DuPont Medical & Pharmaceutical Protection has achieved several milestones in its Tyvek Medical Packaging Transition Project (MPTP), having completed half of its eight-phase project. Speakers from DuPont provided medical device manufacturers with regulatory updates as well as material testing data results during a recent PMP News Webcast and at a lunchtime meeting at MD&M East in Philadelphia.
In an effort to ensure continuous and reliable supply for the future, DuPont is making a significant investment to transition the manufacturing of Tyvek 1073B and Tyvek 1059B to its latest flash-spinning technology and production lines at its Richmond, VA, and Luxembourg facilities. (DuPont Tyvek 2FS and Tyvek Asuron are already produced with the new technology.) DuPont has engaged regulatory bodies governing more than 90% of the medical devices sold globally to minimize cost and effort for medical device manufacturers.
The MPTP comprises three parts: the U.S. FDA Transition Protocol, DuPont’s Phantom Protocol, and DuPont's Product Stewardship testing, collectively producing data to support the industry and proving functional equivalence, explained Roseann C. Salasin, Global Marketing Director, during the Webcast.
Also speaking during the Webcast were Bruce A. Yost, Global Technical Director; Thierry Wagner, European Regulatory Director; and Karen Polkinghorne, Packaging Engineer & MDM Specialist. Polkinghorne also presented during the luncheon, and she was joined by Jose Arevalo, Business Development Manager, Southeastern Region & Latin America; and Leslie Love, Business Development Manager, Northeastern Region.
Testing of developmental material has been completed and that of transition protocol material has already begun by Nelson Laboratories and NAMSA, with some initial transition protocol results already available, explained Yost. Tyvek 1073B and Tyvek 1059B development materials were compared with control materials; materials were tested before sterilization and after being exposed to six different sterilization methods as well as under accelerated aging conditions. Yost presented several diagrams outlining results during the Webcast.
Notable differences between both the developmental and transition Protocol materials and current materials include an increase in puncture resistance, which Yost says should reflect better performance in distribution testing, as well as an increase in opacity, which is expected to be a desirable feature in terms of printing, Yost said.
Both materials have also been found to be thicker by at least 10%, explained Yost. But he does not expect it to present an issue in terms of sealing. “We tried to model the sealing performance of the new material versus the old, and we have been very successful. We do not see that as an issue,” he said. He also added that DuPont’s “target is to have thickness uniformity as good as, if not better than, the existing material.”
Transition protocol material has already been shipped to sterile packaging manufacturers for conversion, and MDMs that have volunteered for the MPTP have already begun creating packages. These packages are targeted to arrive at Nelson at the end of July for a range of tests, explained Polkinghorne. The packages represent 77 different combinations in terms of package configuration, sterilization method, and Tyvek style, and they are compiled and can be searched via DuPont’s new online MPTP Cell Descriptor Tool. (MDM names are not listed.)
Packages will be tested for seal strength using ASTM F88, package integrity using ASTM F1929, and microbial barrier using ASTM 2638, as well as be inspected visually using ASTM F1886, explained Yost. Presterilization and poststerilization testing data are expected to be available in the first quarter of 2014; accelerated aging up to 5 years as well as one-year real-time aging data are expected during the first quarter of 2015. (For more testing details as well as information on the Phantom Protocol and Product Stewardship activities, please view the Webcast.)
MDMs will be able to purchase transition protocol material through their packaging converters under "controlled sales" later in July 2013 for use in internal risk assessments as well as in qualifications for new medical device packaging, explained Polkinghorne. The material is not intended for use in packaging for currently marketed medical devices until regulatory compliance in those markets can be assured, she added.
In October 2012, FDA’s CDRH accepted DuPont’s transition protocol amendments regarding functional equivalence testing, and four notified bodies in the EU have also received them and have reported no issues, Wagner reported in the Webcast. These authorities await final testing results.
DuPont also plans to review MPTP data with several of Japan’s authorities. Following Japan’s official guidance (Yakushokuki), medical device manufacturers should determine whether they need to report use of the Tyvek produced on the newer assets as a minor change notification, which Wagner explains is a “one-way notification that does not need regulatory authority approval.”
China, on the other hand, has decided to perform its own testing to determine functional equivalence, so SFDA—Jinan is currently testing the Transition Protocol material for basis weight, delamination, microbial barrier, tensile strength, and other properties, explained Wagner. Upon completion of its testing later this year, SFDA—Jinan will issue a final report on the results.
To ready their packaging operations for commercialization of the transition protocol Tyvek, Polkinghorne advised MDMs to begin change management processes, including risk assessments, and to plan to use controlled sales material in tests in support of those risk assessments. In addition, MDMs should forecast their needs for transition materials and contact SPMs and DuPont with questions, she said.
Updates on DuPont’s MPTP progress, along with the online MPTP Cell Descriptor Tool, are available atwww.Transition.Tyvek.com.
The DuPont team addressed several audience questions during the live Webcast. View the archived Webcast here.