A cell separation device and method

Abstract

The present invention relates to a cell separation device and method, which comprises: a centrifugal cup installed in a centrifugal chamber, comprising a liquid inlet flow channel and a liquid outlet flow channel; a liquid circuit unit, comprising a pump assembly, a valve assembly and a pipeline, for supplying and extracting liquid from the centrifugal cup, and dispensing into a plurality of final product bags; the pump assembly and the valve assembly are in the pipeline path; a host control unit, comprising a drive motor, a waste liquid tank and a centrifugal chamber, connected to the pump assembly and the valve assembly, and controlling the drive motor, the pump assembly and the valve assembly; the drive motor is connected to the centrifugal cup in a transmission manner, for rotating the centrifugal cup to achieve a first cell centrifugal treatment, extracting a primary product solution, discharging waste, a second cell centrifugal treatment and a preparation treatment; a frame, fixedly mounted on the top of the host control unit, for hanging a liquid bag. The above-mentioned cell separation device has the characteristics of low damage, high throughput, high efficiency, high recovery rate and sterility.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a cell separation device and method. Background Art

[0002] Cell therapy is a treatment method that injects cell-based drugs into the patient's body to treat diseases. However, the production process of cell-based drugs involves many preparation steps and complex processes. The complex process operations and the cell in vitro environment have a significant impact on the biological activity of cells, especially in the cell separation process, which is the first step in the production of cell-based drugs.

[0003] The two schemes commonly used in existing equipment are density gradient centrifugation and countercurrent centrifugation. In the density gradient centrifugation, cell samples are centrifuged, and after the cell samples are centrifuged and stratified, cell separation is performed. However, the fluid shear force during the centrifugation process will cause high shear damage to the cells, resulting in reduced cell biological activity and low purity of separated cells. The countercurrent centrifugation performs dual-dimensional stratification of cell samples in terms of density and size to obtain highly concentrated cell fluid. However, the separation efficiency of the countercurrent centrifugation is low, and long-term treatment will significantly reduce cell biological activity.

[0004] Therefore, the existing technology not only has the defects of low efficiency and high damage, but also has the difficulty in meeting the needs of high recovery rate and high throughput for fully automatic and fully closed cell separation. Summary of the invention

[0005] The present invention provides a cell separation device and method, which has the characteristics of low damage, high throughput, high efficiency, high recovery rate and sterility, can significantly improve the shortcomings of low cell biological activity in the prior art, and meet the needs of fully automatic and fully closed cell separation.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] The present invention provides a cell separation device, which comprises:

[0008] The centrifuge cup is installed in the centrifugal chamber, and includes a liquid inlet flow channel and a liquid outlet flow channel, and is used for performing the first cell centrifugation treatment, extracting the initial product solution, discharging waste, the second cell centrifugation treatment and the preparation treatment; the liquid inlet flow channel is a channel for flowing into the centrifuge cup; the liquid outlet flow channel is a channel for extracting the solution from the centrifuge cup;

[0009] A liquid circuit unit, comprising a pump assembly, a valve assembly and a pipeline, for supplying and extracting liquid from the centrifuge cup, and dispensing liquid into a plurality of final product bags; the pump assembly and the valve assembly are in the pipeline path;

[0010] A host control unit includes a drive motor, a waste liquid tank and the centrifugal chamber, and is connected to the pump assembly and the valve assembly, and controls the drive motor, the pump assembly and the valve assembly; the drive motor is in driving connection with the centrifugal cup, and is used to rotate the centrifugal cup to achieve the first cell centrifugation treatment, extraction of the initial product solution, waste discharge treatment, the second cell centrifugation treatment and preparation treatment; the waste liquid tank is used to collect the solution after cleaning and waste discharge;

[0011] The frame is fixedly mounted on the top of the host control unit and is used to hang separation liquid bags containing separation liquid, sample liquid bags containing liquid to be separated, cleaning liquid bags containing cleaning liquid, initial product bags and final product bags; the cleaning liquid is used for cleaning during the cell separation process.

[0012] Furthermore, the centrifuge cup further comprises a liquid pushing plate, which extends from the center of the centrifuge cup in a radial direction, and a gap is formed between an end of the liquid pushing plate away from the axis and an inner wall of the centrifuge cup.

[0013] Furthermore, the centrifugal cup also includes a cup body and a cup cover;

[0014] The liquid pushing plate is fixedly connected to the cup body and / or the cup cover;

[0015] The cup cover is sealed and connected to the top of the cup body, and a centrifugal cavity is formed between the cup cover and the cup body;

[0016] The liquid pushing plate is distributed in the centrifugal chamber along the circumference of the cup body, and there is a gap between the other end of the liquid pushing plate adjacent to the axis and the axis of the cup body;

[0017] The liquid inlet channel and the liquid outlet channel are both connected to the outside of the cup body and the centrifugal chamber; the liquid inlet channel has a first liquid inlet arranged on the outside of the cup body and / or a second liquid inlet arranged at the bottom of the inner wall of the cup body; the liquid outlet channel has a first liquid outlet arranged at the top of the centrifugal chamber and / or a second liquid outlet arranged at the top of the side wall of the cup body.

[0018] Furthermore, a chamfer of 5° to 50° is formed between the side wall and the bottom wall of the cup body.

[0019] Furthermore, the liquid circuit unit further comprises a liquid circuit switching device, and the liquid circuit switching device is used to perform closed switching of the final product solution and to dispense the solution into a plurality of the final product bags;

[0020] The liquid circuit unit further includes a first bubble sensor, a second bubble sensor and a third bubble sensor; the first bubble sensor, the second bubble sensor and the third bubble sensor are used to monitor the flow direction of the pipeline in the liquid circuit unit.

[0021] In addition, the present invention also provides a cell separation method of a cell separation device, the cell separation method comprising:

[0022] The separation liquid and the liquid to be separated flow into the centrifuge cup through the pipeline, and the first cell centrifugation treatment is performed through the centrifuge cup, and the pipeline is cleaned during the first cell centrifugation treatment;

[0023] After cleaning the pipeline, extracting the primary product solution from the centrifuge cup, and pumping the extracted primary product solution into the primary product bag through the pipeline;

[0024] Discharging the solution remaining in the centrifuge cup after extraction and cleaning the centrifuge cup;

[0025] The primary product solution in the primary product bag flows into the cleaned centrifuge cup through a pipeline, and performs a second cell centrifugation treatment to obtain a concentrated solution;

[0026] The concentrated solution is subjected to formulation treatment to obtain a final product solution, and the final product solution is packaged into a plurality of final product bags.

