Aseptic connector for aseptically transferring a liquid medium

By designing a coupling device for sterile connectors, key components are protected at the starting position to prevent contamination and sterile connections are achieved at the operating position, the risk of contamination of liquid media when transferring in the bioreactor is solved, and sterile transfer is achieved at low clean room levels.

CN113710307BActive Publication Date: 2025-07-08SARTORIUS STEDIM BIOTECH GMBH
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Patent Information

Application Number
CN202080026082.0
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-04-03
Filing Date
2020-04-02
Publication Date
2025-07-08
Estimated Expiration
2040-04-02

AI Technical Summary

Technical Problem

In the prior art, liquid media has a risk of contamination when transferred in a bioreactor, especially when sterile connections are difficult to achieve in the case of low clean room grades.

Method used

A sterile connector is designed, including two coupling devices, ensuring sterile state during liquid transfer by protecting key components at the starting position to prevent contamination and achieving sterile connections at the operating position.

Benefits of technology

The sterile transfer of liquid media into a bioreactor under low clean room grades is achieved, which simplifies operation and reduces the risk of contamination, and is suitable for bioreactors with closed systems.

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Abstract

The present invention relates to a sterile connector for aseptically transferring a liquid medium from a liquid container (2) into a bioprocessing device (3), wherein the sterile connector (1) has two coupling devices (4a, 4b). It is proposed that the coupling devices (4a, 4b) each have a housing (5a, 5b) and an adjusting element (8a, 8b) adjustably arranged in the inner space (6a, 6b) of the housing to form a channel (7a, 7b), wherein the channel (7a, 7b) extends from the adjusting element inlet opening (9a, 9b) to the adjusting element outlet opening (10a, 10b); the housings (5a, 5b) can be mechanically connected to each other and have a fluid inlet (11a, 11b) and a fluid outlet (12a, 12b), wherein in the connected state of the housings (5a, 5b), the fluid outlet (12a) of one housing (5a) and the fluid inlet (11b) of the other housing (5b) overlap each other; in the connected state of the housings (5a, 5b), the adjusting elements (8a, 8b) can each be adjusted from a starting position to an operating position, in which starting position the fluid connection between the channel (7a, 7b) and the adjusting element inlet opening (9a, 9b) on the one hand and between the channel (7a, 7b) and the adjusting element outlet opening (10a, 10b) on the other hand is blocked, and in which operating position the adjusting element inlet opening (9a, 9b) is in fluid connection with the fluid inlet (11a, 11b) and the adjusting element outlet opening (10a, 10b) is in fluid connection with the fluid outlet (12a, 12b).
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Description

Technical Field

[0001] The present invention relates to a sterile connector for aseptically transferring a liquid, especially a biological, medium according to the preamble of claim 1, a coupling device for a sterile connector according to the preamble of claim 14, a packaging assembly having a packaging part and at least one such coupling device aseptically packaged therein or such a sterile connector aseptically packaged therein according to claim 15, and the use of such a sterile connector aseptically packaged, such a coupling device aseptically packaged, and / or such a packaging assembly according to claim 17. Background Art

[0002] Bioprocessing equipment is generally understood here as a device by means of which a biotechnological process can be carried out or supported. Here, only by way of example, bioreactors are mentioned, in which microorganisms or tissue cells are cultivated under defined conditions. Such devices usually have a container in which, on the one hand, a biological reaction medium from substances provided for biotechnological processes, such as microorganisms or tissue cells, is accommodated, and on the other hand, a corresponding nutrient medium is accommodated in order to be able to carry out corresponding biotechnological method steps, such as fermentation or cultivation.

[0003] An example of such a bioreactor is, on the one hand, a production bioreactor, i.e., a relatively large bioreactor on a production scale (or production standard, i.e., Produktionsmaßstab) with a working volume of, for example, several hundred or several thousand liters, for the industrial manufacture of microbial products or cell products, especially biopharmaceuticals. Such a bioreactor forms a fermentation broth as a product, which is usually further processed in a so-called downstream process in order to obtain the product from the cells or the culture supernatant (or culture supernatant liquid, i.e., Kulturüberstand). Another example is a laboratory bioreactor, i.e., a relatively small bioreactor on a laboratory scale with a working volume of, for example, less than 10 liters. Such a laboratory bioreactor is used, for example, for the manufacture of ATMPs (advanced therapy medicinal products, drugs for novel therapies) and / or for cell expansion, by means of which a sufficient number of cells, especially tissue cells or microbial cells, can be produced for the respective application purposes. One application scenario for this is the proliferation of human cells, such as T cells (T lymphocytes), which are taken from a patient, then expanded ex vivo, and subsequently reinjected into the patient.

[0004] In particular, in the case of manufacturing ATMPs using laboratory bioreactors, but in principle also in the case of production bioreactors, it is particularly important to aseptically add various liquid, e.g., biological, media to the respective bioreactor. Since many ATMPs cannot be aseptically filtered or finally sterilized, the manufacturing of these pharmaceuticals is carried out aseptically in a cleanroom of the corresponding cleanroom class. Thus, adding a liquid medium to a bioreactor or transferring a liquid medium between two culture vessels and / or bioreactors inherently involves a risk of contamination, and therefore such processing steps are typically carried out in a cleanroom of cleanroom class A (Annex 1 of the GMP guidelines) or ISO 5 (ISO 14644-1). However, due to high monitoring requirements, elaborate gowning procedures, etc., manufacturing pharmaceuticals in such cleanrooms is very cost-intensive.

[0005] For this reason, especially in the field of manufacturing ATMPs, there is a need for closed systems for cell culture or expansion, whereby cleanrooms of a lower cleanroom class, such as cleanroom class D (Annex 1 of the GMP guidelines) or ISO 8 (ISO 14644-1), can be used. But a challenge here is to add a liquid medium to such a closed system in the simplest possible way. Although various connection systems are known, such as Luer connectors, Luer lock connectors, etc., in order to couple, for example, small-volume liquid containers such as syringes or pear-shaped bottles (or long-necked pear-shaped bottles, vials, i.e., Phiole) to a closed system. However, there is a risk of contamination at the coupling site where the two coupling devices of the connector (for a Luer connector, a male Luer fitting and a female Luer fitting) are interconnected, and therefore particular attention must be paid to aseptic conditions when making the connection. Summary of the Invention

[0006] The problem on which the present invention is based is to design and improve an aseptic connector for aseptically transferring a liquid medium from a liquid container to a bioprocessing device in such a way that aseptic conditions can be created in a simple manner during medium transfer.

[0007] In the aseptic connector for aseptically transferring a liquid, especially biological, medium according to the preamble of claim 1, the above problem is solved by the features of the characterizing part of claim 1.

