If you aren’t acquainted with Packaging Compliance Labs, our headquarters is in southwest Michigan. Our sales office is in Denver, Colorado. So, yeah, we clearly like winter! Last week, the Polar Vortex brought once-in-a-lifetime cold temperatures throughout the Midwest—and a foot of snow came with it. What a not-so-hot mess. As the polar vortex cleared out we shifted gears and today, everything coated in a half inch of ice, with more on the way.
Luckily, the PCL Team is always warmed up and ready to help our customers avoid the storms that can shut down a medical device. To prove it, we’ve expanded our lab capacity with two brand new, state-of-the-art, walk-in accelerated aging chambers along with three new reach-in chambers.
One of our engineers, Sean Thompson, has been working diligently to qualify each of the chambers by performing IQ/OQ/PQ as outlined in ISO 11607. What’s in it for you? All the benefits of shorter queue times and greater capacity to complete your medical device packaging accelerated aging studies!
ISO 11607 IQ Validation, Check!
By meticulously following the ISO 11607 Installation Qualification (IQ) process, we can maintain our high quality standards for client projects. This qualification involves validation of many installation and safety factors, as well as testing each chamber’s overall function and features.
ISO 11607 OQ Validation, Check!
Next comes the Operational Qualification (OQ). This portion of the standard had Sean wiring up all corners of the empty chamber and center point with calibrated thermocouples. The highly sensitive thermocouples read temperature and humidity across every cubic centimeter of the chamber. The result is that we have 100 percent confidence that every cubic centimeter of the chamber will consistently hold the exact specified temperatures and humidity settings while empty.
ISO 11607 PQ Validation? Or the Chamber of Secrets?
Once that qualification is complete, the Performance Qualification (PQ) takes place. For this final stretch, Sean performs a similar wiring up of many thermocouples throughout the chamber. This time, the chamber is filled with boxes and packaging systems to prove that the same precision of temperature and humidity conditions are met in every corner, while running at full capacity.
Yes, it’s another Michigan winter, but with PCL’s lab testing facility, all of the unpredictability stays outside where it belongs. The only challenge you might see is that we have to watch closely that Sean isn’t enjoying the hot temperatures inside the chamber a little bit too much. We’ll keep Sean in check, while you take a look at your packaging’s accelerated aging and conditioning needs and give us a call! You might also like this IQ/OQ/PQ article.