Manufactured from USP Class VI, platinum-cured silicone elastomer, AdvantaPure's BioClosure Systems offer the utmost in purity. They're clean room manufactured, biologically safe, and work with vessels of glass, metal, or plastic. Stoppers, caps, inserts for True Unions, GL45's, and other styles, with or without tubing, are available.
BioClosure Systems are not intended for implantation or continuous steam applications.Key Features- Ideally suited for pharmaceutical, biotech, and laboratory environments
- High purity components offer optimal performance in single-use process systems
- Silicone elastomer meets USP Class VI, FDA CFR 177.2600, ISO 10993-18, European Pharmacopoeia 3.1.9, and other industry standards
- Manufactured and packaged in a Class 7 (Class 10,000) ISO-certified clean room
- 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
- Withstands temperatures ranging between -100ºF (-73.3ºC) and 400ºF (204.4ºC)
- Select stopper sizes available; other closures manufactured on a custom basis
- 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
