公开(公告)号：US20120208039A1

公开(公告)日：2012-08-16

申请号：US13501912

申请日：2010-10-29

Applicant: Magali Barbaroux ,  Eric Chevalier ,  Steve Wasterlain

Inventor： Magali Barbaroux ,  Eric Chevalier ,  Steve Wasterlain

IPC: B32B37/18 ,  B32B27/08 ,  B29C47/06

CPC classification number: B32B27/08 ,  B32B2307/7242 ,  B32B2439/46 ,  B65D65/40 ,  Y10T428/31913

Abstract: Monolayer contact film, designed, once made integral with a multilayer functional film, to constitute a final multilayer film of a pouch wall; the pouch having seams, and designed to be filled with biopharmaceutical product, and composed of a selected material that can be part of the composition of the final multilayer film, be in contact with the biopharmaceutical product, without degradation of the film and biopharmaceutical product, be sealable on itself, with a thickness that is less than the thickness of a single contact layer of the final multilayer film suitable for the production of seams of the single contact layer on itself, of which one surface functions as an interface for interlocking with a first interface for making the multilayer functional film integral, and whose other surface has as its final function to constitute the contact surface of the final multilayer film with the biopharmaceutical product.

Abstract translation: 设计成与多层功能膜一体形成的单层接触膜构成袋壁的最终多层膜; 设计成填充有生物制药产品的袋，并且由可以作为最终多层膜的组合物的一部分的选定材料组成的袋与生物药物产物接触，而不会降解膜和生物药物产品， 可以自身密封，其厚度小于最终多层膜的单个接触层的厚度，其适用于生产单个接触层本身的接缝，其中一个表面用作与互锁的接口 用于使多层功能膜成为一体的第一界面，并且其另一表面具有构成最终多层膜与生物药物产品的接触表面的最终功能。

公开(公告)号：US20120128275A1

公开(公告)日：2012-05-24

申请号：US13378369

申请日：2010-06-14

Applicant: Nicolas Voute

Inventor： Nicolas Voute

IPC: B65D33/00

CPC classification number: B65D79/02 ,  B65B31/02 ,  B65D75/38 ,  B65D77/04 ,  B65D81/2084 ,  G01N31/22

Abstract: A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, a second closed, outer casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.

Abstract translation: 袋包括：第一封闭的内壳，由至少一个具有高容量气体屏障的无孔塑料材料制成，限定第一空间，形成用于容纳生物药物产品或装置的密封袋，第二封闭 外壳，由具有高容量气体屏障的至少一个无孔塑料材料制成，限定其中所述密封袋位于的第二空间，间隔元件，至少一个选定的示踪气体，位于第一或 在密封袋之外的第二空间，具有比在狭缝感觉下的第二空间或第一空间中更高的分压，至少一个比色检测器分别位于密封袋外部的第二空间中 或者在第一空间中，通过从第一颜色切换到第二不同颜色来响应于示踪气体的浓度。

公开(公告)号：US20120110960A1

公开(公告)日：2012-05-10

申请号：US13322481

申请日：2010-05-25

Applicant: Stephane BAUD ,  Bastien GUILLOT

Inventor： Stephane BAUD ,  Bastien GUILLOT

IPC: A61J1/05 ,  B65B1/04

CPC classification number: B65D77/06 ,  A61J1/05 ,  B65B3/003 ,  B65B7/02 ,  B65D77/061 ,  B65D85/68 ,  B65D88/60 ,  B65D90/0053 ,  B65D90/046 ,  B65D2585/6897 ,  B65D2590/046

Abstract: The container includes a lower wall and an erect side wall limiting an upper opening of a housing for accommodating a flexible pouch containing a fluid; containment elements including a containment wall, the gap between its peripheral edge and the side wall being limited; the containment wall adapted to be applied against the pouch and held fixed in this position by holding elements arranged in the container and borne by the containment elements by a structural and functional combination, and being movable between an inactive retracted state and an active expanded state, in which a distal end part is either moved away from the side wall or applied there against without any chance of sliding; and adapted to be applied at any desired location of a zone of the side wall such that the containment wall can be applied and held against the pouch regardless of how full the latter is.