[0027] Furthermore, the step of flowing the separation liquid and the liquid to be separated into a centrifuge cup through a pipeline and performing a first cell centrifugation treatment through the centrifuge cup comprises:

[0028] The separation liquid flows into the centrifugal cup through the first pipeline, and the centrifugal cup is rotated at a first speed for a first predetermined time; the first pipeline includes a first branch pipeline and a second branch pipeline, and the first branch pipeline and the second branch pipeline partially overlap;

[0029] The liquid to be separated flows into the centrifuge cup through the second branch pipeline, and the centrifuge cup is rotated at a second rotation speed for a second predetermined time.

[0030] Furthermore, the step of pumping the extracted primary product solution into the primary product bag via a pipeline comprises:

[0031] The rotation speed of the centrifugal cup is maintained at a third rotation speed, and the primary product solution is extracted from the liquid outlet channel in the centrifugal cup through the valve assembly and the pump assembly, and flows into the primary product bag through the first branch pipeline.

[0032] Furthermore, the primary product solution in the primary product bag flows into the cleaned centrifuge cup through a pipeline, and a second cell centrifugation treatment is performed to obtain a concentrated solution, comprising:

[0033] The primary product solution in the primary product bag flows into the cleaned centrifugal cup through the second branch pipeline, and the cleaning solution flows into the primary product bag through the valve assembly and the pump assembly for solution cleaning treatment, and the solution after solution cleaning flows into the centrifugal cup through the second branch pipeline;

[0034] After a preset volume of cleaning solution flows into the centrifuge cup, the centrifuge cup is subjected to the second cell centrifugation treatment, and waste liquid is discharged to obtain the concentrated solution.

[0035] Furthermore, the step of packaging the final product solution into a plurality of final product bags comprises:

[0036] The final product solution is switched in a closed manner and dispensed into a plurality of final product bags through a liquid path switching device.

[0037] Compared with the prior art, the present invention has the following beneficial effects:

[0038] 1. In the cell separation device of the present invention, the centrifuge cup includes an inlet flow channel and an outlet flow channel, the liquid circuit unit includes a pump assembly, a valve assembly and a pipeline, the host control unit includes a drive motor, a waste liquid tank and a centrifugal bin, and the frame is used to hang separation liquid bags, sample liquid bags, cleaning liquid bags, initial product bags and final product bags. Since the drive motor is connected to the centrifuge cup by transmission, and the inlet flow channel and the outlet flow channel of the centrifuge cup are connected to the liquid bag through the liquid circuit unit, the centrifuge cup can realize the first cell centrifugation treatment, the extraction of the initial product solution, the waste treatment, the second cell centrifugation treatment and the preparation treatment. Therefore, the cell separation device using the above structure can realize fully automatic and fully enclosed cell separation, so that the cell separation device has the characteristics of high throughput, high efficiency, high recovery rate and sterility, which can significantly improve the shortcomings of low cell biological activity in the prior art.

[0039] 2. The cell separation device of the present invention is provided with a liquid pushing plate in the centrifuge cup. When the driving motor drives the centrifuge cup to rotate, the liquid pushing plate is used to increase the driving force of the liquid centrifugation. The liquid pushing plate first pushes the nearby liquid, and the nearby liquid continues to push the distant liquid, so that the shear stress of the inner layer of liquid is lower, and the shear and friction of the cells are reduced, thereby improving the activity of the cells; at the same time, there is a gap between the liquid pushing plate and the inner wall of the centrifuge cup, and the pressure of the liquid on both sides of the liquid pushing plate can be balanced through the gap, so that the liquid surface is smooth, easier to separate, and the time required for separation is reduced; therefore, the liquid pushing plate arranged in the centrifuge cup can improve the efficiency of centrifugal stratification, and can also significantly reduce the fluid shear force in the centrifuge cup during centrifugation, so that the cell separation device has the characteristics of low damage, high throughput, high efficiency, high recovery rate, and sterility, which can significantly improve the shortcomings of low cell biological activity in the prior art and meet the needs of fully automatic and fully closed cell separation.

[0040] 3. The cell separation method of the present invention completes the first cell centrifugation treatment, extraction of the initial product solution, waste discharge treatment, the second cell centrifugation treatment and the preparation treatment steps through a cell separation device. Through the reasonable arrangement of each step and the cooperation of the above-mentioned cell separation device, not only the cell separation process is fully automatic and fully closed, but also the cell recovery efficiency and biological activity are improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 It is a schematic diagram of the overall structure of the cell separation device of the present invention;

[0042] Figure 2 This is a schematic diagram of the principle of the liquid circuit unit of the cell separation device of the present invention;

[0043] Figure 3 for Figure 1 Schematic diagram of the overall structure of the centrifugal cup;

[0044] Figure 4 for Figure 3 A cross-sectional view of the centrifugal cup;

[0045] Figure 5 The figure is a flow chart of the cell separation method of the present invention.

[0046] Among them, 1-main control unit, 2-frame, 3-centrifuge cup, 4-centrifuge chamber, 5-waste liquid tank, 6-push plate, 7-liquid inlet channel, 8-liquid outlet channel, 9-gap, 10-pump assembly, 11-centrifuge chamber cover, 12-sterile sampling device, 13-control panel, 14-touch screen, 15-cup body, 16-cup cover, 17-first liquid inlet, 18-second liquid inlet, 19-first liquid outlet, 20-second liquid outlet, 21-chamfer, 22-waste liquid bag, 23-cleaning liquid bag, 24-culture medium liquid bag, 25-spare liquid bag, 26-final product bag, 27-initial product bag, 28-separation liquid bag, 29-sample liquid bag, 30-first bubble sensor, 31-second bubble sensor, 32-third bubble sensor, 33-first pipeline, 34 -first port, 35-second pipeline, 36-second port, 37-first sealing ring, 38-second sealing ring, 39-bearing, 40-weighing unit, 41-display switch, 42-hook, 43-first control valve, 44-second control valve, 45-third control valve, 46-fourth control valve, 47-fifth control valve, 48-sixth control valve, 49-seventh control valve, 50-eighth control valve, 51-ninth control valve, 52-tenth control valve, 53-eleventh control valve, 54-twelfth control valve, 55-thirteenth control valve, 56-control button, 57-third pipeline, 58-first branch pipeline, 59-second branch pipeline, 60-third branch pipeline, 61-fourth branch pipeline, 62-fifth branch pipeline, 63-sixth branch pipeline DETAILED DESCRIPTION

