Packaging Science

The LIGHTHOUSE laser absorption spectroscopy method for headspace gas analysis enables robust characterization of the primary packaging of sterile pharmaceutical drug product.

LIGHTHOUSE’s analytical packaging science methods enable critical characterization of the package performance in relation to the critical quality attributes of the product. Container closure integrity defects and permeation properties of a package that pose risk to the product sterility and stability can be readily identified and characterized.

 

Container Closure Integrity

Loss of container closure integrity (CCI) can occur due to component defects such as cracks in glass, out-of-specification vial/stopper dimensions or improper vial/stopper combinations, or process issues such as displaced stoppers, misaligned tooling, or rough handling.

LIGHTHOUSE has developed deep expertise in CCI and can support your testing activities in a variety of ways. Application Scientists are there to help perform CCI test method development, support with science-based studies, and even can come on-site for critical troubleshooting analysis.

 

Container Closure Integrity Testing


Cold Storage

New cell and gene therapies as well as certain live viral vaccines require deep cold storage. LIGHTHOUSE headspace equipment helps identify if there are package integrity issues at these low storage temperatures.

Permeation

LIGHTHOUSE headspace analysis enables quick and accurate permeation measurements of primary packaging material, enabling a determination of the degradation risk posed to your pharmaceutical drug from degradation. For many sterile liquids, powders, freeze dried formulations, and solid dosage product this means protection against reactive gases such as moisture, oxygen, and/or carbon dioxide.

The nondestructive nature of the analysis allows permeation monitoring of a single sample over time resulting in a very accurate determination of permeation rates.

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Wherever you need support optimizing product and process quality throughout the product lifecycle, LIGHTHOUSE experts are available for you.

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