Automated headspace inspection system for parenteral containers
Ensure the integrity of pharmaceutical containers by precisely monitoring headspace oxygen, pressure, and carbon dioxide levels for guaranteed product quality and compliance.
Inspects Headspace and Container Closure Integrity
The PULSAR Headspace Inspection System from LIGHTHOUSE Instruments offers a robust solution for pharmaceutical manufacturers seeking reliable container closure integrity (CCI) and headspace gas analysis. Specializing in high-speed, continuous inspection, this system automates the monitoring of oxygen, pressure, and carbon dioxide levels in sealed parenteral containers. It’s ideal for applications involving vial-packaged vaccines, lyophilized injectables, and nitrogen-filled vials.
Capable of processing up to 9,000 containers per hour, the system supports a wide range of container sizes from 2R to 100R, with the flexibility to handle both tubing and molded configurations. The PULSAR system integrates seamlessly into existing production lines, featuring a 21 CFR Part 11 compliant database for secure data management. Engineered for efficiency, it utilizes optimized compressed nitrogen and air to minimize operational consumption.
The equipment comes with comprehensive installation and qualification support, including IQ/OQ, as well as user training to ensure smooth implementation. With its compact dimensions and quick delivery on a leasing basis, the PULSAR Headspace CCI Inspection System offers pharmaceutical manufacturers a versatile and compliant inspection capability.
Benefits
- Maximizes inspection efficiency with high throughput of up to 9,000 containers per hour.
- Ensures product integrity with comprehensive headspace and container closure integrity analysis.
- Minimizes operational costs with reduced nitrogen and air consumption.
- Provides secure data management through 21 CFR Part 11 compliance.
- Facilitates seamless integration into existing production lines, supporting various container types and sizes.
- Applications
- Powder products,Parenteral containers,Biopharmaceuticals,Freeze dried products,Modified headspace liquid products,Pharmaceuticals
- End products
- Pre-filled syringe solutions,Lyophilized pharmaceutical injectables,Vial-packaged vaccines,Powdered antibiotics,Nitrogen-filled drug vials,Liquid medicinal solutions in modified headspace
- Steps before
- Freeze Drying,Modified Headspace Packaging
- Steps after
- Quality Assurance,Packing,Distribution
- Input ingredients
- sealed parenteral containers,product samples,freeze dried products,modified headspace liquid products,modified headspace powder products,vials,tubing containers,molded containers,amber containers,clear containers
- Output ingredients
- headspace oxygen levels,headspace pressure levels,headspace carbon dioxide levels,CCI inspection results
- Market info
- Lighthouse Instruments is known for its expertise in providing high-precision laser-based inspection and measurement systems, primarily for the pharmaceutical industry, specializing in non-destructive testing solutions for ensuring container integrity and product quality.
- Container Sizes
- Vials ranging in size from 2R to 100R,or 16.0 mm to 47.0 mm
- Container Capability
- Tubing or molded
- Amber or clear
- Maximum Throughput
- 9000 containers per hour
- Software Compliance
- 21 CFR Part 11 compliant database
- Dimensions
- 330 cm x 130 cm
- Compressed Nitrogen
- 25 slpm @ >3.5 barg
- Electrical Power
- 200 – 240 VAC 1-phase,15 amp 50/60 Hz
- Compressed Air
- 35 scfm @ >5.5 barg
- Inspection method
- Headspace oxygen,pressure,carbon dioxide levels
- Inspection capability
- 100% automated inspection
- Container sizes compatibility
- 2R to 100R,or 16.0 mm to 47.0 mm
- Container type compatibility
- Tubing or molded
- Amber or clear
- Operation speed
- 9000 containers per hour
- Automation level
- PLC-controlled
- Project basis usage
- Per project machine lease
- Installation support
- Lighthouse engineer support
- System qualification support
- IQ/OQ
- User support
- Training and start-up support
- Container Size
- 2R to 100R,or 16.0 mm to 47.0 mm
- Container Material
- Tubing or Molded
- Amber or Clear
- Machine footprint
- 330 cm x 130 cm
- Compact footprint
- Small footprint
- Container Sizes
- 2R to 100R,or 16.0 mm to 47.0 mm
- Container Capability
- Tubing or molded
- Amber or clear
- Dimensions
- 330 cm x 130 cm