[0008] An important basic consideration is as follows: An aseptic connector is proposed which has two coupling devices to be interconnected for liquid transfer from a liquid container (which is, for example, a minimal liquid container) to a bioprocessing device (which is especially a bioreactor), wherein these coupling devices are initially provided in a state in which the preferably aseptic parts decisive for liquid transfer are not readily accessible to contamination by the user, since these parts are covered in the coupling devices in this state and are thus protected against contact.

[0009] In particular, the channels of the corresponding coupling devices, and at least the discharge opening for one of the coupling devices and at least the corresponding inlet opening for the other coupling device are in a preferably sterile position protected against contamination in this state. After the two coupling devices are then properly connected to each other, they can each be brought into a state in which the parts decisive for liquid transfer are removed from the protected, preferably sterile position and are thus connected to each other and aligned with each other such that liquid transfer can take place. Then, in this state allowing transfer, the previously protected and still sterile discharge opening of one coupling device and the previously protected and still sterile inlet opening of the other coupling device are arranged opposite each other such that the liquid medium can flow from one coupling device into the other coupling device. In this state, the liquid medium only comes into contact with the previously protected and still sterile sections of these coupling devices in the region of the transition from one coupling device to the other. The regions that were previously unprotected and accordingly exposed to the risk of possible contamination are spaced apart from the regions through which the fluid flows, so that bacteria or other media cannot enter the liquid medium.

[0010] Particularly preferably, before the two coupling devices are connected to each other, the liquid container (from which the medium is to be discharged) and / or the bioprocessing device (to which the medium is to be added) have been aseptically connected to the respective associated coupling device. This is particularly preferably done on the manufacturer's side. It is then conceivable that the manufacturer of the liquid container has provided it with the associated coupling device with a sterile connector, where the liquid container has particularly preferably been filled on the manufacturer's side at this point in time, and where the liquid container and the coupling device are preferably provided to the user for use as a single-use part in the properly connected state. The corresponding also applies to the bioprocessing device, where it is likewise conceivable that the manufacturer of the device has provided it with the associated coupling device with a sterile connector, and if necessary also with a plurality of such coupling devices, where the bioprocessing device and the corresponding coupling device are preferably provided to the user for use as a single-use part in the properly connected state.

[0011] In this way, the two coupling devices of the aseptic connector are not contaminable at any preferably aseptic site that is decisive for liquid transfer before the connection is established, because an aseptic connection already exists in the region where the medium reaches the coupling device connected thereto from the liquid container and in the region where the medium reaches the bioprocessing device from the other coupling device. The sections of the coupling devices (through which the medium is duly guided from the coupling device associated with the liquid container into the respective other coupling device) are only moved out of the protected, preferably aseptic regions of the respective coupling devices after the two coupling devices are interconnected and are brought together with each other. In particular, these two sections are brought directly together with each other, and they cannot come into contact with other contaminable sections of the coupling device or with the user when they are moved from the protected region to their duly defined end positions. Since after the two coupling devices are interconnected, the still-aseptic parts of the coupling devices are duly arranged opposite each other and brought into contact with each other, and contamination of these parts is impossible during this movement, an aseptic connection between the liquid container and the bioprocessing device can be established in a particularly simple manner by means of the proposed (or according to the suggestion, i.e., vorschlagsgemäßen) aseptic connector.

[0012] Specifically, it is now proposed that the coupling devices each have a housing with a preferably aseptic housing interior space and a preferably aseptic adjusting element adjustably arranged in the housing interior space and forming a channel, wherein the channel extends through the adjusting element from an adjusting element inlet opening to an adjusting element outlet opening; the housing of one coupling device can be mechanically connected to the housing of the other coupling device; the respective housing has a fluid inlet and a fluid outlet, which connect the housing interior space to the surroundings, wherein in the mechanically interconnected state of the housings, the fluid outlet of one housing and the fluid inlet of the other housing overlap each other; in the mechanically interconnected state of the housings, the adjusting elements can each be adjusted from a starting position to an operating position, in which the fluid connection between the channel and the adjusting element inlet opening on the one hand and between the channel and the adjusting element outlet opening on the other hand is blocked, and in which the adjusting element inlet opening is in fluid connection with the fluid inlet and the adjusting element outlet opening is in fluid connection with the fluid outlet.

[0013] "The housing" is here understood in a completely general sense as a component which at least sectionally, preferably substantially completely, surrounds the adjusting element in at least one peripheral direction. If the adjusting element is rotatably arranged as will also be explained below, the adjusting element is at least sectionally or substantially completely surrounded by the housing with respect to the axis of rotation in the radial direction of the housing. The latter is just preferred when the adjusting element inlet opening and the adjusting element outlet opening point radially outwards with respect to the axis of rotation. However, in principle it is also conceivable that the adjusting element inlet opening and the adjusting element outlet opening point parallel to the axis of rotation, where in this case the adjusting element is preferably at least sectionally or substantially completely surrounded by the housing in the axial direction. In principle, the adjusting element can also move linearly, where then the housing preferably at least sectionally or substantially completely surrounds the adjusting element at the side parallel to the direction of movement, where in this case the adjusting element inlet opening and the adjusting element outlet opening of the adjusting element point in a direction transverse to the direction of movement.

[0014] "Substantially completely" means that, apart from the fluid inlet and the fluid outlet, the housing is here completely enclosed in the corresponding direction.

[0015] In any case, the housing is designed such that it protects the adjusting element inlet opening and the adjusting element outlet opening in the starting position of the adjusting element and thereby remains sterile, and in the operating position of the adjusting element allows: the adjusting element outlet opening associated with a coupling device of an especially liquid container and the adjusting element inlet opening associated with another coupling device of an especially bioprocessing device to be brought into an overlap.

[0016] "Overlap" is here understood to mean that the two corresponding openings partially or completely coincide in a direction parallel to the central axis of the opening.

[0017] Particularly preferred embodiments are given in claims 2 to 7, namely how the preferably sterile adjustment element inlet opening and the preferably sterile adjustment element outlet opening in the starting position can be arranged in the housing in an optimal and contamination-protected manner relative to the surroundings, and how they can be arranged relative to one another in the operating position while maintaining sterility. For this purpose, in the corresponding housing, there are in particular areas that are hermetically sealed and preferably already sterile in the delivered state, in which the channels extending through the adjustment elements extend in the starting position of the adjustment elements. Only by moving the adjustment element from its starting position to its operating position can the channels and accordingly the adjustment element inlet opening or the adjustment element outlet opening reach the non-sterile area. However, when using a sterile connector as specified, the two coupling devices are pre-connected to each other in such a way that the movement of the adjustment element from the starting position to the operating position does not result in any contact between the adjustment element inlet opening, the adjustment element outlet opening, the channels and the surroundings.

[0018] "Hermetically sealed" or "hermetically sealed" means in the context that a sealing is provided that prevents the intrusion of contaminants, in particular bacteria. In another embodiment, "hermetically sealed" or "hermetically sealed" means the sterile and / or contamination-protected area of the sterile connector. In a particularly preferred embodiment, the terms "hermetically sealed" or "hermetically sealed" also include the term "sterile" and are thus interchangeable.