[0047] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0048] Embodiment 1

[0049] like Figure 1 As shown in the structure, this embodiment provides a cell separation device, which includes a host control unit 1, a frame 2, a centrifuge cup 3 and a liquid circuit unit;

[0050] like Figure 1 , Figure 3 and Figure 4 As shown in the structure, the centrifuge cup 3 is installed in the centrifuge chamber 4 of the host control unit 1, including an inlet flow channel 7 and an outlet flow channel 8, which are used for the first cell centrifugation treatment, extraction of the initial product solution, waste treatment, the second cell centrifugation treatment and preparation treatment; the inlet flow channel 7 is a channel for flowing into the centrifuge cup 3; the outlet flow channel 8 is a channel for extracting the solution from the centrifuge cup 3;

[0051] The liquid circuit unit includes a pump assembly 10, a valve assembly and a pipeline, which are used to supply and extract liquid from the centrifugal cup 3, and to distribute it to multiple final product bags 26; the pump assembly 10 and the valve assembly are in the pipeline path; the pipeline adopts a sterile catheter; the pump assembly 10 can be a peristaltic pump; the liquid circuit unit can also include a sterile sampling device 12, the sterile sampling device 12 can be connected to the second branch pipeline 59 between the pump assembly 10 and the centrifugal cup 3 through a sterile catheter, and the additional sterile sampling device 12 facilitates the extraction of samples in the centrifugal cup 3 for quality inspection; the first port 34 and the second port 36 of the pump assembly 10 are both connected to the waste liquid bag 22; the first port 34 of the pump assembly 10 is connected to the second liquid outlet 20 of the centrifugal cup 3;

[0052] The host control unit 1 includes a drive motor (not shown in the figure), a waste liquid tank 5 and a centrifugal chamber 4, and is connected to a pump assembly 10 and a valve assembly, and controls the drive motor, the pump assembly 10 and the valve assembly; the drive motor is in transmission connection with the centrifugal cup 3, and is used to rotate the centrifugal cup 3 to achieve the first cell centrifugation treatment, extracting the initial product solution, the waste discharge treatment, the second cell centrifugation treatment and the preparation treatment; the waste liquid tank 5 is used to collect the solution after washing and after the waste discharge; the host control unit 1 is the basis of the entire cell separation device, the waste liquid tank 5 can directly accommodate the waste liquid, and a waste liquid bag 22 for accommodating the waste liquid can also be placed in the waste liquid tank 5; the waste liquid tank 5 is provided with an opening to facilitate the removal of the waste liquid bag 22 or waste liquid; the centrifugal chamber 4 is used to accommodate the centrifugal cup 3; in order to maintain the neat appearance of the cell separation device, an openable centrifugal chamber cover 11 is provided on the top of the centrifugal chamber 4, and the centrifugal cup 3 can be covered in the base 1 through the centrifugal chamber cover 11, and the centrifugal chamber cover 11 is opened to facilitate the removal of the centrifugal cup 3;

[0053] The frame 2 is fixedly installed on the top of the host control unit 1, and is used to hang the separation liquid bag 28 containing the separation liquid, the sample liquid bag 29 containing the liquid to be separated, the cleaning liquid bag 23 containing the cleaning liquid, the initial product bag 27 and the final product bag 26; the cleaning liquid is used for cleaning during the cell separation process; the frame 2 is mainly used to hang the liquid bag, which can be Figure 1 The frame 2 is composed of two vertical support rods and a crossbeam fixedly connected to the top of the two support rods; the bottom end of the support rod is fixedly installed on the top of the host control unit 1; and a hanging space for the liquid bag is formed between the frame 2 and the host control unit 1. In addition to the above-mentioned separation liquid bag 28, sample liquid bag 29, cleaning liquid bag 23, primary product bag 27 and final product bag 26, the liquid bag can also include a waste liquid bag 22, a culture medium liquid bag 24, a spare liquid bag 25 and a middle product bag (not shown in the figure); in the actual production process, the primary product bag 27 can also be used as a middle product bag after completing the task of accommodating the primary product.

[0054] In the above-mentioned cell separation device, the centrifugal cup 3 includes an inlet flow channel 7 and an outlet flow channel 8, the liquid circuit unit includes a pump assembly 10, a valve assembly and multiple pipelines, the host control unit 1 includes a driving motor, a waste liquid tank 5 and a centrifugal chamber 4, and the frame 2 is used to hang a separation liquid bag 28 containing separation liquid, a sample liquid bag 29 containing liquid to be separated, a cleaning liquid bag 23 containing cleaning liquid, an initial product bag 27 and a final product bag 26. Since the driving motor is connected to the centrifugal cup 3 by transmission, and the inlet flow channel 7 and the outlet flow channel 8 of the centrifugal cup 3 are connected to each liquid bag through the liquid circuit unit, the centrifugal cup 3 can realize the first cell centrifugation treatment, the extraction of the initial product solution, the waste treatment, the second cell centrifugation treatment and the preparation treatment. Therefore, the cell separation device using the above-mentioned structure can realize fully automatic and fully enclosed cell separation, so that the cell separation device has the characteristics of high throughput, high efficiency, high recovery rate and sterility, which can significantly improve the shortcomings of low cell biological activity in the prior art.

[0055] In a preferred embodiment, the centrifuge cup 3 further includes a liquid pushing plate 6 , which extends radially from the center of the centrifuge cup 3 , and a gap 9 is formed between the end of the liquid pushing plate 6 away from the axis and the inner wall of the centrifuge cup 3 .

[0056] In the above-mentioned cell separation device, a liquid pushing plate 6 is arranged in the centrifugal cup 3. When the driving motor drives the centrifugal cup 3 to rotate, the liquid pushing plate 6 is used to increase the driving force of the liquid centrifugation. The liquid pushing plate 6 first pushes the nearby liquid, and the nearby liquid continues to push the distant liquid, so that the shear stress of the inner layer of liquid is lower, and the shear and friction of the cells are reduced, thereby improving the activity of the cells; at the same time, there is a gap 9 between the end of the liquid pushing plate 6 and the inner wall of the centrifugal cup 3, and the gap 9 can balance the pressure of the liquid on both sides of the liquid pushing plate 6, so that the liquid surface is smooth, easier to separate, and the time required for separation is reduced; therefore, by adding the liquid pushing plate 6 in the centrifugal cup 3, the above-mentioned cell separation device can not only improve the efficiency of centrifugal stratification, but also significantly reduce the fluid shear force in the centrifugal cup 3 during the centrifugation process, so that the cell separation device has the characteristics of low damage, high throughput, high efficiency, high recovery rate, and sterility, which can significantly improve the shortcomings of low cell biological activity in the prior art and meet the needs of fully automatic and fully closed cell separation.

