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1. 发明公开

EP3227186A1 PREPARING A DOUBLE CHAMBER CONTAINER 有权
标题翻译：准备一个双室容器
公开(公告)号：EP3227186A1
公开(公告)日：2017-10-11
申请号：EP15804784.5
申请日：2015-12-04
申请人： F. Hoffmann-La Roche AG
发明人： WERK, Tobias , LÜMKEMANN, Jörg , MAHLER, Hanns-Christian
IPC分类号： B65B3/00 , B65B7/28
CPC分类号： B65B7/2821 , B65B3/003 , B65B2230/02
摘要： A method of preparing a double chamber container (1) comprises the steps of: filling a substance in the interior of the double chamber container (1), freeze-drying the substance inside the double chamber container (1), inserting a middle plunger (81) in the interior of the double chamber container (1) such that a distal chamber and a proximal chamber are formed, wherein the middle plunger (81) seals the distal chamber from the proximal chamber and wherein the freeze-dried substance is inside the distal chamber, filling a reconstitution medium in the proximal chamber of the double chamber container (1), and sealing a distal opening (14) of the double chamber container (1) and a proximal opening (13) of the double chamber container (1). The method particularly also comprises the steps of providing a holder (2) having a seat (21) designed to receive the double chamber container (1) in an upright position and arranging the double chamber container (1) in the seat (21) of the holder (2) such that, in the upright position, a distal end side (12) of the double chamber container (1) extends downwardly and a proximal end side (13) of the double chamber container (1) extends upwardly. Thereby, the double chamber container (1) is arranged in the seat (21) of the holder (2) while the substance is filled in the interior of the double chamber container (1), while the substance is freeze-dried inside the double chamber container (1), while the middle plunger (81) is inserted in the interior of the double chamber container (1), while the reconstitution medium is filled in the proximal chamber of the double chamber container (1), and while the proximal opening (13) of the double chamber container (1) is sealed.
摘要翻译：制备双室容器（1）的方法包括以下步骤：将物质填充到双室容器（1）的内部，冷冻干燥双室容器（1）内的物质，将中间柱塞在所述双室容器（1）内部形成远端室和近端室，其中所述中间柱塞（81）将所述远端室从所述近端室密封，并且其中所述冻干物质在所述双室容器在所述双室容器（1）的近端室中填充重构介质，并密封所述双室容器（1）的远端开口（14）和所述双室容器（1）的近端开口（13））。该方法特别地还包括以下步骤：提供具有设计成在直立位置接收双室容器（1）的座（21）并且将双室容器（1）布置在座（21）中的座所述保持器2使得在所述直立位置中所述双室容器1的远端侧12向下延伸并且所述双室容器1的近端侧13向上延伸。由此，在双室容器（1）的内部填充物质的同时，将双室容器（1）布置在支架（2）的座（21）中，同时将物质在双室容器（1）中，而中间柱塞（81）插入双腔室容器（1）的内部，而重构介质填充在双腔室容器（1）的近端腔室中，而近端腔室双腔室容器（1）的开口（13）被密封。

2. 发明公开

EP3886785A1 MANUFACTURING A FLEXIBLE CONTAINER 审中-实审
公开(公告)号：EP3886785A1
公开(公告)日：2021-10-06
申请号：EP19809444.3
申请日：2019-11-25
申请人： F. Hoffmann-La Roche AG
发明人： LEMA MARTINEZ, Carmen , LUEMKEMANN, Joerg , WERK, Tobias , ZUMSTEIN, Thomas , KULLMANN, Daniel
IPC分类号： A61J1/10 , A61J1/14 , A61J1/20 , A61J1/06

3. 发明公开

EP3725688A1 PREPARING A DOUBLE CHAMBER CONTAINER 有权
公开(公告)号：EP3725688A1
公开(公告)日：2020-10-21
申请号：EP20177968.3
申请日：2015-12-04
申请人： F. Hoffmann-La Roche AG
发明人： WERK, Tobias , LÜMKEMANN, Jörg , MAHLER, Hanns-Christian
IPC分类号： B65B3/00 , B65B7/28
摘要： A method of preparing a double chamber container (1) comprises the steps of: filling a substance in the interior of the double chamber container (1), freeze-drying the substance inside the double chamber container (1), inserting a middle plunger (81) in the interior of the double chamber container (1) such that a distal chamber and a proximal chamber are formed, wherein the middle plunger (81) seals the distal chamber from the proximal chamber and wherein the freeze-dried substance is inside the distal chamber, filling a reconstitution medium in the proximal chamber of the double chamber container (1), and sealing a distal opening (14) of the double chamber container (1) and a proximal opening (13) of the double chamber container (1). The method particularly also comprises the steps of providing a holder (2) having a seat (21) designed to receive the double chamber container (1) in an upright position and arranging the double chamber container (1) in the seat (21) of the holder (2) such that, in the upright position, a distal end side (12) of the double chamber container (1) extends downwardly and a proximal end side (13) of the double chamber container (1) extends upwardly. Thereby, the double chamber container (1) is arranged in the seat (21) of the holder (2) while the substance is filled in the interior of the double chamber container (1), while the substance is freeze-dried inside the double chamber container (1), while the middle plunger (81) is inserted in the interior of the double chamber container (1), while the reconstitution medium is filled in the proximal chamber of the double chamber container (1), and while the proximal opening (13) of the double chamber container (1) is sealed.

