Sartorius Stedim Biotech S.A.

Aubagne, France

Sartorius Stedim Biotech S.A.

Aubagne, France
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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.


The container includes a lower wall and an erect side wall limiting an upper opening of a housing for accommodating a flexible pouch containing a fluid; containment elements including a containment wall, the gap between its peripheral edge and the side wall being limited; the containment wall adapted to be applied against the pouch and held fixed in this position by holding elements arranged in the container and borne by the containment elements by a structural and functional combination, and being movable between an inactive retracted state and an active expanded state, in which a distal end part is either moved away from the side wall or applied there against without any chance of sliding; and adapted to be applied at any desired location of a zone of the side wall such that the containment wall can be applied and held against the pouch regardless of how full the latter is.


The sensing device (12) includes support and fixing elements (13), elements (14) for capturing the parameter, fixed rigidly to the support and fixing elements (13), including a sensing face (14a), situated in a chamber (17), a solid internal chamber end wall (30) disposed transversely, an open part (18) made in the chamber peripheral wall (27), the chamber (17) being a holding chamber (17) able to ensure confinement of the content (C) therein, and being isolated from the inside space (3a) of the container and safeguarded from the agitation prevailing therein, by the internal end wall (30) of the chamber so as to minimize the impact of this agitation on the measurement of the parameter of the content (C) by the sensing face (14a).


A pouch (2) includes: a first, inner, envelope (1) which is closed, delimiting a first space (6) forming a pouch stricto sensu (1) intended for receiving a biopharmaceutical product or device; a second, outer, envelope (8) which is closed, delimiting a second space (9) in which is located the first envelope/pouch stricto sensu (1); a spacer element (11); at least one tracer gas located in the first space (6) or in the intermediate space (14) at a partial pressure different from that of the intermediate space or of the first space; and at least one colorimetric detection layer (12), responding to the concentration of tracer gas which reaches it by changing from a first color to a second color, and being an integral part of a wall (3, 4) of the first envelope/defined pouch (1) and/or of a wall (13) of the second envelope and/or of the spacer element.


Patent
Sartorius Stedim Biotech S.A. | Date: 2010-03-16

A mixing container includes a flexible container, mixing elements and an upper bearing having a rigid flange. The flange is provided with an insertion passage that fluidically communicates with the inside space on one end and with the outside of the container on the other end. The flange is fixed in a rigid and sealing manner to the upper part of the wall of the container around an insertion opening, the insertion passage and the insertion opening communicating fluidically. The flange also supports, on the inside thereof, an upper bearing that is arranged inside, adjacent to the insertion passage, without preventing the fluidic communication between the insertion passage and the insertion opening. The mixing container is used to receive a biopharmaceutical content to be mixed.


A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, a second closed, outer casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.


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.


Patent
Sartorius Stedim Biotech S.A. | Date: 2011-04-20

A connection part providing communication between biopharmaceutical containers and/or conduits, includes a connection sheath (32) and two connection skirts (38a, 38b). The connection sheath (32) and both connection skirts (38a, 38b) have resiliency such that the connection part (30), from a disassembled state, is transversely stretchable, at the site of both connection skirts (38a, 38b) thereof, until transversely widened without loss of integrity so as to be made threadable through both collars (14, 24). Then, due to the resiliency thereof, the connection part contacts, with resilient clamping for support and with sealability, the coupled portion of the outer surface of both collars (14, 24). Moreover, from the assembled state, the connection part is transversely stretchable, at the site of both connection skirts (38a, 38b) thereof, until transversely widened so as to be capable of being unthreaded from both collars (14, 24) and thus be converted to the disassembled state.


A flexible bag for biopharmaceutical use, includes a shell for receiving, in an inner space thereof, a flowable biopharmaceutical product, and flexible walls joined by fixed and sealed rigid-connection areas, two opposite walls being connected to each other by the peripheries thereof, at least one inlet port and one outlet port, a port being combined with a passage of the shell and mounted thereon by fixed and sealed connection elements, a plurality of similar outlet ports grouped together in a tapping area, a tapping wall provided with at least one opening for the passage and assembly of the outlet port for the similar outlet ports, fixed and sealed port-shell connection elements which are rigidly, fixedly, and sealingly connected to the tapping wall around the at least one opening for the passage and assembly of the outlet port, and an area for folding the two opposite walls.


Patent
Sartorius Stedim Biotech S.A. | Date: 2011-02-11

A sterilizable biopharmaceutical packaging includes an opening for inserting biopharmaceutical contents to be sterilized, the opening being separate from a sterilization gas conveyance channel so that the opening can be closed independently and before closing the sterilization gas conveyance channel. The opening is directly adjacent to an inner space for receiving the biopharmaceutical contents so that the contents to be sterilized are inserted directly into the inner space from outside the packaging. The elements for controlling the distribution of the sterilization gas open/close the sterilization gas conveyance channel independently of the opening or closing of the insertion opening. After sterilization, the outer wall, the sterilization gas conveyance channel, and the opening/closing element are capable of remaining rigidly connected therebetween so as to form a sterilized biopharmaceutical packaging that contains the sterilized biopharmaceutical contents and can be subjected to one or more integrity tests at any desired time after the sterilization.

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