Material Notes:
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