DuPont sterile medical packaging available for testing

DUPONT recently announced the availability of the DuPont? Tyvek? Transition Protocol Materials to support medical device manufacturers with their risk assessments; quality management and change control systems as well as allowing them to qualify the material for new device packages.  While the material is representative of what will be commercially available in the future, it is not intended for use in packaging of existing commercial devices until all applicable regulations in the country of sale have been met.

The Medical Packaging Transition Project is a global collaboration engaging more than 50 organizations including regulatory bodies, test houses, sterile packaging manufacturers and medical device manufacturers.  Medical device manufacturers, in particular, will be able to perform additional testing as desired or to qualify the material for any new medical device packaging where needed prior to full commercialization. 

“We are excited to have reached this major milestone and are on target for full commercialization in early 2015,” said Roseann Salasin, global marketing director, DuPont Protection Technologies.  “DuPont appreciates the efforts of all these entities as we work together to meet the needs of a growing global population for safe and sustainable medical packaging solutions.”

In 2011 DuPont Protection Technologies announced the Medical Packaging Transition Project, a multi-year investment of more than $30 million to transition DuPont Tyvek 1073B and 1059B materials to the latest flash-spun technology and equipment. The goal is to ensure the continuity and flexibility of future supply into medical and pharmaceutical packaging applications worldwide.  

Over the next year DuPont and participating companies will be conducting a multitude of tests of Tyvek Transition Protocol Material made on the company’s newer assets, including the U.S. FDA approved Tyvek Transition Protocol testing.  The purpose of this broad-based testing is to minimize the effort and cost of conversion for the healthcare packaging industry.  Medical device manufacturers will be able to perform additional testing as desired or to qualify the material for any new medical device packaging where needed prior to full commercialization. 

Medical and pharmaceutical device manufacturers can purchase Tyvek Transition Protocol Material from their sterile packaging manufacturers.  Sterile packaging manufacturers (SPMs) can purchase the material directly from DuPont by referencing the new and unique SKU numbers that have been provided to them in a separate communication. Tyvek transition materials will be sold under a “controlled sales” process.  DuPont encourages device manufacturers to communicate their needs for this material to their SPM as soon as possible.