Almost 174 years to the day, after Jim Bowie, Davy Crockett, William Travis, and a couple hundred others were killed defending the Alamo, the upteenth annual Healthpack Conference is coming to within 4 blocks of the historic mission in San Antonio, TX. In a weak moment I was approached by the instigators (agitators?) of the event, Messers Spitzley and Larsen, and agreed to craft a presentation which they entitled, “How to test your package system labels for materials compatability and adhesion over time“.
It’s a critical topic but what we discovered in a survey that was taken by the IOPP Medical Device Technical Committee’s Labeling Task Group, no one does it exactly the same. The FDA gives us a broad and general edict in the Quality System Reguilations, CFR 21, Part 820, Subpart K. “Label Integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate, use”. In a nutshell, the label needs to stick to the packaging component substrate and stand up to the abuse of sterilization, shipping, handling, and storage until it gets thrown away. It also needs to remain readable after this journey from manufacturing final pack to the landfill. How to test for these qualities and predict how well the labeling on a terminally sterlized device package will survive is the topic I’ll try to address.
Rather than standing up there and presenting what I think people are interested in, I thought I’d use this forum to see what people that work with device labeling day in and day out actually want to hear. Take a look at the survey that we took last fall (attached below), which had ten basic questions. Part of the presentation will be based up on those responses, which come from a broad spectrum of device manufacturers, but I know there are additional issues, test methods, and techniques that should be addressed. One of the things we are working on in the Labeling Task Group is some sort of protocol or guidance that can be used to help qualify and validate pressure sensitive labeling of terminally sterilized device packaging. Any feedback via email or blog comment section would be helpful to the group.
Labeling Task Group 09
I know budgets are tight but Healthpack is a pretty useful conference for those of us in medical device packaging. I can’t pretend that all the presentations have been scintillating over the years, but there are a heck of a lot more useful and interesting presentations at this event than at most others I’ve attended. There is nothing wrong with San Antonio, the historic Gunther Hotel, or Riverwalk either, for that matter. Please take a couple minutes to give me some feedback on the topic of pressure sensitive labeling. If you don’t who knows what you might wind up with in early March…..