[0019] Claim 8 relates to the particularly preferred orientation of all parts through which fluid flows in the operating position of the corresponding adjustment element. Here, particularly preferably, the two fluid inlet parts of the housing, the two fluid outlet parts of the housing and the two channels of the adjustment element extend coaxially with one another. In principle, however, other extensions can also be envisaged here.

[0020] Further preferred designs in claims 9 to 11 relate to the adjustment movement of the corresponding adjustment elements between the starting position and the operating position. In particular, the adjustment movement of one adjustment element is accompanied by a corresponding adjustment movement of the other adjustment element, that is to say, the two adjustment elements move synchronously and are simultaneously in their starting position and simultaneously in their operating position. This is preferably achieved by a transmission device, in particular a gear transmission device. The transmission device can be operated by the user from outside the housing, thereby causing the adjustment movement of the two adjustment elements.

[0021] According to a particularly preferred design of claim 12, the fluid inlet of one housing and the fluid outlet of the other housing can be connected or are already connected to a hose or a small tube. As already explained above, it is particularly preferred that the liquid container has been connected to one associated coupling device and the bioprocessing device has been connected to the other associated coupling device on the manufacturer's side, which can also be carried out by means of a corresponding hose or a corresponding small tube.

[0022] Claim 13 defines a preferred feasible solution for connecting the two housings to each other.

[0023] According to another teaching of independent significance of claim 14, there is claimed a sterile connector, in particular the coupling device of the proposed sterile connector, for aseptically transferring a liquid, in particular a biological, medium from a liquid container to a bioprocessing device, in particular a bioreactor. In view of the fact that the proposed sterile connector has two coupling devices, all relevant explanations regarding the first-mentioned teaching can be referred to.

[0024] According to another teaching of independent significance of claim 15, there is claimed a packaging assembly having a packaging part and having at least one, preferably exactly one, of the proposed coupling devices aseptically packaged therein or the proposed sterile connector aseptically packaged therein. In view of the fact that the proposed packaging assembly has the proposed sterile connector or the proposed coupling device, all relevant explanations regarding the first-mentioned and second-mentioned teachings can be referred to.

[0025] According to claim 16, furthermore, either the liquid container or the bioprocessing device can be aseptically packaged in the packaging part, wherein the liquid container or the bioprocessing device has been fluid-technologically coupled to the coupling device in the packaging part.

[0026] According to another teaching of independent significance of claim 17, there is claimed the use of the proposed sterile connector aseptically packaged, the proposed coupling device aseptically packaged, and / or the proposed packaging assembly for aseptically transferring a liquid, in particular a biological, medium from a liquid container to a bioprocessing device, in particular a bioreactor. In view of the fact that the proposed use involves the use of the proposed sterile connector, the proposed coupling device, and / or the proposed packaging assembly, all relevant explanations regarding the above teachings can be referred to.

[0027] With the proposed packaging assembly and the proposed use, it has been recognized that a liquid medium can be supplied to a closed system, in particular a bioreactor, particularly simply and without any appreciable risk of contamination, by means of the proposed sterile connector or by means of the proposed coupling device, in such a way that the coupling device keeps the parts decisive for the liquid transfer in a sterile state, i.e. in the starting position, until the liquid transfer actually takes place, i.e. in the operating position.

[0028] In a particularly preferred design according to claim 18, the individual parts mentioned, in particular the proposed coupling device, in particular two coupling devices, preferably also the liquid container and / or the bioprocessing equipment and / or one or more hoses or tubes, are preferably designed as single-use parts, and these parts are preferably designed from plastic material. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The invention will now be explained in more detail with reference to the drawings which show only one embodiment. In the drawings:

[0030] Figure 1 A perspective view of the proposed sterile connector when its two coupling devices are connected is shown;

[0031] Figure 2 Two coupling devices in the connected state are shown in perspective view, a) in the starting position of the two adjusting elements and b) in the operating position of the two adjusting elements;

[0032] Figure 3 Two coupling devices in the connected state are shown in cross-section, a) in the starting position of the two adjusting elements and b) in the operating position of the two adjusting elements; and

[0033] Figure 4 A perspective view of the proposed packaging assembly having the proposed coupling device and a liquid container coupled thereto and of the proposed packaging assembly having another proposed coupling device and a bioprocessing equipment coupled thereto is shown. DETAILED DESCRIPTION OF THE INVENTION

[0034] Figures 1 to 4The proposed aseptic connector 1 shown in the figure is used to aseptically transfer a liquid, especially a biological medium, from a liquid container 2 (here a small-capacity liquid container, i.e., a liquid container with a small accommodation volume of at most 30 ml, for example) to a bioprocessing device 3 (here a bioreactor). The proposed aseptic connector 1 has two coupling devices 4a, 4b that can be mechanically and fluid-technologically connected to each other, where one coupling device 4a is associated with the liquid container 2 and the other coupling device 4b is associated with the bioprocessing device 3. "Associated" means that the coupling device 4a can be connected or is already connected to the liquid container 2, and the coupling device 4b can be connected or is already connected to the bioprocessing device 3. Here, it is particularly preferred that, on the manufacturer's side, specifically in the aseptic state, on the one hand, the liquid container 2 has been connected to the coupling device 4a associated with it, and on the other hand, the bioprocessing device 3 has been connected to the coupling device 4b associated with it.

[0035] The bioprocessing device 3, especially the bioreactor, forms a closed system or is integrated into a closed system here. The bioreactor is designed, for example, as a laboratory bioreactor, i.e., a bioreactor that, unlike a production bioreactor, has a relatively small working volume (maximum available filling volume) of up to 10 liters. Such a bioreactor is used to perform biotechnological processes, which are preferably used here to manufacture drugs for novel therapies (ATMP). The biotechnological process can also be, for example, a cell expansion process for T cells. In any case, a biological reaction medium is provided in the bioreactor, which especially has tissue cells or microbial cells as well as a nutrient medium. It is necessary here to aseptically add a liquid medium to the closed system.

