DuPont Readies Tyvek for the Future
DuPont Medical Packaging has announced plans to modernize the manufacturing technology behind its longest-standing and most-popular styles of Tyvek. The global manufacturer will 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 flash-spinning technology on one of the lines. To help the highly regulated medical device industry shift to materials made on the new lines, DuPont has developed a seven-phase transition plan that includes a Transition Protocol that FDA approved in March.
Mike Scholla, global regulatory director, DuPont Medical and Pharmaceutical Protection, will be speaking about the transition in a Webcast April 4, 2012, titled "DuPont Tyvek in 2012 and Beyond."
|Roseann Salasin, Global Marketing Director, DuPont Medical and Pharmaceutical Protection|
“We are making the transition to the latest flash-spinning technology in order to increase capacity to ensure continuity of supply,” explained Roseann Salasin, global marketing director, DuPont Medical and Pharmaceutical Protection, in an earlier industry Webcast. “Our goal is to provide a seamless transition and to prove functional equivalence. Based on our experience with Tyvek 2FS and Tyvek Asuron, we are confident that we will be able to prove that Tyvek 1073B and Tyvek 1059B made with the newer flash-spinning technology are functionally equivalent to those produced using previous technology.”
DuPont had been producing Tyvek 1073B and Tyvek 1059B with 40-year-old flash-spinning technology and equipment using the same polymer source. With demand for healthcare products and quality packaging materials increasing globally, DuPont elected to increase capacity and add redundancy by qualifying these styles on its newer lines, Salasin later told PMP News.
DuPont is seeking to make the transition as seamless as possible. “Our goal is to eliminate the need for regulatory submissions associated with the transition and to mitigate or eliminate such costs,” explained Mike Scholla, global regulatory director, DuPont Medical and Pharmaceutical Protection. “FDA has responded to our plan in writing saying that it would not normally require submission of amended 510(k)s or PMAs.”
DuPont is investing $30 million in the transition, most of which will be spent on significant development efforts and the testing protocol. DuPont and sterile medical packaging manufacturers have already begun conducting extensive preliminary testing on developmental (prototypic) samples before initiating the protocol, gathering product attribute data on porosity, puncture resistance, tensile strength, delamination, cytotoxicity, and other characteristics, explained Bruce Yost, global technical director, DuPont Medical and Pharmaceutical Protection.
Now in Phase Two, DuPont is in the process of identifying the medical device manufacturers and sterile packaging manufacturers that will participate in the protocol by generating more than 50,000 packages for evaluation and testing. “This transition will truly be a collaborative effort,” Scholla said, encouraging Webcast attendees interested in participating in that effort to contact DuPont. “We will consider additional medical device manufacturers beyond those we have already begun to work with.”
|Mike Scholla, Global Regulatory Director, DuPont Medical and Pharmaceutical Protection|
Added Yost: “Our protocol calls for testing samples of Tyvek using 60 different U.S FDA-approved medical devices having a qualified design manufactured with a validated process. A variety of device types, packaging configurations and sizes, bottom webs, and coating technologies will be used.” DuPont and its partner sterile packaging manufacturers and medical device manufacturers expect to start making test packages in the third quarter of 2012.
An independent lab will conduct all tests, which will include pre- and post-sterilization evaluations of pouches and header bags, flexible blisters, and rigid tray-and-lidding combinations. These packages will also be studied during accelerated aging using ASTM F1980-07 and real-time aging, both at 1-, 2.5-, and 5-year intervals. Testing will include visual inspection, package integrity using ASTM F1929, seal-strength testing using ASTM F88, and microbial barrier testing using ASTM F2638. For instance, “dye penetration is the best at picking up channels in seals, and FDA agreed with our suggested protocol,” explained Scholla.
Printing and labeling compatibilities will also be evaluated, added Scholla.
More packages of Tyvek 1073B than that of Tyvek 1059B are planned for testing, mainly because DuPont would be hard-pressed to find enough applications to support a testing grid equivalent to that of Tyvek 1073B, Scholla said.
DuPont plans to submit its statistical analysis of the third-party testing data to FDA during the first quarter of 2014. A summary report will be presented to regulatory authorities in Japan and China and to select notified bodies in the EU. "FDA is expected to concur with our analysis and issue guidance," Scholla explained.
Medical device manufacturers participating in the protocol will be provided with testing results pertaining to their own devices and packages, and all data will be summarized for the medical industry in a general report that will not identify specific companies or products, added Scholla.
Tyvek will still be made using virgin HDPE, and Yost explained that DuPont is qualifying multiple global suppliers as part of the plan. Enhancements to Tyvek 1073B and Tyvek 1059B may be possible, he said. “We have seen some improvements, but we need to verify and validate them, and we should have more data by the second quarter of 2012,” added Salasin.
|Bruce Yost, global technical director, DuPont Medical and Pharmaceutical Protection|
To support existing demand for traditionally manufactured Tyvek 1073B and Tyvek 1059B, DuPont is restarting a previously idled line that had once supplied medical packaging materials. Tyvek 1073B and Tyvek 1059B materials produced by this line are expected to begin shipping in late summer, Salasin told PMP News. “Using these materials should be seamless because the line had originally produced Tyvek 1073B and Tyvek 1059B,” she says.
In 2012, DuPont expects to have limited quantities of Tyvek 1073B and Tyvek 1059B produced using the latest technology available for controlled sales for new medical devices, explained Salasin.
When asked during the Webcast whether the latest flash-spinning technology would result in any changes that could be considered “greener,” Salasin stated that DuPont should see such progress. “While our primary reason for the transition was to increase capacity, the newer manufacturing process is more sustainable,” she said.
To read FDA's letter approving DuPont's Transition Protocol, see a timeline of key milestones in each of the seven phases, and watch a video on the transition, please visit www.medicalpackaging.dupont.com or www.medicalpackagingtransition.DuPont.com.
This article has been updated on March 12, 2012.