DRIVE SHAFT SYSTEM FOR USE WITH A VESSEL AND VESSEL HOLDER FOR MIXING FLUIDS - Patent application

Abstract

The present disclosure relates to a drive shaft system (1) for use with a vessel for mixing fluids, the vessel being a vessel for biological reactions, and a vessel holder for holding the vessel, the drive shaft system comprising: a drive shaft coupling (4) having a vessel connection part (5) for connecting the drive shaft coupling to the vessel, a motor connection part (6) for detachably connecting the drive shaft coupling to a stationary part of a motor of the vessel holder, the motor connection part being provided with first alignment elements (25, 26) that are rotatably aligned with second alignment elements (27, 28) provided on the stationary part, a drive shaft (9) rotatably disposed within the drive shaft coupling, the drive shaft (9) having a first drive shaft end (10) configured to be detachably coupled to a rotatable output shaft end of the motor, a second drive shaft end (12), and an agitator (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 comprising 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 attaching such a container assembly to such a container holder.

Background Art

[0002] Installing a container, such as a single-use manufacturing container like a bioreactor bag, in a container holder, such as a multi-use container holder, is often a cumbersome and time-consuming task that may require multiple operators. The drive shaft system of the container must be properly connected to the motor of the container holder, for example, to drive a stirring device inside the container. Further, the container must also be safely suspended within the bioreactor holder. Current processes can lead to errors and improper installations. U.S. Patent Application Publication No. 2005 / 239198 discloses a stirred tank reactor system for use preferably as a single-use bioreactor. The bioreactor system includes, for example, a flexible bag having an opening and a stirring shaft having an impeller. The stirring shaft can be connected to a bearing, and the bearing can seal to the bag via a seal or O-ring. The upper end of the stirring shaft may be releasably connected to a motor coupling. Dutch Patent No. 2003460 further discloses a stirrer for stirring, for example, liquid food, the stirrer having an impeller and at least one coupling means provided at one end of the shaft for releasably coupling the stirrer to the "reverse coupling" means of a drive motor. Further, U.S. Patent Application Publication No. 2011 / 188928 discloses a mixer coupled to a support housing. The mixer is connected to a container that includes, for example, a flexible bag. The drive shafts of the container and the mixer can be releasably connected to a motor mount using a self-aligning coupling.WO 2016 / 191874 discloses a mounting assembly including a drive coupler configured to engage a coupling member on a shaft positionable within a container that secures an opening to allow passage of the shaft, and a funnel disposed within the opening to receive the drive coupler and direct the drive coupler to a coupling member, and U.S. Patent Application Publication No. 2008 / 175095 discloses a mounting assembly for a plastic bulk container.

[0003] It is therefore an object of the present disclosure to facilitate placement of a container in a container holder. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2005 / 239198 [Patent Document 2] Dutch Patent No. 2003460 [Patent Document 3] US Patent Application Publication No. 2011 / 188928 Summary of the Invention

[0005] According to the present disclosure, a container for mixing fluids and For holding said container DRIVE SHAFT SYSTEM FOR USE WITH A VESSEL HOLDER - Patent application A container assembly comprising: wherein the vessel for mixing fluids is a vessel for biological reactions, a drive shaft coupling, A vessel connection for connecting a drive shaft coupling to a vessel the drive shaft coupling is connected to the vessel by the vessel connection; a motor connection part for releasably connecting the drive shaft coupling to a fixed part of a motor of a container holder, the motor connection part being provided with a first alignment element, such as a notch or a protrusion, which is rotationally aligned with a second alignment element, such as a protrusion or a notch, provided on the fixed part of the motor; a drive shaft rotatably disposed within a drive shaft coupling, a first drive shaft end configured to removably couple to a rotatable output shaft end of the motor; a second drive shaft end; a drive shaft, preferably a stirrer connected to a second drive shaft end; The drive shaft portion provided with the agitator extends between the drive shaft coupling and the second drive shaft end, the drive shaft being surrounded by the container, the container being a flexible container;a drive shaft; In operation, the drive shaft is configured to be driven by the motor about its longitudinal axis to rotate the agitator to mix the fluid.

[0006] The drive shaft system described above facilitates mounting of a vessel, such as a bioreactor bag, to the holder. The drive shaft coupling in particular allows for the connection of a rotatable output shaft end of a motor for driving an agitator in the vessel with the drive shaft and simultaneously allows for mounting of the vessel to the holder. Thus, the vessel may be installed by a single operator. Furthermore, proper rotational alignment between one of the vessels and the vessel holder is advantageously facilitated.

