PolyMedex color specialists utilize a library of over 130 highly pure biocompatible pigments to achieve accurate colors while accommodating clients’ regulatory constraints. Conversely color concentrates contain a limited number of generic polymers and pigments that may limit regulatory compliance. Dissimilar carrier polymers can also result in gels that negatively impact surface quality and tensile properties in the finished catheter. “Regardless of whether a medical device will be sold in the US, Europe, or Asia,” says Byron Flagg, Product Manager at PolyMedex Discovery Group, “device designers value the control over ingredients a custom colored polymer offers.”
PolyMedex blends its custom polymers in twin screw extruders at low pigment concentrations to ensure homogeneous pigment dispersion without agglomerates, whereas color concentrates by definition contain very high pigment concentrations that do not disperse in a single screw extruder or injection molding press, resulting in surface bumps and nibs.
PolyMedex production facilities are ISO 9001:2008 certified and utilize a proprietary computerized pigment dispensing system for validated repeatability. Every production lot of colored polymer is digitally scanned to ensure lot-to-lot consistency. Rigorous process control ensures that PolyMedex colored polymers achieve or exceed the consistency found from mass produced color concentrates.
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