Abstract translation: 容器包括限定用于容纳含有流体的柔性袋的壳体的上开口的下壁和直立侧壁; 容纳元件包括容纳壁，其周缘和侧壁之间的间隙被限制; 所述容纳壁适于抵靠所述袋施加并且通过保持固定在所述容器中的元件并通过结构和功能组合由所述容纳元件承载并保持固定在该位置，并且可在非活动缩回状态和主动展开状态之间移动， 其中远端部分远离侧壁移动或在其上施加，而没有任何滑动的机会; 并且适于施加在侧壁的区域的任何期望位置，使得容纳壁可以施加并保持抵靠袋，而不管后者是多么充满。

公开(公告)号：US08522601B2

公开(公告)日：2013-09-03

申请号：US12864927

申请日：2008-12-29

Applicant: Nicolas Voute ,  Magnus Stering ,  Martin Dahlberg ,  Hartmut Langer

Inventor： Nicolas Voute ,  Magnus Stering ,  Martin Dahlberg ,  Hartmut Langer

IPC: G01M3/04

CPC classification number: G01M3/3218

Abstract: There is a bag (1) that has at least one lateral gusset (4) and at least one port (8), a source (10) of pressurized gas, elements (11) for measuring the pressure of the gas; —there are two restraining plates and spacer strips. The bag is placed flat between the two restraining plates (2a, 2b). At least one spacer strip (15a, 15b) is inserted between the two small walls of each gusset in order to prevent these walls from resting on one another. The port is connected to the gas source and the pressure measuring elements. The gas is sent under pressure into the bag, the expansion of the bag being limited by the restraining plates; then, the pressure drop in the bag is compared to a predefined threshold.

Abstract translation: 存在具有至少一个侧向角撑板（4）和至少一个端口（8），加压气体源（10）的袋（1），用于测量气体压力的元件（11） - 有两个限制板和间隔条。 将袋子平放在两个限制板（2a，2b）之间。 在每个角撑板的两个小壁之间插入至少一个间隔条（15a，15b），以防止这些壁彼此搁置。 该端口连接到气源和压力测量元件。 气体在压力下送入袋中，袋的膨胀被限制板限制; 然后将袋中的压降与预定义的阈值进行比较。

公开(公告)号：US20130139618A1

公开(公告)日：2013-06-06

申请号：US13807943

申请日：2011-07-01

Applicant: Sebastien Chaussin ,  Martin Heule

Inventor： Sebastien Chaussin ,  Martin Heule

IPC: G01N33/48

CPC classification number: G01N33/48 ,  C12M23/26 ,  C12M23/28 ,  C12M41/36

Abstract: The sensing device (12) includes support and fixing elements (13), elements (14) for capturing the parameter, fixed rigidly to the support and fixing elements (13), including a sensing face (14a), situated in a chamber (17), a solid internal chamber end wall (30) disposed transversely, an open part (18) made in the chamber peripheral wall (27), the chamber (17) being a holding chamber (17) able to ensure confinement of the content (C) therein, and being isolated from the inside space (3a) of the container and safeguarded from the agitation prevailing therein, by the internal end wall (30) of the chamber so as to minimize the impact of this agitation on the measurement of the parameter of the content (C) by the sensing face (14a).

Abstract translation: 感测装置（12）包括支撑和固定元件（13），用于捕获参数的元件（14），刚性地固定到支撑件和固定元件（13）上，固定元件（13）包括位于腔室（17）中的感测面 ），横向设置的固体内室端壁（30），在室周壁（27）中制成的开口部分（18），所述腔室（17）是能够确保内容物的限制的保持室（17） C），并且与容器的内部空间（3a）隔离，并且通过室的内部端壁（30）免受其中的搅动的影响，以便最小化该搅拌对测量的影响 通过感测面（14a）的内容（C）的参数。

