Formulation mixing and dispensing system and method

Abstract

This specification provides a formulation mixing and dispensing system and method. Based on the above formulation mixing and dispensing system, firstly, according to preset self-test rules, the states of relevant solenoid valves are adjusted, and a peristaltic pump and a pressure sensor are used in combination to detect whether the tubing and clamps meet preset requirements. If the preset requirements are met, the system sequentially performs the first calibration process, the liquid inlet process, the mixing process, the second calibration process, the pre-filling process, and the dispensing process according to preset first calibration rules, preset liquid inlet rules, preset mixing rules, preset second calibration rules, preset pre-filling rules, and preset dispensing rules. This enables highly efficient and accurate automated mixing and dispensing of cell fluid formulations; and effectively reduces damage and contamination of cell fluid during mixing and dispensing, minimizing cell fluid loss and waste.

Description

Technical Field

[0001] This manual pertains to the field of biological agent preparation and packaging technology, and particularly relates to formulation mixing and packaging systems and methods. Background Technology

[0002] With the development of biotechnology, the production of cell products has received increasing attention. Among them, the packaging of cell fluid preparations is an important step in the production of cell products.

[0003] Due to the unique nature of cell products, the dispensing process for cell fluid formulations typically requires high precision. However, with existing conventional equipment and methods, problems often arise during the mixing and dispensing of cell fluid formulations, such as low operational accuracy and the ease with which cells can be damaged or contaminated during the mixing and dispensing process.

[0004] There is currently no effective solution to the above problems. Summary of the Invention

[0005] This specification provides a formulation mixing and dispensing system and method that can achieve automated mixing and dispensing of cell fluid formulations with high efficiency and precision; and effectively reduces damage and contamination of cell fluid during the mixing and dispensing process, thereby reducing cell fluid consumption and waste.

[0006] This specification provides a formulation mixing and dispensing system, comprising at least: a liquid inlet section, a mixing section, a dispensing section, and a peristaltic pump; the liquid inlet section, the mixing section, and the dispensing section are respectively connected to the peristaltic pump via a first connecting pipe, a second connecting pipe, and a third connecting pipe; and a first solenoid valve, a second solenoid valve, and a third solenoid valve are respectively installed on the first connecting pipe, the second connecting pipe, and the third connecting pipe; wherein...

[0007] The liquid inlet section includes at least a first stock solution bag and a second stock solution bag; the first stock solution bag and the second stock solution bag are respectively connected to a first connecting pipe through corresponding first liquid inlet pipes and second liquid inlet pipes, and corresponding first liquid inlet valves and second liquid inlet valves are respectively provided on the first liquid inlet pipes and second liquid inlet pipes; the first stock solution bag and the second stock solution bag are also respectively connected to corresponding first gravity sensors and second gravity sensors; the first stock solution bag and the second stock solution bag respectively store first stock solution and second stock solution; the first stock solution bag and the second stock solution bag are also respectively provided with corresponding pipe clamps; a first bubble sensor is also provided on the first connecting pipe; wherein, the first gravity sensor and the second gravity sensor are used to calibrate the flow rate of the first pipe during the liquid inlet stage;

[0008] The mixing unit includes at least a mixing bag; the mixing bag is connected to a second connecting pipe; the mixing bag is used to temporarily store and mix the cell fluid; the mixing bag is also provided with a corresponding tube clamp.

[0009] The dispensing section includes at least a first dispensing container and a second dispensing container; the first dispensing container and the second dispensing container are respectively connected to a third connecting pipe through corresponding first dispensing pipes and second dispensing pipes, and corresponding first dispensing valves and second dispensing valves are provided on the first dispensing pipes and second dispensing pipes; a pressure sensor is also provided at the end of the third connecting pipe; the first dispensing container and the second dispensing container are used to store the target cell fluid obtained after mixing; the first dispensing container and the second dispensing container are also provided with corresponding tube clamps;

[0010] The peristaltic pump is also connected to a filter valve via a fourth connecting pipe, and a fourth solenoid valve is also provided on the fourth connecting pipe; a first metering tube is also provided on the pipe between the filter valve and the fourth solenoid valve; a second bubble sensor is provided between the fourth solenoid valve and the second solenoid valve; a third bubble sensor is provided at a position adjacent to the first metering tube and away from the fourth solenoid valve; wherein, the first metering tube, the second bubble sensor, and the third bubble sensor are used to calibrate the flow rate of the second pipe during the dispensing stage;

[0011] A fifth connecting pipe is also connected between the fourth connecting pipe and the third connecting pipe; and a fifth solenoid valve is also provided on the fifth connecting pipe. The connection point between the fifth connecting pipe and the fourth connecting pipe is located between the air filter valve and the fourth solenoid valve, and the connection point between the fifth connecting pipe and the third connecting pipe is located between the third solenoid valve and the peristaltic pump; wherein, the fifth solenoid valve is used to control the pre-filling operation of the dispensing stage.

[0012] In one embodiment, the mixing section further includes: a mixing support, a motor, a moving body, and a mixing plate;

[0013] The mixing bag is mounted on a mixing support; and a cooling plate is provided on the mixing support at a position a first distance away from the mounted mixing bag.

[0014] The mixing plate is disposed on the moving body; the moving body is connected to the motor; the movement is configured to move within a specified range opposite to the cooling plate;

[0015] Furthermore, the cooling plate is equipped with a temperature sensor; the temperature sensor is connected to the cooling module; and the cooling module is connected to the cooling plate through a heat dissipation channel.

[0016] In one embodiment, the packaging unit further includes: a third packaging container...an Mth packaging container; where M is an integer greater than or equal to 3;

[0017] And / or, the liquid inlet section further includes: a third raw liquid bag...an Nth raw liquid bag; wherein, N is an integer greater than or equal to 3.

[0018] In one embodiment, the system further includes a sixth connecting pipe; wherein the sixth connecting pipe is connected in parallel with the fourth connecting pipe, and a second metering pipe and a sixth solenoid valve are provided on the sixth connecting pipe.

[0019] This instruction manual also provides a method for mixing and dispensing a formulation, including:

[0020] According to the preset self-test rules, by adjusting the state of the relevant solenoid valves and combining the peristaltic pump and the air pressure sensor, the pipeline and pipe clamp are tested to see if they meet the preset requirements.

[0021] If the pipeline and clamps meet the preset requirements, calibrate the first pipeline flow rate during the liquid inlet stage according to the preset first calibration rule;

[0022] According to the preset liquid inlet rules, by adjusting the state of the solenoid valve of the liquid inlet section, and by combining the peristaltic pump and the corresponding gravity sensor, the corresponding first liquid and second liquid are sequentially drawn from the first liquid bag and the second liquid bag and transported to the mixing bag.

[0023] According to the preset mixing rules, the mixing unit is controlled within a specified temperature range to mix the cell fluid in the mixing bag to obtain the target cell fluid that meets the requirements.

[0024] According to the preset second calibration rule, calibrate the flow rate of the second pipeline during the dispensing stage;

[0025] According to the preset pre-filling rules, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to perform a pre-filling operation on the pipeline between the third and fifth solenoid valves.

[0026] According to the preset dispensing rules, by adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump, the target cell fluid in the mixing bag is transported to the first dispensing container and the second dispensing container respectively.

[0027] In one embodiment, after adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump to transport the target cell solution in the mixing bag to the first dispensing container and the second dispensing container respectively, the method further includes:

[0028] When the first and second dispensing containers are dispensing bags, the first and second dispensing containers are vented according to the preset venting rules by adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump and a pressure sensor.

[0029] In one embodiment, according to preset self-test rules, the states of relevant solenoid valves are adjusted, and a peristaltic pump and a pressure sensor are used in combination to detect whether the pipeline and pipe clamps meet preset requirements, including:

[0030] To check whether the third connecting pipe meets the preset requirements, follow these steps:

[0031] The following method is used to check whether the tube clamps installed on the first dispensing container meet the preset requirements:

[0032] According to the preset self-test rules, the states of the third solenoid valve, the fourth solenoid valve, and the first dispensing valve are set to the open state, and the states of the first solenoid valve, the second solenoid valve, and the second dispensing valve are set to the closed state.

[0033] Control the peristaltic pump to run counterclockwise at a specified speed during the third detection period; and use a pressure sensor to collect the pipeline pressure value during the third detection period.

[0034] Calculate the increase in pipeline air pressure during the third testing period based on the pipeline air pressure value during the third testing period.

[0035] The test checks whether the increase in pipeline air pressure during the third test period is less than a preset threshold.

[0036] If the increase in pipeline air pressure during the third detection period is less than the preset threshold, the clamp installed on the first dispensing container is determined to meet the preset requirements.

