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No small debate when it comes to defect size

Medical package testers are revealing a lot more about their subjects these days. How? Using high-frequency ultrasound, for one. With it, engineers can locate defects as small as 10 µm in packages. Attendees of HealthPack 2003 heard this news from Jack Richtsmeier, business development manager of Sonoscan Inc. The firm’s technology, Acoustic Micro Imaging (AMI), can locate voids, cracks, delaminations, and disbonds in many types of medical and pharmaceutical packaging. Cardinal Health, for instance, has used it to test foil laminate pouches. 

But is such test sensitivity really necessary? This question kept popping up throughout the two-day conference, held in Scottsdale, AZ. The event also featured the second meeting of IoPP’s recently recharged Medical Device Packaging Technical Committee. 

Hal Miller doesn’t think so. Director of packaging technology for Johnson & Johnson, Miller gave the keynote speech “Quality Healthcare and the Challenges for Packaging Innovations.” He lamented the effort to make package testers more sensitive. 

“Package testers are too focused on sensitivity. Instead, [industry should] limit sensitivity to 50 µm, for example. It should focus on making a nondestructive, whole-package integrity test for porous packages.”

Medical packaging consultant Don Barcan agrees. Barcan led the HealthPack workshop, “Establishing a Seal Matrix,” along with Steve Franks of T.M. Electronics and Kent Hevenor of DT Converting Technologies. Barcan says that “testing should be about improving the packaging process, not about finding the smallest defects.” He adds that improvements should focus on making the testing process more reliable and repeatable.

But if Miller and Barcan aren’t convinced that greater sensitivity is needed, other professionals in industry are. At nearly every medical package testing conference I’ve attended, at least one attendee asks a version of the question, “What is the smallest hole that presents a threat to sterility?” This conference was no different. 

Such questions were raised during IoPP’s Medical Device Packaging Technical Committee meeting during Pack Expo International last November. The committee then formed the Defect Characterization Task Group. During HealthPack, chair Laura Bix of Michigan State University’s School of Packaging updated the committee on research to identify the defect size that could cause loss of package sterility. (Her presentation will soon be available to IoPP members at IoPP’s Medical Device Packaging Technical Committee’s Web site,

Bix’s proposal inspired a lively debate. Committee cochair Curt Larsen of DuPont Medical Packaging reports that “some members argued that the research would be dealing with defect sizes below the current detection capability of the device industry.”

Thanks to the committee, this debate will continue. Miller’s and Barcan’s points are valid, as is another raised by John Ozcomert, director of technology for Rexam Healthcare Flexibles: “We know there is medical paper out there with 40-µm pores, albeit with a tortuous path, so why test below this size if this package has been shown to be OK?” 

But as technologies like AMI emerge, medical packagers will naturally wonder whether they may find out more about packages previously deemed acceptable. The question of defect size, then, logically follows. Whether it will yield useful answers or merely confuse industry—and possibly FDA, as some IoPP committee members worried—remains to be seen. 

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