Percent Change in Seal Strength Relative to the Control for Maximum Load ASTM F88 Upper -15-10 -5 0 5 10 15 Percent Change = Mean (Test-Control)/Mean(Control)*100
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 -15-10 -5 0 5 10 15 Percent Change = Mean (Test-Control)/Mean(Control)*100
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 -15-10 -5 0 5 10 15 Percent Change = Mean (Test-Control)/Mean(Control)*100
Percent Change in Seal Strength Relative to the Control for Average Load ASTM F88 Upper -15-10 -5 0 5 10 15 Percent Change = Mean (Test-Control)/Mean(Control)*100
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 -15-10 -5 0 5 10 15 Percent Change = Mean (Test-Control)/Mean(Control)*100
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 -15-10 -5 0 5 10 15 Percent Change = Mean (Test-Control)/Mean(Control)*100
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 11 0 13 0 24 0 EO 35 0 35 0 55 0 Gamma 15 0 15 0 38** 0 Electron-beam 15 0 Steam 15 0 Dry Heat 5 0 Low Temp. H 2 0 2 5 0 Low Temp. C 2 H 4 0 3 5 0 14 0 EO 34 1*** Gamma 15 0 Electron-beam 15 0 Steam 5 0 5 0 EO 15 0 Gamma 5 0 Electron-beam 5 0 5 0 2 1**** EO 25 0 15 0 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.
Microbial Barrier Summary for Coated 1073B ASTM F2638 1.00 1-Year 3-Year 5-Year 1-Year Real-Time Aging 0.75 Difference in the Means (Test-Control) % pmax 0.50 0.25 0.00-0.25-0.50-0.75-1.00 Dashed line ( )=Mean of the difference in the means
Microbial Barrier Summary for Uncoated 1073B ASTM F2638 2.50 1-Year 3-Year 5-Year 1-Year Real-Time Aging 2.00 Difference in the Means (Test-Control) % pmax 1.50 1.00 0.50 0.00-0.50-1.00-1.50-2.00-2.50 Dashed line ( )=Mean of the difference in the means
Microbial Barrier Summary for Coated 1059B ASTM F2638 1.00 1-Year 3-Year 5-Year 1-Year Real-Time Aging 0.75 Difference in the Means (Test-Control) % pmax 0.50 0.25 0.00-0.25-0.50-0.75-1.00 Dashed line ( )=Mean of the difference in the means
Microbial Barrier Summary for Uncoated 1059B ASTM F2638 1.00 1-Year 3-Year 5-Year 1-Year Real-Time Aging 0.75 Difference in the Means (Test-Control) % pmax 0.50 0.25 0.00-0.25-0.50-0.75-1.00 Dashed line ( )=Mean of the difference in the means
Package Integrity Testing Summary through 1-Year Real-Time Aging ASTM F1929 Transition Protocol Material Current Tyvek 8000 7000 7019 7020 6000 5000 Count 4000 3000 2000 1000 0 Not Penetrated 1 Penetrated Not Penetrated 0 Penetrated Sealing Condition: Lower Nominal Upper
Pre- & Visual Inspection Summary ASTM F1886M 20000 Transition Protocol Material Current Tyvek 50000 Transition Protocol Material Current Tyvek 17317 17314 40000 40042 40053 15000 30000 Count 10000 Count 20000 5000 10000 0 No Material 0 1 Material No Material Material 0 No Material 2 0 Material No Material Material Sealing Condition: Lower Nominal Upper