[0037] In one embodiment, according to preset self-test rules, the state of relevant solenoid valves is adjusted, and a peristaltic pump and a pressure sensor are used in combination to detect whether the pipeline and pipe clamp meet preset requirements, including:

[0038] The following method is used to check whether the tube clamps installed on the first dispensing container meet the preset requirements:

[0039] According to the preset self-test rules, the states of the third solenoid valve, the fourth solenoid valve, and the dispensing valve are set to the open state, and the states of the first solenoid valve and the second solenoid valve are set to the closed state.

[0040] Control the peristaltic pump to run counterclockwise at a specified speed during the third detection period; and use a pressure sensor to collect the pipeline pressure value during the third detection period.

[0041] Calculate the increase in pipeline air pressure during the third testing period based on the pipeline air pressure value during the third testing period.

[0042] The test checks whether the increase in pipeline air pressure during the third test period is less than a preset threshold.

[0043] If the increase in pipeline air pressure during the third detection period is less than the preset threshold, the clamp installed on the first dispensing container is determined to meet the preset requirements.

[0044] In one embodiment, calibrating the first pipeline flow rate during the liquid inlet stage according to a preset first calibration rule includes:

[0045] According to the preset first calibration rule, the states of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve are set to the open state, and the state of the second liquid inlet valve is set to the closed state.

[0046] The initial gravity value of the first raw material bag was obtained using the first gravity sensor;

[0047] After controlling the peristaltic pump to run clockwise at a specified speed for a calibration period, stop the peristaltic pump.

[0048] The final gravity value of the first raw material bag was obtained using the first gravity sensor;

[0049] Based on the initial and final gravity values ​​of the first raw material bag, as well as the calibration time period, the calibrated first pipeline flow rate corresponding to the specified speed of the peristaltic pump during the liquid inlet stage is determined.

[0050] In one embodiment, according to a preset liquid inlet rule, by adjusting the state of the solenoid valve of the liquid inlet section and combining a peristaltic pump and a corresponding gravity sensor, the corresponding first and second stock solutions are sequentially drawn from the first stock solution bag and the second stock solution bag and transported to the mixing bag, including:

[0051] According to the preset liquid inlet rules, the states of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve are set to the open state, and the states of the third solenoid valve and the second liquid inlet valve are set to the closed state.

[0052] The peristaltic pump is controlled to run clockwise at a specified speed, and the gravity value of the first raw material bag is monitored using the first gravity sensor;

[0053] When the gravity value of the first raw material bag decreases from the first gravity value, the peristaltic pump is stopped; and the state of the second inlet valve is set to open, and the state of the first inlet valve is set to closed.

[0054] The peristaltic pump is controlled to run clockwise at a specified speed, and the gravity value of the second stock solution bag is monitored using a second gravity sensor;

[0055] When the gravity value of the second raw material bag decreases from the second gravity value, the peristaltic pump is controlled to stop running.

[0056] In one embodiment, according to a preset mixing rule, the mixing unit is controlled within a specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements, including:

[0057] According to the preset mixing rules, obtain the current volume parameters of the mixing bag and the current temperature parameters of the cooling plate;

[0058] Based on the current volume parameters of the mixing bag, generate matching control parameters; and based on these control parameters, adjust the pressing speed and / or pressing amplitude of the moving body driving the mixing plate to press the mixing bag using a motor.

[0059] Check whether the current temperature parameter of the cooling plate is higher than the preset temperature threshold;

[0060] If the current temperature parameters of the cooling plate are determined to be higher than the preset temperature threshold, the cooling module is activated to cool the cooling plate.

[0061] In one embodiment, calibrating the second pipeline flow rate during the dispensing stage according to a preset second calibration rule includes:

[0062] According to the preset second calibration rule, the states of the second solenoid valve and the fourth solenoid valve are set to the open state, and the states of the fifth solenoid valve, the first solenoid valve, and the third solenoid valve are set to the closed state.

[0063] Control the peristaltic pump to run counterclockwise at a specified speed, monitor and record the first time when the second bubble sensor detects a change in value, and the second time when the third bubble sensor detects a change in value;

[0064] Based on the volume of the first metering tube, the first time, and the second time, the calibrated second pipeline flow rate corresponding to the specified speed of the peristaltic pump during the dispensing stage is determined.

[0065] In one embodiment, according to a preset pre-filling rule, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to pre-fill the pipeline between the third and fifth solenoid valves, including:

[0066] According to the preset pre-filling rule, the state of the fifth solenoid valve and the second solenoid valve is set to the open state, and the state of the third solenoid valve and the fourth solenoid valve is set to the closed state.

[0067] Control the peristaltic pump to run counterclockwise at a specified speed so that the pipeline between the third and fifth solenoid valves is pre-filled with target cell fluid.

[0068] In one embodiment, according to a preset dispensing rule, the state of the solenoid valve in the dispensing section is adjusted, and a peristaltic pump is used to transport the target cell fluid in the mixing bag to the first dispensing container and the second dispensing container, respectively, including:

[0069] According to the preset dispensing rules, the states of the second dispensing valve, the second solenoid valve, and the fourth solenoid valve are set to the open state; and the peristaltic pump is controlled to run counterclockwise at a specified speed for a dispensing period, so as to fill the pipeline between the third solenoid valve and the second dispensing container in the third connecting pipeline with the corresponding target cell fluid; wherein, the duration of the dispensing period is determined according to the specified volume of the target cell fluid to be dispensed in the dispensing container and the flow rate of the second pipeline.

[0070] Set the first dispensing valve to the open state and the second dispensing valve to the closed state; and control the peristaltic pump to run counterclockwise for a specified dispensing period at a specified speed to input the corresponding target cell fluid into the first dispensing container;

[0071] Set the fifth and second solenoid valves to the open state, and set the first dispensing valve and the third solenoid valve to the closed state; and control the peristaltic pump to run clockwise at a specified speed to fill in air, and use the filled air to push the target cell fluid in the pipeline between the third solenoid valve and the mixing bag back into the mixing bag.

[0072] Set the third, fourth, and second solenoid valves to the open state, and the fifth and second solenoid valves to the closed state; and control the peristaltic pump to run counterclockwise at a specified speed to input the corresponding target cell fluid into the second dispensing container;

[0073] Set the state of the first dispensing valve to the open state and the state of the second dispensing valve to the closed state; and control the peristaltic pump to run counterclockwise at a specified speed to input the target cell fluid in the first dispensing pipeline into the first dispensing container.

[0074] In one embodiment, according to a preset venting rule, the state of the solenoid valve in the dispensing section is adjusted, and a peristaltic pump and a pressure sensor are used to vent the first and second dispensing containers, including:

[0075] According to the preset exhaust rules, the first dispensing valve, the second dispensing valve, and the third solenoid valve are set to the open state, and the peristaltic pump is controlled to run clockwise at a specified speed to exhaust the first dispensing container and the second dispensing container.

[0076] The air pressure value of the third connecting pipe is monitored using an air pressure sensor;

[0077] When the air pressure value of the third connecting pipe is detected to be less than or equal to the preset air pressure threshold, the peristaltic pump stops operating.

[0078] This specification also provides a computer-readable storage medium storing computer instructions that, when executed by a processor, implement the relevant steps of the formulation mixing and dispensing method.

[0079] Based on the formulation mixing and dispensing system and method provided in this specification, the aforementioned formulation mixing and dispensing system includes at least the following structures: a liquid inlet section, a mixing section, a dispensing section, and a peristaltic pump. These structures are connected via corresponding pipelines, each equipped with a corresponding electromagnetic control valve. When specifically mixing and dispensing cell fluid formulations using the aforementioned formulation mixing and dispensing system, the following steps can be taken: First, according to preset self-test rules, the states of the relevant electromagnetic valves are adjusted, and the peristaltic pump and pressure sensor are used in combination to detect whether the pipelines and clamps meet preset requirements. If the pipelines and clamps meet the preset requirements, the flow rate of the first pipeline during the liquid inlet stage is calibrated according to a preset first calibration rule. Then, according to the preset liquid inlet rules, the states of the electromagnetic valves in the liquid inlet section are adjusted, and the peristaltic pump and corresponding gravity sensor are used in combination to sequentially draw the corresponding first and second stock solutions from the first and second stock solution bags, respectively, and deliver them to the container. The mixture is transported to a mixing bag; according to preset mixing rules, the mixing unit is controlled within a specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements; according to preset second calibration rules, the flow rate of the second pipeline in the dispensing stage is calibrated; according to preset pre-filling rules, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to pre-fill the pipeline between the third and fifth solenoid valves; according to preset dispensing rules, the state of the solenoid valves in the dispensing unit is adjusted, and a peristaltic pump is used to transport the target cell solution in the mixing bag to the first dispensing container and the second dispensing container respectively. This allows for relatively efficient and accurate automatic mixing and dispensing of cell solution preparations; and effectively reduces damage and contamination of the cell solution during the mixing and dispensing process, reducing cell solution consumption and waste. Attached Figure Description

