BioClosure® Container Closure Systems

High Purity Container Closures

Manufactured from AdvantaSil® 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. Full BPOG standardized extractables test protocol has been performed by a fully-accredited, third-party test lab.

BioClosure systems are not intended for implantation or continuous steam applications.

 

KEY FEATURES

  • Engineered 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 Class 7 (Class 10,000) ISO-certified clean rooms
  • Both silicone and TPE are certified free of animal-derived ingredients
  • AdvantaFlex tubing is 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 -169.6°F (-112°C) and 400°F (204.4°C), depending on the silicone formulation
  • 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 standard silicone and thermoplastic elastomer compounds used to make BioClosure Systems have a Master File with the U.S. Food and Drug Administration

Full BPOG standardized extractables test results for AdvantaFlex closures and tubing are available on request

AdvantaPure's BioClosure Systems are manufactured from pure silicone or TPE that's free of animal-derived components. Your processes stay biologically safe.