Arkema Inc. Extends Notification for Change to Medical Grade Pebax® Polymers

King of Prussia, PA — Arkema Inc. has implemented a 12-month advance notice for product specification changes on all Pebax® SA 01 MED polymers in order to provide medical device manufacturers with the necessary time for regulatory assessment.  Previously, notifications of change for these polymers sold in the medical market were unrestricted, similar to grades sold in non-medical markets.

Pebax® polymer grades that include “MED” in the nomenclature are considered by Arkema to be medical grades.  Pebax® SA 01 MED is a thermoplastic elastomer made of a rigid polyamide segment and a flexible segment, offering a combination of performances well-suited for medical extrusion applications, including tubing used in regulated devices.

Medical grades of Pebax® polymer are USP Class VI-tested and have distinct product testing specifications for each lot of material.  Lot testing is performed for viscosity, color (Yellowness Index), gels, and moisture content, in accordance with established Arkema test procedures.  Effective immediately, any necessary modifications to these test procedures or specification limits will be preceded by market notification 12 months in advance of the change.

“Pebax® MED polymer grades are commonly used in medical devices that are subject to regulatory controls,” said Aurelien Paumier, Director for the Technical Polymers business unit at Arkema Inc.

“Our extended change notice is intended to provide device companies with the opportunity to evaluate and manage changes in light of their regulatory process,” Paumier noted.

About Arkema: A global chemical company and France’s leading chemicals producer, Arkema is building the future of the chemical industry every day. Deploying a responsible, innovation-based approach, we produce state-of-the-art specialty chemicals that provide customers with practical solutions to such challenges as climate change, access to drinking water, the future of energy, fossil fuel preservation and the need for lighter materials. With operations in more than 40 countries, approximately 13,200 employees and 9 research centers, Arkema generates annual revenue of $8.2 billion*and holds leadership positions in all of its markets with a portfolio of internationally recognized brands.  The world is our inspiration.