[0080] To more clearly illustrate the embodiments of this specification, the accompanying drawings used in the embodiments will be briefly introduced below. The drawings described below are only some embodiments recorded in this specification. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0081] Figure 1 This is a schematic diagram of the structural composition of a formulation mixing and dispensing system provided in one embodiment of this specification;

[0082] Figure 2 This is a schematic diagram of the structure of the mixing section in a formulation mixing and dispensing system provided in one embodiment of this specification;

[0083] Figure 3 This is a schematic diagram of the structural composition of a temperature control structure in a formulation mixing and dispensing system provided in one embodiment of this specification;

[0084] Figure 4This is a schematic diagram of an optimized structural composition of a formulation mixing and dispensing system provided in one embodiment of this specification;

[0085] Figure 5 This is a schematic diagram of another optimized structural composition of the formulation mixing and dispensing system provided in one embodiment of this specification;

[0086] Figure 6 This is a schematic diagram of an optimized structural composition of a formulation mixing and dispensing system provided in one embodiment of this specification;

[0087] Figure 7 This is a schematic flowchart of a formulation mixing and dispensing method provided in one embodiment of this specification;

[0088] Figure 8 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0089] Figure 9 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0090] Figure 10 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0091] Figure 11 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0092] Figure 12 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0093] Figure 13 This is a schematic diagram of the structural composition of an electronic device provided in one embodiment of this specification;

[0094] Figure 14 This is a schematic diagram of the structural composition of a formulation mixing and dispensing device provided in one embodiment of this specification;

[0095] Figure 15 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0096] Figure 16 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0097] Figure 17This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0098] Figure 18 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0099] Figure 19 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0100] Figure 20 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0101] Figure 21 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0102] Figure 22 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example.

[0103] Figure 23 This is a schematic diagram illustrating one embodiment of the formulation mixing and dispensing method provided in the embodiments of this specification, applied in a scenario example. Detailed Implementation

[0104] To enable those skilled in the art to better understand the technical solutions in this specification, the technical solutions in the embodiments of this specification will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this specification, and not all embodiments. Based on the embodiments in this specification, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this specification.

[0105] It should be noted that the information and data related to users involved in the embodiments of this specification are all information and data authorized by the user or fully authorized by the relevant parties. Furthermore, the collection, storage, use, processing, transmission, provision, disclosure, and application of the relevant data all comply with relevant laws, regulations, and standards, and necessary confidentiality measures have been taken. They do not violate public order and good morals, and corresponding operation entry points are provided for users or relevant parties to choose to authorize or refuse.

[0106] It should also be noted that in the embodiments of this specification, certain software, components, models and other existing solutions in the industry may be mentioned. These should be regarded as exemplary and are only intended to illustrate the feasibility of implementing the technical solution of this application. However, it does not mean that the applicant has used or necessarily used the solution.

[0107] See Figure 1 As shown in the embodiments of this specification, a formulation mixing and dispensing system is provided, which may include at least: a liquid inlet section, a mixing section, a dispensing section, and a peristaltic pump; the liquid inlet section, the mixing section, and the dispensing section are respectively connected to the peristaltic pump through a first connecting pipe, a second connecting pipe, and a third connecting pipe; and a first solenoid valve, a second solenoid valve, and a third solenoid valve are respectively provided on the first connecting pipe, the second connecting pipe, and the third connecting pipe; wherein,

[0108] The liquid inlet section includes at least a first stock solution bag and a second stock solution bag; the first stock solution bag and the second stock solution bag are respectively connected to a first connecting pipe through corresponding first liquid inlet pipes and second liquid inlet pipes, and corresponding first liquid inlet valves and second liquid inlet valves are respectively provided on the first liquid inlet pipes and second liquid inlet pipes; the first stock solution bag and the second stock solution bag are also respectively connected to corresponding first gravity sensors and second gravity sensors; the first stock solution bag and the second stock solution bag respectively store first stock solution and second stock solution; the first stock solution bag and the second stock solution bag are also respectively provided with corresponding pipe clamps; a first bubble sensor is also provided on the first connecting pipe; wherein, the first gravity sensor and the second gravity sensor are used to calibrate the flow rate of the first pipe during the liquid inlet stage;

[0109] The mixing unit includes at least a mixing bag; the mixing bag is connected to a second connecting pipe; the mixing bag is used to temporarily store and mix the cell fluid; the mixing bag is also provided with a corresponding tube clamp.

[0110] The dispensing section includes at least a first dispensing container and a second dispensing container; the first dispensing container and the second dispensing container are respectively connected to a third connecting pipe through corresponding first dispensing pipes and second dispensing pipes, and corresponding first dispensing valves and second dispensing valves are provided on the first dispensing pipes and second dispensing pipes; a pressure sensor is also provided at the end of the third connecting pipe; the first dispensing container and the second dispensing container are used to store the target cell fluid obtained after mixing; the first dispensing container and the second dispensing container are also provided with corresponding tube clamps;

[0111] The peristaltic pump is also connected to a filter valve via a fourth connecting pipe, and a fourth solenoid valve is also provided on the fourth connecting pipe; a first metering tube is also provided on the pipe between the filter valve and the fourth solenoid valve; a second bubble sensor is provided between the fourth solenoid valve and the second solenoid valve; a third bubble sensor is provided at a position adjacent to the first metering tube and away from the fourth solenoid valve; wherein, the first metering tube, the second bubble sensor, and the third bubble sensor are used to calibrate the flow rate of the second pipe during the dispensing stage;

[0112] A fifth connecting pipe is also connected between the fourth connecting pipe and the third connecting pipe; and a fifth solenoid valve is also provided on the fifth connecting pipe. The connection point between the fifth connecting pipe and the fourth connecting pipe is located between the air filter valve and the fourth solenoid valve, and the connection point between the fifth connecting pipe and the third connecting pipe is located between the third solenoid valve and the peristaltic pump; wherein, the fifth solenoid valve is used to control the pre-filling operation of the dispensing stage.

[0113] Specifically, the liquid inlet section includes at least a first stock solution bag and a second stock solution bag. The first and second stock solution bags can respectively store the first and second stock solutions to be mixed and dispensed.

[0114] The first and second stock solutions mentioned above can specifically include at least one of the following: cell sap, lyophilized solution, nutrient solution, etc. It should be noted that the stock solutions listed above are merely illustrative. In actual implementation, depending on the specific application scenario and processing requirements, the first and second stock solutions may also include other types of stock solutions. This specification does not limit this.

[0115] In addition to the first raw liquid bag and the second raw liquid bag, the above-mentioned liquid inlet section may further include a number of raw liquid bags, such as a third raw liquid bag storing a third raw liquid, depending on the specific application scenario and processing requirements.

[0116] The following explanation focuses on the case where the liquid inlet section contains only two liquid bags: a first liquid bag and a second liquid bag. For cases containing more liquid bags, please refer to the embodiment with two liquid bags. This specification will not elaborate further.

[0117] Specifically, the liquid inlet section can also be equipped with multiple hooks for attaching liquid bags such as the first liquid bag and the second liquid bag.

[0118] Furthermore, the aforementioned hooks are respectively connected to corresponding gravity sensors such as the first gravity sensor and the second gravity sensor. Specifically, these gravity sensors can be gravity scales, etc.

[0119] In this way, when a raw material bag is hung on a hook, the weight value of the raw material bag can be detected and collected in real time by a gravity sensor connected to the hook.

[0120] Specifically, the first gravity sensor corresponds to the first raw liquid bag and is used to detect and collect the gravity value of the first raw liquid bag; the second gravity sensor corresponds to the second raw liquid bag and is used to detect and collect the gravity value of the second raw liquid bag.

[0121] In addition, the first and second raw material bags are each equipped with a tube clamp. During normal dispensing, the tube clamps are set to the open state so that the required raw material can be drawn from the first and second raw material bags.

[0122] Specifically, the first and second raw material bags can be directly connected to the corresponding first and second inlet pipes, respectively. The first and second inlet pipes are then connected to the first connecting pipe.

[0123] Furthermore, a first inlet valve and a second inlet valve can be respectively installed on the first inlet pipeline and the second inlet pipeline to control the on / off state of the corresponding inlet pipeline. A first solenoid valve can also be installed on the first connecting pipeline to control the on / off state of the corresponding first connecting pipeline.

[0124] A first bubble sensor is also installed in the first connecting pipe. The first bubble sensor can be used to detect whether there is raw liquid flowing through the first connecting pipe.

[0125] Specifically, the aforementioned first bubble sensor can be installed in the pipeline between the first solenoid valve and the connection point of the first liquid inlet pipeline and the first connecting pipeline in the first connecting pipeline.

