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 for medical device manufacturers is the ability of the package to maintain sterility from the point of sterilization until the product is opened for use.
Bacteria and viruses, which range in size from 0.002 microns to 100 microns, are a constant contamination threat to packaged medical devices—and the health of patients. That’s why medical packages must not only protect the contents from punctures and other damage, they must provide an effective microbial barrier.
DuPont™ Tyvek® has been recognized as a standard of excellence for sterile medical packaging for more than 40 years. Medical device manufacturers around the world specify Tyvek® because it provides a higher degree of protection for medical devices and supplies than any other porous material used for sterile packaging applications.
The unique structure of Tyvek®—tough, continuous filaments of high-density polyethylene (HDPE)—gives it inherent advantages over other materials. Specifically, Tyvek® provides superior microbial barrier protection, significantly reduced risk of package failure and a virtually particulate-free delivery of sterilized medical devices and supplies into the sterile field.
Superior Microbial Barrier
Tyvek® provides the best microbial barrier of all porous medical packaging materials used today, including medical-grade papers. That’s because the unique structure of Tyvek® creates a tortuous path with substantial lateral movement, making it harder for bacterial spores and other contaminating microorganisms to get through.
In fact, microbial barrier test data consistently prove that Tyvek® holds out bacterial spores and test particles better than other porous packaging materials—even under the most rigorous conditions in highly contaminated environments.
Microbial Barrier Testing
The microbial barrier performance of porous medical packaging materials can be compared using ASTM F2638, a standard test method that measures the ability of a porous substrate to prevent particle penetration, which is highly correlated to microbiological spore penetration. All materials have a face velocity where maximum percent particle penetration (pMax) occurs. The lower the percent penetration, the better the performance.
Tyvek® medical and pharmaceutical packaging styles all have a pMax of less than 0.5%. The pMax of other porous sterile barrier materials ranges from 8% to approximately 18%.
Long-Term Sterility Maintenance
A long-term shelf-life study proved conclusively that Tyvek® can maintain sterility for at least five years, providing package integrity is not compromised. The test was designed to have a more severe microbial challenge than typically found in healthcare environments. The results of the study showed that Tyvek® is a remarkably reliable microbial barrier that maintains its physical properties after aging.