Ideally, package integrity tests se

Ideally, package integrity tests selected to support marketed-product stability studies are able to verify the absence of the smallest leaks of concern for a given product–package system. In other words, the product's maximum allowable leakage limit falls within the chosen test method leak detection range. However, the test methodology most appropriate for a particular product–package system may be unable to detect the very smallest leaks of concern. In some cases the package contents interfere with the ability of leak test methodologies to detect the smallest leaks. For example, proteinaceous ingredients or even salts may clog leak pathways, inhibiting leak detection by gas flow methods such as vacuum decay or mass extraction. It is prudent to understand the product's potential to interfere with the selected leak test method, both initially after package assembly and over time.