Data You Can Use
A couple of years ago, Nick Fotis worried that he and his fellow medical packaging engineers werenï¿½t getting quite the data they needed from material converters. As director of the Packaging Technology Center for Cardinal Health, Fotis had heard that engineers were seeing different results from their testing than those they had seen on material data sheets.
Fotis decided to take action. He started a task group in 2002 in the then-rejuvenated Medical Device Packaging Committee of the Institute of Packaging Professionals. After surveying the industry, his group found that the alarm was generally unfounded. ï¿½Most engineers surveyed [said] that data sheets were generally reliable,ï¿½ Fotis says.
But the group still saw a need for standardization. ï¿½There was a concern that people were using typical values as opposed to engineering values to decide which materials to select,ï¿½ Fotis explains. ï¿½To an engineer, mean values are not as important as the ranges, as expressed by the mean and standard deviation. You donï¿½t want to drive over a bridge that was engineered with steel that, on average, meets load requirements.ï¿½
Thankfully, medical packaging engineers shouldnï¿½t have to cross bridges like that much longer. The task group, which includes both material users and converters, released draft guidelines for standardizing data sheets at this yearï¿½s HealthPack. The guidelines can be viewed at www.iopp.org under the Medical Device Packaging Committeeï¿½s Material Specifications Task Group.
ï¿½The feedback I have received at the IoPP meetings has been encouraging,ï¿½ says Fotis. ï¿½People feel that any efforts to make data sheets easier to read and to compare will be a step in the right direction.ï¿½
ï¿½Converters see value in a consistent format for data sheets,ï¿½ says John Ozcomert, PhD, director of technology for Amcor Flexibles Healthcare. ï¿½It is a good idea to describe structures in the same way and to employ consistent test methods and units of measure. We are willing to standardize.ï¿½ Several converters have posted data sheets revised according to the draft guidelines on the site.
There is some debate, though, as to how much of an influence these changes will have on material choice. Fotis believes they will have a definite impact. ï¿½An engineer may make an entirely different decision if they understand the variability inherent in the process. Much of this information is not available and only discovered after testing.ï¿½
Ozcomert, however, says data sheets usually donï¿½t play a role in the final decision. ï¿½Users generally rely on data sheets to screen materials and to decide whether to bring a material in for testing,ï¿½ he says. ï¿½Suitability for end-use is generally determined through packaging trials of the medical device.ï¿½
Standardized data sheets should benefit both users and converters. ï¿½Converters that [follow the guidelines] will make it very easy for packaging engineers to compare their offerings. Those films, etc., that display the required properties will stand out,ï¿½ says Fotis.
The draft guidelines are just the first step, say Ozcomert and Fotis. ï¿½Customers are interested in how materials meet certain regulations,ï¿½ says Ozcomert. ï¿½The next step should be to include details on whether materials include heavy metals or bovine ingredients, for instance.ï¿½
Fotis foresees another step. ï¿½I envision a future where just like with Froogle, you can type in the physical properties needed into search engines. The software will scan the Web for data sheets formatted to meet IoPP guidelines and return a list of candidate materials and contact information within seconds.ï¿½
With converters and users working so closely, the outcome should be a balanced one.