Percent Change in Seal Strength Relative to the Control for Maximum Load ASTM F88

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1 Percent Change in Seal Strength Relative to the Control for Maximum Load ASTM F88 Upper Percent Change = Mean (Test-Control)/Mean(Control)*100

2 Percent Change in Seal Strength Relative to the Control for Maximum Load ASTM F88 Nominal 1-Year 3-Year 5-Year 1-Year Real-Time Aging Percent Change = Mean (Test-Control)/Mean(Control)*100

3 Percent Change in Seal Strength Relative to the Control for Maximum Load ASTM F88 Lower 1-Year 3-Year 5-Year 1-Year Real-Time Aging Percent Change = Mean (Test-Control)/Mean(Control)*100

4 Percent Change in Seal Strength Relative to the Control for Average Load ASTM F88 Upper Percent Change = Mean (Test-Control)/Mean(Control)*100

5 Percent Change in Seal Strength Relative to the Control for Average Load ASTM F88 Nominal 1-Year 3-Year 5-Year 1-Year Real-Time Aging Percent Change = Mean (Test-Control)/Mean(Control)*100

6 Percent Change in Seal Strength Relative to the Control for Average Load ASTM F88 Lower 1-Year 3-Year 5-Year 1-Year Real-Time Aging Percent Change = Mean (Test-Control)/Mean(Control)*100

7 Cumulative Pass/Fail Summary for Seal Strength through 1-Year Real-Time Aging* ASTM F88 Tyvek Style Coating Type Sterilization Type Pouches and Bags Form-Fill-Seal Rigid Trays Pass Fail Pass Fail Pass Fail 1073B 1059B Coated Uncoated Coated Uncoated EO Gamma ** 0 Electron-beam 15 0 Steam 15 0 Dry Heat 5 0 Low Temp. H Low Temp. C 2 H EO 34 1*** Gamma 15 0 Electron-beam 15 0 Steam EO 15 0 Gamma 5 0 Electron-beam **** EO THERE ARE NO CELLS IN THE MPTP FOR THIS CATEGORY * At all time points, vent bag, Kwikbreathe True Header bag and weld seal bag seal strengths are not included; the failure modes were non-peelable seals. (3 cells) ** For one Cell at two time points, Transition Protocol material and Current material exhibited a majority of seal failures which were not peel failures; thus the seal strength results were not included in the final analysis. *** For one Cell at one time point, the package configuration exceeded the upper end of the equivalence limit by 0.06 lb/in., implying that the Transition Protocol material seal strength was stronger than the Current material. **** For one Cell, the package configuration exceeded the upper end of the equivalence limit by 0.05 lb/in. at the upper sealing condition, implying that the Transition Protocol material seal strength was stronger than the Current material.

8 Microbial Barrier Summary for Coated 1073B ASTM F Year 3-Year 5-Year 1-Year Real-Time Aging 0.75 Difference in the Means (Test-Control) % pmax Dashed line ( )=Mean of the difference in the means

9 Microbial Barrier Summary for Uncoated 1073B ASTM F Year 3-Year 5-Year 1-Year Real-Time Aging 2.00 Difference in the Means (Test-Control) % pmax Dashed line ( )=Mean of the difference in the means

10 Microbial Barrier Summary for Coated 1059B ASTM F Year 3-Year 5-Year 1-Year Real-Time Aging 0.75 Difference in the Means (Test-Control) % pmax Dashed line ( )=Mean of the difference in the means

11 Microbial Barrier Summary for Uncoated 1059B ASTM F Year 3-Year 5-Year 1-Year Real-Time Aging 0.75 Difference in the Means (Test-Control) % pmax Dashed line ( )=Mean of the difference in the means

12 Package Integrity Testing Summary through 1-Year Real-Time Aging ASTM F1929 Transition Protocol Material Current Tyvek Count Not Penetrated 1 Penetrated Not Penetrated 0 Penetrated Sealing Condition: Lower Nominal Upper

13 Pre- & Visual Inspection Summary ASTM F1886M Transition Protocol Material Current Tyvek Transition Protocol Material Current Tyvek Count Count No Material 0 1 Material No Material Material 0 No Material 2 0 Material No Material Material Sealing Condition: Lower Nominal Upper

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