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 environments
Silicone elastomer meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9, and other industry standards
Assembled and packaged in a Class 7 (Class 10, 000) ISO-certified clean room
Both silicone and TPE are certified free of animal-derived ingredients
Documented lot traceable
For single or repeated use sterilizable through autoclave or gamma radiation
Single use applications reduce cleaning and validation requirements and costs, plus cross contamination risks
Smooth, gap-free surfaces for a true seal and a secure environment
Longer life expectancy, more consistent performance, and higher purity than parts made from rubber materials
Resistant to cracking and particle migration
No taste or odor transfer
Excellent chemical resistance properties
Silicone withstands temperatures ranging between -100F (-73.3C) and 400F (204.4C)
Select stopper sizes available; other silicone closures custom manufactured
Certain 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 metal
Available with tubing installed
Validation and extractables test portfolios available upon request
The silicone and thermoplastic elastomer compounds used to make BioClosure Systems have a Master File with the U.S. Food and Drug Administration
AdvantaPure's BioClosure Systems are manufactured from pure silicone or TPE that's free of animal-derived components. Your processes stay biologically safe.