More than 70,000 packages from 40 medical device manufacturers have been tested under the DuPont Medical Packaging Transition Project (MPTP), and results continue to indicate functional equivalence, reported members of the DuPont team during a Webcast on October 2. The Web event, “The Results Are In – DuPont Publishes First Tyvek Transition Package Data,” provided the first complete summary of pre- and post-sterilization package data and the latest accelerated aging results as part of the transition of Tyvek 1073B and Tyvek 1059B to manufacturing lines that use the company’s latest flash-spinning technology.
Speaking during the Webcast from DuPont Medical & Pharmaceutical Protection were Bruce A. Yost, Global Technical Director; Mike Scholla, Global Regulatory Director; and Leslie Love, MDM Specialist.
DuPont had shared initial test results in a May 2014 Webcast, and the October 2 Webcast shared the final testing results for pre- and post-sterilization package data. “Everything is still functionally equivalent,” Yost reported. “As we get additional data we will share it in the spring of 2015. Third quarter 2015 is when we expect a letter from the U.S. FDA affirming functional equivalence. We are still on target.”
The summary is the first of five published data reports summarizing results from all 60 package testing cells in the U.S. FDA Transition Protocol as well as the 18 package testing cells in the Phantom Protocol. Nelson Laboratories conducted all testing, meeting all timelines and generating hundreds of thousands of data points, Yost reported. MPTP data to date includes 114,729 package visual inspections according to ASTM F1886M; 53,664 seal strength measurements according to ASTM F88; 9,522 package integrity tests according to ASTM F1929; and 1,302 microbial barrier tests according to ASTM F2638. “And we’re still counting because we have lots of additional testing to go,” Yost said.
Yost shared summaries of pre- and post-sterilization package testing data for visual inspection, package integrity, and microbial barrier. For visual inspection, “We have over 115,000 data points, only three had a material defect,” Yost explained. “This is well within the functionally equivalent parameters we’ve established for the protocol.” For package integrity, “there’s over 8,000 data points, and no failures, so obviously functionally equivalent.” (For graphs of the test results, including microbial barrier, please view the on-demand Webcast at www.medicalpackagingcommunity.com).
Yost also discussed seal strength testing results, noting that there were 479 instances of functional equivalence. There was one instance of a “high sealing condition” for a pre-sterilization form-fill-seal (FFS) package using uncoated Tyvek 1059B that did exceed “the high end of the equivalence limit by 0.05 lb/in.,” but Yost called it an “anomaly” that was not duplicated with post-sterilization data. “That’s a very small amount, but what it shows is that the Transition Protocol material is stronger than the current material. We believe it is an anomaly, and we are doing a root cause failure analysis.”
Yost also presented a “drill down” of data on seal strength for coated versus uncoated 1073B testing cells and for coated 1073B lids/rigid trays, stating that additional graphs for other package configurations are available from DuPont at www.transition.tyvek.com. He also presented package integrity, microbial barrier, and seal strength testing results for 52 cells after one-year accelerated aging.
Yost also shared three-year accelerated aging data on material puncture strength, material tensile strength, and material microbial barrier. Results from additional tests conducted per industry request, such as dynamic/static coefficient of friction, Parker (surface) smoothness, and surface energy are also available on the DuPont site.
“The take home is that the material performance is equivalent or better than the current material,” says Yost.
In terms of regulatory activity, Scholla offered a brief update with some discussion of guidance from European Notified Bodies and encouraged attendees to tune in for more details during an upcoming November 13 Webcast.
Love examined what MDMs need to do to get ready for commercialization of the Transition Protocol material.
“We need you to engage with your quality and regulatory teams, go through your change management process, run risk assessments, and work on associated documentation related with this,” she advised.
Transition Protocol material is now available through sterile packaging manufacturers “for any kind of testing, such as process verification and other testing you deem necessary as part of your risk assessment,” she added. “From a documentation and risk assessment perspective it is important that you are ready to accept both the current and the Transition Protocol material interchangeably.”
Love also announced that DuPont is working on a new digital MPTP package test results selector tool that will enable MDMs to search for current MPTP testing results by selecting Tyvek style and package design.
A new app for mobile devices is also coming soon to enable MDMs to access MPTP data and documents from their smart phones and tablets.
Yost, Scholla, and Love answered several attendee questions live, and their responses can be heard in the on-demand event.
The next Webcast “The Results Are In…But What Can I Do with Them?” will be held on November 13, and it will feature Scholla, Love, and DuPont statistician for the transition project, Jennifer H. Van Mullekom. Please visit www.medicalpackagingcommunity.com to register.