[0007] An embodiment relates to a drive shaft system as previously described, wherein the motor connection is provided with a plurality of first alignment elements, such as two, three, four or even more first alignment elements.

[0008] As discussed above, the first alignment element(s) and / or the second alignment element(s) may comprise a notch, protrusion, or any other visually discernible feature. It is further contemplated that the first alignment element(s) and / or the second alignment element(s) may be configured to provide an audible sound, such as a click, upon proper alignment. It is also contemplated that the first alignment element(s) and / or the second alignment element(s) may be configured to generate an electronic signal upon proper alignment, for example by using a suitable electronic sensor.

[0009] According to the present invention, the vessel for mixing fluids is a vessel for biological reactions. However, the vessel may also be comprised by a medium and feed preparation system, a seed bioreactor, a holding vessel, a buffer preparation system, etc. The skilled person will also understand that the expression fluid can relate to liquids per se, but also to substances that behave like a fluid, including (spherical) microcarriers, which may be liquid or solid.

[0010] 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, comprise a rigid bottom shell with also flexible container sides. The container may also be entirely flexible, such as in the case of a bag.

[0011] One embodiment relates to a drive shaft system as described above, wherein the first alignment element and / or the plurality of first alignment elements and the second alignment element and / or the plurality of second alignment elements are provided such that, in an operational state, the inlet and / or outlet port and / or sensor port of the container are located near the mounting opening of the container holder, thus advantageously facilitating proper rotational alignment between one container and the container holder, and the inlet and / or outlet port and / or sensor port are therefore easily accessible to an operator.

[0012] One embodiment relates to the drive shaft system described above, where the container is configured for single use, and therefore does not need to be cleaned, sterilized, etc., but can be disposed of after use.

[0013] In the context of this patent application, a "single-use" vessel obviously means a culture vessel that is disposed of after (single) use. This reduces the risk of cross-contamination, improves biological and process safety, reduces cleaning and validation requirements, and ultimately reduces costs. In contrast to the traditional stainless steel "multiple-use" systems, e.g. plastic bags can be used as culture vessels. Single-use vessels are particularly suitable for any kind of biopharmaceuticals. In contrast, in the art, "multiple-use" means a culture vessel that is obviously to be reused. Such culture vessels require cleaning, sterilization, etc. after each use.

[0014] However, in the context of this patent application, "multiple use" generally refers to the reusability of the container holder. Single-use containers may advantageously be placed in such a multi-use container holder. Obviously, only the single-use containers are then discarded after a single use, and the multi-use container holder, which is obviously reused, is not discarded.

[0015] The container is , small The container may be at least partially rigid. The container may, for example, comprise a rigid bottom shell with flexible container sides. The container may also be completely rigid, as in the case of the plastic containers discussed above.

[0016] One embodiment relates to a drive shaft system as described above, wherein the flexible container comprises a bag and the container connection is a bag connection for connecting the drive shaft coupling to the bag.

[0017] One embodiment relates to a drive shaft system as described above, wherein the first drive shaft end is configured to self-align with the motor output shaft end of the motor, thus facilitating the establishment of a suitable connection between the motor output shaft and the drive shaft for efficiently transmitting torque of the motor to the drive shaft.

[0018] One embodiment relates to a drive shaft system as described above, where the first drive shaft end includes one or more alignment teeth spaced circumferentially along the first drive shaft end, such alignment teeth (or splines) facilitating a proper connection between the teeth of the motor output shaft end and the (alignment) teeth of the drive shaft.

[0019] One embodiment relates to the aforementioned drive shaft system, where one or more alignment teeth comprise two circumferentially opposing alignment surfaces that converge towards each other in the insertion direction, so that when such "arrow-shaped" alignment teeth are inserted in or on the motor output shaft end in the (longitudinal) insertion direction, the alignment teeth automatically rotate to their appropriate position relative to the (teeth of) the motor output shaft end.

[0020] One embodiment relates to a drive shaft system as described above, wherein the two opposing alignment surfaces subtend an angle of less than 90 degrees, such as between 30 and 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 rotation of the alignment teeth to their desired rotational position.

[0021] One embodiment relates to the aforementioned drive shaft system, in which the two opposing alignment surfaces converge at an insertion edge, which is inclined backwards with respect to the insertion direction, thus making the insertion easier.