[0057] Furthermore, the centrifugal cup 3 also includes a cup body 15 and a cup cover 16; the cup cover 16 is sealed and connected to the top of the cup body 15, and a centrifugal cavity for accommodating liquid is formed between the cup cover 16 and the cup body 15; two liquid pushing plates 6 can be provided, and the two liquid pushing plates 6 are distributed in the centrifugal cavity along the circumference of the cup body 15, and both extend along the radial direction of the cup body 15, and there is a gap 9 between the end of the liquid pushing plate 6 away from the axis and the inner wall of the centrifugal cup 3, and the other end of the liquid pushing plate 6 adjacent to the axis and the cup body There is a gap 9 between the axes of the cup body 15; the liquid pusher plate 6 can be fixedly connected to the cup body 15 and / or the cup cover 16; the liquid inlet channel 7 and the liquid outlet channel 8 are both connected to the outside of the cup body 15 and the centrifugal cavity; the liquid inlet channel 7 has a first liquid inlet 17 arranged on the outside of the cup body 15 and a second liquid inlet 18 arranged at the bottom of the inner side wall of the cup body 15; the liquid outlet channel 8 has a first liquid outlet 19 arranged at the top of the centrifugal cavity and a second liquid outlet 20 arranged at the top of the side wall of the cup body 15; the cup body 15 A chamfer 21 of 5° to 50° is formed between the side wall and the bottom wall, and the chamfer 21 is arranged to facilitate the discharge of liquid, so that the volume of the residual liquid in the centrifugal cup 3 is less than 0.2 ml; the centrifugal cup 3 can also include a rotating adapter installed at the bottom of the cup body 15, a first sealing ring 37 installed between the liquid inlet channel 7 and the cup cover 16, a second sealing ring 38 installed between the liquid outlet channel 8 and the cup cover 16, and a bearing 39 installed between the liquid outlet channel 8 and the cup cover 16; the rotating adapter is transmission-connected between the centrifugal cup 3 and the drive motor; the cup cover 16 is provided with a center hole; part of the liquid outlet channel 8 is concentrically sleeved on the outer peripheral side of the liquid inlet channel 7 and passes through the center hole; the first sealing ring 37, the second sealing ring 38 and the bearing 39 are all installed in the center hole; the first sealing ring 37 and the second sealing ring 38 can make the liquid inlet channel and the liquid outlet channel sealed and isolated, and the bearing 39 can make the liquid inlet channel and the liquid outlet channel and the cup cover 16 rotate relative to each other.

[0058] On the basis of the above-mentioned various cell separation devices, the liquid circuit unit also includes a liquid circuit switching device, which is used to perform closed switching of the final product solution and divide it into multiple final product bags; the liquid circuit unit also includes a first bubble sensor 30, a second bubble sensor 31 and a third bubble sensor 32; the first bubble sensor 30, the second bubble sensor 31 and the third bubble sensor 32 are used to monitor the flow direction of the pipeline in the liquid circuit unit. The first bubble sensor 30 is installed in the pipeline connected to the cleaning liquid bag 23, the culture medium liquid bag 24, the spare liquid bag 25, and the final product bag 26; the second bubble sensor 31 is installed in the pipeline connected to the primary product bag 27, the intermediate product bag, the separation liquid bag 28 and the sample liquid bag 29; the third bubble sensor 32 is installed in the pipeline connected to the first liquid inlet 17 of the centrifuge cup 3.

[0059] In order to accurately control the liquid temperature, inlet and outlet quality in the centrifuge cup 3, the above-mentioned cell separation device also includes a temperature control module installed in the centrifugal bin 4 and a weighing unit 40 installed in the frame 2; the temperature control module can adopt a semiconductor thermoelectric cooling device, which can realize temperature control in the range of 4°C to 40°C in the bin, and the control error is less than 1°C, and the preferred temperature is 5±1°C to ensure the biological activity of the cells; the weighing unit 40 can realize real-time monitoring of the weight of the liquid bag in the frame 2, and the measurement error is less than 1g.

[0060] like Figure 1 As shown, the host control unit 1 may include a control panel 13 and a touch screen 14, through which input and output control and display can be realized; the control panel 13 is provided with a control button 56 for controlling the pump assembly 10 and the valve assembly; the control panel 13 and the touch screen 14 are both connected to the weighing unit, the temperature control module, the drive motor, the pump assembly 10 and the valve assembly signal. Figure 1 As shown in the structure, a display switch 41 for controlling the touch screen 14 is also provided on the side of the host control unit 1. In order to facilitate the hanging of the liquid bag, a plurality of hooks 42 are also provided on the top of the frame 2. The host control unit 1 can independently control the operation of each unit and its process parameters through the control program and the touch screen 14, such as: the volume and path of the inlet and outlet samples, the centrifugal speed, acceleration, time of the driving motor, the mixing speed, intensity, etc.

[0061] For the convenience of explanation, Figure 2 As shown, the valve assembly may include a first control valve 43, a second control valve 44, a third control valve 45, a fourth control valve 46, a fifth control valve 47, a sixth control valve 48, a seventh control valve 49, an eighth control valve 50, a ninth control valve 51, a tenth control valve 52, an eleventh control valve 53, a twelfth control valve 54 and a thirteenth control valve 55; the pipeline includes a first pipeline 33, a second pipeline 35 and a third pipeline 57; wherein:

