Information & Ideas
Tyvek® provides a unique combination of physical properties that no other sterile packaging material can match, consistently outperforming other commercially available porous packaging materials—including medical-grade papers—in test after test.
Printing on Tyvek® medical and pharmaceutical packaging styles can be done using standard commercial printing equipment and suitable inks. These guidelines can help you obtain optimum printing results.
Only Tyvek® offers sterilization compatibility with all of the most commonly used methods for sterilizing medical devices. Made of HDPE, Tyvek® is extremely stable when exposed to sterilant gases and high-energy sterilization processes.
After terminal sterilization, Tyvek® can maintain the sterility of medical devices for at least five years, enhancing the sustainability of a medical product because it can be stored for long periods with no need to re-sterilize or re-package.
Studies comparing medical-grade paper to Tyvek® prove that Tyvek® is a low lint packaging material that generates far fewer airborne particulates that could contaminate either the medical device or the sterile field.
With its clean peel and low lint features, Tyvek® generates far fewer airborne particulates than medical-grade papers when packages are opened or handled, minimizing the risk of device contamination.
The unique structure of DuPont™ Tyvek®—tough, continuous filaments—provides a proven microbial barrier, outperforming medical-grade papers.
DuPont™ Tyvek® medical and pharmaceutical packaging styles comply with the materials portion of ISO 11607-1:2006(R)2010 and meet all the acceptable performance criteria for bio-compatibility and other regulatory requirements.
To measure the physical properties of Tyvek®, DuPont uses test methods based on recognized industry methodologies from ASTM, ISO and other organizations. Because many of these methods were developed for paper, DuPont has modified some of them.
The tough, continuous filaments of Tyvek® give it superior tear strength and puncture resistance compared to medical-grade papers, making Tyvek® an optimal solution for puncture resistant packaging of medical devices and pharmaceutical products.
Unlike medical-grade paper, Tyvek® has excellent moisture resistance, enabling it to maintain its superior strength and puncture resistance—even when wet. And, its high MVTR means Tyvek® enables an effective EO sterilant concentration to be achieved.
These guidelines provide important information about the three main considerations for heat sealing: dwell time, temperature and pressure. Other factors that can affect heat seals are also described.
Because the sterile barrier system is one of the first lines of defense against healthcare-associated infections (HAIs), it is important to select a packaging material that provides the highest possible degree of protection, as Tyvek® does.
For more than 40 years, Tyvek® has been advancing the science of protection for medical devices and pharmaceutical applications by expanding the packaging and sterilization choices available to manufacturers.
Tyvek® supports sustainability in healthcare across the full package lifecycle, from material minimization through recycling and reuse.
An overview of the unique demands of medical packaging design, including supporting safe use, microbial protection, sterilization compatibility, and efficient manufacturing.
DuPont Medical and Pharmaceutical Protection selected Nelson Laboratories as the independent testing lab that will perform the medical package testing for the DuPont™ Tyvek® Medical Packaging Transition Project (MPTP).
After undergoing electron-beam sterilization with doses of radiation up to 100 kGy, DuPont™ Tyvek® maintains its superior microbial barrier and strength properties.
Tyvek® that has undergone gamma sterilization with doses of radiation up to 100 kGy maintains its excellent microbial barrier properties and experiences only slight changes in tensile strength, elongation and color—even after aging.
EtO sterilization does not compromise the superior strength and microbial barrier properties of the medical and pharmaceutical styles of DuPont™ Tyvek®—even after five years of real-time aging.
Tyvek® Medical Packaging Transition Project data demonstrating functional equivalence, as well as regulatory guidance documents from authorities around the world are available for download. New technical data is added as it becomes available.
Tyvek® medical and pharmaceutical packaging styles are manufactured in facilities that are ISO 9001:2008 certified. These facilities strictly adhere to good manufacturing practices, good laboratory practices and quality control measures.
DuPont Medical and Pharmaceutical Protection has compiled documentation demonstrating compliance of Tyvek® to the materials portion of the ISO 11607-1:2006(R)2010 Standard. A guidebook containing compliance information is available for download.