ELIX Polymers provides leading quality assurance and technical value services for pre-coloured ABS used in healthcare applications
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 February 5 and 6 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-coloured ABS compounds, has its own stand, K60, in Hall 7.2. It will show its product portfolio, demonstrate new innovations, and discuss its service offering.
Quality assurance lies at the heart of the ELIX value proposal. In the case of medical grades of the company’s ABS, it covers all pre-coloured formulations, including the colour recipes. Colour stability is achieved through a purpose-developed material selection and homologation process, 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 take a pre-coloured product, or they can take an ABS in its natural colour and blend it themselves during moulding, using a colour masterbatch. To reduce their exposure to risk in regulatory compliance, several medical OEMs prefer ELIX pre-coloured medical ABS. This is because ELIX guarantees the biocompatibility of the complete material formulation, including the additives and the complete colour recipe.
Even though the concentrations of a certain substance in a natural ABS and in a colour masterbatch may separately comply with relevant legislation, the maximum concentration limits may be exceeded in the resulting coloured ABS when blending the natural ABS with the masterbatch to achieve the target colour. In addition, use of masterbatch can increase the risk of non-compliance because there may be interaction among components – something that is not always easy to predict. These risks are minimised with pre-coloured ABS, as the compliance is verified and certified on the final coloured material formulation. ELIX tests the biocompatibility of its coloured grades of medical ABS in accordance with ISO 10993-1 and USP class VI.
Reduction of complexity is a natural consequence of having just one partner providing multiple aspects of value. Since ELIX can supply medical-grade ABS in the target colour, medical OEM customers don’t need to involve and manage different parties; they do not have to obtain separate declarations from each different supplier, or evaluate the risks of potential interaction between substances provided by different suppliers. They can get all the relevant certifications, covering the complete material formulation, in one step, from a single source. This also results in a higher warranty for medical OEMs.
Batch production implemented at ELIX makes product traceability much easier than with production in big run sizes typical of the mass polymerization process. Batch production makes it possible to conduct specific tests on individual batches, in accordance with customers’ specific requests. Moreover, batch sizes can be more easily adapted to customer needs and resulting lead times are shorter than average industry lead times.
ELIX key technical services
Many medical OEMs prefer ELIX pre-coloured ABS solutions because of the positive impact of ELIX technical services on their businesses. These services comprise the colour development service, product stewardship, special testing, formulation and sample storage, mould simulation service and injection moulding guidelines.
ELIX medical ABS is available in numerous colours; customers have access to a database of more than 120 matched colours. But the company’s Colour Development service offers even more: new colours can be developed on request by a highly experienced team 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 constant surveillance of admitted substances and concentrations and by guaranteeing that optimized formulations stay within legal limits.
The continuously changing medical regulatory framework presents an important risk for medical OEMs. This risk is considerably reduced by the ELIX Product Stewardship service, with a significant positive impact on an OEM’s business.
The recent changes to ISO 10993 (Biological evaluation of medical devices), and in particular to Part 18 (Chemical characterization of materials), put great emphasis on chemical characterization of materials. ELIX Polymers provides support to medical OEMs through its Special Testing service, which provides internal and external tests beyond what is included on the TDS, to characterize ELIX material. Test methods include infra-red spectroscopy, gas chromatography and other techniques. New types of tests are also available on demand.
ELIX technical service comprises a no-change agreement and sample storage for medical ABS grades. In connection with a long-term supply agreement, three years no-change product formulation (including colour recipe) is assured and three years sample storage is provided.
ELIX also offers key Technical Services in the field of material processing. For a robust injection moulding process, mould simulation and mould design support are very useful in predicting material processing behaviour. ELIX offers a Mould Simulation service, which consists of Moldflow and Moldex3D software files that include ELIX medical ABS material data properties. These files can be used in software simulations to predict an optimized injection process, reducing scrap rates and increasing quality in parts.
Injection moulding guidelines are also a valuable support to injection moulders – both during the design phase for selecting the right equipment, tools and processing parameters, as well as in the production phase to identify common defects and their root causes, and in solving such issues.
ELIX quality assurance and technical service represents 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.