Tyvek® Rx: June 2015
On May 21, 2015, more than 400 people from around the world attended a webinar titled: “DuPont Submission to the U.S. FDA Fast Approaching the Finish Line—Are You Ready?” This was the most recent in an ongoing series of webinars conducted by members of the DuPont Medical and Pharmaceutical Protection Team to help the medical packaging industry get ready for the DuPont™ Tyvek® Transition. Following the presentation, the speakers responded to questions submitted by attendees during a brief Q&A session.
Here are highlights from the webinar:
Michael H. Scholla, Ph.D., Global Director, Regulatory and Standards; Medical Packaging Fellow, presented an overview of DuPont regulatory submissions completed to date, as well as the timing for submissions of the remaining reports to the U.S. FDA, Health Canada, BSI Assurance UK Ltd, LNE/G-MED, SGS UK Ltd, TÜV Rheinland LGA Products GmbH and TÜV SÜD Product Service GmbH. As shown in the table presented by Scholla, all remaining Cell Reports and Regulatory Summary Reports will be submitted by July 2015. U.S. FDA affirmation of Functional Equivalence is expected in September 2015.
During the webinar, Scholla also discussed sterilization and ethylene oxide (EO) residual testing; shared helpful hints and a list of important considerations for medical device manufacturers (MDMs); and concluded by giving an overview of the new Tyvek® for Medical and Pharmaceutical Packaging Reference Library that is now available online.
Bruce A. Yost, Ph.D., Global Technical Director, shared an updated timeline for publication of Tyvek® Medical Packaging Transition Project (MPTP) test results in Industry Summary Reports.
He also presented some of the most up-to-date package testing results, including tables showing pass/fail summary for seal strength (ASTM F88) for the following time points: 1-, 3-, 5- and 7-year accelerated aging and 1-year real-time aging. All package results to date continue to indicate Functional Equivalence.
In addition to sharing new package data, Yost provided a listing of the new Transition Protocol material data that is now available at www.areyouready.tyvek.com.
Helping You Get Ready
Packaging Engineer and MDM Specialist Karen Polkinghorne focused on what MDMs need to do to get ready for the Tyvek® Transition—and what tools and resources are available from DuPont Medical and Pharmaceutical Protection to help you.
Recognizing that it is sometimes challenging to find the MPTP data and documents you need because of the sheer volume of information posted on our website, Polkinghorne shared a few helpful hints to help you navigate our website more quickly and easily.
She also reviewed the DuPont 2015 Commercialization Plan; discussed the benefits of interchangeability; and presented a brief checklist to help MDMs answer the question: “Are You Ready?”
The next global MPTP webinar is scheduled for September 24, 2015. Mark your calendar!