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. Theyre 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.
- 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 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 -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 are available on request
s BioClosure Systems are manufactured from pure silicone or TPE thats free of animal-derived components. Your processes stay biologically safe.
BioClosure System Assemblies
Standardized configurations for media bottles, flasks and carboys using AdvantaFlex Biopharmaceutical Grade TPE tubing and molded components are available.
Silicone Bottle Stoppers
Use as a disposable item to reduce cross contamination risks, cleaning requirements, and validation time and costs.
Download a printable version of our BioClosure Systems brochure. BioClosure_Systems.pdf (400KB)
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