Drive shaft system for use with containers and container holders for mixing fluids

Abstract

The present disclosure relates to a drive shaft system (1) for use with a container for mixing fluids as a container for biological reactions and a container holder for holding the container, the drive shaft system (1) comprising:-a drive shaft coupling (4) having: a container connection (5) for connecting the drive shaft coupling to the container; a motor connection (6) for detachably connecting the drive shaft coupling to a fixing part of a motor of the container holder, the motor connection being provided with a first alignment element (25, 26) rotationally aligned with a second alignment element (27, 28) provided on the fixing part; a driveshaft (9) rotationally arranged in the driveshaft coupling, having: a first driveshaft end (10) configured for detachable coupling to a rotatable output shaft end of the motor; a second drive shaft end (12); and a stirring device (13) connected to the drive shaft.

Description

Technical Field

[0001] The present disclosure relates to a drive shaft system for use with a container and a container holder for mixing fluids, a container assembly including such a drive shaft system and a container, a container holder for use with such a drive shaft system or such a container assembly, and a method for installing such a container assembly in such a container holder. Background Art

[0002] Installing a container such as a disposable production container such as a bioreactor bag into a container holder such as a container that can be used multiple times is usually a cumbersome and lengthy task that may require multiple operators. In order to drive the stirring device in the container, the drive shaft system of the container must, for example, be properly connected to the motor of the container holder. In addition, the container must also be safely suspended in the bioreactor holder. Current processing may cause errors and inappropriate installation. US2005 / 239198A1 discloses a stirred tank reactor system preferably used as a disposable bioreactor. The bioreactor system, for example, includes a flexible bag with an opening and a stirring shaft with an impeller. The stirring shaft can be connected to a bearing, and the bearing can be sealed to the bag by a seal or an O-ring. The upper end of the stirring shaft is releasably connected to a motor coupling. In addition, NL 2003460 C2 further discloses a stirrer for stirring, for example, liquid food, having an impeller and at least one coupling device, which is arranged at one end of the shaft for releasably connecting the stirrer to a "counter-coupling" device of a drive motor. In addition, US2011 / 188928 A1 discloses a mixer coupled to a support housing. The mixer is connected to a container, for example, comprising a flexible bag. The container and the drive shaft of the mixer can be releasably connected to a motor mounting portion having a self-aligning coupling.

[0003] It is therefore an object of the present disclosure to facilitate installation of a container into a container holder. Summary of the invention

[0004] According to the present disclosure, there is provided a drive shaft system for use with a container for mixing fluids and a container holder, wherein the container for mixing fluids is a container for biological reactions, the drive shaft system comprising:

[0005] - A drive shaft coupling having:

[0006] a container connection for connecting the drive shaft coupling to the container;

[0007] a motor connection portion for detachably connecting the drive shaft coupling to a fixed portion of a motor of the container holder, wherein the motor connection portion is provided with a first alignment element, such as a recess or a protrusion, which is rotationally aligned with a second alignment element, such as a protrusion or a recess, provided on the fixed portion of the motor;

[0008] - a drive shaft rotatably arranged in the drive shaft coupling, comprising:

[0009] a first drive shaft end configured for removable coupling to a rotatable output shaft end of the motor;

[0010] a second drive shaft end; and

[0011] a stirring device connected to the drive shaft, preferably to the second drive shaft end,

[0012] Wherein, in an operating state, the drive shaft is configured to be driven by the motor around a longitudinal axis of the drive shaft so as to rotate the stirring device for mixing fluids.

[0013] The drive shaft system described above makes it easy to install a container such as a bioreactor bag in a holder. The drive shaft coupling in particular allows the drive shaft to be connected to the rotatable output shaft end of a motor for driving a stirring device in the container, while allowing the container to be installed in the holder. Therefore, the container can be installed by a single operator. In addition, the proper rotational alignment between the container and the container holder is advantageously facilitated on the one hand.

[0014] One embodiment relates to the aforementioned drive shaft system, wherein the motor connection is provided with a plurality of first alignment elements, such as two, three, four or even more first alignment elements.

[0015] As previously mentioned, the first alignment element(s) and / or the second alignment element(s) may include notches, protrusions, or any other visually discernible features. In addition, it is conceivable that the first alignment element(s) and / or the second alignment element(s) are configured to provide an audible sound, such as a click, when properly aligned. It is also conceivable that the first alignment element(s) and / or the second alignment element(s) are configured to generate an electronic signal when properly aligned, for example by using an appropriate electronic sensor.

[0016] According to the present invention, the container that mixed fluid is used is the container that is used for bioreaction.But described container can also comprise culture medium and feed preparation system, seed bioreactor, holding dish, buffer preparation system etc.Technician will also understand that expression fluid can relate to liquid itself, but also relate to the material that shows fluid behavior, such as comprising (spherical) microcarrier that can be liquid or solid.

