Pre-Colored Medical ABS Compounds for Laser Marking
Elix Polymers’ specialty medical pre-colored ABS compounds are based on existing biocompatible M203FC and M205FC.
Laser marking is a useful tool for implementing the mandatory unique device identification (UDI) that is required by actual medical legislations to protect against counterfeiting. ELIX Polymers has developed special medical pre-colored ABS formulations based on existing biocompatible materials M203FC or M205FC, to maximize laser marking results on medical devices and to ensure full compliance with regulations.
EU’s new Medical Device Regulation (MDR) and US’ Code of Federal Regulations Title 21 on labelling of medical devices (21 CFR 801 Subpart B) enforce the use of a UDI system to be placed on medical devices and on their packaging to reduce the risk of counterfeiting, improve traceability and better manage incident reporting, device recalls and other adverse events. Several medical devices must be directly marked with a unique device identifier (CFR 21 Sec. 801.45 or EU MDR Part C 4.10 about the UDI system in reusable devices); in general, if the devices are intended to be used more than once and to be cleaned or disinfected before each use.
Laser marking makes it possible to attach a unique identifier to the medical device and offers a series of additional advantages compared to alternative technologies such as labelling, pad printing, or hot stamping.
Some materials can be more easily laser-marked than others, while some will provide very poor results. Therefore, it is critical that we first select the correct medical materials and subsequently adapt the laser equipment type and settings accordingly. In addition to the material, special attention should be given to its color; in particular, the color formulation and its compatibility with the base material to create certain laser marking effects or colors of contrast.
ABS (Acrylonitrile Butadiene Styrene) polymers are materials that are widely used to produce external enclosures, covers or shells for reusable devices. ABS is a laser markable material where correct laser settings adapted to the ABS material produce acceptable laser marking results. But there may be some limitations since the text or information to be laser-marked could produce an undesired color, level of contrast or an unexpected resolution. Additionally, there is an important risk of no longer complying with regulations, especially in the medical devices sector.
For these reasons ELIX Polymers has developed special medical ABS formulations based on M203FC and M205FC materials that optimize laser marking to achieve a specific color change and a targeted level of contrast over a given color background that is fully compliant with regulations.
ELIX special ABS formulations are also particularly valuable when other relevant material properties must be maintained along with laser marking optimization, like for example, the biocompatibility requirement of ISO 10993.
Since ABS and its color are both important factors for obtaining the required laser marking effect, a critical aspect of this type of development is to create a database selection of available pigments with the highest performance under different laser systems. Several combinations of material-color samples must be prepared and pass a laser processing qualification process. Before this step, a core aspect is to obtain an optimal dispersion of the selected color pigments of the color formulation in the ABS material formulation. The mix of color masterbatches with ABS material in natural color during the injection molding process cannot guarantee the same level of color homogeneity as pre-colored ABS. The reason for this resides in a better dispersion of pigment powders in the ABS matrix during the compounding extrusion process that is required for producing pre-colored ABS.
In the case of medical devices requiring biocompatibility, among the available pigments used for optimizing laser marking contrast, only the ones with biocompatibility properties and within the legal admissible concentrations can be used to guarantee compliance with the required medical regulation. The ELIX Product Stewardship department provides essential support for this task, which also adds value by conducting a constant surveillance of admitted substances and concentrations and by guaranteeing that the complete formulation, including the color formulation, stay within legal limits. Re-combined validated pigments provide new color formulations for medical ABS, where laser marking contrast is enhanced while guaranteeing the same target color material is maintained.
