NEWS

At the Medical Design & Manufacturing West 2008 trade show in January, attendees sat in on a medical device packaging preshow seminar. Industry experts addressed major points of standards and test methods and opened the floor to questions during the eight-hour event, which was chaired by Randall Troutman of Oliver Medical (Grand Rapids, MI).

Leading the seminar with the first discussion, Karen K. Greene, technical director, DDL Inc. (Costa Mesa, CA), explained the importance of employing the TIR 22 for effective compliance with ISO 11607. Audience members voiced their concerns on a challenge they faced in meeting the standards, such as test failures. Greene said packagers must be current on a case-by-case basis.

Curtis Larsen, principal, Spartan Design Group (Hudson, WI) and a PMP News Editorial Advisory Board member, spoke on the topic of conditioning aging and distribution testing. He praised packaging professionals in general during his discussion.

“Medical device packaging has done a hell of a job of complying with standards,” Larsen said. He said that many testing methods produce a valid, measurable result, such as the visual integrity test (ASTM# F1886).

Larsen referenced a July 2006 PMP News article on integrity tests called “How Low Can You Go?” as a resource guide. The article can be found online at www.devicelink.com/pmpn/archive/06/07/020.html.

Additional speakers included Lora Keena of Oliver Medical. Her investigation of package failure analysis pointed to specific issues that deal primarily with seal strength.

Rounding out the session was a case history by Jason Crosby, medical business manager, Plastic Ingenuity Inc. (Cross Plains, WI). The success of the company’s creation of a custom thermoform package relied on alternative engineering attempts, such as using coined hinges instead of double hinges and conducting frequent conversations with customers.