Abstract: A device including: a bag, a tube section having a wall defining a free longitudinal space, and a plastic connector, which are all fused together, the wall including a contact layer made of a material other than PVC, selected from PE, EVA, PP, ETFE, and PVDF, and a functional layer including at least one basic functional layer of a material selected for the function thereof (flexibility, sturdiness, handling, opacity or transparence, gas barrier) and selected from the family including PE, PET, a PA, EVA, EVOH, SEBS, PETG, and PVDF, a bag, another tube section, and/or a connector fused to the biopharmaceutical tube and including a contact layer made of a material capable of being in contact with the biopharmaceutical material, which is capable of being fused onto itself, and which is identical or similar to the material of the contact layer of the biopharmaceutical tube.

Abstract: A multilayer film for manufacturing a pouch, includes: a core layer, and an outer layer, wherein: the outer layer and the core layer are made integral with a tie layer, the core layer includes an ethylene vinyl alcohol copolymer having an ethylene content ranging from 25 to 48 mol %, alone or in mixture with an ionomer acid ethylene copolymer, the outer layer includes a polyolefin having a density ranging from 0.910 g/cm3 to 0.940 g/cm3 or a copolymer of ethylene and ?-olefin having a density ranging from 0.870 g/cm3 to 0.910 g/cm3, or a mixture thereof, the tie layer includes a copolymer of polyolefin grafted with a carboxylic acid or an anhydride of carboxylic acid, alone or in mixture with (H) a copolymer of polyolefin. The process for manufacturing such a film, and the single-use pouch manufactured from that film are also described.

Abstract: A film for manufacturing a pouch includes a contact layer including (A) a copolymer of ethylene and ?-olefin having a density in the range of 0.870 g/cm3 to 0.910 g/cm3, alone or in mixture with (B) a polyolefin having a density in the range of 0.910 g/cm3 to 0.940 g/cm3, the contact layer including less than 0.10 wt %, preferably less than 0.07 wt %, of additives able to release a degradation compound further to gamma irradiation in the range of 25 kGy-50 kGy that can slow down or delay cellular growth. The process for manufacturing such a film, as well as the single-use pouch manufactured from that film are also described.

Abstract: A multilayer film includes a contact layer, a core layer, and an outer layer, the contact and core layers being integral with a first tie layer; and the outer and core layers being integral with a second tie layer; the contact layer includes a copolymer of ethylene and ?-olefin having a density from 0.870 to 0.910 g/cm3, alone or in mixture with a polyolefin having a density from 0.910 to 0.940 g/cm3; the core layer includes a flex-crack resistant ethylene vinyl alcohol copolymer having an ethylene content from 25 to 48 mol % or a mixture of an ethylene vinyl alcohol copolymer having an ethylene content from 25 to 48 mol %, and an ionomer acid ethylene copolymer; the outer layer includes a polyolefin having a density from 0.910 to 0.940 g/cm3, alone or in mixture with a copolymer of ethylene and ?-olefin having a density from 0.870 to 0.910 g/cm3.

Abstract: A mixing vessel includes a flexible container, elements for mixing its contents, aeration elements, a drain/lower bearing port having a rigid flange provided with a drain passage, attached in a tight manner to the lower portion of the container wall, supporting a lower bearing that is adjacent to the drain passage. The vessel includes an extended element for dispensing aeration gas and is spaced essentially radially from the drain/bearing port; at least one tubular element for dispensing aeration gas extends from the extended dispensing element, in the inside space, along the inside surface of the lower portion and the side portion of the wall of the container and extends on the outside of the container from the upper portion; at least one mixing element is spaced essentially from the lower portion of the container wall, from the lower bearing, and from at least one extended element for dispensing aeration gas.

Abstract: A closure for a container has an upper part (1) that can be connected to the container. The upper part (1) has an opening (2) and an outer hollow body (3). An inner hollow body (4) is arranged coaxially in the outer hollow body (3) with an intermediate space therebetween. A lower part (7) in the form of a hollow body can be displaced longitudinally in the intermediate space. A plug (5) is held coaxially in the lower part (7) and opens or closes the opening as the lower part (7) is displaced longitudinally in the intermediate space.

Abstract: A device including: a bag, a tube section having a wall defining a free longitudinal space, and a plastic connector, which are all fused together, the wall including a contact layer made of a material other than PVC, selected from PE, EVA, PP, ETFE, and PVDF, and a functional layer including at least one basic functional layer of a material selected for the function thereof (flexibility, sturdiness, handling, opacity or transparence, gas barrier) and selected from the family including PE, PET, a PA, EVA, EVOH, SEBS, PETG, and PVDF, a bag, another tube section, and/or a connector fused to the biopharmaceutical tube and including a contact layer made of a material capable of being in contact with the biopharmaceutical material, which is capable of being fused onto itself, and which is identical or similar to the material of the contact layer of the biopharmaceutical tube.

Abstract: Monolayer contact film, designed, once made integral with a multilayer functional film, to constitute a final multilayer film of a pouch wall; the pouch having seams, and designed to be filled with biopharmaceutical product, and composed of a selected material that can be part of the composition of the final multilayer film, be in contact with the biopharmaceutical product, without degradation of the film and biopharmaceutical product, be sealable on itself, with a thickness that is less than the thickness of a single contact layer of the final multilayer film suitable for the production of seams of the single contact layer on itself, of which one surface functions as an interface for interlocking with a first interface for making the multilayer functional film integral, and whose other surface has as its final function to constitute the contact surface of the final multilayer film with the biopharmaceutical product.

Abstract: Process of producing a biopharmaceutical product includes providing a pouch unit including a pouch and at least one port, and optionally, a functional device; filling the pouch with the product; carrying out the production process, and at at least one stage thereof, using or generating a liquid or small solid incident body within the biopharmaceutical product; the pouch unit incorporating a support and replacement element formed by or integrated in the pouch wall, or in the port or functional device so as to be accessible from the inside space and be in direct physical contact with the contents of the pouch, arranged so as to be able to be loaded with the incident body and pass between the support and replacement element and the contents, such that the incident body is loaded on the support and replacement element when it is not or should not be within the biopharmaceutical product.

Abstract: A closure for a container has an upper part (1) that can be connected to the container. The upper part (1) has an opening (2) and an outer hollow body (3). An inner hollow body (4) is arranged coaxially in the outer hollow body (3) with an intermediate space therebetween. A lower part (7) in the form of a hollow body can be displaced longitudinally in the intermediate space. A plug (5) is held coaxially in the lower part (7) and opens or closes the opening as the lower part (7) is displaced longitudinally in the intermediate space.

Abstract: A process is disclosed for making devices which release active material, e.g. a drug, at a controlled rate, which device comprises a closed container and the active material. The device is made by first making a hollow envelope, e.g. by extrusion or moulding, followed by introducing the active material into the void of the envelope. The device may have a ring or cylindrical form.