[0062] The first pipeline 33 is used to connect the centrifuge cup 3 with the primary product bag 27, the centrifuge cup 3 with the separation liquid bag 28, and the centrifuge cup 3 with the sample liquid bag 29. A fifth control valve 47 is provided between the primary product bag 27 and the first pipeline 33; a sixth control valve 48 is provided between the separation liquid bag 28 and the first pipeline 33; a seventh control valve 49 is provided between the sample liquid bag 29 and the first pipeline 33; the first pipeline 33 is connected to the centrifuge cup 3 through the first branch pipeline 58 and the second branch pipeline 59, and the first branch pipeline 58 and the second branch pipeline 59 partially overlap, that is, the first branch pipeline 58 and the second branch pipeline 59 overlap at both ends of the pump assembly 10 and merge into the same main pipeline; the first branch pipeline 58 is installed with a thirteenth control valve 55 for connecting the pump assembly 10 with the inlet flow channel 7 of the centrifuge cup 3; the second branch pipeline 59 is installed with a tenth control valve 52 for connecting the pump assembly 10 with the outlet flow channel 8 of the centrifuge cup 3;

[0063] The second pipeline 35 is used to connect the pump assembly 10 with the cleaning liquid bag 23, the pump assembly 10 with the culture medium bag 24, the pump assembly 10 with the spare liquid bag 25, and the pump assembly 10 with the final product bag 26. A first control valve 43 is installed between the cleaning liquid bag 23 and the second pipeline 35, a second control valve 44 is installed between the culture medium bag 24 and the second pipeline 35, a third control valve 45 is installed between the spare liquid bag 25 and the second pipeline 35, and a fourth control valve 46 is installed between the final product bag 26 and the second pipeline 35; the second The pipeline 35 also includes a third branch pipeline 60 and a fourth branch pipeline 61, wherein the third branch pipeline 60 is used to connect the first port 34 of the pump assembly 10 with the cleaning liquid bag 23, the culture medium bag 24, the spare liquid bag 25, and the final product bag 26, and the eighth control valve 50 is installed in the third branch pipeline 60; the fourth branch pipeline 61 is used to connect the second port 36 of the pump assembly 10 with the cleaning liquid bag 23, the culture medium bag 24, the spare liquid bag 25, and the final product bag 26, and the ninth control valve 51 is installed in the fourth branch pipeline 61;

[0064] The third pipeline 57 is used to connect the pump assembly 10 with the waste liquid bag 22. The third pipeline 57 may include a fifth branch pipeline 62 and a sixth branch pipeline 63, wherein one end of the fifth branch pipeline 62 and one end of the sixth branch pipeline 63 are both connected to the waste liquid bag 22, the other end of the fifth branch pipeline 62 is connected to the first port 34 of the pump assembly 10, and the other end of the sixth branch pipeline 63 is connected to the second port 36 of the pump assembly 10, and an eleventh control valve 53 is installed in the fifth branch pipeline 62, and a twelfth control valve 54 is installed in the sixth branch pipeline 63.

[0065] Embodiment 2

[0066] This embodiment provides a cell separation method of a cell separation device, such as Figure 5As shown, the sorting method comprises the following steps:

[0067] Step S10, the separation liquid and the liquid to be separated flow into the centrifuge cup 3 through the pipeline, and the first cell centrifugation treatment is performed through the centrifuge cup 3, and the pipeline is cleaned during the first cell centrifugation treatment; the separation liquid and the liquid to be separated flow into the centrifuge cup through the pipeline, and the first cell centrifugation treatment is performed through the centrifuge cup 3, specifically including:

[0068] The separation liquid flows into the centrifuge cup 3 through the first pipeline 33, and the centrifuge cup 3 is rotated at a first speed for a first predetermined time; the first pipeline 33 includes a first branch pipeline 58 and a second branch pipeline 59, and the first branch pipeline 58 and the second branch pipeline 59 partially overlap; the liquid to be separated flows into the centrifuge cup 3 through the second branch pipeline 59, and the centrifuge cup is rotated at a second speed for a second predetermined time.

[0069] Step S20, after cleaning the pipeline, extracting the primary product solution from the centrifugal cup 3, and pumping the extracted primary product solution into the primary product bag 27 through the pipeline; pumping the extracted primary product solution into the primary product bag 27 through the pipeline, including:

[0070] The rotation speed of the centrifugal cup 3 is maintained at the third rotation speed, and the primary product solution is extracted from the liquid outlet channel 8 in the centrifugal cup 3 through the valve assembly and the pump assembly 10, and flows into the primary product bag 27 through the first branch pipeline 58.

[0071] Step S30, discharging the solution remaining in the centrifuge cup 3 after extraction, and cleaning the centrifuge cup 3;

[0072] Step S40, the primary product solution in the primary product bag 27 flows into the cleaned centrifuge cup 3 through the pipeline, and performs a second cell centrifugation treatment to obtain a concentrated solution, specifically comprising:

[0073] The primary product solution in the primary product bag 27 flows into the cleaned centrifugal cup 3 through the second branch pipe 59, and the cleaning solution flows into the primary product bag 27 through the valve assembly and the pump assembly 10 for solution cleaning treatment, and the solution after solution cleaning flows into the centrifugal cup 3 through the second branch pipe 59;

[0074] After the preset volume of cleaning liquid flows into the centrifugal cup 3, the centrifugal cup 3 is subjected to the second cell centrifugation treatment, and the waste liquid is discharged to obtain a concentrated solution. The second cell centrifugation treatment is a treatment process of discharging the waste liquid through the liquid outlet channel at different speeds.

[0075] Step S50, performing preparation treatment on the concentrated solution to obtain a final product solution, and packing the final product solution into a plurality of final product bags 26. When packing the final product solution into a plurality of final product bags 26, specifically including:

[0076] The final product solution is switched in a closed manner and dispensed into a plurality of final product bags 26 through a liquid path switching device.

[0077] The above-mentioned cell separation method completes the first cell centrifugation treatment, extraction of primary product solution, waste discharge treatment, second cell centrifugation treatment and preparation treatment steps through a cell separation device. Through the reasonable arrangement of each step and the cooperation of the above-mentioned cell separation device, not only the cell separation process is fully automatic and fully closed, but also the cell recovery efficiency and biological activity are improved.

