ISTA is making a lot of headway with the development of its new testing protocol, ISTA 4AB. This fall software for simulating distribution environments is scheduled to enter beta testing, ready for actual use and verification, according to ISTA. PMP News’ July issue will have a detailed report on ISTA 4AB, based on news out of the group’s annual forum on transport packaging, Dimensions.04. ISTA 4AB couldn’t have come at a better time. At the IoPP medical device packaging committee's last meeting, held during HealthPack 2004 in Palm Beach, FL, guest speaker Dennis Young shared some surprising news about shipping tests. Young had been invited to share the findings of the Medical Device Packaging Benchmarking Project.

The work was initiated by IoPP and ISTA, sponsored by DuPont, and administered by Young. Out of the 25 medical device firms surveyed for the project, a significant number of respondents reported that they do not use many of the methods designed for testing transportation packaging. These include ASTM D4169, ISO 4180, and several ISTA methods. Firms were also given the chance to include internally designed tests modeled after ASTM, ISO, or ISTA methods, or even other internal methods based on measurements of distribution hazards. Nonetheless, the number of firms never using each these methods were consistently significant, ranging from 4 to as high as 13.

But Hal Miller doesn't immediately see the need to sound the alarm. Miller is president of PACE Solutions, a consultancy focusing on sterile medical device packaging, and formerly corporate director of packaging technology for Johnson & Johnson. He can't "imagine large and mid-size companies not performing distribution hazard testing to some extent. Besides, FDA knows this is a key requirement for product and package integrity, and it looks for it." He also points out that "the one selection that was not included was actual over-the-road testing. I would suspect that companies still test this way since distribution testing labs and equipment are expensive."

With that said, Miller believes "that the industry varies widely, as shown in the study, on just what testing to do. Packagers want a 'cookbook' to tell them exactly what to do." ISTA 4AB may be the cookbook. During the HealthPack conference, Dave Huntley, general manager for the instrument group of Lansmont Corp., explained ISTA 4AB. "With this method, you will be able to bring data from the field into the lab," said Huntley.

ISTA 4AB will help packagers understand how lab tests mimic the hazards of the environment, says Miller. "This is where ISTA 4AB may be of great assistance," he says. "But, first and foremost, 4AB assumes you understand what hazards and distribution cycles your package will experience. With that known, 4AB will provide a custom protocol for one to test to. This is as close to cookbook as one can get." By cookbook or from scratch, medical device firms should be testing their packages to ensure they hold up during shipping.