ISO and EN Medical Packaging StandardsInch toward Harmonization

Originally Published MPMN April 2003

PRODUCT UPDATE

ISO and EN Medical Packaging Standards Inch toward Harmonization

The standards' different scopes have eased progress

by Norbert Sparrow

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 U.S. delegate to the ISO 11607 revision committee. Scholla presented a progress report on revisions that are being introduced to ISO 11607 at a private meeting in February during Medical Design & Manufacturing West in Anaheim, CA.

Fortunately for manufacturers, the rival medical packaging standards crafted by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) have rather different scopes. ISO 11607 deals with process validation, as well as materials and design, whereas EN 868 covers only the selection and testing of materials that make up the packaging. The complementary nature of the standards has allowed OEMs to achieve global compliance without excessive difficulty. However, there is sufficient overlap in the materials area to create confusion. Scholla cites the methods used to test a material's porosity as one example.

Different tests are favored in Europe and the United States to rate porosity, and neither group is about to switch, says Scholla. To further complicate matters, in the Bendsten test, which is specified by the standard developed by CEN, the greater the porosity, the higher the resulting number. In the Gurley Hill test used by U.S. OEMs, the opposite is true. To achieve consensus, the ISO document lists a number of test methods that can be used to meet requirements. After all, notes Scholla, there is no single best way to test every package; it all depends on what's inside.

Scholla remarks that the second edition of the ISO standard includes notations, where applicable, informing manufacturers of what they 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. This revised standard has been approved and is awaiting publication.

To take things to the next level and lay the groundwork for harmonization, the draft third edition of ISO 11607 has been divided into two parts: Part 1 for materials and design, Part 2 for processes. Conventional wisdom has it that EN 868 will not cover processing validation, since quality systems are under the purview of other standards, according to Scholla. "It's still not entirely clear that a CEN standard can't deal with processes," notes Scholla. "After all, problems and recalls rarely crop up because of the packaging . . . they are usually process related." Nevertheless, by introducing two parts into the ISO standard, a potential obstacle to harmonizing the two standards has been eliminated, and the selection and testing of materials can now proceed regardless of whether or not EN 868 integrates process controls.

Redefining Medical Packaging

Defining packaging in a medical context was a critical step to moving forward during these discussions, says Scholla, and this has produced some fundamental changes to the ISO document. "One of the things that makes medical packaging unique," he says, "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.

Defining primary medical packaging as a sterile barrier system was something of a breakthrough, and the term is being embraced around the world. For example, the European Sterilization and Packaging System, a trade association representing medical packaging manufacturers and converters, is reportedly changing its name to the European Sterile Barrier Association.

During the talk, Scholla also drew attention to a requirement in Part 2 of ISO 11607 that mandates process validation for preformed sterile barrier systems. This has not always been done, says Scholla, but it should be. "The device firm has to validate its sealing process; why shouldn't the company that's responsible for three out of the four package seals?"

Looking Ahead

The working draft of the revised ISO standard has been distributed to experts of the ISO and EN technical committees on medical packaging. Comments from the international members will be compiled prior to a meeting in Frankfurt, Germany, in June. "The comments will be resolved, country by country," says Scholla, "and a revised document will come out as a committee draft." He stresses that each step of the process has to be affirmed by ISO and CEN members for harmonization to proceed. Following more comments and revisions, and accounting for translation time, a draft international standard (DIS) will then be issued. The best-case scenario, according to Scholla, is for balloting to begin in the fall of 2004, with publication of the standard in 2005.

"This is something we have wanted for 10 years," says Scholla, "and I'm pretty excited about seeing the light at the end of the tunnel." Everyone has become comfortable with standards, notes Scholla, and the fits of pique about who is responsible for what have fallen by the wayside. "Most of the arguments surrounding medical packaging have been hammered out during the past 10 years," says Scholla, citing the heated debate over expiry dating that divided the United States and Europe. With time has come the awareness that posturing is counterproductive. "In the end, it simply costs medical device companies more when standards are not harmonized," says Scholla.

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