Method and device for dispensing a cell preparation

Abstract

This invention discloses a method and apparatus for dispensing cell preparations. The dispensing method includes: sequentially connecting an injection device, a final product bag, and a cryopreservation assembly via a control valve; closing three ports of the control valve before starting the injection device; controlling the injection device to perform pre-treatment of venting and vacuuming; controlling the injection device to start and extract the cell preparation from the final product bag according to a predetermined target cell preparation volume; and controlling the injection device to inject the extracted cell preparation into the cryopreservation assembly to complete the dispensing process. This invention achieves precise controlled dispensing of cell preparations through an injection device. Combined with the control valve, the connection status of each pipeline can be easily controlled. The overall structure is simple and reliable. Compared to manual dispensing, it not only achieves higher dispensing accuracy but also significantly improves dispensing efficiency and consistency.

Description

Technical Field

[0001] This invention relates to the field of biomedical device technology, and in particular to a method and apparatus for dispensing cell preparations. Background Technology

[0002] Existing cell preparation filling equipment relies heavily on manual operation and involves cumbersome installation procedures, resulting in low volumetric accuracy. Furthermore, due to manual operation, maintaining consistent volume across multiple filling processes is difficult, leading to low consistency and consequently reducing the efficiency and accuracy of cell preparation filling. Summary of the Invention

[0003] In view of the above problems, the present invention is proposed to provide a method and apparatus for dispensing cell preparations that overcomes or at least partially solves the above problems.

[0004] Other features and advantages of the invention will become apparent from the following detailed description, or may be learned in part by practice of the invention.

[0005] According to a first aspect of the present invention, a method and apparatus for dispensing cell preparations are provided. The method and apparatus for dispensing cell preparations include: sequentially connecting an injection device, a final product bag, and a cryopreservation component through a control master valve; and closing three valve ports of the control master valve before the injection device is started, namely a first control valve connected to the injection device, a second control valve connected to the final product bag, and a third control valve connected to the cryopreservation component. Open the first control valve and the third control valve to control the injection device to perform exhaust and vacuum pretreatment. After the pretreatment is completed, close the third control valve. The second control valve is opened, and the injection device is controlled to start and extract the cell preparation from the final product bag according to the predetermined target cell preparation capacity. After the cell preparation capacity extracted by the injection device reaches the target cell preparation capacity, the second control valve is closed, wherein the target cell preparation capacity is not less than the storage capacity of the cryopreservation component. Open the third control valve to control the injection device to inject the extracted cell preparation into the cryopreservation component, completing the dispensing process.

[0006] In some embodiments of the present invention, the cryopreservation component is an N-cell cryopreservation bag or m parallel independent cryopreservation bags, wherein the m parallel independent cryopreservation bags are respectively connected to a multi-way stopcock valve and a switching device, and N and m are both positive integers.

[0007] In some embodiments of the present invention, when the cryopreservation component is an N-cell cryopreservation bag, the method includes: After the cell preparation injection operation is performed and the injection device is started, the extracted cell preparation is injected into the N-cell cryopreservation bag. After the cell preparation fills the N-cell cryopreservation bag, the third control valve is closed. The N-cell cryopreservation bag is heat-sealed and replaced with a new N-cell cryopreservation bag. The third control valve is then opened, and the aforementioned cell preparation injection operation is repeated.

[0008] In some embodiments of the present invention, the method further includes: connecting an air filter with a tube clamp to the N-cell cryopreservation bag; controlling the tube clamp to open and connect to the air filter during the pre-treatment of venting and vacuuming of the injection device; and closing the tube clamp after performing the cell preparation injection operation.