[0126] Specifically, the aforementioned mixing bag is used to temporarily store cell solutions (e.g., the first stock solution and / or the second stock solution, etc.), and to mix the stored cell solutions under the required environmental conditions to obtain a well-mixed target cell solution that meets the requirements.

[0127] The mixing bag can also be equipped with corresponding clamps. During normal dispensing, the clamps will be in the open position.

[0128] The mixing bag is connected to the second connecting pipe. Furthermore, a second solenoid valve is installed on the second connecting pipe to control the on / off state of the corresponding second connecting pipe.

[0129] Furthermore, the aforementioned mixing section also includes a mixing structure and a temperature control structure. In this way, the mixing section can, on the one hand, use the temperature control structure to maintain the cell solution stored in the mixing bag within a specified temperature range that matches the cell solution, thus avoiding damage to the cell solution due to excessively high or low temperatures; on the other hand, the mixing structure can perform a more suitable mixing treatment on the cell solution stored in the mixing bag, ensuring that the cell solution in the mixing bag is thoroughly mixed and has good consistency, while reducing damage to the cell solution caused by the mixing process.

[0130] Specifically, the above-mentioned dispensing section includes at least a first dispensing container and a second dispensing container; wherein the first dispensing container and the second dispensing container can be used to store the target cell fluid obtained after dispensing and mixing, so as to preserve or use it later.

[0131] Specifically, the first and second repackaging containers can be repackaging bags or repackaging bottles.

[0132] Specifically, when using dispensing bags as containers to dispense and store target cell fluid, in order to avoid damage to the cell fluid during subsequent freezing and storage, the bags can be vented before freezing to remove excess air.

[0133] In addition to the first and second dispensing containers, the aforementioned dispensing section may further include a greater number of dispensing containers depending on the specific application scenario and processing requirements.

[0134] The following description primarily uses the case where the packaging section contains only two packaging containers, a first packaging container and a second packaging container, as an example. For cases containing a larger number of packaging containers, please refer to the embodiment containing two packaging containers. This specification will not elaborate further.

[0135] The first and second dispensing containers may also be equipped with corresponding tube clamps. During normal dispensing, the tube clamps will be in the open position.

[0136] The first and second dispensing containers can be directly connected to the first and second dispensing pipelines, respectively, which in turn are connected to a third connecting pipeline. Furthermore, corresponding first and second dispensing valves can be installed on the first and second dispensing pipelines to control their on / off states. A third solenoid valve can also be installed on the third connecting pipeline to control its on / off state.

[0137] In addition, a pressure sensor can be connected to the end of the third connecting pipe, away from the peristaltic pump. Specifically, this pressure sensor can be used to detect and collect the pressure values ​​in the relevant pipes.

[0138] Specifically, the peristaltic pump is also connected to a filter valve via a fourth connecting pipe.

[0139] Specifically, the aforementioned air filter valve can be connected to a sterilization air filtration device. Accordingly, the air entering the system can be filtered through the air filter valve to ensure that the air entering the system is safe and reliable, and will not damage or contaminate the cell fluid in the system.

[0140] A fourth solenoid valve is also installed on the aforementioned fourth connecting pipe to control the opening and closing of the fourth connecting pipe.

[0141] Specifically, a fifth connecting pipe is installed between the fourth and third connecting pipes. A fifth solenoid valve may also be installed on this fifth connecting pipe.

[0142] Specifically, the aforementioned first solenoid valve, second solenoid valve, third solenoid valve, fourth solenoid valve, fifth solenoid valve, first inlet valve, second inlet valve, first dispensing valve, and second dispensing valve can be electromagnetic control valves, or simply solenoid valves.

[0143] In addition, a flow meter for detecting the flow rate of cell fluid in the aforementioned pipeline can also be installed.

[0144] Specifically, the aforementioned formulation mixing and dispensing system may further include a processor. This processor can be connected to the liquid inlet, mixing, and dispensing sections. Based on this processor, on the one hand, the operating status of each structural module in the formulation mixing and dispensing system can be monitored; on the other hand, the corresponding mixing and dispensing processes can be automatically completed by controlling the electromagnetic control valves in the relevant pipelines and the relevant devices in the relevant structural modules.

[0145] The above-mentioned mixing and dispensing process includes at least the following stages: liquid inlet stage, mixing stage, and dispensing stage. In some cases, the above-mentioned mixing and dispensing process may also include an venting stage.

[0146] Specifically, the above-mentioned liquid inlet stage can be understood as the stage of drawing the stock solution from the stock solution bag and transferring it into the mixing bag. The above-mentioned mixing stage can be understood as the stage of mixing the cell solution stored in the mixing bag. The above-mentioned dispensing stage can be understood as the stage of transferring the cell solution from the mixing bag into the corresponding dispensing containers. The above-mentioned venting stage can be understood as the stage of venting the dispensing containers after they have stored the cell solution.

[0147] Furthermore, the aforementioned liquid-feeding stage may include: a first calibration process, liquid-feeding treatment, etc. The aforementioned dispensing stage may include: a second calibration process, pre-filling treatment, dispensing treatment, etc.

[0148] In practice, the aforementioned first gravity sensor and second gravity sensor can be used for the first calibration process to calibrate the first pipeline flow rate during the liquid inlet stage.

[0149] The volume of the first metering tube is known and fixed. Accordingly, the combination of the first metering tube, the second bubble sensor, and the third bubble sensor can be used for the second calibration process to calibrate the flow rate of the second pipeline during the dispensing stage.

[0150] The combination of the fifth solenoid valve and the fifth connecting pipe can be used for pre-filling treatment, so that the pipe between the third solenoid valve and the fifth solenoid valve is pre-filled with the target cell fluid to cooperate with the dispensing process in the dispensing stage, so that the subsequent dispensing process can be completed more accurately, reducing the loss and waste of the target cell fluid.

[0151] The aforementioned formulation mixing and dispensing system includes at least the following structures: a liquid inlet, a mixing section, a dispensing section, and a peristaltic pump. These structures are connected by corresponding pipelines, each equipped with a corresponding electromagnetic control valve. Furthermore, the system can first utilize devices such as pressure sensors to perform self-checks on the pipelines and clamps, ensuring that the pipeline airtightness and clamp condition meet preset requirements. Then, after a first calibration process to calibrate the flow rate of the first pipeline during the liquid inlet stage, the liquid inlet section precisely controls the extraction of a specific volume of the first and second stock solutions from the first and second stock solution bags and transports it to the mixing bag. Next, the mixing section precisely controls the mixing of the cell fluid in the mixing bag within a specified temperature range, ensuring thorough mixing while minimizing or even eliminating damage and contamination. Finally, after a second calibration process and pre-filling, the dispensing section precisely controls the transport and dispensing of the well-mixed target cell fluid into the corresponding dispensing containers according to specific dispensing requirements. This enables more efficient and precise automated mixing and dispensing of cell fluid preparations; and effectively reduces damage and contamination of cell fluid during the mixing and dispensing process, thus reducing cell fluid consumption and waste.

[0152] In some embodiments, flow meters may also be installed on the first, second, and third connecting pipes. These flow meters can be used to detect the liquid flow rate in the relevant pipes.

[0153] Furthermore, bubble sensors can be installed on the aforementioned first, second, and third connecting pipes, as well as the corresponding dispensing and inlet pipes. These bubble sensors can detect the liquid flow in the relevant pipes.

[0154] In some embodiments, see Figure 2 As shown, the mixing section may further include structures such as a mixing support, a motor, a moving body, and a mixing plate;

[0155] Specifically, the mixing bag can be hung on a mixing support; and a cooling plate is provided on the mixing support at a position that is a first distance away from the hanging mixing bag.

[0156] The mixing plate is disposed on the moving body; the moving body is connected to the motor; the movement is configured to move within a specified range opposite to the cooling plate.

[0157] The aforementioned first distance can be understood as a small value close to 0, such as 0.1 cm.

[0158] Specifically, the side of the mixing plate closest to the mixing bag can be made of a relatively soft rubber material. This effectively reduces mechanical damage to the cell fluid when using the mixing plate to mix the mixing bag.

[0159] The aforementioned cooling plate can be made of a material with high heat dissipation properties (e.g., iron). This allows for effective heat dissipation, promptly lowering the temperature of the cell solution in the mixing bag and ensuring it remains within a suitable specified temperature range (e.g., greater than or equal to 2 degrees Celsius and less than or equal to 8 degrees Celsius), thus reducing damage and disruption to the cell solution caused by temperature factors.

[0160] The aforementioned movable body may include at least a base. The bottom of the base is provided with pulleys; specifically, the pulleys may be mounted on a slide rail. A mixing plate is provided on the upper part of the base.