4. 发明公开

EP4052048A1 FLUID ANALYSIS ARRANGEMENT AND METHOD 审中-实审
公开(公告)号：EP4052048A1
公开(公告)日：2022-09-07
申请号：EP20797133.4
申请日：2020-10-30
申请人： F. Hoffmann-La Roche AG
发明人： NIESS, Alexander Fidelis , LEBOUC-HAEFLIGER, Vanessa , LEMA MARTINEZ, Carmen , LUEMKEMANN, Joerg , AMRHEIN, Sven , JOHN, Jasmin , ZUMSTEIN, Thomas , BURRI, Sven , STEINER, Roger , WERK, Tobias
IPC分类号： G01N35/10 , G01N35/00

5. 发明授权

EP3227187B1 CLOSING A CHAMBER OF A CONTAINER FOR A PHARMACEUTICAL PRODUCT 有权
公开(公告)号：EP3227187B1
公开(公告)日：2019-07-17
申请号：EP15813716.6
申请日：2015-12-04
申请人： F. Hoffmann-La Roche AG
发明人： WERK, Tobias , LÜMKEMANN, Jörg , MAHLER, Hanns-Christian , KISSLING, Tom
IPC分类号： B65B3/00 , B65B7/28 , B67B1/04 , B65D51/24

6. 发明公开

EP3475692A1 INSPECTION DEVICE 无效
公开(公告)号：EP3475692A1
公开(公告)日：2019-05-01
申请号：EP17735445.3
申请日：2017-06-27
申请人： F. Hoffmann-La Roche AG
发明人： WERK, Tobias , DORN, Anke , LUDWIG, Imke, Sonja , MAHLER, Hanns-Christian , LUTHRINGER, Denis , LEMA MARTINEZ, Carmen , LÜMKEMANN, Jörg
IPC分类号： G01N29/24 , G01N21/88

7. 发明公开

EP3161466A1 METHOD FOR DETERMINING WHETHER RECONSTITUTION OF A SOLUTION IN A CONTAINER IS COMPLETED 有权
标题翻译：用于确定重构的溶液终止在容器中
公开(公告)号：EP3161466A1
公开(公告)日：2017-05-03
申请号：EP15733681.9
申请日：2015-06-26
申请人： F. Hoffmann-La Roche AG
发明人： LUEMKEMANN, Joerg , RIETMANN, René , STEINER, Roger , MAHLER, Hanns-Christian , WERK, Tobias
IPC分类号： G01N27/06 , G01N13/00
CPC分类号： G01N27/07 , G01N13/00 , G01N27/06 , G01N33/15 , G01N2013/006
摘要： A method for determining whether reconstitution of a solution (6) in a container (1) is completed comprises the steps of: - selecting a predetermined amount of a solid substance (2) and a predetermined amount of a liquid solvent (5) from which the reconstituted solution (6) is to be prepared, - preparing a solution (6) by solving the predetermined amount of the solid substance (2) in the predetermined amount of the liquid solvent (5), - measuring the impedance (Z) or the resistance (R) of the solution (6), - determining whether the change of the measured impedance (Z) or the resistance (R) within a measuring time interval of a predetermined duration is below a defined threshold, and - determining that reconstitution of the solution (6) is completed when the change of the measured impedance (Z) is below the defined threshold.
摘要翻译：一种用于确定性采矿方法无论是在一个容器（1）完成后的溶液（6）的重构包括以下步骤： - 选择的固体物质的预定量的（2）和液体溶剂的预定量的（5），从该重构溶液（6）是要准备， - 通过在液体溶剂（5）的预定量的解决固体物质（2）的预定量的制备溶液（6）， - 测量所述阻抗（Z）或电阻（R）的溶液（6）的， - 确定性采矿是否经过了规定的持续时间的测量时间间隔内所测量的阻抗（Z）或电阻（R）的变化低于定义的阈值，以及 - 确定挖掘做了重构的溶液（6）完成时测量的阻抗（Z）的变化低于定义的阈值。