[0022] One embodiment relates to a drive shaft system as described above, where the container connection comprises a tri-clamp connection, which is relatively easy to manufacture and allows the weight of the container to be safely suspended from the drive shaft system.

[0023] Books In line with the rationale behind the disclosure, The above The vessel assembly can be conveniently placed into the bioreactor holder "one at a time" by a single operator.

[0024] One embodiment relates to a container assembly as previously described, wherein the container is configured for single use.

[0025] One embodiment relates to the aforementioned container assembly, wherein the container Partially It is a rigid container.

[0026] One embodiment relates to a container assembly as previously described, wherein the container is a flexible container.

[0027] One embodiment relates to a container assembly as previously described, wherein the flexible container comprises a bag and the container connection is a bag connection for connecting the drive shaft coupling to the bag.

[0028] One embodiment relates to the aforementioned container assembly, wherein in the inoperative state, the flexible container is folded around a portion of the drive shaft extending between the drive shaft coupling and the second drive shaft end.

[0029] An embodiment relates to the aforementioned container assembly, where 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 an operational state from an inoperative state. During transport, the flexible container, such as a bioreactor bag, is "rolled up" around the drive shaft portion. During filling, the flexible container unfolds radially, which results in a much shorter unfolding in the direction away than if the bag unfolded upwards or downwards, i.e., axially. Easier unfolding results in a better and more secure fit into the flexible container holder with less folding. Folding is undesirable as cells may accumulate there during the bioreaction process and spontaneously differentiate during the bioprocess.

[0030] Another aspect of the present disclosure relates to a container holder for holding a container for mixing fluids, the container for mixing fluids being ,before A vessel for biological reactions for use with the vessel assembly described above, a motor having a fixing part for detachable connection to a motor connection part of a drive shaft coupling, the second alignment element being provided on the fixing part of the motor for rotational alignment with a first alignment element provided on the motor connection part of the drive shaft coupling, The motor includes a rotatable output shaft end configured to removably couple to the first drive shaft end for driving the drive shaft about the longitudinal axis to rotate the agitator.

[0031] An embodiment relates to a container holder as mentioned above, wherein a plurality of second alignment elements, such as two, three, four or more, are provided on the fixed part of the motor.

[0032] One embodiment relates to the aforementioned container holder, wherein the first alignment element and / or the plurality of first alignment elements and the second alignment element and / or the plurality of second alignment elements are arranged such that, in an operational state, the inlet and / or outlet port and / or sensor port of the container are located near the mounting opening of the container holder.

[0033] One embodiment relates to the aforementioned container holder, wherein the fixed portion is removably connectable to the motor connection portion of the drive shaft coupling, and the rotatable output shaft end is removably couplable to the first drive shaft end for driving the drive shaft about the longitudinal axis to rotate the agitator device.

[0034] An embodiment relates to the aforementioned container holder, wherein the fixed part of the motor comprises one or more gripping elements configured to radially engage with the motor connecting part for releasably connecting the drive shaft coupling to the fixed part of the motor, so that the drive shaft coupling can be easily connected and disconnected to the fixed part of the motor without the need for additional installation tools.

[0035] One embodiment relates to the aforementioned container holder, wherein one or more gripping elements are configured to radially engage an outer periphery of the motor connection portion, and the one or more gripping elements are configured to engage the outer periphery at a radially inner position and disengage the outer periphery at a radially outer position.

[0036] In one embodiment, the container holder as described above, the one or more gripping elements are spring-biased towards a radially inner position. Thus, less force is required by an operator to connect the drive shaft coupling to the fixed part of the motor. Furthermore, accidental disengagement of the gripping elements is prevented.

[0037] One embodiment relates to a container holder as previously described, wherein the one or more gripping elements comprise a pair of radially opposed gripping elements that can be easily pressed toward one another by an operator using one hand.

[0038] One embodiment relates to a vessel holder as previously described, wherein a pair of gripping elements move towards each other at a radially inner position and move away from each other at a radially outer position.

[0039] One embodiment relates to a container holder as described above, wherein the motor fixing part is provided with a release mechanism, such as a release button, which when actuated, e.g. pressed, causes the motor connection part to radially disengage from the gripping element or elements, thus facilitating removal of the drive shaft coupling from the motor fixing part.

