DuPont submits MPTP regulatory reports, shares executive summary with industryDuPont submits MPTP regulatory reports, shares executive summary with industry
November 17, 2015
DuPont reports that it has reached significant milestones in regulatory submissions and industry summaries pertaining to the Tyvek Medical Packaging Transition Project (MPTP). The effort seeks to demonstrate that Tyvek 1073B and Tyvek 1059B manufactured with DuPont’s latest flash-spinning technology on production lines at its Richmond, VA, and Luxembourg facilities are functionally equivalent to Current Tyvek manufactured on the older production lines. The MPTP comprises three parts: the U.S. FDA Transition Protocol; DuPont’s Phantom Protocol; and Biocompatibility, Food Contact and Pharmacopeia Testing, collectively producing data to support the industry and proving functional equivalence, DuPont told PMP News early on during the project.
DuPont reported in August that it has submitted confidential MPTP regulatory reports to the U.S. FDA, Health Canada, and five notified bodies: BSI Assurance UK Ltd., LNE/GMED, SGS United Kingdom Limited, TÜV Rheinland LGA Products GmbH, and TÜV SÜD Product Service GmbH. These submissions included information on 78 different device/package combinations (also called “cells”) as well as summaries after these study time points: pre- and post-sterilization, 1-year accelerated aging, 3-year accelerated aging, 5-year accelerated aging, and 1-year real-time aging. DuPont also provided an executive summary report.
DuPont has also posted publically new data summaries and documents to its Web site www.areyouready.tyvek.com covering 1-year real-time aging and 5-year accelerated aging, and it has published an Industry Executive Summary Report as well as a document on compliance with EN ISO 11607.
PMP News spoke with Michael Scholla, Ph.D., Global Director, Regulatory and Standards; Medical Packaging Fellow, on the significance of these milestones. “We laid out a protocol to test a hypothesis and did all the work with the help of sterile packaging manufacturers, medical device manufacturers, and third-party labs,” he explains. “Based upon the agreed-upon attributes and the protocol, there’s only one conclusion—functional equivalence.”
The executive summary presents results from the following tests of specific attributes: ASTM F88 (seal strength), ASTM F2638 (microbial barrier), ASTM F1929 (package integrity testing), and ASTM F1886M (visual inspection).
Scholla explains that out of thousands of tests, there were only six instances in which the data showed an anomaly. “Three did not pass visual inspection, but there were no channels or breaches in the seals,” he explains. “There were two instances in which the seal strength did not meet specifications, but they were higher than the maximum allowed by five or six hundredths of a pound. There was one package that showed dye penetration, but that package was not available for a root cause failure analysis. So for five out of six anomalies we have a root cause.” (The Industry Executive Summary Report details these exceptions.)
Given that there were more than 100,000 packages tested visually, more than 50,000 seal-strength measurements taken, more than 14,000 package integrity tests performed, and more than 2,500 microbial barrier evaluations, these six anomalies do not preclude functional equivalence, DuPont states.
“These results, in conjunction with EO residual documentation provided by MDMs showing MDM requirements were met, overwhelmingly supports declaring Functional Equivalence between Current Tyvek and Transition Protocol material for styles 1073B and 1059B,” DuPont states in the Industry Executive Summary Report.
The reports provide “final results to MDMs to complete their risk assessments,” says Scholla. “Under the Quality System Regulation, ISO 13485 [a quality management systems standard for medical devices], companies must have a change management or change control process to assess a change and take steps to mitigate the risks associated with that change. Data is used to assess whether the risks are minimized.”
Given that the reports have just been submitted to regulators and notified bodies, Scholla believes that they will need some time to review the data. In the meantime, he advises MDMs to prepare to “have very specific conversations with your notified bodies on how to reference and document the reports.”
In a letter to industry announcing these milestones, DuPont states that it expects U.S. FDA affirmation of functional equivalence in September 2015 and is on track to begin commercial sales in October 2015. The letter was signed by Scholla along with Margaret Pyers, Global Marketing Manager; and Bruce Yost, Global Technical Director.
Testing will still continue for packages from all cells for 3-year real-time aging and 5-year real-time aging. Packages from 11 cells will continue through 7- and 10-year accelerated aging and 10-year real-time aging, Scholla reports. “When these reports are issued, we’ll submit them to the U.S. FDA, Health Canada, and the five notified bodies,” he says.
To view past Webcasts on the MPTP as well as find other information on sterile medical packaging, please visit www.medicalpackagingcommunity.com.
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