Upcoming revisions of EN ISO 11607 & new guidance

Pharmaceutical & Medical Packaging News staff

At the two-day conference on Medical Packaging for Patient Safety and Health Care Effectiveness held in Helsinki, every speaker mentioned at least once what has become the absolute industry standard: EN ISO 11607.

It was further proof of the leading point made by Thierry Wagner, whose talk was devoted to this key regulatory requirement, as well as an upcoming guidance document, ISO TS 16775.

The Regulatory Affairs Director Europe, Middle East & Africa DuPont Medical & Pharmaceutical Protection, Wagner described for conference participants recent revisions and developments as well as what regulators expect.

The good news, he told the audience, is that six years after its introduction, EN ISO 11607 covering Packaging for Terminally Sterilized Medical Devices has been confirmed with a few minor revisions by the technical committee in charge and is currently in the voting phase. It is a truly global standard, he added, harmonized with the MDD in Europe, recognized by the US FDA, a national standard in Japan, Korea, and Australia and many more.

"Some say it is not specific enough, but this is a trade-off we accept for winning this global consensus," he said, calling it a horizontal standard with a scope covering a broad range of products.

To help navigate the gray areas, Wagner said we can soon expect to see up to 120 pages of counsel and advice in ISO TS 16775 that has been finalized by the technical committee and is currently in the voting phase.

There is a collective agreement this guidance is needed, yet guidance that is informative and not normative. Or put another way, he said, rather than adding "you shall" statements, the industry needs more helpful "how-to" statements.

Looking at the current landscape, he said, despite six years' experience among medical device manufacturers in Europe, there are still products on the market that have not been validated accordingly. Today, the Notified Bodies who authorize a CE mark under the current Medical Device Directive are giving more attention to packaging and there is more data available on materials, yet there remain significant differences in how products are reviewed and approved.

A relatively recent development is the emergence of testing services for packaging. A challenge continues to be the level of expertise available, creating an opportunity for those with an experience and knowledge in this field.

"There is a great job future for packaging engineers helping companies to figure out the optimum packaging solutions for their product range," he told the audience.

Meanwhile on the end-user side, he said, hospitals are paying much more attention to sterilized medical devices following the recommendations on Healthcare Associated Infections in Europe issued by the European Commission.

Healthcare Associated infections are generating a health care cost estimated at be at least €5.48 billion and, more critically, are responsible for an estimated 37,000 fatalities annually.

State of the art packaging is a key element in the effort to reduce fatalities and costs, yet paradoxically, the investment in innovative solutions also arrives in a context of sharply increasing cost pressures.

Key points that have emerged in discussions of EN ISO 11607 over the past six years centered on two key words: validation and design of packaging.

Medical device manufacturers have struggled, he said, to validate testing methods that are reliable, repeatable and reproducible for sterile barrier systems. The annex B of EN ISO 11607 listing available test methods will be amended in the next revision to show which ones have a precision and bias statement, a great help to properly validate test methods.

Two strong concepts that have been introduced are "product family" and "worst case configuration."

Both help to reduce the costs and complexity of testing but each is equally hard to define.

To illustrate the issues, he described the advantages for establishing medical packaging product families, such as pouches, trays, or header bags of different sizes, but using the same materials and sealing technologies.

Development and validation of any single product in these families can be demanding, so the establishment of a standard "family" can significantly reduce the development work and spread the cost over different products.

The packaging design, development, and validation efforts should be considered as an investment, and consistent and reliable quality is best achieved by a quality-by-design approach, spending most of the effort in the design phase.

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John Brosky, Contributing Writer