[0040] In one embodiment, the aforementioned container holder relates to a motor fixing part that is provided with a safety mechanism, such as a safety latch, which prevents one or more gripping elements from accidentally disengaging the motor connection part when activated, e.g. when pressed, thereby increasing safety and preventing accidents.

[0041] In one embodiment, the container holder as described above, a safety mechanism prevents the release mechanism from being accidentally activated, and thus there is an additional safety measure to prevent the drive shaft coupling (and container) from accidentally disengaging from the fixed portion of the motor.

[0042] Another aspect of the present disclosure relates to a method for mounting the aforementioned container assembly to the aforementioned container holder for holding a container, comprising: - detachably connecting the motor at a fixed portion to a motor connection portion of the drive shaft coupling such that a first drive shaft end is capable of driving the drive shaft about a longitudinal axis to rotate the agitator and such that the first alignment element is rotationally aligned with a second alignment element provided on the fixed portion of the motor.

[0043] One embodiment relates to the aforementioned method, - a further step of rotationally aligning the first alignment element and the second alignment element so that, in an operational state, the inlet port and / or the outlet port and / or the sensor port of the container are located near the mounting opening of the container holder.

[0044] One embodiment relates to the aforementioned method, - a further step of releasably connecting the drive shaft coupling to the fixed part of the motor such that one or more gripping elements of the fixed part of the motor radially engage the motor connection part. [Brief description of the drawings]

[0045] The present disclosure is explained in more detail below with reference to exemplary embodiments illustrated in the drawings.

[0046] [Figure 1] 1 illustrates an exemplary embodiment of a container holder having an exemplary embodiment of a container assembly disposed therein. [Diagram 2] 2 is a cross-sectional view of an exemplary embodiment of a container holder having an exemplary embodiment of a container assembly disposed therein, such as the exemplary embodiment of the container holder of FIG. 1. [Diagram 3] 3 is a perspective view of an exemplary embodiment of a container holder having an exemplary embodiment of a container assembly disposed therein, such as the exemplary embodiment of FIGS. 1 and 2. FIG. [Figure 4] FIG. 4 is a perspective view of an exemplary embodiment of a drive shaft system, such as for use with the exemplary embodiment of FIGS. 1-3. [Diagram 5] 4 is a cutaway view of an upper region of an exemplary embodiment of a container holder having an exemplary embodiment of a container assembly disposed therein, such as the exemplary embodiment of FIGS. 1-3. FIG. [Figure 6] FIG. 6 is a perspective view of an exemplary embodiment of a first drive shaft end of a drive shaft configured to be removably coupled to an exemplary embodiment of a rotatable output shaft end of a motor, such as for use with the exemplary embodiments of FIGS. 1 to 5 . [Figure 7] FIG. 6 is a plan view of an exemplary embodiment of a motor stationary portion including one or more gripping elements configured to radially engage the motor connection portion to releasably connect a drive shaft coupling to the motor stationary portion, such as for use with the exemplary embodiments of FIGS. 1 to 5. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] FIG. 1 shows an exemplary embodiment of a vessel holder 3, e.g. a flexible vessel holder 3 shown in FIG. 1, such as a bioreactor bag holder 3, in which an exemplary embodiment of a vessel assembly 18 is arranged includes a drive shaft system 1 and a vessel 2, preferably a single-use flexible vessel 2, e.g. a bioreactor bag 2 shown in FIG. 1. However, the vessel 2 may also be included by a medium and feed preparation system, a seed bioreactor, a holding vessel, a buffer preparation system, etc., basically any mixing system in which the drive shaft system according to the present disclosure can be used. It should be noted that the expression "flexible" in "flexible vessel holder 3" relates to the flexibility (e.g. foldability) of the flexible vessel 2 and not to the holder 3, which is usually rigid. The flexible vessel holder 3 and / or the flexible vessel 2 shown in FIG. 1 can be configured for an operation / working volume of 1-10.000I, preferably 10-5.000I, more preferably 50-3.000I, e.g. 40-60I. The flexible container holder 3 is configured to hold the flexible container 2 inside an enclosure 32, such as a cylindrical enclosure 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 by a container connection 5 in the form of a bag connection 5. The flexible container holder 3 is equipped with a motor 8 having a fastening part 7 (shown more clearly in FIG. 2 ) for releasably connecting to a motor connection 6 of the drive shaft coupling 4. In the illustrated exemplary embodiment, the bioreaction process taking place in the flexible container 2 in an operational state can be controlled by a control panel 31 and various controllers. The flexible container 2 can be attached or placed in the enclosure 32 of the flexible container holder 3 via a mounting opening 29, such as a door 29, e.g. a laterally opening door 29. The container 2 can, in some embodiments, be Partially It may be made of rigid material, such as plastic. Preferably, the container 2 is also therefore configured for single use, i.e. to be discarded after use. teeth, It may be partly rigid or partly flexible, for example comprising a rigid bottom shell with flexible container sides.