[0078] The specific operation process of the above cell separation method can be carried out by the following steps:

[0079] The first step is to install the centrifugal cup 3, the liquid bag and the sterile catheter, install the centrifugal cup 3 in the centrifugal chamber 4 of the base 1, hang the liquid bag on the frame 2, and connect the centrifugal cup 3, the pump assembly 10, the liquid bag and the bubble sensor through the sterile catheter, close each control valve, keep each control valve in a normally closed state, and make each sterile catheter in a disconnected state;

[0080] The second step is to inject the sample. The pump assembly 10, the sixth control valve 48 and the thirteenth control valve 55 are turned on to allow the separation liquid of the preset volume in the separation liquid bag 28 to enter the centrifugal cup 3 through the sixth control valve 48, the first pipeline 33, the pump assembly 10, the first branch pipeline 58, the thirteenth control valve 55 and the liquid outlet flow channel 8. The pump assembly 10, the sixth control valve 48 and the thirteenth control valve 55 are turned off. The driving motor drives the centrifugal cup 3 to centrifugally rotate at a first speed for a first predetermined time. The first speed can be set according to demand, such as a range of 2000 rpm to 3500 rpm. The first predetermined time can be set according to the demand, such as 5s or 10s; the pump assembly 10, the seventh control valve 49, and the tenth control valve 52 are opened to introduce the cell sample solution, and the 25ml-120ml cell sample in the sample liquid bag 29 enters the centrifugal cup 3 through the seventh control valve 49, the first pipeline 33, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52, and the liquid inlet channel 7; the pump assembly 10, the seventh control valve 49, and the tenth control valve 52 are closed, and the centrifugal cup 3 maintains the first speed and centrifuges for the second predetermined time, which can be 240s;

[0081] The third step is to clean the liquid circuit unit. The pump assembly 10, the first control valve 43, the eighth control valve 50 and the seventh control valve 49 are opened to allow the cell cleaning solution in the range of 15ml to 20ml in the cleaning liquid bag 23 to enter the sample liquid bag 29 through the first control valve 43, the second pipeline 35, the third branch pipeline 60, the eighth control valve 50, the pump assembly 10, the first pipeline 33, and the seventh control valve 49. The pump assembly 10, the first control valve 43, the eighth control valve 50 and the seventh control valve 49 are closed. The pump assembly 10, the first control valve 43, the ninth control valve 51 and the tenth control valve 52 are opened to allow the cell cleaning solution in the range of 20ml to 30ml in the cleaning liquid bag 23 to enter the centrifuge cup 3 through the first control valve 43, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the pump assembly 10, the tenth control valve 52 and the liquid inlet channel 7. The pump assembly 10, the first control valve 43, the ninth control valve 51 and the tenth control valve valve 52; open the pump assembly 10, the first control valve 43, the ninth control valve 51 and the eleventh control valve 53, so that 5ml to 20ml of the cell washing solution in the washing solution bag 23 enters the waste liquid bag 22 through the first control valve 43, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the pump assembly 10, the fifth branch pipeline 62, and the eleventh control valve 53, and close the pump assembly 10, the first control valve 43, the ninth control valve 51 and the eleventh control valve 53. 3; open the pump assembly 10, the first control valve 43, the ninth control valve 51 and the twelfth control valve 54, so that 10ml to 30ml of the cell washing solution in the washing solution bag 23 enters the waste liquid bag 22 through the first control valve 43, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the pump assembly 10, the sixth branch pipeline 63, and the twelfth control valve 54, and close the pump assembly 10, the first control valve 43, the ninth control valve 51 and the twelfth control valve 54;

[0082] Step 4: Sample discharging of the initial product. The first speed of the driving motor is reduced to a second speed, which may be a speed in the range of 1500 rpm to 3500 rpm. The first speed and the second speed may be the same or different. Sample discharging is started while maintaining the second predetermined time. The tenth control valve 52 and the fifth control valve 47 are opened, and the pump assembly 10 is controlled to reverse. 80 ml to 100 ml of PBMC (Peripheral blood mononuclear cell) solution in the centrifugal cup 3 is sampled to the initial product bag 27 through the liquid inlet channel 7, the second branch pipeline 59, the tenth control valve 52, the first pipeline 33, the pump assembly 10, and the fifth control valve 47. The pump assembly 10, the tenth control valve 52, and the fifth control valve 47 are closed, and the centrifugal cup 3 stops rotating.

[0083] Step 5: Clean the centrifugal cup 3 and the liquid circuit unit, open the pump assembly 10, the tenth control valve 52 and the twelfth control valve 54, and introduce the waste liquid in the centrifugal cup 3 into the waste liquid bag 22 through the liquid inlet channel 7, the second branch pipeline 59, the tenth control valve 52, the first pipeline 33, the pump assembly 10, the sixth branch pipeline 63, and the twelfth control valve 54, and close the pump assembly 10, the tenth control valve 52 and the twelfth control valve 54; open the pump assembly 10, the first control valve 43, the eighth control valve 50 and the twelfth control valve 54, and introduce all the waste liquid in the pipeline into the waste liquid bag 22, and close the pump assembly 10, the first control valve 43, the eighth control valve 50 and the twelfth control valve 54; clean the centrifugal cup 3, open the pump assembly 10, the first control valve 43, the ninth control valve 51 and the tenth control valve 52, so that 180ml to 200ml of cell cleaning solution in the cleaning liquid bag 23 enters the centrifugal cup 3 through the first control valve 43, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52, and the liquid inlet channel 7, and close the pump assembly 10, the first control valve 43, the ninth control valve 51 and the tenth control valve 52; clean the liquid outlet channel 8 of the centrifugal cup 3, open the pump assembly 10, the first control valve 43, the ninth control valve 51 and The thirteenth control valve 55 allows 30ml to 40ml of cell washing solution in the washing solution bag 23 to enter the centrifugal cup 3 through the first control valve 43, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the pump assembly 10, the first pipeline 33, the thirteenth control valve 55, the first branch pipeline 58, and the liquid outlet channel 8, and closes the pump assembly 10, the first control valve 43, the ninth control valve 51 and the thirteenth control valve 55; opens the pump assembly 10, the tenth control valve 52 and the twelfth control valve 54, and allows the solution in the centrifugal cup 3 to enter the centrifugal cup 3 through the liquid inlet channel 7, the second branch pipeline 59, the tenth control valve 52, the first pipeline 33, the sixth branch pipeline 58, and the liquid outlet channel 8. The pipeline 63 and the twelfth control valve 54 are all discharged to the waste liquid bag 22, and the pump assembly 10, the tenth control valve 52 and the twelfth control valve 54 are closed; the pump assembly 10, the first control valve 43, the ninth control valve 51 and the eleventh control valve 53 are opened, and 10ml to 20ml of the cell washing liquid in the washing liquid bag 23 are discharged into the waste liquid bag 22, the ninth control valve 51 and the eleventh control valve 53 are closed, the eighth control valve 50 and the twelfth control valve 54 are opened, and 20ml to 30ml of the cell washing liquid in the washing liquid bag 23 are discharged into the waste liquid bag 22, and the pump assembly 10, the first control valve 43, the eighth control valve 50 and the twelfth control valve 54 are closed;

