Biocompatible thermoplastic compounds for use in medical devices
Biocompatible thermoplastic compounds for use in medical devices
A series of biocompatible styrenic-based thermoplastic elastomer (TPE) compounds suitable for use in medical devices has been developed to provide healthcare designers and engineers additional TPE material options that make it easier to obtain regulatory approval for medical components and devices.
The inclusion of these materials 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 over molding, 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 - 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. Applications for TPEs range from drug delivery systems, that require multi-shot over molding 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, 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.
A series of biocompatible styrenic-based thermoplastic elastomer (TPE) compounds suitable for use in medical devices has been developed to provide healthcare designers and engineers additional TPE material options that make it easier to obtain regulatory approval for medical components and devices.
The inclusion of these materials 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 over molding, 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 - 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. Applications for TPEs range from drug delivery systems, that require multi-shot over molding 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, 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.
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