Healthpack was the usual rousing success with a sellout crowd at the Gunther Hotel and along San Antonio’s Riverwalk. There were some casualties in the rough and tumble world of terminally sterilized medical device packaging but for the most part things were under control. I think the gentleman in the photo was an innocent bystander in a river front brawl between the ISTA and ASTM 4169 gangs over the package distribution standards turf. Another rumor was that the E labeling posse and the printed leaflets/IFU boyz came to blows again, but it’s unclear at this time. It was a good conference though, and many of the topics were germane to the issues of the day and a number of new ideas were explored.
When good HealthPacks go bad…
One of the more interesting ideas was proposed by Nicholas Berendt of the Sealed Air Corp., a converter of sterile barrier packaging. The theory was if the converter, (eg the company that takes raw material and prints, diecuts, laminates, folds, spindles, and mutilates it into pouches, lids, labels, IFU’s, etc.), could to a series of tests up front and provide data, it could seriously reduce package engineering time validating new packaging films as well as increase speed to market. I have thought for a number of years that the same thing could be easily done with new label stock. The testing is not nearly as rigorous as what would be needed for a barrier film and pre qualification might make it easier to qualify and validate new label material. As I mentioned in my Healthpack presentation, labeling is usually a very small part of the total package as far as cost and time and effort thats devoted to it. Because of this, available engineering time to test new materials, including label stocks, is generally limited and not in the number one spot on the package engineering agenda. Due to this ‘fact of packaging life’, the older, larger, more established companies are driving the ’89 Chrysler Cordoba of label stocks while newer companies, who have to evaluate all their new packaging materials anyway, are zipping along in the ’09 VW Passat, 1.8L Audi Turbo label stocks. While it’s true that the established firms have the fine Corinthian leather, they don’t have all the new innovations and added features of the newer models. These would include brighter, whiter, more opaque face stocks and tackfied emulsion adhesives that have decent repositionable characteristics in final pack yet superior ultimate bond to tough substrates like tyvek. Plus the new materials are a solid 25% less costly than the older materials. That should make the purchasing and sourcing peoples ears perk up but again, as a percentage of the total expense of the product the label part is still puny; we’re talking about a deck chair on the Titanic here.
Distinguished gents of HealthPack
The question then, is if we performed a series of ASTM and other tests on new label stock that addressed the twin FDA regulatory concerns in CFR 21, Part 820, the Quality System Regulations, of adhesion and legibility, would that be of value to device manufacturers and in particular packaging engineers? I realize that package size and weight are crucial to package testing and that special conditions need to be considered for various configurations, but I can’t help but think that if you need to get from Minneapolis to Milwaukee, that starting out in Madison would be a lot quicker, less costly, and less painless than starting out in Minneapolis. Please weigh in on the attached poll and let me know how you feel your company, particularly your Reg Affairs folks, would react to this concept. I will anxiously await your feedback.