[0084] Step 6: Initial product cleaning. Open the pump assembly 10, the fifth control valve 47 and the tenth control valve 52 to transport all samples in the initial product bag 27 to the centrifuge cup 3 through the first pipeline 33, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52 and the liquid inlet channel 7. Close the pump assembly 10, the fifth control valve 47 and the tenth control valve 52. Open the pump assembly 10, the first control valve 43, the eighth control valve 50 and the fifth control valve 47 to allow 90ml to 100ml of cell cleaning solution in the cleaning solution bag 23 to pass through the first control valve 43, the second pipeline 35, the third branch pipeline 60, the eighth control valve 50, the pump assembly 10, the first pipeline 33, the second branch pipeline 59, the eighth control valve 52 and the liquid inlet channel 7. The first control valve 43 and the fifth control valve 47 are connected to the primary product bag 27, and the pump assembly 10, the first control valve 43, the eighth control valve 50 and the fifth control valve 47 are closed; the pump assembly 10, the fifth control valve 47 and the tenth control valve 52 are opened, and all the samples in the primary product bag 27 are transported to the centrifugal cup 3 through the fifth control valve 47, the first pipeline 33, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52 and the liquid inlet flow channel 7, and the pump assembly 10, the fifth control valve 47 and the tenth control valve 52 are closed; the pump assembly 10, the first control valve 43, the ninth control valve 51 and the tenth control valve 52 are opened, and 180ml to 200ml of the cleaning liquid in the cleaning liquid bag 23 are transferred to the centrifugal cup 3 through the fifth control valve 47, the first pipeline 33, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52 and the liquid inlet flow channel 7. ml of cell washing liquid is delivered to the centrifugal cup 3 through the first control valve 43, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52, and the liquid inlet channel 7, and the pump assembly 10, the first control valve 43, the ninth control valve 51 and the tenth control valve 52 are closed; the centrifugal cup 3 is controlled to rotate at a first speed by a driving motor, and the first speed can be a speed within the range of 2000 rpm to 3500 rpm, and maintained for a third predetermined time, which can be 300s, and the first centrifugal washing is started; the first speed is maintained to start automatic waste liquid discharge, and the pump assembly 1 is opened. 0, the tenth control valve 52 and the twelfth control valve 54, the solution in the centrifugal cup 3 is discharged to the waste liquid bag 22 through the liquid inlet flow channel 7, the second branch pipeline 59, the tenth control valve 52, the first pipeline 33, the pump assembly 10, the sixth branch pipeline 63, and the twelfth control valve 54, and then reduced to a third speed and discharged waste liquid, the third speed can be 1000rpm to 2000rpm, and finally reduced to a fourth speed and continued to discharge waste liquid, the fourth speed can be a speed in the range of 300 to 600rpm, maintained for a fourth predetermined time, the fourth predetermined time can be 320s, and the pump assembly 10, the tenth control valve 52 and the twelfth control valve 54 are closed;Open the pump assembly 10, the second control valve 44, the ninth control valve 51 and the tenth control valve 52, and deliver 200 ml of the culture medium solution in the culture medium bag 24 to the centrifugal cup 3 through the second control valve 44, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the first pipeline 33, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52, and the liquid inlet channel 7, and close the pump assembly 10, the second control valve 44, the ninth control valve 51 and the tenth control valve 52; adjust the speed of the centrifugal cup 3 to the first speed, maintain it for the second predetermined time, and perform the second centrifugal cleaning;

[0085] The seventh step is concentration. The centrifugal cup 3 is kept rotating at the first speed. The pump assembly 10, the tenth control valve 52 and the twelfth control valve 54 are opened. The solution in the centrifugal cup 3 is discharged to the waste liquid bag 22 through the liquid inlet channel 7, the second branch pipeline 59, the tenth control valve 52, the first pipeline 33, the pump assembly 10, the sixth branch pipeline 63 and the twelfth control valve 54. Then, the speed of the centrifugal cup 3 is reduced to the third speed to discharge the waste liquid, and finally reduced to the fourth speed to continue to discharge the waste liquid, and maintained for the fifth predetermined time, which can be 480s. When the third bubble sensor 32 detects bubbles, the centrifugal cup 3 is centrifuged for 30s and the rotation is stopped;

[0086] Step 8, preparation, open the pump assembly 10, the second control valve 44, the ninth control valve 51 and the tenth control valve 52, and deliver 200 ml of the culture medium solution in the culture medium bag 24 to the centrifugal cup 3 through the second control valve 44, the second pipeline 35, the fourth branch pipeline 61, the ninth control valve 51, the first pipeline 33, the pump assembly 10, the second branch pipeline 59, the tenth control valve 52, and the liquid inlet channel 7, and close the pump assembly 10, the second control valve 44, the ninth control valve 51 and the tenth control valve 52 to mix the centrifugal cup 3 by forward and reverse rotation;

[0087] The ninth step is to pack the product. The driving motor is started to increase the speed of the centrifugal cup 3 to 30-80 rpm. The pump assembly 10, the tenth control valve 52, the ninth control valve 51 and the fourth control valve 46 are opened to sequentially deliver the final product sample in the centrifugal cup 3 to the final product bag 26 through the liquid inlet channel 7, the second branch pipeline 59, the tenth control valve 52, the first pipeline 33, the pump assembly 10 and the fourth control valve 46. The pump assembly 10, the tenth control valve 52, the ninth control valve 51 and the fourth control valve 46 are closed. Finally, Start the first bubble sensor 30 and the third bubble sensor 32 to automatically collect the remaining final product solution, open the pump assembly 10, the tenth control valve 52, the ninth control valve 51 and the third control valve 45, and put the final product sample in the centrifuge cup 3 into the spare liquid bag 25 through the liquid inlet channel 7, the second branch pipeline 59, the tenth control valve 52, the first pipeline 33, the pump assembly 10, and the third control valve 45, and then close the pump assembly 10, the tenth control valve 52, the ninth control valve 51 and the third control valve 45. When it is necessary to pack multiple final product bags 26, the switching device can be used to realize the sequential switching and packing of multiple final product bags 26. The switching device can be a control device containing a three-way valve, or a control device through heat sealing and plugging, such as: the final product bag 26 can be connected to the pipeline above the fourth control valve 46 through a sterile pipe connection machine.

