Silicone elastomer OEM1

custom-made

Parker’s Medical Systems Business Unit is a single source FDA registered and ISO 13485 certified medical device contract manufacturing firm. Our range of capabilities for the manufacture of elastomeric molded medical components and finished devices includes engineering, design, and complete tool management. We offer a wide range of molded, insert-molded and over-molded medical grade elastomer components that are manufactured in either a clean environment or in ISO Class 8 cleanroom. Process Capabilities: We specialize in medium to high volume molding of conventional high consistency silicone rubber and organic rubber via compression and injection/compression molding processes. Our horizontal and vertical molding process capabilities for the manufacture of medium to high volume elastomer molded medical device components includes semiautomatic, automatic cold-runner, conventional runner injection and compression methods. Our proficiency in high-volume silicone and organic rubber “flashless” vacuum transfer molding is supported by press sizes up to 500 tons and utilization of high cavitation tooling. Elastomer Materials: All silicone elastomer medical components will pass ISO 10993 tests and we follow a strict mold validation protocol. Parker elastomers with select antimicrobial additives have shown excellent efficacy & biocompatibility while maintaining mechanical properties and process stability. Where required, we can provide custom material formulations to match performance and functional requirements of molded components. Our base material offerings include • Silicone • EPDM • Nitrile • Organics • Antimicrobials