In June 2011, the DuPont Medical and Pharmaceutical Protection Team held several webcasts to make an exciting announcement: DuPont will be transitioning DuPont™ Tyvek® 1073B and Tyvek® 1059B to manufacturing lines that use our latest flash-spinning technology.
If you were unable to attend one of the webcasts, perhaps you have read about the transition on our website (www.medicalpackaging.dupont.com) or in an industry publication such as Pharmaceutical & Medical Packaging News and European Medical Device Technology.
We’ve also been conducting meetings with sterile packaging manufacturers (SPMs) and medical device manufacturers (MDMs) around the world to discuss this important news and what we are doing to make this transition process seamless for you and the healthcare industry.
Basic facts about the transition
For those of you who may not know about the transition, here are some basic facts:
• We are doing this to help ensure greater continuity and flexibility of supply to meet the growing demand for healthcare packaging around the globe.
• Working with the U.S. Food and Drug Administration (FDA), we have developed a transition protocol that is based on sound principles of design and statistical analysis.
• The transition protocol is a systematic method for generating data to prove that the DuPont™ Tyvek® produced with the latest flash-spinning technology is functionally equivalent in performance to the DuPont™ Tyvek® you now use.
• This protocol was approved by the U.S. FDA. You can read a copy of the letter on our website.
• DuPont is investing more than $30 million to ensure that you have ample supply of DuPont™ Tyvek® 1073B and Tyvek® 1059B for the future and to prove functional equivalence so there will be no need for regulatory re-submissions.
Transition protocol timeline
We are now in phase 2 of the transition protocol timeline. Select SPMs and MDMs are now testing and evaluating prototypic Design of Experiments (DOE) materials.
And, we are currently in the process of selecting SPMs and MDMs to participate in protocol testing for phase 3, which is scheduled to begin during the first quarter of 2012.
During phase 2, we are also evaluating third-party laboratories to select the one that will conduct the protocol testing and we are conducting verification/optimization runs at our Richmond, Va., and Luxembourg sites.
Helping you stay informed
We understand how critical timely communications are to the success of your business. That’s why we will be making announcements well in advance about any actions that your organization may be required to take.
We also will be providing updates about our progress against key milestones and posting new information on our website as soon as it becomes available so you can stay informed on a regular basis.
We encourage you to visit www.medicalpackaging.dupont.com to watch the video, see answers to frequently asked questions and read the letter from the U.S. FDA.
Members of the DuPont Medical and Pharmaceutical Protection Team are also available to answer any specific questions you may have. Contact us at 1.800.44.TYVEK.