Leakage assessment of flexible pouches using dye penetration test with correlation to modeled bacterial aerosol challenge test.

Package integrity is a primary measure of a package's ability to keep the contained product inside and to keep potential contaminants out. In this study, injecting and vacuum dye penetration methods were applied for the assessment of the package integrity of retortable flexible pouches having various sizes of micro-channels. The purpose of this study is to evaluate the usefulness of dye penetration as a physical test that can be incorporated into a stability protocol and compare the results of the dye penetration test with those from the bacterial aerosol challenge test. The study found a direct correlation between the results of the vacuum dye penetration test and those of the microbial test. The critical leak size that can ensure the flexible package integrity was 15 μm. To detect defective pouches, the dye vacuum testing had a sensitivity similar to that of bioaerosol challenge test.