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This important step in the Medical Packaging Transition Project (MPTP) provides the industry with at least one year’s notice before beginning the full commercialization of Tyvek® Transition Protocol material in 2015.
For more than 40 years, Tyvek® has helped protect the health of millions of patients worldwide by keeping pharmaceutical and medical devices clean and sterile. Announced in 2011, the MPTP is a multi-year investment of more than $30 million to transition the manufacturing of DuPont™ Tyvek® 1073B and Tyvek® 1059B to the latest flash-spun technology and equipment to ensure the continuity and flexibility of future supply into medical and pharmaceutical packaging applications worldwide.
Prior to issuing the formal Change Notification, a significant amount of material testing had been completed and all results to date indicate that the Transition Protocol materials are functionally equivalent to current Tyvek®. Extensive package testing is now in progress.
“All cells for the U.S. FDA Transition Protocol and the Phantom Protocol have been received at Nelson Laboratories and package testing is well under way,” said Bruce A. Yost, Ph.D., technical director, DuPont Medical and Pharmaceutical Protection. “We are pleased with the results we have seen to date and look forward to sharing data with the industry during our next transition project webinar on May 7, 2014.”
DuPont recently received a final validation report from the China Food and Drug Administration (CFDA) - Jinan Quality Supervision and Inspection Center for Medical Devices stating that: “For the DuPont™ Tyvek® products manufactured with DuPont’s latest flash-spinning technology and current manufactured DuPont™ Tyvek® products, all the testing results meet the criteria of functional equivalence and non-inferiority under the DuPont Validation Protocol.” English translations of the CFDA-Jinan Inspection Center summary report and other documents including a comprehensive list of testing for the MPTP are currently available at www.transition.tyvek.com.
Invitations for the May webinar, “Are You Ready for the DuPont™ Tyvek® Transition?” will be coming soon. You can make sure to get an invitation by registering to become a member of the DuPont sponsored Medical Packaging Community at https://presentations.inxpo.com/Shows/UBM/UBMCanon/DuPont/Microsite/registration.htm?ShowKey=6602&AffiliateKey=13647&AffiliateData=DuPontPR3.31.14.
