As you are probably well aware by now, DuPont will be transitioning DuPont™ Tyvek® 1073B and Tyvek® 1059B to manufacturing lines that use our latest flash-spinning technology. Since the last transition update was published in the December 2011 edition of the Tyvek® Rx eNewsletter, there has been much progress made toward key milestones.
On April 4, 2012, Michael H. Scholla, Ph.D., global regulatory director for DuPont Medical and Pharmaceutical Protection, conducted a webinar to share information about the progress that has been made to date. Dr. Scholla discussed changes that have been made to the US FDA Transition Protocol ("Transition Protocol") testing matrix, details about the “Phantom” protocol and what’s happening on the regulatory front.
For those of you who were unable to attend the webinar, here’s a summary of what’s new with the transition project. We have also posted updated FAQs on our website and created a new page, DuPont™ Tyvek® in 2012 and Beyond, where we have posted letters and statements from regulatory agencies around the world. We encourage you to visit our website often for updates.
Transition Protocol testing matrix
The Transition Protocol testing matrix has been modified to better reflect the input we received from Sterile Packaging Manufacturers (SPMs) and Medical Device Manufacturers (MDMs) about how DuPont™ Tyvek® is used in the industry. As a result, we added cells where meaningful industry data could be generated to show functional equivalence and eliminated some of the less common sterilization packaging configurations.
The cell selection process is nearly complete, with participation and confidentiality agreements being finalized. Currently, there are approximately 34 different MDMs from various regions, including Latin America, Canada, Europe and Asia Pacific, participating in the Transition Protocol testing.
Currently, package configurations include: 22 pouches and 5 header bags; 18 form-fill-seals; and 15 lids and trays. Film types include: PET, nylon, PE, EVA/Surlyn®/EVA and other films. Tray types include: PETG, PS and PVC.
Both air knife and hot melt are represented for coating types and methodologies. Package size extremes range from 2” x 2” to 28” x 35”.
The “Phantom” protocol, which was finalized in April 2012, will include the following activities:
- Product stewardship information collection
- Polymer characterization
- DuPont™ Tyvek® 1073B and Tyvek® 1059B sheet characterization
- Pharmacopeia/food contact testing (U.S., Europe)
- Other fabric/package properties
- Steam sterilization protocol definition and data generation
- Low-temperature oxidative sterilization protocol definition and data generation
- Other fabric/package properties and data generation
- 10-year aging protocol definition and data generation:
- accelerated aging for 7 and 10 years
- real-time aging for 10 years
We have agreement with the Center for Devices and Radiological Health (CDRH) at the U.S. FDA on the Transition Protocol and have posted the letter from the agency on our website.
We have been working with the top four Notified Bodies in Europe to provide guidance on how to implement the change. We have received guidance letters from three of them, which we have posted on our website.
In Japan, the Ministry of Health, Labour and Welfare has referred us to the Japan Medical Device Manufacturers Association (JMED) to develop guidance on how to implement the change.
We are working with the Jinan Test Center in China to evaluate the material characteristics of our current DuPont™ Tyvek® 1073B and Tyvek® 1059B products. When materials are available for the production of Transition Protocol test packages, they will be submitted to the Jinan Test Center for evaluation. We then expect them to issue guidance after their evaluation of the materials produced on the newer assets.
Phase 3 DuPont™ Tyvek® development feedback, which includes package performance and converting, as well as fabric properties and characteristics, is expected to be completed in August 2012.
Phase 4 Transition Protocol fabric creation is scheduled to be completed during the fourth quarter of 2012. We anticipate that device package creation and sterilization will begin soon thereafter.
If you have not already done so, we encourage you to visit www.medicalpacking.dupont.com to watch the Medical Packaging Transition Project ("MPTP") video, see answers to frequently asked questions and read about regulatory guidance from around the world.
Members of the DuPont Medical and Pharmaceutical Protection Team are available to answer any specific questions you may have. Contact us at 1.800.44.TYVEK.