Global custom engineered thermoplastics compounder RTP Company has expanded its line of biocompatible compounds for medical devices to include thermoplastic elastomer (TPE) bondable grades. RTP Company’s new RTP 6042 MD and RTP 6003 MD Series TPE compounds have been pre-tested for compliance with ISO 10993 (part 5 in vitro cytotoxicity, part 10 irritation, and part 11 systemic toxicity) biocompatibility standards.
RTP 6042 MD Series TPE compounds have a Shore A hardness range from 40 to 70 and RTP 6003 MD Series have a Shore A hardness range from 45 to 75. These products are formulated to bond with ABS, PC, PC alloys, rigid TPU, or co-polyester substrates using either multi-shot or insert molding processes. A statement of biocompatibility is available for these compounds to help medical device designers demonstrate to regulatory bodies a pattern of concern for safety.
“To meet the growing demand for bondable TPEs in medical devices, RTP Company is helping product designers and OEMs by streamlining the material selection process with products that have been pre-tested for biocompatibility,” said Josh Blackmore, RTP Company’s Global Healthcare Manager. “RTP Company’s MD Series TPE compounds offer a broad performance range, that includes gamma and EtO sterilizability, combined with highly sought-after elastomeric properties.”
“Using TPEs is a great way to enhance the design and functionality of medical devices by providing better grip or non-skid surfaces, improving tactile feel and ergonomics, or delivering aesthetics for corporate branding and increased consumer appeal,” said Paul Killian, RTP Company’s Business Manager – TPE Products. “The ability to bond TPEs to engineering grade thermoplastic substrates using multi-shot overmolding processing also reduces assembly time and can reduce manufacturing costs.”
Naturally opaque, the new MD Series TPE compounds are fully colorable with RTP Company’s biocompatible color products which provide pre-tested ISO 10993 compliance in precolored resins and color masterbatches. Additionally, these products are designated as change controlled formulas to ensure there is no modification to ingredients without customer authorization.
Key applications include surgical tools, fixation devices, and positioners that require tactile feel and slip resistance; drug delivery systems such as transdermal patches, injection pens, and inhaler pumps; and intravenous and catheter systems.