[0009] In some embodiments of the present invention, when the cryopreservation assembly consists of m independent cryopreservation bags connected in parallel, the method includes: Open the third control valve to perform the cell preparation injection operation. After the injection device is started, open the multi-port stopcock valve corresponding to the first independent cryopreservation bag at the injection station near the third control valve to inject the extracted cell preparation into the first independent cryopreservation bag. After the first independent cryopreservation bag is filled, close the multi-port stopcock valve. Perform the sequence adjustment operation, control the switching device to adjust the order of each independent cryopreservation bag, switch the new independent cryopreservation bag to the injection station near the third control valve, open the multi-port stopcock valve corresponding to the new independent cryopreservation bag, perform the cell preparation injection operation, and close the multi-port stopcock valve after the new independent cryopreservation bag is filled. Repeat the sequential adjustment and cell preparation injection operations until all individual cryopreservation bags are filled with cell preparation.

[0010] In some embodiments of the present invention, a quality inspection bag is connected to m parallel independent cryopreservation bags, and a peristaltic pump is connected to the main control valve. The method further includes: After all the individual cryopreservation bags are filled with cell preparation, the second control valve is closed, the injection device is started and the remaining cell preparation in the injection device is discharged and fed into the quality inspection bag and the pipeline connected to the quality inspection bag. After the injection device has been emptied, the first control valve is closed; Start the peristaltic pump to input all the residual cell preparations in the tubing connected to the quality inspection bag into the quality inspection bag.

[0011] In some embodiments of the present invention, the exhaust and vacuum pretreatment further includes: opening the second control valve, starting the injection device and venting the airflow in the injection device into the final product bag, so that the cell preparation in the final product bag is mixed evenly.

[0012] In some embodiments of the present invention, the method further includes: fitting a closed sterile sleeve over the outer side of the rear end of the injection device, wherein when the injection device is started, the sterile sleeve maintains a sterile environment for the air in the outer space of the injection device.

[0013] In some embodiments of the present invention, the method further includes: when a leak alarm is detected in the pipeline before the dispensing process is completed, performing heat sealing on the cryopreservation bags in the already dispensed cryopreservation components.

[0014] According to a first aspect of the present invention, a cell preparation dispensing apparatus is provided, which is applied to the cell preparation dispensing method described in any of the above claims. The cell preparation dispensing apparatus includes: a control valve, an injection device, a final product bag, and a cryopreservation assembly, wherein the injection device, the final product bag, and the cryopreservation assembly are respectively connected to the control valve. The main control valve includes three valve ports: a first control valve connected to the injection device, a second control valve connected to the final product bag, and a third control valve connected to the cryopreservation component. The cryopreservation assembly is an N-cell cryopreservation bag or m parallel independent cryopreservation bags, wherein the m parallel independent cryopreservation bags are respectively connected to a multi-way stopcock valve and a switching device, and N and m are both positive integers.

[0015] The technical solutions provided in the embodiments of the present invention have at least the following technical effects or advantages: The cell preparation dispensing method described in this embodiment of the invention achieves precise control and dispensing of cell preparations through an injection device. With the help of a control valve, the connection status of each pipeline can be easily controlled. The overall structure is simple and reliable. Compared with manual dispensing, it not only has higher dispensing accuracy but also significantly improves dispensing efficiency and enhances dispensing consistency.

[0016] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention are described below. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 A schematic flowchart of a cell preparation dispensing method provided in an embodiment of the present invention; Figure 2 A schematic diagram of the principle structure of a cell preparation dispensing device provided in an embodiment of the present invention; Figure 3 A schematic diagram of the principle structure when the cryopreservation component is an N-cell cryopreservation bag; Figure 4 This is a schematic diagram illustrating the principle structure when the cryopreservation component consists of m independent cryopreservation bags connected in parallel.

[0019] Explanation of reference numerals in the attached figures: 1. Injection device; 2. Sterile sleeve; 3. Main control valve; 4. Final product bag; 5. Cryopreservation assembly; 6. Peristaltic pump; 31. First control valve; 32. Second control valve; 33. Third control valve. Detailed Implementation

[0020] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings.

