Craven noted she is seeing an increased number of sensitive
products that can’t handle the traditional higher doses associated with radiation sterilization in the 25-50 kilogray range. (A
kilogray is a derived metric measurement unit of absorbed radiation dose of ionizing radiation). This trend largely is driven
by material considerations of specialized polymers that provide
a specific device function, but may not be well-suited to radiation sterilization.
“Contract gamma sterilizers and in-house systems are able to
mitigate this by optimizing their processes to provide tighter dose
ranges,” she said.“Medical device manufacturers are also qualifying lower sterilization doses so that doses can be reduced overall.
Devices may also be irradiated at lower temperatures, such as irradiation with dry ice, or packaged in oxygen-free environments
to minimize the radiation side effects on some of these more sensitive materials.”
Get Ready for Tyvek
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DuPont’s Tyvek medical packaging materials are highly popular because they don’t generate many particles when opening a
package—a result of being made from continuous filaments, not
short fibers like papers. Tyvek also resists tearing. When papers
are torn during opening, or are abraded, short fibers may be released to the device, or the environment.
MEDICAL DEVICE MANUFACTURING
Laser Marking & Engraving
Now, DuPont soon will fully commercialize its Tyvek“Transi-tion Protocol Materials”that have been in development for several years. DuPont is coordinating the change process using a U.S.
Food and Drug Administration (FDA) transition protocol and is
periodically issuing new information and test data to prove functional equivalency of the new transition materials to the current
1073B and 1059B products. The change involves moving production of Tyvek 1073B and 1059B to the latest flash spinning technology and equipment. It is expected that FDA approval will be
granted by the third quarter of 2015.
Medical Devices Catheters
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• Catheters & other Medical Devices Printing & Marking
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DuPont’s equivalency letter alone may not be enough to prove
equivalency in all cases, however. It would be prudent for individual manufacturers to confirm equivalency by performing their
own validations. This especially is true for the EtO sterilization
process. Are the products packaged in the various packaging configurations with the new Tyvek easier or harder to sterilize with
EtO? The parameters set for EtO sterilization often conflict with
the requirements for product release.“An EtO process may have a
more robust sterilization result in terms of sterility of the product,
but that robustness may increase the level of EtO residuals on the
product that have to be removed prior to release for patient use,”
said Mike Rahn, director of SteriPro Laboratories.
Compliant to ISO 13485:2003
Applied Manufacturing Technologies, Inc.
Tel: 888-634-1143; 714-630-9530 • Fax: 714-630-9531
This Tyvek change also may be more significant for OEMs that
use EtO sterilization as their terminal sterilization process. While
form, fit, function and stability may be proven as functionally equivalent, or even improved for the manufacturing packaging process
with the new Tyvek, the impact to the EtO sterilization may need
to be evaluated by the OEMs for their existing validated processes.
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DuPont already has rolled out controlled sales of its Tyvek