STERILE CONNECTOR FOR THE STERILE TRANSFER OF A LIQUID MEDIUM

Abstract

Various embodiments provide a connector for the sterile transfer of a liquid medium from a container to a bioprocess engineering system. The connector has two coupling devices. The coupling devices each have a housing and a control element which is adjustably mounted in the housing interior and forms a channel. The channel extends from a control element inlet opening to a control element outlet opening. The housings are able to be mechanically connected to one another and have a fluid inlet and a fluid outlet. The fluid outlet of one housing and the fluid inlet of the other housing overlap. The control elements are each adjustable from a starting position, into an operating position, in which the control element inlet opening is fluidically connected to the fluid inlet and the control element outlet opening is fluidically connected to the fluid outlet.

Claims

1. A sterile connector for the sterile transfer of a liquid medium from a liquid container to a bioprocess engineering system, wherein the sterile connector has two coupling devices, wherein the coupling devices each have a housing having a housing interior and a control element which is adjustably mounted in the housing interior and forms a channel, wherein the channel extends through the control element from a control element inlet opening to a control element outlet opening, wherein the housing of one coupling device is configured to be mechanically connected to the housing of the other coupling device, wherein each housing has a fluid inlet and a fluid outlet which connect the housing interior to the surroundings, wherein, in the mechanically connected state of the housings, the fluid outlet of one housing and the fluid inlet of the other housing overlap, wherein, in the mechanically connected state of the housings, the control elements are each adjustable from a starting position, in which a fluid connection between the channel and the control element inlet opening on the one hand and between the channel and the control element outlet opening on the other hand is blocked, into an operating position, in which the control element inlet opening is fluidically connected to the fluid inlet and the control element outlet opening is fluidically connected to the fluid outlet.

2. The sterile connector as claimed in claim 1, wherein, in the starting position, each channel extends in a region of the housing interior that is hermetically sealed with respect to the surroundings of the housing.

3. The sterile connector as claimed in claim 1, wherein, in the starting position, a portion of the respective control element closes the fluid inlet and/or a portion of the respective control element closes the fluid outlet of the respective housing in a hermetically tight manner, and/or wherein, in the starting position, a portion of the respective control element extending around the control element inlet opening and/or a portion of the respective control element extending around the control element outlet opening is in contact in a hermetically sealing manner with the housing inner wall of the respective housing, and/or wherein, in the starting position, a portion of the respective housing extending around the fluid inlet and/or a portion of the respective housing extending around the fluid outlet is in contact in a hermetically sealing manner with the respective control element.

4. The sterile connector as claimed in claim 1, wherein the control element of one housing projects from the housing interior through the fluid outlet of the housing and/or wherein the control element of the other housing projects from the housing interior through the fluid inlet of the housing.

5. The sterile connector as claimed in claim 1, wherein the control element of one housing and the control element of the other housing, in the mechanically connected state of the housings, at least when the two control elements are in their operating position.

6. The sterile connector as claimed in claim 1, wherein, in the mechanically connected state of the housings, when the two control elements are in their operating position, a portion of one control element extending around the control element outlet opening and a portion of the other control element extending around the control element inlet opening are in contact with one another in such a manner that the respective channel is hermetically sealed with respect to the respective housing.

7. The sterile connector as claimed in claim 1, wherein each control element is produced in part or completely, from an elastomer, and/or wherein each housing is produced in part, from an elastomer.

8. The sterile connector as claimed in claim 1, wherein, in the mechanically connected state of the housings, when the two control elements are in their operating position, in the case of both coupling devices in each case the fluid inlet and the control element inlet opening and/or the fluid outlet and the control element outlet opening overlap and the fluid outlet and the fluid inlet of the other housing overlap.

9. The sterile connector as claimed in claim 1, wherein, in the mechanically connected state of the housings, an adjusting movement of one control element between its starting position and its operating position is accompanied by a corresponding adjusting movement of the other control element.

10. The sterile connector as claimed in claim 9, wherein the adjusting movement of each control element between its starting position and its operating position is a rotational movement or a linear movement.

11. The sterile connector as claimed in claim 9, wherein the adjusting movement of each control element between its starting position and its operating position is limited in the starting position and/or operating position via a stop.

