This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.
The DuPont™ Tyvek® Medical Packaging Transition Project, known as the MPTP, includes a systematic method for generating data to prove that the Tyvek® produced on the new lines is functionally equivalent in performance to the Tyvek® you purchase today. This is being done in an effort to help mitigate regulatory requalification and minimize costs to individual companies serving this market. Functional equivalence means that the attribute you are measuring may be different, even statistically, but it still meets functional and performance requirements, so that it will perform similarly to current Tyvek® in your process and applications.
Three Study Components
The Tyvek® Medical Packaging Transition Project is comprised of three study components:
-
U.S. FDA Transition Protocol (“Transition Protocol”)—a study plan involving production and testing of sterilized medical device packages that has been reviewed and accepted by the Center for Devices and Radiological Health (CDRH) at the U.S. FDA.
-
Phantom Protocol—additional testing of applications and technologies that are outside the scope of the Transition Protocol but have been requested by the industry to support risk assessments.
-
Product Stewardship—every DuPont product that is commercialized requires a formal DuPont Product Stewardship study to assess product risk and fitness for use.
MPTP—A Top Priority for DuPont
DuPont is making a multi-year investment of more than $30 million and has a global, cross-functional team working on the DuPont™ Tyvek® Medical Packaging Transition Project to help make this transition process seamless for sterile packaging manufacturers (SPMs), medical device manufacturers (MDMs) and the healthcare industry. This investment by DuPont covers:
-
Global regulatory and industry support
-
Raw materials for multiple line and polymer testing
-
Developmental package creation and testing
-
Transition Protocol package creation and testing
-
Third-party laboratory testing
-
Phantom Protocol
-
Product Stewardship
Collaborative Effort
The DuPont™ Tyvek® Medical Packaging Transition Project is a collaborative effort involving SPMs, MDMs, regulatory authorities, testing laboratories and contract sterilizers around the world. The DuPont™ Tyvek® Medical Packaging Transition Project would not be possible without this industry collaboration.
MPTP Data and Regulatory Guidance Documents
To assist MDMs with their risk assessments, we post data from the DuPont™ Tyvek® Medical Packaging Transition Project as it becomes available. In addition to data, guidance obtained from regulatory authorities around the world is posted to help MDMs stay informed.
