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

 

 

MPTP Webinar Save the Date

DuPont Publishes First Tyvek® Transition Package Data

Save the Date! The next MPTP Webinar will be October 2, 2014 at 11:00 a.m. EST. Registration link coming soon.
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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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