APAF-BP: AdvantaFlex® Biopharmaceutical Grade TPE Tubing
AdvantaFlex addresses the need for a flexible, translucent, sterilizable, moldable, heat sealable, and weldable biopharmaceutical tubing for fluid processing. AdvantaFlex TPE tubing maintains its physical properties following sterilization processes, resists kinking, remains translucent for visible product flow, and does not become gummy.
KEY FEATURES
- Sterile weldable and heat sealable
- Now available as leak-proof molded connections and tubing
- Made from FDA-approved ingredients
- Certified free of silicone oils and animal-derived ingredients
- Sterilizable by autoclave or gamma radiation
- Available with validated sterility assurance of 10-6 via gamma irradiation per ISO 11137 method VDmax 25
- Meets various ISO and USP standards, including Class VI
- Meets European Pharmacopoeia 3.2.2.1 standards
- REACH, RoHS and California Proposition 65 compliant
- Excellent low absorption and adsorption characteristics as compared to silicone
- Low permeability as compared to silicone
- Smooth interior for excellent flow and performance
- Translucent for fluid flow visibility
- Excellent tubing component for single-use systems
- Sizes from 1/8″ (.125) through 1″ (1.000) I.D.
- Custom lengths, sizes, and packaging available
- Supplied double bagged
- Documented quality control; lot traceable with identification on polybags
- Single resin validation — no need to graft to other tubing materials like silicone for media filling and sampling applications that involve peristaltic pumps; helps eliminate operator errors
- “Extractables” test portfolio available
- AdvantaFlex has a Master File with the U.S. Food and Drug Administration (#28810)
- Complete validation package available upon request
APPLICATIONS
- Sterile filling
- Vaccine production
- Pharmaceutical sampling and delivery systems
- Single-use systems
- Bioreactor processes
- Cell media, harvesting, and fermentation
- Pharmaceutical production and processing
- High purity water transfer
- Filtration
Because of its ability to be sealed and welded, AdvantaFlex is ideal for filling and sampling applications.
Brochure Advanta Flex