12. The sterile connector as claimed in claim 1, wherein the fluid inlet of one housing and the fluid outlet of the other housing is configured to be connected or is connected to a flexible tube or a pipe for the delivery of a liquid medium, and/or wherein the fluid outlet of the other housing is fluidically coupled via the flexible tube or the pipe with a bioprocess engineering system.

13. The sterile connector as claimed in claim 1, wherein the two housings are configured to be connected together in a form-fitting manner.

14. A coupling device of a sterile connector for the sterile transfer of a liquid medium from a liquid container to a bioprocess engineering system, a sterile connector as claimed in claim 1, wherein the coupling device has a housing having a housing interior and a control element which is adjustably mounted in the housing interior and forms a channel, wherein the channel extends through the control element from a control element inlet opening to a control element outlet opening, wherein the housing of the coupling device is configured to be mechanically connected to the housing of a further coupling device of the sterile connector, wherein the housing has a fluid inlet and a fluid outlet which connect the housing interior to the surroundings, wherein, in the mechanically connected state of the housings, the fluid outlet of the housing of the coupling device and the fluid inlet of the housing of the further coupling device are configured to be brought to overlap, wherein, in the mechanically connected state of the housings, the control element is adjustable from a starting position, in which a fluid connection between the channel and the control element inlet opening on the one hand and between the channel and the control element outlet opening on the other hand is blocked, into an operating position, in which the control element inlet opening is fluidically connected to the fluid inlet and the control element outlet opening is fluidically connected to the fluid outlet.

15. A packaging arrangement having a packaging and having a sterile connector as claimed in claim 1 sterile packaged therein.

16. The packaging arrangement as claimed in claim 15, wherein the control element of the coupling device sterile packaged in the packaging is in its starting position, and wherein there is additionally sterile packaged in the packaging a liquid container, which is fluidically coupled with the coupling device, or there is sterile packaged a bioprocess engineering system which is fluidically coupled with the coupling device.

17. A use of a sterile packaged sterile connector as claimed in claim 1 for the sterile transfer of a liquid medium from a liquid container to a bioprocess engineering system.

18. The use as claimed in claim 17, wherein at least one coupling device and/or the flexible tube(s) or the pipe(s) are produced at least in part from a plastics material.

19. The sterile connector as claimed in claim 2, wherein, in the starting position, the control element inlet opening and the control element outlet opening each face the housing inner wall of the respective housing.

20. The sterile connector as claimed in claim 8, wherein, in the mechanically connected state of the housings, when the two control elements are in their operating position, the two fluid inlets, the two fluid outlets and the two channels are oriented coaxially with one another.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Various aspects will be explained in greater detail herein below with reference to a drawing illustrating only one exemplary embodiment. In the drawing:

[0050] FIG. 1 shows, in a perspective view, a proposed sterile connector during connection of its two coupling devices,

[0051] FIG. 2 shows, in a perspective view, the two coupling devices in the connected state a) in the starting position of the two control elements and b) in the operating position of the two control elements,

[0052] FIG. 3 shows, in a cutaway view, the two coupling devices in the connected state a) in the starting position of the two control elements and b) in the operating position of the two control elements, and

[0053] FIG. 4 shows, in a perspective view, a proposed packaging arrangement having a proposed coupling device and a liquid container connected thereto, and a proposed packaging arrangement having a further proposed coupling device and a bioprocess engineering system connected thereto.

DETAILED DESCRIPTION

[0054] The proposed sterile connector 1 illustrated in FIGS. 1 to 4 serves for the sterile transfer of a liquid medium, in particular a biological medium, from a liquid container 2, here a minimum-quantity liquid container, that is to say a liquid container having a small capacity of, for example, not more than 30 ml, to a bioprocess engineering system 3, here to a bioreactor. The proposed sterile connector 1 has two coupling devices 4a, 4b which are able to be mechanically and fluidically connected together, of which one coupling device 4a is associated with the liquid container 2 and the other coupling device 4b is associated with the bioprocess engineering system 3. “Associated” means that the coupling device 4a is able to be connected or is connected to the liquid container 2 and the coupling device 4b is able to be connected or is connected to the bioprocess engineering system 3. In some embodiments, on the one hand the liquid container 2 has already been connected to the associated coupling device 4a and the bioprocess engineering system 3 has already been connected to the associated coupling device 4b by the manufacturer, namely in the sterile state.