[0017] One embodiment relates to aforementioned drive shaft system, wherein in such a way that under operating state, the inlet and / or outlet port and / or sensor port of container are located near the mounting opening of container holder, first alignment element and / or multiple first alignment elements, second alignment element and / or multiple second alignment elements are arranged. Therefore, it is advantageous to facilitate the proper rotation alignment between container and container holder on one hand. Therefore, the inlet and / or outlet port and / or sensor port are easily accessible to the operator.

[0018] One embodiment relates to the aforementioned drive shaft system, wherein the container is configured for single use. Therefore, the container does not have to be cleaned, sterilized, etc., but can be discarded after use.

[0019] In the context of this patent application, a "single-use" container means a culture dish that is clearly to be discarded after (one-time) use. This reduces the risk of cross contamination, enhances biological and handling safety, reduces cleaning and validation requirements, and ultimately leads to cost reduction. In contrast to traditional stainless steel "multiple-use" systems, for example, plastic bags can be used as culture dishes. Single-use containers are particularly suitable for any type of biopharmaceutical products. In the art, "multiple-use" by contrast means a culture dish that is clearly to be reused. Such culture dishes need to be cleaned, disinfected, etc. after each use.

[0020] However, in the context of the present patent application, "multiple use" generally refers to the reusability of the container holder. A single-use container can advantageously be mounted in such a multiple-use container holder. Specifically, after a single use, only the single-use container is discarded after the single use, not the multiple-use container holder which is obviously reused.

[0021] One embodiment relates to the aforementioned drive shaft system, wherein the container is a rigid container, such as a plastic container. Preferably, the rigid container is again configured for single use / disposal. The container may be at least partially rigid. The container may, for example, include a rigid bottom shell with flexible container sides. The container may also be completely rigid, such as in the case of the aforementioned plastic container.

[0022] One embodiment relates to the aforementioned drive shaft system, wherein the container is a flexible container. Such a flexible container is, for example, easy to transport. The container may be at least partially flexible. The container may, for example, again comprise a rigid bottom shell with flexible container sides. The container may also be completely flexible, such as in the case of a bag.

[0023] One embodiment is directed to the aforementioned drive shaft system wherein the flexible container comprises a bag, wherein the container connection is a bag connection for connecting the drive shaft coupling to the bag.

[0024] One embodiment relates to the aforementioned drive shaft system, wherein the first drive shaft end is configured to self-align with the motor output shaft end of the motor, thereby facilitating the establishment of a proper connection between the motor output shaft and the drive shaft for efficient transmission of the motor torque to the drive shaft.

[0025] One embodiment relates to the aforementioned drive shaft system, wherein the first drive shaft end includes one or more alignment teeth, which are spaced circumferentially along the first drive shaft end. Such alignment teeth (or splines) facilitate proper connection between the teeth of the motor output shaft end and the (alignment) teeth of the drive shaft.

[0026] One embodiment relates to the aforementioned drive shaft system, wherein the one or more alignment teeth comprise two circumferentially opposite alignment surfaces converging towards each other in the insertion direction. Thus, when such "narrow shape" alignment teeth are inserted into or onto the motor output shaft end in the (longitudinal) insertion direction, the alignment teeth automatically rotate to their proper position relative to the motor output shaft end (teeth).

[0027] One embodiment relates to the aforementioned drive shaft system, wherein the two opposing alignment surfaces enclose 90 degrees or less, such as 30 to 60 degrees. A relatively sharp angle, i.e., less than 90 degrees, is preferred to facilitate proper insertion into or onto the motor output shaft and rotating the alignment teeth to their desired rotational position.

[0028] One embodiment relates to the aforementioned drive shaft system, wherein the two opposing alignment surfaces converge at an insertion edge, wherein the insertion edge is tilted rearwardly relative to the insertion direction. Thus, insertion is made easier.

[0029] One embodiment is directed to the aforementioned drive shaft system, wherein the container connection comprises a three-clamp connection. Such a three-clamp connection is relatively easy to produce and allows the weight of the container to be safely suspended on the drive shaft system.

[0030] Another aspect of the present disclosure relates to a container assembly comprising the aforementioned drive shaft system and a container for mixing fluids, wherein the container for mixing fluids is a container for a bioreactor, wherein the drive shaft coupling is connected to the container by means of a container connection, wherein the portion of the drive shaft extending between the drive shaft coupling and the second drive shaft end provided with a stirring device is surrounded by the container. In accordance with the basic principles behind the present disclosure, such a container assembly can be conveniently installed in a bioreactor holder by one operator in a one-time completion.

[0031] One embodiment is directed to the aforementioned container assembly, wherein the container is configured for single use.

[0032] One embodiment is directed to the aforementioned container assembly, wherein the container is a rigid container.

[0033] One embodiment is directed to the aforementioned container assembly, wherein the container is a flexible container.

