Abstract: Disclosed is a fluid connection system including a sleeve, a pipe and a fluid connector, the fluid connector including at least one rigid body made from a sterilizable biocompatible material, and the pipe including a flexible connection portion made from a sterilizable biocompatible material that is at least partially elastomeric. The fluid connector and the flexible connection portion of the pipe are assembled to one another, with the flexible connection portion of the pipe surrounding the rigid body, and the sleeve being shrunk tightly, but with free movement, on the pipe.

Abstract: A bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

Abstract: A method for testing the integrity of a bioreactor container includes providing a bioreactor container having a fluid-tight, at least locally flexible wall and having at least one container opening and providing a test apparatus having a bioreactor container compartment and a fluid-permeable and/or structured reception sheet arranged replaceably on the bioreactor container compartment. The method continues by arranging the bioreactor container in the bioreactor container compartment so that the bioreactor container wall contacts the reception sheet in the bioreactor container compartment, connecting the container opening of the bioreactor container to a fluid source filling the bioreactor container with a fluid from the fluid source to generate a predetermined positive pressure P1 in the bioreactor container at a first time T1 and determining whether the bioreactor container is sufficiently leaktight.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: Disclosed is a coupling device for sealingly coupling a first wall defining a flexible pipe (11) to a tubular nozzle (9) of a connector (1) in a biopharmaceutical assembly, the coupling device including the connector (1) including the tubular nozzle (9), on which one end of the pipe can be inserted along an axis A, a plurality of flexible tabs (3) extending from an intermediate area (7) of the coupling body toward the free end (la) of the nozzle, an abutment clamp (16), a connection interface (6), a separate ring (2), axially movable between an inoperative position and an operative position, for covering the flexible tabs (3) such as to push same radially inward in order to press the pipe onto the nozzle in the operative position, the tabs extending substantially parallel to the axis (A) when the ring (2) is in the operative position.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A device for a tight connection between a first housing (1) having a wall (3), an opening (4), a flange (5) and a door (6), and a second housing (2) having a wall (7), an opening (8), a flange (9) and a door (10). The flanges are complementary, and elements are used to displace the door (6). Elements are used to hold the two doors against each other, and the housings communicate between each other via a communication space (13). There is an inner annular critical line on the door (6) and an outer annular critical line of risk of contamination on the flange (9). The device includes elements (25 and/or 26) that are structurally integrated into the door (6) and/or the flange (9) and can form a separation between the communication space and the inner annular critical line and/or the outer annular critical line, when the doors are open.

Abstract: A bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

Abstract: 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.

Abstract: The invention relates to a housing (1) that is especially designed to be associated with a device for a tight connection to a second housing (2), said first housing comprising a structure including a wall (3) defining a space (1a), an opening (4) defined by a flange (5) that can be hermetically applied to a second flange (9) of the second housing (2), holding means that can keep the first flange and the second flange (9) applied to each other, a door (6) supported by carrying means (11 a), the door leaf (6v) being mobile in such a way as to be closed or open and having an outer face (6a) that can ensure the hermetic application of a second door (10) of the second housing (2), fixing means for holding the leaves (6v, 1 Ov) against each other, displacement manoeuvring means (11b), and means for controlling the displacement manoeuvring means (11b), and, when the leaf (6v) is open, an inlet/outlet space (13a) in/of the inner space (1a) forming part of a communication space (13) between the two housings (1, 2), wh

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

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 bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

Abstract: A method for testing the integrity of a bioreactor container includes providing a bioreactor container having a fluid-tight, at least locally flexible wall and having at least one container opening and providing a test apparatus having a bioreactor container compartment and a fluid-permeable and/or structured reception sheet arranged replaceably on the bioreactor container compartment. The method continues by arranging the bioreactor container in the bioreactor container compartment so that the bioreactor container wall contacts the reception sheet in the bioreactor container compartment, connecting the container opening of the bioreactor container to a fluid source filling the bioreactor container with a fluid from the fluid source to generate a predetermined positive pressure Pi in the bioreactor container at a first time Ti and determining whether the bioreactor container is sufficiently leaktight.

Abstract: A method of mixing including providing a flexible container which comprises at least two components, assembling the components from outside the flexible container to form a centrally disposed magnetic driven shaft with at least one impeller, whereby the integrity of the flexible container is maintained, filling the flexible container having the centrally disposed magnetic driven shaft with one or more ingredients of the contents to be mixed; engaging a magnetic element of the centrally disposed magnetic driven shaft with an external magnetic drive element; analyzing the contents of the flexible container using at least one sensor or a sampling line on the flexible container; and draining the contents of the flexible container through a drain port at the bottom of the flexible container.

Abstract: A disposable mixing vessel comprising a flexible container, a centrally disposed shaft having first and second ends with one or more impellers thereon and a magnetic element associated with a first shaft end, a first flange adapted to rotatably engage the first shaft end and a second flange adapted to rotatably engage the second shaft end.

Abstract: A system for use in freezing, thawing, transporting or storing biopharmaceutical materials which includes a container, a holder and plurality of heat transfer members. The container is configured to hold biopharmaceutical materials therein. The holder has a cavity for receiving the container and includes an interior surface bounding the cavity. A plurality of pockets contact outer surfaces of the container and is received in the cavity. Each pocket of the plurality of pockets includes a pocket cavity. A heat transfer member actively controls the temperature of biopharmaceutical materials held in the container and is received in the pocket cavity.

Abstract: 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.

Abstract: A system for use in freezing, thawing, transporting or storing biopharmaceutical materials which includes a container, a holder and plurality of heat transfer members. The container is configured to hold biopharmaceutical materials therein. The holder has a cavity for receiving the container and includes an interior surface bounding the cavity. A plurality of pockets contact outer surfaces of the container and is received in the cavity. Each pocket of the plurality of pockets includes a pocket cavity. A heat transfer member actively controls the temperature of biopharmaceutical materials held in the container and is received in the pocket cavity.