[0048] As shown in FIG. 2, the motor 8 may include a rotatable output shaft end 11 configured to removably couple to a first drive shaft end 10 of the drive shaft 9 for driving (e.g., providing torque and rotation) the drive shaft 9 about a longitudinal axis X to rotate an agitator 13, such as an impeller 13, to mix the fluid. A vessel holder 3, such as the illustrated flexible vessel holder 3, may further include a holder arm 33. The motor 8 may be attached to the holder arm 33, such as an end thereof located on the longitudinal axis X above the flexible vessel 2. The flexible vessel 2 may be suspended from the holder arm 33 via the motor connection 6 of the drive shaft coupling 4. The agitator 13 may include a three-blade screw or the like.

[0049] As can be seen from figures 3, 4 and 5, the container connection 5 in the form of a bag connection 5 may comprise a tri-clamp connection 17, although other connection means are also conceivable.

[0050] 4 and 7, a motor connection 6 for detachably connecting a drive shaft coupling 4 to a fixed part 7 of a motor 8 of a container holder 3, such as the illustrated flexible container holder 3, may comprise a splined connection and comprises a first alignment element 25, 26, such as a notch 25, 26 or a protrusion (FIG. 4), which is rotationally aligned with a second alignment element 27, 28, such as a protrusion 27, 28 or a notch (FIG. 7), provided on the fixed part 7 of the motor 8. The first alignment element 25, 26 and the second alignment element 27, 28 are provided such that, in an operating condition, an inlet and / or outlet port 30 and / or a sensor port 30 of the container 2, in this case the flexible container 2, is located (rotationally) near a mounting opening 29 of the flexible container holder 3 (as shown in FIG. 1). As mentioned above, the first alignment element(s) 25, 26 and / or the second alignment element(s) 27, 28 may comprise notches 25, 26, protrusions 27, 28, or any other visually recognizable feature. It is further contemplated that the first alignment element(s) 25, 26 and / or the second alignment element(s) 27, 28 may be configured to provide an audible sound, such as a click, upon proper alignment. It is also contemplated that the first alignment element(s) 25, 26 and / or the second alignment element(s) 27, 28 may be configured to generate an electronic signal upon proper alignment, for example by using a suitable electronic sensor. The electronic signal may then be processed for purposes of rotational alignment.

[0051] Generally speaking, apart from arranging the first alignment elements 25, 26 and the second alignment elements 27, 28 such that, in an operating state, the inlet and / or outlet ports 30 and / or the sensor port 30 of the container 2 are positioned (in the rotational direction) near the mounting opening 29 of the flexible container holder 3 (as shown in FIG. 1 ), the first alignment elements 25, 26 and the second alignment elements 27, 28 can also be configured to ensure other predetermined rotational orientations (around the longitudinal axis X) between the fixed part 7 of the drive motor 8 and / or the container holder 3, on the one hand, and the flexible container 2, on the other hand.

[0052] As can be seen in FIG. 6, the first drive shaft end 10 is preferably configured to be self-aligned with the motor output shaft end 11 of the motor 8. In addition, the first drive shaft end 10 may comprise one or more splines or alignment teeth 14 spaced circumferentially C along the first drive shaft end 10. The one or more alignment teeth 14 may also comprise two circumferentially opposite alignment surfaces 15 that converge towards each other in the insertion direction I. The two opposite alignment surfaces 15 may subtend an angle (a) of 90 degrees or less, such as 30 to 60 degrees. Furthermore, the two opposite alignment surfaces 15 may converge at an insertion edge 16, which is inclined backward P with respect to the insertion direction I. The rotatable output shaft end 11 may comprise a similar alignment tooth 34 having a shape complementary to that of the alignment tooth 14. For example, three, four or more alignment teeth 14, 34 may be provided depending on the torque to be transmitted.

