Non-destructive headspace analyzer for pharmaceutical packages
Ensure non-destructive and accurate headspace analysis for pharmaceutical packaging to optimize quality control and meet stringent regulatory standards.
Analyzes Headspace and Inspects Pharmaceutical Vials
WILCO’s SPECTRA series, including the HSX 100, HSX 300, HSX 500, and NIV 300, offers comprehensive non-destructive inspection solutions for the pharmaceutical, biotech, and chemical industries. These systems are designed for meticulous headspace analysis and NIR spectroscopy, ensuring thorough quality control in parenterals and lyophilized products. The SPECTRA HSX models utilize advanced laser systems for headspace gas detection, nitrogen purging efficiency, and container closure integrity testing, configurable with up to ten test heads for enhanced sensitivity and throughput of up to 500 vials per minute. The NIV 300 model employs near-infrared spectroscopy to analyze moisture content and detect lyophilization defects at speeds up to 600 samples per minute, fully automated for minimal human intervention. All systems are GMP-compliant, integrate seamlessly into production lines, and offer optional modules for additional inspection such as visual systems and 2D DataMatrix code readers. Designed with an easy format changeover and user-friendly interface, these analyzers ensure reliable, continuous operation and support dynamic production requirements.
Benefits
- Enhances production efficiency with high-speed, continuous inspection.
- Ensures product safety and compliance through non-destructive testing.
- Minimizes labor requirements with fully automated, user-friendly systems.
- Adapts to various container sizes and types without additional tools.
- Maintains data integrity with 21 CFR Part 11 compliance for secure data handling.
- Applications
- Bfs bottles,Syringes,Iv bags,Lyophilized products,Vials,Liquid products,Parenterals,Ampoules,Solid products,Lvp bottles,Pharmaceuticals
- End products
- Pre-filled syringes with biologic drugs,Sterile saline ampoules,Large volume parenteral bottles for intravenous fluids,Lyophilized antibiotics,Bfs bottle packaging for eye drops,Vaccine vials,Infusion bags with nutrient solutions
- Steps before
- Lyophilization,Filling of parenterals,Packaging of vials and ampoules
- Steps after
- Visual Inspection,Packing,Labeling
- Input ingredients
- pharmaceutical packages,vials,syringes,ampoules,plastic containers,glass containers,lyophilized products,liquid products,solid products,2ml to 100ml containers,partial pressure of oxygen,carbon dioxide,modified headspace conditions
- Output ingredients
- tested pharmaceutical packages,non-destructive headspace analysis results,moisture concentration data,lyo defects analysis,container closure integrity testing results,nitrogen purging efficiency results,vacuum verification results,data in compliance with 21 CFR part 11,reliable product handling,headspace conditions verification
- Market info
- Inspection speed
- Up to 600 vials per minute
- Container size
- 2 ml up to 100 ml
- Non-destructive analysis
- Headspace Analysis
- Sensitivity enhancements
- Integration of up to 10 test heads
- Laser technology
- Latest generation for maximum sensitivity
- Throughput
- Up to 500 samples per minute
- Automation
- Fully automated with online calibration
- NIR Spectroscopy
- For moisture detection and lyo defects
- Inspection methods
- Integration with other technologies
- Compliance
- 21 CFR part 11
- Calibration system
- Integrated online calibration tool
- Automation level
- Fully automated / PLC
- Batch vs. continuous operation
- Inline Continuous
- Inspection speed
- Up to 600 vials per minute
- Detection method
- Non-destructive Headspace Analysis
- Integration capability
- Optional integration with other inspection technologies
- Calibration system
- Integrated online calibration system
- Test head integration
- Up to ten test heads
- Product handling
- Reliable product handling
- Changeover time
- Toolless format changeover
- Cleaning method
- Designed according to GMP guidelines
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Product state
- Liquid / Lyophilized / Solid
- Nitrogen purging efficiency
- Available
- Vacuum verification
- Available
- ISO Standards
- ISO 9001
- Footprint
- Compact
- Test Head Integration
- Up to 10 test heads
- Container Size Compatibility
- 2 ml to 100 ml
- Container Type Compatibility
- Glass / Plastic Vials and Ampoules
- Non-Destructive Testing Method
- Headspace Analysis
- Platform Type
- SPECTRA HSX
- Control panel type
- Fully integrated in PLC and HMI system
- Integration possibilities
- Optional integration of visual inspection systems and 2D DataMatrix Code reader
- Customization of laser system
- New milestones in terms of sensitivity and inspection speed
- Test heads customization
- Up to 10 test heads can be integrated
- Inspection module integration
- Integration of NIR spectroscopy modules or barcode readers