[0021] The accompanying drawings illustrate various structural schematics according to embodiments of the present disclosure. These drawings are not to scale, and some details have been enlarged for clarity, and some details may have been omitted. The shapes of the various regions and layers shown in the drawings, as well as their relative sizes and positional relationships, are merely exemplary and may deviate from reality due to manufacturing tolerances or technical limitations. Furthermore, those skilled in the art can design regions / layers with different shapes, sizes, and relative positions as needed.

[0022] In the context of this disclosure, when a layer / component is referred to as being "above" another layer / component, that layer / component may be directly above the other layer / component, or there may be an intermediate layer / component between them. Additionally, if a layer / component is "above" another layer / component in one orientation, then when the orientation is reversed, that layer / component may be "below" the other layer / component. In the context of this disclosure, similar or identical components may be denoted by the same or similar reference numerals.

[0023] To better understand the above technical solutions, the following will describe the above technical solutions in detail with reference to specific implementation methods. It should be understood that the embodiments of this disclosure and the specific features in the embodiments are detailed descriptions of the technical solutions of the present invention, rather than limitations on the technical solutions of the present invention. In the absence of conflict, the embodiments of the present invention and the technical features in the embodiments can be combined with each other.

[0024] Figure 1 This is a schematic flowchart of a cell preparation dispensing method provided in an embodiment of the present invention, as shown below. Figure 1 As shown, the dispensing method for this cell preparation includes the following steps: S1. The injection device 1, the final product bag 4, and the cryopreservation component 5 are connected sequentially by the main control valve 3. Before the injection device 1 is started, the three valve ports of the main control valve 3 are closed, namely the first control valve 31 connected to the injection device 1, the second control valve 32 connected to the final product bag 4, and the third control valve 33 connected to the cryopreservation component 5. Combination Figure 2 As shown, in this embodiment of the invention, the injection device 1, the final product bag 4, and the cryopreservation component 5 are respectively connected to the main control valve 3. The main control valve 3 includes three valve ports: a first control valve 31 connected to the injection device 1, a second control valve 32 connected to the final product bag 4, and a third control valve 33 connected to the cryopreservation component 5. By controlling the opening and closing of the first control valve 31, the connection state of the injection device 1 can be controlled accordingly. By controlling the opening and closing of the second control valve 32, the connection state of the final product bag 4 can be controlled accordingly. By controlling the opening and closing of the third control valve 33, the connection state of the cryopreservation component 5 can be controlled accordingly.

[0025] The injection device 1 is a syringe with a stepper motor. The stepper motor can control the position of the syringe plunger, thereby achieving stable control of the input and output of the preparation. The stroke of the syringe plunger is mapped to the volume and the plunger's moving speed. The reason why different speeds correspond to different mapping relationships is that during speed changes, the liquid will have inertia and produce slight movement when the plunger is in motion. However, this slight movement will cause deviations in the accurate dispensing of the liquid. Therefore, in order to improve dispensing accuracy and reduce the impact of movement and residue in the tubing, the following measures are taken.

[0026] The cryopreservation component 5 is an N-link cryopreservation bag or m parallel independent cryopreservation bags, wherein the m parallel independent cryopreservation bags are respectively connected to a multi-way stopcock valve and a switching device, and N and m are both positive integers.

[0027] The N-link cryopreservation bag is a cryopreservation bag with one inlet and outlet connecting multiple capacity bags. The capacity bags are connected to each other, and the connecting sections between the capacity bags are heat-sealed so that each capacity bag can be an independent unit.

[0028] S2. Open the first control valve 31 and the third control valve 33 to control the injection device 1 to perform exhaust and vacuum pretreatment. After the pretreatment is completed, close the third control valve 33. S3. Open the second control valve 32, and control the injection device 1 to start and extract the cell preparation from the final product bag 4 according to the predetermined target cell preparation capacity. After the cell preparation capacity extracted by the injection device 1 reaches the target cell preparation capacity, close the second control valve 32. The target cell preparation capacity is not less than the storage capacity of the cryopreservation component 5. S4. Open the third control valve 33 to control the injection device 1 to inject the extracted cell preparation into the cryopreservation component 5 to complete the dispensing process.