[0034] One embodiment is directed to the aforementioned container assembly wherein the flexible container comprises a bag, wherein the container connection is a bag connection for connecting the drive shaft coupling to the bag.

[0035] One embodiment is directed to the aforementioned container assembly wherein, in the non-operating state, the flexible container is folded around the portion of the drive shaft extending between the drive shaft coupling and the second drive shaft end.

[0036] One embodiment relates to the aforementioned container assembly, wherein the flexible container is configured to expand radially away from the drive shaft portion extending between the drive shaft coupling and the second drive shaft end to reach the operational state from the non-operating state. During transportation, the flexible container, such as a bioreactor bag, is rolled up around the drive shaft portion. During filling, the flexible container is radially unfolded, which causes a much shorter unfolding in the distance direction than when the bag is unfolded upward or downward, i.e., axially. Easier unfolding will result in a better and more reliable fit with the flexible container holder with less folding. Folding is not desirable because cells may accumulate at the folds during the bioreaction process and spontaneously differentiate in the bioprocess.

[0037] Another aspect of the present disclosure relates to a container holder for holding a container for mixing fluids, wherein the container for mixing fluids is a container for biological reaction, which is used with the aforementioned drive shaft system or the aforementioned container assembly, the container holder comprising:

[0038] a motor having a fixing portion for detachably connecting to a motor connecting portion of the drive shaft coupling, wherein a second alignment element is arranged on the fixing portion of the motor for rotational alignment with a first alignment element arranged on the motor connecting portion of the drive shaft coupling;

[0039] Therein, the motor includes a rotatable output shaft end configured to be removably coupled to the first drive shaft end for driving the drive shaft about the longitudinal axis to rotate the stirring device.

[0040] One embodiment relates to the aforementioned container holder, wherein a plurality of second alignment elements, such as two, three, four or more, are provided on the fixed portion of the motor.

[0041] One embodiment relates to the aforementioned container holder, wherein a first alignment element and / or a plurality of first alignment elements, a second alignment element and / or a plurality of second alignment elements are arranged in such a manner that, in an operating state, an inlet port and / or an outlet port and / or a sensor port of the container are located near a mounting opening of the container holder.

[0042] One embodiment relates to the aforementioned container holder, wherein the fixed portion is removably connected to the motor connection portion of the drive shaft coupling, and wherein the rotatable output shaft end is removably coupled to the first drive shaft end for driving the drive shaft about the longitudinal axis to rotate the stirring device.

[0043] One embodiment relates to the aforementioned container holder, wherein the fixed part of the motor includes one or more clamping elements, which are configured to radially engage the motor connecting part for detachably connecting the drive shaft coupling to the fixed part of the motor. Thus, the drive shaft coupling can be easily connected to and disconnected from the fixed part of the motor without additional installation of required tools.

[0044] One embodiment relates to the aforementioned container holder, wherein one or more clamping elements are configured to radially engage an outer circumference of the motor connection portion, wherein the one or more clamping elements are configured to engage the outer circumference at a radially inward position and disengage the outer circumference at a radially outward position.

[0045] One embodiment relates to the aforementioned container holder, wherein one or more clamping elements are spring-loaded toward a radially inward position. Thus, the operator needs less force to connect the drive shaft coupling to the fixed part of the motor. In addition, accidental disengagement of the clamping elements is prevented.

[0046] One embodiment relates to the aforementioned container holder, wherein the one or more gripping elements include a pair of diametrically opposed gripping elements. Such diametrically opposed gripping elements can be easily pressed toward each other by an operator using a single hand.

[0047] One embodiment is directed to the aforementioned container holder, wherein the pair of clamping elements moves toward each other in a radially inward position and moves away from each other in a radially outward position.

[0048] One embodiment relates to the aforementioned container holder, wherein the fixed part of the motor includes a release mechanism such as a release button, which, when actuated such as being pressed, causes one or more clamping elements to radially disengage from the motor connection part. Thus, removing the drive shaft coupling from the fixed part of the motor is facilitated.

[0049] One embodiment relates to the aforementioned container holder, wherein the fixed portion of the motor includes a safety mechanism such as a safety latch, which, when actuated such as being pressed, prevents one or more clamping elements from accidentally disengaging from the motor connection portion, thereby increasing safety and preventing accidents.

[0050] One embodiment relates to the aforementioned container holder, wherein the safety mechanism prevents the release mechanism from being accidentally actuated.Thus, there is an additional safety measure to prevent the drive shaft coupling (and the container) from accidentally disengaging from the fixed part of the motor.

[0051] Another aspect of the present disclosure relates to a method for installing the aforementioned container assembly in the aforementioned container holder for holding a container, the method comprising the steps of:

[0052] - A motor having a fixed part is detachably connected to a motor connecting part of a drive shaft coupling in such a way that the first drive shaft end can drive the drive shaft around the longitudinal axis so as to rotate the stirring device, and in such a way that the first alignment element is rotationally aligned with the second alignment element arranged on the fixed part of the motor.

