ELIX Polymers
The Next Gen of Medical Device Equipment

The EU’s Medical Device Regulation (MDR) mandates a UDI system placed on medical devices and their packaging to reduce the risk of counterfeiting, improve traceability, and better manage incident reporting. Laser marking considered an ideal method for medical devices to be linked or attached to a UDI requires specific materials to provide the most optimal results. In addition to the material, operators need to pay further attention to its colour formulation to achieve compatibility with the base material and create exceptional durable quality and contrast markings.

To tackle the challenges associated with formulating the appropriate colours and manufacturing the materials required for laser marking, ELIX Polymers creates distinct pre-coloured acrylonitrile butadiene styrene (ABS) formulations based on current biocompatible materials M203FC and M205FC. ABS is a laser markable material where the right laser settings matched to the appropriate ABS material and pigments will create the desired laser marking results. However, only selected colour pigments in strictly controlled concentrations can be used due to the need for compliance with legislation (such as the requirement for biocompatibility according to ISO 10993). As a consequence, the text to be laser-marked may generate an undesirable colour, degree of contrast, or resolution. Furthermore, the marked text may fade away with time, so it is important to make it readable during the entire lifetime of the medical device and chemically resistant to repeated cleaning, disinfection, and sterilization procedures.

Focused on drug delivery devices and medical device applications, ELIX Polymers has created unique pre coloured ABS formulations that optimize laser markings to achieve a specific colour shift and a targeted level of contrast over a specific colour background while staying compliant with regulations.

These ABS polymers provide a balance of optimal surface quality and reliable mechanical properties while retaining these attributes even under gamma radiation sterilizations.

With a track record stretching over 45 years, ELIX Polymers provides its expertise in ABS polymers and is equipped with the resources, skills, and experienced teams to bring value to its customers through highly personalized solutions.

The company’s solutions for the medical industry are centered on regulatory compliance, product safety and a global supply strategy.

ELIX Polymers stands out from their competitors in the material manufacturing landscape due to their capacity to fulfil biocompatibility and environmental regulatory criteria, add new material properties and reduce client workloads and associated risks regarding the blending of pre-coloured ABS compositions. Regarding selecting a medical grade of ABS, plastics processors have two options: they may use a pre-coloured product or use an ABS in its natural colour and blend it using a colour masterbatch during the moulding process.

Various medical OEMs prefer ELIX’s pre-coloured medical ABS to reduce regulatory compliance risk. This is because ELIX ensures the biocompatibility of the whole material composition, including all additives and colour recipes.

Specific ABS properties for intelligent medical devices have been developed by ELIX Polymers, like conductive or permanent antistatic ABS, light blocking properties or EMI/RFI shielding properties. The company has also expanded its portfolio of ABS grades for filament 3D printing, which has been developed following careful examination of specific customer demands. By collaborating with several major 3D printing machine and filament manufacturers, Elix Polymers has optimized five ABS grades for 3D printing, and all of them exhibit improved printing performance, minimal warpage, dimensional precision, and excellent resolution.

The portfolio includes ELIX ABS 3D-FC, a medical ABS and food contact grade for filament 3D printing that meets biocompatibility standards ISO 10993-1 and USP class VI for use in medical devices. This grade can be used for designing & developing new medical devices, 3D printing of functional patient-specific devices such as surgical guides, splints, implants, prosthetics or 3D printing of functional models of body parts, organs and bones.

The 3D printing technology allows for faster production and saves lives, since conventional production technologies would require much longer lead times.

Bolstered by a diverse product portfolio, ELIX Polymers has evolved into a multi award-winning company that has successfully aided several clients with medical grade ELIX ABS M203-FC and ELIX ABS M205-FC.

These medical ABS grades are used in several medical device applications in both Europe and the United States and have their own registered Drug Master Files (DMF) at the FDA, including specific medical colour formulations. ELIX’s colour development services and product stewardship, which offers regulatory support, played a crucial role in ensuring the success of these projects.

This approach involving the end user throughout all stages of the development process has the potential to become a new standard within the medical device industry

The company seeks to increase the range of applications for its thermoplastic products in the medical device manufacturing sector. ELIX also aspires to be a driving force in the new plastics economy, engaging in the reinterpretation of plastic waste as a raw material. For these reasons ELIX was the first ABS manufacturer to get the ISCC+ certification for sustainable materials. The company has developed E-LOOP, the brand name that covers all circular economy initiatives, including a circular plastics portfolio and responsible innovation programmes. The E-LOOP ABS portfolio includes already new medical ABS grades with chemical recycled and/or bio-based content and the availability of such certified grades will grow in the next two years.

By fostering the change of the value chain towards a circular economy model, the company strives to provide top-of-the-line sustainable solutions. Along with its team of professionals who make up the human capital of ELIX Polymers, the company strides forward with continuous improvement, innovation and state-of-the-art technology.