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1. 发明授权

US10240117B2 Bioreactor container and integrity check method for bioreactor containers 有权
公开(公告)号：US10240117B2
公开(公告)日：2019-03-26
申请号：US14886617
申请日：2015-10-19
申请人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
发明人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
IPC分类号： C12M1/34 , C12M1/00 , A61J1/10 , B32B1/02 , B32B3/30 , B32B5/02 , B32B5/18 , G01M3/22 , G01M3/32 , G01M3/04 , A61J1/16
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.

2. 发明申请

US20140193897A1 BIOREACTOR CONTAINER AND INTEGRITY CHECK METHOD FOR BIOREACTOR CONTAINERS 有权
标题翻译：生物反应器容器和生物反应器容器的完整性检查方法
公开(公告)号：US20140193897A1
公开(公告)日：2014-07-10
申请号：US14130061
申请日：2012-06-15
申请人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
发明人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
IPC分类号： C12M1/00 , G01M3/04
CPC分类号： C12M23/14 , A61J1/10 , A61J1/16 , B32B1/02 , B32B3/30 , B32B5/022 , B32B5/024 , B32B5/18 , B32B2307/726 , B32B2307/7265 , C12M23/02 , C12M23/26 , F04C2270/0421 , G01M3/04 , G01M3/22 , G01M3/3218 , G01M3/3272
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.
摘要翻译：生物反应器容器包括至少局部柔性壁和至少一个容器开口。生物反应器容器的壁具有流体密封的内部片材和至少局部流体可渗透或结构化的外部片材。还提供了用于测试生物反应器容器的完整性的方法。

3. 发明申请

US20140165707A1 TEST METHOD AND APPARATUS FOR BIOREACTOR CONTAINERS AND USE 有权
标题翻译：用于生物反应器容器的测试方法和设备和使用
公开(公告)号：US20140165707A1
公开(公告)日：2014-06-19
申请号：US14130035
申请日：2012-06-26
申请人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
发明人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
IPC分类号： G01M3/32
CPC分类号： G01M3/32 , C12M41/00 , G01M3/329
摘要： 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.
摘要翻译：用于测试生物反应器容器的完整性的方法包括提供具有流体密封的至少局部柔性壁的生物反应器容器，并且具有至少一个容器开口并提供具有生物反应器容器隔室和流体可渗透和/ 或结构化接收片可更换地布置在生物反应器容器隔室上。该方法继续通过将生物反应器容器布置在生物反应器容器隔室中，使得生物反应器容器壁与生物反应器容器隔室中的接收片接触，将生物反应器容器的容器开口连接到填充生物反应器容器的流体源，流体源，以在第一时间Ti在生物反应器容器中产生预定的正压力Pi，并确定生物反应器容器是否充分泄漏。

4. 发明授权

US09534980B2 Test method and apparatus for bioreactor containers having reception sheet clamped between bioreactor container and bioreactor container compartment 有权
标题翻译：具有夹在生物反应器容器和生物反应器容器室之间的接收片的生物反应器容器的测试方法和装置
公开(公告)号：US09534980B2
公开(公告)日：2017-01-03
申请号：US14130035
申请日：2012-06-26
申请人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
发明人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
IPC分类号： G01M3/04 , G01M3/32 , C12M1/34
CPC分类号： G01M3/32 , C12M41/00 , G01M3/329
摘要： 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.
摘要翻译：用于测试生物反应器容器的完整性的方法包括提供具有流体密封的至少局部柔性壁的生物反应器容器，并且具有至少一个容器开口并提供具有生物反应器容器隔室和流体可渗透和/ 或结构化接收片可更换地布置在生物反应器容器隔室上。该方法继续通过将生物反应器容器布置在生物反应器容器隔室中，使得生物反应器容器壁与生物反应器容器隔室中的接收片接触，将生物反应器容器的容器开口连接到填充生物反应器容器的流体源，流体源，以在第一时间T1在生物反应器容器中产生预定的正压力P1，并确定生物反应器容器是否充分密封。

5. 发明申请

US20160040109A1 BIOREACTOR CONTAINER AND INTEGRITY CHECK METHOD FOR BIOREACTOR CONTAINERS 审中-公开
标题翻译：生物反应器容器和生物反应器容器的完整性检查方法
公开(公告)号：US20160040109A1
公开(公告)日：2016-02-11
申请号：US14886617
申请日：2015-10-19
申请人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
发明人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
IPC分类号： C12M1/00
CPC分类号： C12M23/14 , A61J1/10 , A61J1/16 , B32B1/02 , B32B3/30 , B32B5/022 , B32B5/024 , B32B5/18 , B32B2307/726 , B32B2307/7265 , C12M23/02 , C12M23/26 , F04C2270/0421 , G01M3/04 , G01M3/22 , G01M3/3218 , G01M3/3272
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.
摘要翻译：生物反应器容器包括至少局部柔性壁和至少一个容器开口。生物反应器容器的壁具有流体密封的内部片材和至少局部流体可渗透或结构化的外部片材。还提供了用于测试生物反应器容器的完整性的方法。

