Ultrafiltration equipment for biological pharmacy

Abstract

The invention relates to the technical field of membrane separation, in particular to bio-pharmaceutical ultrafiltration equipment which comprises a supporting frame and a plurality of ultrafiltration membrane modules arranged on the supporting frame and further comprises a main feeding pipe arranged on the supporting frame, and the main feeding pipe is connected with a solution storage tank and used for guiding out a solution to be filtered. A plurality of ultrafiltration membrane modules can be freely switched between a parallel connection mode and a series connection mode: in the parallel connection mode, the feed ports of the ultrafiltration membrane modules are independently or jointly connected to a main feed pipe, and the discharge ports of the ultrafiltration membrane modules are independently or jointly connected to a main discharge pipe, so that parallel filtration treatment of a large-flux solution is realized; in the series connection mode, the discharge port of the previous-stage ultrafiltration membrane module is directly connected to the feed port of the next-stage ultrafiltration membrane module through the switching assembly to form a multi-stage series connection filtering channel, and meanwhile, the backflow assembly synchronously adjusts the backflow path so as to meet the small-batch high-precision filtering requirement and improve the equipment utilization rate.

Description

Technical Field

[0001] This invention relates to the field of membrane separation technology, specifically to an ultrafiltration device for biopharmaceutical applications. Background Technology

[0002] Ultrafiltration equipment for biopharmaceuticals is a key process equipment designed based on the ultrafiltration principle in membrane separation technology. Its core is to achieve efficient separation, concentration, and buffer replacement of target products (such as proteins, antibodies, vaccines, etc.) and impurities (such as host cell proteins, endotoxins, small molecule metabolites, etc.) in biological solutions through a semi-permeable membrane with a specific pore size under pressure. This equipment usually adopts a cross-flow filtration mode to reduce membrane fouling and is equipped with reusable hydrophilic membrane packs (such as PES material). It has advantages such as convenient operation, linear process scale-up, high product yield, and stable quality. It is widely used in the purification, sterilization, desalting, and formulation of biopharmaceuticals and is one of the core tools to ensure the safety, efficacy, and economic efficiency of biopharmaceutical production.

[0003] In the existing biopharmaceutical ultrafiltration process technology system, in order to improve the overall production throughput to meet the needs of large-scale industrialization, the industry generally adopts an integrated design scheme of multiple membrane modules in parallel. This scheme achieves parallel filtration of solutions by connecting multiple independent ultrafiltration membrane modules in parallel to the same liquid supply system. However, this mode of configuring equipment at one time based on the maximum capacity requirement has significant drawbacks: because this design requires the equipment to be configured according to the maximum throughput, it leads to low equipment utilization during small-batch production. Therefore, we propose an ultrafiltration device for biopharmaceutical applications. Summary of the Invention

[0004] To address the aforementioned technical problems, this application provides an ultrafiltration device for biopharmaceutical applications, including a support frame and multiple ultrafiltration membrane modules mounted on the support frame. It also includes a main feed pipe mounted on the support frame, connected to a solution storage tank for discharging the solution to be filtered. A main discharge pipe, connected to a concentrate collection tank, is mounted on the support frame for collecting the filtered concentrate. A switching component, connected to the multiple ultrafiltration membrane modules, is mounted on the support frame to switch the modules from a parallel connection to a series connection. In the parallel connection mode, the inlets and outlets of each ultrafiltration membrane module are connected to the main feed pipe, and their outlets are also connected to the main discharge pipe, enabling parallel filtration of large batches of solution. In the series connection mode, the outlet of the preceding ultrafiltration membrane module is connected to the inlet of the following ultrafiltration membrane module via the switching component, forming a multi-stage series filtration path to adapt to small-batch production and improve equipment utilization.

[0005] In some embodiments, the support frame is provided with a reflux assembly. When multiple ultrafiltration membrane modules are connected in parallel, the reflux assembly is used to connect the outlets of multiple ultrafiltration membrane modules independently to the solution storage tank for reflux regulation. When multiple ultrafiltration membrane modules are switched to series mode, the reflux assembly switches simultaneously so that the outlet of the subsequent ultrafiltration membrane module is connected to the outlet of the previous ultrafiltration membrane module for reflux regulation.