[0053] As shown in Figures 5 and 7, the fixed part 7 of the motor 8 may comprise one or more gripping elements 20 configured to radially engage with the motor connection part 6 for releasably connecting the drive shaft coupling 4 to the fixed part 7 of the motor 8. The one or more gripping elements 20 are preferably configured to radially engage with an outer periphery 21 of the motor connection part 6, the one or more gripping elements 20 being configured to engage with the outer periphery 21 at a radially inner position (e.g., as shown in Figure 4) and disengage the outer periphery 21 at a radially outer position. The one or more gripping elements 20 are preferably spring biased 22 towards the radially inner position. The one or more gripping elements 20 may further comprise a pair of radially opposed gripping elements 20. The pair of gripping elements 20 may move towards each other at the radially inner position and move away from each other at the radially outer position. The fixed part 7 of the motor 8 may further comprise a release mechanism 23, such as a release button 23, which when activated, e.g. when pressed, causes the gripping element or elements 20 to radially disengage the motor connection 6. The force exerted on the release button 23 may be transmitted to the gripping element 20 by a mechanical linkage 37. As shown in FIG. 7, the fixed part 7 of the motor 8 may also comprise a safety mechanism 24, such as a safety latch 24, which when activated, e.g. when pressed, prevents the gripping element or elements 20 from accidentally disengaging the motor connection 6. Here, the safety mechanism 24 may prevent the release mechanism 23 from being accidentally activated. To facilitate the insertion of the motor connection 6 of the drive shaft coupling into the fixed part 7 of the motor 8, the motor connection may have a "double arrow shape" 35, as shown in FIG. 5, with an inclined surface inclined towards the longitudinal axis X in the insertion direction I when viewed in cross section. The gripping element 20 can also have a similar “inverted” arrow shape when viewed in cross section, as shown in FIG. 5, with the inclined surface 36 inclined toward the longitudinal axis X in the insertion direction I to facilitate insertion of the double arrow shape 35 of the motor connection part 6.

[0054] According to one aspect of the present disclosure, a container assembly 18 can be provided, comprising a drive shaft system 1 and a container 2 for a biological reaction, preferably a flexible container 2 for single use, where a drive shaft coupling 4 is connected to, for example, the flexible container 2 using a container connection 5, such as a bag connection 5, and a drive shaft portion 19 with an agitator 13 extending between the drive shaft coupling 4 and a second drive shaft end 12 is surrounded by the container 2, such as the flexible container 2 (e.g., as shown in FIG. 2). In an inoperative state, such as when transporting the container assembly 18, the flexible container 2 may be folded around the drive shaft portion 19 extending between the drive shaft coupling 4 and the second drive shaft end 12. Here, the flexible container 2 can be configured to radially expand away from the drive shaft portion 19 extending between the drive shaft coupling 4 and the second drive shaft end 12 to reach an operative state from an inoperative state.

[0055] Another aspect of the present disclosure relates to a method for mounting the aforementioned container assembly 18 to a container holder 3, such as a flexible container holder 3, for holding a container 2, such as a flexible container 2, comprising: - detachably connecting a motor 8 at a fixed part 7 to the motor connection part 6 of the drive shaft coupling 4 such that a first drive shaft end 10 is capable of driving a drive shaft 9 about a longitudinal axis X in order to rotate the agitator 13.

[0056] According to the present disclosure, the method includes: - includes the further step of detachably connecting the motor connection part 6 of the drive shaft coupling 4 to the fixed part 7 of the motor 8 of the container holder 3 such that the first alignment elements 25, 26 are rotationally aligned with second alignment elements 27, 28 provided on the fixed part 7 of the motor 8 (as shown in Figures 4 and 7).

[0057] The aforementioned method is - A further step of rotationally aligning the first alignment elements 25, 26 and the second alignment elements 27, 28 such that, in the operational state, the inlet and / or outlet ports 30 and / or sensor ports 30 of the container 2 are located near the mounting opening 29 of the container holder 3 (e.g. as shown in Figure 1).