[0161] Furthermore, the aforementioned moving body can be connected to a motor via a transmission structure (e.g., a belt).

[0162] Based on the above structure, when the motor is running, the moving body can be driven by the belt to reciprocate along the slide rail within a specified range, so that the mixing plate can imitate the human hand to press the mixing bag back and forth, so as to better mix the cell fluid in the mixing bag and obtain a target cell fluid with high consistency.

[0163] Specifically, the aforementioned moving body and motor can also be connected to the processor. Accordingly, the processor can adjust the specified range, i.e., adjust the maximum interval distance between the mixing plate and the mixing bag, by adjusting the length of the slide rail between the mixing plate and the mixing bag, thereby adjusting the range of motion of the mixing plate during reciprocating motion; it can also adjust the speed of the mixing plate during reciprocating motion and the magnitude of the force exerted on the mixing bag by sending corresponding commands to the motor, depending on the specific circumstances.

[0164] In some embodiments, see Figure 3 As shown, the cooling plate may also be equipped with a temperature sensor; the temperature sensor is connected to the cooling module; the cooling module is connected to the cooling plate through a heat dissipation channel.

[0165] Specifically, the aforementioned cooling module can be a fan or other modules that can promote heat dissipation and cooling.

[0166] Specifically, the temperature sensor can also be connected to a temperature control switch, and the temperature control switch can also be connected to a refrigeration module.

[0167] In practice, the temperature sensor can indirectly monitor the temperature of the cell solution in the mixing bag by monitoring the temperature of the cooling plate.

[0168] When the temperature of the cell fluid is detected to be below the lower limit of the specified temperature range (e.g., T1, 2 degrees Celsius), it can be determined that the overall heat generated is not significant, and the normal heat dissipation of the cooling plate is sufficient to ensure that the cell fluid temperature meets the requirements. Therefore, the temperature control switch can automatically shut off to stop the cooling module from operating, reducing energy waste.

[0169] When the temperature of the cell fluid is detected to be higher than the upper limit of the specified temperature range (e.g., T2, 8 degrees Celsius), it can be determined that the total heat generated is large. If the normal heat dissipation of the cooling plate alone cannot ensure that the cell fluid temperature meets the requirements, the temperature control switch can be automatically turned on to control the cooling module to start working, so as to actively dissipate heat and cool the cooling plate through the heat dissipation channel in a timely manner to ensure that the cell fluid temperature meets the requirements.

[0170] Based on the above structure, the operation of the refrigeration module can be intelligently controlled. This ensures that the temperature of the cell fluid meets the requirements, effectively preventing damage and destruction of the cell fluid due to problems, while also reducing energy consumption and waste, thus achieving energy-saving effects.

[0171] Specifically, the aforementioned temperature control switch, refrigeration module, and temperature sensor can also be connected to the processor.

[0172] In practice, after detecting that the current temperature is higher than the upper limit of the specified temperature range, the processor can further detect the temperature range to which the current temperature belongs; then, based on the temperature range to which the current temperature belongs, it determines the target cooling strategy that matches the temperature curve from the preset cooling strategy set; and starts and controls the operation of the cooling module according to the target cooling strategy.

[0173] Specifically, the aforementioned set of preset cooling strategies can include multiple preset cooling strategies. Each preset cooling strategy corresponds to a temperature range.

[0174] The aforementioned preset cooling strategies can be specifically obtained by clustering a large number of historical cooling control records of the refrigeration module.

[0175] Thus, when the current temperature is detected to be higher than the upper limit of the specified temperature range, and the difference between the current temperature and the upper limit is large, indicating a high temperature range, the processor can control the cooling module to operate at a relatively high cooling power according to the matching target cooling strategy, for more drastic cooling and heat dissipation. When the current temperature is detected to be higher than the upper limit of the specified temperature range, and the difference between the current temperature and the upper limit is small, indicating a low temperature range, the processor can control the cooling module to operate at a relatively low cooling power according to the matching target cooling strategy, for more gentle cooling and heat dissipation. This allows for more precise and intelligent cooling and heat dissipation during the cell fluid dispensing process.

[0176] In some embodiments, see Figure 4 As shown, the packaging section may further include: a third packaging container...the Mth packaging container; where M is an integer greater than or equal to 3;

[0177] And / or, the liquid inlet may further include: a third raw liquid bag...an Nth raw liquid bag; wherein N is an integer greater than or equal to 3.

[0178] The first stock solution bag, the second stock solution bag, ... the Nth stock solution bag can each store the first stock solution, the second stock solution, ... the Nth stock solution, respectively. Depending on the specific circumstances, the first stock solution, the second stock solution, ... the Nth stock solution can be the same or different.

[0179] The first, second, ..., Mth dispensing containers can be used to store the target cell solution obtained after dispensing and mixing. Depending on the specific circumstances, the volume of the target cell solution dispensed into the first, second, ..., Mth dispensing containers can be the same or different.

[0180] Thus, based on the above-mentioned formulation mixing and dispensing system, the above structure can be used to perform relatively more complex cell fluid mixing and dispensing processes.

[0181] In some embodiments, see Figure 5 As shown, the system may further include a sixth connecting pipeline; wherein, the sixth connecting pipeline may be connected in parallel with the fourth connecting pipeline, and a second quantitative pipe and a sixth solenoid valve are provided on the sixth connecting pipeline.

[0182] The volume of the second metering tube is known and fixed. The volume of the first metering tube may be the same as or different from that of the second metering tube. The sixth solenoid valve is used to control the on / off state of the sixth connecting pipe.

[0183] For details, please refer to Figure 5 As shown, one connection point between the sixth connecting pipe and the fourth connecting pipe can be located between the third bubble sensor and the first quantitative tube, and the other connection point between the sixth connecting pipe and the fourth connecting pipe can be located between the second bubble sensor and the fourth solenoid valve.

[0184] Accordingly, the sixth connecting pipe and the fourth connecting pipe can share the second bubble sensor and the third bubble sensor.

[0185] In practice, the second quantitative tube, the second bubble sensor, and the third bubble sensor can be used in combination for the first calibration process to calibrate the first pipeline flow rate during the liquid inlet stage.

[0186] The first quantitative tube, the second bubble sensor, and the third bubble sensor can be used in combination to perform a second calibration process to calibrate the flow rate of the second pipeline during the dispensing stage.

[0187] Thus, based on the above-mentioned formulation mixing and dispensing system, the corresponding second calibration process can be precisely completed by utilizing the relevant structures of the fourth and sixth connecting pipes.

[0188] Further reading Figure 6 As shown, the dispensing section of the above-mentioned formulation mixing and dispensing system further includes: a third dispensing container...the Mth dispensing container; where M is an integer greater than or equal to 3; and the liquid inlet section further includes: a third stock solution bag...the Nth stock solution bag; where N is an integer greater than or equal to 3.

[0189] Meanwhile, the above-mentioned formulation mixing and dispensing system may also include a sixth connecting pipeline; wherein the sixth connecting pipeline is connected in parallel with the fourth connecting pipeline, and a second metering tube and a sixth solenoid valve are provided on the sixth connecting pipeline.

[0190] Based on the above-mentioned formulation mixing and dispensing system, it can accurately complete the corresponding second calibration process while supporting relatively complex cell fluid mixing and dispensing processes, meeting diverse scenario requirements.

[0191] See Figure 7 As shown in the embodiments of this specification, a formulation mixing and dispensing method based on the above-described cell fluid direct dispensing system is also provided. In specific implementation, it may include the following:

[0192] S701: According to the preset self-test rules, by adjusting the state of the relevant solenoid valves and combining the peristaltic pump and the air pressure sensor, the pipeline and pipe clamp are tested to see if they meet the preset requirements.

[0193] S702: If the pipeline and clamps meet the preset requirements, calibrate the first pipeline flow rate during the liquid inlet stage according to the preset first calibration rule;

[0194] S703: According to the preset liquid inlet rules, by adjusting the state of the solenoid valve of the liquid inlet section, and by combining the peristaltic pump and the corresponding gravity sensor, the corresponding first liquid and second liquid are sequentially drawn from the first liquid bag and the second liquid bag and transported to the mixing bag.

[0195] S704: According to the preset mixing rules, the mixing unit is controlled within the specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements.

[0196] S705: According to the preset second calibration rule, calibrate the second pipeline flow rate during the dispensing stage;

[0197] S706: According to the preset pre-filling rule, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to perform a pre-filling operation on the pipeline between the third and fifth solenoid valves.

[0198] S707: According to the preset dispensing rules, by adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump, the target cell fluid in the mixing bag is transported to the first dispensing container and the second dispensing container respectively.

