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.

- Updated MPTP Executive Overview
- MPTP Testing Summary
- Medical Transition Protocol Cell Descriptions
MPTP FAQs

 

DuPont™ Tyvek® Sheet Property Data

Transition Protocol Materials Specification and Miscellaneous Properties Data Sheet
- Tyvek 1073B Current vs. Transition Material Comparisons
- Tyvek 1059B Current vs. Transition Material Comparisons
- 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
- Percent Shrinkage After Steam Sterilization 
- Differential Scanning Calorimetry 
- Infrared Spectrum "Fingerprinting" via ATR-FTIR

Biocompatibility, Food Contact and Pharmacopeia Results

- Biocompatibility, Food Contact and Pharmacopeia Testing

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

Transition Protocol Test Matrix

Phantom Protocol Data
Data will be published as available

- Phantom Protocol Test Matrix

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.

Guidance from U.S. F.D.A.
Updated Guidance from U.S. F.D.A.
Regulatory Guidance from Japan
- Updated Guidance from Japan
- Summary of Guidance from China, CFDA-Jinan


European Notified Bodies

BSI Assurance UK Ltd
SGS United Kingdom Limited
TüV Rheinland LGA Products GmbH
TüV SÜD Product Service GmbH

Resources

MPTP Industry Collaborators
DuPont MPTP Experts
Industry Organizations
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