[0053] One embodiment relates to the aforementioned method, comprising the further steps of:

[0054] - rotationally aligning the first alignment element and the second alignment element in such a way that in the operating state the inlet port and / or the outlet port and / or the sensor port of the container is located adjacent to the mounting opening of the container holder.

[0055] One embodiment relates to the aforementioned method, comprising the further steps of:

[0056] - detachably connecting the drive shaft coupling to the fixed part of the motor in such a way that the clamping element or elements of the fixed part of the motor radially engage the motor connecting part. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] The present disclosure will be explained in more detail below with reference to illustrative embodiments shown in the accompanying drawings, in which:

[0058] Figure 1 An example embodiment of a container holder having an example embodiment of a container assembly configured therein is shown;

[0059] Figure 2 Shows such as Figure 1 a cross-section of an example embodiment of a container holder of an example embodiment of a container holder having an example embodiment of a container assembly disposed therein;

[0060] Figure 3 Shows such as Figure 1 and Figure 2 a perspective view of an example embodiment of an example embodiment of a container holder having an example embodiment of a container assembly configured therein;

[0061] Figure 4 Shows that Figures 1 to 3 a perspective view of an example embodiment of a drive shaft system for use with an example embodiment of

[0062] Figure 5 Shows such as Figures 1 to 3a cross-sectional view of an upper region of an example embodiment of an example embodiment of a container holder having an example embodiment of a container assembly disposed therein;

[0063] Figure 6 Shows that Figures 1 to 5 a perspective view of an example embodiment of a first drive shaft end portion of an example embodiment of a drive shaft configured for removable coupling to an example embodiment of a rotatable output shaft end portion of a motor for use with an example embodiment of a motor; and

[0064] Figure 7 Shows that Figures 1 to 5 A plan view of an example embodiment of a fixed portion of a motor including one or more clamping elements configured to radially engage a motor connecting portion for removably connecting a drive shaft coupling to the fixed portion of the motor for use together. DETAILED DESCRIPTION

[0065] Figure 1 For example, Figure 1 The flexible container holder 3 shown, such as a bioreactor bag holder 3, in which an example embodiment of a container assembly 18 is arranged, the container holder 3 includes a drive shaft system 1 and a container 2, such as preferably for single use, such as Figure 1 The flexible container 2 of the bioreactor bag 2 shown. However, the container 2 may also include (not shown) a medium and feed preparation system, a seed bioreactor, a holding dish, a buffer preparation system, etc., and essentially any mixing system that can use the drive shaft system according to the present disclosure. Please note that the expression "flexible" in "flexible container holder 3" refers to the flexibility of the flexible container 2 (such as foldability), rather than the flexibility of the holder 3, which is usually rigid. Figure 1 The flexible container holder 3 and / or the flexible container 2 shown can be configured for an operating / working volume of 1 to 10,000 liters, preferably 10 to 5,000 liters, more preferably 50 to 3,000 liters, such as 40 to 60 liters. The flexible container holder 3 is configured for holding the flexible container 2 inside a housing 32 such as a cylindrical housing 32 having a substantially open top side and a substantially closed bottom side. The drive shaft coupling 4 is connected to the flexible container 2 using a container connection 5 in the form of a bag connection 5. The flexible container holder 3 includes a motor 8 having a fixing portion 7, the fixing portion 7 (such as Figure 2) is used to be detachably connected to the motor connection 6 of the drive shaft coupling 4. For the example embodiment shown, in the operating state, the bioreaction process occurring in the flexible container 2 can be controlled by means of a control panel 31 and various controllers. The flexible container 2 can be installed or configured in the enclosure 32 of the flexible container holder 3 via a mounting opening 29 such as a door 29, for example a door 29 that opens laterally. In some embodiments, the container 2 can also be rigid, such as made of plastic. Preferably, the container 2 is also configured to be disposable, i.e., discarded after use. The container 2 can also be partially rigid or partially flexible, for example, including a rigid bottom shell with a flexible container side.

[0066] like Figure 2 As shown, in order to rotate a stirring device 13, such as an impeller 13, for mixing fluids, the motor 8 may include a rotatable output shaft end 11 configured to be detachably coupled to a first drive shaft end 10 of a drive shaft 9 for driving the drive shaft 9 about the longitudinal axis X (e.g., applying torque and rotation to the drive shaft 9). The container holder 3, such as the flexible container holder 3 shown, may also include a holder arm 33. The motor 8 may be attached to the holder arm 33, such as to an end of the holder arm 33 located above the flexible container 2 on the longitudinal axis X. The flexible container 2 may be suspended from the holder arm 33 via the motor connection 6 of the drive shaft coupling 4. The stirring device 13 may include a three-blade screw or the like.

