ELIX Polymers provides top quality assurance and services of technical value for pre-colored ABS used in healthcare applications

Tarragona, February 26, 2020 - ELIX Polymers, a leading specialist in high-performance ABS materials, will demonstrate its commitment in the healthcare sector at Pharmapack 2020, the European pharma packaging industry exhibition taking place on 5 and 6 February at Paris Expo, Porte de Versailles. The company, which is enhancing the visibility of its quality assurance and key technical services associated with medical-grade pre-colored ABS compounds, has its own stand, K60, in Hall 7.2. It will show its product portfolio, demonstrate new innovations, and discuss its offer of services.

Quality assurance lies at the heart of the ELIX value proposal. Regarding the company’s medical grades of ABS, all the pre-colored formulations are covered, including the color recipes. Color stability is achieved through a custom-developed process of material selection and official approval, testing on all incoming raw materials, intermediate control during manufacturing, and extended testing procedures on final compounds.

Processors can take one of two approaches when it comes to choosing a medical grade of ABS: they can either use a pre-colored product, or they can take an ABS in its natural color and blend it themselves during molding, using a color masterbatch. Several medical OEMs prefer ELIX’s pre-colored medical ABS, which allows them to reduce their exposure to regulatory compliance risk. This is because ELIX guarantees the biocompatibility of the complete material formulation, including the additives and the complete color recipe.

Even though the concentrations of a certain substance in a natural ABS and in a color masterbatch may separately comply with relevant legislation, the maximum concentration limits may be exceeded in the resulting colored ABS when natural ABS is blended with the masterbatch to achieve the target color. In addition, using a masterbatch can increase the risk of non-compliance because the components may interact with each other – something that is not always easy to predict. These risks are minimized by using pre-colored ABS, given that compliance is verified and certified by the formulation of the final colored material. ELIX tests the biocompatibility of its colored grades of medical ABS in accordance with ISO 10993-1 and USP class VI.

Reduced complexity is the natural result of having just one partner who can provide value in multiple aspects. Since ELIX can supply medical-grade ABS in the target color, medical OEM customers don’t have to involve and manage several parties; they don’t have to obtain separate declarations from each supplier or evaluate the risks of potential interactions between substances provided by various suppliers. They can get all the relevant certifications that cover the complete material formulation in one step and from a single source. This also results in a higher warranty for medical OEMs.

The batch production process implemented at ELIX makes product traceability much easier than with large production runs that are typical of the mass polymerization process. Batch production makes it possible to conduct specific tests on individual batches, in accordance with the specific requests of customers. Moreover, batch sizes can be adapted more easily to customer needs, and the resulting lead times are shorter than the average industry lead times.

ELIX’s key technical services

Many medical OEMs prefer ELIX pre-colored ABS solutions because of the positive impact of ELIX’s technical services on their businesses. These services include the color development service, product stewardship, special testing, formulation and sample storage, the mold simulation service, and injection molding guidelines.

ELIX’s medical ABS is available in numerous colors; customers have access to a database of more than 120 matched colors. But the company’s Color Development service offers even more: new colors can be developed on request by a highly experienced team that is specialized in the selection of FDA and EU-FC approved pigments and additives. The list of admitted ingredients is provided by the ELIX Product Stewardship department, which adds value by constantly monitoring the admitted substances and concentrations and by guaranteeing that optimized formulations stay within the legal limits.

The continuously changing medical regulatory framework represents an important risk to medical OEMs. This risk is considerably reduced by the ELIX Product Stewardship service, resulting in a significant positive impact on an OEM’s business.

The recent changes to ISO 10993 (Biological evaluation of medical devices), particularly to Part 18 (Chemical characterization of materials), place great emphasis on the chemical characterization of materials. ELIX Polymers provides support to medical OEMs through its Special Testing service, which provides internal and external testing beyond what is included in the TDS for characterizing ELIX’s materials. Test methods include infrared spectroscopy, gas chromatography and other techniques. New types of tests are also available on demand.

ELIX’s technical service includes a no-change agreement and sample storage for medical ABS grades. In conjunction with a long-term supply agreement, it is assured that there will be no changes to a product formulation for three years (including the color recipe), and sample storage for three years is furthermore provided.

ELIX also offers key Technical Services in the field of materials processing. Predicting the processing behavior of a material is essential to a robust injection molding process, for which mold simulation and mold design support are highly useful. ELIX offers a Mold Simulation service, which consists in Moldflow and Moldex3D software files that include the material data properties of ELIX medical ABS. These files can be used in software simulations to predict an optimized injection process, thereby reducing scrap rates and increasing part quality.

Injection molding guidelines are also a valuable support tool for injection molders – not only during the design phase for selecting the right equipment, tools, and processing parameters, but also in the production phase to identify common defects and their root causes and to resolve such issues.

ELIX’s quality assurance and technical service represent a key value proposal to Medical OEMs and their supply chain. It is complemented by ELIX Commercial services, which are offered through the ELIX customer service and sales team.

Reader Enquiries

ELIX Polymers
Polígono Industrial - Crta. Vila-seca-La Pineda s/n
43110 La Canonja (Tarragona)
Spain

+34 977 83 54 00

info@​elix-polymers.com

www.elix-polymers.com

@ELIXPolymers

elix-polymers

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