Container Closure Integrity Testing (CCIT)
LIGHTHOUSE headspace CCI testing enables
- Rapid and non-destructive CCI testing
- Detection of all leak sizes
- Testing throughout the product life-cycle
- Detection of temporary leaks
- Testing of large sample sets
- Testing on both empty and filled containers
Test container closure integrity with headspace gas analysis
LIGHTHOUSE technology enables container closure integrity testing (CCIT) by detecting gas exchange through even the smallest defects. From products stored at room temperature down to cryogenic conditions, LIGHTHOUSE analyzers deliver reliable CCIT for a wide range of packages and products throughout their product life-cycle.
Moreover, non-destructive headspace analysis can detect even temporary defects, offering valuable data-driven insights into potential process risks that could impact closure integrity.
Replace dye ingress testing with headspace gas ingress for CCIT
Imagine a dye ingress test, but replace the dye with a tracer gas. This creates an excellent general CCI test method that is sensitive, analytical and deterministic.
By using the CCI test vessel in combination with headspace analysis, you are able to accommodate requests from regulators to replace probabilistic tests with a deterministic one.
More importantly, the method can be validated with robust, science-based analytical data for the detection of critical leaks down to 0.2 µm.
Replacing Blue Dye Ingress with Headspace Gas Ingress
Replacing Blue Dye Ingress with Headspace Gas Ingress
Closure integrity and vacuum retention of freeze-dried products
Freeze-dried products are typically sealed under reduced pressure to ensure optimal reconstitution, prevent air interactions, and ensure long-term stability.
With the updated EU GMP Annex 1, demonstrating maintenance of vacuum throughout a product’s shelf life has become a requirement – which can be directly monitored using non-destructive headspace analysis.
In addition, monitoring headspace gas levels offers a highly effective way to detect a loss in closure integrity – even if the loss in closure was temporary.
Qualification of Raised Stopper Limits
Qualification of Raised Stopper Limits
https://vimeo.com/448523739
Closure integrity during cold storage & transport
Cold storage at -80°C and below increases the risk of losing closure integrity by pushing packaging components to their limits and potentially causing temporary leaks.
Non-destructive headspace analysis is uniquely capable of detecting these transient leaks in large sample sets, making it ideal for packaging and process development.
LIGHTHOUSE analytical services provides data-driven support to ensure the integrity of your sterile pharmaceutical products through comprehensive cold storage testing solutions.
Knowledge Center
Latest Resources on Container Closure Integrity Testing
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Flyers
Compliance Program for EU Annex 1 Container Closure Requirements
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Case studies
Achieving Container Closure Integrity During Cryogenic Storage Conditions Using an Optimized Vial Stopper Combination
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Case studies
100% Container Closure Inspection of Freeze Dried Product in Quarantine
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Case studies
Ensuring Container Closure Integrity (CCI) for Products requiring Deep Cold Storage by correlating Seal Quality to CCI
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Articles
Method Development for a CCI Test Using Headspace Gas Ingress
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