Tyvek® Rx: April 2014
In a press release dated March 31, 2014, DuPont Protection Technologies announced that it had recently issued a formal Change Notification for Tyvek® 1073B and Tyvek® 1059B to all customers who have a Change Notification Agreement in place.
This important step in the Medical Packaging Transition Project (MPTP) provides the industry with at least one year’s notice before beginning full commercialization of Tyvek® Transition Protocol material in 3Q 2015.
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.
On the regulatory front, DuPont recently received a final validation report from the 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 or non-inferiority under the DuPont Validation Protocol.” An English translation of key sections of this report is posted at www.areyouready.tyvek.com.
The latest in a series of webinars about the DuPont™ Tyvek® Medical Packaging Transition Project (MPTP) is scheduled for May 7, 2014. During this webinar—titled “Are You Ready for the DuPont™ Tyvek® Transition?”—our team of experts will share the latest material and package test results, regulatory status and other information to help you be ready for full commercialization. Register now http://www.ubmcanon.com/.