Disposable bioreactor

Abstract

The utility model relates to the field of microbial culture, in particular to a disposable bioreactor, which comprises a tank body, a flexible container and a mixing system, the mixing system comprises a stirring shaft attached to the flexible container, the upper end part of the stirring shaft is connected with a hub, the hub is provided with at least three groups of guy cable supporting structures, and the guy cable supporting structures are connected with the tank body. The guy cable supporting structure comprises a guy cable, a welding disc and a fastener, and one end of the guy cable is fixed to the hub. The guy rope starts from the hub and sequentially penetrates through the welding disc and the fastening piece. The guy cable and the welding disc are integrally formed, the welding disc is fixed to the side wall of the flexible container in a sealed mode, and the guy cable is fixed to the tank body through the fastener. According to the utility model, the upper end part of the stirring shaft is fixed at a corresponding position through the guy cable supporting structure with certain strength, and a supporting force is provided for the upper end part, so that the stirring shaft is not easy to shake in the rotating process; meanwhile, the integrated attachment structure of the guy and the flexible container reduces the risks of fluid leakage and accidental contamination, and packaging, storage and installation of the flexible container are facilitated.

Description

Technical Field

[0001] The utility model relates to the field of microorganism culture, in particular to a disposable bioreactor. Background Art

[0002] Disposable reaction vessels are increasingly widely used in the field of biopharmaceuticals for culturing cells and microorganisms in a controlled environment to obtain products such as drugs, vaccines, and antibodies. A disposable bioreactor system generally includes a disposable flexible container, a tank support structure for accommodating and supporting the flexible container, and a liquid material mixing system placed inside the flexible container. How to optimize the structures of the flexible container, the tank support structure, and the liquid material mixing system to achieve efficient biological culture, prevent leakage, and maintain sterility has become a research direction in the industry.

[0003] The liquid material mixing system is usually designed at the bottom of the flexible container and consists of a driving motor and a stirring shaft attached to the flexible container. The stirring shaft extends upward from a central position at the base of the flexible container into the container interior. Since the vertical length of the stirring shaft is selected according to the number of required stirring paddles, it is often impossible to keep it vertical solely relying on its attachment part to the flexible container. A supporting structure with a hub is needed to position the upper part of the stirring shaft, and at the same time, the supporting structure shall not affect the circumferential operation of the stirring shaft.

[0004] In the prior art, the supporting structure mainly consists of a hub, a connector, and a rigid rod. The connector is generally a flexible sleeve. As Figure 1 shown, at least 3 flexible sleeve connectors are evenly distributed in the circumferential direction of the hub and are connected to the orifices on the side wall of the flexible container. At least 3 rigid rods with a certain diameter are respectively inserted into the flexible sleeve connectors to provide support for the stirring shaft. However, this structure has the following defects:

[0005] 1. The flexible sleeves are respectively connected to the hub and the orifices on the side wall of the flexible container. The connections between the flexible sleeves and the hub and the orifices are not integrally formed structures, and there is a risk of fluid leakage at the connections.

[0006] 2. During the process of inserting at least 3 rigid rods into the flexible sleeves, there is a risk of piercing the flexible sleeves and thus bringing the risk of accidental bacterial contamination.

[0007] 3. The structure of at least 3 flexible connectors is not conducive to the packaging and transportation of the flexible container and the installation of the flexible container in the tank support structure. Summary of the Utility Model

[0008] The purpose of the utility model is to provide a disposable bioreactor to solve the problems raised in the background art.

[0009] To achieve the above object, the present utility model provides the following technical solution: a disposable bioreactor, comprising a tank body, a flexible container and a mixing system. The mixing system includes a stirring shaft attached to the flexible container. The upper end of the stirring shaft is connected to a hub. The hub is provided with at least three cable support structures. The cable support structure includes a cable, a welding plate and a fastener. One end of the cable is fixed to the hub. The cable starts from the hub and passes through the welding plate and the fastener in sequence. The cable is integrally formed with the welding plate. The welding plate is sealed and fixed to the side wall of the flexible container. The cable is fixed to the tank body through the fastener.

[0010] Preferably, the welding plate includes a welding edge and a sealing plate. The cable passes through the sealing plate and is sealed at the connection. The welding edge is located around the sealing plate and is welded to the side wall of the flexible container.

[0011] Preferably, a collision prevention frame is further provided on the side of the sealing plate facing the inner side wall of the tank body. The collision prevention frame is in the shape of an annular protrusion and is positioned corresponding to the fastener.

[0012] Preferably, the fastener includes a pair of screwing screws, a countersunk head bolt and a hand-tightening nut. The cable passes through the pair of screwing screws. The countersunk head bolt presses the cable against the inside of the pair of screwing screws perpendicularly to the pair of screwing screws. The pair of screwing screws passes through the tank body and is in threaded cooperation with the hand-tightening nut outside the tank body.

[0013] Preferably, the cable is made of stainless steel and the outer surface is coated with a bio-toxicity-free material that can be irradiated and sterilized.

