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New Program Makes Elastomer Compounds Available to Medical Manufacturers
ROSEMONT, Ill.--Earlier this fall, the Thermoplastic Elastomer Division of Teknor Apex Company announced its MedalistTM program, intended to serve as a single source of elastomers for medical manufacturers. Described by Teknor Apex as "an innovative and far-ranging medical-elastomers program," the Medalist program provides device manufacturers with numerous new high-purity thermoplastic elastomer compounds, along with a comprehensive body of tools and information for designers and processors.
"The new Medalist initiative is a leap forward in our capability for serving medical manufacturers," said Andy Claytor, sales director, in a statement released by the company. "While Teknor Apex has long supplied medical-grade compounds, the comprehensiveness of the Medalist range and the technical resources that accompany it will enable customers to use our program as a single source of elastomers for an array of applications and to eliminate guesswork in making material selections."
The initial range of 33 Medalist compounds is already extensive. Shore A hardness spans a broad range, from 5 to 87. Clear, translucent, and opaque formulations are available. The compounds fall into three series: Versatile Series (MD-100), with widely differing grades that are said to meet many requirements encountered in medical manufacturing; Resilient Series (MD-200), formulated for enhanced toughness, oil-resistance, or heat-resistance; and Bondable Series (MD-300), for over-molding onto a variety of thermoplastic substrates. The three series are available worldwide.
"All 33 Medalist compounds have been tested for compliance with ISO 10993-5 cytotoxicity standards and are free of animal-derived materials, vinyl, phthalates, latex, and additives not directly required for medical applications," said Lisa Charno, medical market manager. "The sheer breadth of Medalist product offerings is remarkable--from super-soft gels to elastomers that are semi-rigid, like hard rubber. Grades are available for every major process in medical manufacturing, from injection molding to blow molding to extrusion of thin film."
To aid designers in selecting the best compound for an application, and processors in optimizing production, Teknor Apex has prepared an expandable handbook and grade selector with information on every Medalist compound, including data on toxicology, sterilization, chemical resistance, and other properties, along with design considerations and processing guidelines. Teknor Apex has established a website at www.medalistmd.com that has data on all Medalist grades.
"The Medalist program is unique because it addresses such a wide range of performance requirements, subjects every one of the available grades to the same comprehensive testing, and addresses as many as possible of the issues that affect users of medical elastomers, including pending regulations," said Charno. "The whole point of the Medalist initiative is to provide--up front--all of the information designers need to make the best raw material choice."
All Medalist elastomers meet ISO-10993-5 standards for non-toxicity and are compliant with U.S. Food & Drug Administration (FDA), RoHS, U.S. Conference of Northeastern Governors (CONEG), and California Proposition 65 requirements relevant to medical applications. They provide the advantages of thermoplastics--outstanding processability, recyclability, colorability, and design freedom--with the elasticity and tensile strength of conventional rubber.
The 17 grades in the Medalist Versatile Series (MD-100) are all clear or translucent and include a 5 Shore A ultra-soft clear gel; tubing grades optimized for softness, kink-resistance, alcohol resistance, or high clarity; and high-flow injection molding elastomer for complex or thin-wall parts. They also include compounds formulated for blow molding and for broad processing latitude; materials free of oil plasticizers; and elastomers with high levels of hardness, elasticity, hot water resistance, dynamic wear resistance, resilience at high temperatures, and surface smoothness.
The ten initial offerings in the Medalist Resilient Series (MD-200) are opaque compounds ranging in Shore A hardness from an ultra-soft 15 to a semi-rigid 80. They include grades optimized for oil resistance and toughness. One formulation is free of oil plasticizer.
The Medalist Bondable Series (MD-300) has six grades for over-molding, including opaque, clear, and translucent formulations. Depending on the grade, substrates include ABS, co-polyester, high-impact polystyrene, nylon, and polycarbonate.
For more information, visit www.teknorapex.com.
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