[0055] The bioprocess engineering system 3, in particular the bioreactor, here forms a closed system or is integrated into a closed system. The bioreactor is, for example, in the form of a laboratory bioreactor, that is to say a bioreactor which, in contrast to a production bioreactor, has a relatively small working volume (maximum available filling volume) of not more than 10 liters. Such a bioreactor is used for carrying out a biotechnological process and for producing an advanced therapy medical product (ATNF). For example, the biotechnological process may also be a cell expansion process for T-cells. In any case, a biological reaction medium which comprises in particular tissue cells or microbial cells and also a nutrient medium is provided in the bioreactor. It is thereby necessary to add the liquid media to the closed system in a sterile manner.

[0056] The coupling devices 4a, 4b each can have a housing 5a, 5b having a sterile housing interior 6a, 6b and a sterile control element 8a, 8b which is adjustably mounted in the housing interior 6a, 6b and forms a channel 7a, 7b, wherein the channel 7a, 7b extends through the control element 8a, 8b from a control element inlet opening 9a, 9b to a control element outlet opening 10a, 10b. It is further possible that the housing 5a of one coupling device 4a is able to be mechanically connected to the housing 5b of the other coupling device 4b. It is also possible that each housing 5a, 5b has a fluid inlet 11a, 11b and a fluid outlet 12a, 12b which connect the housing interior 6a, 6b to the surroundings of the respective housing 5a, 5b, 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 overlap. Finally, it is also possible that, in the mechanically connected state of the housings 5a, 5b, the control elements 8a, 8b are each adjustable from a starting position (FIG. 2a), FIG. 3a)), in which a fluid connection between the channel 7a, 7b and the control element inlet opening 9a, 9b on the one hand and between the channel 7a, 7b and the control element outlet opening 10a, 10b on the other hand is blocked, into an operating position (FIG. 2b), FIG. 3b)), in which the control element inlet opening 9a, 9b is fluidically connected to the fluid inlet 11a, 11b and the control element outlet opening 10a, 10b is fluidically connected to the fluid outlet 12a, 12b, in particular completely.

[0057] In the proposed sterile connector 1, or the proposed coupling devices 4a, 4b which are to be connected together, it is thus provided that the control elements 8a, 8b can be moved from a starting position into an operating position, wherein in the starting position the parts that are relevant for the fluid transfer, namely the channel 7a, 7b, the control element inlet opening 9a, 9b and/or the control element outlet opening 10a, 10b, are in a sterile state. The sterile state is ensured in that the parts that are relevant for the fluid transfer, in the starting position of the control element 8a, 8b, can be sterile and covered with respect to the surroundings of the housing 5a, 5b and accordingly protected against contamination. If the two coupling devices 4a, 4b are connected together as intended, the control elements 8a, 8b are able to move into the operating position, in which the transfer of the liquid medium can then take place. In the operating position, said parts that are relevant for the fluid transfer are still sterile, since the two coupling devices 4a, 4b, or the two housings 5a, 5b, were connected together beforehand, that is to say before the movement from the starting position into the operating position, in such a manner that the parts that are relevant for the fluid transfer could not come into contact with the surroundings at any time.

[0058] In the exemplary embodiment illustrated here, each channel 7a, 7b extends in the starting position in a region of the housing interior 6a, 6b that is hermetically sealed with respect to the surroundings of the housing 5a, 5b and that is already sterile here in the delivery state. Furthermore, here, the control element inlet opening 9a, 9b and the control element outlet opening 10a, 10b each face the housing inner wall 13a, 13b of the respective housing 5a, 5b in the starting position.

