Test Method Development, Experimental Design and Positive Controls

Package integrity can be defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures. The characterization of integrity separates packages into leaking and non-leaking samples and allows for the validation of a test method to be a very simple experiment. There are only two conditions, non-leaking and leaking. Samples representing both groups are subjected to a test and the results for each should be measurably different from the other. Samples with either a non-leaking circumstance or a known leak defect are introduced to the test and should be correctly identified as non-leaking or defective.