[0006] In some embodiments, the ultrafiltration membrane module has three stages. The feed inlet of the first stage ultrafiltration membrane module is connected to the main feed pipe via a conduit one. The feed inlets of the second and third stage ultrafiltration membrane modules are connected to a three-way pipe, and the three-way pipe is connected to the main feed pipe via a conduit two. The discharge outlet of the third stage ultrafiltration membrane module is connected to the main discharge pipe via a conduit six. The switching component includes an electric three-way valve disposed on one side of the third stage and the second stage. The electric three-way valve is connected to the three-way pipe by a conduit three. The electric three-way valve is connected to the main discharge pipe by a conduit four. The two electric three-way valves are connected to the discharge ports of the first stage and the second stage ultrafiltration membrane modules by conduits five. Furthermore, a valve assembly is installed inside the tee pipe to disconnect or connect the tee pipe and the main feed pipe.

[0007] In some embodiments, the valve assembly includes a cylindrical plug slidably connected within a tee tube, a hollow column fixedly connected to one end of the tee tube, a push rod fixedly connected to one end of the cylindrical plug, one end of the push rod being located inside the hollow column and slidably connected to its inner wall, and moving the push rod causing the cylindrical plug to move.

[0008] In some embodiments, a sliding column is fixedly connected to one end of the push rod, and a guide groove is provided on the inner wall of the hollow cylinder. One end of the sliding column is located in the guide groove, and a drive motor with an output shaft connected to the push rod is fixedly connected to one end of the hollow cylinder. When the drive motor is started to drive the push rod to rotate, the sliding column slides along the guide groove to drive the cylindrical plug to move.

[0009] In some embodiments, a cross rod is fixedly connected to the output shaft of the drive motor, and a cross groove is provided at one end of the push rod. One end of the cross rod is located in the cross groove and is slidably connected to its inner wall to guide and limit the sliding of the push rod.

[0010] In some embodiments, the guide groove includes a spiral groove formed on the inner wall of the hollow column, one end of the sliding column is located in the spiral groove and is slidably connected to its inner wall.

[0011] In some embodiments, the reflux assembly includes two U-shaped tubes disposed on a support frame, one U-shaped tube having its two ends connected to conduit six and conduit five respectively, and the other U-shaped tube having its two ends connected to two conduit fives respectively; An electric three-way valve is also installed on the U-shaped tube, and a main return pipe is installed on the mounting bracket. A conduit seven is connected between the electric three-way valve and the main return pipe. Furthermore, an L-shaped tube is conductively connected to the conduit five of the first-stage ultrafiltration membrane module, and a conduit seven is also conductively connected between one end of the L-shaped tube and the main reflux tube.

[0012] In some embodiments, a water pump is installed on the U-shaped pipe, and a water pump is also installed on the L-shaped pipe.

[0013] In some embodiments, an annular groove communicating with one end of the spiral groove is provided inside the hollow column, and a tension spring is fixedly connected between the output shaft of the drive motor and the push rod. A shaft is fixedly connected to one end of the cylindrical plug, and multiple stirring blades are fixedly connected to the shaft. When the drive motor is started, the shaft rotates to drive the stirring blades to stir the mixed solution.

[0014] The present invention has at least the following beneficial effects: This device can freely switch between parallel and series modes using a switching component: In parallel mode, the inlets of each ultrafiltration membrane module are connected independently or jointly to the main feed pipe, and the outlets are connected independently or jointly to the main outlet pipe, to achieve parallel filtration of high-flux solutions; In series mode, the outlet of the previous stage ultrafiltration membrane module is directly connected to the inlet of the next stage ultrafiltration membrane module through the switching component, forming a multi-stage series filtration path. At the same time, the reflux component adjusts the reflux path synchronously to adapt to the needs of small-batch high-precision filtration and improve equipment utilization. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 For the present invention Figure 1 Another structural diagram; Figure 3 For the present invention Figure 1 Schematic diagram of partial cross-section; Figure 4 For the present invention Figure 3 Another structural diagram; Figure 5 For the present invention Figure 4 Schematic diagram of partial cross-section; Figure 6 For the present invention Figure 5 Schematic diagram of the structure of area A in the middle; Figure 7 For the present invention Figure 5 Schematic diagram of partial cross-section; Figure 8 This is a schematic diagram of the hollow column structure of the present invention.

