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Global custom engineered thermoplastics compounder RTP Company has introduced a series of biocompatible styrenic-based thermoplastic elastomer (TPE) compounds suitable for use in medical devices. RTP 2700 S MD Series materials have been pretested for compliance with ISO 10993-5/10/11 biocompatibility standards and are available in hardnesses ranging from 30 to 80 Shore A.
“Our RTP 2700 S MD Series TPE compounds were developed to provide healthcare designers and engineers additional TPE material options that make it easier to obtain regulatory approval for medical components and devices,” said Josh Blackmore, Global Market Manager—Healthcare. “Having ISO 10993 biocompatibility testing compliance makes these RTP Company materials ideal candidates for many healthcare applications because the formulations have been pretested for cytotoxicity, irritation, and acute systemic toxicity. The inclusion of these materials to our TPE product portfolio will make it possible for OEMs to advance the design and function of their medical devices.”
These biocompatible TPE compounds offer a number of advantages to medical device applications including gamma and EtO sterilizability. They can be processed via multi-shot overmolding, with inherent bondability to polypropylene substrates, to add “soft touch,” ergonomic features for molded-in stoppers, seals, and masks. Good flexibility is maintained over their entire 30 to 80 Shore A hardness range and these products are cost competitive when replacing alternative medical grade TPE materials such as thermoplastic vulcanizate (TPV) or olefinic-based thermoplastic elastomer (TEO).
Naturally translucent, these TPE compounds are fully colorable with RTP Company’s companion EMD Series color products — which offer biocompatibility compliance to precolored resins and color masterbatches. “These materials have a very neutral color and are appropriate for use in many Class I and II medical devices,” explained Blackmore. “Such translucent or clear materials are often preferred for many medical applications.”
Applications for RTP 2700 S MD Series TPEs range from drug delivery systems, that require multi-shot overmolding for ergonomics and cost efficiency, to disposable devices that require good needle stick and reseal performance, tear strength, or compression set properties. These materials will also benefit other applications such as surgical tools that require slip-resistance when moist and color identification for accurate tool identification. They can also be used in respiratory care requiring materials that offer a high degree of clarity and low tack for contact with patient’s skin.
“The mechanical property versatility and processing flexibility of these biocompatible TPE compounds from RTP Company, along with easing FDA approval for medical devices in which they are used, will allow greater innovation that will ultimately lead to improved products and procedures to advance medical treatment,” said Blackmore.