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 January 2020

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)

• Industry Summary Report (5-Year Real-Time Aging) - NEW January 2020

• Industry Executive Summary Report (5-Year Real-Time Aging) - NEW January 2020

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 2020

Tyvek® 1059B Legacy vs. Transition Material Comparisons (Real-Time Aging)- UPDATED January 2020

Material Sterilization Details

Specification Properties of Transition 1073B

Specification Properties of Transition 1059B

Miscellaneous Properties of Transition 1073B

Miscellaneous Properties of Transition 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 2020

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 2020

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

September 30, 2015

European Notified Bodies

- Position Statements with Protocol Review

BSI Assurance UK Ltd

LNE/G-MED

SGS United Kingdom Limited

TüV Rheinland LGA Products GmbH

TüV SÜD Product Service GmbH

- Position Statements

DQS Medizinprodukte GmbH

NSAI Inc.

AMTAC Certification Services Ltd and Intertek SEMKO AB

Resources

MPTP Industry Collaborators

DuPont MPTP Experts

Industry Organizations

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