[0199] It should be noted that, in some cases, based on the above-described formulation mixing and dispensing system, the bulk solutions in more than two bulk solution bags can be mixed in the inlet section to obtain the target cell solution that meets the requirements; the target cell solution can also be dispensed in more than two dispensing containers in the dispensing section. The above process can be referred to the implementation process involving only two bulk solution bags and two dispensing containers described above.

[0200] Based on the above embodiments, the corresponding structures in the formulation mixing and dispensing system can be effectively utilized according to specific processing rules. Operations such as self-testing, first calibration, liquid injection, mixing, second calibration, pre-filling, and dispensing can be performed sequentially according to the corresponding rules. This enables relatively efficient and accurate automated dispensing of cell fluid formulations, and effectively reduces damage and contamination to the cell fluid during the mixing and dispensing process.

[0201] In some embodiments, prior to implementation, reference may be made to Figure 1 The diagram shows the structure of the formulation mixing and dispensing system. Based on the specific application scenario and dispensing requirements, determine the system configuration parameters such as the number of original solution bags and the number of dispensing containers. Then, based on the above system configuration parameters, use fully enclosed disposable consumables, along with equipment such as aseptic connectors and heat sealers, to connect and construct the required formulation mixing and dispensing system.

[0202] After constructing the above-mentioned formulation mixing and dispensing system, the clamps of the mixing bag, the original solution bag, and the dispensing container can be set to the open state; then, according to the preset self-inspection rules, the airtightness of the pipelines in the system and the actual state of the clamps are tested to determine whether the pipelines and clamps meet the preset requirements.

[0203] In some embodiments, after adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump to transport the target cell fluid in the mixing bag to the first dispensing container and the second dispensing container respectively, the method may further include the following:

[0204] When the first and second dispensing containers are dispensing bags, the method, in its specific implementation, further includes:

[0205] S708: According to the preset exhaust rules, the state of the solenoid valve of the dispensing section is adjusted, and the first dispensing container and the second dispensing container are vented using a peristaltic pump and a pressure sensor.

[0206] This avoids the possibility of the aliquot bags bursting due to air in them during subsequent cryopreservation, which could damage or contaminate the target cell fluid inside.

[0207] Conversely, when the first and second dispensing containers are dispensing bottles, the user does not need to perform venting treatment on the dispensing bottles containing the target cells.

[0208] In some embodiments, the above-mentioned self-test rules are used to adjust the state of relevant solenoid valves and combine peristaltic pumps and pressure sensors to detect whether the pipeline and pipe clamps meet the preset requirements. For specific implementation, please refer to [reference needed]. Figure 8 As shown, the third connecting pipe can be checked to see if it meets the preset requirements in the following way:

[0209] S1: According to the preset self-test rules, set the state of the third solenoid valve and the fourth solenoid valve to the open state, and set the state of the dispensing valve, the first solenoid valve and the second solenoid valve to the closed state.

[0210] S2: Control the peristaltic pump to run counterclockwise at a specified speed for the first detection period and then stop, and set the status of the third and fourth solenoid valves to the closed state;

[0211] S3: Use a pressure sensor to collect the pipeline pressure value during the second detection period;

[0212] S4: Determine the pipeline air pressure change data during the second detection period based on the pipeline air pressure value during the second detection period;

[0213] S5: Check whether the pipeline air pressure change data during the second detection time period matches the preset air pressure change reference data;

[0214] S6: If the pipeline air pressure change data during the second detection period matches the preset air pressure change reference data, then the third connecting pipeline meets the preset requirements.

[0215] Specifically, the specified speed can be understood as the rotational speed of the peristaltic pump under normal operating conditions.

[0216] The first and second detection time periods mentioned above, as well as the preset air pressure change reference data, can be specifically determined in advance by statistically organizing a large amount of experimental test data.

[0217] In practice, based on the preset air pressure change reference data, when the air pressure change data of the pipeline during the second detection period is found to be as follows: during the second detection period, after the pipeline air pressure value drops to a value greater than the outside atmospheric pressure, it remains stable within the air pressure range based on that value. It can be determined that this matches the preset air pressure change reference data. Therefore, it can be determined that the air tightness test of the third connecting pipeline has passed and the third connecting pipeline meets the preset requirements.

[0218] Conversely, if the pipeline air pressure change data during the second detection period shows that the pipeline air pressure value keeps decreasing, even to a level close to the outside atmospheric pressure, it can be determined that it does not match the preset air pressure change reference data; thus, it can be determined that the airtightness test of the third connecting pipeline has failed and the third connecting pipeline does not meet the preset requirements.

[0219] Following a similar approach, by adjusting the state of the relevant solenoid valves and combining a peristaltic pump and a pressure sensor, it is possible to detect with comparable accuracy whether the first connecting pipe, the second connecting pipe, the fourth connecting pipe, the fifth connecting pipe, and the corresponding dispensing pipe, liquid inlet pipe, and other pipelines meet the preset requirements.

[0220] In some embodiments, the above-mentioned self-test rules are used to adjust the state of relevant solenoid valves and combine peristaltic pumps and pressure sensors to detect whether the pipeline and pipe clamps meet preset requirements. For specific implementation, please refer to [reference needed]. Figure 9 As shown, the clamps installed on the first dispensing container can be checked to see if they meet the preset requirements in the following manner:

[0221] S1: According to the preset self-test rules, set the state of the third solenoid valve, the fourth solenoid valve, and the first dispensing valve to the open state, and set the state of the first solenoid valve, the second solenoid valve, and the second dispensing valve to the closed state.

[0222] S2: Control the peristaltic pump to run counterclockwise at a specified speed during the third detection period; and use a pressure sensor to collect the pipeline pressure value during the third detection period;

[0223] S3: Calculate the increase in pipeline pressure during the third detection period based on the pipeline pressure value during the third detection period.

[0224] S4: Detect whether the increase in pipeline air pressure during the third detection time period is less than the preset threshold.

[0225] S5: If the increase in pipeline air pressure during the third detection period is less than the preset threshold, the clamp on the first dispensing container is determined to meet the preset requirements.

[0226] The aforementioned third detection time period and preset amplitude threshold can be specifically determined in advance by statistically organizing a large amount of experimental test data.

[0227] In practice, if the increase in pipeline air pressure during the third detection period is less than the preset threshold, it can be determined that air has entered the first dispensing container normally, the clamp of the first dispensing container is opened normally, and thus it can be determined that the clamp set on the first dispensing container meets the preset requirements.

[0228] Conversely, if the increase in pipeline air pressure during the third detection period is greater than or equal to the preset threshold, it can be determined that air has not entered the first dispensing container normally, the clamp of the first dispensing container has not opened normally, and thus it can be determined that the clamp installed on the first dispensing container does not meet the preset requirements.

[0229] By adjusting the state of the relevant solenoid valves and combining the peristaltic pump and the pressure sensor, it is equally accurate to detect whether the tube clamps installed on other raw material bags (e.g., the first raw material bag and the second raw material bag), mixing bags, and other dispensing containers (e.g., the second dispensing container) meet the preset requirements.

[0230] This allows for targeted self-inspection of the tubing and clamps in the system using existing simple equipment before the actual mixing and dispensing process is carried out according to preset self-inspection rules. This ensures that the preset requirements are met and avoids issues such as the airtightness of the tubing or the condition of the clamps during the subsequent cell fluid dispensing process, which could prevent the automatic dispensing of cell fluid from being completed accurately or cause damage or contamination to the cell fluid during the dispensing process.

[0231] In some embodiments, if a pipeline or clamp is detected to be non-compliant with preset requirements, an error message can be generated and displayed to the user to prompt the user to reconnect and reassemble the corresponding formulation mixing and dispensing system.

[0232] Furthermore, the error message can also include pipe identification information for pipes that do not meet preset requirements, as well as clamp identification information for clamps that do not meet preset requirements. Accordingly, users can also use the pipe identification information and clamp identification information to perform targeted repairs and adjustments to certain specific pipes and clamps in the current formulation mixing and dispensing system.

[0233] In some embodiments, see Figure 10 As shown, the above-mentioned calibration of the first pipeline flow rate during the liquid inlet stage according to the preset first calibration rule may include the following in specific implementation:

[0234] S1: According to the preset first calibration rule, set the state of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve to the open state, and set the state of the second liquid inlet valve to the closed state.

[0235] S2: The initial gravity value of the first raw material bag is obtained by using the first gravity sensor;

[0236] S3: Control the peristaltic pump to run clockwise at a specified speed for a calibration period, then stop the peristaltic pump.

[0237] S4: The final gravity value of the first raw material bag is obtained by using the first gravity sensor;

[0238] S5: Based on the initial gravity value and the final gravity value of the first raw material bag, as well as the calibration time period, determine the calibrated first pipeline flow rate corresponding to the specified speed of the peristaltic pump during the liquid inlet stage.

