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May 17, 2012

Arkema Now Demanding 12-Month Advance Notice on Product Spec Changes to Help Medical Device Manufacturers Meet Testing Deadlines

Advance notice of product specification changes on all Arkema Inc. Pebax® SA 01 MED will now be given to medical customers 12 months before they are instituted, according to a company press release. In the past, no notice was given and changes could be made anytime, making it much harder for users of these polymers to plan and run their manufacturing lines.

The diversified chemical producer said that it has put in place a 12-month advance notice for polymers in order to provide medical device manufacturers with the time they need to go through regulatory appraisal. In the past, notifications of change for these polymers sold in the medical market were unrestricted, similar to grades sold in non-medical markets, according to the press release.

“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,” according to the press release.

Polymers are "smart" plastic material which play a variety of roles in medicine. They can be used in everything from near-infrared (NIR) light, where, according to early experiments, as reported by, the plastic material will break down into non-toxic particles in response to lower-power NIR light, possibly leading to improved treatment of tumors, or improvements in the release of tracing compounds and imaging agents for improved medical diagnostics applications, to tissue engineering .

”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, associated with scorching, soiling and general product degradation due to chemical exposure and processing), 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,” the press release states.

“Pebax MED polymer grades are commonly used in medical devices that are subject to regulatory controls,” said Aurelien Paumier, director for thetechnical polymers business unit of Arkema Inc., in the press release. “Our extended change notice is intended to provide device companies with the opportunity to evaluate and manage changes in light of their regulatory process.”

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