Through industry collaboration and work with regulatory labs, DuPont is targeting the entire value chain within medical packaging by requalifying work with the FDA and other regulatory agencies around the world. DuPont is working with several global medical device manufacturers in advance of the commercialization of several new product grades, which is scheduled for early 2015.
As of this month, DuPont announced that transition protocol amendments have been made and accepted by the Center for Devices and Radiological Health at the FDA in the U.S. Additionally, Europe’s four largest regulatory bodies have received a copy of the amendments. In Japan, regulatory bodies are reviewing the data and in China testing criteria has been established.
From a technical standpoint, DuPont has completed development of material assessments, has successfully produced and tested transition protocol materials, shipped materials to participating Sterile Packaging Manufacturers for conversion and conducted a formal DuPont Product Stewardship review.
According to Diego Boeri, a senior executive with DuPont’s Tyvek business, DuPont still has a lot of work to do on the project during the next 18 months. The key goal is making the transition protocol material available in advance of full commercialization, which is estimated for early 2015. This will support MDM efforts to complete internal risk assessments prior to commercialization and enable them to qualify material for new device packaging, he says.
“We are really optimistic about the project. It’s not just an internal operation effort. It’s a massive activity where we are working with the whole value chain in medical packaging market," says Boeri. "We are requalifying our work with the FDA and other regulatory agencies around the world so that our customers have to do less work to bring their proudcts to market.”