[0058] The aforementioned method is - A further step of releasably connecting the drive shaft coupling 4 to the fixed part 7 of the motor 8 such that one or more gripping elements 20 of the fixed part 7 of the motor 8 radially engage with the motor connection part 6 (as shown in Figures 5 and 7). [Explanation of symbols]

[0059] 1 Drive shaft system 2 (Single-use) flexible containers 3 (Multiple Use) Flexible Container Holder 4 Drive shaft coupling 5 Bag connection 6 Motor connection 7 Motor fixing part 8 Motor 9 Drive shaft 10 first drive shaft end 11 Rotatable output shaft end of the motor 12 second drive shaft end 13 Stirring device 14 Alignment teeth on first drive shaft end 15 Alignment Surface 16 Insertion edge 17 Tri-clamp connection 18 (Single Use) Flexible Container Assembly 19 A portion of the drive shaft between the drive shaft coupling and the second drive shaft end 20 Gripping elements 21 Motor connection periphery 22 Spring 23 Release button 24 Safety Latch 25 Lower Notch 26 Upper notch 27 Lower convex part 28 Upper convex part 29 Mounting opening 30 Inlet / Outlet / Sensor Port 31 Control Panel 32 Flexible Container Holder Enclosure 33 Holder arm 34 Alignment teeth on the end of the rotatable output shaft of the motor 35 Double-arrow shape of motor connection 36 Inclined surface of gripping element 37 Mechanical Linkages X Longitudinal / Rotational Axis C circumferential direction I Insertion direction α Angle enclosed by the alignment surface β Rear angle of insertion edge

Claims

1. A flexible biological reaction vessel (2) for mixing fluids, Drive shaft (9) and A stirring device (13) connected to the drive shaft and surrounded by the flexible biological reaction vessel, A container holder configured to hold the flexible biological reaction vessel, and comprising a motor (8) for rotating the drive shaft around its longitudinal axis (X) to stir the fluid inside the flexible biological reaction vessel with the stirring device, A drive shaft coupling (4) is coupled to the flexible bioreaction vessel and configured to provide a connection between the drive shaft and the motor, A container assembly (18) comprising, The aforementioned drive shaft coupling is The drive shaft coupling is connected to the flexible biological reaction vessel by a container connection part (5), A motor connection part (6) is provided to detachably connect the drive shaft coupling to the fixed part (7) of the motor (8), Equipped with, The motor connection portion includes a first alignment element (25, 26) configured to be aligned in the rotational direction with a second alignment element (27, 28) provided on the fixed portion (7) of the motor (8). The drive shaft is rotatably disposed within the drive shaft coupling and configured to be detachably coupled to the rotatable output shaft end (11) of the motor, in a container assembly (18).

2. The container assembly (18) according to claim 1, wherein the flexible bioreaction vessel (2) is configured for single use.

3. The container assembly (18) according to claim 2, wherein the flexible biological reaction vessel (2) comprises a bag (2), and the container connection portion (5) is a bag connection portion (5) for connecting the drive shaft coupling (4) to the bag.

4. In a non-operational state, the flexible bioreaction vessel (2) is folded around the drive shaft portion (19) that extends between the drive shaft coupling (4) and the second drive shaft end (12), the vessel assembly (18) according to claim 1.

5. The container assembly (18) according to claim 1, wherein the flexible biological reaction vessel (2) is configured to expand radially away from the drive shaft portion (19) extending between the drive shaft coupling (4) and the stirring device (13) so as to move from a non-operational state to an operational state.

6. The flexible biological reaction vessel (2) is partially rigid, the vessel assembly (18) according to claim 1.

7. The container assembly (18) according to claim 6, wherein the flexible biological reaction vessel (2) comprises a rigid bottom and flexible sides.

8. The container assembly (18) according to claim 1, wherein the motor connection portion (6) comprises a plurality of first alignment elements (25, 26).

9. The container assembly (18) according to claim 1, wherein the first alignment elements (25, 26) and / or the plurality of first alignment elements (25, 26) and the second alignment elements (27, 28) and / or the plurality of second alignment elements (27, 28) are provided such that, in the operating state, the inlet and / or outlet ports and / or sensor supports of the flexible bioreaction vessel (2) are located near the mounting opening (29) of the container holder (3).

10. The container assembly (18) according to claim 1, wherein the first drive shaft end (10) is configured to self-align with the motor output shaft end (11) of the motor (8).

11. The container assembly (18) according to claim 10, wherein the first drive shaft end (10) is provided with one or more alignment teeth (14) spaced apart in the circumferential direction (C) along the first drive shaft end.

12. The container assembly (18) according to claim 11, wherein the one or more alignment teeth (14) have two circumferential alignment surfaces (15) on both sides that converge toward each other in the insertion direction (I).

