DuPont™ Tyvek® offers a portfolio of strong, durable, lightweight and flexible nonwoven products made from high-density polyethylene fibers. Since its introduction in 1967, Tyvek® has enabled new dimensions of protection, security and safety in a wide variety of industries and applications. One of the first commercial applications for this innovative material was medical packaging, where the unique structure of Tyvek® gives it inherent advantages over other materials to help keep medical devices sterile, providing the trusted protection patients and healthcare providers need to accomplish bigger things.
Tyvek® has been recognized as a standard of excellence for sterile medical packaging since the early 1970s. It earned this distinction due to its outstanding microbial barrier, exceptional strength and compatibility with all of the most commonly used sterilization methods.
Over the years, Tyvek® has helped protect the health of literally millions of patients worldwide and has enabled many advances in medical device technology, including improved drug delivery systems and the use of newer sterilization methods such as low-temperature gas plasma sterilization.
The history of Tyvek® began in 1955 when DuPont researcher Jim White made a chance discovery of a new fiber source. A program to develop the new material was set up and a year later DuPont submitted a patent proposal for strong yarn linear polyethylene. It took several more years for research teams to perfect the complex manufacturing process, which was based on the flash-spinning technology invented by DuPont scientist Herbert Blades. In 1965, the new engineered sheet structure was registered under the trademark name Tyvek®, and in April 1967 DuPont began commercial production.
Tyvek® was a product unlike any other that members of the healthcare industry had ever seen before. Interest in this new microbial barrier product was quite high. In the late 1960s and early 1970s, hospitals were being pressured to reduce labor costs associated with re-sterilizing devices and medical device manufacturers (MDMs) began developing disposable medical devices that were terminally sterilized. Until Tyvek® was introduced, there weren’t any porous packaging materials available that would perform well during gas sterilization—the most widespread form of sterilization at the time.
That’s why Tyvek® was met with such enthusiasm. It offers outstanding resistance to microbial penetration, is puncture resistant and strong enough for packaging most any disposable devices—even sharps and heavy kits—and doesn’t become brittle after gas sterilization.
In addition to its superior performance during gas and ethylene oxide (EO) sterilization—the second most popular form of sterilization in the late 1960s and early 1970s—Tyvek® was shown to be strong enough to resist rips and tears, decreasing the likelihood of damaged products and returns. And, Tyvek® generates very few airborne particles when packages are opened or handled, minimizing the risk of device contamination.
After MDMs discovered the exceptional strength, durability and versatility of Tyvek®, they started looking for new ways to take advantage of the optimum balance of properties that Tyvek® offers. Soon, Tyvek® was being used in virtually every form of sterile medical packaging and a wide variety of pharmaceutical packaging applications—both sterile and non-sterile.
The strength and toughness of Tyvek® have also enabled MDMs to expand their packaging options by installing faster, more efficient machinery, such as high-speed form-fill-seal packaging equipment, and to create innovative packaging designs for new devices and kits as medical procedures and market needs continue to evolve.
Every minute of every day someone around the world is receiving medical treatment in a doctor’s office, urgent care center, clinic, hospital or other healthcare setting. Whether they are receiving an injection, getting stitches following a minor accident or undergoing major surgery, the sterility of the medical devices and supplies being used to treat these patients is critical. When medical devices and supplies are protected by Tyvek® for medical packaging, healthcare professionals can have peace of mind and their patients can have better outcomes.
Tyvek® is used in virtually every form of sterile medical packaging to protect a wide variety of medical devices and supplies, including: sutures; cardiovascular catheters; prefillable syringes; endoscopic instrumentation; surgical preparation kits; injection systems; tissue grafts; electrosurgical accessories; and implantable devices such as heart pacemakers, hip stems and artificial knees, to name just a few.
Tyvek® is also the material of choice for many custom medical packaging applications such as:
Recognizing the rapid advancement of medical device technologies and growing demand, particularly as the world’s aging population increases and access to quality medical care improves in developing nations, DuPont announced in 2011 that it was beginning a multi-year project to transition two medical packaging styles—Tyvek® 1073B and Tyvek® 1059B—to manufacturing lines that use the latest flash-spinning technology. This transition would help ensure greater continuity and flexibility of future supply of Tyvek® for medical packaging.
The DuPont™ Tyvek® Medical Packaging Transition Project (MPTP), which was completed in 2016, was an extensive collaborative effort involving sterile packaging manufacturers (SPMs), MDMs, regulatory authorities, testing laboratories and contract sterilizers around the world. The success of this project would not have been possible without this unprecedented industry collaboration.
DuPont will remain focused on the future, working to meet the evolving needs of the industry by developing new products and solutions; continuing to share information and expertise; participating on activities within industry standards-setting organizations; and supporting MDMs with knowledge about materials, packaging design and processing.