[0067] As from Figure 3 , Figure 4 and Figure 5 As can be seen, the container connection 5 in the form of a bag connection 5 may comprise a three-clamp type connection 17, although other connection arrangements are also contemplated.

[0068] like Figure 4 and Figure 7 As shown, the motor connection part 6 for detachably connecting the drive shaft coupling 4 to the fixed part 7 of the motor 8 of the container holder 3 such as the flexible container holder 3 as shown in the figure can be provided with a spline connection and include first alignment elements 25, 26 (such as notches 25, 26 or protrusions) Figure 4 ) to align with second alignment elements 27, 28 (such as protrusions 27, 28 or recesses) provided on the fixing portion 7 of the motor 8 Figure 7 ) rotationally aligned. So that in the operating state, the inlet and / or outlet port 30 of the container 2 and / or the sensor port 30 is (rotationally) located in the flexible container 2 near the mounting opening 29 of the flexible container holder 3 (such as Figure 1As shown in the figure, the first alignment elements 25, 26 and the second alignment elements 27, 28 are arranged. As mentioned in the foregoing, the (multiple) first alignment elements 25, 26 and / or the (multiple) second alignment elements 27, 28 may include recesses 25, 26, protrusions 27, 28 or any other visually discernible features. In addition. It is conceivable that the (multiple) first alignment elements 25, 26 and / or the (multiple) second alignment elements 27, 28 are configured to provide an audible sound, such as a click, when properly aligned. It is also conceivable that the (multiple) first alignment elements 25, 26 and / or the (multiple) second alignment elements 27, 28 are configured to generate an electronic signal when properly aligned, for example by using an appropriate electronic sensor. The electronic signal can then be processed for the purpose of rotational alignment.

[0069] Generally speaking, except that in an operating state, the inlet and / or outlet port 30 of the container 2 and / or the sensor port 30 is (rotationally) located near the mounting opening 29 of the flexible container holder 3 (such as Figure 1 In addition to arranging the first alignment elements 25, 26 and the second alignment elements 27, 28 in the manner shown in the figure, the first alignment elements 25, 26 and the second alignment elements 27, 28 can also be constructed to ensure other predetermined rotational orientations (around the longitudinal axis X) between the fixing part 7 of the motor 8 and / or the container holder 3 on the one hand and the flexible container 2 on the other hand.

[0070] from Figure 6 As can be seen in the figure, the first drive shaft end 10 is preferably configured to be self-aligned with the motor output shaft end 11 of the motor 8. Here, the first drive shaft end 10 may include one or more splines or alignment teeth 14, which are spaced apart in the circumferential direction C along the first drive shaft end 10. One or more alignment teeth 14 may also include two circumferentially opposite alignment surfaces 15 that converge toward each other in the insertion direction I. The two opposite alignment surfaces 15 may enclose an angle (α) of 90 degrees or less, such as 30 to 60 degrees. In addition, the two opposite alignment surfaces 15 may converge at an insertion edge 16, wherein the insertion edge 16 is tilted backward (β) relative to the insertion direction I. The rotatable output shaft end 11 may include similar alignment teeth 34 having a shape complementary to the shape of the alignment teeth 14. Three, four or more alignment teeth 14, 34 may be provided, depending on, for example, the torque to be transmitted.

[0071] like Figure 5 and Figure 7As shown, the fixed portion 7 of the motor 8 may include one or more clamping elements 20, which are configured to radially engage the motor connecting portion 6 for detachably connecting the drive shaft coupling 4 to the fixed portion 7 of the motor 8. The one or more clamping elements 20 are preferably configured to radially engage the outer circumference 21 of the motor connecting portion 6, wherein the one or more clamping elements 20 are configured to engage the outer circumference 21 at a radially inward position (such as, for example, Figure 4 ) and disengage from the outer circumference 21 in a radially outward position. The one or more clamping elements 20 are preferably urged toward a radially inward position by a spring 22. The one or more clamping elements 20 may also include a pair of radially opposite clamping elements 20. The pair of clamping elements 20 can move toward each other in a radially inward position and move away from each other in a radially outward position. The fixed portion 7 of the motor 8 may also include a release mechanism 23 such as a release button 23, which, when actuated such as by being pressed, causes the one or more clamping elements 20 to radially disengage from the motor connection portion 6. The force applied to the release button 23 can be transmitted to the clamping element 20 by means of a mechanical linkage device 37. As Figure 7 As shown, the fixed part 7 of the motor 8 may also include a safety mechanism 24 such as a safety latch 24, which, when actuated, such as by being pressed, prevents the one or more clamping elements 20 from accidentally disengaging from the motor connecting part 6. The safety mechanism 24 can prevent the release mechanism 23 from being accidentally actuated. In order to facilitate the insertion of the motor connecting part 6 of the drive shaft coupling into the fixed part 7 of the motor 8, as shown in FIG. Figure 5 As shown, when viewed in cross section, the motor connection may have a "double arrow shape" 35 with an inclined surface that is inclined in the insertion direction I toward the longitudinal axis X. Figure 5 As shown, the clamping element 20 may also have a similar “reverse” arrow shape when viewed in cross section, with its inclined surface 36 inclined in the insertion direction I towards the longitudinal axis X to facilitate insertion of the double arrow shape 35 of the motor connection 6 .

