BioClosure® System Assemblies

Single Use; for Bottles, Flasks and Carboys

BioClosure System AssembliesBioClosure System Assemblies, made from AdvantaFlex® biopharmaceutical grade TPE, provide a ready to use, cost effective solution to reduce assembly time and eliminate cleaning validations. The Single-Use, closed cap system features a robust design to protect product integrity and decrease the risk of contamination. BioClosure System Assemblies are an ideal choice for bioprocessing applications such as aseptic sampling, cell growth and filling.

Full BPOG standardized extractables test protocol has been performed by a fully-accredited, third-party test lab; applies to AdvantaFlex closures and tubing only.

 

KEY FEATURES

  • All systems come preassembled with fluid transfer tubing for easy use
  • Meets various ISO and USP standards, including Class VI
  • Assembled and packaged in Class 7 (Class 10,000) ISO-certified clean rooms
  • Easy connections – AdvantaFlex tubing is sterile weldable and heat sealable
  • AdvantaFlex tubing is certified free of animal-derived ingredients
  • Documented lot traceable with identification on packaging
  • Documented quality control per ISO 9001:2015 AdvantaFlex validation and extractables test portfolios available upon request
  • AdvantaFlex has a Master File with the U.S Food and Drug Administration (#28810)

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