DuPont™ Tyvek® has been recognized as a standard of excellence for sterile medical packaging for more than 40 years. Tyvek® earned this distinction because it provides a higher degree of protection for medical devices and supplies than any other porous material used for sterile packaging applications.
This higher degree of protection—proven in test after test—means that Tyvek® maintains sterility of medical devices and supplies to the point of use better than medical-grade papers. This helps you improve patient outcomes and reduce costs.
The secret to the superior performance of Tyvek® is that it’s not a paper, but rather a sheet of flashspun and bonded high-density polyethylene (HDPE) filaments. Continuous strands of very fine, interconnected filaments are 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.
Excellent Barrier to Microbial Penetration
The sterility of medical devices and supplies is critical to patient outcomes. So when it comes to selecting packaging materials for medical devices, the number-one priority of medical device manufacturers is the ability of the package to maintain sterility from the point of sterilization until the product is opened for use. Medical packages must not only protect the contents from punctures and other damage, they must provide an effective microbial barrier.
Tyvek® is highly resistant to penetration by bacterial spores and other contaminating microorganisms—even under the most rigorous conditions in highly contaminated environments.
Particulate and bacteriological tests clearly demonstrate that Tyvek® outperforms medical-grade papers, including other commercially available porous packaging materials. What’s more, comprehensive shelf-life studies have shown that Tyvek® can maintain sterility for at least five years if package integrity is not compromised.
Superior Tear Strength and Puncture Resistance
The tough, continuous filaments of Tyvek® protect medical packages from product breakthrough from the inside as well as from penetration by an object outside the package during rough handling.
As proven in test after test, Tyvek® has superior puncture resistance and tear strength compared to medical-grade papers. In fact, Tyvek® is so tough, it resists punctures—even from the irregular or sharp edges of many surgical devices. And, if a medical package made with Tyvek® is nicked, tears do not readily propagate.
Outstanding Moisture Resistance
Tyvek® is highly resistant to penetration by water. That’s because Tyvek® is hydrophobic and does not absorb moisture. Water in contact with Tyvek® does not wet its surface or spread; it simply remains as droplets on the surface.
This outstanding moisture resistance gives Tyvek® distinct advantages compared to medical-grade paper. For example, when medical-grade paper absorbs moisture, its strength and puncture resistance are reduced. This can greatly influence package performance, especially during distribution and handling. In sharp contrast, Tyvek® maintains its superior strength both wet and dry.
Outstanding moisture resistance also means that Tyvek® minimizes the risk of medical packages being affected by waterborne contaminants.
Tyvek® has superior hydrostatic head properties compared to medical-grade papers. Hydrostatic head is the measure of the pressure required to force three drops of water through a substrate. The higher the value, the more resistant the package is to water.
When a paper lid on a sterile medical package is opened, it can release a significant number of particulates, but that’s not an issue with Tyvek®. The unique structure of Tyvek®—tough, continuous filaments of HDPE—results in clean peel and low lint features that enhance presentation and enable virtually particulate-free delivery of devices and supplies into the sterile field.
So in addition to providing ease of opening, Tyvek® for medical packaging minimizes the risk of contaminating the medical device or the sterile field when a medical package is opened or handled.
Particulate generation tests comparing Tyvek® to medical-grade papers showed conclusively that Tyvek® generates far fewer airborne particulates. The particulate generation testing measured the quantity and the size of particles generated by Tyvek® and medical-grade papers both before and after being torn in half. The bottom line is that Tyvek® for medical packaging helps reduce the risk of contamination.