Medical Packaging Transition Project Data | DuPont™ Tyvek®

DuPont is investing more than $30 million in the Tyvek® Medical Packaging Transition Project (MPTP) to ensure continuity and flexibility of future supply. To assist medical device manufacturers with their risk assessments, we post specific Tyvek® transition project information on this website as it becomes available.

To download the slides from the latest Medical Packaging Transition Project webinar on May 21st regarding DuPont's submission to the U.S. FDA, please click here

DuPont™ Tyvek® Medical Packaging Transition Project (MPTP)

- Package Data Confirms Functional Equivalence - NEW JUNE 2015
2015 Commercialization Plan 
Executive Overview
Testing Summary 
Milestones
Cell Descriptors
FAQs - UPDATED JUNE 2015
Risk Assessment Building Blocks
Package Test Results Selector Tool - UPDATED JUNE 2015


Medical Packaging Transition Project Industry Reports

-
Industry Summary Report (Pre/Post Sterilization) 
- Publication Correction to Industry Summary Report (Pre/Post Sterilization) 
Industry Summary Report (1-Year Accelerated Aging) 
Publication Correction to Industry Summary Report (1-Year Accelerated Aging)
Industry Summary Report (3-Year Accelerated Aging) - NEW JUNE 2015


DuPont™ Tyvek® Transition Material Property Data

Transition Protocol Materials Specification and Miscellaneous Properties Data Sheet (English)
Transition Protocol Materials Specification and Miscellaneous Properties Data Sheet (Metric)
Tyvek 1073B Current vs. Transition Material Comparisons (Accelerated Aging)
Tyvek 1059B Current vs. Transition Material Comparisons (Accelerated Aging)
Tyvek 1073B Current vs. Transition Material Comparisons (Real-Time Aging) 
Tyvek 1059B Current vs. Transition Material Comparison (Real-Time Aging) 
Material Sterilization Details
Specification Properties of 1073B
Specification Properties of 1059B
Miscellaneous Properties of 1073B
Miscellaneous Properties of 1059B
Microbial Barrier Properties of 1073B and 1059B
Effects of Sterilization and Accelerated Aging on Microbial Barrier for 1073B (ASTM F2638) 
Effects of Sterilization and Real-Time Aging on Microbial Barrier for 1073B (ASTM F2638) 
Effects of Sterilization and Accelerated Aging on Microbial Barrier for 1059B (ASTM F2638) 
Effects of Sterilization and Real-Time Aging on Microbial Barrier for 1059B (ASTM F2638) 
- Effects of Sterilization and Accelerated Aging on Microbial Barrier for 1073B (ASTM F1608) 
- Effects of Sterilization and Accelerated Aging on Microbial Barrier for 1059B (ASTM F1608)

DuPont™ Tyvek® Transition Material Additional Testing (Phantom Protocol Testing)

Printing Trials 
Seal Strength Comparison Fingerprints
Effects of Steam Sterilization 
Differential Scanning Calorimetry 
Infrared Spectrum "Fingerprinting" via ATR-FTIR
Hydrostatic Head and Surface Energy
- Freeze-Thaw Dimensional Stability Study
Particle Generation Properties
- Static/Dynamic Coefficient of Friction
- Parker Surface Smoothness

Biocompatibility, Food Contact and Pharmacopeia Results

Biocompatibility, Food Contact and Pharmacopeia Testing

U.S. FDA Protocol Package Data
Data will be published as available

Package Test Results Selector Tool - UPDATED JUNE 2015
Transition Protocol Test Matrix Status 
- Interim Test Results after Accelerated Aging, Pass/Fail Summary for Seal Strength 
Interim Test Results after Real-Time Aging, Pass/Fail Summary for Seal Strength 

Phantom Protocol Package Data
Data will be published as available

Phantom Protocol Test Matrix Status 

Developmental Material Data

Developmental Materials Data Charts as of September 2012
Additional Accelerated Aging Data - Developmental Materials

Regulatory Guidance

In addition to Tyvek® transition project data, guidance obtained from regulatory authorities around the world is posted to help medical device manufacturers stay informed. For more information on regulatory letters, testing certificates, as well as Device Master Files, please visit our Medical Packaging Reference Library.

- Guidance from U.S. F.D.A. 

- Regulatory Guidance from Japan

Summary of Guidance from China, CFDA-Jinan
Guidance from Health Canada


European Notified Bodies

- Position Statements with Protocol Review

- Position Statements

Resources

MPTP Industry Collaborators
DuPont MPTP Experts
Industry Organizations
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