Electron-beam sterilization, with radiation doses typically ranging from 25 kGy to 100 kGy, is a popular sterilization method for single-use medical devices. Some medical packaging materials are not radiation stable, making them subject to chain scission reactions that can greatly reduce their physical properties. But that’s not a problem for DuPont™ Tyvek®.
After exposure to electron-beam radiation doses up to 100 kGy, medical and pharmaceutical packaging styles of Tyvek® maintain excellent microbial barrier properties and experience only slight changes in tensile strength, elongation and color.
The superior properties of Tyvek® are also maintained after electron-beam sterilization followed by exposure to accelerated and real-time aging, clearly demonstrating the radiation stability of Tyvek®.
Unlike other porous materials, Tyvek® resists post electron-beam sterilization brittleness and maintains its excellent low-linting performance when packages are opened.
Undesirable odors produced by electron-beam sterilization can be aerated out of medical packages made with Tyvek® because it is a porous material. Nonporous materials can trap these odors inside the packaging.
Another advantage of the porous nature of Tyvek® is that it allows medical packages to equilibrate rapidly from the pressure changes that occur during electron-beam sterilization.
It is important to note that although Tyvek® may withstand re-sterilization with electron-beam radiation, the device itself may not. If re-sterilization is required, gas sterilization can also be performed. Tyvek® will remain flexible after re-sterilization and will continue to provide an excellent microbial barrier.