[0059] Each control element 8a, 8b is here a control element which is rotatably mounted and, as shown in FIG. 3, has a substantially round cross section. Correspondingly, each control element 8a, 8b has a substantially cylindrical circumference extending around the axis of rotation x.sub.a, x.sub.b of the control element 8a, 8b, wherein the respective control element inlet opening 9a, 9b and the respective control element outlet opening 10a, 10b are here arranged on the circumference and face in the radial direction, based on the axes of rotation x.sub.a, x.sub.b. The channel 7a, 7b connecting the respective control element inlet opening 9a, 9b to the respective control element outlet opening 10a, 10b has here a linear path. The channel here runs centrally through the respective control element 8a, 8b, that is to say also through the axis of rotation x.sub.a, x.sub.b of the respective control element 8a, 8b. The control element inlet opening 9a, 9b and the control element outlet opening 10a, 10b of the respective control element 8a, 8b here lie diametrically opposite one another. In an alternative exemplary embodiment not shown here, it is also conceivable that the control element inlet opening and/or control element outlet opening of the control element 8a, 8b can be oriented laterally, that is to say parallel to the axis of rotation x.sub.a, x.sub.b. In addition or alternatively, it is also conceivable in a further exemplary embodiment not shown here to provide a linearly movable control element instead of a rotatable control element 8a, 8b. The remarks concerning the control elements 8a, 8b which are here rotatable accordingly equally apply also to control elements that are otherwise configured or adjustable, in particular also to linearly adjustable control elements.

[0060] The fluid inlet 11a of one housing 5a and the fluid outlet 12b of the other housing 5b is here channel-shaped, that is to say is in the form of an inlet or outlet channel leading from outside into the housing interior 6a, 6b, whereas the fluid outlet 12a of one housing 5a and the fluid inlet 11b of the other housing 5b is here in the form of an opening which connects the housing interior 6a, 6b directly to the surroundings. In one exemplary embodiment, the cross section of the fluid inlet 11a of one housing 5a and of 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 of the fluid inlet 11b of the other housing 5b. The “cross section” is always based on a section transverse to the direction of flow. The longitudinal extent of the fluid inlet 11a of one housing 5a and of the fluid outlet 12b of the other housing 5b is here additionally larger than the longitudinal extent of the fluid outlet 12a of one housing 5a and of the fluid inlet 11b of the other housing 5b. The latter is approximately zero. The “longitudinal extent” is always based on the direction of flow.

[0061] Furthermore, here, in the starting position, a portion, in particular a circumferential portion Ua.sub.1, Ub.sub.1, of the respective control element 8a, 8b closes the fluid inlet 11a, 11b of the respective housing 5a, 5b in a hermetically tight manner. In addition or alternatively, it is here further provided that, in the starting position, a further portion, in particular a further circumferential portion Ua.sub.2, Ube, of the respective control element 8a, 8b closes the fluid outlet 12a, 12b of the respective housing 5a, 5b in a hermetically tight manner.

[0062] Furthermore, here, in the starting position, a portion, in particular a circumferential portion Ua.sub.3, Ub.sub.3, of the respective control element 8a, 8b extending around the control element inlet opening 9a, 9b is in contact in a hermetically sealing manner with the housing inner wall 13a, 13b of the respective housing 5a, 5b. In addition or alternatively, it is here provided that, in the starting position, a portion, in particular a circumferential portion Ua.sub.4, Ub.sub.4, of the respective control element 8a, 8b extending around the control element outlet opening 10a, 10b is in contact in a hermetically sealing manner with the housing inner wall 13a, 13b of the respective housing 5a, 5b.

[0063] Moreover, here, in the starting position, a portion Aa.sub.1, extending around the fluid inlet 11a, of the housing 5a of the coupling device 4a that is here associated with the liquid container 2 and/or a portion Ab.sub.2, extending around the fluid outlet 12b, of the housing 5b of the coupling device 4b that is here associated with the bioprocess engineering system 3 is in contact in a hermetically sealing manner with the respective control element 8a, 8b, namely the portion Aa.sub.1 with the control element 8a and the portion Ab.sub.2 with the control element 8b. Here, it is further provided that, in the starting position, a portion Aa.sub.2, extending around the fluid outlet 12a, of the housing 5a of the coupling device 4a that is here associated with the liquid container 2 and/or a portion Ab.sub.1, extending around the fluid inlet 11b, of the housing 5b of the coupling device 4b that is here associated with the bioprocess engineering system 3 is in contact in a hermetically sealing manner with the respective control element 8a, 8b.