[0014] Preferably, the outer surface of the cable is coated with a polyethylene ultra-high molecular weight material.

[0015] Preferably, at least three cables are evenly distributed along the circumferential direction of the hub. The cables start from the center of the hub and extend radially outward.

[0016] Compared with the prior art, the beneficial effects of the present utility model are as follows:

[0017] 1. The present utility model fixes the upper end of the stirring shaft at a corresponding position through a cable support structure with a certain strength, provides a supporting force to the upper end, and makes the stirring shaft not prone to shaking during rotation.

[0018] 2. The present utility model integrally attaches the cable and the side wall of the flexible container through the welding plate, reduces the risk of fluid leakage and accidental contamination, and is conducive to the packaging, storage and installation of the flexible container.

[0019] 3. The outer surface of the guy wire of the present utility model is coated with a biotoxic-free material that can be sterilized by irradiation, which can isolate the guy wire from the contents in the flexible container.

[0020] 4. The present utility model adopts a structure in which the middle part of the welding disc is sealed with the guy wire and the outside is welded to the flexible container, so that after the guy wire passes through the flexible container and the welding disc, the flexible container still remains isolated from the outside.

[0021] 5. The sealing plate of the present utility model is thickened and has a certain strength, which can protect the flexible container when contacting with the fastener; at the same time, a collision-proof frame is convex on the side of the closed plate facing the tank body, and the collision-proof frame can frame the fastener and limit it to the middle position of the welding disc. Description of the Drawings

[0022] Figure 1 is a schematic diagram of the cooperation between the flexible container and the flexible sleeve in the prior art;

[0023] Figure 2 is a three-dimensional sectional view (hiding the welding disc and the fastener) of the embodiment of the present utility model;

[0024] Figure 3 is Figure 2 the front view from a

[0025] Figure 4 is a schematic diagram of the connection between the guy wire and the flexible container and the tank body in the embodiment of the present utility model;

[0026] Figure 5 is Figure 4 the front view of the welding disc in Detailed Embodiment

[0027] Please refer to Figure 2 and Figure 3 , a disposable bioreactor is disclosed in the embodiment of the present utility model, which includes a tank body 2, a flexible container 1 that is aseptically isolated from the outside, and a mixing system 3 that is integrally attached to the flexible container 1 inside the flexible container 1.

[0028] The tank body 2 is a stainless steel tank body 2, which is located outside the flexible container 1 and surrounds the side wall and bottom surface of the flexible container 1, serving to accommodate and support the flexible container 1. The mixing system 3 includes a magnetic drive, a stirring shaft 31, and three groups of blade units 32 distributed along the length direction of the stirring shaft 31. The magnetic drive is located at the bottom of the flexible container 1, and the stirring shaft 31 is driven by the magnetic drive to rotate.

[0029] The present utility model does not involve the improvement of the connection structure between the flexible container 1 and the tank body 2 and the connection structure between the flexible container 1 and the mixing system 3. Therefore, the specific structure thereof will not be described in this embodiment, and the relevant structures can all adopt the prior art.

[0030] The stirring shaft 31 extends upward from the central position at the bottom of the flexible container 1 into the interior of the flexible container 1, thereby forming an upper end portion 311 and a lower end portion 312 of the stirring shaft 31. Both the upper end portion 311 and the lower end portion 312 of the stirring shaft 31 are connected to the hubs 33 by bearings, and the lower end portion 312 is connected to the bottom of the flexible container 1 through the hubs 33.

[0031] The hub 33 of the upper end portion 311 is provided with three sets of guy wire support structures. The guy wire support structures include guy wires 4, welding plates 5, and fasteners 6. The initial end of the guy wire 4 is fixed to the hub 33. The guy wire 4 starts from the hub 33, is connected to the flexible container 1 through the welding plate 5, and then the end portion is fixed to the tank body 2 through the fastener 6. For details, refer to Figure 4 and Figure 5 ,

[0032] The flexible container 1 is generally installed at the center of the bottom of the tank body 2. Therefore, the three guy wires 4 can be of the same length. The guy wires 4 are made of stainless steel, are evenly fixed to the hub 33, and extend radially outward from the center of the hub 33. The outer surface of the guy wire 4 is coated with a non-biologically toxic material that can be sterilized by irradiation, such as ultra-high molecular weight polyethylene material, to isolate the guy wire 4 from the contents in the flexible container 1.

[0033] The guy wire 4 and the welding plate 5 are of an integral structure. The welding plate 5 includes a welding edge 51 and a sealing plate 53. The guy wire 4 passes through the sealing plate 53, and a sealed connection is adopted between the sealing plate 53 and the guy wire 4. The periphery of the sealing plate 53 is the welding edge 51, and the welding edge 51 is welded to the side wall of the flexible container 1, which can make the flexible container 1 still be isolated from the outside after the guy wire 4 passes through the flexible container 1, thereby realizing the integral attachment of the flexible container 1 and the guy wire support structure.

