Tyvek® medical packaging transition data

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.

The U.S. FDA has affirmed functional equivalence for Transition Tyvek® and has notified the industry of this news

Webinar: To download the slides from the latest Medical Packaging Transition Project webinar held on October 6, please click here.

DuPont™ Tyvek® Medical Packaging Transition Project (MPTP)

• October 2018 Open Letter to the Medical Packaging Industry - NEW October 2018

• December 2017 Open Letter to the Medical Packaging Industry on Interchangeability

• May 2017 Open Letter to the Medical Packaging Industry

• August 2015 Open Letter to the Medical Packaging Industry

• July 2015 Open Letter to the Medical Packaging Industry

• Overview of Tyvek® Medical Packaging Transition Project (MPTP)

• MPTP Styles 1073B and 1059B Compliance to EN ISO 11607

• Package Data Confirms Functional Equivalence

• Executive Summary & FAQs

• Testing Summary - UPDATED December 2017

• MPTP Materials List

• Cell Descriptors

• Risk Assessment Building Blocks

• Package Test Results Selector Tool - UPDATED February 2018

• Aligned Test Methods and Sampling Plan

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)

• Industry Summary Report (5-Year Accelerated Aging)

• Industry Summary Report (7-Year Accelerated Aging)

• Industry Summary Report (10-Year Accelerated Aging)

• Industry Summary Report (1-Year Real-Time Aging)

• Industry Summary Report (3-Year Real-Time Aging) - NEW December 2017

Transition Tyvek® and Legacy Tyvek® Property Data

• Specification Properties of Transition Tyvek® 1073B and 1059B

• Miscellaneous Properties of Transition Tyvek® 1073B and 1059B

• Specification Properties of Legacy Tyvek® 1073B and 1059B.

• Miscellaneous Properties of Legacy Tyvek® 1073B and 1059B

• Comparison of Specification Properties of Legacy Tyvek® 1073B and 1059B to Transition Tyvek®1073B and 1059B

• Comparison of Miscellaneous Properties of Legacy Tyvek® 1073B and 1059B to Transition Tyvek®1073B and 1059B

• Tyvek® 1073B Legacy vs. Transition Material Comparisons (Accelerated Aging)

• Tyvek® 1059B Legacy vs. Transition Material Comparisons (Accelerated Aging)

• Tyvek® 1073B Legacy vs. Transition Material Comparisons (Real-Time Aging)- UPDATED January 2018

• Tyvek® 1059B Legacy vs. Transition Material Comparisons (Real-Time Aging)- UPDATED January 2018

• Material Sterilization Details

• Specification Properties of Transition 1073B

• Specification Properties of Transition 1059B

• Miscellaneous Properties of Transition 1073B

• Miscellaneous Properties of Transition 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)- UPDATED January 2018

• 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)- UPDATED January 2018

• 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)

• Effect of 30 Days of UV Sunlight Exposure

• Comparison of Color Measurement (L,a,b)

• 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

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.

• March 1, 2011

• October 18, 2012

• FDA Letter Affirming Functional Equivalence

- Guidance from Japan

• September 19, 2012

• September 25, 2013

• June 1, 2015

- Guidance from China

• Summary of Guidance from China, CFDA-Jinan

- Guidance from Health Canada

• May 7, 2014