[0016] In the diagram: 1-Support frame; 11-Ultrafiltration membrane module; 2-Main feed pipe; 3-Main discharge pipe; 4-Switching assembly; 5-Recirculation assembly; 41-Conduit 1; 42-T-way pipe; 43-Conduit 2; 44-Conduit 6; 45-Electric three-way valve; 46-Conduit 3; 47-Conduit 4; 48-Conduit 5; 49-Valve assembly; 51-Cylindrical plug; 52-Hollow column; 53-Push rod; 54-Sliding column; 55-Guide groove; 56-Drive motor; 57-Cross rod; 58-Cross groove; 59-Spiral groove; 61-U-shaped pipe; 63-Main reflux pipe; 64-Conduit 7; 65-L-shaped pipe; 66-Water pump; 67-Annular groove; 68-Tension spring; 69-Shaft 1; 71-Agitator blade. Detailed Implementation

[0017] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0018] Please see Figures 1-8 The present invention provides a technical solution: an ultrafiltration device for biopharmaceutical use, comprising a support frame 1 and a plurality of ultrafiltration membrane modules 11 disposed on the support frame 1, and further comprising: The main feed pipe 2 is mounted on the support frame 1 and connected to the solution storage tank for discharging the solution to be filtered. The main discharge pipe 3 is installed on the support frame 1 and connected to the concentrate collection tank for collecting the filtered concentrate; The switching component 4 is set on the support frame 1 and connected to multiple ultrafiltration membrane modules 11. It is used to switch multiple ultrafiltration membrane modules 11 from parallel mode to series mode. In parallel mode, the inlet of each ultrafiltration membrane module 11 is connected to the main inlet pipe 2 and the outlet is connected to the main outlet pipe 3 to realize parallel filtration of large batches of solution. Series mode: The outlet of the previous stage ultrafiltration membrane module 11 is connected to the inlet of the next stage ultrafiltration membrane module 11 through the switching component 4, forming a multi-stage series filtration path to adapt to small-batch production and improve equipment utilization. The reflux assembly 5 is mounted on the support frame 1 and connected to multiple ultrafiltration membrane modules 11. When the multiple ultrafiltration membrane modules 11 are in parallel mode, the reflux assembly 5 is used to connect the multiple ultrafiltration membrane modules 11 independently to the solution storage tank for reflux regulation. When the multiple ultrafiltration membrane modules 11 are switched to series mode, the reflux assembly 5 switches simultaneously so that the outlet of the subsequent ultrafiltration membrane module 11 is connected to the outlet of the previous ultrafiltration membrane module 11 for reflux regulation. Specifically, this device can freely switch between parallel and series modes using the switching component 4. In parallel mode, the inlet of each ultrafiltration membrane module 11 is connected to the main feed pipe 2 independently or jointly, and the outlet is connected to the main outlet pipe 3 independently or jointly, to achieve parallel filtration of high-flux solutions. In series mode, the outlet of the previous ultrafiltration membrane module 11 is directly connected to the inlet of the next ultrafiltration membrane module 11 through the switching component 4, forming a multi-stage series filtration path. At the same time, the reflux component 5 adjusts the reflux path synchronously to adapt to the needs of small-batch high-precision filtration and improve equipment utilization.

