Activité : Single Use Process
Type : Closed system, Molded
Brand : AdvantaPure
Application : Transfer
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.
Main features :
- Assembled and packaged in a Class 7 (Class 10,000) ISO-certified clean room
- Aucun transfert de goût ou d'odeur
- Le silicone et le TPE sont tous deux certifiés exempts d'ingrédients d'origine animale (ADCF)
- Traçabilité des lots documentée
- Tests de validation et d'extractibles disponibles sur demande.
- Engineered for pharmaceutical, biotech, and laboratory environments
Full BPOG standardized extractables test protocol has been performed by a fully-accredited, third-party test lab.
Standardized configurations for media bottles, flasks and carboys using AdvantaFlex Biopharmaceutical Grade TPE tubing and molded components are available.
Additional features :
- Silicone elastomer meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9, and other industry standards
- Silicone withstands temperatures ranging between -169.6°F (-112°C) and 400°F (204.4°C), depending on the silicone formulation
- Longer life expectancy, more consistent performance, and higher purity than parts made from rubber materials
- Available with tubing installed
- Resistant to cracking and particle migration