Originally Published PMPN April 2003
NEWS
Harmonizing ISO 11607 and EN 868 |
| Michael H. Scholla, PhD |
There is a good chance that two major medical packaging standards, ISO 11607 and EN 868, can be at least partially harmonized in the coming years, said Michael H. Scholla, PhD, at a private talk held during the Medical Design & Manufacturing West conference in Anaheim, CA.
Scholla told attendees that the standard for the International Organization for Standardization (ISO; Geneva) has been revised to reference each area where the standard for the European Committee for Standardization (CEN; Brussels) is different. Scholla, the senior consultant for DuPont Medical Packaging (Wilmington, DE), said this will mean that medical packaging personnel will not need to move between the two documents when designing and making medical packaging on a global basis. The CEN standard covers Europe while the ISO standard comprises the rest of the world.
For the second edition, which has been approved but not yet printed, "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. As cochair of the packaging committee for the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, VA), Scholla is one of the American delegates to the ISO 11607 revision process.
Further revisions for a third edition are under way and could go into effect as soon as 2005. The goal is to produce an ISO/EN 11607 that would replace EN 868 entirely, Scholla said. To achieve a combined ISO/EN standard, the balloting processes will run simultaneously within ISO and CEN, he said. ISO is taking the lead on getting the document in place, but CEN will conduct its own ballots at every step. If they affirm it, a combined standard will result.
ISO 11607 includes materials, design, and processes, while EN 868 just covers materials and design. As a result, the proposed third-edition ISO document is split into two parts, Part 1 for materials and design and Part 2 for processes. This way, he said, if CEN agrees to include processes, EN 868 might be able to be harmonized with the entire ISO 11607. If it doesn't, harmonization with Part 1 of the ISO document could still occur. ISO will not delete processes from its document because "the source of packaging recalls is rarely materials; it is usually design or process," Scholla said.
One major change to the ISO document is 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 proposed third-edition 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 currently requires process validation for preformed sterile barrier systems. This had never before been mandated, Scholla said. "A device manufacturer's process has to be validated. In the case of a preformed pouch, it only makes sense that the company responsible for sealing three of the four sides of the pouch should also be validated," he said.
The U.S. delegation—AAMI's packaging committee—will meet on April 23 in Arlington to develop U.S. comments on the revision for consideration. Other nations' delegations will meet around the same time. All will be present at ISO's meeting in Frankfurt, Germany, in early June to which CEN delegates will be invited. After that meeting, the document will undergo further revisions and then be issued as a draft international standard. If there are no snags, it will be balloted in the fall of 2004. "The best case scenario is that we will not see it published until 2005," Scholla said.
"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."
Copyright ©2003 Pharmaceutical & Medical Packaging News
