Packaging systems behave in much the same way. Packaging Compliance Labs utilizes environmental chambers to simulate conditions expected during transport of medical goods around the world and to simulate an increased passage of time for accelerated aging. Just like your Thanksgiving turkey, too much or too little can have a detrimental effect on the packaging system. Too much heat can warp packaging and cause seals to release, while too low of temperatures may not adequately challenge the package system. Just like a burned turkey won’t get eaten, an over-exposed sample may not be able to be tested. Likewise, an under-conditioned package may not have been challenged enough, leading to falsely acceptable test outcomes. Much like an undercooked turkey, this package may allow for an ingress of microorganisms, potentially leading to illness or infection.
This is where standards come in. Much like The FDA recommends cooking turkey to a minimum internal temperature of 165oF, they have also recognized a number of standards that specify packaging conditioning profiles. For example, ASTM D4332 and ISTA 3A contain a variety of temperature and humidity profiles expected to be seen during transportation. Much like a turkey recipe from Martha Stewart, the standards specify temperature and duration (and often humidity) to ensure that packaging is exposed to a predetermined conditioning profile based on the package type and expected distribution environment.
Let PCL be the conditioning experts for your next project. We can help you determine the best profiles and durations based upon your package system and the nature of your study. You’ll be thankful that you did.