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Revisions to ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” accomplishes what the original 1997 version failed to do. The new standard eliminates the need for the European packaging standard EN 868-1 by incorporating its requirements. The harmonized document covers materials, manufacturing, and package design requirements for terminally sterilized medical device packaging.

The draft of the revised ISO 11607 can currently be viewed online and will be published later this year. According to John Spitzley of Spartan Design Group and JM Hansen & Associates (Tonka Bay, MN), there will be a formal ballot to withdraw EN 868-1. Spitzley spoke at MD&M West.

EN 868-1 is made up of standards that are general requirements for sterile packaging materials. Requirements for specific materials such as sterilization wraps, papers, and Tyvek are included in vertical standards parts 2 through 10 of EN 868. Spitzley, one of the writers of the original and revised versions of ISO 11607, said that the authors of the 1997 version of ISO 11607 thought EN 868-1 would eventually be replaced after ISO 11607 was published. However, European companies and regulatory bodies did not readily accept ISO 11607, and so the standard was not widely recognized or used in Europe. As a result, many U.S. firms assumed they needed to comply with both ISO 11607 and EN 868-1 as separate standards.

Harmonizing the two standards also gave Spitzley and his coauthors an opportunity to revise the formatting of ISO 11607. Spitzley said device manufacturers were having difficulty complying with both standards, in part because neither was easy to read. The documents did not follow the normal packaging development process flow. In addition, EN 868-1 did not cover manufacturing or package design evaluation.

At a meeting of ISO TC 198, WG 7 in Kyoto, Japan, in May 2002, the attendees agreed upon a new format for the harmonized guidelines. The new ISO 11607 is a two-part document. Part I addresses materials (incorporating EN 868-1) and package design and evaluation, and Part II covers package assembly and validation requirements.

Part II is a completely new section. Among the topics it covers are test methods and validation requirements, including installation qualification, operational qualification, and performance qualification.

“One of the biggest changes is that you need to do performance tests of your packaging based on the worst-case scenario,” said Patrick Nolan. Nolan, chief operating officer of DDL Inc. (Eden Prairie, MN), was another of the standard's authors.

This new format also allowed the authors to develop four critical definitions. The goal was to make terminology throughout the document more clear and consistent, Spitzley said. Definitions were developed for sterile barrier systems (SBS), preformed SBS, protective packaging, and package systems.

What U.S. packaging engineers often refer to as primary packaging is now called SBS, says Nolan. All secondary or tertiary packaging is now called protective packaging. In addition, he said, what U.S. engineers refer to as accelerated aging is now called stability testing. And real-time shelf-life testing must begin simultaneously.

The new version also includes two annexes. One provides guidance on medical packaging. The other is an extensive, updated, centralized list of recommended test methods and procedures for packaging materials and preformed SBS.

The new version is expected to be named an FDA consensus standard in the fall of 2006, says Nolan. That should reduce the documentation burden on those who follow it.

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