At DuPont, the science of protection has evolved over two centuries, resulting in a broad range of high-performance materials that are playing an important role in helping to improve the lives of people around the world. A prime example is DuPont™ Tyvek® for medical packaging.
The introduction of Tyvek® for medical packaging helped change the course of healthcare by enabling the transformation to single-use medical devices and by helping medical professionals improve patient outcomes and reduce costs.
Early History of Tyvek®
The history of Tyvek® begins in 1955 when Jim White, a DuPont researcher, noticed white polyethylene fluff coming out of a pipe in a DuPont experimental lab. After examining this material, it was found to have some very interesting properties.
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 manufacturing process for what was to become a new engineered sheet structure from DuPont. The manufacturing process was based on the flash-spinning technology invented by DuPont scientist Herbert Blades.
A pilot facility was established in 1959 for trial applications such as book covers, tags, labels and certain garments. In 1965, the new engineered sheet structure was registered under the trademark name Tyvek® and construction of a new manufacturing building began at the DuPont Spruance facility in Richmond, VA. Equipment was built to exacting mechanical tolerances, operators were trained and in 1967, plant operations began. Later that year, the new product was officially introduced and soon afterward, the many advantages Tyvek® offers for medical packaging applications became apparent.
Meeting an Emerging Need in Medical Packaging
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 so medical device manufacturers 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 microbial penetration resistance, is puncture-resistant and strong enough for packaging any disposable devices—even sharps and heavy kits—and it 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 device contamination.
Helping Advance Healthcare Packaging
After medical device manufacturers 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, becoming the material of choice for peel pouches, bags and lids for trays.
As the industry continued to change and grow, medical device manufacturers found that Tyvek® met their evolving needs. In response to this continuous growth through innovation, increased demand and globalization, additional manufacturing capacity was added at the Richmond facility in 1975 and production of Tyvek® began at the DuPont facility in Luxembourg in 1988.
Providing a higher degree of protection for medical devices and supplies than any other porous material used for sterile packaging applications, Tyvek® has expanded the packaging and sterilization choices available to medical device manufacturers. It has enabled them to create innovative packaging designs for new devices and kits as procedures and market needs continue to evolve.
In fact, many advances in medical device technology would not have been possible without Tyvek®, including the use of newer sterilization techniques, as well as improved drug delivery systems.