[0029] When the cell preparation to be dispensed is in a small volume, the embodiments of the present invention can use an N-cell cryopreservation bag as the cryopreservation component 5, specifically: Figure 3 This is a schematic diagram illustrating the principle structure of a cryopreservation unit consisting of an N-cell cryopreservation bag. Figure 3 As shown, when the cryopreservation component 5 is an N-cell cryopreservation bag, the embodiment of the present invention includes: performing a cell preparation injection operation; after controlling the injection device 1 to start, injecting the extracted cell preparation into the N-cell cryopreservation bag, filling the N-cell cryopreservation bag with the cell preparation, and then closing the third control valve 33; performing a heat-sealing treatment on the N-cell cryopreservation bag, replacing it with a new N-cell cryopreservation bag, opening the third control valve 33, and repeating the aforementioned cell preparation injection operation.

[0030] For example, in this embodiment of the invention, the movement of the syringe plunger is controlled by a stepper motor. This movement is after the pre-treatment of exhaust and vacuuming. The exhaust and vacuuming process is such that the plunger has reached the bottom, ensuring that there is no gas in the syringe. 5 ml of cell preparation from the final product bag 4 (the liquid volume in the syringe is controlled by the movement of the plunger, i.e., pulling the plunger to the 5 ml mark, the target cell preparation volume is 5 ml) is injected into the injection device 1. Then, 5 ml of cell preparation is injected into the N-cell cryopreservation bag (for example, the storage capacity of the N-cell cryopreservation bag is 5 ml). The 5 ml of cell preparation is evenly injected into each volume bag in the N-cell cryopreservation bag.

[0031] To improve injection efficiency and reduce injection pressure, this embodiment of the invention further includes: connecting an air filter with a tube clamp to the N-cell cryopreservation bag; controlling the tube clamp to open and connect with the air filter during the pre-treatment of exhaust and vacuuming of the injection device 1; and closing the tube clamp after performing the cell preparation injection operation; the tube clamp is used to control the connection status between the N-cell cryopreservation bag and the air filter.

[0032] When the cell preparation to be dispensed is in a large volume, this embodiment of the invention can use m parallel independent cryopreservation bags as cryopreservation component 5, specifically: Figure 4 This is a schematic diagram illustrating the principle structure when the cryopreservation component consists of m independent cryopreservation bags connected in parallel. Figure 4 As shown, when the cryopreservation component 5 consists of m independently cryopreservation bags connected in parallel, the method includes: Open the third control valve 33 to perform the cell preparation injection operation. After the injection device 1 is started, open the multi-port stopcock valve corresponding to the first independent cryopreservation bag at the injection station near the third control valve 33 to inject the extracted cell preparation into the first independent cryopreservation bag. After the first independent cryopreservation bag is filled, close the multi-port stopcock valve. The sequence adjustment operation is performed, the switching device is controlled to adjust the sequence of each independent cryopreservation bag, the new independent cryopreservation bag is switched to the injection station near the third control valve 33, the multi-port stopcock valve corresponding to the new independent cryopreservation bag is opened, the cell preparation injection operation is performed, and the multi-port stopcock valve is closed after the new independent cryopreservation bag is filled. Repeat the sequential adjustment and cell preparation injection operations until all individual cryopreservation bags are filled with cell preparation.

[0033] The switching device is a lead screw motor, which can switch and adjust the order of each independent cryopreservation bag, thereby switching the new independent cryopreservation bag to the injection station near the third control valve 33.

[0034] For example, open the third control valve 33 below the final product bag 4, and inject 21 mL of cell preparation (i.e., the target cell preparation volume) from the final product bag 4 into the injection device 1. The cryopreservation component 5 includes 20 parallel 1 mL independent cryopreservation bags, i.e., the storage capacity of the cryopreservation component 5 is 20 mL. Open the third control valve 33, and inject the extracted cell preparation into the first 1 mL independent cryopreservation bag. After the first independent cryopreservation bag is filled, close the multi-port stopcock valve, and then switch the next empty independent cryopreservation bag to the injection station near the third control valve 33. Repeat this operation until all 20 1 mL independent cryopreservation bags are filled.