[0072] According to one aspect of the present disclosure, a container assembly 18 can be provided, which comprises a drive shaft system 1 and a container 2 for bioreactors, such as a flexible container 2, which is preferably disposable, wherein a drive shaft coupling 4 is connected to the flexible container 2, such as a bag connection 5, by means of a container connection 5, such as a bag connection 5, wherein a drive shaft section 19 extending between the drive shaft coupling 4 and the second drive shaft end 12 and provided with a stirring device 13 is surrounded by the container 2, such as the flexible container 2 (e.g., in Figure 2). In a non-operating state, such as when transporting the container assembly 18, the flexible container 2 can be folded around the drive shaft portion 19 extending between the drive shaft coupling 4 and the second drive shaft end 12. The flexible container 2 can be configured to expand radially away from the drive shaft portion 19 extending between the drive shaft coupling 4 and the second drive shaft end 12 to reach the operating state from the non-operating state.

[0073] Another aspect of the present disclosure relates to a method for installing the aforementioned container assembly 18 in a container holder 3 such as a flexible container holder 3 for holding a container 2 such as a flexible container 2, the method comprising the steps of:

[0074] A motor 8 with a fixing portion 7 is detachably connected to the motor connection portion 6 of the drive shaft coupling 4 in such a way that the first drive shaft end 10 can drive the drive shaft 9 about the longitudinal axis X in order to rotate the stirring device 13 .

[0075] According to the aforementioned method of the present disclosure, it also includes the steps of:

[0076] - so that the first alignment elements 25, 26 are rotationally aligned with the second alignment elements 27, 28 provided on the fixing part 7 of the motor 8 (eg Figure 4 and Figure 7 The motor connecting portion 6 of the drive shaft coupling 4 is detachably connected to the fixing portion 7 of the motor 8 of the container holder 3 in the manner shown in FIG.

[0077] The aforementioned method may further comprise the steps of:

[0078] - so that in the operating state the inlet and / or outlet port 30 of the container 2 and / or the sensor port 30 is located near the mounting opening 29 of the container holder 3 (e.g. Figure 1 The first alignment elements 25, 26 and the second alignment elements 27, 28 are rotationally aligned in the manner shown in FIG.

[0079] The aforementioned method may further comprise the steps of:

[0080] so that the one or more clamping elements 20 of the fixing part 7 of the motor 8 radially engage the motor connecting part 6 (e.g. Figure 5 and Figure 7 The drive shaft coupling 4 is detachably connected to the fixed part 7 of the motor 8 in the manner shown in FIG.

[0081] Although the present disclosure has been described above with reference to example embodiments, variations within the scope of the present disclosure will be readily apparent to those skilled in the art upon reading the above description. These variations are within the scope of the independent and dependent claims. Furthermore, it is to be understood that express rights are claimed for the variations described in the dependent claims. It should also be noted that the example embodiments shown in the figures or features thereof may be combined to produce embodiments not explicitly shown in the figures.

[0082] Reference numerals list

[0083] 1. Drive shaft system

[0084] 2. (Disposable) Flexible Container

[0085] 3. (Multiple use) Flexible container holder

[0086] 4. Drive shaft coupling

[0087] 5.Bag connection

[0088] 6. Motor connection

[0089] 7.Motor fixing part

[0090] 8. Motor

[0091] 9. Drive shaft

[0092] 10. End of the first drive shaft

[0093] 11. The end of the rotatable output shaft of the motor

[0094] 12. Second drive shaft end

[0095] 13. Stirring device

[0096] 14. Alignment teeth at the end of the first drive shaft

[0097] 15. Alignment Surface

[0098] 16.Insert Edge

[0099] 17. Three-clamp connection

[0100] 18. (Disposable) Flexible Container Components

[0101] 19. The portion of the drive shaft between the drive shaft coupling and the second drive shaft end

