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DuPont™ Tyvek® Information

 

DuPont™ Tyvek® Medical Packaging

 

Beacon Converters, Inc has been a provider of DuPont™ Tyvek® Medical packaging for over 40 years.

Beacon manufactures a wide variety of Tyvek® based products including pouches, header bags, lids, die cut sheets, rollstock, tie wraps and lift tabs. Available in coated and uncoated formats Tyvek® products are suitable for EO, Gamma, E-Beam and under controlled conditions, Steam sterilization.

The DuPont™ Tyvek® Transition Project

DuPont™ developed a Medical Products Transition Project (MPTP ) Protocol for Tyvek® to be interchangeable between the older (legacy) product made off the older assets that have been creating Tyvek® for decades to product made off the newer assets (transition). Beacon Converters has been involved since the very early phases of the Tyvek® Transition Project. The Tyvek® Medical Packaging Transition Project has three main components:

  1. U.S. FDA Transition Protocol (“Transition Protocol”)—a study plan involving production and testing of sterilized medical device packages that has been reviewed and accepted by the Center for Devices and Radiological Health (CDRH) at the U.S. FDA.
  2. Phantom Protocol—additional testing of applications and technologies that are outside the scope of the Transition Protocol but have been requested by the industry to support risk assessments.
  3. Product Stewardship—Biocompatibility, Food Contact and Pharmacopeia testing.

Beacon was an active participant in the protocol with six cells representing various combinations of Tyvek® and companion films. Beacon is confident in our ability to use both materials interchangeably in our processes. There are a myriad of supporting documents available and on DuPont’s website at www.transition.tyvek.com . We have also compiled a list of links to some of the documentation you will find helpful. Remember Beacon and DuPont™ are here to help you navigate the transition from legacy to transition.

Helpful Protocol Documentation

  1. Tyvek® Medical Packaging Transition Overview
  2. DuPont Website Reports and Data
  3. Medical Packaging Transition Data and Documents
  4. Official Letter of Affirmation from US FDA CDRH 
  5. Commercialization Plan
  6. ISO 11607 Compliance for Transition Tyvek® 
  7. Comprehensive List of Testing Done as part of MPTP
  8. 5-year accelerated aging Report 
  9. Executive Summary Report 
  10. Specification for Transition 1073B and Transition 1059B 
  11. Specification Properties of DuPont™ Tyvek® 1073B and 1059B Transition Protocol Materials—English Units 
  12. Specification Properties of DuPont™ Tyvek® 1073B and 1059B Transition Protocol Materials—Metric Units

Click here to contact Beacon about our Protocol Test Results or for help in finding other Transition Documentation.

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