[0035] In this embodiment of the invention, the number m of the independent cryopreservation bags and the storage capacity of each independent cryopreservation bag can be selected according to actual needs, as long as the capacity of the target cell preparation is not less than the storage capacity of the cryopreservation component 5.

[0036] In this embodiment of the invention, the purpose of ensuring that the target cell preparation capacity is not less than the storage capacity of the cryopreservation component 5 is that, during the process of injecting the cell preparation into the cryopreservation component 5, some cell preparation will exist in the transmission pipeline. Therefore, in order to ensure that the injection volume in the cryopreservation component 5 meets the requirements, the target cell preparation capacity should not be less than the storage capacity of the cryopreservation component 5.

[0037] To ensure complete drainage of the cell preparation in the delivery pipeline, this embodiment of the invention connects quality inspection bags to m parallel independent cryopreservation bags and installs a peristaltic pump 6 on the main control valve 3. The method further includes: After all the individual cryopreservation bags are filled with cell preparation, the second control valve 32 is closed, the injection device 1 is started and the remaining cell preparation in the injection device 1 is discharged and input into the quality inspection bag and the pipeline connected to the quality inspection bag. After the injection device 1 is emptied, the first control valve 31 is closed; Start the peristaltic pump 6 to input all the residual cell preparations in the tubing connected to the quality inspection bag into the quality inspection bag.

[0038] During the pretreatment of venting and vacuuming, the liquid pusher is pushed and pulled two or three times at full stroke to vent air bubbles in the pipeline; the embodiment of the present invention also includes: opening the second control valve 32, starting the injection device 1 and venting the airflow in the injection device 1 into the final product bag 4, so that the cell preparation in the final product bag 4 is mixed evenly.

[0039] Before opening the second control valve 32 to discharge the airflow in the injection device 1 into the final product bag 4, this embodiment of the invention can also first open the third control valve 33 to control the injection device 1 to extract the air bubbles in the cryopreservation device, and then close the third control valve 33 before opening the second control valve 32, thereby achieving better exhaust and vacuum pretreatment.

[0040] To ensure that the push-pull rod of the injection device 1 does not introduce external contaminated air sources during the push-pull process, the embodiment of the present invention further includes: a closed sterile sleeve 2 is fitted on the outer side of the rear end of the injection device 1, and when the injection device 1 is started, the sterile sleeve 2 maintains a sterile environment in the air in the outer space of the injection device 1.

[0041] Both during and after the dispensing process, the appearance of the product needs to be inspected to ensure that the cell preparation is leak-free. The embodiments of the present invention also include: before opening the second control valve 32 for vacuum pretreatment, the integrity of the final product bag 4 is checked, and after the dispensing process is completed and the third control valve 33 is closed, the integrity of the cryopreservation component 5 is checked.

[0042] In one embodiment, when a leak alarm is detected in the pipeline before the dispensing process is completed, the cryopreservation bags in the already dispensed cryopreservation component 5 are heat-sealed. This can be understood as the leak being detected by any pressure sensor installed in the cryopreservation component 5 during the dispensing process. The pressure sensor is typically located on the pipeline above the individual cryopreservation bags. Leaks usually occur at bifurcation points in the pipeline path because there are often adhesive connections at these points. Pressure after adhesive bonding can cause these weak points to rupture, forming leaks. Therefore, the pressure sensor is installed near the bifurcation point in the pipeline path between the cryopreservation bag and the injection device, i.e., on the pipeline above the individual cryopreservation bags. The leak is detected when the pressure of a particular pressure sensor is reached. When the detected pressure differs from that of other pressure sensors (or exceeds the deviation range), the location of the abnormal pressure sensor is identified, and a leakage alarm is triggered. The previously dispensed individual cryopreservation bags at that location are then heat-sealed. An automatic heat-sealing function is added to the control valve above the corresponding individual cryopreservation bag, directly heat-sealing the dispensed bags to prevent leakage contamination of the liquid within. If the liquid is cell fluid, this significantly reduces cell fluid loss, as cells are scarce for subsequent processing. Contamination during dispensing leads to waste of the entire liquid. Timely heat-sealing of the dispensed individual cryopreservation bags greatly protects the cell fluid available for subsequent processes.

