Pre- & Post-Sterilization Visual Inspection Summary ASTM F1886M

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Olivia Constance Burns
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1 Pre- & Visual Inspection Summary ASTM F1886M 2 Transition Protocol Material Current Tyvek Transition Protocol Material Current Tyvek Count Count 2 No Material 1 Material No Material Material No Material 2 Material No Material Material Sealing Condition:

2 Pre- & Package Integrity Summary ASTM F1929 Transition Protocol Material Current Tyvek Transition Protocol Material Current Tyvek Count Count Not Not Not Not Sealing Condition:

3 Pre- & Microbial Barrier Summary for Coated and Uncoated 73B and 9B ASTM F B 9B Difference in the Means (Test-Control) % pmax Coated Uncoated Dashed line ( )=Mean of the difference in the means Transition Protocol material is functionally equivalent to current Tyvek. Negative numbers indicate test performed better than control, as evidenced by ALL dashed lines (which fall below zero).

4 Industry Summary: MPTP Test Results at Pre- and, Pass/Fail Summary for Seal Strength* ASTM F88 Tyvek Style Coating Type Sterilization Type Pouches and Bags Form-Fill-Seal Rigid Trays Pass Fail Pass Fail Pass Fail 73B 9B Coated Uncoated Coated Uncoated Pre-sterilization EO Gamma Electron-beam 3 Steam 3 Dry Heat 1 Low Temp. H Low Temp. C 2 H Pre-sterilization 14 EO 7 Gamma 3 Electron-beam 3 Steam 1 Pre-sterilization EO 3 Gamma 1 Electron-beam 1 Pre-sterilization 2 1** EO 3 There are no cells in the MPTP for this category *Vent bag, Kwikbreathe True Header bag and weld seal bag seal strengths are not included; the failure modes were non-peelable seals. ** A high sealing condition for one package configuration exceeded the high end of the equivalence limit by. lb/in., implying that the Transition Protocol material seal strength was stronger than the current material. A root cause failure analysis (RCFA) is underway. This anomaly was not duplicated with post-sterilization data.

5 Percent Change in Seal Strength Relative to the Control for Maximum Load ASTM F Percent Change = Mean (Test-Control)/Mean(Control)* As a population, maximum load seal strengths for test are ~4-6% higher than control.

6 Percent Change in Seal Strength Relative to the Control for Average Load ASTM F Percent Change = Mean (Test-Control)/Mean(Control)* As a population, average load seal strengths for test are ~-9% higher than control.

7 Percent Change in Seal Strength Relative to the Control for Coated and Uncoated 73B Cells ASTM F88 Coated Uncoated Percent Change = Mean (Test-Control)/Mean(Control)* As a population, the percent change in seal strength for coated 73B cells is less than uncoated cells.

8 Percent Change in Seal Strength Relative to the Control for Coated and Uncoated 9B Cells ASTM F88 Coated Uncoated Percent Change = Mean (Test-Control)/Mean(Control)*

9 Percent Change in Seal Strength Relative to the Control for Coated 73B FFS ASTM F Percent Change = Mean (Test-Control)/Mean(Control)*

10 Percent Change in Seal Strength Relative to the Control for Coated 73B Lids/Rigid Trays ASTM F Percent Change = Mean (Test-Control)/Mean(Control)*

11 Percent Change in Seal Strength Relative to the Control for Coated 9B FFS ASTM F Percent Change = Mean (Test-Control)/Mean(Control)*

12 Percent Change in Seal Strength Relative to the Control for Uncoated 9B FFS ASTM F Percent Change = Mean (Test-Control)/Mean(Control)*

13 Percent Change in Seal Strength Relative to the Control for Coated 73B Pouches/Bags ASTM F Percent Change = Mean (Test-Control)/Mean(Control)*

14 Percent Change in Seal Strength Relative to the Control for Uncoated 73B Pouches/Bags ASTM F Percent Change = Mean (Test-Control)/Mean(Control)*

15 Percent Change in Seal Strength Relative to the Control for Uncoated 9B Pouches/Bags ASTM F Percent Change = Mean (Test-Control)/Mean(Control)*

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