Headspace analyzation for small volume parenterals
Achieve unparalleled precision in gas concentration measurement for small volume parenterals with this headspace analyzer, expertly tailored for non-destructive testing and ensuring top-quality sterile injectable drug production.
Measures Gas Concentrations in Pharmaceutical Packaging
The NEO HSX series from WILCO AG offers a cutting-edge solution for non-destructive laser headspace analysis in pharmaceutical packaging. Utilizing advanced laser absorption spectroscopy, the system precisely measures gas concentrations such as oxygen and carbon dioxide in vials, syringes, and ampoules, ensuring package integrity for sterile injectables. This series includes the NEO HSX ONE and NEO HSX DUO, with the latter providing simultaneous dual-laser capability for enhanced measurement accuracy. Ideal for pharmaceutical manufacturers and R&D labs, the NEO HSX operates seamlessly on manual or automated lines, boosting efficiency with a 50% reduction in measurement deviation due to its fourth-generation laser technology. Featuring the intuitive MAVIS operation system, the platform supports robust, operator-independent testing with constant feedback via LED status bars. Its modular design allows easy integration into existing workflows, offering flexibility with interchangeable sample holders and compliance with 21 CFR Part 11 and ISO Class 7 environments. Additionally, the system ensures process continuity with an integrated UPS and offers seamless data connectivity via OPC UA server.
Benefits
- Enhances quality control with non-destructive testing, ensuring product safety.
- Increases accuracy with a 50% reduction in measurement deviation, optimizing batch consistency.
- Simplifies operations with user-friendly MAVIS interface, reducing operator training time.
- Adapts easily to changing production needs with flexible, interchangeable sample holders.
- Ensures regulatory compliance with 21 CFR Part 11 and supports ISO Class 7 environments.
- Applications
- Bfs bottles,Syringes,Iv bags,Bfs cards,Vials,Parenterals,Ampoules,Auto-injectors,Aerosol cans,Small volume parenterals,Metal packaging,Steel cans,Large volume parenterals,Pharmaceuticals
- End products
- Sterile injectable drugs,Solvent-filled bfs bottles,Antibiotic ampoules,Pain relief auto-injectors,Iv saline bags,Pressurized inhaler cans,Insulin glass vials,Multi-dose vials for vaccines,Single-use syringes with pre-measured doses,Eye dropper bfs cards
- Steps before
- Sample preparation,Filling of containers,Development of recipes,Conditioning of test samples
- Steps after
- Data analysis,Process validation,Final product approval,Storage of tested samples
- Input ingredients
- small volume parenterals,large volume parenterals,BFS cards,BFS bottles,IV bags,vials,ampoules,syringes,aerosol cans,steel cans,compressed air,carbon dioxide,gases
- Output ingredients
- oxygen concentration measurements,carbon dioxide concentration measurements,leak test results,media fill inspection results,residual oxygen measurements,headspace analysis data,container closure integrity tests,differential pressure measurement results
- Market info
- Headspace Analyzer Type
- NEO HSX ONE / NEO HSX DUO
- Laser Measurement
- O2 and CO2
- Capacity
- 1–100 ml vials,0.5–10 ml syringes
- Measurement Accuracy
- 50% higher precision
- Operation System
- MAVIS
- Compliance
- 21 CFR part 11,ISO Class 7
- Process Safety
- Position monitoring
- Automation Level
- Manual/Robot supported
- Test Modes
- GMP / Development Mode
- Interface
- Customizable by widgets
- Operation Method
- One-hand operation
- Data Protection
- Integrated UPS
- Compliance Standard
- USP1207
- Sensitivity
- Vacuum decay test procedure
- Sample Holder
- Exchangeable (Plug,Play)
- Temperature Resistance
- -
- Batch vs. continuous operation
- Batch / Inline Continuous
- Site of Operation
- Lab and Production
- Automation level
- Manual / PLC / SCADA
- Intuitive operation
- MAVIS system
- Sample inspection
- Manual or robot supported
- Inspection method
- Non-destructive
- Laser wavelength options
- O2 and CO2
- Guided testing
- Operator Guidance System
- Process safety
- SST with position monitoring
- One-hand operation
- Available
- Biological compatibility
- Compatible with small volume parenterals
- Cleanability
- Non-destructive measurement for sterility
- Corrosive resistance
- Suitable for pharmaceutical packaging
- Density/particle size
- 0.1 µm leak size detection
- Container type
- Vials,ampoules,syringes
- Headspace Analysis
- O2 and CO2 measurement
- Inspection type
- Non-destructive
- Packaging size
- 1 - 100 ml vials,1 - 20 ml ampoules,0.5 - 10 ml syringes
- System Type
- Desktop
- Footprint
- Compact
- Sample Holder
- Exchangeable
- Control Panel Type
- Intuitive Interface (MAVIS)
- Laser Integration
- Single or Dual Laser Heads
- Display
- 12.1" Color Display
- Operator Guidance
- LED Status Bar
- Control panel type
- MAVIS operation system
- Integration possibilities
- OPC UA server connectivity
- Sample holder customization
- Exchangeable holders with position monitoring
- Interface customization
- Customizable interface with widgets