As the regulatory climate shifts to a model of zero failures, we now see medical pouch testing becoming a new area of focus. Because I am at the validation support portal of our company, I have the opportunity to speak with hundreds of medical device packaging engineers, and typically these conversations begin after they have experienced a non-compliance issue with their sterile device packaging program. When speaking with these packaging engineers, together we have developed a root cause pathway that suggests inadequate pouch testing cycles were often the culprit.
As I’ve mentioned in previous blogs, the theoretical design of experiment type of data collection is, of course, essential for rolling out a sterile device packaging program. It is important to remember however that multiple conditions can change in the real world, causing a creep of the laboratory data that was collected when developing parameters for your sterile device packaging plan.
I’ve noticed a huge boost in the sales of our medical pouch testing machinery, like our PTT-100-V, and our DP-150 dye penetration kits, as medical device packagers are beginning to see the value of regular testing. Many of these engineers now proceed with a “Once Bitten Twice Shy”, mindset as they eventually realize that a preventative measure is far easier to manage than a medical device packaging recall or a 483 event.
We will cover this issue more thoroughly in future blogs, but I think the message is quite crisp and clear – test your medical device pouches often and avoid surprises that may develop when long testing cycles are the method of choice.
Considering how easy it is to perform a simple ASTM f – 88 peel test it is surprising to me that more companies are not testing multiple times throughout the day. I have noticed in the past 6 months that many of the medical device engineers are telling me that they are testing once in the morning, once in the middle of the day, and once at the end of the day, and many are testing each hour depending on their throughput.
Remember that reams of theoretical data developed during your initial validation are worthless unless you maintain their value through continuous observation of your medical device packaging process.