6. 发明授权

US09637716B2 Bioreactor container and integrity check method for bioreactor containers 有权
公开(公告)号：US09637716B2
公开(公告)日：2017-05-02
申请号：US14130061
申请日：2012-06-15
申请人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
发明人： Martin Dahlberg , Isabelle Gay , Lars Boettcher , Stefan Obermann , Rainer Sandrock
IPC分类号： C12M1/34 , C12M1/00 , A61J1/10 , B32B1/02 , B32B3/30 , B32B5/02 , B32B5/18 , G01M3/22 , G01M3/32 , G01M3/04 , A61J1/16
CPC分类号： C12M23/14 , A61J1/10 , A61J1/16 , B32B1/02 , B32B3/30 , B32B5/022 , B32B5/024 , B32B5/18 , B32B2307/726 , B32B2307/7265 , C12M23/02 , C12M23/26 , F04C2270/0421 , G01M3/04 , G01M3/22 , G01M3/3218 , G01M3/3272
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.

7. 发明授权

US10766003B2 Presterilizable filtration system to be disposed of after a single use 有权
公开(公告)号：US10766003B2
公开(公告)日：2020-09-08
申请号：US12933433
申请日：2009-03-13
申请人： Lars Boettcher , Frank Guthof , Jan Schaefer , Isabelle Gay
发明人： Lars Boettcher , Frank Guthof , Jan Schaefer , Isabelle Gay
IPC分类号： B01D61/18 , A61M1/36
摘要： A presterilizable filtration system is provided and is to be disposed of after a single use. The system has a recirculation tank and a filtration module that are connected to each other in a circuit via a hose system that can be regulated by at least one valve. The valve has a disposable separate valve part that can be integrated in the hose system and a reusable actuator.

8. 发明申请

US20110005984A1 PRESTERILIZABLE FILTRATION SYSTEM TO BE DISPOSED OF AFTER A SINGLE USE 审中-公开
标题翻译：一次性使用后的预处理过滤系统
公开(公告)号：US20110005984A1
公开(公告)日：2011-01-13
申请号：US12933433
申请日：2009-03-13
申请人： Lars Boettcher , Frank Guthof , Jan Schaefer , Isabelle Gay
发明人： Lars Boettcher , Frank Guthof , Jan Schaefer , Isabelle Gay
IPC分类号： B01D35/157
摘要： A presterilizable filtration system is provided and is to be disposed of after a single use. The system has a recirculation tank and a filtration module that are connected to each other in a circuit via a hose system that can be regulated by at least one valve. The valve has a disposable separate valve part that can be integrated in the hose system and a reusable actuator.
摘要翻译：提供了可预过滤的过滤系统，并在一次使用后进行处理。该系统具有循环罐和过滤模块，其通过可由至少一个阀调节的软管系统在电路中彼此连接。该阀具有可以集成在软管系统中的一次性单独的阀部件和可重复使用的致动器。

9. 发明授权

US09301520B2 Systems and methods for freezing, storing and thawing biopharmaceutical materials 有权
公开(公告)号：US09301520B2
公开(公告)日：2016-04-05
申请号：US11963106
申请日：2007-12-21
申请人： Jonathan Cutting , Isabelle Gay , Eric K. Lee , Nicolas Voute
发明人： Jonathan Cutting , Isabelle Gay , Eric K. Lee , Nicolas Voute
IPC分类号： B65D1/32 , A01N1/02 , F25C1/22
CPC分类号： F17C3/085 , A01N1/02 , A01N1/0263 , B01L7/00 , F25C1/22 , Y10T29/53443
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.

10. 发明申请

US20130086871A1 STERILIZABLE BIOPHARMACEUTICAL PACKAGING 有权
标题翻译：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
申请人： Isabelle Gay , Gaelle Nodin , Nicolas Mendyk , Stephanie Armau
发明人： Isabelle Gay , Gaelle Nodin , Nicolas Mendyk , Stephanie Armau
IPC分类号： B65B17/00
CPC分类号： B65B55/18 , A61L2/0094 , A61L2/20 , A61L2/204 , A61L2/206 , A61L2/208 , A61L2/26 , A61L2202/181 , B65B55/02 , B65D81/245
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。

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