About Us Contact Us Resources News & Events Technical Support Careers Applications Products Services Life Cycle Stability Testing Home • Life Cycle • Quality • Stability Testing • 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 Permeation Oxygen Permeation Moisture Permeation Carbon Dioxide Permeation 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. CCIT in Lieu of Sterility Testing FMS-Pressure/Moisture Headspace Analyzer FMS-Oxygen Headspace Analyzer Webinar: CCIT Method Development Webinar: Using Positive Controls in CCI Studies Permeation 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. Oxygen Permeation 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. Case Study: Headspace Oxygen Consumption Study FMS-Oxygen Headspace Analyzer Webinar: Protecting Oxygen Sensitive Formulations Webinar: Oxygen Permeation in Pre-filled Syringes Moisture Permeation 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. FMS-Pressure/Moisture Headspace Analyzer Case Study: Stability Study Moisture Permeation Webinar: Non-Destructive Moisture Analysis of Freeze Dried Product 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. FMS-Carbon Dioxide Headspace Analyzer Quick Links APPLICATIONS Container Closure Integrity Testing Oxygen Monitoring Water Activity Determination Moisture Determination PRODUCTS Automation Laboratory Instruments SERVICES Lab Testing On-site Testing Equipment Lease LIFE CYCLE Development Manufacturing Quality Control Contact Us Wherever you need support optimizing product and process quality throughout the product lifecycle, LIGHTHOUSE experts are available for you. Request Info Corporate Headquarters 2050 Avon Court Charlottesville, VA 22902 Telephone: +1 (434) 293-3081 E-mail: info@lighthouseinstruments.com European Support Center Science Park 408 1098XH Amsterdam The Netherlands Telephone: +31 20 7051 050 E-mail: euinfo@lighthouseinstruments.com Site Map | Cookie Policy | Privacy Policy | Terms of Use Subscribe to our newsletter Sign up to receive information on headspace analysis applications, industry updates, webinars and other events. Select your application area of interest below: LIGHTHOUSE © 2021 | Website created by Advanta Advertising, LLC