Container Closure Integrity Testing
What is your Container Closure Integrity (CCI) strategy? Recent regulatory revisions have put emphasis on appropriately designed CCI studies and robust method validation. LIGHTHOUSE offers complete solutions for CCI testing throughout the product life cycle, from Development to Manufacturing and Quality Control.
Loss of CCI can occur due to component defects (e.g. cracks in glass, out of specification stopper dimensions or improper vial/stopper combinations) or process defects (e.g. stopper pop-up prior to capping, misaligned tooling, rough handing ). Rapid, nondestructive, headspace analysis enables at-line and in-line leak detection by monitoring changes in headspace gas composition or changes in total headspace pressure.
LIGHTHOUSE offers CCI solutions for:
- Package Development
- Cold Storage Studies
- Transport Studies
- Ingress of Oxygen and Carbon Dioxide
- Vacuum Maintenance
- CCI testing in lieu of sterility testing
- Qualification of Filling, Freeze Drying and Packaging lines
- Validation of Raised Stopper Limits
- 100% Finished Product Inspection
- Recalls and Investigations
Our CCI solutions included:
- Feasibility Studies
- CCI Process and Package studies
- CCI Method Development
- CCI Method Validation Protocols
- Automated CCI Lease Platforms
- Onsite trouble shooting and support