ISTA Views

OCTOBER | 2016

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12 ista views • October 2016 • Q: A: On the ISTA website there is a comprehensive list, in chorological order, of procedure and project changes as well as the procedure's current version date. This list provides a brief description of the change that occurred and if it was technical or editorial in nature. The procedure change list can be found under Test Protocols and then Procedure Changes on the ISTA website. As always, the most current versions of all ISTA test procedures and projects can be found on How do I know if or what changes have occurred to ISTA test procedures and projects? Eric Hiser ISTA Vice President - Technical Online Testing Platform ISTA Seeking Your Input ISTA is exploring the potential of developing an online testing platform to save time and improve package testing. As part of this undertaking, we are seeking to understand how much testing is being conducted in laboratories world-wide. Please take this opportunity to improve testing within our industry and provide feedback in an anonymous 10 question survey. Your input is valued and imperative. As a member driven association with a mission to enhance the effectiveness of package design and testing, we are reliant on guidance from industry professionals to guide projects such as this. Visit the following survey to provide your feedback: ISTA Technical Update ISTA Announces New Certification Council A Certification Council was recently assembled and tasked with enhancing the ISTA member experience by improving all matters that pertain to the Certification of ISTA Test Laboratories, Personnel and Packaged-Products Systems. The Council's first order of business is to review the current process of certifying a non-thermal test laboratory. Be on the lookout for enhancements to this process in the months to come. Congratulations to the following Certification Council Members and thank you for your contributions to ISTA. CHAIR Kyle Dunno Sealed Air MEMBERS Michel Comtois Micom Laboratories, Inc. Matt Dodge TEN-E Packaging Services Braden Israel Ross Products Division of Abbott Laboratories Michael Morrow Clemson University Brian Proteau Keurig Green Mountain ISTA 3A, 3B, and 3E Recognized by the FDA as Concensus Standards For many years ISTA test procedures have been referenced in ISO 11607 which serves as the principal guidance document for validating terminally sterilized medical device packaging systems. Recently ISTA took the steps required to also have ISTA 3A, 3B, and 3E directly recognized by the FDA. With the FDA's announcement in Vol. 81, No. 183 of the Federal Register on Wednesday, September 21, 2016 ISTA 3A, 3B, and 3E were officially recognized by the FDA as consensus standards and are now present on the FDA's CDRH Recognized Consensus Standards Database. "It's exciting news" said ISTA President A.J. Gruber "The recognition from the FDA further bolsters the credibility of ISTA 3-Series testing and hopefully will drive further participation within our Association from the medical device industry." James Raw Smithers Rapra and Smithers Pira Limited Jason Sherrier Georgia-Pacific Corrugated LLC Edmund Tang Westpak, Inc. Bryan Williams Lansmont Corporation

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