摘要:
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.
摘要:
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.
摘要:
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.
摘要:
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), wherein the carrying means (11a) and the displacement manoeuvring means (11b) for the door (6) are arranged in such a way that, when the leaf (6v) is open, it extends essentially past the limit (13b, 13c) of the inlet/outlet space (13a), a distancing space (12) being thus created between the inlet/outlet space (13a) and the leaf (6v) in the open state.
摘要:
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 (11a), 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), wherein the carrying means (11a) and the displacement manoeuvring means (11b) for the door (6) are arranged in such a way that, when the leaf (6v) is open, it extends essentially past the limit (13b, 13c) of the inlet/outlet space (13a), a distancing space (12) being thus created between the inlet/outlet space (13a) and the leaf (6v) in the open state.
摘要:
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.
摘要:
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.
摘要:
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.
摘要:
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.
摘要:
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.