INEOS Styrolution’s certified glass fiber filled styrenics grade for medical devices used by Fleima-Plastic
- Novodur® HD M203FC G3: INEOS Styrolution’s first regulatory compliant glass fiber filled ABS for selected medical applications
- Fleima-Plastic brings first applications to market based on Novodur® HD M203FC G3
INEOS Styrolution has recently introduced a new grade of innovative styrenics – Novodur® HD M203FC G3. This certified glass fiber filled ABS is already being used in medical accessories by the global medical device manufacturer Fleima-Plastic.
Novodur® HD M203FC G3 – a glass fiber filled medical polymer grade – is going to be a first choice material for demanding healthcare applications like medical spikes, as well as for medical applications requiring structural stability and high flowability. In addition to its regulatory compliance for selected applications, the product’s characteristics such as good impact strength, surface quality and processability mean that it can even be used to produce complex geometrics.
Most importantly, the material was designed to meet strict regulatory requirements. The glass fiber reinforcement and the ABS material comply with the requirements of USP Class VI, selected ISO 10993 biocompatibility standards and various food contact regulation. The regulatory compliance makes certification of the end product much easier for device manufacturers, no matter where in the world they want to launch products. Due to its unique properties and regulatory compliance, Novodur® HD M203FC G3 has the potential to become a global standard material for healthcare applications.
Customers have long sought materials that give them confidence in getting their own application approved. With the introduction of Novodur® HD M203FC G3, INEOS Styrolution can offer manufacturers a reinforced styrenic grade which is already compliant with healthcare regulations, saving them time and money in getting products regulatory compliant. Alexander Silvestre, Global Director for Healthcare at INEOS Styrolution elaborates, “We are providing medical device designers the option to choose a superior product that meets both the technical and regulatory demands. The Novodur® HD M203FC G3 grade is the first glass fiber filled polymer grade to be offered with the full complement of healthcare compliance documents worldwide.”
INEOS Styrolution’s close collaboration with Fleima Plastic (Masterflex Group) - a leading global manufacturer of spikes and caps made of ABS - has been integral to developing this medical polymer grade and launching its application in markets around the world. The challenge was to create a material with the required stiffness. Products must not bend, so they are reinforced with glass fiber to achieve the required stiffness, while still being regulatory compliant. “Thanks to these special glass fibers, this ABS material has an exceptionally high E-modulus and a significantly improved compression, bending, tensile and impact strength,” says Ismail Dogru, Key Account Manager at Fleima Plastic. In addition to housings, Fleima Plastic will also manufacture spikes and caps made with Novodur® HD M203FC G3. This makes Fleima Plastic the first manufacturer releasing products that exploit the properties of this new medical polymer grade.