[0239] Based on the above embodiments, the first pipeline flow rate during the liquid inlet phase of the peristaltic pump can be accurately calibrated and determined at a specified speed.

[0240] In practice, multiple tests can be conducted in the same manner to collect gravity values ​​at multiple time points. These gravity values ​​can then be combined to more accurately determine the calibrated cell fluid flow rate in the pipeline.

[0241] Specifically, for example, the initial gravity value of the first raw material bag is G1 (corresponding to the gravity value collected at the first time point), the gravity value collected after the first calibration interval is G2 (corresponding to the gravity value collected at the second time point)... and the gravity value collected after the (n-1)th calibration interval is Gn (corresponding to the gravity value collected at the nth time point). The duration of the calibration interval is T. Following this method, the calibrated flow velocity of the first pipeline can be calculated as follows:

[0242] After obtaining the calibrated flow rate of the first pipeline, the specific duration of the inlet time for each stock solution bag can be determined by calculating the quotient of the required stock solution volume for each bag and the flow rate of the first pipeline. Specifically, the required volume can be understood as the volume of stock solution needed to prepare the target cell solution.

[0243] For example, when a volume of V1 (i.e., the required amount of the first stock solution) needs to be drawn from the first stock solution bag and fed into the mixing bag, the duration of the liquid feeding time for the first stock solution bag can be calculated as: T1 = V1 / S.

[0244] Accordingly, during the subsequent liquid feeding stage, when controlling the first stock solution bag to feed liquid into the mixing bag, the peristaltic pump can be controlled to run at a specified speed for a duration T1, and then stopped to precisely control the transfer of a volume V1 of the first stock solution from the first stock solution bag to the mixing bag. Then, the control can be switched to feed liquid from the second stock solution bag into the mixing bag.

[0245] In some embodiments, the above-mentioned calibration of the first pipeline flow rate during the liquid inlet stage according to a preset first calibration rule may further include the following: adjusting the state of the relevant solenoid valve and controlling the peristaltic pump to run at a specified speed to pump the first stock solution from the first stock solution bag to the second metering tube; monitoring and recording the first time when the second bubble sensor detects a change value and the second time when the third bubble sensor detects a change value; and determining the calibrated first pipeline flow rate corresponding to the specified speed of the peristaltic pump during the liquid inlet stage based on the volume of the second metering tube, the first time, and the second time.

[0246] The first time mentioned above can refer to the time when the change from air to liquid in the pipeline is detected by the second bubble sensor, and the second time mentioned above can refer to the time when the change from air to liquid in the pipeline is detected by the third bubble sensor.

[0247] In practice, the quotient obtained by dividing the volume of the second metering tube by the difference between the second and first times can be used as the calibrated first pipeline flow rate.

[0248] In some embodiments, according to a preset liquid inlet rule, the state of the solenoid valve of the liquid inlet section is adjusted, and a peristaltic pump and a corresponding gravity sensor are used in combination to sequentially draw the corresponding first stock solution and second stock solution from the first stock solution bag and the second stock solution bag, and transport them to the mixing bag. In specific implementation, the following may be included:

[0249] S1: According to the preset liquid inlet rules, set the state of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve to the open state, and set the state of the third solenoid valve and the second liquid inlet valve to the closed state.

[0250] S2: Control the peristaltic pump to run clockwise at a specified speed, and use the first gravity sensor to monitor the gravity value of the first raw material bag;

[0251] S3: When the gravity value of the first raw material bag decreases from the first gravity value, control the peristaltic pump to stop running; and set the state of the second inlet valve to the open state and the state of the first inlet valve to the closed state.

[0252] S4: Control the peristaltic pump to run clockwise at a specified speed, and use the second gravity sensor to monitor the gravity value of the second raw material bag;

[0253] S5: When the gravity value of the second raw material bag is detected to have decreased, control the peristaltic pump to stop running.

[0254] The first and second gravity values ​​can be set according to specific packaging requirements. For example, the first gravity value can be 1.5N and the second gravity value can be 2N.

[0255] Specifically, the process of sequentially drawing the corresponding first stock solution and second stock solution from the first stock solution bag and the second stock solution bag and transporting them to the mixing bag can refer to first drawing the required amount of first stock solution from the first stock solution bag and transporting it to the mixing bag; then drawing the required amount of second stock solution from the second stock solution bag and transporting it to the mixing bag.

[0256] In practice, if there is a third stock solution bag and the third stock solution stored in the third stock solution bag needs to be transported to a mixing bag for mixing, the above steps can be repeated to draw the required amount of third stock solution from the third stock solution bag and transport it to the mixing bag.

[0257] Based on the above embodiments, the above-described formulation mixing and dispensing system can be used to accurately extract and control the required amounts of the first and second stock solutions and transport them into the mixing bag.

[0258] In some embodiments, according to a preset liquid inlet rule, the state of the solenoid valve of the liquid inlet section is adjusted, and a peristaltic pump and a corresponding gravity sensor are used to sequentially draw the corresponding first stock solution and second stock solution from the first stock solution bag and the second stock solution bag, and transport them to the mixing bag. In specific implementations, the following may also be included:

[0259] S1: According to the preset liquid inlet rules, set the state of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve to the open state, and set the state of the third solenoid valve and the second liquid inlet valve to the closed state.

[0260] S2: Control the peristaltic pump to run clockwise at a specified speed for the first liquid inlet time period, and then control the peristaltic pump to stop running; wherein, the duration of the first liquid inlet time period is equal to the ratio of the required amount of the first raw liquid to the flow rate of the first pipeline;

[0261] S3: Set the state of the second inlet valve to open and the state of the first inlet valve to closed;

[0262] S4: Control the peristaltic pump to run clockwise at a specified speed for the second liquid inlet time period, and then control the peristaltic pump to stop running; wherein, the duration of the second liquid inlet time period is equal to the ratio of the required amount of the second raw liquid to the flow rate of the first pipeline.

[0263] In some embodiments, the above-mentioned mixing unit controls the cell fluid in the mixing bag to be mixed within a specified temperature range according to a preset mixing rule in order to obtain the target cell fluid that meets the requirements. In specific implementation, it may include the following:

[0264] S1: According to the preset mixing rules, obtain the current volume parameters of the mixing bag and the current temperature parameters of the cooling plate;

[0265] S2: Generate matching control parameters based on the current volume parameters of the mixing bag; and based on these control parameters, adjust the pressing speed and / or pressing amplitude of the moving body driving the mixing plate to press the mixing bag through the motor;

[0266] S3: Detects whether the current temperature parameter of the cooling plate is higher than the preset temperature threshold;

[0267] S4: If the current temperature parameter of the cooling plate is determined to be higher than the preset temperature threshold, start the cooling module to cool down the cooling plate.

[0268] Specifically, the pressing amplitude can be adjusted by changing the maximum interval between the mixing plate and the mixing bag, as well as the acceleration of the mixing plate.

[0269] In practice, when the amount of cell fluid transported to the mixing bag is small and the volume parameter is small, matching control parameters can be generated and used to control the mixing plate to mix the mixing bag at a lower pressing speed and / or a smaller pressing amplitude. In this way, while ensuring that the cell fluid in the mixing bag is mixed and has good consistency, the force applied to the mixing bag can be reduced to avoid excessive force that could damage the cell fluid.

[0270] When the amount of cell fluid transported to the mixing bag is large and the volume parameters are high, matching control parameters can be generated and used to control the mixing plate to mix the mixing bag at a higher pressing speed and / or a larger pressing amplitude. This effectively ensures that the cell fluid in the mixing bag is thoroughly mixed, resulting in a more consistent mixture.

[0271] Specifically, the aforementioned pre-defined mixing rules also include a mapping model between volume parameters and control parameters. Correspondingly, the volume parameters can be substituted into the mapping model to determine the corresponding control parameters. This mapping model can be pre-constructed using a large amount of experimental test data through data fitting.

[0272] The preset temperature threshold can be the upper limit of a specified temperature range.

[0273] Because the cooling plate is close to or even in direct contact with the mixing bag, the current temperature parameters of the cooling plate can characterize the current temperature of the cell solution in the mixing bag.

[0274] In practice, when the current temperature parameter of the cooling plate is detected to be higher than the preset temperature threshold, it can be determined that the current temperature of the cell fluid is greater than the upper limit of the specified temperature range. The cooling module can then be automatically activated to cool the cooling plate. Conversely, when the current temperature parameter of the cooling plate is detected to be lower than the lower limit of the specified temperature range, the cooling module can be automatically shut down. This effectively ensures that the temperature of the cell fluid is maintained within the specified temperature range.

[0275] In some embodiments, the mixing unit may also be equipped with a camera. The camera faces the mixing bag and is connected to the processor. The mixing bag may be made of a transparent material.

