DATA FROM DEVELOPMENTAL MATERIAL TESTING AS OF SEPTEMBER 2012 DEMONSTRATES EVIDENCE OF FUNCTIONAL EQUIVALENCE.
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1 DATA FROM DEVELOPMENTAL MATERIAL TESTING AS OF SEPTEMBER 212 DEMONSTRATES EVIDENCE OF FUNCTIONAL EQUIVALENCE.
2 173B Materials Basis Weight Delamination oz/yd /in Gurley Hill Porosity sec/1 cc Target values represent data from rolls across different line and polymer combinations.
3 159B Materials Basis Weight Delamination oz/yd /in Gurley Hill Porosity sec/1 cc Target values represent data from 2 rolls across different line and polymer combinations.
4 173B Materials 2 Mullen Burst psi 8 Spencer Puncture in.- /in. 2 5 Tensile Strength (MD) /in. 5 Tensile Strength (CD) /in Target values represent data from rolls across different line and polymer combinations.
5 173B Materials 25 Tensile Elongation (MD) % 25 Tensile Elongation (CD) % 1 Opacity % 1 Thickness (Individual)* mils Target values represent data from rolls across different line and polymer combinations. *Thickness variability target is equal to or less than incumbent product.
6 159B Materials 2 Mullen Burst psi 8 Spencer Puncture in.- /in. 2 5 Tensile Strength (MD) /in. 5 Tensile Strength (CD) /in Target values represent data from 2 rolls across different line and polymer combinations.
7 159B Materials 25 Tensile Elongation (MD) % 25 Tensile Elongation (CD) % 1 Opacity % 1 Thickness (Individual)* mils Target values represent data from 2 rolls across different line and polymer combinations. *Thickness variability target is equal to or less than incumbent product.
8 173B Materials vs. Control Material Tensile Strength (MD) /4 in. Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 173B
9 173B Materials vs. Control Material Tensile Strength (CD) /4 in. Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 173B
10 173B Materials vs. Control Material Puncture 3.5 Pre-Sterilization Steam 3.5 Ethylene Oxide (EO) kgy kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM F1342 Control = DuPont Tyvek 173B
11 173B Materials vs. Control Material Elongation (MD) % Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 173B
12 173B Materials vs. Control Material Elongation (CD) % Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 173B
13 159B Materials vs. Control Material Tensile Strength (MD) /4 in. Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 159B
14 159B Materials vs. Control Material Tensile Strength (CD) /4 in. Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 159B
15 159B Materials vs. Control Material Puncture 3.5 Pre-Sterilization Steam 3.5 Ethylene Oxide (EO) kgy kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM F1342 Control = DuPont Tyvek 159B
16 159B Materials vs. Control Material Elongation (MD) % Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 159B
17 159B Materials vs. Control Material Elongation (CD) % Pre-Sterilization Steam Ethylene Oxide (EO) 5 kgy 5 kgy : 1 year accelerated aging Control Control: 1 year accelerated aging ASTM D534 Control = DuPont Tyvek 159B
18 MATERIAL PROPERTY DATA GENERATION FOR CHINA S STATE FOOD AND DRUG ADMINISTRATION (SFDA) Results from Part 1 of a two-part study. Tests on current Tyvek 173B and Tyvek 159B materials were conducted at two DuPont R&D facilities (Spruance in Richmond, Va., and DRDM in Shanghai, China) and at SFDA-Jinan Quality Supervision and Inspection Center for Medical Devices, to assess capabilities. In Part 2, SFDA-Jinan will perform testing on Transition Protocol materials. Upon completion, SFDA-Jinan will provide a report indicating that the Transition Protocol materials are functionally equivalent to current Tyvek.
19 DuPont Tyvek 173B Material Properties Basis Weight Gurley Hill Porosity oz/yd 2 seconds Delamination /in DuPont Richmond DuPont Shanghai SFDA-Jinan
20 DuPont Tyvek 159B Material Properties Basis Weight Gurley Hill Porosity oz/yd 2 seconds Delamination /in DuPont Richmond DuPont Shanghai SFDA-Jinan
21 DuPont Tyvek 173B Material Properties 2 Mullen Burst psi 6 Tensile Strength (MD) /in. 6 Tensile Strength (CD) /in DuPont Richmond DuPont Shanghai SFDA-Jinan
22 DuPont Tyvek 173B Material Properties Hydrostatic Head in. of H 2 O 8 6 Microbial Barrier LRV DuPont Richmond DuPont Shanghai SFDA-Jinan Third-party Lab
23 DuPont Tyvek 159B Material Properties 2 Mullen Burst psi 6 Tensile Strength (MD) /in. 6 Tensile Strength (CD) /in DuPont Richmond DuPont Shanghai SFDA-Jinan
24 DuPont Tyvek 159B Material Properties Hydrostatic Head in. of H 2 O 8 6 Microbial Barrier LRV DuPont Richmond DuPont Shanghai SFDA-Jinan Third-party Lab
25 This information is based upon technical data that DuPont believes to be reliable. It is subject to revision as additional knowledge and experience are gained. DuPont makes no guarantee of results and assumes no obligation or liability in connection with this information. It is intended for use by persons having technical skill for evaluation under their specific end-use conditions at their own discretion and risk. Since conditions of use are outside our control, WE MAKE NO WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATIONS, NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE AND ASSUME NO LIABILITY IN CONNECTION WITH ANY USE OF THIS INFORMATION. This information is not intended as a license to operate under or a recommendation to infringe any patent or technical information of DuPont or others covering any material or its use. Copyright 212 DuPont. All rights reserved. The DuPont Oval Logo, DuPont, and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates.
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General Overview Fluoroguard is a range of colorless, odorless, and chemically inert polymer additives based on fluorinated synthetic oil. Fluoroguard is designed for a variety of uses in gears, bushings,