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The material from Ineos Styrolution (Frankfurt, Germany) features impact strength, surface quality and processability; it also comes with a suite of regulatory compliance documents to help manufacturers save time and money when seeking regulatory approval for end products.

Norbert Sparrow

February 23, 2017

2 Min Read
Glass-fiber-filled styrenic debuts in medical device application

The first glass-fiber-filled ABS from materials supplier Ineos Styrolution (Frankfurt, Germany) that complies with a full range of regulatory requirements is now on the market in a medical application developed by Fleima-Plastic. Located in Wald-Michelbach, Germany, Fleima-Plastic provides contract molding and other plastics processing services primarily to medical device OEMs. A global manufacturer of ABS-based spikes and caps, Fleima-Plastic closely collaborated with Ineos Styrolution in developing the material for medical applications.

The Novodur HD M203FC G3 material is being used to mold medical spikes at Fleima Plastic.

Since it is being used to manufacture medical spikes in this instance, a key property of the material is stiffness. “Thanks to these special glass fibers, the ABS material has exceptionally high e-modulus and significantly improved compression, bending, tensile and impact strength,” said Ismail Dogru, Key Account Manager, Fleima-Plastic.

But that is only part of the story: Novodur HD M203FC G3 was designed to meet the strict regulatory requirements of USP Class VI, parts of ISO 10993 (biocompatibility) and various food contact standards, according to Ineos Styrolution. Because the material is compliant with healthcare regulations, achieving regulatory approval for end products made with the material can be accelerated, noted the company. “We are providing medical device designers with the option to choose a product that meets both technical and regulatory demands,” said Alexander Silvestre, Global Director for Healthcare. "Novodur HD M203FC G3 is the first glass-fiber-filled polymer grade to be offered with the full complement of healthcare compliance documents worldwide,” he added.

The medical device supply chain will meet in Cleveland, OH, on March 29 and 30, 2017, when UBM’s newest trade show and conference, Advanced Design & Manufacturing (ADM) Cleveland, debuts. Five zones on the show floor are devoted to medical manufacturing, plastics, packaging, automation and robotics, and design and manufacturing. Numerous conference sessions are targeted to the medical manufacturing, automotive and other key industry sectors. Go to the PLASTEC Cleveland website to learn more and to register to attend.

Fleima-Plastic is the first manufacturer to use this material in medical applications—to mold housings and caps in addition to the aforementioned spikes—but it will soon have plenty of company, hopes Ineos Styrolution. Because of its properties and regulatory bona fides, “Novodur HD M203FC G3 has the potential to become a global standard material for healthcare applications,” said the company. 

About the Author(s)

Norbert Sparrow

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.

www.linkedin.com/in/norbertsparrow

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