When developing packaging for medical devices there are two primary concerns. The first is maintaing product integrity throughout the shipping and storage process. This means we want to make sure the device does not get damanged between the time it is packaged and the time in goes into the hands of the physician or patient. To determine that we would subject the device to simulated extreme shipping and storage conditions prior to design verification and validation testing.

The second main concern in packaging development is to ensure that the product can be sterilized and that the sterile barrier is maintained until the product is opened by the user. As part of design verification/validation we would test the sterilized product to ensure the sterilization process was effective and test the sterile barrier using the ASTM test method mentioned above to make sure that sterility was maintained after simulated extreme shipping and storage.