Manufactured by DuPont™ Liveo™ Healthcare Solutions, this Liveo™ Pharma TPE Tubing is weldable and designed for the transfer of high-purity fluids in pharmaceutical and biotechnological manufacturing processes. This product is not to be used in medical applications involving implantation in the human body or contact with internal body fluids and tissues.
| Technical Detail | 65A Durometer; 1/4 inch ID x 7/16 inch OD (0.25 inch x 0.438 inch, 6.35 mm x 11.11 mm) x 50 ft coil (15.24 m) |
| Materials | TPE |
| CAD Model Available | No |
| Packaging | 50 ft coil (15.24 m) |
| Manufacturing Environment Classification | ISO Class 7 / 10,000 / Grade C |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Colorant in Part | No |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 60 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| California Prop. 65 | NO Substances on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 6/1/2022 12:00:00 am |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| Human Derived Ingredients | Does NOT intentionally contain human derived ingredients |
| Latex | Does NOT intentionally contain natural latex |
| Latex in Packaging | Information Not Available |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Pyrogen free - Tested via USP <151>/<161> |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2024 January 23 (240 Substances) |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| Autoclave Max Temperature (C) | 121.0 |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| Steam Compatible | Yes |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Finished Component |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Finished Component |
| Residual Solvents: Tested via ICH Q3C Standard | Contains NO ICH Q3C Class 1 or 2 Residual Solvents |
| Elemental Impurities: Tested via ICH Q3D Standard | No ICH Q3D Testing Performed |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | Suitable for intended use according to USP <665> |
| Visible-Subvisible Particulate Claim | USP <788> |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| Integrity Tested? | No |
The products in our inventory are intended solely for use as components for further manufacturing, processing or incorporation into a finished device. These products are not intended for use as finished devices. Customers are solely responsible for determining whether a Qosina component product is appropriate for customer’s intended use and for ensuring that the use of the component product is in compliance with applicable laws. Our components are not available for sale to hospitals, physicians, and pharmacists.
