5.1 These test methods provide a rapid, simple to apply method to detect small leaks in flexible package seals or walls at the leak rate level of greater than 1 × 10⁻⁴ sccs, thus providing a measure of package integrity. Porous barrier film packages made non-porous with an impermeable film forming coating may demonstrate lateral leakage through the barrier material. Verification of leakage differences from background leakage must be included in validation methods. The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials.

5.2 While theoretical leak rate sensitivity can be established by calculation, the test measurement is in pressure units and the measuring instrument must be calibrated, certified, and verified with these units.

5.3 The pressure decay method of leak testing is a physical measure of package integrity. When testing medical packaging which must conform to ISO 11607-1: 2006 standards, it may necessary to verify the results of the pressure decay test method with other sterile package integrity test methods.

5.4 Test Method A allows packages to be pressurized without restraint. In Test Method A the pouch, tray, or other type package will contain a volume of air defined by its mechanical configuration and its ability to resist internal pressure applied. This test method requires that the package reach a stable volume configuration (stop stretching) to make a measurement.

5.5 Test Method B allows the use of rigid restraining plates against the walls of the package to limit its volume and stabilize the package volume.