{"id":40,"date":"2021-03-05T16:09:43","date_gmt":"2021-03-05T21:09:43","guid":{"rendered":"https:\/\/www.elastomer.kuraray.com\/us\/applications\/medical\/"},"modified":"2024-09-12T05:55:30","modified_gmt":"2024-09-12T09:55:30","slug":"medical-grade-tpe","status":"publish","type":"page","link":"https:\/\/www.elastomer.kuraray.com\/us\/applications\/medical-grade-tpe\/","title":{"rendered":"Medical"},"content":{"rendered":"\n
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Medical grade TPEs<\/h1>\n\n\n\n

Author<\/p>

Robin Conrad<\/a><\/p><\/div><\/div><\/div><\/div>\n\n\n\n

Demand from manufacturers of medical devices for thermoplastic elastomers (TPEs) has been rising for years. Kuraray has established itself as a reliable and efficient producer and supplier of medical grade TPEs. Hydrogenated styrenic block co-polymers (HSBC) from Kuraray are safe and allow high performance and flexibility in the development of medical devices. Selected grades are biocompatible in conformance with ISO 10993 as well as being USP-, EU- and FDA-compliant. In other words, they conform to key standards for medical and food contact uses.<\/p>\n\n\n\n

The HSBC-type medical grade TPEs from Kuraray can replace conventional materials such as PVC and silicone in many applications that require flexibility and elasticity, e.g., IV bags, tubing, stoppers, etc. In addition to their versatility, they often simplify manufacturing and can be used safely in many medical applications. Last but not least, they have key advantages compared with the materials used in the past.<\/p>\n<\/div>\n\n\n\n

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Elastomers in medical devices and tubing<\/figcaption><\/figure>\n<\/div>\n<\/div>\n\n\n\n
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Medical Grade TPEs<\/a><\/p>\n\n\n\n

Further TPEs<\/a><\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Medical Grade SEPTON\u2122 and HYBRAR\u2122<\/h2>\n\n\n\n

The HSBC-type medical grade TPEs from Kuraray have many positive properties. For example, they do not have the critical drawbacks of PVC and are cheaper than silicone. They are also readily recyclable. Products made from medical grade TPEs are sterilizable in various methods and contain only very small quantities of extractables\/leechables. Moreover, TPEs have excellent density.<\/p>\n\n\n\n

The products in the HYBRAR\u2122 7000-series, namely HYBRAR\u2122 7125F (V-SEPS) and HYBRAR\u2122 7311F (V-SEEPS), are an extremely robust, transparent and flexible solution for medical films and tubing. HYBRAR\u2122 is very easy to process thanks to its good compatibility with polypropylene and high affinity to polyolefins. Compounds produced from HYBRAR\u2122 and polypropylene have high tensile strength and excellent impact resistance. Compared with other elastomers, the polymer structure of HYBRAR\u2122 ensures relatively good permeability to oxygen and moisture.<\/p>\n<\/div>\n\n\n\n

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Medical Grade TPEs from Kuraray<\/h4>\n\n\n\n
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  • SEPTON\u2122 2004F<\/li>\n\n\n\n
  • HYBRAR\u2122 7125F<\/li>\n\n\n\n
  • HYBRAR\u2122 7311F<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n
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    Features and Benefits<\/h4>\n\n\n\n
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    • Affordable Solution for soft-touch applications<\/li>\n\n\n\n
    • Good processability<\/li>\n\n\n\n
    • High transparency<\/li>\n\n\n\n
    • Latex protein-free<\/li>\n\n\n\n
    • Plasticizer-free components<\/li>\n\n\n\n
    • Phthalate-free<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n
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      Applications<\/h4>\n\n\n\n
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      • Alternative to PVC<\/li>\n\n\n\n
      • Alternative to silicone and natural rubber<\/li>\n\n\n\n
      • Medical films<\/li>\n\n\n\n
      • Medical tubing<\/li>\n\n\n\n
      • IV bags<\/li>\n\n\n\n
      • Catheter bags<\/li>\n\n\n\n
      • Elastic nonwovens<\/li>\n\n\n\n
      • Plasters<\/li>\n\n\n\n
      • Orthopedic gels<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n
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        High Level of safety<\/h3>\n\n\n\n

