Fabricados en Silicona Platinum USP Class VI o en Advantaflex TPE biofarmacéutico. Este tipo de tapones son seguros y pueden trabajar sin problema con recipientes de vidrio, metal o plástico. Se pueden moldear con un tubo incorporado para trasiego del producto (bajo demanda).
Este tipo de tapones no es adecuado para su empleo como implante o para aplicaciones con vapor continuo.
CARACTERÍSTICAS
- Diseñado para la industrias farma, biotecc y laboratorios
- la silicona platinum empleada cumple con USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9, y otros estándares
- Ensamblado y envasado en Sala Blanca Clase 7
- Tanto la silicona como el Advantaflex empleado están libres de ingredientes de origen animal.
- Trazabilidad total
- Para apliacaciones single use aunque es esterilizable con autoclave o por radiación gamma
- 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 protocol is in process for tubing
- BioClosure Systems are manufactured from pure silicone or TPE that’s free of animal-derived components. Your processes stay biologically safe.