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
- MPTP Milestones
- Medical Transition Protocol Cell Descriptions
MPTP FAQs

 

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
- 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 and Gurley Hill Porosity 
- Differential Scanning Calorimetry 
- Infrared Spectrum "Fingerprinting" via ATR-FTIR
- Hydrostatic Head and Surface Energy
- Dimensional Stability Study
- Particle Generation Properties

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 Status
- Pre and Post-Sterilization Initial Results

Phantom Protocol 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.

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
- Guidance from Health Canada


European Notified Bodies

BSI Assurance UK Ltd
- LNE/G-MED
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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