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With our partner Foster Corporation, a leading specialist in polymer technologies, we provide medical device manufacturers with high performance polymers and additives for their medical applications including Class I, II and III devices, combination products, and drug delivery applications. We support the entire product life cycle, from new product development through commercialization with custom services that include product selection, material characterization, process engineering, regulatory support, inventory management and logistics.
LOTTE Advanced Materials offer “medical grade” polycarbonate and ABS (opaque and clear) products that feature biocompatibility tested products (ISO 10993 and USP Class VI) as well as EtO and gamma sterilizable products that meet the needs of a wide range of medical applications.
Available Medical Grades
Copolymers comprised of soft elastomer and rigid polyamide (nylon) segments which allows for a wide range of physical and mechanical properties by varying the monomer block types and ratios. These plasticizer free, melt processible thermoplastic elastomers are USP Class VI certified and pass ISO 10993. They are sterilization resistant (ETO, steam, gamma), and provide consistent mechanical properties at room and body temperature.
Flexible polyamides (nylons) produced from castor oil, a renewable resource, with low specific gravities (1.03), making them 15% lighter than Nylon 6. Rilsan® polymers offer outstanding ductility, low moisture absorption, and ease of processing. Rilsan® Clear grades are copolyamides that are generally used in flexible components that require transparency.
Flexible polyamides produced from hydrocarbon that offer the lowest specific gravities (1.01) of all polyamides. Rilsamid® polymers offer outstanding ductility, low moisture absorption and ease of processing by extrusion or injection molding.
Melt processible fluoropolymers with excellent chemical resistance, high purity, high thermal stability and low friction. Unlike other fluoropolymers, Kynar® has high tensile strength and excellent resistance to permeation and radiation. These polymer are USP Class VI certified and can be gamma or steam sterilized.
Semi-crystalline, semi-aromatic polyamide comprised of meta-xylene diamine that offers superior mechanical strength over Nylon 6 and 6/6, with substantially less moisture absorption. MX-Nylon also offers superior gas barrier properties against oxygen and carbon dioxide for packaging applications.
Aromatic thermoplastic polyurethanes available in polyether and polyester grades. Fully automated, continuous reaction production provides lot-to-lot consistency for grades ranging in Shore hardness from 75A to 70D. USP VI biocompatibility grades are available.
Polycarbonate and ABS have been, and still are, polymer material staples of the medical industry. LOTTE Advanced Materials offer “medical grade” polycarbonate and ABS (opaque and clear) products that feature biocompatibility tested products (ISO 10993 and USP Class VI) as well as EtO and gamma sterilizable products that meet the needs of a wide range of medical applications.
Aran’s Protex Med® homopolymer polypropylene is available in pellet form as a permanently implantable material choice for applications that require either injection molding or extrusion processing options. Support for Protex Med® PP includes technical data sheet (TDS), FDA Masterfile reference data, certifications to technical specifications and ISO 10993-5 (cytotoxicity), as well as suitability for long term implantation supported by data derived form FDA 510(k) cleared surgical mesh.
Shepherd’s bismuth subcarbonate is manufactured using a proprietary milling process to achieve particle sizes below 0.3 micrometers (1.2 x 10-5 inches). These fine particles allow for optimal dispersion of the radiopaque filler throughout the polymer during melt blending. This results in the excellent surface finish and consistent radiopacity throughout the device component.
Manufactured by Degradable Solutions (a Sunstar Group company), calc-i-pur™ β tricalcium phosphate is a biocompatible mineral powder comprised of calcium salt and phosphoric acid. calc-i-pur™ is commonly used in the manufacturing of orthopedic implants to stimulate bone growth. Osteoconductive composites containing TCP minerals can be custom manufactured using bioresorbable polymers, including PLA, PGA as well as hydroxyapatite additives (HA) for biphasic formulations. calc-i-pur™ is available in GMP and non-GMP batches.
calc-i-pur™ meets the general requirements of ASTM F1088, “Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation.
Two grades of Combat™ Antimicrobial are currently available. Combat AD is commonly used in thermoplastic urethanes (TPU) and silicones for indwelling devices such as central venous (CV) catheters. Combat™ AK master batch is designed using Agion AK antimicrobial additive: a large particle zeolite (> 6 μm) and a low proportioned ionic silver (4-6%).Combat AK is commonly used in polycarbonate and acrylonitrile butadiene styrene (ABS) polymers for high-touch surface components and devices. These include bedrails, diagnostic equipment housings and instrument handles.
For further information please refer to www.fostercomp.com