INFORMATION & IDEAS
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.
The unique structure of DuPont™ Tyvek®—tough, continuous filaments—provides a proven microbial barrier, outperforming medical-grade papers.
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.
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.
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.
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.
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.
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.
Tyvek® supports sustainability in healthcare across the full package lifecycle, from material minimization through recycling and reuse.
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.
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.
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.
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.
An overview of the unique demands of medical packaging design, including supporting safe use, microbial protection, sterilization compatibility, and efficient manufacturing.