WEINHEIM, Germany—The new fluorolelastomer from Freudenberg Sealing Technologies GmbH and Co. is "long-term compliant and future-proof."
The new FKM, a peroxidic-crosslinked compound, has passed its regulatory requirements and is going to market as 75 FKM 239961.
The FKM, which complies with all pertinent European Union and FDA regulations, is designed for use in the pharmaceutical and food and beverage spaces.
"This uncompromisingly complies with the latest regulations," said Martin Scherer, material developer at Freudenberg Sealing Technologies. "This is important because there are constant updates on the cleanliness of food contact materials, especially in Europe."
Freudenberg Sealing Technologies uses fluoroplastics and rubber that belong to the PFAS, or polymeric per- and polyfluoroalkyl substances family.
"These large, long-chain molecules are classified as safe for humans and nature by expert bodies such as the OECD (Organization for Economic Co-operation and Development)," Freudenberg said in an April 17 release. "When used and disposed of properly, there is no risk to human health and the environment."
The new FKM has been issued pharma-specific approval, according to USP Chapter 87—which means there are no toxic effects on cell cultures.
"With this advancement, bisphenol crosslinked FKM materials can be replaced in the food industry," Freudenberg said. "These properties, compared to commercially available materials and the very wide range of applications at temperatures from -25°C to 200°C, make it the ideal material for product-contacting applications in the food, beverage and pharmaceutical industries."
Freudenberg added that it is analyzing the draft of the EU-PFAS restriction published in mid-February. Deadline for public statements and consultation of the bodies on the new EU legislation run until the beginning of 2024.
The restriction is to enter into force in 2025 with a transitional period of 1.5 years; to what extent remains unclear, Freudenberg said.
Freudenberg notes that the new FKM can be used for applications where seals that comprise other elastomers, such as EPDM or HNBR, are too weak.
Breakdowns can be caused by pure citrus juices, dairy products or aromatic oils, such as orange or hop oil, Freudenberg said.
O-rings and diaphragms for pumps currently are being made from the new FKM, though Freudenberg said it has plans to customize products made from the new FKM in the future as well.
"The material experts at Freudenberg Sealing Technologies follow the legal regulations very closely," the company said. "All of the company's fluoropolymer suppliers must confirm that they comply with the thresholds for already restricted PFAS chemicals and Freudenberg verifies this information with their own analyses in the laboratory."
The company will highlight this product and others—including a hygienic line and its radial shaft seals—at the upcoming Interphex trade fair from April 25-27 in New York and at the FoodPro trade fair from July 23-26 in Melbourne.
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