[0036] Now, it is important that the coupling devices 4a, 4b each have a housing 5a, 5b with a preferably aseptic housing interior space 6a, 6b and preferably aseptic adjustment elements 8a, 8b that are adjustably arranged in the housing interior spaces 6a, 6b and form channels 7a, 7b, where the channels 7a, 7b extend from an adjustment element inlet opening 9a, 9b through the adjustment elements 8a, 8b to an adjustment element outlet opening 10a, 10b. Additionally, it is important that the housing 5a of one coupling device 4a can be mechanically connected to the housing 5b of the other coupling device 4b. It is also important that the respective housings 5a, 5b have a fluid inlet 11a, 11b and a fluid outlet 12a, 12b that connect the housing interior spaces 6a, 6b to the surroundings of the respective housings 5a, 5b, where, in the mechanically interconnected state of the housings 5a, 5b, the fluid outlet 12a of one housing 5a and the fluid inlet 11b of the other housing 5b overlap. Finally, it is also important that, in the mechanically interconnected state of the housings 5a, 5b, the adjustment elements 8a, 8b can each be moved from the starting position ( Figure 2a), Figure 3 a)) Adjust to the operating position ( Figure 2 b), Figure 3 b)) In this starting position, on the one hand, the fluid connection between the channels 7a, 7b and the adjustment element inlet openings 9a, 9b and, on the other hand, between the channels 7a, 7b and the adjustment element outlet openings 10a, 10b is blocked. In this operating position, the adjustment element inlet openings 9a, 9b and the fluid inlet parts 11a, 11b and the adjustment element outlet openings 10a, 10b and the fluid outlet parts 12a, 12b are in fluid connection, especially completely.

[0037] For the proposed sterile connector 1 or the proposed coupling devices 4a, 4b to be interconnected, the adjustment elements 8a, 8b are therefore arranged to be movable from the starting position into the operating position, wherein in the starting position, the parts decisive for fluid transfer, namely the channels 7a, 7b, the adjustment element inlet openings 9a, 9b and / or the adjustment element outlet openings 10a, 10b, are in a sterile state. The sterile state is ensured by the following measures: The parts decisive for fluid transfer are preferably in a sterile state in the starting position of the adjustment elements 8a, 8b and are covered with respect to the surroundings of the housings 5a, 5b and are accordingly protected from contamination. If the two coupling devices 4a, 4b are properly interconnected, the adjustment elements 8a, 8b can be moved into the operating position, in which the liquid medium can then be transferred. In the operating position, the parts decisive for fluid transfer remain sterile because the two coupling devices 4a, 4b or the two housings 5a, 5b are interconnected in such a way before the movement from the starting position into the operating position that the parts decisive for fluid transfer are not in contact with the surroundings at any time.

[0038] In the embodiment shown here and preferred in this regard, the respective channels 7a, 7b extend in the starting position in the following regions of the inner spaces 6a, 6b of the housings, which regions are sealed hermetically with respect to the surroundings of the housings 5a, 5b and are preferably already sterile in the delivered state. Furthermore, here and preferably, in the starting position, the adjustment element inlet openings 9a, 9b and the adjustment element outlet openings 10a, 10b each point to the inner walls 13a, 13b of the respective housings 5a, 5b.

[0039] The respective adjustment elements 8a, 8b are here and preferably arranged to be rotatable and, as Figure 3 shown, have a substantially circular cross-section. Accordingly, the respective adjustment elements 8a, 8b have a rotational axis x around the adjustment elements 8a, 8b a 、x bThe substantially cylindrical periphery, wherein the respective adjusting elements enter the openings 9a, 9b and the respective adjusting element discharge openings 10a, 10b are here and preferably arranged at the periphery and relative to the rotational axis x a , x b point in the radial direction. The channels 7a, 7b connecting the respective adjusting element inlet openings 9a, 9b to the respective adjusting element discharge openings 10a, 10b are here and preferably have a straight extension. Here, the channels extend centrally through the respective adjusting elements 8a, 8b and thus also through the rotational axes x a , x b of the respective adjusting elements 8a, 8b. The adjusting element inlet openings 9a, 9b and the adjusting element discharge openings 10a, 10b of the respective adjusting elements 8a, 8b are here and preferably exactly opposite each other. In alternative and here not shown embodiments it is also conceivable that the adjusting element inlet openings and / or the adjusting element discharge openings of the adjusting elements 8a, 8b can be laterally, i.e. parallel to the rotational axis x a , x b oriented. Additionally or alternatively, in another embodiment not shown here it is also conceivable to provide linearly movable adjusting elements instead of the rotatable adjusting elements 8a, 8b. The explanations made here for the preferably rotatable adjusting elements 8a, 8b accordingly also apply to adjusting elements of different designs or adjustability, especially also to linearly adjustable adjusting elements.

[0040] The fluid inlet 11a of one housing 5a and the fluid outlet 12b of the other housing 5b are here channel-shaped, i.e. designed as inlet or outlet channels leading from the outside into the housing interior spaces 6a, 6b, while the fluid outlet 12a of one housing 5a and the fluid inlet 11b of the other housing 5b are here designed as openings which directly connect the housing interior spaces 6a, 6b to the surroundings. In an exemplary embodiment, the cross-section of the fluid inlet 11a of one housing 5a and the fluid outlet 12b of the other housing 5b is smaller than the cross-section of the fluid outlet 12a of one housing 5a and the fluid inlet 11b of the other housing 5b. Here, the "cross-section" is always with respect to a section transverse to the flow direction. Furthermore here, the longitudinal extension of the fluid inlet 11a of one housing 5a and the fluid outlet 12b of the other housing 5b is greater than the longitudinal extension of the fluid outlet 12a of one housing 5a and the fluid inlet 11b of the other housing 5b. The latter is almost zero. The "longitudinal extension" is here always with respect to the flow direction.

[0041] Furthermore, now here and preferably, in the starting position, a section of the respective adjusting elements 8a, 8b, in particular the peripheral sections Ua1, Ub1, closes the fluid inlets 11a, 11b of the respective housings 5a, 5b in a gastight seal. Additionally or alternatively, it is also preferably provided here that, in the starting position, another section of the respective adjusting elements 8a, 8b, in particular another peripheral section Ua2, Ub2, closes the fluid outlets 12a, 12b of the respective housings 5a, 5b in a gastight seal.

[0042] Furthermore, here and preferably, in the starting position, the section extending around the adjusting element inlet openings 9a, 9b, in particular the peripheral sections Ua3, Ub3 of the respective adjusting elements 8a, 8b, bears in a sealing manner against the inner walls 13a, 13b of the respective housings 5a, 5b. Additionally or alternatively, it is preferably provided here that, in the starting position, the section extending around the adjusting element outlet openings 10a, 10b, in particular the peripheral sections Ua4, Ub4 of the respective adjusting elements 8a, 8b, bears in a sealing manner against the inner walls 13a, 13b of the respective housings 5a, 5b.

[0043] Furthermore, here and preferably, in the starting position, the section Aa1 of the housing 5a of the coupling device 4a associated here with the liquid container 2 and extending around the fluid inlet 11a, and / or the section Ab2 of the housing 5b of the coupling device 4b associated here with the bioprocessing device 3 and extending around the fluid outlet 12b, bears in a sealing manner against the respective adjusting elements 8a, 8b, i.e. the section Aa1 bears against the adjusting element 8a and the section Ab2 bears against the adjusting element 8b. It is also preferably provided here that, in the starting position, the section Aa2 of the housing 5a of the coupling device 4a associated here with the liquid container 2 and extending around the fluid outlet 12a, and / or the section Ab1 of the housing 5b of the coupling device 4b associated here with the bioprocessing device 3 and extending around the fluid inlet 11b, bears in a sealing manner against the respective adjusting elements 8a, 8b.