[0088] By adopting the sorting method of the above-mentioned cell separation device, the structure of the liquid pushing plate 6 is arranged in the centrifuge cup 3 to avoid shear damage to the cells, shorten the separation time, and improve the separation efficiency, which is shortened from the separation time of 15 minutes in the prior art to 5 minutes. The problem of low cell separation efficiency in the prior art is solved, and low-damage, high-throughput, high-efficiency, and high-recovery cell separation is achieved.

[0089] Obviously, those skilled in the art can make various changes and modifications to the embodiments of the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A cell separation device, characterized in that: include: The centrifuge cup is installed in the centrifugal chamber, and includes a liquid inlet flow channel and a liquid outlet flow channel, and is used for performing the first cell centrifugation treatment, extracting the initial product solution, discharging waste, the second cell centrifugation treatment and the preparation treatment; the liquid inlet flow channel is a channel for flowing into the centrifuge cup; the liquid outlet flow channel is a channel for extracting the solution from the centrifuge cup; A liquid circuit unit, comprising a pump assembly, a valve assembly and a pipeline, for supplying and extracting liquid from the centrifuge cup, and dispensing liquid into a plurality of final product bags; the pump assembly and the valve assembly are in the pipeline path; A host control unit includes a drive motor, a waste liquid tank and the centrifugal chamber, is connected to the pump assembly and the valve assembly, and controls the drive motor, the pump assembly and the valve assembly; the drive motor is in driving connection with the centrifugal cup, and is used to rotate the centrifugal cup to achieve the first cell centrifugation treatment, extraction of the initial product solution, waste discharge treatment, the second cell centrifugation treatment and preparation treatment; the waste liquid tank is used to collect the solution after cleaning and waste discharge; The frame is fixedly mounted on the top of the host control unit and is used to hang separation liquid bags containing separation liquid, sample liquid bags containing liquid to be separated, cleaning liquid bags containing cleaning liquid, initial product bags and final product bags; the cleaning liquid is used for cleaning during the cell separation process.

2. The cell separation device according to claim 1, characterized in that: The centrifugal cup further comprises a liquid pushing plate, which extends from the center of the centrifugal cup in a radial direction, and a gap is formed between an end of the liquid pushing plate away from the axis and an inner wall of the centrifugal cup.

3. The cell separation device according to claim 2, characterized in that: The centrifugal cup also includes a cup body and a cup cover; The liquid pushing plate is fixedly connected to the cup body and / or the cup cover; The cup cover is sealed and connected to the top of the cup body, and a centrifugal cavity is formed between the cup cover and the cup body; The liquid pushing plate is distributed in the centrifugal chamber along the circumference of the cup body, and there is a gap between the other end of the liquid pushing plate adjacent to the axis and the axis of the cup body; The liquid inlet channel and the liquid outlet channel are both connected to the outside of the cup body and the centrifugal chamber; the liquid inlet channel has a first liquid inlet arranged on the outside of the cup body and / or a second liquid inlet arranged at the bottom of the inner wall of the cup body; the liquid outlet channel has a first liquid outlet arranged at the top of the centrifugal chamber and / or a second liquid outlet arranged at the top of the side wall of the cup body.

4. The cell separation device according to claim 3, characterized in that: A chamfer of 5° to 50° is formed between the side wall and the bottom wall of the cup body.

5. The cell separation device according to any one of claims 1 to 4, characterized in that: The liquid circuit unit further includes a liquid circuit switching device, which is used to perform closed switching of the final product solution and to dispense the solution into a plurality of the final product bags; The liquid circuit unit further includes a first bubble sensor, a second bubble sensor and a third bubble sensor; the first bubble sensor, the second bubble sensor and the third bubble sensor are used to monitor the flow direction of the pipeline in the liquid circuit unit.

6. A cell separation method using the cell separation device according to any one of claims 1 to 5, characterized in that: include: The separation liquid and the liquid to be separated flow into the centrifuge cup through the pipeline, and the first cell centrifugation treatment is performed through the centrifuge cup, and the pipeline is cleaned during the first cell centrifugation treatment; After cleaning the pipeline, extracting the primary product solution from the centrifuge cup, and pumping the extracted primary product solution into the primary product bag through the pipeline; Discharging the solution remaining in the centrifuge cup after extraction and cleaning the centrifuge cup; The primary product solution in the primary product bag flows into the cleaned centrifuge cup through a pipeline, and performs a second cell centrifugation treatment to obtain a concentrated solution; The concentrated solution is subjected to formulation treatment to obtain a final product solution, and the final product solution is packaged into a plurality of final product bags.

7. The cell separation method according to claim 6, characterized in that The step of flowing the separation liquid and the liquid to be separated into a centrifuge cup through a pipeline, and performing a first cell centrifugation treatment through the centrifuge cup, comprises: The separation liquid flows into the centrifugal cup through the first pipeline, and the centrifugal cup is rotated at a first speed for a first predetermined time; the first pipeline includes a first branch pipeline and a second branch pipeline, and the first branch pipeline and the second branch pipeline partially overlap; The liquid to be separated flows into the centrifuge cup through the second branch pipeline, and the centrifuge cup is rotated at a second rotation speed for a second predetermined time.

8. The cell separation method according to claim 6, characterized in that: The step of pumping the extracted primary product solution into the primary product bag via a pipeline comprises: The rotation speed of the centrifugal cup is maintained at a third rotation speed, and the primary product solution is extracted from the liquid outlet channel in the centrifugal cup through the valve assembly and the pump assembly, and flows into the primary product bag through the first branch pipeline.

9. The cell separation method according to claim 6, characterized in that: The process of flowing the primary product solution in the primary product bag into the cleaned centrifuge cup through a pipeline and performing a second cell centrifugation treatment to obtain a concentrated solution comprises: The primary product solution in the primary product bag flows into the cleaned centrifugal cup through the second branch pipeline, and the cleaning solution flows into the primary product bag through the valve assembly and the pump assembly for solution cleaning treatment, and the solution after solution cleaning flows into the centrifugal cup through the second branch pipeline; After a preset volume of cleaning solution flows into the centrifuge cup, the centrifuge cup is subjected to the second cell centrifugation treatment, and waste liquid is discharged to obtain the concentrated solution.

10. The cell separation method according to claim 9, characterized in that: The step of packaging the final product solution into a plurality of final product bags comprises: The final product solution is switched in a closed manner and dispensed into a plurality of final product bags through a liquid path switching device.

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