SPMC's FAQs provide guidance for your technical challenges.
We use Tyvek® pouches for our gamma sterilized medical devices and I need to know the environmental condition or parameters at which these sterilized products should be stored i.e., warehouse to prevent the deterioration of the packaging.
Last Updated On May 15, 2008
The best course of action is to verify the appropriate storage conditions with your SPM; however a good rule is to maintain storage between 60 to 80 F, with ambient humidity of less then 50% Rh. In general, a standard Tyvek® to PET/PE pouch is stable over a range of storage conditions, as long as they are not exposed to extreme conditions for a long period of time. Tyvek® and polyethylene can be subject to phenolic yellowing due to prolonged exposure to UV light, or the exhaust from propane driven fork trucks. Primary packaging should remain in its original containers until time of use.