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
Package Development
Choosing the right package for your sterile drug product is critical. LIGHTHOUSE scientists provide you with in-depth expertise in designing and executing studies to identify appropriate packaging components ensuring good package integrity.
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.
Vacuum
Maintenance
Regulatory guidance (Eudralex 2008) explicitly states that containers closed under vacuum should be checked for the maintenance of a vacuum and LIGHTHOUSE headspace technology can make direct nondestructive measurements of vacuum throughout the entire product lifecycle.
Oxygen
Ingress
LIGHTHOUSE headspace analysis can be used in a variety of ways to detect a leaking container. Our oxygen ingress test method makes rapid, non-destructive oxygen measurements to determine the amount of air that has leaked into a container through a closure defect.
CO2
Ingress
The LIGHTHOUSE CO2 ingress method involves exposing a sample container to a CO2 atmosphere and then making a headspace measurement to detect trace amounts of CO2 that have ingressed through a leak.
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.
