LIGHTHOUSE’s non-destructive headspace measurement systems are designed with the measurement performance and data integrity capabilities needed to perform shelf life stability testing.
Whether you are doing CCI in lieu of sterility or assessments of moisture, oxygen or carbon dioxide permeation through packages we have ready to execute method development protocols.
LIGHTHOUSE engineers have designed validatable systems and LIGHTHOUSE scientists have developed qualified test methods for all your sterile product stability testing needs.
CCI in Lieu of Sterility
LIGHTHOUSE’s innovative container closure integrity (CCI) tests are a direct replacement for blue dye testing and can be used in lieu of sterility testing as part of shelf life stability protocols.
Nondestructive and quantitative analytical methods are now recommended for CCI testing and LIGHTHOUSE engineers have designed a line of headspace analyzers with measurement performance and data integrity features that make implementation, validation and ongoing use simple and cost effective.
LIGHTHOUSE headspace analyzers are capable of assessing permeation of reactive gases through sterile product packages. The risk of degradation caused by permeation of reactive gases (e.g. oxygen, moisture and carbon dioxide) through packaging materials and components can be monitored as part of product stability shelf life protocols.
LIGHTHOUSE engineers have designed instruments and LIGHTHOUSE scientists have developed test methods to help you assess finished package permeation as part of product shelf life stability protocols.
LIGHTHOUSE scientists have developed methods for investigating oxygen permeation rates by monitoring the change in headspace oxygen over the product shelf-life.
LIGHTHOUSE’s rapid and non-destructive headspace measurement systems are designed to measure oxygen permeation into sterile product packages.
LIGHTHOUSE understands the risk for potential degradation of your dry product due to moisture permeation. Our laser-based headspace analysis systems utilizing frequency modulation spectroscopy (FMS) provide rapid, non-destructive analysis of headspace moisture.
LIGHTHOUSE scientists have developed methods for investigating moisture permeation rates by monitoring the change in headspace moisture over the product shelf-life.
Carbon Dioxide Permeation
LIGHTHOUSE pioneered rapid nondestructive headspace carbon dioxide analysis for sealed sterile pharmaceutical containers. This technique has been used to identify container closure integrity failures in frozen product shipped on dry ice. Permeation of carbon dioxide into a pharmaceutical product container can have detrimental effects on the drug formulation impacting efficacy and stability.