Analysis Of The Effects Of 12 Months Accelerated Aging Testing, Obtained At Two Equivalent Aging Programs, On A Medical Grade Proprietary Chevron Pouch

The Food and Drug Administration requires that all sterile medical devices be tested and documented for a labeled shelflife. This thesis analyzed the effects of 12 months of accelerated aging testing, obtained at two equivalent aging programs, on a medical-grade chevron pouch constructed from a proprietary BOPET/PE film sealed to 1073B uncoated Tyvek®. The equivalent of 12 of months accelerated aging was obtained at 55°C and 70°C, and samples were also evaluated pre-aging to serve as a baseline for comparison. The aging model was based upon ASTM F-1980, "Standard Guide For Accelerated Aging of Sterile Barrier Systems for Medical Devices" and the Arrhenius equation. The peel strength of the manufacturer's seal was evaluated per ASTM F-88, "Standard Test Method for Seal Strength of Flexible Barrier Materials." This thesis demonstrated that there does exist an effect on seal strength due to accelerated aging of this pouch, and that effect is equivalent between 55°C and 70°C.