Manufactured from USP Class VI, platinum-cured silicone elastomer or from AdvantaFlex biopharmaceutical grade TPE, AdvantaPure's BioClosure Systems offer the utmost in purity. They're biologically safe and work with vessels of glass, metal or plastic. Stoppers, caps, inserts for True Unions and GL45's, and other styles, with or without tubing, are available.Ideally suited for pharmaceutical, biotech, and laboratory environmentsSilicone elastomer meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9, and other industry standardsAssembled and packaged in a Class 7 (Class 10, 000) ISO-certified clean roomBoth silicone and TPE are certified free of animal-derived ingredientsDocumented lot traceableFor single or repeated use sterilizable through autoclave or gamma radiationSingle use applications reduce cleaning and validation requirements and costs, plus cross contamination risksSmooth, gap-free surfaces for a true seal and a secure environmentLonger life expectancy, more consistent performance, and higher purity than parts made from rubber materialsResistant to cracking and particle migrationNo taste or odor transferExcellent chemical resistance propertiesSilicone withstands temperatures ranging between -100F (-73.3C) and 400F (204.4C)Select stopper sizes available; other silicone closures custom manufacturedCertain styles available manufactured from AdvantaFlex biopharmaceutical grade TPE (thermoplastic elastomer)For use with flexible container systems, laboratory apparatus and bottles, and sampling and storage receptacles of glass, plastics, or metalAvailable with tubing installedValidation and extractables test portfolios available upon requestThe silicone and thermoplastic elastomer compounds used to make BioClosure Systems have a Master File with the U.S. Food and Drug AdministrationAdvantaPure's BioClosure Systems are manufactured from pure silicone or TPE that's free of animal-derived components. Your processes stay biologically safe.