ELIX Polymers offers leading range of specialty ABS materials for the global healthcare sector
Leading specialty ABS producer ELIX Polymers had a spotlight on global grades for healthcare applications at Fakuma.
“ELIX medical ABS grades meet the stringent requirements of the medical device industry,” says Aurelie Mannella, Industry Manager Healthcare. “Our range includes two USP Class VI and ISO 19993 biocompatibility grades, which have registered device and drug master file approvals for use in medical and food-contact applications in Europe and the USA. We supply leading medical injection moulders and global pharmaceutical companies on both continents.”
Applications already benefitting from ELIX medical ABS grades include infusion systems, respiratory devices, auto-injector devices, and housings for various products. The grades offer a very well balanced property profile, with a very good flow behaviour and excellent chemical resistance.
ELIX currently has a portfolio of more than 130 colours approved for use in medical device applications. It also has a strong capability to develop and produce new colours, taking responsibility for pigment compliance. “We have implemented various actions that assure the colours we use have no impact on extractables and leachables,” says Manella. “Colorants and dyes, as well as dispersants and process aids, can only be used in our recipes if they are approved in the base material; only FDA/EU pigments are used.”
The company recently expanded its Healthcare portfolio with ELIX M545TF, a grade for use in products that come into contact with food and which also require extra toughness and resistance to high temperatures. It has been migration tested with different food simulants, enabling ELIX Polymers to advise its customers about migration issues and regulatory compliance during the product design phase.
In addition to injection moulding medical grades of ABS, ELIX Polymers now also offers ELIX ABS-3D FC filament for 3D printing using FFF (Fused Filament Fabrication) technology, often referred to as FDM (Fused Deposition Modelling). This grade, which is also available in numerous colours, is biocompatible according to USP Class VI. This means that it can also be used in food contact applications.
ELIX ABS-3D FC is easy to print, provides very good inter-layer adhesion, and enables production of high resolution, low-warpage parts. Compatible with most FFF 3D printers, it is part of a growing range of grades available from ELIX Polymers for the 3D printing community.