Sterilizable biopharmaceutical packaging and method of making a sterilizable biopharmeceutical packaging
    1.
    发明授权
    Sterilizable biopharmaceutical packaging and method of making a sterilizable biopharmeceutical packaging 有权
    可灭菌的生物药物包装和可灭菌生物制药包装的方法

    公开(公告)号:US09242753B2

    公开(公告)日:2016-01-26

    申请号:US13642593

    申请日:2011-02-11

    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.

    摘要翻译: 可灭菌的生物药物包装包括用于插入要灭菌的生物制药内容物的开口,所述开口与灭菌气体输送通道分开,使得开口可以独立地关闭并且在关闭灭菌气体输送通道之前。 开口直接邻近用于接收生物药物内容物的内部空间,使得待消毒的内容物从包装外部直接插入内部空间。 用于控制灭菌气体的分配的元件独立于插入开口的打开或关闭来打开/关闭灭菌气体输送通道。 灭菌后,外壁,灭菌气体输送通道和打开/关闭元件能够保持其间的刚性连接,从而形成包含灭菌的生物药物内容物并可进行一次或多次完整性测试的无菌生物药物包装 灭菌后任何所需时间。

    STERILIZABLE BIOPHARMACEUTICAL PACKAGING
    2.
    发明申请
    STERILIZABLE BIOPHARMACEUTICAL PACKAGING 有权
    无菌生物包装

    公开(公告)号:US20130086871A1

    公开(公告)日:2013-04-11

    申请号:US13642593

    申请日:2011-02-11

    IPC分类号: B65B17/00

    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.

    摘要翻译: 可灭菌的生物药物包装包括用于插入要灭菌的生物制药内容物的开口,所述开口与灭菌气体输送通道分开,使得开口可以独立地关闭并且在关闭灭菌气体输送通道之前。 开口直接邻近用于接收生物药物内容物的内部空间,使得待消毒的内容物从包装外部直接插入内部空间。 用于控制灭菌气体的分配的元件独立于插入开口的打开或关闭来打开/关闭灭菌气体输送通道。 灭菌后,外壁,灭菌气体输送通道和打开/关闭元件能够保持其间的刚性连接,从而形成包含灭菌的生物药物内容物并可进行一次或多次完整性测试的无菌生物药物包装 灭菌后任何所需时间。

    Tight connection and tight transfer between two housings in view of an aseptic transfer therebetween
    3.
    发明授权
    Tight connection and tight transfer between two housings in view of an aseptic transfer therebetween 有权
    考虑到它们之间的无菌转移,两个壳体之间的紧密连接和紧密转移

    公开(公告)号:US09283556B2

    公开(公告)日:2016-03-15

    申请号:US13511221

    申请日:2010-11-23

    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.

    摘要翻译: 一种用于在具有壁(3),开口(4),凸缘(5)和门(6)的第一壳体(1)和具有壁(7)的第二壳体(2)之间紧密连接的装置 ),开口(8),凸缘(9)和门(10)。 凸缘是互补的,元件用于移动门(6)。 元件用于将两个门彼此夹持,并且壳体经由通信空间(13)彼此通信。 在门(6)上有一个内环形临界线和一个在法兰(9)上有污染风险的外环形临界线。 该装置包括结构上集成到门(6)和/或凸缘(9)中的元件(25和/或26),并且可以在连通空间与内环形临界线和/或外环 关门线,门打开时。

    Chamber for sealed junction device and aseptic transfer device
    4.
    发明授权
    Chamber for sealed junction device and aseptic transfer device 有权
    密封接头装置和无菌转移装置

    公开(公告)号:US09168520B2

    公开(公告)日:2015-10-27

    申请号:US13511210

    申请日:2010-11-23

    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.

    摘要翻译: 本发明涉及一种特别设计成与用于紧密连接到第二壳体(2)的装置相关联的壳体(1),所述第一壳体包括包括限定空间(1a)的壁(3)的结构, 由法兰(5)限定的能够气密地施加到第二壳体(2)的第二凸缘(9)的开口(4),保持装置可以将第一凸缘和第二凸缘(9)保持在每个 另一方面,由承载装置(11a)支撑的门(6),所述门扇叶片(6v)可以以关闭或打开的方式移动,并且具有外表面(6a),所述外表面(6a)可以确保密封地施加 第二壳体(2)的第二门(10),用于将叶片(6v,10v)相对于彼此保持的固定装置,位移操纵装置(11b)和用于控制排量操纵装置(11b)的装置, 当叶片(6v)打开时,内部空间(1a)中的入口/出口空间(13a)形成在通风空间(13)的一部分之间, 两个壳体(1,2),其中用于门(6)的运送装置(11a)和排量操纵装置(11b)以这样的方式布置,使得当叶片(6v)打开时,其基本上延伸 入口/出口空间(13a)的极限(13b,13c),在打开状态下在入口/出口空间(13a)和叶子(6v)之间形成的间隔空间(12)。

    HOUSING FOR TIGHT CONNECTION DEVICE AND ASEPTIC TRANSFER DEVICE
    5.
    发明申请
    HOUSING FOR TIGHT CONNECTION DEVICE AND ASEPTIC TRANSFER DEVICE 有权
    用于紧密连接装置和非传送装置的壳体

    公开(公告)号:US20120292311A1

    公开(公告)日:2012-11-22

    申请号:US13511210

    申请日:2010-11-23

    IPC分类号: H02G3/08

    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.

    摘要翻译: 本发明涉及一种特别设计成与用于紧密连接到第二壳体(2)的装置相关联的壳体(1),所述第一壳体包括包括限定空间(1a)的壁(3)的结构, 由法兰(5)限定的能够气密地施加到第二壳体(2)的第二凸缘(9)的开口(4),保持装置可以将第一凸缘和第二凸缘(9)保持在每个 另一方面,由承载装置(11a)支撑的门(6),门扇叶片(6v)以可关闭或打开的方式移动,并且具有可以确保第二个密封件的密封应用的外表面(6a) 第二壳体(2)的门(10),用于将叶片(6v,110v)相对于彼此保持的固定装置,位移操纵装置(11b)和用于控制排量操纵装置(11b)的装置,以及当 叶片(6v)打开,内部空间(1a)中的入口/出口空间(13a)形成在通风空间(13)的一部分之间, 两个壳体(1,2),其中用于门(6)的运送装置(11a)和排量操纵装置(11b)以这样的方式布置,使得当叶片(6v)打开时,其基本上延伸 入口/出口空间(13a)的极限(13b,13c),在打开状态下在入口/出口空间(13a)和叶子(6v)之间形成的间隔空间(12)。

    TIGHT CONNECTION AND TIGHT TRANSFER BETWEEN TWO HOUSINGS IN VIEW OF AN ASEPTIC TRANSFER THEREBETWEEN
    6.
    发明申请

    公开(公告)号:US20120267367A1

    公开(公告)日:2012-10-25

    申请号:US13511221

    申请日:2010-11-23

    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.

    摘要翻译: 一种用于在具有壁(3),开口(4),凸缘(5)和门(6)的第一壳体(1)和具有壁(7)的第二壳体(2)之间紧密连接的装置 ),开口(8),凸缘(9)和门(10)。 凸缘是互补的,元件用于移动门(6)。 元件用于将两个门彼此夹持,并且壳体经由通信空间(13)彼此通信。 在门(6)上有一个内环形临界线和一个在法兰(9)上有污染风险的外环形临界线。 该装置包括结构上集成到门(6)和/或凸缘(9)中的元件(25和/或26),并且可以在连通空间与内环形临界线和/或外环 关门线,门打开时。