Saint-Gobain Life Sciences Bioprocess Solutions Welded top and sealed tubing C-Flex Tubing for Biopharmaceutical Applications Features Benefits Sealable and weldable either pre- or poststerilization Sterilizable by gamma irradiation and autoclave Validation package available for all C-Flex commercial formulations. Moldable bondable and formable for singleuse assemblies and overmolds Non-pyrogenic non-cytotoxic non-hemolytic Trust the Original C-Flex is the original patented thermoplastic elastomer tubing specifically designed to meet the critical demands of pharmaceutical and biopharmaceutical applications for fluid processing with excellent heat seal and sterile weld capabilities. For over 25 years C-Flex has been the thermoplastic elastomer tubing most widely used and validated by the worlds leading pharmaceutical and biopharmaceutical companies. Each coil of C-Flex tubing is extruded to precise ID and wall dimensions. All tubing is formulated to meet the standards of the biopharmaceutical industry and is quality tested before leaving the Saint-Gobain Performance Plastics production facilities. The Material Difference C-Flex tubing is part of a family of TPE tubing offering the widest range of formulations and sizes in the industry including translucent tubing for fluid flow visibility opaque tubing for application when sensitivity for light is required and custom formulations from 50A to 80A durometer. C-Flex is also available as C-Flex Braided to use in applications where a thermoplastic tube is desired but the pressure requirements exceed those allowable by a non-reinforced thermoplastic material. All are available in custom sizes lengths and packaging. C-Flex tubing has a secure global supply chain with redundant manufacturing sites in the United States and Europe with validated manufacturing processes. Significantly less permeable than silicone Smooth inner bore for superior fluid flow All formulas are Animal-Derived Component Free Single-use Appli
cations Aseptic sealing disconnections Aseptic welding connections Ideal for use in single-use assemblies Buffer and media preparation Cell culture operations Purification operations Diagnostic products Biopharma manufacturing Single-use fluid transfer sets Tubing and bags manifolds Laboratory RD Easy Validation Process C-Flex tubing is manufactured from pharmaceutical-grade thermoplastic materials and is fully characterized validated and tested to a variety of specifications including USP Class VI ISO 10993-3 Ames Genotoxicity ISO 10993-4 Hemolysis Indirect ISO 10993-5 Cytotoxicity In-Vitro ISO 10993-11 Systemic Toxicity In-Vivo and European Pharmacopeia. Extensive biological chemical physical properties and extractable testing performed on unsterilized and sterilized C-Flex tubing is available to assist in the validation of C-Flex application. FLS-5067E-1016-BPS Remains flexible from -45C to 135C -50F to 275F 2016 Saint-Gobain Performance Plastics High-purity water systems Typical Physical Properties of C-Flex FORMULATION Property Reference 374 082 072 Appearance Translucent Translucent Opaque ASTM D2240 60 60 60 Durometer Shore A Tensile Strength psi ASTM D412 1190 1106 1196 Elongation ASTM D412 915 874 862 Tensile Modulus 100300 psi ASTM D412 244385 256400 247389 Tensile Set 300 Stretch ASTM D412 24 29 26 Compression Set Constant Defl. B 22hrs 70C ASTM D395 83 89 86 Brittle Point C ASTM D746 -65 -64 -66 Low Temperature Flexibility -45C ASTM D380 Pass Pass Pass Sterilization Methods Chemical Resistance Acids DiluteWeak Acceptable Acids StrongConcentrated Acceptable Bases DiluteWeak Acceptable Bases StrongConcentrated Acceptable Salts Acceptable High-purity Water Acceptable Alcohol Not recommended OilWater Emulsion Test before using Organic Solvent Not recommended Autoclavable one time 30 minute cycle at 121C Radiation up to 40kGy NOTE C-Flex tubing will deteriorate with repeated autoclaving. Radiation is the recommended method of steriliza
tion for all C-Flex thermoplastic materials. Characteristics The manufacturing process is carefully controlled from raw material through production. Inspection and lot traceability information is readily accessible as batch numbers are assigned. All packages are identified by external labeling on both the bag and the crush-proof box. Brief or intermittent contact is acceptable. NOTE It is the users responsibility to insure the suitability and safety of C-Flex for all intended usesapplications. C-Flex comes in a wide variety of sizes and formulations. FLS-5067E-1016-BPS One-piece overmolded C-Flex manifold maintains inner bore diameters with superior reliability and product integrity. 2016 Saint-Gobain Performance Plastics