[0064] As is shown in particular by FIGS. 3a) and 3b), the control element 8a of one housing 5a and the control element 8b of the other housing 5b are in contact with one another under preload in the mechanically connected state of the housings 5a, 5b at least when the two operating elements 8a, 8b are in their operating position, here also when the two operating elements 8a, 8b are in their starting position. Here, the two control elements 8a, 8b are always in contact with one another under preload. This is achieved in particular in that the control elements 8a, 8b are produced either completely or at least only in the region of their mutual contact from a comparatively flexible plastics material, in particular from an elastomer, in particular from a silicone material. In this manner, the control elements 8a, 8b are able to deform elastically in the region of mutual contact. As is shown in FIG. 3, here, in the mechanically connected state of the housings 5a, 5b, when the two control elements 8a, 8b are in their operating position, a portion, in particular a circumferential portion Ua.sub.4, of one control element 8a extending around the control element outlet opening 10a and a portion, in particular a circumferential portion Ub.sub.3, of the other control element 8b extending around the control element inlet opening 9b are in contact with one another in such a manner that the respective channel 7a, 7b is hermetically sealed with respect to the respective housing 5a, 5b.

[0065] For the purpose of hermetic sealing, there is provided in particular an elastomer, as mentioned. In some embodiments, each control element 8a, 8b is produced in part or completely from such an elastomer, in particular from a silicone material. Each housing 5a, 5b can also be produced, at least in part, from an elastomer, in particular from a silicone material, although it can be that the housing 5a, 5b is produced from a plastics material with as little elasticity as possible, such as from a plastics material with relatively low elasticity, in particular a thermoplastic or Vero material. According to some embodiments, it is provided that each control element 8a, 8b is produced in part or completely, in particular in the portion, here the circumferential portion Ua.sub.1, Ub.sub.1, that closes the fluid inlet 11a, 11b in a hermetically tight manner, and/or in the portion, here the circumferential portion Ua.sub.2, Ube, that closes the fluid outlet 12a, 12b in a hermetically tight manner, and/or in the portion, here the circumferential portion Ua.sub.3, Ub.sub.3, that extends around the control element inlet opening 9a, 9b, and/or in the portion, here the circumferential portion Ua.sub.4, Ub.sub.4, that extends around the control element outlet opening 10a, 10b, from an elastomer, in particular from a silicone material. In addition or alternatively, it can be provided that each housing 5a, 5b is produced in part, in particular in the portion Aa.sub.1, Ab.sub.1 extending around the fluid inlet 11a, 11b and/or in the portion Aa.sub.2, Abe extending around the fluid inlet 12a, 12b, from an elastomer, in particular from a silicone material, and in some embodiments for the rest from a plastics material with relatively low elasticity, in particular a thermoplastic or Vero material.

[0066] As is further illustrated in FIG. 3b), in the mechanically connected state of the housings 5a, 5b, when the two control elements 8a, 8b are in their operating position, in the case of the coupling devices 4a, 4b in each case the fluid inlet 11a, 11b and the control element inlet opening 9a, 9b on the one hand and/or the fluid outlet 12a, 12b and the control element outlet opening 10a, 10b on the other hand overlap. In particular, they are oriented coaxially with one another. At the same time, the fluid outlet 12a of one housing 5a and the fluid inlet 11b of the other housing 5b overlap. They too are here oriented coaxially with one another. In some embodiments, as shown in FIG. 3b), the two fluid inlets 11a, 11b, the two fluid outlets 12a, 12b and the two channels 7a, 7b are here oriented coaxially with one another.

[0067] The adjusting movement, illustrated in FIG. 3a) by a circular arrow, of one control element 8a between its starting position and its operating position is here accompanied by a corresponding adjusting movement of the other control element 8b. This can apply here only for the mechanically connected state of the housings 5a, 5b, as is illustrated in FIGS. 2 and 3. For this purpose, a transmission 14 is here provided, which transmission, as shown in FIG. 2, can be a gear train 14. The transmission 14 has at least two transmission components, in some embodiments each in the form of a gear wheel and/or gear wheel segment 14a, 14b. There is here provided as the gear wheel segment 14a, 14b, for example, a toothed circumferential portion of a circular disk, wherein, instead of a disk having a full circumference as here, the disk may also be in the form of only a sector of a circle, wherein the toothing then extends along the circular arc. Here, two gear wheel segments 14a, 14b are provided as transmission components. In the mechanically connected state of the housings 5a, 5b, the transmission 14 effects a synchronous adjustment of the two control elements 8a, 8b between their starting position and their operating position. In addition, a transmission component of the transmission 14, in particular a gear wheel or gear wheel segment 14b of the transmission 14, is here connected or able to be connected in a rotationally fixed manner to an actuating element 15 for manually actuating the transmission 14. The actuating element 15 can be a lever, a crank or the like.

