Press Release Summary:
Supplied in pellet form for injection-molded applications, radiation-stabilized MakrolonÂ® Rx2435 meets requirements of U.S. FDA-Modified ISO 10993, Part 1 Biological Evaluation of Medical Devices tests. Potential thin-wall applications include dialysis components, catheter connectors, drug delivery devices, and surgical instruments such as trocars, retractors, and handles.
Original Press Release:
Bayer Materialscience LLC Develops New Radiation-Stabilized Medical Grade of Polycarbonate Resin to Meet Increasing Demand for Thin-Wall Applications
High-flow Makrolon® Rx2435 has met the requirements of the FDA-Modified ISO 10993, Part 1 tests
Pittsburgh, June 10, 2009 - Building upon the proven efficacy of Makrolon® Rx2530, Bayer MaterialScience LLC has developed a new medical grade that addresses the increasing demand for a radiation sterilizable material for thin-wall medical applications. Introducing Makrolon Rx2435 polycarbonate resin.
Like Makrolon Rx2530 polycarbonate, Makrolon Rx2435 resin exhibits a good balance of mechanical strength and toughness. What differentiates Makrolon Rx2435 resin from previous medical grades is its ease of flow, which was enhanced specifically to meet the needs of thin-wall applications. Like Makrolon Rx2530 polycarbonate, the new grade meets the requirements of U.S. Food and Drug Administration (FDA)-Modified ISO 10993, Part 1 "Biological Evaluation of Medical Devices" tests, the widely accepted standard for biocompatibility.
"We see a growing trend in the health care market for thin-wall applications," said Kevin Dunay, market segment leader, Medical Polycarbonates NAFTA, Bayer MaterialScience LLC. "Makrolon Rx2435 extends our medical grade product portfolio, reinforcing our commitment to provide material solutions for an expanding breadth of medical applications."
Potential thin-wall applications for Makrolon Rx2435 include dialysis components, catheter connectors, surgical instruments - such as trocars, retractors and handles - and drug delivery devices.
The resin is supplied in pellet form for injection-molded applications. It is gamma-stabilized and typically offered in the color Gamma (color code 451118), one of the Rx Medical colors from Bayer MaterialScience's LEDA® compounded color technology. However, Makrolon Rx2435 polycarbonate resin can also be colored in any of Bayer MaterialScience's other Rx Medical colors, all of which meet FDA-Modified ISO 10993, Part 1 testing requirements.
Makrolon Rx2435 polycarbonate is the latest in a long line of material innovations from Bayer MaterialScience. For almost 50 years, medical device OEMs and the health care market have relied on Bayer MaterialScience's proven materials and technical expertise. It's a track record that began with the use of Makrolon polycarbonate in the first blood oxygenators and renal dialyzers in the 1960s.
Bayer MaterialScience LLC is one of the leading producers of polymers and high-performance plastics in North America and is part of the global Bayer MaterialScience business with nearly 15,100 employees at 30 sites around the world and 2008 sales of 9.7 billion euros. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life. The main segments served are the automotive, electrical and electronics, construction, medical, and sports and leisure industries.
For more information about Bayer MaterialScience's Makrolon Rx2435, call 1-800-662-2927, e-mail firstname.lastname@example.org or visit www.bayermaterialsciencenafta.com.