[0044] As especially Figure 3As shown in a) and b), the adjusting element 8a of one housing 5a and the adjusting element 8b of the other housing 5b are prestressed against each other in the state where the housings 5a and 5b are mechanically connected to each other, at least when both adjusting elements 8a and 8b are in their operating positions, and here preferably also when both adjusting elements 8a and 8b are in their starting positions. Here and preferably, the two adjusting elements 8a and 8b are constantly prestressed against each other. This is achieved in particular by the following measures: The adjusting elements 8a and 8b are designed either integrally or at least only in the regions where they come into contact with each other, from a relatively soft plastic, in particular from an elastomer, in particular from a silicone (or siloxane, i.e., Silikon) material. In this way, the adjusting elements 8a and 8b can elastically deform in the regions where they come into contact with each other. As Figure 3 shown, here and preferably, in the state where the housings 5a and 5b are mechanically connected to each other, when both adjusting elements 8a and 8b are in their operating positions, the section extending around the discharge opening 10a of the adjusting element, in particular the peripheral section Ua4 of one adjusting element 8a, and the section extending around the inlet opening 9b of the adjusting element, in particular the peripheral section Ub3 of the other adjusting element 8b, are in contact with each other in such a way as to seal the corresponding channels 7a, 7b towards the corresponding housings 5a, 5b.

[0045] As described, an elastomer is provided for the purpose of hermetically sealing. Particularly preferably, the adjusting elements 8a, 8b are designed in sections or completely from such an elastomer, in particular from a silicone resin material. The corresponding housings 5a, 5b can also be designed in sections from an elastomer, in particular from a silicone resin material, in any case, although preferably the housings 5a, 5b are designed from a plastic with as little elasticity as possible, preferably from a plastic with lower elasticity, in particular a thermoplastic or Vero material. According to a particularly preferred design, the corresponding adjusting elements 8a, 8b are designed in sections or completely, in particular in the sections (here the peripheral sections Ua1, Ub1) that hermetically seal the fluid inlets 11a, 11b, and / or in the sections (here the peripheral sections Ua2, Ub2) that hermetically seal the fluid outlets 12a, 12b, and / or in the sections (here the peripheral sections Ua3, Ub3) that extend around the adjusting element inlet openings 9a, 9b, and / or in the sections (here the peripheral sections Ua4, Ub4) that extend around the adjusting element outlet openings 10a, 10b, from an elastomer, in particular from a silicone resin material. Additionally or alternatively, it can be provided that the corresponding housings 5a, 5b are designed in sections, in particular in the sections Aa1, Ab1 that extend around the fluid inlets 11a, 11b, and / or in the sections Aa2, Ab2 that extend around the fluid outlets 12a, 12b, from an elastomer, in particular from a silicone resin material, and preferably from a plastic with lower elasticity, in particular a thermoplastic or Vero material, elsewhere.

[0046] Furthermore, as Figure 3 shown in b), in the mechanically interconnected state of the housings 5a, 5b, when both adjusting elements 8a, 8b are in their operating positions, for the coupling devices 4a, 4b, on the one hand, the fluid inlets 11a, 11b and the adjusting element inlet openings 9a, 9b, and / or on the other hand, the fluid outlets 12a, 12b and the adjusting element outlet openings 10a, 10b, are respectively overlapped with each other. In particular, they are coaxially oriented towards each other. Here, the fluid outlet 12a of one housing 5a and the fluid inlet 11b of the other housing 5b are also overlapped with each other at the same time. They are preferably also coaxially oriented towards each other here. Particularly preferably, as Figure 3 shown in b), the two fluid inlets 11a, 11b, the two fluid outlets 12a, 12b, and the two channels 7a, 7b are coaxially oriented towards each other.

[0047] Between the starting position and the operating position of an adjusting element 8a Figure 3The adjustment movement shown by the circumferential arrow in a), here and preferably accompanied by a corresponding adjustment movement of another adjustment element 8b. This applies here and preferably only to the mechanically interconnected state of the housings 5a, 5b, as shown in Figure 2 and 3 shown. For this purpose, a transmission 14 is provided here and preferably, as Figure 2 shown, which is particularly preferably a gear transmission. The transmission 14 has at least two transmission components, preferably in the form of gears and / or gear segments 14a, 14b respectively. As the gear segments 14a, 14b, for example, toothed peripheral sections of circular discs are provided here, where instead of a completely circumferential disc as here, the disc can also only have the shape of a sector, whereupon the toothing extends along an arc. Here and preferably, two gear segments 14a, 14b are provided as transmission components. In the mechanically interconnected state of the housings 5a, 5b, the transmission 14 causes a synchronous adjustment between the two adjustment elements 8a, 8b between their starting position and their operating position. Furthermore, here and preferably, the transmission components of the transmission 14, in particular the gear or the gear segment 14b of the transmission 14, are non-rotatably connected or connectable to an operating element 15 for manually operating the transmission 14. The operating element 15 can be a rod (or lever, i.e., Hebel), a crank, etc.

[0048] The adjustment movement of the corresponding adjustment elements 8a, 8b between the starting position and the operating position, as described above, here and preferably is a rotational movement, that is, the adjustment elements 8a, 8b are respectively rotatable adjustment elements. The corresponding adjustment elements 8a, 8b here and preferably adjust at an angle of less than 45 degrees, preferably less than 40 degrees, further preferably less than 35 degrees, further preferably less than 30 degrees between the starting position and the operating position. In principle, in an alternative embodiment not shown here, as described, a linear movement of the corresponding adjustment element can also be considered as the adjustment movement.

[0049] The adjustment movement of the corresponding adjustment elements 8a, 8b can be restricted in one or two directions, that is, towards the starting position and / or towards the operating position. Here and preferably, this is ensured in two directions by the fact that at least one transmission component, here two transmission components, are gear segments 14a, 14b, so that the adjustment movement is only feasible in the toothed peripheral section, that is, for example, only in an angular range of less than 45 degrees, preferably less than 40 degrees, further preferably less than 35 degrees, further preferably less than 30 degrees. Additionally or alternatively, as Figure 3Only shown exemplary in a) and b), the adjustment movement can be limited by the stops 16a, 16b in the starting position and / or by the stops 17a, 17b in the operating position. The corresponding stops 16a, 16b and / or the corresponding stops 17a, 17b can be arranged inside the housings 5a, 5b as here, or can also be arranged outside the housings 5a, 5b.

[0050] In this way, the starting position can be set as a defined position, especially on the manufacturer's side, so that it is reliably ensured that the parts decisive for the fluid transfer are located in a protected and especially sterile area. Then, the operating position can be set as a defined position, especially on the user's side, so that it is reliably ensured that the respective adjustment elements enter the openings 9a, 9b and are in overlap with the respectively associated fluid inlet parts 11a, 11b, and the respective adjustment element outlet openings 10a, 10b and are in overlap with the respectively associated fluid outlet parts 12a, 12b.