[0068] The adjusting movement of each control element 8a, 8b between the starting position and the operating position is here a rotational movement, as indicated hereinbefore, that is to say the control element 8a, 8b is here in each case a rotatable control element. Each control element 8a, 8b is here adjusted between the starting position and the operating position in an angle of less than 45 degrees, of less than 40 degrees, of less than 35 degrees, or less than 30 degrees. In principle, in an alternative exemplary embodiment not illustrated here, a linear movement of each control element is also conceivable as the adjusting movement, as mentioned.

[0069] The adjusting movement of each control element 8a, 8b can be limited in one or both directions, that is to say towards the starting position and/or towards the operating position. Here, this is ensured in both directions in that at least one transmission component, here both transmission components, is or are a gear wheel segment 14a, 14b, so that an adjusting movement is possible only in the toothed circumferential portion, that is to say, for example, only in an angle range of less than 45 degrees, of less than 40 degrees, of less than 35 degrees, or of less than 30 degrees. In addition or alternatively, as is shown merely by way of example in FIGS. 3a) and b), the adjusting movement can be limited in the starting position via a stop 16a, 16b and/or in the operating position via a stop 17a, 17b. The respective stop 16a, 16b and/or the respective stop 17a, 17b can be provided inside the housing 5a, 5b, as is the case here, or also outside the housing 5a, 5b.

[0070] In this manner, the starting position can initially be set as the defined position, in particular by the manufacturer, so that it is reliably ensured that the parts that are relevant for the fluid transfer are in the protected and in particular sterile region. Then, the operating position can be set as the defined position, in particular by the user, so that it is reliably ensured that each control element inlet opening 9a, 9b overlaps the respective associated fluid inlet 11a, 11b and each control element outlet opening 10a, 10b overlaps the respective associated fluid outlet 12a, 12b.

[0071] FIGS. 1 and 2 further show that the fluid inlet 11a of one housing 5a and the fluid outlet 12b of the other housing 5b are here able to be connected or are connected, in particular via a plug-in connection, in each case to a flexible tube 18a, 18b or a pipe. Here, the fluid inlet 11a of one housing 5a is coupled via a flexible tube 18a or a pipe with the liquid container 2. In addition or alternatively, as is likewise shown in FIGS. 1 and 2, the fluid outlet 12b of the other housing 5b is fluidically coupled via a flexible tube 18b or a pipe with the bioprocess engineering system 3, here the bioreactor.

[0072] It can further be seen from FIGS. 1 to 3 that the housings 5a, 5b are able to be connected to one another in a form-fitting manner. Here, merely by way of example, they are able to pushed together, for example via a dovetail connection or the like. However, it is in principle also conceivable that the housings 5a, 5b are able to be latched together. It can be that only the housings 5a, 5b are securely held together when the adjusting movement of the control elements 8a, 8b is carried out. Since the control elements, at least in the operating position, can be in contact with one another under preload, the form-fitting connection can likewise exists in the direction of the preload. Here, the form-fitting connection between the housings 5a, 5b is present in the direction of flow of the liquid medium on transfer thereof.

[0073] According to various embodiments, each coupling device 4a, 4b, that is to say here the coupling device 4a associated with the liquid container 2 and/or the coupling device 4b associated with the bioprocess engineering system 3, is provided as such. In particular, the coupling device 4a, 4b is a coupling device of the proposed sterile connector 1.

[0074] Such a coupling device 4a has a housing 5a having a housing interior 6a and a control element 8a which is adjustably mounted in the housing interior 6a and forms a channel 7a, wherein the channel 7a extends through the control element 8a from a control element inlet opening 9a to a control element outlet opening 10a. The housing 5a of the coupling device 4a is able to be mechanically connected to the housing 5b of a further coupling device 4b, wherein reference may be made with regard to the configuration of the further coupling device 4b to the remarks concerning the proposed first coupling device 4a. The housing 5a has a fluid inlet 11a and a fluid outlet 12a which connect the housing interior 6a to the surroundings, wherein, in the mechanically connected state 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 further coupling device 4b are able to be brought to overlap. In the mechanically connected state of the housings 5a, 5b, the control element 8a is adjustable from a starting position, in which a fluid connection between the channel 7a and the control element inlet opening 9a on the one hand and between the channel 7a and the control element outlet opening 10a on the other hand is blocked, into an operating position, in which the control element inlet opening 9a is fluidically connected to the fluid inlet 11a and the control element outlet opening 10a is fluidically connected to the fluid outlet 12a. In this respect, reference may be made to all remarks concerning the proposed sterile connector 1.