公开(公告)号：US20120003733A1

公开(公告)日：2012-01-05

申请号：US13257129

申请日：2010-03-16

Applicant: Mareva Gueneron

Inventor： Mareva Gueneron

IPC: C12M1/00 ,  B01F15/06 ,  B01F13/00 ,  B01F13/02 ,  B01F13/08

CPC classification number: C12M27/02 ,  C12M23/26 ,  C12M29/06

Abstract: A mixing container includes a flexible container, mixing elements and an upper bearing having a rigid flange. The flange is provided with an insertion passage that fluidically communicates with the inside space on one end and with the outside of the container on the other end. The flange is fixed in a rigid and sealing manner to the upper part of the wall of the container around an insertion opening, the insertion passage and the insertion opening communicating fluidically. The flange also supports, on the inside thereof, an upper bearing that is arranged inside, adjacent to the insertion passage, without preventing the fluidic communication between the insertion passage and the insertion opening. The mixing container is used to receive a biopharmaceutical content to be mixed.

Abstract translation: 混合容器包括柔性容器，混合元件和具有刚性凸缘的上轴承。 凸缘设置有插入通道，该插入通道在一端上与内部空间流体连通，另一端与容器的外部流体连通。 凸缘以刚性和密封的方式固定到容器壁的上部周围的插入口，插入通道和插入开口是流体流通的。 凸缘在其内侧还支撑着布置在与插入通道相邻的内侧的上轴承，而不阻止插入通道与插入开口之间的流体连通。 混合容器用于接收要混合的生物药物含量。

公开(公告)号：US20130319575A1

公开(公告)日：2013-12-05

申请号：US13990881

申请日：2011-11-25

Applicant: Nicolas Mendyk

Inventor： Nicolas Mendyk

IPC: B65D27/32

CPC classification number: B65D27/32 ,  A61J1/1475

Abstract: A flexible bag for biopharmaceutical use, includes a shell for receiving, in an inner space thereof, a flowable biopharmaceutical product, and flexible walls joined by fixed and sealed rigid-connection areas, two opposite walls being connected to each other by the peripheries thereof, at least one inlet port and one outlet port, a port being combined with a passage of the shell and mounted thereon by fixed and sealed connection elements, a plurality of similar outlet ports grouped together in a tapping area, a tapping wall provided with at least one opening for the passage and assembly of the outlet port for the similar outlet ports, fixed and sealed port-shell connection elements which are rigidly, fixedly, and sealingly connected to the tapping wall around the at least one opening for the passage and assembly of the outlet port, and an area for folding the two opposite walls.

Abstract translation: 一种用于生物药物使用的柔性袋，包括用于在其内部空间中容纳可流动的生物药物产品的壳体，以及通过固定和密封的刚性连接区域连接的柔性壁，两个相对的壁通过其周边彼此连接， 至少一个入口端口和一个出口端口，端口与壳体的通道组合并通过固定和密封的连接元件安装在其上，多个类似的出口端口组合在一起的出料区域， 用于类似出口的出口的通道和组装的一个开口，固定和密封的端口 - 壳连接元件，其刚性地，固定地并且密封地连接到围绕所述至少一个开口的攻丝壁，用于通过和组装 出口和用于折叠两个相对的壁的区域。

公开(公告)号：US20130161229A1

公开(公告)日：2013-06-27

申请号：US13817190

申请日：2011-08-10

Applicant: Magali Barbaroux ,  Maréva Gueneron

Inventor： Magali Barbaroux ,  Maréva Gueneron

IPC: A61J1/20

CPC classification number: C12M23/20 ,  A61B10/0096 ,  A61J1/20 ,  B32B1/08 ,  B32B27/08 ,  B32B27/302 ,  B32B27/304 ,  B32B27/306 ,  B32B27/32 ,  B32B27/322 ,  B32B27/34 ,  B32B27/36 ,  B32B2307/41 ,  B32B2307/412 ,  B32B2307/536 ,  B32B2307/546 ,  B32B2307/7163 ,  B32B2307/72 ,  B32B2307/7242 ,  B32B2439/80 ,  B32B2535/00 ,  B32B2597/00 ,  F16L11/045

Abstract: A device including: a bag, a tube section having a wall defining a free longitudinal space, and a plastic connector, which are all fused together, the wall including a contact layer made of a material other than PVC, selected from PE, EVA, PP, ETFE, and PVDF, and a functional layer including at least one basic functional layer of a material selected for the function thereof (flexibility, sturdiness, handling, opacity or transparence, gas barrier) and selected from the family including PE, PET, a PA, EVA, EVOH, SEBS, PETG, and PVDF, a bag, another tube section, and/or a connector fused to the biopharmaceutical tube and including a contact layer made of a material capable of being in contact with the biopharmaceutical material, which is capable of being fused onto itself, and which is identical or similar to the material of the contact layer of the biopharmaceutical tube.

