The transition from Legacy Tyvek® to Transition Tyvek® will take longer than planned. This means that manufacturers will have more time to carry it out. Discover here all the available tools to help you maintain compliance.
DuPont™, the company that manufactures Tyvek® (a packaging material widely used by medical device manufacturers), announced in 2011 its decision to replace their Legacy Tyvek® with the new Transition Tyvek®.
From a regulatory point of view, this change directly impacts Medical Device (MD) manufacturers that use Legacy Tyvek® in their products. Therefore, DuPont™ set up a transition program called the « Medical Packaging Transition Project » (MPTP) to help them implement this significant modification.
Quick Reminder of the Tyvek® Transition
DuPont™ has published a series of essential guidelines and documents to help MD manufacturers ensure the ongoing compliance of their devices that use Tyvek® and to minimize costs. During the transition, manufacturers must evaluate, validate and demonstrate the interchangeability between both types of Tyvek® in their technical documentation.
Let’s not forget that the Transition was supposed to take place by June 2016 but DuPont™ decided to continue Legacy Tyvek® distribution until 2017, and possibly even 2018. This way, MD manufacturers have more time to integrate the interchangeability into their documentation.
If you use Tyvek®, contact us.