[0051] Figure 1 and Figure 2 It is also shown that here and preferably, the fluid inlet part 11a of one housing 5a and the fluid outlet part 12b of the other housing 5b can be connected or are connected, especially by a plug connection, by means of hoses 18a, 18b or small tubes respectively. Here and preferably, the fluid inlet part 11a of one housing 5a is coupled to the liquid container 2 by means of a hose 18a or a small tube. Additionally or alternatively, as Figure 1 and 2 It is also shown that the fluid outlet part 12b of the other housing 5b is fluid-technically coupled to the bioprocessing device 3 (here a bioreactor) by means of a hose 18b or a small tube.

[0052] Furthermore, Figures 1 to 3 It can be seen that the housings 5a, 5b can be connected to each other in a form-fitting manner. Here, these housings can be plugged together, for example, only exemplary by a dovetail connection or the like. But in principle, it is also conceivable that the housings 5a, 5b can be snap-connected to each other. It is only important that the housings 5a, 5b are reliably held together when the adjustment movement of the adjustment elements 8a, 8b is carried out. Since these adjustment elements are preferably pressed against each other under prestress in the operating position in any case, a form-fitting is preferably also present in the direction of extension of the prestress. Here and preferably, a form-fitting exists between the housings 5a, 5b during the transfer of the medium in the flow direction of the liquid medium.

[0053] According to another teaching of independent significance, the corresponding coupling devices 4a, 4b are claimed, namely the coupling device 4a associated here with the liquid container 2 and / or the coupling device 4b associated with the bioprocessing device 3 per se. In particular, the coupling devices 4a, 4b are the coupling devices of the proposed sterile connector 1.

[0054] Such a coupling device 4a has a housing 5a with a housing interior space 6a and an adjustment element 8a adjustably arranged in the housing interior space 6a and forming a channel 7a, where the channel 7a extends from an adjustment element inlet opening 9a through the adjustment element 8a to an adjustment element outlet opening 10a. The housing 5a of the coupling device 4a can be mechanically connected to the housing 5b of another coupling device 4b, where, with regard to the design of the other coupling device 4b, reference can be made to the description made for the proposed first coupling device 4a. The housing 5a has a fluid inlet 11a and a fluid outlet 12a, which connect the housing interior space 6a to the surrounding environment, where, in the state of mechanical connection of the housings 5a, 5b, the fluid outlet 12a of the housing 5a of the proposed coupling device 4a and the fluid inlet 11b of the housing 5b of the other coupling device 4b can be in overlap with each other. In the state of mechanical connection of the housings 5a, 5b with each other, the adjustment element 8a can be adjusted from a starting position to an operating position, in which the fluid connection is blocked on the one hand between the channel 7a and the adjustment element inlet opening 9a and on the other hand between the channel 7a and the adjustment element outlet opening 10a, and in which the adjustment element inlet opening 9a and the fluid inlet 11a and the adjustment element outlet opening 10a and the fluid outlet 12a can be in fluid connection. In this regard, all descriptions made for the proposed sterile connector 1 can be referred to.

[0055] According to another teaching of independent significance, a packaging assembly 19, 21 is claimed, which has packaging parts 20, 22 and at least one, preferably exactly one, of the proposed coupling devices 4a, 4b sterilely packaged therein or the proposed sterile connector 1 sterilely packaged therein. In this regard, all descriptions made for the proposed sterile connector 1 and the proposed coupling device 4a can be referred to.

[0056] According to one embodiment, as Figure 4 the packaging assembly 19 shown above is provided with a packaging part 20 and the proposed coupling device 4a sterilely packaged therein and the liquid container 2, which is especially filled and already filled on the manufacturer's side, sterilely packaged therein. The liquid container 2 is hereby fluid-technologically coupled in the packaging state to the proposed coupling device 4a of the sterile connector 1, and the control element 8a of the coupling device 4a is hereby in its starting position.

[0057] According to another embodiment, as inFigure 4 The packaging assembly 21 shown below is provided with a packaging section 22 and the proposed coupling device 4b aseptically packaged therein, as well as the bioprocessing device 3 aseptically packaged therein, here a bioreactor. The bioprocessing device 3 or bioreactor is hereby fluid-technologically coupled to the proposed coupling device 4b of the aseptic connector 1 in the packaged state, and the adjustment element 8b of the coupling device 4b is in its starting position. Here and preferably, the packaging assembly 21 additionally also has an actuating element 15, which is used to manually operate the transmission 14 in the later assembled state of the aseptic connector 1, i.e., when the housings 5a, 5b are connected to each other as described, and accordingly to adjust the adjustment elements 8a, 8b from the starting position to the operating position.

[0058] In an alternative embodiment not shown here, a packaging assembly with a packaging section can also be envisaged, in which only one proposed aseptic connector 1 including two coupling devices 4a, 4b is aseptically packaged. In principle, it is also conceivable to provide a packaging assembly in which only the corresponding coupling devices 4a, 4b are aseptically packaged.

[0059] According to yet another teaching, which is also of independent significance, the use per se of the proposed aseptic connector 1 aseptically packaged, the proposed coupling devices 4a, 4b aseptically packaged, and / or the proposed packaging assemblies 19, 21 for the aseptic transfer of a liquid, especially biological, medium from a liquid container 2 to a bioprocessing device 3, especially a bioreactor, is claimed. In this regard, with respect to the claimed use, all the explanations made for the proposed aseptic connector 1, the proposed coupling devices 4a, 4b, and the proposed packaging assemblies 19, 21 can also be referred to.

[0060] According to Figure 4 In the embodiment shown, after disassembling the unit composed of the coupling device 4a and the liquid container 2 on the one hand and after disassembling the unit composed of the coupling device 4b and the bioprocessing device 3 on the other hand, one coupling device 4a is connected to the other coupling device 4b as described by using connection hoses 18a, 18b or small tubes. Then the adjustment elements 8a, 8b are adjusted especially synchronously from their starting position to their operating position, so that the transfer of the liquid medium from the liquid container 2 via the coupling device 4a and the coupling device 4b to the bioprocessing device 3 can thus be achieved.

[0061] In a particularly preferred design, at least the proposed coupling device 4a or the proposed coupling device 4b, in particular both coupling devices 4a, 4b, preferably also the liquid container 2 and / or the bioprocessing device 3 and / or one or more hoses 18a, 18b or tubules are each disposable components. The corresponding components, namely the corresponding coupling devices 4a, 4b, the liquid container 2, the bioprocessing device 3 and / or the corresponding hoses 18a, 18b or the corresponding tubules, are designed at least partly, preferably at least predominantly, from plastic material. As plastics for the individual components, silicone materials and / or polymer materials, in particular elastomers and / or thermoplastics and / or Vero materials are especially considered. Examples thereof are PE (polyethylene), PP (polypropylene), PTFE (polytetrafluoroethylene), PBT (polybutylene terephthalate), PSU (polysulfone), PESU (polyethersulfone), PC (polycarbonate).

