BIOPHARMACEUTICAL DEVICE FOR SINGLE USE IN THE PREPARATION, STORAGE, TRANSPORT OF A BIOPHARMACEUTICAL PRODUCT AND CORRESPONDING MULTILAYER TUBE.

摘要

The device (1) comprises a pocket (2), a pipe section (5) having a wall (10) limiting a longitudinal free space (11), a connector (4), made of plastic material, welded together, the wall (10) having a contact layer (12) of a material other than PVC selected from PE, EVA, PP, ETFE, PVDF and a functional layer (13) comprising at least one functional elemental layer ( 13i) made of a material chosen for its function (flexibility, robustness, manipulation, opacity or transparency, gas barrier) and chosen from the family comprising PE, PET, PA, EVA, EVOH, SEBS, PETG, PVDF, a bag (2), another tube section (5) and / or a connector (4), welded to the biopharmaceutical tube (5) having a contact layer (16) of a selected material adapted to be in contact with the biopharmaceutical product and to be weldable on itself, and identical or similar to the material of the contact layer (12) of the biopha tube (5), the contact layer (12) of the biopharmaceutical tube (5) being welded to the contact layer (16) of the pocket (2), another tube section (5) and / or biopharmaceutical connector (4). ), with substantial physical continuity between the respective contact layers (12, 16).