LIGHTHOUSE knows that by the time you reach the release testing stage in your pharmaceutical products lifecycle, you need to be confident in the manufacturing process and final product quality.
LIGHTHOUSE equipment can be used in QC labs to perform final release tests. The non-destructive nature of the measurement allows test samples to be used for other testing purposes if desired and also means that, because the sample stays intact, there is lower risk for product cross contamination and sample disposal issues after analysis.
Vacuum Maintenance
Maintenance of vacuum in freeze dried product is a subject of strict regulatory guidance (Eudralex 2008).
LIGHTHOUSE’s market-leading headspace analysis systems can detect changes in headspace conditions to assess maintenance of vacuum ensuring your product will meet the highest quality standards.
Lyo Moisture
LIGHTHOUSE systems for measuring lyophilized product residual product moisture content offer a rapid, non-destructive method that streamlines moisture analysis efforts and ensures the quality of finished product. Headspace water vapor levels measured inside of a freeze-dried vial have been directly correlated to Karl Fischer measurements of those same vials. Headspace water vapor measurements have also been directly correlated to the degradation of the API, which means that the stability of a dry product could be defined in terms of the water vapor pressure inside the sealed vial. The applications of headspace moisture analysis take advantage of the fact that it is straightforward to analyze the headspace moisture content of all vials in a statistically relevant sample set.
Headspace Oxygen
LIGHTHOUSE’s laser-based headspace method for oxygen analysis is a rapid and non-destructive measurement technique resulting in efficient release testing of oxygen sensitive products.
The non-destructive nature of the measurement saves quality control product samples that may be in limited supply and means the same samples can be used for other testing purposes if desired. It also means that the same sample could be followed for the full shelf life with time point measurements giving direct insight into the sample evolution over time.