13. The container assembly (18) according to claim 12, wherein the two side alignment surfaces (15) enclose an angle (a) of 90 degrees or less.

14. The container assembly (18) according to claim 12 or 13, wherein the two side alignment surfaces (15) converge at an insertion edge (16), and the insertion edge is inclined rearward (P) with respect to the insertion direction (I).

15. The container assembly (18) according to claim 1, wherein the container connection portion (5) is provided with a triclam connection portion (17).

16. A container holder (3) for holding a flexible biological reaction vessel (2) for mixing fluids, Equipped with a motor (8), The motor (8) has a fixed portion (7), and the fixed portion is detachably connected to the motor connection portion (6) of the drive shaft coupling (4). The fixed portion is provided with a second alignment element (27, 28), and the second alignment element (27, 28) is configured to be aligned in the rotational direction with the first alignment element (25, 26) provided on the motor connection portion (6). The motor includes a rotatable output shaft end (11) that is detachably coupled to the first drive shaft end (10) of the drive shaft (9) in order to drive the drive shaft (9) around a longitudinal axis (X) to rotate the stirring device (13), and a container holder (3).

17. The container holder (3) according to claim 16, wherein a plurality of second alignment elements (27, 28) are provided on the fixing portion (7) of the motor (8).

18. The container holder (3) according to claim 16 or 17, wherein the fixed portion (7) is detachably connected to the motor connection portion (6) of the drive shaft coupling (4), and the rotatable output shaft end (11) is detachably coupled to the first drive shaft end (10) to drive the drive shaft (9) around the longitudinal axis (X) in order to rotate the stirring device (13).

19. The container holder (3) according to claim 16 or 17, wherein the fixed portion (7) of the motor (8) comprises one or more gripping elements (20) configured to engage radially with the motor connection portion (6) for detachably connecting the drive shaft coupling (4) to the fixed portion of the motor.

20. The container holder (3) according to claim 19, wherein one or more gripping elements (20) are configured to engage radially with the outer circumference (21) of the motor connection portion (6), and the one or more gripping elements are configured to engage with the outer circumference at a radially inward position and to disengage from the outer circumference at a radially outward position.

21. The container holder (3) according to claim 20, wherein one or more gripping elements (20) are spring-biased (22) toward the radially inward position.

22. The container holder (3) according to claim 19, wherein the one or more gripping elements (20) comprises a pair of radially opposing gripping elements.

23. The container holder (3) according to claim 22, wherein the pair of gripping elements (20) move toward each other at the radially inward position and move away from each other at the radially outward position.

24. The container holder (3) according to claim 19, wherein the fixing portion (7) of the motor (8) is provided with a release mechanism (23) that, when in operation, causes the motor connection portion (6) to be radially disengaged from the one or more gripping elements (20).

25. The container holder (3) according to claim 19, wherein the fixing portion (7) of the motor (8) is provided with a safety mechanism (24) that prevents the one or more gripping elements (20) from accidentally disengaging from the motor connection portion (6) during operation.

26. The container holder (3) according to claim 24 or 25, wherein the safety mechanism (24) prevents the release mechanism (23) from being activated by mistake.

27. A method for installing the container assembly (18) described in claim 1 into the container holder (3), The fixing part (7) is detachably connected to the motor connection part (6), The first drive shaft end (10) is configured to drive the drive shaft (9), A method comprising the step of aligning the first alignment elements (25, 26) with the second alignment elements (27, 28) in the rotational direction.

28. The method according to claim 27, further comprising the step of rotatably aligning the first alignment elements (25, 26) and the second alignment elements (27, 28) such that, in the operating state, the inlet port and / or outlet port and / or sensor support of the container (2) is located near the mounting opening (29) of the container holder (3).

29. The method according to claim 27, The fixed portion (7) of the motor (8) includes one or more gripping elements (20) configured to engage radially with the motor connection portion (6) in order to detachably connect the drive shaft coupling (4) to the fixed portion of the motor, The one or more gripping elements (20) are configured to engage radially with the outer circumference (21) of the motor connection portion (6), The one or more gripping elements (20) are configured to engage with the outer circumference at a radially inward position and to disengage from the outer circumference at a radially outward position. Furthermore, the method described above is A method comprising the step of detachably connecting the drive shaft coupling (4) to the fixed portion (7) of the motor such that one or more gripping elements (20) of the fixed portion (7) of the motor engage radially with the motor connection portion (6).

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