Ritter GmbH, a German manufacturer of labware and medical products, is moving ahead of the competition with its Polysteribox sterilization and transport container, which uses a new Ultem polyetherimide (PEI) healthcare resin grade from SABIC Innovative Plastics. Patient safety concerns have raised the bar for chemical cleaning and autoclave sterilization of reusable medical devices, requiring manufacturers to find new materials that can withstand stronger alkalinity and higher temperatures. As it has done for many customers, SABIC Innovative Plastics developed a special grade of its workhorse Ultem resin to meet Ritter’s need to comply with the new, tougher standards, demonstrating the company’s ongoing efforts to help healthcare customers meet increasingly stringent regulatory, quality and cost mandates.
“Today’s healthcare industry is incredibly dynamic, requiring the latest material solutions to meet new safety, quality and cost demands from regulators, clinicians and the public,” says Rob de Jong, Specialty Product manager, SABIC Innovative Plastics. “To help customers stay abreast of these changes, SABIC Innovative Plastics continues to develop specialty materials that meet or exceed the latest regulations. Our work with Ritter on the new Ultem healthcare resin showcases our ability to create specialized grades under tight timeframes. We’re delighted that this new, ultra-high-performance material is helping a valued customer offer an improved product to the marketplace.”
The enhanced Ultem healthcare resin grade, which meets ISO10993 certification criteria for biocompatibility, maintains its high performance and attractive, transparent appearance even after 1,000 cycles of chemical cleaning at a PH of 12 or 13 and 1,000 cycles of autoclaving at temperatures of up to 148C. Longer useful life helps to reduce total system cost of the application.
“We were using a different grade of Ultem resin for the Polysteribox container when we learned about the new chemical cleaning and autoclave requirements,” says Michael Fuchs, Ritter Medical Products manager. “SABIC Innovative Plastics immediately began development work to create a new grade meeting our specifications, which included high stiffness, ductility and compressive strength, transparency to see inside without opening the container, and colorability. We were extremely pleased with the fast response and excellent results provided by the SABIC Innovative Plastics’ team. The new, enhanced Ultem resin grade has enabled us to lead our competition by offering a fully compliant product.”
Cleaner Means Safer
With the current emphasis on patient and clinician safety, such as avoiding hospital-borne infections, stricter requirements for cleanliness of reusable medical devices and equipment have been advised by the Robert Koch Institut. The new Ultem resin grade enables the Ritter Polysteribox to maintain its performance and quality during repeated cleanings using harsh, alkaline chemicals.
In addition, by upgrading to the new Ultem resin material, Ritter was able to raise the autoclave vacuum sterilization temperature of its Polysteribox container to 134C. Not only does this higher temperature appear to destroy such pathogens as bovine spongiform encephalopathy, but it also shortens the total autoclave time to 20 minutes (vs. 30 minutes at the previous temperature of 121C). Shorter autoclaving cycles help healthcare organizations and pharmaceutical companies improve productivity and reduce costs.
In both cases, the material retains ductility, transparency and mechanical properties over a long lifespan.
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