[0019] The ultrafiltration membrane module 11 has three stages. The feed inlet of the first stage ultrafiltration membrane module 11 is connected to the main feed pipe 2 by a conduit 41. The feed inlets of the second and third stage ultrafiltration membrane modules 11 are connected to a three-way pipe 42. The three-way pipe 42 is connected to the main feed pipe 2 by a conduit 43. The discharge outlet of the third stage ultrafiltration membrane module 11 is connected to the main discharge pipe 3 by a conduit 44. The switching component 4 includes an electric three-way valve 45 located on the third and second stage side. The electric three-way valve 45 is connected to the three-way pipe 42 by a conduit 46, and the electric three-way valve 45 is connected to the main discharge pipe 3 by a conduit 47. The two electric three-way valves 45 are connected to the discharge ports of the first and second stage ultrafiltration membrane modules 11 by conduits 48. Specifically, by controlling the electric three-way valve 45 through the program, it is possible to select whether the discharge port of the previous stage ultrafiltration membrane module 11 is directly connected to the main discharge pipe 3 or connected to the inlet of the next stage ultrafiltration membrane module 11, that is, the three-way pipe 42 of the next stage. Furthermore, a valve assembly 49 is provided inside the three-way pipe 42 to disconnect or connect the three-way pipe 42 and the main feed pipe 2. Specifically, through the valve assembly 49, it is possible to select whether the feed port of the next-stage ultrafiltration membrane module 11 is directly connected to the main feed pipe 2 or connected to the discharge port of the previous-stage ultrafiltration membrane module 11.

[0020] The valve assembly 49 includes a cylindrical plug 51 that is slidably connected inside a three-way pipe 42. A hollow column 52 is fixedly connected to one end of the three-way pipe 42, and a push rod 53 is fixedly connected to one end of the cylindrical plug 51. One end of the push rod 53 is located inside the hollow column 52 and is slidably connected to its inner wall. Moving the push rod 53 causes the cylindrical plug 51 to move, thereby blocking or opening the three-way pipe 42 and the conduit 43.

[0021] One end of the push rod 53 is fixedly connected to a sliding column 54. A guide groove 55 is provided on the inner wall of the hollow cylinder. One end of the sliding column 54 is located in the guide groove 55. One end of the hollow column 52 is fixedly connected to a drive motor 56 that is connected to the output shaft and the push rod 53. When the drive motor 56 is started to drive the push rod 53 to rotate, the sliding column 54 slides along the guide groove 55 to drive the cylindrical plug 51 to move.

[0022] A cross rod 57 is fixedly connected to the output shaft of the drive motor 56. A cross groove 58 is opened at one end of the push rod 53. One end of the cross rod 57 is located in the cross groove 58 and is slidably connected to its inner wall to guide and limit the sliding of the push rod 53.

[0023] The guide groove 55 includes a spiral groove 59 formed on the inner wall of the hollow column 52. One end of the sliding column 54 is located in the spiral groove 59 and is slidably connected to its inner wall. Specifically, the drive motor 56 is started to drive the cross rod 57 to rotate, thereby driving the push rod 53 to rotate, which in turn drives the sliding column 54 to slide along the spiral groove 59, thereby driving the push rod 53 and the cylindrical plug 51 to move.

[0024] The reflux assembly 5 includes two U-shaped tubes 61 mounted on the support frame 1. One U-shaped tube 61 is connected to the six conduit 44 and the five conduit 48 at both ends, respectively. The other U-shaped tube 61 is connected to the two conduits 48 at both ends, respectively. At this time, the concentrate discharged from the next ultrafiltration membrane module 11 can be partially guided to the feed port of the next stage through this U-shaped tube 61.

[0025] An electric three-way valve 45 is also installed on the U-shaped tube 61, and a main return pipe 63 is installed on the mounting bracket. A conduit 7 64 is connected between the electric three-way valve 45 and the main return pipe 63. When multiple ultrafiltration membrane modules 11 are in parallel mode, the electric three-way valve 45 is controlled by the program so that the U-shaped tube 61 is connected to the main return pipe 63 only through the conduit 7 64, thereby guiding part of the concentrate discharged from multiple ultrafiltration membrane modules 11 to the solution storage tank. Furthermore, an L-shaped tube 65 is connected to the conduit 48 of the first-stage ultrafiltration membrane module 11. One end of the L-shaped tube 65 is also connected to the main reflux pipe 63 via a conduit 64. Specifically, the first-stage ultrafiltration membrane module 11 is directly connected to the main reflux pipe 63 via the L-shaped tube 65 and the conduit 64. This is because, whether in parallel or series mode, the concentrated liquid discharged from the first-stage ultrafiltration membrane module 11 is partially returned to the solution storage tank.