        Medical products have to meet high standards of safety and reliability. The biocompatibility of selected HSBC-type medical grade TPEs from Kuraray is certified as conforming to ISO 10933, including ISO 10993-4 (Tests for interactions with blood), -5 (Tests for cyclotoxicity), -10 (Tests for skin sensitization) and -11 (Tests for systemic toxicity). Medical grade TPEs from Kuraray also meet the requirements of USP class \u02c287\u02c3 (In-Vitro Biological Reactivity \u2013 Cytotoxicity Testing) and USP class \u02c288\u02c3 (In-Vivo Biological Reactivity \u2013 Class I\u2013VI Testing). Moreover, they are FDA-compliant. They are also tested in accordance with ASTM F2148.<\/p>\n\n\n\n

        The HSBC-type medical grade TPEs from Kuraray are very safe. Products manufactured from these materials can be used wherever hygiene is particularly important. SEPTON\u2122 and HYBRAR\u2122 do not contain phthalates or other plasticizers and only contain extremely small quantities of extractables and leechables. Since they are latex protein-free, they do not expose patients to a risk of allergies. Medical grade TPEs can be sterilized using all common methods, including e-beam, gamma, ethylene oxide and autoclave methods.<\/p>\n\n\n\n

        Several SEPTON\u2122 and HYBRAR\u2122 grades are produced without using materials derived from animal origin.<\/p>\n<\/div>\n\n\n\n

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        Medical grade TPEs from Kuraray adhere to various regulatory standards.<\/figcaption><\/figure>\n<\/div>\n<\/div>\n\n\n\n
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        High flexibility and quality<\/h3>\n\n\n\n

        The flexibility and rubber-like elasticity of hydrogenated styrenic block co-polymers from Kuraray allow a wide range of applications and considerable design freedom. The medical grade TPEs from Kuraray can be processed using a variety of methods. That means injection molding, blow molding, extruding and co-extruding can be used for cost-efficient production of injected parts as well as films, sheets, profiles and tubes. Thanks to problem-free scalability, they are suitable for both mass production and prototyping.<\/p>\n\n\n\n

        SEPTON\u2122 and HYBRAR\u2122 are recyclable, transparent, clear and fully colorable. The HSBC-type medical grade TPEs from Kuraray are heat-resistant, compression-resistant and kink-resistant. They also have good tensile stretch and produce strong seals in overmolding. High functional TPEs dissipate electrostatic charges. They are x-ray opaque and have lower frictional force.<\/p>\n<\/div>\n\n\n\n

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        Alternative to PVC and silicone<\/h3>\n\n\n\n

        The HSBC-type TPEs from Kuraray have key benefits compared with alternative materials. Unlike PVC \u2013 one of today\u2019s most common plastics \u2013, medical grade TPEs do not contain phthalate plasticizers. They are increasingly being used as an alternative to PVC because both customers and patients want environmentally friendly alternatives to be used in the manufacture of medical devices.<\/p>\n\n\n\n

        Furthermore, \u2013 unlike from PVC \u2013 the production of TPEs does not produce dioxins, which are carcinogenic, disrupt hormone balance and accumulate in fatty tissue of humans and animals. Nor is there another problem that occurs with PVC, the release of chlorine and dioxins during use and incineration. Such burdens on the environment and human health do not occur with TPEs.<\/p>\n\n\n\n

        TPEs are also becoming increasingly attractive as an alternative to silicone: Medical grade TPEs are easier to produce and store than liquid silicone and the production process is more robust.<\/p>\n\n\n\n

        Two other aspects should be considered when looking at TPE vs. silicone. One benefit compared with silicones is that elastomers may be easier to source than silicone due to the restricted availability of siloxane. Manufacturers of medical devices are also concerned about the threatened closure of ethylene oxide sterilization plants, as has already occurred in the USA.<\/p>\n<\/div>\n\n\n\n

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        Key Applications of medical grade TPEs<\/h3>\n\n\n\n

        Films and IV bags<\/h4>\n\n\n\n

        Kuraray has styrene block copolymers with excellent softness and elasticity, which can be used as dry blend in film production or extrusion. In view of their excellent compatibility with polyolefins and polypropylene (PP), these materials allow greater flexibility in the design of film properties than is generally possible when using commercial polyolefin and PP resins on their own.<\/p>\n\n\n\n

        Tubes<\/h4>\n\n\n\n

        HYBRAR\u2122 is an extremely robust, transparent and flexible product for medical tubes and is more environment-friendly than PVC. HYBRAR\u2122 has good compatibility with polypropylene and high affinity to polyolefins, making it very easy to process.<\/p>\n\n\n\n

