EDITORIAL

The revised ISO 11607 standard—formally known as EN/ISO 11607:2006, Parts 1 and 2—offers medical device manufacturers (MDMs) further guidance on sterile packaging. But that is all it is—guidance. MDMs will have to make several decisions on their own.

“There are a lot of areas for interpretation in ISO 11607,” says Randy Troutman, technical director of Oliver Medical (Grand Rapids, MI). “The standard tells you what you have to do to comply, not how to do it.”

Troutman will be leading a daylong packaging conference at the upcoming Medical Design & Manufacturing East 2008 in New York City June 2. The standard will be a key topic throughout speaker presentations.

Troutman likes to compare ISO 11607 compliance with making change. “There are 293 ways to make change for a dollar—and they all still add up to a dollar,” he says. “Companies need to figure out what makes sense for their company in terms of risks and resources and develop their approach for medical packaging compliance.”

Industry does get a little frustrated over such freedom. “I constantly hear the question, ‘Is there one test method that will work for all my packages?’ Of course not—there simply isn’t one method that will work for everything,” Troutman says.

Troutman is planning an interactive approach to help address these and other questions about ISO 11607. “It will be a hands-on environment, where you can ask questions in an open forum—the best way to learn from your peers,” he says.

Karen Greene, technical director of DDL West (Costa Mesa, CA), will lead off with an overview of Technical Information Report 22 from AAMI (a cookbook approach to ISO 11607) in “The Compliance Sweet Spot.”

PMP News editorial advisory board members Curt Larsen and Mike Scholla will also share their expertise. Larsen, principal of Spartan Design Group, will present “Medical Packaging Con­ditioning/Aging and Distribution Simulation.” And Scholla, senior consultant of DuPont, will present “What to Expect from an EC-Notified Body when Being Audited for Compliance to EN/ISO 11607:2006, Parts 1 and 2.”

Afternoon sessions will offer a look into real-world applications. Karl Hemmerich, plant manager of Steris Isomedix Services’ gamma irradiation facility, will discuss sterilization and packaging materials.

Mary Czarnopys, market manager, converted products, of Perfecseal, will discuss abrasion testing of packaging films, while Lora Keena, director of quality and regulatory for Oliver Medical, will focus on the “Root Cause Package Failure Analysis.” And Jason Crosby, medical business manager of Plastic Ingenuity Inc., will share “The Art and Science of Thermoforming.”

Troutman will also be encouraging industry to get involved in IoPP’s Medical Device Pack­aging Technical Committee (MDPTC). “Not only is it a way to help support your industry, but it allows you to share information with your peers to answer some key questions.”

Perhaps that is the best way to learn about ISO 11607 and determine your own approach to compliance. There are 119 unique “shall” statements in EN/ISO 11607 Parts 1 and 2, Scholla points out. Thankfully, you have ISO 11607 appendices and TIR 22 from AAMI—and input from peers and your packaging suppliers—to help you decide how your company can comply.

Daphne Allen
Editor