DuPont™ Tyvek® 1059B for Sterile Medical Packaging
Tyvek® 1059B provides robust protection for medium-risk, sterile medical packaging applications. Lighter weight than Tyvek® 1073B, this proven performer is ideal for smaller devices and those with rounded edges.
Recognized as a standard of excellence for sterile medical packaging, Tyvek® 1059B offers outstanding resistance to microbial penetration, significantly reduced risk of package failure, compatibility with a broad range of sterilization methods, and a low risk of device contamination.
Outstanding Resistance to Microbial Penetration
Even under the most rigorous conditions in highly contaminated environments, Tyvek® 1059B is highly resistant to penetration by bacterial spores and other contaminating microorganisms. Microbial barrier test data consistently prove that all styles of Tyvek® for sterile medical packaging—Tyvek® 1073B, Tyvek® 1059B and Tyvek® 2FS™—hold out bacterial spores and test particles better than other commercially available porous medical packaging materials, including medical-grade papers. In addition, a long-term shelf life study proved conclusively that Tyvek® 1059B can maintain sterility for at least five years if package integrity is not compromised.
Significantly Reduced Risk of Package Failure
The tough, continuous filaments of Tyvek® 1059B help protect package integrity from both product breakthrough inside and rough handling outside. Compared to medical-grade papers, Tyvek® 1059B has superior tear strength and puncture resistance. What’s more, because it is breathable, Tyvek® 1059B minimizes the formation of condensation due to temperature extremes that can occur during transport.
Compatibility with a Broad Range of Sterilization Methods
Unlike medical-grade papers and films, Tyvek® 1059B is compatible with all of the most commonly used sterilization methods. So no matter which process you use for your sterile medical packaging—ethylene oxide (EO), gamma, electron-beam, steam (under controlled conditions) or newer methods (such as low-temperature oxidative sterilization)—Tyvek® 1059B will retain its protective properties, color and flexibility.
Low Risk of Device Contamination
The unique structure of Tyvek® 1059B—tough, continuous filaments—creates both a tortuous path for superior microbial barrier and excellent strength properties. It also means that Tyvek® 1059B generates very few airborne particles when sterile medical packaging is opened or handled. This clean peel minimizes the risk of introducing particulates into a clean environment.
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.
INFORMATION & IDEAS
Meeting Regulatory Requirements
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.
- Guidelines for Printing on Tyvek®
- Tyvek® Resists Punctures
- Advancing the Science of Protection
- Heat Sealing Guidelines
- Low Lint Means Reduced Risk