SABIC, a specialist in the chemical industry, will highlight at MD&M West 2024 in Booth 3287 its ULTEM HU resins, which is designed to help medical device manufacturers choose alternatives to ethylene oxide (EtO) sterilisation.
SABIC
Demand is growing for materials compatible with other sterilisation methods in anticipation of a new ruling by the U.S. Environmental Protection Agency (EPA) that may reduce EtO emissions from commercial sterilisation facilities. ULTEM HU resins are stable across many popular sterilisation processes, providing the potential for multiple use options. These resins can also withstand multiple sterilisation cycles. Their excellent retention of strength and colour can help reduce breakage and discolouration, thereby potentially extending the useful life of applications made with these materials.
“Increasingly stringent environmental regulations are challenging the medical device industry to find materials that support compliance,” said Maureen MacDonald-Stein, director, portfolio strategy and marketing, SABIC’s Specialties business. “SABIC’s knowledgeable team of industry experts and our ongoing innovation help enable the proactive development of material solutions to address these types of challenges. In the case of upcoming reductions in EtO emissions, we offer specialty thermoplastics that help device makers to smoothly transition to other sterilisation methods without impacting key material properties.”
At MD&M West, SABIC will give a presentation on this topic, titled “How thermoplastic material selection impacts durability and sterilisation of medical devices.” The talk, given by Paul Nugent, SABIC’s senior business manager, will take place on 7th February at 3:30 p.m. PST in Design Alley. It will cover properties and performance data for ULTEM HU resins compared to those of polyphenylsulfone (PPSU) resin before and after sterilisation, and application case studies.
Providing alternatives to EtO sterilisation
Ethylene oxide gas is a human carcinogen, and long-term exposure can lead to harmful effects. Therefore, on 11th April, 2023, the EPA issued a proposal to strengthen and update Clean Air Act standards for EtO emitted from commercial sterilising facilities. The proposed rule would reduce EtO emissions by an estimated 80%.
According to the U.S. Food and Drug Administration (FDA), approximately 50% of sterile medical devices are treated with EtO, totalling about 20 billion devices each year. In view of the upcoming EPA rule, which requires changes such as reducing the amount of EtO applied in medical device sterilisation, device makers may wish to use other methods.
ULTEM HU resins are compatible with a number of mainstream sterilisation methods, including vaporised hydrogen peroxide (VHP) gas plasma, steam autoclave, gamma radiation, electron beam, X-ray and ultraviolet-C. Under exposure to repeated sterilisation cycles, these materials retain their high strength, dimensional stability and attractive aesthetics.
Customers can choose ULTEM HU1000 resin, an unfilled polyetherimide (PEI) featuring excellent mechanical and thermal properties, or ULTEM HU1004 resin a PEI blend offering good ductility and enhanced hydrostability. These grades are biocompatible, resistant to chemicals and inherently flame retardant.
Thanks to their strength and stiffness, unreinforced ULTEM HU resins can replace metal in medical device components, where they deliver light weight, design flexibility and streamlined processing. SABIC’s glass fibre-reinforced grades, such as ULTEM HU2200 and HU2300 resins, may also be options when even higher strength is required.
SABIC’s medical-grade products are backed by its Healthcare Product Policy, which validates these materials meet global safety standards, are covered by an FDA Drug or Device Master File and are subject to formula lock and a stringent change management process.