[0034] The fastener 6 includes a pair of screwing screws 61, a countersunk head bolt 62, and a hand-tightening nut 63. The guy wire 4 passes through the pair of screwing screws 61, and the countersunk head bolt 62 fastens the guy wire 4 to the inside of the pair of screwing screws 61 vertically to the pair of screwing screws 61. Installation holes are provided on the side wall of the tank body 2 for the pair of screwing screws 61 and the guy wire 4 to pass through. One end of the pair of screwing screws 61 has a head limit, and the other end has an external thread. When the pair of screwing screws 61 passes through the tank body 2, the head limit remains inside the tank body 2, and the pair of screwing screws 61 can be locked on the outside of the tank body 2 through the hand-tightening nut 63. The hand-tightening nut 63 also has a through hole for the guy wire 4 to pass through, and a certain surplus length of the guy wire 4 is left outside the hand-tightening nut 63.

[0035] The sealing plate 53 is thickened and has a certain strength, and can protect the flexible container 1 when contacting the counter-rotating screw 61. To limit the counter-rotating screw 61 to the middle position of the welding plate, an anti-collision border 52 is integrally formed on the side of the sealing plate 53 facing the inner wall of the tank body 2. The anti-collision border 52 is in the shape of an annular protrusion, and the cable 4 passes through its inner side. The position where the anti-collision border 52 is provided corresponds to the position where the counter-rotating screw 61 is located, and can frame the counter-rotating screw 61, thereby limiting its position and protecting the flexible container 1.

[0036] During the installation of this embodiment, first place the flexible container 1 equipped with the cable 4 inside the tank body 2, and then lock the counter-rotating screw 61 to the cable 4 through the countersunk head bolt 62 according to the installation position of the flexible container 1 in the tank body 2; then pass the counter-rotating screw 61 through the reserved installation hole on the tank body 2 and fix it with the hand-tightening nut 63 outside the tank body 2; finally, together with the structure already installed inside the flexible container 1, perform irradiation sterilization and aseptic packaging.

[0037] In summary, the utility model fixes the upper end portion 311 of the stirring shaft 31 at the corresponding position through the cable supporting structure with a certain strength, provides a supporting force for the upper end portion 311, and makes the stirring shaft 31 not prone to shaking during the rotation process; at the same time, the integral attachment structure of the cable 4 and the flexible container 1 reduces the risk of fluid leakage and accidental contamination, and is conducive to the packaging, storage and installation of the flexible container 1.

[0038] Finally, it should be noted that the above are only the preferred embodiments of the present utility model and are not used to limit the present utility model. Although the present utility model has been described in detail with reference to the foregoing embodiments, for those skilled in the art, they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present utility model shall be included in the protection scope of the present utility model.

Claims

1. Disposable bioreactor, comprising a tank body (2), a flexible container (1) and a mixing system (3), the mixing system (3) comprising a stirring shaft (31) attached to the flexible container (1), the upper end (311) of the stirring shaft (31) being connected to a hub (33), characterized in that: The hub (33) is provided with at least three cable support structures, the cable support structures comprising cables (4), welding plates (5) and fasteners (6), one end of the cable (4) being fixed to the hub (33); the cable (4) starting from the hub (33), passing successively through the welding plate (5) and the fastener (6); the cable (4) being integrally formed with the welding plate (5), the welding plate (5) being sealingly fixed to the side wall of the flexible container (1), and the cable (4) being fixed to the tank body (2) by the fastener (6).

2. The disposable bioreactor according to claim 1, wherein: The welding plate (5) comprises a welding edge (51) and a sealing plate (53), the cable (4) passing through the sealing plate (53) and being sealed at the connection; the welding edge (51) is located around the sealing plate (53) and is welded to the side wall of the flexible container (1).

3. The disposable bioreactor according to claim 2, characterized in that: A collision prevention frame (52) is further provided on the side of the sealing plate (53) facing the inner side wall of the tank body (2), the collision prevention frame (52) being in the form of a ring-shaped protrusion and corresponding in position to the fastener (6).

4. The disposable bioreactor according to claim 1, wherein: The fastener (6) comprises a pair of screwing screws (61), a countersunk head bolt (62) and a hand-tightening nut (63), the cable (4) passing through the pair of screwing screws (61), and the countersunk head bolt (62) pressing the cable (4) tightly inside the pair of screwing screws (61) perpendicular to the pair of screwing screws (61); the pair of screwing screws (61) passing through the tank body (2) and being in threaded cooperation with the hand-tightening nut (63) on the outer side of the tank body (2).

5. The disposable bioreactor according to claim 1, wherein: The cable (4) is made of stainless steel and is coated on the outer surface with a bio-toxicity-free material that can be sterilized by irradiation.

6. The disposable bioreactor according to claim 5, wherein: The outer surface of the cable (4) is coated with a polyethylene of ultra-high molecular weight material.

7. The disposable bioreactor according to claim 1, characterized in that: At least three of the cables (4) are evenly distributed circumferentially along the hub (33), and the cables (4) start from the center of the hub (33) and extend radially outwards.

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