Experimental Design, Test Method Development and Positive Control White paper
Package integrity is the ability of the package to maintain the sterility barrier and protect the product within until it is put to use. Package integrity test methods help classify the products into two categories namely, non-leaking and leaking. Samples representing both categories are put through a test to determine the parameters and values that will differentiate the leaky from the non-leaky. 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. This test is a well-designed experiment containing two types of control variables; positive and negative. Positive controls (leaking samples) are used to draw out unique experimental results differing from the results of the negative controls. In this case study the primary focus is on creating positive control leaking samples for package integrity testing.