Bright and intense colours are relevant for patients because they stimulate a positive attitude to take the drug medication, they help the distinction of different device part and facilitate the way how to use the device itself. In addition, they help to distinguish different types of drugs that are targeting to different types of diseases.
Despite colour in medical device applications is such a key property, there are strict regulatory limitations in the type of pigments admitted in the colour formulations, and in their maximum allowed concentrations. When the biocompatibility requirement according to ISO 10993 must be met, not only the base ABS material must be biocompatible but also all the additives compounded with the material, including the colour formulation with all its different pigments. No biocompatible pigments must be directly excluded, and maximum allowed pigment concentrations must not be exceeded.
Furthermore, special attention must be given to possible mutual interactions among different pigments, ABS material and other additives. ELIX Polymers eliminates those risks to OEMs, processors and developers providing a medical precoloured ABS material formulation that includes the complete colour recipe and does not need any further material modification.
The complete formulation has been fully reviewed and pre-tested to meet biocompatibility according to ISO 10993 and other regulatory requirements. This is a much safer approach for medical OEMs and moulders instead of choosing a medical ABS in natural colour and compound it themselves with a masterbatch colour, during the injection moulding process.
The ABS market offers mostly natural ABS, forcing processors, OEMs and moulders to buy natural ABS and assume most responsibilities and risks, additional quality control costs and regulatory compliance verifications at different development and production stages.
As mentioned, in the case of pre-tested pre-coloured medical ABS, the material formulation must not be modified by the customer, reducing responsibilities, supporting the medical device approval process, and avoiding the risk of compounding mistakes during the injection moulding production process. All required medical compliance certifications are already provided by ELIX and are referring to the complete material formulation, including all included colour pigments, additives, and related concentrations.
Regulatory compliance is a pre-requisite for inhalation medical device, but there are also other important quality properties that are strictly related with colour: its homogeneity along the complete device part, its consistency from lot to lot productions, or required colour target contrast in case of surface laser marking (typically for traceability reasons to comply with UDI EU MDR and US CFR regulations).