[0102] 20. Clamping element

[0103] 21.Outer circumference of motor connection

[0104] 22. Spring

[0105] 23. Release button

[0106] 24. Safety latch

[0107] 25. Lower notch

[0108] 26. Upper notch

[0109] 27. Lower protrusion

[0110] 28. Upper protrusion

[0111] 29. Install the opening

[0112] 30. Inlet port / outlet port / sensor port

[0113] 31. Control Panel

[0114] 32. Flexible container holder enclosure

[0115] 33. Retainer Arm

[0116] 34. Alignment teeth on the end of the rotatable output shaft of the motor

[0117] 35. Double arrow shape on the motor connection

[0118] 36. Inclined surface of the clamping element

[0119] 37. Mechanical linkage device

[0120] X. Longitudinal / rotational axis

[0121] C.Circumferential direction

[0122] I. Insertion direction

[0123] α. Angle enclosed by the alignment surfaces

[0124] β. Backward angle of the insertion edge

Claims

1. A drive shaft system (1) for use with a container (2) for mixing fluids and a container holder (3) for holding the container, wherein the container (2) for mixing fluids is a container for a biological reaction, the drive shaft system comprising: - a drive shaft coupling (4) having: a container connection portion (5) for connecting the drive shaft coupling to the container; a motor connection part (6) for detachably connecting the drive shaft coupling to a fixed part (7) of a motor (8) of the container holder, wherein the motor connection part (6) is provided with a first alignment element (25, 26) rotationally aligned with a second alignment element (27, 28) provided on the fixed part (7) of the motor (8); - a drive shaft (9) rotatably arranged in the drive shaft coupling, comprising: a first drive shaft end (10) configured for removable coupling to a rotatable output shaft end (11) of the motor; A second drive shaft end (12); and a stirring device (13) connected to the drive shaft, preferably to the second drive shaft end, Therein, in an operating state, the drive shaft is configured to be driven by the motor around a longitudinal axis (X) of the drive shaft so as to rotate the stirring device for mixing fluids.

2. The drive shaft system (1) according to claim 1, wherein: The motor connection part (6) is provided with a plurality of first alignment elements (25, 26).

3. The drive shaft system (1) according to claim 1 or 2, wherein: The first alignment element (25, 26) and / or a plurality of the first alignment elements (25, 26) and the second alignment element (27, 28) and / or a plurality of the second alignment elements (27, 28) are arranged in such a way that, in an operating state, an inlet port and / or an outlet port and / or a sensor port of the container (2) are located near a mounting opening (29) of the container holder (3).

4. The drive shaft system (1) according to claim 1, 2 or 3, wherein: The container (2) is configured for single use.

5. Drive shaft system (1) according to any one of the preceding claims, wherein: The container (2) is a rigid container.

6. Drive shaft system (1) according to any one of the preceding claims 1 to 4, wherein: The container (2) is a flexible container.

7. The drive shaft system (1) according to claim 6, wherein: The flexible container comprises a bag (2), wherein the container connection (5) is a bag connection (5) for connecting the drive shaft coupling (4) to the bag.

8. Drive shaft system (1) according to any one of the preceding claims, wherein: The first drive shaft end (10) is configured to self-align with a motor output shaft end (11) of the motor (8).

9. The drive shaft system (1) according to claim 8, wherein: The first drive shaft end (10) includes one or more alignment teeth (14) spaced apart in a circumferential direction (C) along the first drive shaft end.

10. The drive shaft system (1) according to claim 9, wherein: The one or more alignment teeth (14) comprise two circumferentially opposite alignment surfaces (15) converging towards each other in the insertion direction (I).

11. The drive shaft system (1) according to claim 10, wherein: The two opposing alignment surfaces (15) enclose an angle (α) of 90 degrees or less, such as 30 to 60 degrees.

12. Drive shaft system (1) according to claim 10 or 11, wherein: The two opposite alignment surfaces (15) converge at an insertion edge (16), wherein the insertion edge is inclined rearwardly (β) relative to the insertion direction (I).

13. Drive shaft system (1) according to any one of the preceding claims, wherein: The container connection portion (5) comprises a three-clamp type connection portion (17).

14. A container assembly (18), comprising a drive shaft system (1) according to any of the preceding claims and a container (2) for mixing fluids, wherein the container (2) for mixing fluids is a container for biological reactions, wherein the drive shaft coupling (4) is connected to the container by means of the container connection portion (5), wherein the drive shaft portion (19) extending between the drive shaft coupling and the second drive shaft end (12) and provided with the stirring device (13) is surrounded by the container.

15. The container assembly (18) according to claim 14, wherein: The container (2) is configured for single use.

16. The container assembly (18) according to any one of the preceding claims 14 to 15, wherein: The container (2) is a rigid container.

17. The container assembly (18) according to any one of the preceding claims 14 to 15, wherein: The container (2) is a flexible container (2).

18. The container assembly (18) according to claim 17, wherein: The flexible container comprises a bag (2), wherein the container connection (5) is a bag connection (5) for connecting the drive shaft coupling (4) to the bag.

19. The container assembly (18) according to claim 17 or 18, wherein: In a non-operating state, the flexible container (2) is folded around the drive shaft portion (19) extending between the drive shaft coupling (4) and the second drive shaft end (12).