[0075] According to various embodiments, a packaging arrangement 19, 21 having a packaging 20, 22 and having at least one, such as exactly one, proposed coupling device 4a, 4b sterile packaged therein or a proposed sterile connector 1 sterile packaged therein is provided. In this respect, reference may be made to all remarks concerning the proposed sterile connector 1 and the proposed coupling device 4a.

[0076] According to one exemplary embodiment, there is provided a packaging arrangement 19 as is shown at the top in FIG. 4, having a packaging 20 and a proposed coupling device 4a sterile packaged therein and a liquid container 2, in particular a filled liquid container, here a liquid container that has already been filled by the manufacturer, sterile packaged therein. The liquid container 2 is thereby fluidically coupled with the proposed coupling device 4a of the sterile connector 1, that is to say already in the packaged state, and the control element 8a of the coupling device 4a is thereby in its starting position.

[0077] According to a further exemplary embodiment, there is provided a packaging arrangement 21 as is shown at the bottom in FIG. 4, having a packaging 22 and a proposed coupling device 4b sterile packaged therein and a bioprocess engineering system 3, here a bioreactor, sterile packaged therein. The bioprocess engineering system 3, or bioreactor, is thereby fluidically coupled with the proposed coupling device 4b of the sterile connector 1, that is to say in the packaged state, and the control element 8b of the coupling device 4b is in its starting position. Here, the packaging arrangement 21 additionally also has an actuating element 15, which is later used, in the assembled state of the sterile connector 1, that is to say when the housings 5a, 5b are connected together as described, for manually actuating the transmission 14 and accordingly for adjusting the control elements 8a, 8b from the starting position into the operating position.

[0078] In an alternative exemplary embodiment not shown here, there is also conceivable a packaging arrangement having a packaging in which only a proposed sterile connector 1, comprising both coupling devices 4a, 4b, is sterile packaged. In principle, it is also conceivable to provide a packaging arrangement in which only the respective coupling device 4a, 4b is sterile packaged.

[0079] According to various embodiments, the use of a sterile packaged proposed sterile connector 1, of a sterile packaged proposed coupling device 4a, 4b and/or of a proposed packaging arrangement 19, 21 for the sterile transfer of a liquid medium, in particular a biological medium, from a liquid container 2 to a bioprocess engineering system 3, in particular to a bioreactor, is provided. In this respect, as regards the provided use too, reference may be made to all remarks concerning the proposed sterile connector 1, the proposed coupling device 4a, 4b and the proposed packaging arrangement 19, 21.

[0080] According to the exemplary embodiment shown in FIG. 4, after the unit comprising the coupling device 4a and the liquid container 2 has been unpacked, on the one hand, and after the unit comprising the coupling device 4b and the bioprocess engineering system 3 has been unpacked, on the other hand, one coupling device 4a is connected to the other coupling device 4b as described, in each case with the flexible tubes 18a, 18b or the pipes producing the connection. The control elements 8a, 8b are then adjusted, in particular synchronously, from their starting position into 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 bioprocess engineering system 3 can then take place.

[0081] In some embodiments, at least the proposed coupling device 4a or the proposed coupling device 4b, in particular both coupling devices 4a, 4b, in some embodiments also the liquid container 2 and/or the bioprocess engineering system 3 and/or the flexible tube(s) 18a, 18b or the pipe(s) is/are in each case a single-use component. Each component, that is to say each coupling device 4a, 4b, the liquid container 2, the bioprocess engineering system 3 and/or each flexible tube 18a, 18b or each pipe, is produced at least in part, in some embodiments at least predominantly, from a plastics material. Suitable plastics materials for the individual components are in particular a silicone material and/or a polymer material, in particular an elastomer and/or thermoplastic and/or Vero material. Examples thereof are PE (polyethylene), PP (polypropylene), PTFE (polytetrafluoroethylene), PBT (polybutylene terephthalate), PSU (polysulfone), PESU (polyethersulfone), PC (polycarbonate).