by Charlie A. Webb CPP, CMC
For those of you that follow Van der Stahl Scientific’s packaging blog you may remember a while back, I wrote a blog about bells and whistles. When I penned that last blog, my hope was that the marketing department would leave engineering alone in our industry and that machine manufacturers would focus in on only usable machine attributes and not bells and whistles. But alas, it seems that I was wrong. In fact, it seems like the trend has gained some momentum and more companies are moving toward touch screen displays and proprietary functions that are designed to create an oooh and aaahhh factor at trade shows. Now, don’t get me wrong. As I’ve mentioned before, I love technology that is thick with features. I’m a ham radio operator and can comfortably sit in my easy chair and read a technical manual cover to cover. I gain great joy in learning about features of my latest electronic gadget. But this isn’t an iPad or an all-band amateur radio. It’s a medical packaging machine and it’s regulated by jaundiced third parties.
When we create too much complexity in machinery with the initial goal of simplicity, we end up with so much data scatter it is impossible to manage, and it is extremely difficult for a third party to interpret. Further, as I had mentioned in an earlier blog, “Don’t Ask a Barber if You Need a Haircut,” you must be careful about gaining confidence in a machinery by asking a machine if it performing as expected, think HAL in 2001 A Space Odyssey. As Ronald Reagan said, “Trust but Verify.” Or as the Texans like to say, “Trust your neighbor, but brand your cattle.”
We have simply focus away from the spirt of validation and the scientific method for that mater when we try to integrate validation within a machine itself. The machine must be compliant to 11607, and every machine that we offer to the medical device manufacturing community meets those robust rigors of the FDA and the ISO 11607.
Our company has taken a very different approach to determining if a machine is working as expected and it’s all centered around whether or not the seal is strong. We don’t ask the customers to believe we’ve created a compliant seal. We believe the customers need to verify that the machine has created a compliant seal. This isn’t marketing, it’s the law. This is why we have sealers that integrate peel testing on the sealer it self, as it is output data that makes or breaks your validation.
So, perhaps the next time you’re perusing a medical packaging trade show, you should think carefully about machines that provide on-board validation ports and features. If you’re hanging your validation on a manufacturer’s proprietary features of the machinery, you’re asking for trouble.
As a certified packaging engineer and certified management consultant that’s had the great fortune to speak with thousands of quality teams over the last two decades, I can tell you that it’s the validation you create through processes and simple and sound science that’s going to keep you from squirming in your seat during an audit … not a packaging machine manufacturer’s bells and whistles.
Your packaging machine is merely a soldier in your sterile device and sterile barrier system battle. It’s not a general or even a sergeant. It’s a simple infantryman that needs to be guided through your skilled hands. And as I tell every single quality group I speak with, if you really want to get serious about your medical packaging program, test your packages regularly. That’s by far the single most important piece of advice on the road to sterile device packaging compliance.