ASTM International Reaches Out to European Packagers

ASTM International invites medical device packaging professionals in Europe to participate in advanced standards development. The group will hold a workshop on ASTM test methods October 6–8 in Prague, Czech Republic. Participating in the meeting is Committee F02 on Flexible Barrier Packaging, and several of the planned presentations focus on medical device packaging test methods and standards.

“This meeting is one of the first ASTM standards committee meetings being held in the European community and in the eastern European region,” says Curt Larsen, a member of the executive board of Committee F02 and a principal of Spartan Design Group. “There are no consensus standards–writing organizations of this kind for European medical device packagers to participate in.” The committee especially hopes to attract members of the CEN Technical Committee 102 Sterilization, Working Group 4, Packaging (CEN/TC 102/WG 4), and the CEN TC102 member companies.

Scheduled presentations include the following:

•Case Study on the Commercial Importance of Validated Test Methods, by Ralf Walther, TUV expert.
•Seal Strength Testing (F88), by Marie Tkacik, Beacon Converters.
•Case Study on the Climatic Conditions in the Distribution Environment, by Curt Larsen and John Spitzley, Spartan Design Group.
•F02.40 TG on Edge-Dip Version of F1929 for Seal Integrity, by Geoff Pavey, Oliver-Tolas Healthcare Packaging.
•F02.40 TG on Dye Test for Seal Integrity of Nonporous Packages, by Dhuanne Dodrill, Rollprint Packaging Products.

Hal Miller, committee chair of ASTM Committee F02 and president of Pace Solutions, says that the committee will be promoting the use of ASTM International standards for flexible packaging in the European community. In particular, “we’d like to gain acceptance of ASTM International standards for sterile medical packaging compliance with ISO 11607,” he says. “We encourage European participation in interlaboratory studies for ASTM test methods.”

Attendees will be able to participate in actual ongoing subcommittee activities during the workshop, Miller adds. “They will be able to understand the benefits of test methods with demonstrated repeatability and reliability,” he says.

Jackie Daly Johnson, president of Beacon Converters, says that “the ASTM workshop in Prague is a great chance for European packaging professionals to see how the ASTM process works, learn more about the use of current ASTM methods, and participate in the precision and bias studies for the developing dye-penetration integrity test methods. These methods are of particular interest to medical device packaging engineers as they are frequently utilized in demonstrating compliance to ISO 11607.”

One year of ASTM membership will be provided to those nonmembers who register. Online registration will be available at www.astm.org/MEETINGS/prague and details at www.astm.org/COMMIT/F02.htm.

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