[0026] A water pump 66 is installed on the U-shaped pipe 61, and a water pump 66 is also installed on the L-shaped pipe 65. The return flow is controlled by starting the water pump 66 through a program.

[0027] The hollow column 52 has an annular groove 67 that communicates with one end of the spiral groove 59, and a tension spring 68 is fixedly connected between the output shaft of the drive motor 56 and the push rod 53. A shaft 69 is fixedly connected to one end of the cylindrical plug 51. Multiple stirring blades 71 are fixedly connected to the shaft 69. When the drive motor 56 is started, the shaft 69 is rotated to drive the stirring blades 71 to stir the mixed solution. Specifically, when multiple ultrafiltration membrane modules 11 are switched to series mode, the drive motor 56 rotates forward to drive the sliding column 54 to slide along the spiral groove 59 into the annular groove 67. At this time, the tension spring 68 is stretched by force to provide self-recovery force. Then the drive motor 56 is started to rotate forward again. At this time, the sliding column 54 slides along the annular groove 67, and the shaft 69 rotates to drive the stirring blades 71 on it to rotate to mix the solution flowing into the three-way pipe 42. Conversely, when the drive motor 56 is started to rotate in reverse, the sliding column 54 is driven to embed into the spiral groove 59, and the tension spring 68 is used to reset in order to cooperate with the rotation of the drive motor 56 to drive the sliding column 54 to slide along the spiral groove 59, thereby driving the cylindrical plug 51 to move and reset.

[0028] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0029] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention.

Claims

1. A biopharmaceutical ultrafiltration device, comprising a support frame (1) and a plurality of ultrafiltration membrane modules (11) disposed on the support frame (1), characterized in that, It also includes: The main feed pipe (2) is set on the support frame (1) and connected to the solution storage tank for exporting the solution to be filtered; The main discharge pipe (3) is set on the support frame (1) and connected to the concentrate collection box for collecting the filtered concentrate; The switching component (4) is set on the support frame (1) and connected to multiple ultrafiltration membrane modules (11) to switch multiple ultrafiltration membrane modules (11) from parallel mode to series mode. In the parallel mode, the inlet of each ultrafiltration membrane module (11) is connected to the main feed pipe (2) and the outlet is connected to the main outlet pipe (3) to realize parallel filtration of large batch solutions. Series mode: The outlet of the previous stage ultrafiltration membrane module (11) is connected to the inlet of the next stage ultrafiltration membrane module (11) through the switching component (4) to form a multi-stage series filtration path to adapt to small-batch production and improve equipment utilization.

2. The ultrafiltration device for biopharmaceutical use according to claim 1, characterized in that: The support frame (1) is provided with a reflux assembly (5). When multiple ultrafiltration membrane modules (11) are in parallel mode, the reflux assembly (5) is used to connect the outlet of multiple ultrafiltration membrane modules (11) independently to the solution storage tank for reflux regulation. When multiple ultrafiltration membrane modules (11) are switched to series mode, the reflux assembly (5) is switched at the same time so that the outlet of the next stage ultrafiltration membrane module (11) is connected to the outlet of the previous stage ultrafiltration membrane module (11) for reflux regulation.

