GEFA UltraPure offer a biopharmaceutical Grade TPE tubing (Thermoplastic Elastomer) which fulfills a need for flexible, translucent, sterilizable, moldable, heat sealable and weldable tubing for fluid processing. AdvantaFlex tubing has undergone extensive physical, chemical, and biological testing and meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.2.2.1.
• Sterile weldable and heat sealable.
• Available as leak-proof molded connections and tubing.
• Made from FDA-approved ingredients Animal Derived Ingredient Free.
• 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.
• REACH, RoHS and California Proposition 65 compliant.
• Excellent low absorption & adsorption characteristics as compared to silicone.
• Low permeability as compared to silicone.
• Smooth interior for excellent flow and performance.
• Translucent for fluid flow visibility.
• Sizes from 1/8” (.125) through 1” (1.000) I.D.
• Custom lengths, sizes, and packaging available.
• Complete validation package & BPOG test results available upon request.
AdvantaFlex TPE tubing maintains its physical properties following sterilization processes, resists kinking, remains translucent for visible product flow, and does not become gummy.
• 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