20. The container assembly (18) according to any one of the preceding claims 17 to 19, wherein: The flexible container (2) is configured for radial expansion away from the drive shaft portion (19) extending between the drive shaft coupling (4) and the second drive shaft end (12) to reach the operative state from the inoperative state.

21. A container holder (3) for holding a container (2) for mixing fluids, wherein the container (2) for mixing fluids is a container for bioreactions, used together with a drive shaft system (1) according to any one of claims 1 to 13 or a container assembly (18) according to any one of claims 14 to 20, the container holder (3) comprising: - the motor (8) having a fixing portion (7) for detachably connecting to the motor connecting portion (6) of the drive shaft coupling (4), wherein the second alignment element (27, 28) is arranged on the fixing portion (7) of the motor (8) for rotational alignment with the first alignment element (25, 26) arranged on the motor connecting portion (6) of the drive shaft coupling (4); The motor comprises a rotatable output shaft end (11) configured to be detachably coupled to the first drive shaft end (10) for driving the drive shaft (9) about the longitudinal axis (X) so as to rotate the stirring device (13).

22. The container holder (3) according to claim 21, wherein: A plurality of second alignment elements (27, 28) are arranged on the fixing portion (7) of the motor (8).

23. The container holder (3) according to claim 21 or 22, wherein: The first alignment element (25, 26) and / or the plurality of first alignment elements (25, 26) and the second alignment element (27, 28) and / or the plurality of second alignment elements (27, 28) are arranged in such a way that, in the operating state, the inlet port and / or the outlet port and / or the sensor port (30) of the container (2) are located near the mounting opening (29) of the container holder (3).

24. The container holder (3) according to claim 21, 22 or 23, wherein: The fixing portion (7) is detachably connected to the motor connection portion (6) of the drive shaft coupling (4), and wherein the rotatable output shaft end (11) is detachably connected to the first drive shaft end (10) for driving the drive shaft (9) around the longitudinal axis (X) so as to rotate the stirring device (13).

25. The container holder (3) according to any one of claims 21 to 24, wherein: The fixed part (7) of the motor (8) comprises one or more clamping elements (20) configured to radially engage the motor connecting part (6) for detachably connecting the drive shaft coupling (4) to the fixed part of the motor.

26. The container holder (3) according to claim 25, wherein: The one or more clamping elements (20) are configured to radially engage an outer circumference (21) of the motor connection portion (6), wherein the one or more clamping elements are configured to engage the outer circumference at a radially inward position and disengage the outer circumference at a radially outward position.

27. The container holder (3) according to claim 26, wherein: The one or more clamping elements (20) are urged toward the radially inward position by a spring (22).

28. The container holder (3) according to any one of claims 25 to 27, wherein: The one or more clamping elements (20) include a pair of diametrically opposed clamping elements.

29. The container holder (3) according to claim 28, wherein: The pair of clamping elements (20) move toward each other at a radially inward position and move away from each other at a radially outward position.

30. The container holder (3) according to any one of claims 25 to 29, wherein: The fixing portion (7) of the motor (8) comprises a release mechanism (23), such as a release button (23), which, when actuated, such as by being pressed, causes the one or more clamping elements (20) to radially disengage from the motor connection portion (6).

31. The container holder (3) according to any one of claims 25 to 30, wherein: The fixing portion (7) of the motor (8) comprises a safety mechanism (24), such as a safety latch (24), which, when actuated, such as by being pressed, prevents the one or more clamping elements (20) from accidentally disengaging from the motor connection portion (6).

32. The container holder (3) according to claims 30 and 31, wherein: The safety mechanism (24) prevents the release mechanism (23) from being accidentally actuated.

33. A method for mounting a container assembly (18) according to any one of claims 14 to 20 in a container holder (3) for holding a container according to any one of claims 21 to 32, comprising the steps of: - The motor (8) having the fixing portion (7) is detachably connected to the motor connecting portion (6) of the drive shaft coupling (4) in such a manner that the first drive shaft end (10) is able to drive the drive shaft (9) around the longitudinal axis (X) so as to rotate the stirring device (13), and in such a manner that the first alignment elements (25, 26) are rotationally aligned with second alignment elements (27, 28) provided on the fixing portion (7) of the motor (8).

34. The method according to claim 33, further comprising the steps of: - The first alignment element (25, 26) and the second alignment element (27, 28) are rotationally aligned in such a way that, in the operating state, the inlet port and / or outlet port and / or sensor port of the container (2) are located near the mounting opening (29) of the container holder (3).

35. A method according to any one of claims 33 to 34, when dependent on claim 25, further comprising the steps of: - The drive shaft coupling (4) is detachably connected to the fixed part (7) of the motor (8) in such a way that one or more clamping elements (20) of the fixed part (7) of the motor (8) radially engage the motor connecting part (6).

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