3370 I.B. Braid-Reinforced Silicone Hose biopharmaceutical products The smooth surface platinum-cured silicone hose designed for transferring high-purity fluid under pressure FeaturesBenefits Consistently smooth inner surface limits particle entrapment Platinum cured to minimize extractables Designed to Maintain Fluid Purity Under Pressure Braid reinforced for increased pressure resistance TYGON 3370 I.B. silicone hose is frequently specified in the most demanding applications requiring sanitary transfer of fluids. Its smooth inner surface reduces the risk of particle entrapment and inhibits excessive residue and microscopic bacterial build-up cleaning and sterilization cycles may become more effective as a result. Additionally an improvement in fluid flow characteristics may occur from the reduced surface area and lowered absorption of fluids to the wall. TYGON 3370 I.B. can easily withstand repeated SIP and CIP cleaning and sterilization cycles making it ideal for repeat-use applications. Its flexibility durability and chemical and temperature resistance provide a unique combination of characteristics required in many pharmaceutical biotechnology laboratory food beverage cosmetic environmental and industrial applications. Tough braid reinforcement permits use under elevated working pressures Withstands repeated CIP and SIP cleaning and sterilization Custom color striping available Typical Applications Sterile filling Media dispensing Vaccine manufacturing Lower Extractables and Exceptional Biocompatibility Bioreactor process lines TYGON 3370 I.B. silicone hose is produced from a platinum curing process to meet the most demanding requirements of biocompatibility. Water purification systems In-house extractability tests have shown that TYGON 3370 I.B. hose has a low extractable content. Lower extractables help to maintain the purity of transported fluids in sensitive applications. Diagnostic test product manufacturing TYGON 3370 I.B. hose complies fully w
ith the requirements of the USP Class VI Criteria and is entirely non-toxic non-hemolytic and non-pyrogenic. Continued monitoring of the hose also ensures minimal bioburden levels are maintained. TYGON 3370 I.B. hose also meets 3-A Sanitary Standard No. 18-01 and FDA 21 CFR Part 177.2600 criteria. TYGON 3370 I.B. silicone hose has a Master File with the U.S. Food and Drug Administration. Food and dairy processing Sanitary fitting assembly TYGON 3370 I.B. Hose Inventory Sizes Part Number AHJ001718 AHJ001719 AHJ001720 AHJ001721 AHJ001722 AHJ001671 AHJ001724 AHJ421725 AHJ421726 AHJ421798 I.D. inches 316 14 38 12 58 34 1 1-14 1-12 2 O.D. inches .443 .515 .687 .847 .980 1.150 1.390 1.636 1.900 2.427 Minimum Bend Radius 14 12 34 1-14 1-12 2-14 3-12 5-34 6-34 8-34 Length feet 50 50 50 50 50 50 50 25 25 25 Max. Working Pressure at 73F at 320F psi psi 170 125 150 105 130 95 125 90 110 80 100 75 70 50 55 40 40 30 20 12 Vacuum Rating In. of Mercury at 73F at 320F 29.9 29.9 29.9 29.9 29.9 29.9 29.9 29.9 29.9 29.9 29.9 29.9 15.0 10.0 10.0 5.0 5.0 0.0 0 0 Working pressures are calculated at a 14 ratio relative to burst pressure using ASTM D1599. The values listed for working and burst pressures are derived from tests conducted under controlled laboratory conditions. Many factors will reduce the hoses ability to withstand pressures including temperature chemical attack stress pulsation and the attachment to fittings. It is imperative that the user conduct tests simulating the conditions of the application prior to specifying the hose for use. TYGON 3370 I.B. Typical Physical Properties Property ASTM Method Value or Rating D2240 70 D412 Translucent 1200 8.3 D412 D624 Die B D792 D570 500 250 44 TYGON 3370 I.B. Sterilization Methods Durometer Hardness Shore A 15 Sec Color 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. 347F 175C for 22 hrs. Brit
tleness by Impact Temp. F C Maximum Recommended Operating Temp.F C Autoclavable Gas Ethylene Oxide Radiation Radiation up to 5.0 MRad 50 Kilogray Dielectric Strength vmil kVmm D149 600 24 Tensile Modulus 200 psi MPa D412 650 4.5 Tensile Set D412 25 TYGON 3370 I.B. Toxicological Profile The biocompatibility of TYGON 3370 I.B. has been tested and found to be non-toxic in the following test protocols USP Systemic Toxicity and Intracutaneous Reactivity USP Intramuscular Implant Cytotoxicity Blood Compatibility USP Physico Chemical Tests TYGON HOSE IS NOT INTENDED FOR USE AS AN IMPLANT MATERIIAL 1.18 0.11 D395 Method B D746 3 10 -112 -80 320 160 Unless otherwise noted all tests were conducted at room temperature 73F. Values shown were determined on 0.075 thick extruded strip or 0.075 thick molded ASTM plaques or molded ASTM durometer buttons. TYGON is a registered trademark. biopharmaceutical products Come through clean. SM Saint-Gobain Performance Plastics 3910 Terry-Diane Street Beaverton MI 48612 Tel 888 387-0067 Tel 989 435-9533 Fax 989 435-2355 Verneret La Mothe-Aux-Aulnaies 89120 Charny France Tel 33-386-637-878 Fax 33-386-637-777 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 W
ARRANTIES 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-3181D-M-1008-SGCS www.biopharm.saint-gobain.com 2008 Saint-Gobain Performance Plastics Corporation
