Leakage analysis of flexible packaging: Establishment of a correlation between mass extraction leakage test and microbial ingress

Package integrity over the shelf life of a product is critical in order to demonstrate the ability to maintain product sterility. The development of a rational physical test method to evaluate the microbial barrier properties of sterile packages has necessitated its correlation to microbiological exclusion. In this study, the ability of a mass extraction leak detector to assess the integrity of multilayer pouches with a perforated microchannel was investigated as an alternative to the microbial challenge test. Results were obtained for defects of four different sizes (15 to100 μm, with 5 mm channel lengths within the sealing component). The results of the tests indicated that the leak tester possessed the ability to detect microchannel defects in sealed packages. Moreover, the mass extraction system was able to reliably distinguish between intact samples and samples with the aforementioned defects. The results of this study could be used to develop a time saving alternative method to analyze the sealing quality of flexible packages.