8. 发明授权

EP3206952B1 METHOD FOR PROVIDING IN A PRIMARY PACKAGING CONTAINER A DRIED SOLID PRODUCT CONTAINING AN ACTIVE PHARMACEUTICAL INGREDIENT 有权
公开(公告)号：EP3206952B1
公开(公告)日：2018-09-05
申请号：EP15780845.2
申请日：2015-10-14
申请人： F. Hoffmann-La Roche AG
发明人： LUEMKEMANN, Joerg , MAHLER, Hanns-Christian , SCHNEIDER, Sebastian , VOELKLE, Joerg , WERK, Tobias
IPC分类号： B65B3/00
CPC分类号： B65B1/04 , A61J1/062 , A61J1/1412 , A61J1/1468 , A61J1/2089 , B65B3/003 , B65B7/2821 , B65B37/06 , B65B63/08
摘要： A method for providing in a primary packaging container (6) a dried solid product (4) containing an active pharmaceutical ingredient is disclosed. The method comprises the steps of - providing a primary packaging container (6); - providing a drying cartridge (1) different from the primary packaging container (6), the drying cartridge (1) being made of a material adapted to hold a liquid product (3) to be dried, wherein the liquid product (3) to be dried contains an active pharmaceutical ingredient, and wherein the drying cartridge (1) is made of a material having a thermal conductivity which is higher than the thermal conductivity of glass; - filling the liquid product (3) to be dried into the drying cartridge (1); - drying the liquid product (3) to be dried in the drying cartridge (1) to form a dried solid product (4) containing the active pharmaceutical ingredient; - transferring the dried solid product (4) from the drying cartridge (1) into the primary packaging container (6).

9. 发明公开

EP3355968A1 MULTI CHAMBER SYRINGE UNIT AND METHOD OF PREPARING A MULTI CHAMBER SYRINGE 有权
公开(公告)号：EP3355968A1
公开(公告)日：2018-08-08
申请号：EP16774503.3
申请日：2016-09-29
申请人： F. Hoffmann-La Roche AG
发明人： LÜMKEMANN, Jörg , MAHLER, Hanns-Christian , WERK, Tobias
IPC分类号： A61M5/28 , A61M5/31
CPC分类号： A61M5/19 , A61K9/0019 , A61K9/06 , A61K38/47 , A61K45/06 , A61M5/284 , A61M5/3129 , A61M5/31511 , A61M5/31596 , A61M2005/1787 , A61M2005/3114 , A61M2005/3132 , A61M2202/0468 , A61M2202/048 , A61M2202/07 , A61M2207/00 , C12Y302/01035
摘要： A multi chamber syringe unit includes a longitudinal body with side wall, distal end side, proximal end side opposite to distal end side, an interior limited by side wall between distal end side and proximal end side and distal opening arranged in distal end side for providing a liquid out of the body. The syringe further includes a separating element arranged in the interior of the body such that distal chamber and proximal chamber are formed in the interior of the body, wherein the separating element seals the distal chamber from the proximal chamber. The syringe has a bypass arrangement provided in the side wall of distal chamber of the body. A first pharmaceutical liquid is arranged in distal chamber of the body and second pharmaceutical liquid in proximal chamber of the body. The multi chamber syringe unit allows for adequately administering plural pharmaceutical liquids by injection.

10. 发明公开

EP3227187A1 CLOSING A CHAMBER OF A CONTAINER FOR A PHARMACEUTICAL PRODUCT 有权
标题翻译：关闭医药产品容器的房间
公开(公告)号：EP3227187A1
公开(公告)日：2017-10-11
申请号：EP15813716.6
申请日：2015-12-04
申请人： F. Hoffmann-La Roche AG
发明人： WERK, Tobias , LÜMKEMANN, Jörg , MAHLER, Hanns-Christian , KISSLING, Tom
IPC分类号： B65B3/00 , B65B7/28 , B67B1/04 , B65D51/24
CPC分类号： B65B7/2821 , A61M5/008 , B65B3/003 , B65B55/027 , B65B63/08 , B65D25/108 , B65D51/00 , B67B1/04
摘要： A device (1) for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat (11), a container carrier (13) and a spacer (12). The plunger seat (11) releasably holds the plunger in a predefined alignment. The container carrier (13) is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer (12) is arranged to position and align the plunger seat (11) adjacent to and distant from the container carrier (13) such that the opening of the container is open when the container is connected to the container carrier (13).
摘要翻译：用于关闭具有用于进入腔室的开口的容器的腔室的装置（1）包括柱塞，柱塞座（11），容器载体（13）和间隔件（12）。柱塞座（11）将柱塞可释放地保持在预定的对齐中。容器载体（13）被布置成在预定位置连接到容器并且相对于容器的开口对准。间隔件（12）被布置成将柱塞座（11）定位和对准在容器载体（13）附近并远离容器载体（13），使得容器的开口在容器连接到容器载体（13）时打开。

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