Automated headspace inspection for parenteral containers
Ensure the integrity and quality of pharmaceuticals by inspecting and monitoring headspace conditions in parenteral containers to meet rigorous safety and compliance standards.
Inspects and Validates Container Closure Integrity
The PULSAR Headspace and Container Closure Integrity Inspection Systems from LIGHTHOUSE Instruments provide pharmaceutical and biotech industries with a robust solution for ensuring product safety and compliance. Utilizing advanced laser headspace technology, the system performs automated, 100% inspection of oxygen, pressure, and carbon dioxide levels in sealed parenteral containers to validate the integrity of various products including lyophilized vaccines, injectable vials, and other pharmaceutical formulations.
Specifically designed for high-speed, continuous operation, the PULSAR systems are capable of processing up to 9,000 containers per hour, supporting efficient production workflows. The equipment integrates seamlessly into existing lines, featuring PLC-control for enhanced operational oversight and optimization. Constructed with durable materials, PULSAR systems ensure long-term reliability and minimal downtime, bolstered by compliance with 21 CFR Part 11 for data integrity and regulatory adherence.
Compact yet powerful, these systems are capable of handling a diverse range of container sizes from 2R to 100R, providing versatility across multiple product types, such as liquids, powders, and freeze-dried substances. LIGHTHOUSE Instruments offers comprehensive installation and qualification support, including IQ/OQ protocols and user training. With options for equipment lease and project-based machine usage, PULSAR systems cater to dynamic production needs, while ensuring consistent quality control in pharmaceutical manufacturing environments.
Benefits
- Ensures product integrity and safety with comprehensive headspace and container closure inspection.
- Increases operational efficiency by processing up to 9,000 containers per hour.
- Enhances data security and compliance with 21 CFR Part 11 software.
- Adapts to diverse production needs with flexible leasing options and versatile container handling.
- Minimizes labor costs and error margins through fully automated, continuous operation.
- Applications
- Pharmaceuticals,Parenteral containers,Liquid products,Freeze dried products,Powder products
- End products
- Lyophilized vaccines,Iv fluid bags,Injectable vials,Serum-filled syringes,Allergy extract vials,Liquid nutritional supplements,Ophthalmic solutions,Hormone injectables,Protein powder supplements,Antibiotic powders
- Steps before
- Product Filling,Headspace Modification
- Steps after
- System Qualification,User Training,System Start-up Support,Performance Testing,Packing
- Input ingredients
- sealed parenteral containers,freeze dried product,modified headspace liquid and powder products,containers with vacuum headspace,containers with partial nitrogen pressure headspace
- Output ingredients
- inspected containers,100% CCI inspected pharmaceutical products,characterized headspace conditions
- 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
- 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
- Automation level
- 100% Automated
- Inspection Type
- Headspace Oxygen,Pressure,and Carbon Dioxide
- Batch vs. continuous operation
- Continuous
- Changeover time
- Fast delivery solution
- Cleaning method
- Not specified
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Machine footprint
- 330 cm x 130 cm
- Container Size
- 2R to 100R,or 16.0 mm to 47.0 mm
- Container Type
- Tubing or molded
- Amber or clear
- Maximum Throughput
- 9000 containers per hour
- Compact footprint
- Small