MATERIALS | MEDICAL COMPOUNDS


Right: Luran S MED is a range of styrenic compounds from Ineos Styrolution targeted at injection moulded housings for portable


medical devices


tions are challenging the medical device industry to find materials that support compliance,” says Mau- reen MacDonald-Stein, Director Portfolio Strategy and Market- ing in SABIC’s Specialties business. “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.” SABIC says its Ultem HU polyetherimide


(PEI) resins, for example, are compatible with a number of sterilisation methods and retain their strength, dimensional stability, and aesthetics under exposure to repeated sterilisation cycles. The company’s PEI compounds are available as both unreinforced and glass-fibre reinforced grades.


Fluoropolymer alternatives A pending regulatory change threatening to affect materials for medical markets is the anticipated restriction of per and polyfluoroalkyl substances (PFAS) in the US and EU. PFAS make up a class of several thousand different fluorine-containing chemicals which are used in many applications. There are concerns over their effects on humans and the environment, as well as their persistence and bio-accumulation. Fluoropolymers such as polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) are currently grouped together by regulators as part of the larger category of PFAS. “In the face of proposed European and individu-


al US state regulations severely restricting or banning the use of PFAS, customers in the health- care industry and other markets are seeking self-lubricated solutions that don’t incorporate these chemicals,” says Ralph R Buoniconti, SABIC Senior Specialist Regulatory. New specialty compounds in SABIC’s LNP


Lubriloy portfolio are presented as alternatives to polymers lubricated with PTFE for reduced friction and enhanced wear resistance. Medical applications include, for example, drug delivery pens and


Self-lubricated compounds reduce


friction between plastic parts to help deliver repeatable and efficient motion in medical devices such as drug delivery pens for injectable drugs


16 COMPOUNDING WORLD | April 2024


pumps, and various latches, gears and bearing surfaces. Lubriloy products are available today in PC, PA66, POM, PPE, PC/ABS, PPA and PBT-based formulations. The new grades include unrein- forced and reinforced products with up to 30% glass fibre. Fluoropolymers are also employed to make parts used in biopharmaceutical manufactur- ing. BPSA responded to the


European Chemical Agency’s (ECHA) proposed ban on PFAS with a statement


requesting that “pharmaceutical and biopharma- ceutical processing, including its supporting supply chain, be regarded as a sector, and permitted the same exemption, or unlimited derogation, as medicinal products.” The BPSA is concerned that extending the


proposed broad restriction of PFAS to cover fluoropolymers could have unintended conse- quences on the global manufacturing of biophar- maceutical products, ultimately impacting availabil- ity of existing medicinal therapies, including vaccines, as well as the development of new therapies,” according to BPSA Executive Director, Chris Clark, (see the BPSA statement).


Styrenics for medics Among the latest additions to the Luran S line of styrenic compounds from Ineos Styrolution is Luran S MED 797S SPF30, an ASA grade targeted at small injection moulded housings for portable medical devices. Available in natural and white, the new grade provides resistance to chemicals and disinfectants, as well as good impact performance over the expected ambient operating temperature range (which the company says makes it a good alternative to standard ABS grades). Like many grades in the Ineos Styrolution


product portfolio, the new MED 797S grade is also available with a mass balance attributed renewable feedstock content. The company says its ISCC- certified 40% renewable content results in a carbon footprint reduction of up to 52% compared to fossil-based Luran S grades. “The market segment of small, mobile medical and hospital devices is growing rapidly,” says Bernd Elbert, Market Development Manager at Ineos Styrolution. “The properties of our new Luran S MED 797S SPF30 make it a very strong contend- er for device housings and casings in this specific category.” NAS ECO is another Ineos Styrolution material


www.compoundingworld.com


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IMAGE: SABIC


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