Arkema Announces Extension to Change Notice for Medical Grade Pebax Polymers

By Calvin Azuri

TMCnet Contributor

 

Arkema, Inc. recently extended the advance notice period for making product specification changes to all Pebax SA 01 MED polymers by 12 months.

 The company announced the extension to ensure that medical device manufacturers have the time to evaluate and scale up to manage changes to their regulatory assessment processes. Prior to this announcement, any notifications of change to polymers sold within the medical market did not require a specific notification period.  

Arkema considers all Pebax polymer grades with "MED" in the nomenclature as medical grades. The Pebax SA 01 MED is a thermoplastic elastomer, consisting of rigid polyamide segment and a flexible segment. The dual combination of performances makes the Pebax SA 01 MED ideal for use in medical extrusion applications.

Medical grades of Pebax polymer undergo USP Class VI-testing and maintain product testing specifications, unique to each lot of material. In keeping with specified Arkema test procedures, each lot is tested for viscosity, color (Yellowness Index), gels and moisture content.

As per the new announcement, all necessary modifications to these test procedures or product specifications will be made 12 months in advance to market notifications.

"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 of Arkema, Inc. "Extended change notice is intended to provide device companies with the opportunity to evaluate and manage changes in light of their regulatory process."

Arkema uses an innovation-based approach in developing next-generation specialty chemicals which deliver practical solutions to a host of specific issues, including changes to the climate, access to safe drinking water and preservation of fossil fuel preservation.