Lighthouse Case Studies

11. Verifying Vacuum Maintenance While Preserving The Product Sample 3/28/2019

    Vacuum in finished sterile product containers is critical for certain pharmaceutical formulations to ensure proper reconstitution before administration to the patient, or to prevent interactions between the formulation and headspace gas. A loss of vacuum can be a clear indicator of a container closure integrity defect or an issue with the original sealing process. Using a LIGHTHOUSE headspace analysis platform for non-destructive headspace pressure determination verifies the maintenance of vacuum while preserving the product sample.

12. Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage 12/28/2018

    During QC testing, a number of vials of liquid vaccine product stored at -80°C were found to have an overpressure, representing a serious safety risk and they needed to identify the root cause.

13. Lyo Chamber Moisture Mapping 12/27/2018

    Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.

14. Root Cause Investigation Into A Possible Container Closure Integrity Failure 12/27/2018

    In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.

15. 100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine 12/26/2018

    A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.