A healthcare worker wearing a surgical mask, gloves, and a hair cap holds up a small, clear vial containing liquid for headspace analysis.

Container Closure Integrity Testing

Good container closure integrity (CCI) is critical for the quality of sterile injectable products and more importantly, patient safety. New regulations are now prompting industry shifts towards validated deterministic methods and science-based data for container closure integrity testing.

Testing CCI with headspace analysis is...

  • Rapid & non-destructive
  • Sensitive to all leak sizes
  • Useable throughout the product life cycle
  • Sensitive to temporary leaks
  • Capable of testing a high throughput of samples
  • Possible on both empty and filled containers

Headspace gas ingress container closure integrity testing

LIGHTHOUSE technology detects closure integrity through the exchange of gas through container defects. From products stored at room temperature down to cryogenic conditions, LIGHTHOUSE analyzers enable reliable container closure integrity testing (CCIT) across a diverse array of packages and products throughout the product life cycle.

Moreover, non-destructive headspace analysis offers the distinct advantage of detecting even temporary losses in CCI, advancing further data-driven insight into potential process risks to closure integrity.

Close-up of glass vials with gray rubber stoppers, arranged in rows.

Replace your blue dye ingress test 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 more 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.

 

 

Replacing Blue Dye Ingress with Headspace Gas Ingress

Replacing Blue Dye Ingress with Headspace Gas Ingress

Several clear glass vials with red caps partially filled with a white substance are arranged on a white surface with a blurred background, highlighting the importance of Container Closure Integrity Testing.

Closure integrity and retention of vacuum of freeze-dried products

Freeze-dried products often require sealing under partial or full vacuum to ensure proper reconstitution and prevent interactions with headspace gases.

The new EU GMP Annex 1 now requires that vacuum levels in product containers should be retained throughout the product’s shelf life, a quality parameter that can be directly monitored with non-destructive headspace analysis.

Moreover, analysis of headspace oxygen levels serve as an effective way to detect a loss in closure integrity – even if the loss in closure was temporary.

 

Close-up of a small frosted vial with a red and white cap on a surface, with additional similar vials and a blue light in the background.

Closure integrity during cold storage & transport

Cold storage of primary packages at -80°C and colder, can significantly increase the risk of leaks. The packaging components are used at the limit of their capabilities risking temporary leaks during storage or transport. By testing a range of packaging components and process parameters these risks can be mitigated.

Non-destructive headspace analysis is the only method suited to detect temporary leaks in large sample sets, making it ideal for package and process development studies. LIGHTHOUSE analytical services can assist in generating data to ensure integrity of your sterile pharmaceutical products with our cold storage testing solutions.

Qualification of Raised Stopper Limits

Qualification of Raised Stopper Limits