With effect from the third quarter of 2015, DuPont™, the chemicals group, will transition the manufacturing of Tyvek® 1059B and 1073B to a new process. Tyvek® is a material incorporated into millions of sterile products and medical devices throughout the world. Medical device manufacturers, that use the 1059B and 1073B Tyvek® grades in their products, must submit significant change notifications to their Notified Bodies and obtain approval for the use of the transition material. TÜV SÜD Product Service has developed a questionnaire to assist with submission of the required documentation and information and make requalification easy and transparent for manufacturers.
Start the Tyvek® approval process now!
As early as 2011, the five leading Notified Bodies – including TÜV SÜD Product Service – in consultation with DuPont™, informed manufacturers that all sterile medical devices that included Tyvek® 1059B and 1073B, would have to be reassessed and how manufacturers could prepare for the transition material. The transition material is to be used in production from the third quarter of 2015 onwards, and all manufacturers, that incorporate Tyvek® 1059B and 1073B in their products, should strive to obtain approval of the new material by then. DuPont™ itself has collected huge volumes of data over the past two years to demonstrate which tests and measurements will not have to be repeated for regulatory requalification.
The Tyvek® questionnaire from TÜV SÜD Product Service takes manufacturers step-by-step through the information necessary for the approval process. The questionnaire is available on CD-ROM for a one-off fee of 850 EUR plus VAT and can be used by companies for all their medical devices affected by the transition. Make sure to order the CD on time from your TÜV SÜD contact.
What is Tyvek®?
Tyvek® is a fibrous fleece made of high-density polyethylene (HDPE), which is noted for its high robustness. Although air- and gas-permeable, the material provides an effective microbial barrier. In the medical device industry, Tyvek® is mainly used for sterile medical packaging. The material is manufactured in an exclusive process. DuPont™, the chemicals group, plans to change this process to the latest technology this year. With effect from the third quarter of 2015, DuPont™ will phase out the traditional manufacturing process of Tyvek® and focus on distributing the transition material.