        HYBRAR\u2122 blends with PP offer good kink resistance and are solvent bondable. Good kink resistance is important for applications where tubing is used to infuse fluids into the body. If medical tubes are bent into tight radius, they must be sufficiently kink-resistant to avoid potentially life-threatening consequences. Tubes with injection-molded components are usually connected by solvent bonding. When using appropriate solvents, high bond strength can be achieved with HYBRAR\u2122.<\/p>\n\n\n\n

        Adhesives<\/h4>\n\n\n\n

        Various products in the SEPTON\u2122 line are biocompatible and safe for skin contact. Therefore, they are an excellent raw material choice to produce adhesives for plasters. Thanks to their balanced adhesive and cohesive properties, medical adhesives containing SEPTON\u2122 products have good release properties, which increases wear comfort, without causing allergies.<\/p>\n\n\n\n

        Soft parts<\/h4>\n\n\n\n

        Kuraray’s portfolio also includes HSBCs for soft parts in medical applications. They are used, for example, to produce syringe stoppers and medical tube connectors, as well as self-sealing applications in containers for vaccine and medicine vials.<\/p>\n<\/div>\n\n\n\n

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        Films and IV bags<\/figcaption><\/figure>\n<\/div>\n\n\n\n
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        Tubes<\/figcaption><\/figure>\n<\/div>\n<\/div>\n\n\n\n
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        Adhesives<\/figcaption><\/figure>\n<\/div>\n\n\n\n
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        Soft parts<\/figcaption><\/figure>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n
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        Disclaimer<\/h4>\n\n\n\n

        Precautions should be taken in handling and storage. Please refer to the appropriate Safety Data Sheet for further safety information. In using SEPTON\u2122 and HYBRAR\u2122, please confirm related laws and regulations, and examine its safety and suitability for the application.<\/p>\n\n\n\n

        For medical, health care and food contact applications, please contact your Kuraray representative for specific information. Even so, users must conduct their own assessment, revisions, registrations as well rely on their own technical and legal judgment to establish the safety and efficacy of their compound and\/or end product with SEPTON\u2122 and HYBRAR\u2122 for any application. SEPTON\u2122 and HYBRAR\u2122 should not be used in any devices or materials intended for implantation in the human body. Nothing contained herein constitutes a license to practice under any patent and it should not be construed as an inducement to infringe any patent and the user is advised to take appropriate steps to be sure that any proposed use of the product will not result in patent infringement.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n

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        Further TPEs for medical applications<\/h2>\n\n\n\n

        Kuraray markets various series of SEPTON\u2122 products \u2013 SEPTON\u2122 2000-series (SEPS), SEPTON\u2122 4000-series (SEEPS) and SEPTON\u2122 8000-series (SEBS) \u2013 that meet the highest quality standards for applications such as medical films, adhesives and tubing. Certain products in the SEPTON\u2122 line, such as the SEPTON\u2122 2000-series and SEPTON\u2122 4000-series, can be used to produce adhesives for plasters. Properties such as low melt viscosity, very good low-temperature performance and excellent processability with low shear rates give the SEPTON\u2122 4000-series improved processing properties and result in soft, flexible compounds over a wide temperature range.<\/p>\n\n\n\n

        Kuraray’s portfolio of hydrogenated styrenic block co-polymers includes various materials that are suitable for use in orthopedic gels. The SEPTON\u2122 4000-series (SEEPS) and the SEPTON\u2122 J-series give orthopedic gels the required stability as well as ultra-soft properties so they have a natural skin-like feeling. The low specific weight and high tear resistance of these elastomers make them a good alternative to silicone in many applications.<\/p>\n\n\n\n

        SEPTON\u2122 J-series and SEPTON\u2122 4000-series were developed for high-performance products where lasting stability and a low compression set are essential. Applications include prosthetic liners and orthopedic bandages. The excellent shock absorbency and non-allergenic properties of these products meet the demanding standards of this sector.<\/p>\n\n\n\n

        Various SEPTON\u2122 products are suitable for use in adhesives for plasters. Examples the SEPTON\u2122 8000-series and the SEPTON\u2122 4000-series, which are an excellent choice for solutions requiring ultra-high purity products.<\/p>\n\n\n\n

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        Contact<\/p>\n\n\n\n

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