
- MAVIS operation system
- Exchangeable sample holders
- Plug,Play
- Laserhead Options
- Single or Dual (O2 and CO2)
- Interface Customization
- Widgets-based
- Position Monitoring System
- Available
- Customizable Interface
- Yes,via widgets
- Sample Holder Type
- Exchangeable