Harmonization of Medical Packaging Standards Envisione

Originally Published MDDI March 2003

NEWSTRENDS

Erik Swain

There is a good chance that two major medical packaging standards, ISO 11607 and EN 868, can be at least partly harmonized in the coming years, said a U.S. expert closely involved with their revision.

Michael Scholla, PhD, senior consultant for DuPont Medical Packaging (Wilmington, DE), recently explained that the ISO standard, whose revisions could take effect as soon as 2005, is likely to reference each area where the CEN standard is different. This means that those in industry will not have to jump back and forth between the two documents when designing and making medical packaging on a global basis. The CEN standard covers Europe, while the ISO standard covers the rest of the world. Scholla shared his views with attendees at a private talk held during the MD&M West conference in Anaheim, CA, "We went through, piece by piece, and put notes on the ISO standard stating that if you want to comply with the CEN standard, here is what you have to do additionally or differently, so people don't have to go back and forth," said Scholla, who as cochair of the AAMI packaging committee, is one of the American delegates to the ISO 11607 revision process.

ISO 11607 covers materials, design, and processes, while EN 868 covers only materials and design. As a result, the revised ISO document is split into two parts, Part 1 for materials and design, and Part 2 for processes. This way, he said, if the new EN 868 expands to include processes, it might be able to be harmonized with the entire ISO 11607. But if it doesn't, harmonization with Part 1 of the ISO document could still take place. ISO will not delete processes from its document because "the source of packaging recalls is rarely materials; it is usually design or process," he said.

One major change to the ISO document is the inclusion of definitions of sterile barrier system, preformed sterile barrier system, protective packaging, and packaging system. These resolved confusion over what different nations considered primary packaging and what they considered secondary packaging, he said.

In another development, Annex B of Part 1 of the revised ISO document lists a number of test methods, derived from a number of different organizations, that can be used to meet the requirements of the standard. It made more sense to simply tell device manufacturers what options are available rather than to recommend specific methods, as no method is best for every single product and package, Scholla said. 

Another new section of Part 1, Annex C, contains a general guidance on medical packaging which could be useful for developing nations without much experience in the field.

Part 2 of the ISO document now requires process validation for pre-formed sterile barrier systems. This had never before been mandated, Scholla said. "A device manufacturer's process has to be validated, so the process of the guy responsible for four of the five seals should be validated too," he said.

The U.S. delegation—AAMI's packaging committee—will meet on April 23 in Arlington, VA, to develop U.S. comments on the revision for consideration. Comments will be presented in early June at ISO's meeting in Frankfurt, Germany. "The best-case scenario is that we will not see it published until 2005," Scholla said. CEN will be involved at every step in hopes that a truly joint document can be achieved, he adds. "I'm pretty excited about it because we can see the light at the end of the tunnel," he said. "Everyone has become comfortable with the idea of standards, and the idea of who owns them and who writes them has fallen by the wayside."

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