by Jennifer Dean
Staff Writer

A truly thorough understanding of ISO 11607 is needed to ensure product efficacy and ultimately, patient safety. And yet, everyday medical device packagers face failures and even product recalls.

So, let’s take a look at the four basic aspects of sterile barrier system expiration dating.

• Relevant definitions
• Performance testing vs. stability evaluation
• Real time vs. accelerated aging
• Suggestions for expiration dating evaluations

A package stability evaluation demonstrates the sterile barrier system maintains integrity over time. So when we say the term “package stability/expiration,” we’re referring to the date the product should be used.

There is a difference between “performance testing” and “stability evaluation.” Performance testing evaluates the interaction between a packaging system and the product in response to the stresses imposed by the manufacturing, sterilization, handling, storage and shipping processes and environment. Whereas, stability evaluation demonstrates a package system’s ability to maintain an acceptable level of its critical characteristics after exposure to specified sterilization cycles and time. Stable testing is usually part of an overall packaging validation program.

When looking at real time vs. accelerated aging, remember that aging should be done using a real-time method. Accelerated again data is acceptable as long as it’s started in parallel with real-time testing sequences. As stated in the ISO 11607 standard, stability testing via accelerated aging protocols will be considered sufficient evidence for claimed expiration dates only until data from real-time aging studies are available.

When evaluating expiration dating evaluations, consideration should be given to worst-case as specified for sterilization cycles, as well as the number of exposures possible in the everyday production environment.

The topic of package/material stability evaluation has generated some great debates and articles from industry leaders. Watch the news wire for more updates on this sometimes tough topic.

by Jennifer Dean
Staff Writer

Last week one of the most innovative creators of our time died. Steve Jobs’ passing was a sad instance of an amazing life cut short, yet again by that dark disease: cancer.

His death came a day after the FDA Commissioner released a set of suggested steps that can be taken to drive biomedical innovation. Jobs had a profound effect on the consumer electronics industry. But his amazing innovations reached far beyond gadgets for listening to music or tablet computers.

These innovations changed the ways in which we communicate, how products look and feel, and the manner in which we find and share information. He also made pioneering changes in the medical device industry.

Jobs’ innovations appear in the growing use of iPads and tablets in the clinical environment. In addition, Apple products such as the iPhonehave been instrumental in fueling the growth of the exciting such as mobile health and telehealth.

After his passing web publications MPMN and Qmed have covered many of the ways Apple technologies are being used in the medical device industry and their impact on the market.

Qmed published the article, “The iPad Touches Medical Device Design”, pointing out that a growing number of design and technology companies are helping medical device manufacturers incorporate a similar look and feel of the iPad into their products.

by Charlie A. Webb CPP, CMC
Staff Writer

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.