SABIC Showcases Cutting-Edge ULTEM HU Resins at MD&M West 2024

SABIC, a public company based in Riyadh, Saudi Arabia, is set to showcase its ULTEM HU resins at MD&M West 2024, providing a viable alternative for medical device manufacturers seeking options beyond ethylene oxide (EtO) sterilization. With a surge in demand for materials compatible with alternative sterilization methods, especially in light of potential EPA regulations on EtO emissions, ULTEM HU resins offer stability across various sterilization processes, presenting the potential for multiple use options. These resins exhibit resilience through multiple sterilization cycles, retaining strength and color, thereby reducing breakage and discoloration and potentially extending the lifespan of applications.

The heightened focus on environmental regulations in the medical device industry has propelled the need for materials aligning with compliance requirements. SABIC, with its team of industry experts and ongoing innovation, is at the forefront, proactively developing material solutions to meet evolving challenges. As the medical device industry anticipates changes in EtO emissions due to forthcoming EPA regulations, SABIC's ULTEM HU resins provide specialized thermoplastics that facilitate a seamless transition to alternative sterilization methods without compromising essential material properties.

At MD&M West 2024, SABIC will present a session titled "How thermoplastic material selection impacts durability and sterilization of medical devices." The presentation will encompass properties and performance data for ULTEM HU resins, comparing them with polyphenylsulfone (PPSU) resin both before and after sterilization, along with relevant application case studies.

Given the potential health risks associated with ethylene oxide gas, classified as a human carcinogen, the EPA proposed a rule on April 11, 2023, to strengthen Clean Air Act standards, aiming to reduce EtO emissions by an estimated 80%. Approximately 50% of sterile medical devices undergo EtO treatment, totaling around 20 billion devices annually. In light of the impending EPA rule, device manufacturers may seek alternative sterilization methods.

ULTEM HU resins prove versatile by being compatible with several mainstream sterilization methods, including vapourized hydrogen peroxide (VHP), gas plasma, steam autoclave, gamma radiation, electron beam, X-ray, and ultraviolet-C. Throughout repeated sterilization cycles, these materials maintain high strength, dimensional stability, and aesthetically pleasing characteristics.

Among the available options, customers can opt for ULTEM HU1000 resin, an unfilled polyetherimide (PEI) with commendable mechanical and thermal properties, or ULTEM HU1004 resin, a PEI blend offering enhanced ductility and hydrostability. Both grades are biocompatible, chemical-resistant, and inherently flame-retardant.

The unreinforced ULTEM HU resins, renowned for their strength and stiffness, can effectively replace metal in medical device components. They bring advantages such as lightweight, design flexibility, and streamlined processing. For applications requiring even higher strength, SABIC offers glass fiber-reinforced grades like ULTEM HU2200 and HU2300 resins.

SABIC's commitment to quality and safety is underscored by its Healthcare Product Policy, which validates that these medical-grade products comply with global safety standards. These materials are covered by an FDA Drug or Device Master File, and their formula is locked, ensuring adherence to a stringent change management process.