[0043] The cell preparation dispensing method described in this embodiment of the invention achieves precise control and dispensing of cell preparations through the injection device 1. With the help of the control valve 3, the connection status of each pipeline can be conveniently controlled. The overall structure is simple and reliable. Compared with manual dispensing, it not only has higher dispensing accuracy, but also significantly improves dispensing efficiency and enhances dispensing consistency.

[0044] Based on the above embodiments, as a supplement to the above... Figure 1 The present invention provides an embodiment of a cell preparation dispensing device for the implementation of the method shown, which is similar to... Figure 1 Corresponding to the method embodiments shown, this device can be specifically applied to various electronic devices, see reference. Figure 2 As shown, the cell preparation dispensing device includes: a main control valve 3, an injection device 1, a final product bag 4, and a cryopreservation assembly 5. The injection device 1, the final product bag 4, and the cryopreservation assembly 5 are all connected to the main control valve 3. The main control valve 3 includes three valve ports: a first control valve 31 connected to the injection device 1, a second control valve 32 connected to the final product bag 4, and a third control valve 33 connected to the cryopreservation assembly 5. The cryopreservation assembly 5 is an N-link cryopreservation bag or m parallel independent cryopreservation bags. The m parallel independent cryopreservation bags are respectively connected to a multi-way stopcock valve and a switching device, where N and m are both positive integers.

[0045] The cell preparation dispensing device described in this embodiment of the invention can perform the cell preparation dispensing method provided in the above embodiments. The cell preparation dispensing device has the corresponding functional steps and beneficial effects of the cell preparation dispensing method described in the above embodiments. For details, please refer to the embodiments of the cell preparation dispensing method described above. The embodiments of this invention will not be repeated here.

[0046] Numerous specific details are set forth in the specification provided herein. However, it will be understood that embodiments of the invention may be practiced without these specific details. In some instances, well-known methods, structures, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0047] Similarly, it should be understood that, in order to streamline this disclosure and aid in understanding one or more of the various inventive aspects, in the above description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof. However, this method of disclosure should not be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as reflected in the claims, inventive aspects lie in fewer than all features of a single foregoing disclosed embodiment. Therefore, the claims following the detailed description are hereby expressly incorporated into that detailed description, wherein each claim itself is a separate embodiment of the invention.

[0048] It should be noted that the above embodiments are illustrative of the invention and not restrictive of the invention, and that those skilled in the art can devise alternative embodiments without departing from the scope of the appended claims.

Claims

1. A method of sub-packing a cell preparation, characterized by, The method for dispensing the cell preparation includes: The injection device, the final product bag, and the cryopreservation assembly are connected sequentially by a main control valve. Before the injection device is started, the three valve ports of the main control valve are closed: the first control valve connected to the injection device, the second control valve connected to the final product bag, and the third control valve connected to the cryopreservation assembly. Open the first control valve and the third control valve to control the injection device to perform exhaust and vacuum pretreatment. After the pretreatment is completed, close the third control valve. The second control valve is opened, and the injection device is controlled to start and extract the cell preparation from the final product bag according to the predetermined target cell preparation capacity. After the cell preparation capacity extracted by the injection device reaches the target cell preparation capacity, the second control valve is closed, wherein the target cell preparation capacity is not less than the storage capacity of the cryopreservation component. Open the third control valve to control the injection device to inject the extracted cell preparation into the cryopreservation component, completing the dispensing process.

2. The method of sub-pooling a cell preparation according to claim 1, characterized in that: The cryopreservation assembly is an N-cell cryopreservation bag or m parallel independent cryopreservation bags, wherein the m parallel independent cryopreservation bags are respectively connected to a multi-way stopcock valve and a switching device, and N and m are both positive integers.

