With industry best practices changing towards a more science-based, holistic approach to container closure integrity (CCI) testing, methods that can be used throughout the complete product life cycle are preferred.
While helium leak rate testing is a method standardly used to perform inherent package integrity studies due to its sensitivity, its use is limited further in the product life cycle. Laser-based headspace analysis can be used to detect CCI defects with a flow-effective defect size of 0.1 micrometers, which is the lowest leakage rate referred to in USP 1207, and can be used throughout the complete product life cycle.
This CCI test method is non-destructive and rapid and can therefore be used to test statistically significant sample sets.
This article demonstrates that headspace analysis is just as sensitive as helium leak rate testing.