Abstract translation: 一种装置，包括：袋子，具有限定自由纵向空间的壁的管部分和塑料连接器，所有塑料连接器都熔合在一起，所述壁包括由不同于PVC的材料制成的接触层，所述接触层选自PE，EVA， PP，ETFE和PVDF，以及功能层，其包括至少一种选自其功能的材料的基本功能层（柔韧性，坚固性，操作性，不透明度或透明性，气体屏障），并且选自包括PE，PET， PA，EVA，EVOH，SEBS，PETG和PVDF，袋，另一管段和/或熔接到生物药物管的连接器，并且包括由能够与生物药物材料接触的材料制成的接触层， 其能够熔合在其自身上，并且与生物药剂管的接触层的材料相同或相似。

公开(公告)号：US20130068316A1

公开(公告)日：2013-03-21

申请号：US13700213

申请日：2011-04-20

Applicant: Mareva Gueneron

Inventor： Mareva Gueneron

IPC: F16L27/107 ,  F16L19/00

CPC classification number: F16L27/107 ,  A61M39/10 ,  A61M2039/1027 ,  A61M2039/1077 ,  A61M2039/1083 ,  A61M2039/1088 ,  F16L19/00 ,  F16L33/30 ,  F16L37/04 ,  Y10T137/0402 ,  Y10T137/598

Abstract: A connection part providing communication between biopharmaceutical containers and/or conduits, includes a connection sheath (32) and two connection skirts (38a, 38b). The connection sheath (32) and both connection skirts (38a, 38b) have resiliency such that the connection part (30), from a disassembled state, is transversely stretchable, at the site of both connection skirts (38a, 38b) thereof, until transversely widened without loss of integrity so as to be made threadable through both collars (14, 24). Then, due to the resiliency thereof, the connection part contacts, with resilient clamping for support and with sealability, the coupled portion of the outer surface of both collars (14, 24). Moreover, from the assembled state, the connection part is transversely stretchable, at the site of both connection skirts (38a, 38b) thereof, until transversely widened so as to be capable of being unthreaded from both collars (14, 24) and thus be converted to the disassembled state.

Abstract translation: 提供生物药物容器和/或导管之间的连通的连接部分包括连接护套（32）和两个连接裙（38a，38b）。 连接护套（32）和两个连接裙（38a，38b）具有弹性，使得连接部分（30）在拆卸状态下可横向拉伸在两个连接裙（38a，38b）的位置，直到 横向加宽而不损失完整性，以便通过两个套环（14,24）进行螺纹连接。 然后，由于其弹性，连接部分与两个套环（14,24）的外表面的连接部分接触，具有用于支撑的弹性夹持和密封性。 此外，从组装状态，连接部在其两个连接裙（38a，38b）的位置处是可横向拉伸的，直到横向加宽，从而能够从两个套环（14,24）脱开，因此是 转换为拆卸状态。

公开(公告)号：US20130086871A1

公开(公告)日：2013-04-11

申请号：US13642593

申请日：2011-02-11

Applicant: Isabelle Gay ,  Gaelle Nodin ,  Nicolas Mendyk ,  Stephanie Armau

Inventor： Isabelle Gay ,  Gaelle Nodin ,  Nicolas Mendyk ,  Stephanie Armau

IPC: B65B17/00

CPC classification number: B65B55/18 ,  A61L2/0094 ,  A61L2/20 ,  A61L2/204 ,  A61L2/206 ,  A61L2/208 ,  A61L2/26 ,  A61L2202/181 ,  B65B55/02 ,  B65D81/245

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. 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.

Abstract translation: 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。