Root Cause Investigation Into A Possible Container Closure Integrity Failure

The LIGHTHOUSE method for non-destructive headspace analysis is a useful tool for root cause investigations into possible container closure integrity issues or for cases where the formulation can degrade in the presence of reactive headspace gases. 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.

In this application, three complaint lyo product samples were delivered for analysis due to discoloration of the product. Headspace oxygen levels were analyzed in each sample and in a control vial from the same batch to understand how the discoloration occurred.