A colorable thermoplastic medical grade elastomer with good fluid resistance, certified non-toxic by MEM elution test. It has USP Class VI Certificate of Compliance for biocompatibility and can be processed using injection molding, extrusion, blow molding or other melt processing techniques. Drug Master File has been established at US FDA National Center for drugs and biologics. Key Features: MEM elution cytotoxicity to L-929 mouse fibroblast cells, 72 hr. exposure to rubber extract; NAmSA, MT023-100 test method; test unit, % cell lysis; typical value 0; USP physiochemical test for elastomer closures, heavy metals such as lead; NAmSA, CP020-004 test method; Test unit, ppm; typical value <1 Additional processing comments: This thermoplastic rubber is a shear-dependent material that can be processed on conventional thermoplastic equipment for injection molding, extrusion, or blow molding. For extrusion, a general purpose screw with a compression ratio of 2.5 to 3.0 is recommended. Material can be recycled. SANTOPRENE rubber is incompatible with acetal and PVC. Values below are for injection molded plaques, side gated, 82.6 mm x 117.5 mm x 3.0 mm. Tensile properties measured across flow. Data provided by Advanced Elastomer Systems. Advanced Elastomer Systems is now a part of ExxonMobil. This grade was removed from the Advanced Elastomers Systems standard product line before the ExxonMobil acquisiton. |