Saint-Gobain TYGON® 2475 I.B.

2475 I.B. High-Purity Pressure Tubing PHARMACEUTICAL SYSTEMS High-purity pressure tubing with low sorption flexibility and clarity available in a single tubing FeaturesBenefits Extremely Low Sorption to Aqueous Fluids Plasticizer Free TYGON 2475 I.B. tubing is one example of Saint-Gobain Performance Plastics commitment to the development of innovative material technologies which positively impact process efficiency. Tough Braid Reinforcement for Elevated Working Pressures Meets USP Class VI and FDA Criteria Minimize Fluid Alteration and Loss Maintaining product integrity during fluid transfer is critical in most pharmaceutical and biotechnology applications. Loss of fluid through migration into the tubing or adherence of fluid onto the tubing walls may create inconsistencies in final product results. TYGON 2475 I.B. High-Purity Tubing is hydrophobic and resists the sorption absorptionadsorption of aqueous fluids. This reduction in sorption minimizes the risk of fluid alteration in single or repeat-use applications. Flexibility Without the Use of Plasticizers Until now clear flexible tubing was restricted from use in many applications due to concern of plasticizer extraction. TYGON 2475 I.B. High-Purity Tubing is entirely free of any plasticizers. This unique tubing uses the latest in polymer technology to provide a clear between braid and flexible tubing choice for sensitive fluid transfer applications. Superb Chemical Resistance Provides Versatility in Cleaning and Sterilization TYGON 2475 I.B. tubing is virtually unaffected by chemical sanitizers and cleaners. As a result it can be cleaned repeatedly without decreasing its service life. The non-wettable surface of the product facilitates complete drainage of fluid during the cleaning process. In addition TYGON 2475 I.B. tubing can be sterilized easily using conventional gamma radiation and gas ethylene oxide. Typical Applications Deionized Water Systems Sterile Fill Lines Cell Harvest and Media Process Syst

ems Water for Injection WFI Transport Preservative Fill Lines Pharmaceutical and Cosmetic Processing Chemical Transfer 2475 I.B. High-Purity Pressure Tubing TYGON 2475 I.B. High-Purity Pressure Tubing Inventory Sizes Part Number ACX00019 ACX00029 ACX00038 ACX00046 ACX00054 ACX42064 I.D. O.D. inches inches 14 38 12 34 34 1-116 1 Length feet 18 50 18 58 12 58 Wall Thickness inches 50 18 78 50 18 532 1-38 316 Minimum Max. Suggested Vacuum Bend Working Rating In. of Radius Pressure at Mercury at 73F psi 73F inches 38 225 1 230 1-14 135 1 50 1-34 25 3-12 50 TYGON 2475 I.B.Typical Physical Properties 29.9 210 29.9 29.9 135 29.9 29.9 125 29.9 Safety factor of 4 to 1 ratio of burst pressure to working pressure using ASTM D1599. Relative Chemical Resistance Properties Tubing TYGON 2475 I.B. Fluoroelastomers Urethane PVC Thermoplastic Rubber Neoprene Nitrile Rubber Silicone EVA Acids conc. med. weak Bases conc. med. weak Salts F E U F U E E U E F E E U E F E U U E F E F F E E E F F E E E E F E E E F U F F E U U U U U F U U F F U F E E U E E U U F E E F E E E F E E E F E E E F E U U U U E Excellent F Fair U Unsatisfactory Alcohols Ketones Percentage of Preservative Remaining 100 90 80 70 60 50 40 30 20 10 0 92 89 TYGON 2475 Silicone 98 75 65 37 24 Benzyl Alcohol 0.9 Phenol 0.4 10 Meta-Cresol 0.4 ASTM Method Value or Rating Durometer Hardness Shore A 15 Sec Color D2240-97 72 Clear Tensile Strength psi MPa Ultimate Elongation Tear Resistance lb-finch kNm Specific Gravity Water Absorption 24 hrs. 23C Compression Set Constant Deflection 158F 70C for 22 hrs. Brittleness by Impact Temp. F C Maximum Recommended Operating Temp.F C Low Temp. Flexibility F C D412-97 2000 13.8 D412-97 D1004-93 700 220 39 D792-91 D570-95 0.9 0.01 D395-89 Method B 84 D746-95 -108 -78 125 52 D380-87 -94 -70 Dielectric Strength vmil kVmm D149-93 587 23.1 Tensile Modulus 100 Elongation psi MPa D412-97 375 2.6 Non-Toxic D412-97 187 Toxicity Tensile Set Unless otherwise noted a

ll tests were conducted at roomtemperature 73F. Values shown were determined on 0.075 thick extruded strip or 0.075 thick molded ASTM plaques or molded ASTM durometer buttons. Comparative AbsorptionAdsorption of TYGON 2475 I.B. Tubing vs. Silicone Tubing Test Methods Used Drug preservatives were analyzed by gas chromatography after 72 hours of contact with each tubing. Property Sterilization of TYGON 2475 I.B. Gas Ethylene Oxide. Radiation Radiation up to 2.5 MRad. TYGON TUBING IS NOT INTENDED FOR USE AS AN IMPLANT MATERIAL Methyl Paraben 0.14 Leading the way in Saint-Gobain Performance Plastics 2664 Gilchrist Road Akron OH 44305 Tel 330 798-9240 Tel 800 798-1554 Fax 330 798-6968 Critical Fluid Transfer and Containment. TYGON is a registered trademark. IMPORTANT It is the users responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics tubing for all intended uses. Laboratory and clinical tests must be conducted in accordance with applicable regulatory requirements in order to determine the safety and effectiveness for use of tubing in any particular application. For a period of 6 months from the date of first sale Saint-Gobain Performance Plastics Corporation warrants this product to be free from defects in materials and workmanship. Our only obligation will be to replace any portion proving defective or at our option to refund the purchase price thereof. User assumes all other risk if any including the risk of injury loss or damage direct or consequential arising out of the use misuse or inability to use this product. THIS WARRANTY IS IN LIEU OF THE WARRANTIES OF MERCHANTABILITY FITNESS FOR PARTICULAR PURPOSE AND ALL OTHER WARRANTIES EXPRESSED OR IMPLIED. No deviation is authorized. Saint-Gobain Performance Plastics Corporation assumes no obligations or liability for any advice furnished by it or for results obtained with respect to those products. All such advice is given and accepted at the buyers risk. FLS-5085A-PDF-1215-SCCS www

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