Claims

1. A sterile connector for aseptically transferring a liquid medium from a liquid container (2) into a bioprocessing device (3). Among them, The sterile connector (1) has two coupling devices (4a, 4b). It is characterized in that: Each of the coupling devices (4a, 4b) has a housing (5a, 5b) with a housing interior space (6a, 6b) and an adjustment element (8a, 8b) adjustably arranged in the housing interior space (6a, 6b) to form channels (7a, 7b), wherein the channels (7a, 7b) extend through the adjustment element (8a, 8b) from an adjustment element inlet opening (9a, 9b) to an adjustment element outlet opening (10a, 10b); The housing (5a) of one coupling device (4a) can be mechanically connected to the housing (5b) of the other coupling device (4b); The respective housings (5a, 5b) have a fluid inlet (11a, 11b) and a fluid outlet (12a, 12b) that connect the housing interior space (6a, 6b) to the surrounding environment, wherein in the mechanically connected state of the housings (5a, 5b), the fluid outlet (12a) of one housing (5a) and the fluid inlet (11b) of the other housing (5b) are in overlap with each other; In order to establish a sterile fluid connection, in the mechanically connected state of the housings (5a, 5b), the adjustment elements (8a, 8b) can be adjusted from a starting position to an operating position respectively, in which starting position, on the one hand, the fluid connection between the channel (7a, 7b) and the adjustment element inlet opening (9a, 9b) and, on the other hand, the fluid connection between the channel (7a, 7b) and the adjustment element outlet opening (10a, 10b) is blocked, and in which operating position, the adjustment element inlet opening (9a, 9b) is in fluid connection with the fluid inlet (11a, 11b) and the adjustment element outlet opening (10a, 10b) is in fluid connection with the fluid outlet (12a, 12b); In the mechanically connected state of the housings (5a, 5b), the adjustment movement of one adjustment element (8a, 8b) between its starting position and its operating position is accompanied by a corresponding adjustment movement of the other adjustment element (8b, 8a); A transmission device (14) is provided, which causes synchronous adjustment of the two adjustment elements (8a, 8b) between their starting position and their operating position in the mechanically connected state of the housings (5a, 5b).

2. The sterile connector according to claim 1, characterized in that, In the starting position, the respective channels (7a, 7b) extend in a region of the housing interior space (6a, 6b) that is hermetically sealed relative to the surrounding environment of the housings (5a, 5b).

3. The aseptic connector according to claim 2, characterized in that, In the starting position, the adjustment element inlet opening (9a, 9b) and the adjustment element outlet opening (10a, 10b) respectively point to the inner wall (13a, 13b) of the housing of the respective housing (5a, 5b).

4. The aseptic connector according to any one of claims 1 to 3, characterized in that, In said starting position, a section of the respective adjusting element (8a, 8b) closes the fluid inlet (11a, 11b) of the respective housing (5a, 5b) in a gastight and sealed manner, and / or a section of the respective adjusting element (8a, 8b) closes the fluid outlet (12a, 12b) of the respective housing (5a, 5b) in a gastight and sealed manner, and / or, In said starting position, a section of the respective adjusting element (8a, 8b) extending around the adjusting element inlet opening (9a, 9b), and / or a section of the respective adjusting element (8a, 8b) extending around the adjusting element outlet opening (10a, 10b), abuts in a sealing manner against the inner wall (13a, 13b) of the respective housing (5a, 5b), and / or, In said starting position, a section (Aa1, Ab1) of the respective housing (5a, 5b) extending around the fluid inlet (11a, 11b), and / or a section (Aa2, Ab2) of the respective housing (5a, 5b) extending around the fluid outlet (12a, 12b), abuts in a sealing manner against the respective adjusting element (8a, 8b).

5. The aseptic connector according to claim 4, wherein, In said starting position, a peripheral section (Ua1, Ub1) of the respective adjusting element (8a, 8b) closes the fluid inlet (11a, 11b) of the respective housing (5a, 5b) in a gastight and sealed manner, and / or a peripheral section (Ua2, Ub2) of the respective adjusting element (8a, 8b) closes the fluid outlet (12a, 12b) of the respective housing (5a, 5b) in a gastight and sealed manner, and / or, In said starting position, a peripheral section (Ua3, Ub3) of the respective adjusting element (8a, 8b) extending around the adjusting element inlet opening (9a, 9b), and / or a peripheral section (Ua4, Ub4) of the respective adjusting element (8a, 8b) extending around the adjusting element outlet opening (10a, 10b), abuts in a sealing manner against the inner wall (13a, 13b) of the respective housing (5a, 5b).

6. The aseptic connector according to any one of claims 1 to 3, characterized in that, The adjusting element (8a) of one housing (5a) projects from the housing interior space (6a) via the fluid outlet (12a) of the housing (5a), and / or the adjusting element (8b) of the other housing (5b) projects from the housing interior space (6b) via the fluid inlet (11b) of the housing (5b).

7. The aseptic connector according to any one of claims 1 to 3, characterized in that, The adjusting element (8a) of one housing (5a) and the adjusting element (8b) of the other housing (5b) abut against each other under prestress in a state where the housings (5a, 5b) are mechanically interconnected, at least when both adjusting elements (8a, 8b) are in their operating positions.

8. The aseptic connector according to claim 7, characterized in that, The adjusting element (8a) of one housing (5a) and the adjusting element (8b) of the other housing (5b) are in prestress contact with each other when the housings (5a, 5b) are mechanically interconnected, at least when both adjusting elements (8a, 8b) are in their operating positions and also when both adjusting elements (8a, 8b) are in their starting positions.

9. The aseptic connector according to claim 7, characterized in that, The adjusting element (8a) of one housing (5a) and the adjusting element (8b) of the other housing (5b) are constantly in prestress contact with each other when the housings (5a, 5b) are mechanically interconnected.

10. The sterile connector according to claim 7, characterized in that, In the region of mutual contact, the adjusting elements (8a, 8b) are elastically deformed.

11. The aseptic connector according to any one of claims 1 to 3, characterized in that, In the state where the housings (5a, 5b) are mechanically interconnected, when the two adjusting elements (8a, 8b) are in their operating positions, the section of one adjusting element (8a) extending around the adjusting element discharge opening (10a) and the section of the other adjusting element (8b) extending around the adjusting element inlet opening (9b) are in contact with each other in such a way as to seal the corresponding channels (7a, 7b) tightly relative to the corresponding housings (5a, 5b).