3. The method of sub-pooling a cell preparation according to claim 2, wherein, When the cryopreservation component is an N-cell cryopreservation bag, the method includes: After the cell preparation injection operation is performed and the injection device is started, the extracted cell preparation is injected into the N-cell cryopreservation bag. After the cell preparation fills the N-cell cryopreservation bag, the third control valve is closed. The N-cell cryopreservation bag is heat-sealed and replaced with a new N-cell cryopreservation bag. The third control valve is then opened, and the aforementioned cell preparation injection operation is repeated.

4. The method of sub-pooling a cell preparation according to claim 3, wherein, The method further includes: connecting an air filter with a tube clamp to the N-cell cryopreservation bag; controlling the tube clamp to open and connect to the air filter during the pre-treatment of venting and vacuuming of the injection device; and closing the tube clamp after performing the cell preparation injection operation.

5. The method of sub-pooling a cell preparation according to claim 2, wherein, When the cryopreservation assembly consists of m independent cryopreservation bags connected in parallel, the method includes: Open the third control valve to perform the cell preparation injection operation. After the injection device is started, open the multi-port stopcock valve corresponding to the first independent cryopreservation bag at the injection station near the third control valve to inject the extracted cell preparation into the first independent cryopreservation bag. After the first independent cryopreservation bag is filled, close the multi-port stopcock valve. Perform the sequence adjustment operation, control the switching device to adjust the order of each independent cryopreservation bag, switch the new independent cryopreservation bag to the injection station near the third control valve, open the multi-port stopcock valve corresponding to the new independent cryopreservation bag, perform the cell preparation injection operation, and close the multi-port stopcock valve after the new independent cryopreservation bag is filled. Repeat the sequential adjustment and cell preparation injection operations until all individual cryopreservation bags are filled with cell preparation.

6. The method of sub-pooling a cell preparation according to claim 5, wherein, The method further includes connecting quality inspection bags to m parallel independent cryopreservation bags and connecting a peristaltic pump to the main control valve. After all the individual cryopreservation bags are filled with cell preparation, the second control valve is closed, the injection device is started and the remaining cell preparation in the injection device is discharged and fed into the quality inspection bag and the pipeline connected to the quality inspection bag. After the injection device has been emptied, the first control valve is closed; Start the peristaltic pump to input all the residual cell preparations in the tubing connected to the quality inspection bag into the quality inspection bag.

7. The method of sub-pooling a cell preparation according to claim 1, wherein, The exhaust and vacuum pretreatment further includes: opening the second control valve, starting the injection device and venting the airflow in the injection device into the final product bag, so that the cell preparation in the final product bag is mixed evenly.

8. The method of sub-pooling a cell preparation of claim 1, wherein, The method further includes: fitting a closed sterile sleeve on the outside of the rear end of the injection device, so that when the injection device is started, the air in the outer space of the injection device is maintained in a sterile environment through the sterile sleeve.

9. The method of sub-pooling a cell preparation of claim 1, wherein, The method further includes: when a leak alarm is detected in the pipeline before the dispensing process is completed, performing heat sealing on the cryopreservation bags in the already dispensed cryopreservation components.

10. A cell preparation dispensing apparatus, applied to the cell preparation dispensing method according to any one of claims 1-9, characterized in that, The cell preparation dispensing device includes: a main control valve, an injection device, a final product bag, and a cryopreservation component, wherein the injection device, the final product bag, and the cryopreservation component are respectively connected to the main control valve; The main control valve includes three valve ports: a first control valve connected to the injection device, a second control valve connected to the final product bag, and a third control valve connected to the cryopreservation component. The cryopreservation assembly is an N-cell cryopreservation bag or m parallel independent cryopreservation bags, wherein the m parallel independent cryopreservation bags are respectively connected to a multi-way stopcock valve and a switching device, and N and m are both positive integers.

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