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ALBIS’ distribution portfolio will now be expanded to include the EVOPRENE® R product series from Alphagary, one of the leading global compound manufacturers with sites in the UK, US, Mexico and Colombia. EVOPRENE® R are TPE-S compounds that are particularly suitable for use in applications with high regulatory requirements, such as food contact, medical and dental applications, as well as children’s toys.
Designed with food grade ingredients as defined by EU 10/2011, 1935/2004 and US FDA 21CFR guidelines, this compound series is targeted toward applications that need to undergo strict regulatory testing. For example, medical devices that have testing requirements derived from Regulation (EU) 2017/745 on medical devices (European Medical Devices Regulation) or USP Class VI biocompatibility requirements are applications where the EVOPRENE® R compound series would be a recommended candidate.
EVOPRENE® R is available with Shore hardness values from A12 to A73. The technical properties of TPE-S compounds are characterized by a good reset behavior and excellent resistance to different media. They behave like rubber but flow like thermoplastics when exposed to heat and pressure.
"The regulatory service, e.g. with biocompatibility verification according to the United States Pharmacopeia or according to the specifications of the ISO 10993 standard means the TPE-S compounds from Alphagary optimally complement our existing healthcare portfolio. Typical applications for TPE-S compounds are syringe plugs, caps and seals as well as connectors and dental applications," says Mike Freudenstein, Director of Global Marketing Healthcare & Industry Management at ALBIS.
"With the EVOPRENE® R product series, we are responding to the increased regulatory requirements of the market and specializing our product range," says Richard Day, European Sales Manager at Alphagary. "Our customers expect transparency and we are happy to oblige them. When a material is chosen for medical, pharmaceutical, food or skin contact applications, we want the name to indicate that the material has been designed with the most appropriate ingredients in mind."
