Delivering One Globally Harmonized Document
Two standards are combined and edited for clarity and ease of use.
The newly revised ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” not only features reorganized guidelines that make the standards easier to understand, but also accomplishes what the original 1997 version of ISO 11607 failed to do. The new standard eliminates the need for EN 868-1 by incorporating its requirements into the new ISO 11607. 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, a formal ballot to withdraw EN 868-1 will be presented to the European Committee for Standardization (CEN). Spitzley spoke at the MD&M West 2006 conference in Anaheim, CA, on January 30.
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 by ISO 11607. However, European companies and regulatory bodies did not readily accept ISO 11607. The standard was not widely recognized or used in Europe. As a result, many U.S. companies 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 way in which ISO 11607 is formatted. Spitzley said device manufacturers were having difficulty complying with ISO 11607 and EN 868-1, in part because neither document was easy to read. The documents did not follow the normal packaging development process flow, and EN 868-1 did not effectively cover manufacturing or package design evaluation. At a May 2002 meeting of ISO TC198, WG7, in Kyoto, Japan, the attendees agreed upon a new format for the harmonized guidelines. The new ISO 11607 is a two-part document in which part one addresses materials (incorporating the essential requirements of EN 868-1), package design, and evaluation. Part two covers package assembly and validation requirements.
Part two is a completely new addition to ISO 11607, but it uses the same terminology as part one to prevent ambiguity or confusion for the readers. Nick Fotis of Cardinal Health also spoke at MD&M West about the new combined standard. He said that part two is based on work done by Study Group Three of the Global Harmonization Task Force and includes contributions from Hal Miller of Pace Solutions. Fotis outlined key sections of part two, including test methods and validation requirements such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The IQ section states how critical process parameters should be defined, controlled, and monitored. Part two also addresses process changes, revalidation, and package system assembly.
Spitzley said that a key element of this new standard was the development of four “critical definitions” to make terminology throughout the document more clear and consistent. Definitions were developed for sterile barrier systems (SBS), preformed SBS, protective packaging, and package systems.
The harmonized ISO 11607 includes two new informative annexes in part one of the document. Annex A provides guidance on medical packaging. Annex B is an extensive, updated, centralized list of recommended test methods and procedures for packaging materials and preformed SBS. Annex B compiles all the test methods previously included in the regular text of the original ISO 11607 document, making them easier to reference. Another new section in part one—which German representatives insisted be included in the revised standard—is called “Information to be Provided.” It covers what information should be included in documents like material certifications and material safety data sheets.
The Association for the Advancement of Medical Instrumentation (AAMI) is starting work on a revised technical information report (TIR 22) that targets people such as engineers who are new to the industry, and it includes guidance for applying ISO 11607 under FDA regulatory framework.