Tyvek® for Gas Plasma Sterilization and Other Low-temp Processes
Tyvek® is compatible with a broad range of sterilization methods, including hydrogen peroxide gas plasma sterilization. Based on test data and extensive long-term use, it is clear that Tyvek® 4057B is well suited for use with the STERRAD® Sterilization System from Advanced Sterilization Products (ASP), Division of Ethicon Inc., a Johnson & Johnson company. The STERRAD® System uses low-temperature hydrogen peroxide gas plasma to enable sterilization of heat-labile devices.
Medical-grade papers, including autoclave paper pouches, are not acceptable for use with the STERRAD® hydrogen peroxide gas plasma sterilization system because cellulosic materials neutralize the sterilizing agent.
ASP has developed a complete range of self-seal pouches, heat-seal pouches and heat-seal rolls made with Tyvek® 4057B for use in the STERRAD® System. More information about the STERRAD® System, including cycle times and performance details, can be found on its website.
In addition to hydrogen peroxide gas plasma sterilization, other low-temperature oxidative sterilization methods such as vaporized hydrogen peroxide, nitrogen dioxide, and low-temperature peracetic acid vapor gas plasma sterilization have been introduced.
Cellulosic materials, such as medical-grade paper, cannot be used with these low-temperature oxidative sterilization processes because they rapidly interact with the oxidizing agent and its superoxide radicals. This can result in an aborted cycle due to inadequate sterilant concentration. Tyvek® is high-density polyethylene (HDPE) and allows for an effective sterilant concentration to be achieved.
It is important to note that although Tyvek® only interacts slightly with these types of sterilants, the surface energy is increased. This can cause a lowering of the hydrostatic head in industrial applications where multiple sterilization cycles are validated. The performance of Tyvek® as a sterile barrier is not affected but the liquid test methods for assessing package integrity (such as dye penetration and water immersion) can produce results that are different from untreated material.
DuPont does not have test data for the performance of Tyvek® in each of these low-temperature oxidative sterilization processes; however, the manufacturers of these sterilizers usually have data on Tyvek® compatibility. Please contact the sterilizer manufacturer for more information.
STERRAD® is a registered trademark of Advanced Sterilization Products.