3. The ultrafiltration device for biopharmaceutical use according to claim 2, characterized in that: The ultrafiltration membrane module (11) has three stages. The feed inlet of the first stage ultrafiltration membrane module (11) is connected to the main feed pipe (2) by a conduit 1 (41). The feed inlets of the second and third stages ultrafiltration membrane modules (11) are connected to a three-way pipe (42). The three-way pipe (42) is connected to the main feed pipe (2) by a conduit 2 (43). The discharge outlet of the third stage ultrafiltration membrane module (11) is connected to the main discharge pipe (3) by a conduit 6 (44). The switching component (4) includes an electric three-way valve (45) disposed on the third stage and the second stage side. The electric three-way valve (45) is connected to the three-way pipe (42) by a conduit three (46). The electric three-way valve (45) is connected to the main discharge pipe (3) by a conduit four (47). The two electric three-way valves (45) are connected to the discharge ports of the first stage and the second stage ultrafiltration membrane module (11) by a conduit five (48). A valve assembly (49) is provided inside the three-way pipe (42) for disconnecting or connecting the three-way pipe (42) and the main feed pipe (2).

4. The ultrafiltration device for biopharmaceutical use according to claim 3, characterized in that: The valve assembly (49) includes a cylindrical plug (51) slidably connected in a three-way pipe (42). A hollow column (52) is fixedly connected to one end of the three-way pipe (42), and a push rod (53) is fixedly connected to one end of the cylindrical plug (51). One end of the push rod (53) is located inside the hollow column (52) and is slidably connected to its inner wall. Moving the push rod (53) causes the cylindrical plug (51) to move.

5. The ultrafiltration device for biopharmaceutical use according to claim 4, characterized in that: One end of the push rod (53) is fixedly connected to a sliding column (54). A guide groove (55) is provided on the inner wall of the hollow cylinder. One end of the sliding column (54) is located in the guide groove (55). One end of the hollow column (52) is fixedly connected to a drive motor (56) whose output shaft is connected to the push rod (53). When the drive motor (56) is started, it drives the push rod (53) to rotate. At the same time, the sliding column (54) slides along the guide groove (55) to drive the cylindrical plug (51) to move.

6. The ultrafiltration device for biopharmaceutical use according to claim 5, characterized in that: A cross rod (57) is fixedly connected to the output shaft of the drive motor (56). A cross groove (58) is provided at one end of the push rod (53). One end of the cross rod (57) is located in the cross groove (58) and is slidably connected to its inner wall to guide and limit the sliding of the push rod (53).

7. The ultrafiltration device for biopharmaceutical use according to claim 6, characterized in that: The guide groove (55) includes a spiral groove (59) formed on the inner wall of the hollow column (52), and one end of the sliding column (54) is located in the spiral groove (59) and is slidably connected to its inner wall.

8. The ultrafiltration device for biopharmaceutical use according to claim 7, characterized in that: The reflux assembly (5) includes two U-shaped tubes (61) mounted on the support frame (1). One U-shaped tube (61) is connected to the sixth conduit (44) and the fifth conduit (48) at both ends, respectively. The other U-shaped tube (61) is connected to the two fifth conduits (48) at both ends, respectively. An electric three-way valve (45) is also installed on the U-shaped pipe (61), and a main return pipe (63) is installed on the mounting bracket. A conduit seven (64) is connected between the electric three-way valve (45) and the main return pipe (63). Furthermore, an L-shaped tube (65) is connected to the fifth conduit (48) of the first-stage ultrafiltration membrane module (11), and a seventh conduit (64) is also connected to one end of the L-shaped tube (65) and the main return tube (63).

9. The ultrafiltration device for biopharmaceutical use according to claim 8, characterized in that: A water pump (66) is installed on the U-shaped pipe (61), and a water pump (66) is also installed on the L-shaped pipe (65).

10. The ultrafiltration device for biopharmaceutical use according to claim 9, characterized in that: The hollow column (52) has an annular groove (67) that communicates with one end of the spiral groove (59), and a tension spring (68) is fixedly connected between the output shaft of the drive motor (56) and the push rod (53). A shaft (69) is fixedly connected to one end of the cylindrical plug (51), and multiple stirring blades (71) are fixedly connected to the shaft (69). The drive motor (56) is started to drive the shaft (69) to rotate, so as to drive the stirring blades (71) to stir the mixed solution.

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