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    STERILIZABLE BIOPHARMACEUTICAL PACKAGING
    3.
    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

    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。

    METHOD AND UNIT FOR THE STERILE FILLING OF A FINAL BASIC CONTAINER WITH CONTENT INTENDED FOR THE BIOPHARMACEUTICAL FIELD
    4.
    发明申请
    METHOD AND UNIT FOR THE STERILE FILLING OF A FINAL BASIC CONTAINER WITH CONTENT INTENDED FOR THE BIOPHARMACEUTICAL FIELD 审中-公开
    用于生物气象领域的最终基本容器的内部填充方法和装置

    公开(公告)号：US20120312415A1

    公开(公告)日：2012-12-13

    申请号：US13577929

    申请日：2011-02-09

    Applicant: Isabelle Gay ,  Nicolas Mendyk

    Inventor： Isabelle Gay ,  Nicolas Mendyk

    IPC: B65B3/04

    CPC classification number: B65B3/003 ,  B65B31/02

    Abstract: A method for the sterile filling of at least one final basic container, includes: providing at least one sterile chamber having at least one sterile entrance port and providing a source container containing the content, located outside the chamber; providing a communication element, a dispensing element and at least one filling member, to form when all are assembled, a sterile fluid filling and transfer line; inserting at least one final container into the chamber; structurally combining at least one final container with at least one filling member; providing inner members and elements in sterile condition for a single-use; inserting the inner element and members which were previously outside the chamber in the chamber in a sterile manner, such that after filling, a new filling process can be performed without sterilizing the inside of the chamber; transferring in a filling step content from the source container into the final container.

    Abstract translation: 用于无菌填充至少一个最终碱性容器的方法包括：提供至少一个具有至少一个无菌入口的无菌室，并提供容纳所述内容物的源容器，位于所述室外; 提供通信元件，分配元件和至少一个填充构件，以在所有组装时形成无菌流体填充和传输线; 将至少一个最终容器插入所述腔室中; 在结构上将至少一个最终容器与至少一个填充构件组合; 提供内部成员和元素在无菌条件下进行一次性使用; 将先前在室外的内部元件和构件以无菌方式插入到腔室中，使得在填充之后，可以在不对腔室内部进行灭菌的情况下执行新的填充过程; 将填充步骤中的内容物从源容器转移到最终容器中。

    SYSTEMS AND METHODS FOR FREEZING, STORING AND THAWING BIOPHARMACEUTICAL MATERIALS
    5.
    发明申请
    SYSTEMS AND METHODS FOR FREEZING, STORING AND THAWING BIOPHARMACEUTICAL MATERIALS 有权
    用于冷冻，储存和治疗生物材料的系统和方法

    公开(公告)号：US20100072216A1

    公开(公告)日：2010-03-25

    申请号：US12236933

    申请日：2008-09-24

    Applicant: Nicolas VOUTE ,  Jonathan CUTTING ,  Isabelle GAY

    Inventor： Nicolas VOUTE ,  Jonathan CUTTING ,  Isabelle GAY

    IPC: B65D25/20 ,  B65B5/00

    CPC classification number: A01N1/0263

    Abstract: A system for use in storing biopharmaceutical materials includes a holder and a container for holding biopharmaceutical materials therein. The container includes a storage portion and a sampling portion connected to each other by a connecting portion. The holder has a storage cavity receiving the storage portion and a sampling cavity receiving the sampling portion. 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 storage cradle bounding the storage cavity of the holder. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage receiving the connecting portion connecting the storage portion to the sampling portion. An outer rim of the holder is connected to the cradle and separated from the cavity.

    Abstract translation: 用于储存生物药物材料的系统包括保持器和用于在其中保持生物药物材料的容器。 容器包括通过连接部分彼此连接的存储部分和采样部分。 保持器具有容纳存储部的存储空间和接收采样部的采样腔。 保持器包括第一部分和第二部分。 容器容纳在第一部分和第二部分之间，以将容器连接到保持器。 保持器包括限定保持器的存储腔的内部存储支架。 支架包括一个限定采样腔的内部采样支架。 采样托架与存储托架分离，并通过接收将存储部分连接到采样部分的连接部分的通道连接到存储支架。 保持器的外缘连接到支架并与空腔分离。

    Sterilizable biopharmaceutical packaging and method of making a sterilizable biopharmeceutical packaging
    7.
    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

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

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

    IPC: B65B55/18 ,  A61L2/20 ,  B65D81/24 ,  B65B55/02 ,  A61L2/00 ,  A61L2/26

    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。

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