Automated headspace analyzer for small volume parenterals
Optimize container closure integrity with high-speed, non-destructive analysis ensuring your pharmaceutical products meet stringent quality standards while maintaining production efficiency.
Performs Non-Destructive Headspace Analysis
The SPECTRA HSX Series from WILCO AG offers robust and precise headspace analysis for pharmaceutical packages such as vials, ampoules, and syringes. This series includes the SPECTRA HSX 100, 300, and 500 models, designed to meet varying production speeds and demands. These analyzers perform non-destructive testing to ensure container closure integrity and assess gas conditions like oxygen and carbon dioxide levels. Capable of integrating up to ten test heads, the SPECTRA HSX 500 achieves a throughput of 500 samples per minute, making it ideal for continuous, high-speed operations. Optional integration with NIR spectroscopy and visual inspection systems enhances versatility, while compliance with GMP standards ensures adherence to pharmaceutical industry requirements. The equipment supports seamless integration into production lines with PLC control and data handling compliant with 21 CFR Part 11. Options for stainless steel construction provide durability and corrosion resistance, crucial for maintaining operational integrity in demanding environments.
Benefits
- Enhances quality assurance with non-destructive testing, preventing product loss.
- Boosts production efficiency with high-speed analysis up to 500 samples per minute.
- Ensures regulatory compliance with GMP-aligned design and 21 CFR Part 11 data handling.
- Adapts to diverse applications with optional NIR and visual inspection integration.
- Provides reliable operation in pharmaceutical environments with robust, corrosion-resistant construction.
- Applications
- Bfs bottles,Syringes,Iv bags,Lyophilized products,Pharmaceutical packages,Vials,Liquid products,Parenterals,Ampoules,Solid products,Pharmaceuticals
- End products
- Sterile liquid injectables,Contrast media in ampoules,Antibiotic vials,Biologics in vials,Lyophilized vaccines,Blood plasma products,Nutrient iv solutions,Monoclonal antibodies,Lyophilized diagnostics,Prefilled syringes
- Steps before
- Preparation of pharmaceutical packages,Filling of vials or syringes,Nitrogen purging,Sealing
- Steps after
- Quality verification,Packaging,Labeling,Distribution
- Input ingredients
- small volume parenterals,large volume parenterals,BFS cards,BFS bottles,IV bags,vials,ampoules,pharmaceutical packages,lyophilized products,glass containers,plastic containers,2ml vials,LVP bottles
- Output ingredients
- inspected vials,inspected ampoules,inspected pharmaceutical packages,quality verified headspace conditions,inspected lyophilized products,moisture concentration data,defects identification,NIR spectra analysis results,completed headspace analysis,container closure integrity test results
- Market info
- Inspection Speed
- Up to 600 vials per minute
- Container Size
- 2 ml to 100 ml
- Non-destructive Analysis
- Yes
- Automation
- Fully Automated
- Test Heads
- Up to 10 integrated
- Pressure Detection
- Oxygen,Carbon Dioxide,Total Pressure
- Compliance
- GMP Guidelines,21 CFR Part 11
- Calibration
- Integrated Online Calibration System
- Changeover
- Toolless Format Changeover
- Inspection Methods
- Headspace Analysis,NIR Spectroscopy
- Inspection Type
- Liquid,Lyophilized,Solid Products
- Moisture Detection
- NIR Spectroscopy
- Headspace Analysis
- Non-destructive,real-time
- Inspection Speed
- Up to 600 vials per minute
- Automation Level
- Fully automatic with PLC
- Changeover Time
- Toolless format changeover
- CIP/SIP
- Compliant with GMP standards
- Batch vs. Continuous Operation
- Inline continuous
- Calibration
- Integrated online system
- Integration Capability
- Optional visual inspection system
- Multi-gas Inspection
- Oxygen,CO2,total pressure
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Machine footprint
- Compact / standard / large
- Control panel type
- Touchscreen / Button panel
- Discharge method
- Gravity / pneumatic
- Compact footprint
- Yes/No
- Integration of multiple test heads
- Up to 10 heads
- Container size compatibility
- 2ml – 100ml
- Integration with Other Inspection Technologies
- Optional integration with visual inspection systems
- Integration of NIR Module
- Optional integration for residual moisture and lyo defects
- Control Panel Type
- Integrated in PLC and HMI system
- Online Calibration System
- Integrated for maximum process reliability
- Integration of Test Heads
- Up to 10 test heads
- Modular Platform
- Flexibility to add further inspection technologies
- Optional 2D DataMatrix Code Reader
- Optional integration
- Optional Near infrared spectroscopy Module
- Allows non-destructive analysis