ABBOTT ASSOCIATES uses only the highest quality materials to ensure your product ~ arrives safely and with integrity.
Why Use Tyvek®?
We choose to work with Tyvek®, which has been shown in numerous tests to outperform Medical-Grade Paper. DuPont™ Tyvek® offers an optimum balance of microbial penetration resistance, tear strength, puncture resistance and clean peel, and unlike medical-grade papers and films, Tyvek® is compatible with all of the most commonly used sterilization methods, including: ethylene oxide (EO), gamma, electron-beam, steam (under controlled conditions) and low-temperature oxidative sterilization processes. Whether Pouches or Lid Stock you can be assured Tyvek® can keep your products safe.
Tyvek® consistently outperforms medical-grade papers.
In tests for microbial barrier, tear and puncture resistance, moisture resistance and particle generation, Tyvek® wins the test! The reason for that is it’s compromised of a sheet of flashspun and bonded high-density polyethylene (HDPE) filaments, randomly oriented and bonded together by heat and pressure during manufacture. The result is a tough, durable sheet structure that provides a unique combination of physical properties that no other sterile packaging material can match.
Reliable Protection for Heavyweight and High-Profile Devices.
Results from testing show that Tyvek® provides superior puncture resistance and tear strength compared to medical-grade papers. Up to eight times stronger than medical-grade papers of equal or greater basis weight, Tyvek® significantly reduces the risk of package failure should there be impact to the lidding during shipping or storage. This breath ability also allows medical packages made with Tyvek® to equilibrate rapidly from the pressure changes that occur not only during shipping but also in storage environments.
Tyvek® Medical Packaging Transition Project (MPTP)
DuPont is transitioning Tyvek® 1073B and Tyvek® 1059B to manufacturing lines that use the latest flash-spinning technology to help ensure greater continuity and flexibility of future supply.
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—Biocompatibility, Food Contact and Pharmacopeia testing
- 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