Oariginally Published EMDM
March/April 2003
A NOTE FROM THE EDITOR
ISO 11607: This Package Deal Is Good News
It goes without saying that reaching a global consensus on medical packaging is not in the same league as achieving world peace. But it is still refreshing to learn that harmonization is alive and well in one small corner of our polarized planet.
Manufacturers with global ambitions currently have to wrestle with two medical packaging standards: EN 868 for Europe and ISO 11607 for the rest
of the world. The good news is that these standards may be at least partially harmonized in the years ahead, according to Michael Scholla, senior consultant for Dupont Medical Packaging and a US delegate to the ISO 11607 revision committee. Scholla presented
a progress report on the revision process at a private meeting in February during the Medical Design & Manufacturing West event in Anaheim, CA, USA.
Currently, the two standards have rather different scopes. ISO 11607 deals with materials and design
as well as process validation, whereas EN 868 covers only the selection and testing of materials that make up the packaging. The complementary nature
of the standards has made the situation a bit more bearable for manufacturers. That said, there is considerable overlap in the materials area, creating ample opportunity for confusion.
To lay the groundwork for harmonization, the revised ISO standard is divided into two parts: Part 1 for materials and design, Part 2 for processes.
Although conventional wisdom has it that EN 868 will not cover processing validation, should the thinking change, the decision was made to eliminate what might be an obstacle to harmonization. By introducing two parts into the ISO standard, harmonization on the selection and testing of materials can now proceed regardless of whether or not EN 868 incorporates process controls.
Scholla noted that the committee also has spent considerable time poring over the ISO standard and, where applicable, inserting notes on what manufacturers need to do differently to comply with EN 868. This will allow companies designing packaging for a global market to reference a single document rather than jumping back and forth between two standards.
Defining packaging in a medical context was a critical step to moving forward during these discussions, said Scholla, and this has produced some fundamental changes to the ISO document. “One of the things that makes medical packaging unique,” said Scholla, “is that it must be sterilizable and must maintain sterility until the point of use.” The ISO draft reflects this property by precisely defining four terms: sterile barrier systems, preformed sterile barrier systems, protective packaging, and packaging systems. It’s worth noting that the notion of a sterile barrier system is gaining ground internationally: the European Sterilization and Packaging System is reportedly changing its name to the European Sterile Barrier Association.
International agreement on test methods has been elusive in the past. “The US and Europe use different tests to measure porosity,” explained Scholla, “and neither group is about to change its method.” To achieve consensus, the ISO document lists a number of test methods that can be used to meet the requirements. After all, remarked Scholla, there is no single best way to test every package; it all depends on what’s inside.
National delegations will have the opportunity to comment on these and other revisions prior to an ISO meeting in Frankfurt in June. The document then will undergo further revisions and be sent out as a draft international standard (DIS). The best-case scenario, according to Scholla, is for balloting to begin in the fall of 2004, with publication of the standard in 2005. Members of industry wishing to make their voices heard should get involved now, stresses Scholla. Once it is in DIS form, no more revisions can be introduced. “At that point, it’s down to a yes or no vote.”
CEN members will be involved throughout the process, and Scholla clearly hopes that this multilateral approach will lead to a successful outcome. “This is something we have wanted for 10 years,” he said, “and I’m pretty excited about seeing the light at the end of the tunnel. In the end, it costs medical device companies more when standards are not harmonized,” Scholla added.
Patience, a respectful dialogue among nations, and a sincere effort to seek workable solutions . . . not a bad blueprint for conflict resolution, if you ask me.
Copyright ©2003 European Medical Device Manufacturer