12. The aseptic connector according to any one of claims 1 to 3, characterized in that, The corresponding adjusting element (8a, 8b) is designed in sections or completely from an elastomer; and / or, The corresponding housing (5a, 5b) is designed in sections from an elastomer.

13. The aseptic connector according to any one of claims 1 to 3, characterized in that, In the state where the housings (5a, 5b) are mechanically interconnected, when the two adjusting elements (8a, 8b) are in their operating positions, for the two coupling devices (4a, 4b), the fluid inlet parts (11a, 11b) and the adjusting element inlet openings (9a, 9b), and / or the fluid discharge parts (12a, 12b) and the adjusting element discharge openings (10a, 10b) are respectively in overlap with each other, and the fluid discharge part (12a) of one housing (5a) and the fluid inlet part (11b) of the other housing (5b) are in overlap with each other.

14. The sterile connector according to claim 13, characterized in that, In the state where the housings (5a, 5b) are mechanically interconnected, when the two adjusting elements (8a, 8b) are in their operating positions, for the two coupling devices (4a, 4b), the fluid inlet parts (11a, 11b) and the adjusting element inlet openings (9a, 9b), and / or the fluid discharge parts (12a, 12b) and the adjusting element discharge openings (10a, 10b) are respectively coaxial with each other, and the fluid discharge part (12a) of one housing (5a) and the fluid inlet part (11b) of the other housing (5b) are coaxial with each other.

15. The sterile connector according to claim 13, characterized in that, In the state where the housings (5a, 5b) are mechanically interconnected, when the two adjusting elements (8a, 8b) are in their operating positions, the two fluid inlet parts (11a, 11b), the two fluid discharge parts (12a, 12b) and the two channels (7a, 7b) are coaxial with each other.

16. The aseptic connector according to any one of claims 1 to 3, characterized in that, The transmission device (14) is a gear transmission device.

17. The sterile connector according to claim 16, wherein, The transmission components of the transmission device (14) are non-rotatably connected or connectable to the actuating element (15).

18. The aseptic connector according to any one of claims 1 to 3, characterized in that, The adjustment movement of the corresponding adjustment elements (8a, 8b) between their starting position and their operating position is a rotational movement or a linear movement.

19. The aseptic connector according to any one of claims 1 to 3, characterized in that, The adjustment movement of the corresponding adjustment elements (8a, 8b) between their starting position and their starting position is limited by stops (16a, 16b, 17a, 17b) in the starting position and / or the operating position.

20. The aseptic connector according to any one of claims 1 to 3, characterized in that The fluid inlet (11a) of one housing (5a) and the fluid outlet (12b) of the other housing (5b) can be connected or are connected by hoses (18a, 18b) or small tubes.

21. The aseptic connector according to claim 20, characterized in that, The fluid inlet (11a) of one housing (5a) is fluid-technologically coupled to the liquid container (2) via the hose (18a) or the small tube for discharging the liquid medium, and / or the fluid outlet (12b) of the other housing (5b) is fluid-technologically coupled to the bioprocessing device (3) via the hose (18b) or the small tube.

22. The sterile connector according to any one of claims 1 to 3, characterized in that, The two housings (5a, 5b) can be connected to each other in a form-fitting manner.

23. A coupling device of a sterile connector (1) for aseptically transferring a liquid medium from a liquid container (2) into a bioprocessing device (3), characterized in that: The coupling device (4a, 4b) has housings (5a, 5b) with housing interior spaces (6a, 6b) and adjustment elements (8a, 8b) adjustably arranged in the housing interior spaces (6a, 6b) to form channels (7a, 7b), wherein the channels (7a, 7b) extend through the adjustment elements (8a, 8b) from the adjustment element inlet openings (9a, 9b) to the adjustment element outlet openings (10a, 10b); the housings (5a, 5b) of the coupling device (4a, 4b) can be mechanically connected to the housings (5b, 5a) of another coupling device (4b, 4a) of the sterile connector (1); The housings (5a, 5b) have fluid inlets (11a, 11b) and fluid outlets (12a, 12b) which connect the housing interior spaces (6a, 6b) to the surroundings, wherein in the mechanically connected state of the housings (5a, 5b), the fluid outlets (12a, 12b) of the housings (5a, 5b) of the coupling device (4a, 4b) and the fluid inlets (11b, 11a) of the housings (5b, 5a) of another coupling device (4b, 4a) can be brought into overlap with each other; For establishing a sterile fluid connection, in the state where the housings (5a, 5b) are mechanically interconnected, the adjusting elements (8a, 8b) can be adjusted from a starting position to an operating position, in which starting position, on the one hand, the fluid connection between the channels (7a, 7b) and the adjusting element inlet openings (9a, 9b) and, on the other hand, between the channels (7a, 7b) and the adjusting element outlet openings (10a, 10b) is blocked, and in which operating position, the adjusting element inlet openings (9a, 9b) are in fluid connection with the fluid inlets (11a, 11b) and the adjusting element outlet openings (10a, 10b) are in fluid connection with the fluid outlets (12a, 12b); In the state where the housings (5a, 5b) are mechanically interconnected, the adjustment movement of one adjusting element (8a, 8b) between its starting position and its operating position is accompanied by a corresponding adjustment movement of the other adjusting element (8b, 8a); A transmission device (14) is provided, which, in the state where the housings (5a, 5b) are mechanically interconnected, causes synchronous adjustment of the two adjusting elements (8a, 8b) between their starting position and their operating position.

24. The coupling device according to claim 23, wherein The sterile connector (1) is provided according to any one of claims 1 to 22.

25. A packaging assembly, having packaging parts (20, 22) and having at least one coupling device (4a, 4b) as claimed in any one of claims 23 to 24 sterilely packaged therein or a sterile connector (1) as claimed in any one of claims 1 to 22 sterilely packaged therein.

26. The packaging component according to claim 25, wherein The adjusting elements (8a, 8b) of the coupling device (4a, 4b) sterilely packaged in the packaging parts (20, 22) are in their starting position, and in the packaging parts (20, 22) there is furthermore sterilely packaged a liquid container (2) fluid-technologically coupled to the coupling device (4a) or a bioprocessing device (3) fluid-technologically coupled to the coupling device (4b).

27. The packaging component according to claim 26, wherein The liquid container (2) is a filled liquid container (2).

28. A method for sterilely transferring a liquid medium from a liquid container (2) to a bioprocessing device (3) by using a sterilely packaged sterile connector (1) as claimed in any one of claims 1 to 22, a sterilely packaged coupling device (4a, 4b) as claimed in any one of claims 23 to 24, and / or a packaging assembly (19, 21) as claimed in any one of claims 25 to 27.

29. The method according to claim 28, wherein At least one coupling device is at least partly designed from plastic material.

30. The method according to claim 29, characterized in that, Furthermore, the liquid container (2) and / or the bioprocessing device (3) and / or one or more hoses (18a, 18b) or small tubes are at least partly designed from plastic material.

Citation Information

Patent Citations

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