Several regulatory and technical milestones have already been reached during the DuPont Tyvek Medical Packaging Transition Project (MPTP), speakers reported during the May 7 Webcast, “Are You Ready for the DuPont Tyvek Transition?” Speakers included Roseann C. Salasin, Global Marketing Director; Bruce A. Yost, Ph.D., Global Technical Director, Thierry Wagner, Regulatory Affairs Director, Europe, Middle-East, and Africa; Mike Scholla, Global Regulatory Director; and Leslie Love, MDM Specialist.

DuPont is transitioning Tyvek 1073B and Tyvek 1059B to manufacturing lines that use the company’s latest flash-spinning technology on its production lines in Richmond, VA, and Luxembourg. DuPont Tyvek 2FS and Tyvek Asuron are already produced using the new technology.

In terms of regulatory developments, Scholla reported that the French notified body LNE/G-MED has joined an existing group of four other notified bodies. LNE/G-MED published a statement on the U.S. FDA Transition Protocol that is in line with those of the other notified bodies. European notified body reviews covered all U.S. FDA Transition Protocol Amendments made after confirmation of the Transition Protocol participants as well as the statistical analysis rationales. “DuPont will provide them with a data set similar to what we will provide to the U.S. FDA,” added Scholla.

Health Canada has also notified DuPont that it is preparing a process that will enable medical device manufacturers to communicate use of the transition material in licensed products should there be no concerns about interchangeability. Under Canada’s current regulatory system, if there is a change in the device packaging and this change has not been reviewed (by Health Canada) in a previous application for similar devices, medical device manufacturers are required to submit a license amendment application prior to introducing the device, Scholla explained. However, Health Canada is instituting a deviation in such guidance for MPTP. If manufacturers determine that DuPont’s data “is fully applicable to the packaging configuration and sterilization process of their device,” they can simply notify Health Canada of the licenses affected by the change and “attest that the configurations and sterilization methods are represented by the testing conducted by DuPont,” Scholla said. If their packaging configuration and/or sterilization process is not covered by the DuPont testing, but there are no “reasonably expected” negative impacts to device sterility over the stated shelf-life, medical device manufacturers can also file a notification. But “if there is a reasonable expectation that differences may negatively impact the device sterility over the stated shelf-life, the manufacturer is to submit a Medical Device License Amendment Application for a manufacturing change and provide supporting validation using their packaging configuration and sterilization process.

This may include sterilization validation, shelf-life validation and package integrity assessment,” Scholla reported. “A specific notification package will be sent by Health Canada to each Canadian licence holder and a template for provision of the attestation information will be provided.” License holders are being asked to wait for these templates before submitting anything to Health Canada, he explained.

Scholla added that this deviation for the MPTP will also serve as a pilot program for Health Canada in which it will develop a regulatory system similar to FDA’s medical device master file program.

In Japan, a minor change notification is required if MDMs evaluate that information needs to be updated in the original submission for their existing products sold in Japan, it was reported. And China’s SFDA—Jinan has also completed its functional equivalence study, and the testing results meet the criteria of functional equivalence and non-inferiority under the DuPont Validation Protocol. A summary of SFDA-Jinan’s report is available on DuPont’s Web site.

In terms of technical developments, Yost explained that Nelson Laboratories has completed all of the pre- and post-sterilization package testing for the U.S. FDA Transition and Phantom protocols. DuPont has been able to analyze and publish results for about half of the U.S. FDA data so far, all of which show functional equivalence. Package testing includes visual inspection, package integrity, seal strength, and microbial barrier performance.

Yost shared transition material testing results for pre- and post-sterilization and 1-year accelerated aging, in addition to that for several other studies requested by the industry including particle generation, steam and low-temperature oxidative sterilization, dimensional stability and surface energy. Results to date indicate that the transition material performance is equivalent to, or better than, current Tyvek, Yost explained. For example, puncture strength is 10 to 15% higher, Yost said. He shared what the team calls “spider diagrams” as well as other charts outlining the results of several tests.

And more test data are coming. “We recognize the industry need for accelerated aging data and will be sharing those results as available over the next 6-12 months,” explains Yost.

Earlier this year at HealthPack 2014, Karen Polkinghorne, DuPont’s packaging engineer and MDM specialist, explained that DuPont’s main report, which will include “a summary of all cells in the protocol tested for 1, 3, and 5 years accelerated and 1 year real time aging,” is expected to be completed and published by the third quarter of 2015, she said.

Previously, DuPont had announced that it has issued a formal change notification letter for DuPont Tyvek 1073B and Tyvek 1059B to all customers who have a Change Notification Agreement in place with DuPont, providing industry with at least one year’s notice before beginning the full commercialization of Tyvek Transition Protocol material in 2015.

During the Webcast, Love advised MDMs to prepare their change management documentation and perform their own risk assessments. MDMs can order controlled sales materials through their SPMs if their risk assessment determines package testing is required, it was reported.

When asked when the last time MDMs could purchase current materials would be, Polkinghorne advised HealthPack attendees that the only way to guarantee receipt of current material is to procure and take delivery of that material prior to DuPont commercializing the Transition material. For planning purposes, any MDMs interested in ensuring a last-time buy of the current materials should begin these discussions with their direct supplier no later than “the end of this year, beginning of next.”

Once FDA affirms functional equivalence of the Transition Material, “DuPont would like to transition to the newer lines as quickly as possible,” she said.

For more details, visit DuPont’s “Are You Ready?” campaign at www.areyouready.tyvek.com or view data at www.Transition.Tyvek.com.

DuPont will share one-year accelerated aging data and more during a September 2014 Webcast. To watch the on-demand Webcast and prepare for the September Webcast, register to become a member of the DuPont-sponsored Medical Packaging Community at www.medicalpackagingcommunity.com.