[0276] In practice, during the mixing process, the camera can capture images containing the mixing bag at preset time intervals (e.g., every minute) and send these images to the processor. The processor can process the images using a pre-trained image detection model to identify cells in the images; then, based on the cells in the images, it can determine the cell density distribution through statistical analysis; based on the cell density distribution, it can determine the current mixing progress; and based on the current mixing progress, it can generate matching control parameters to adjust the pressing speed and / or pressing amplitude of the mixing plate when pressing the mixing bag. This allows for more precise and effective control of the mixing process, resulting in better mixing effects.

[0277] In some embodiments, see Figure 11 As shown, the second pipeline flow rate during the dispensing stage is calibrated according to the preset second calibration rule. In specific implementation, this may include the following:

[0278] S1: According to the preset second calibration rule, set the state of the second solenoid valve and the fourth solenoid valve to the open state, and set the state of the fifth solenoid valve, the first solenoid valve and the third solenoid valve to the closed state.

[0279] S2: Control the peristaltic pump to run counterclockwise at a specified speed, monitor and record the first time when the second bubble sensor detects a change in value, and the second time when the third bubble sensor detects a change in value;

[0280] S3: Based on the volume of the first metering tube, the first time, and the second time, determine the calibrated second pipeline flow rate corresponding to the specified speed of the peristaltic pump during the dispensing stage.

[0281] Based on the above embodiments, the flow rate of the second pipeline can be accurately calibrated and determined when the peristaltic pump is running at a specified speed during the dispensing stage.

[0282] After obtaining the calibrated flow rate of the second pipeline, the specific duration of the dispensing time for each dispensing container can be determined by calculating the quotient of the specified volume of the target cell fluid to be dispensed in each dispensing container and the flow rate of the second pipeline.

[0283] In some embodiments, the above-mentioned pre-filling operation, which involves adjusting the state of the fifth solenoid valve according to a preset pre-filling rule and using a peristaltic pump to pre-fill the pipeline between the third and fifth solenoid valves, may specifically include:

[0284] S1: According to the preset pre-filling rule, set the state of the fifth solenoid valve and the second solenoid valve to the open state, and set the state of the third solenoid valve and the fourth solenoid valve to the closed state.

[0285] S2: Control the peristaltic pump to run counterclockwise at a specified speed so that the pipeline between the third solenoid valve and the fifth solenoid valve is pre-filled with target cell fluid.

[0286] See Figure 1 As shown, during the dispensing stage, by performing the aforementioned pre-filling operation, the tubing below the third solenoid valve can be filled with the target cell fluid before dispensing the target solution into the dispensing container. This allows for precise control of the dispensing operation, starting from the third solenoid valve, to accurately input and dispense the specified volume of target cell fluid into the dispensing container, while minimizing the consumption and waste of the target cell fluid.

[0287] In some embodiments, see Figure 12 As shown, according to the preset dispensing rules, the target cell solution in the mixing bag is transported to the first dispensing container and the second dispensing container respectively by adjusting the state of the solenoid valve of the dispensing unit and using a peristaltic pump. In specific implementation, it may include the following:

[0288] S1: According to the preset dispensing rules, the states of the second dispensing valve, the second solenoid valve, and the fourth solenoid valve are set to the open state; and the peristaltic pump is controlled to run counterclockwise at a specified speed for a dispensing period, so as to fill the pipeline between the third solenoid valve and the second dispensing container in the third connecting pipeline with the corresponding target cell fluid; wherein, the duration of the dispensing period is determined according to the specified volume of the target cell fluid to be dispensed in the dispensing container and the flow rate of the second pipeline;

[0289] S2: Set the first dispensing valve to the open state and the second dispensing valve to the closed state; and control the peristaltic pump to run counterclockwise for the specified dispensing time period to input the corresponding target cell fluid into the first dispensing container;

[0290] S3: Set the state of the fifth solenoid valve and the second solenoid valve to the open state, and set the state of the first dispensing valve and the third solenoid valve to the closed state; and control the peristaltic pump to run clockwise at a specified speed to fill in air, and use the filled air to push the target cell fluid in the pipeline between the third solenoid valve and the mixing bag back to the mixing bag.

[0291] S4: Set the third solenoid valve, the fourth solenoid valve, and the second dispensing valve to the open state, and set the fifth solenoid valve and the second solenoid valve to the closed state; and control the peristaltic pump to run counterclockwise at a specified speed to input the corresponding target cell fluid into the second dispensing container;

[0292] S5: Set the state of the first dispensing valve to the open state and the state of the second dispensing valve to the closed state; and control the peristaltic pump to run counterclockwise at a specified speed to input the target cell fluid in the first dispensing pipeline into the first dispensing container.

[0293] Specifically, the designated volume of the target cell solution to be dispensed into the dispensing container can be denoted as V, and the calibrated flow rate of the second tubing can be denoted as S2. Correspondingly, the specific duration of the dispensing time can be expressed as: V / S2.

[0294] It should be noted that the specified volume may be the same or different for different repackaging containers.

[0295] Based on the above embodiments, the formulation mixing and dispensing system can accurately transport and dispense a specified volume of target cell fluid into the corresponding dispensing containers; at the same time, it can reduce the loss and waste of cell fluid.

[0296] When there are more dispensing containers that need to be dispensed with the target cell solution, the above-described steps can be repeated to sequentially transport and dispense the target cell solution into other dispensing containers. This instruction manual will not elaborate further on this.

[0297] In some embodiments, the above-mentioned exhaust treatment of the first and second dispensing containers is performed by adjusting the state of the solenoid valve of the dispensing section according to a preset exhaust rule, and by using a peristaltic pump and a pressure sensor. In specific implementation, it may include the following:

[0298] S1: According to the preset exhaust rules, set the first dispensing valve, the second dispensing valve, and the third solenoid valve to the open state, and control the peristaltic pump to run clockwise at a specified speed to exhaust the first dispensing container and the second dispensing container.

[0299] S2: Use a pressure sensor to monitor the pressure value of the third connecting pipe;

[0300] S3: When the air pressure in the third connecting pipe is detected to be less than or equal to the preset air pressure threshold, the peristaltic pump will stop operating.

[0301] Based on the above embodiments, residual air in the dispensing container can be effectively emptied, so that the target cell fluid in the dispensing container can be better preserved and used subsequently.

[0302] In some embodiments, after obtaining a dispensing container containing the target cell fluid, the dispensing container can be frozen for later use.

[0303] As can be seen from the above, based on the formulation mixing and dispensing method provided in the embodiments of this specification, using the formulation mixing and dispensing system with at least the following structure (including a liquid inlet section, a mixing section, a dispensing section, and a peristaltic pump), when specifically performing cell fluid formulation mixing and dispensing, the system can first, according to preset self-test rules, adjust the state of relevant solenoid valves and combine the peristaltic pump and pressure sensor to detect whether the tubing and clamps meet preset requirements; if the tubing and clamps meet the preset requirements, calibrate the first tubing flow rate in the liquid inlet stage according to preset first calibration rules; according to preset liquid inlet rules, adjust the state of the solenoid valve in the liquid inlet section and combine the peristaltic pump and corresponding gravity sensor to sequentially dispense the first original liquid... The first and second stock solutions are drawn from the first and second stock solution bags and transported to the mixing bag. According to a preset mixing rule, the mixing unit is controlled within a specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements. According to a preset second calibration rule, the flow rate of the second pipeline in the dispensing stage is calibrated. According to a preset pre-filling rule, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to pre-fill the pipeline between the third and fifth solenoid valves. According to a preset dispensing rule, the state of the solenoid valves in the dispensing unit is adjusted, and a peristaltic pump is used to transport the target cell solution from the mixing bag to the first and second dispensing containers respectively. This allows for relatively efficient and accurate automatic mixing and dispensing of cell solution preparations, and effectively reduces damage and contamination of the cell solution during the mixing and dispensing process, minimizing cell solution loss and waste.

[0304] This specification provides an electronic device through its embodiments. (See attached document.) Figure 13 As shown. The electronic device includes a network communication port 1301, a processor 1302, and a memory 1303. These structures are connected by internal cables so that they can perform specific data interaction.

[0305] Specifically, the network communication port 1301 can be used to receive mixed packaging instructions.

[0306] The processor 1302 can specifically be used to respond to mixing and dispensing commands, and according to preset self-test rules, adjust the state of relevant solenoid valves and combine a peristaltic pump and a pressure sensor to detect whether the pipeline and clamp meet preset requirements; if the pipeline and clamp meet the preset requirements, calibrate the flow rate of the first pipeline in the liquid inlet stage according to preset first calibration rules; according to preset liquid inlet rules, adjust the state of the solenoid valve of the liquid inlet section and combine a peristaltic pump and a corresponding gravity sensor to sequentially draw the corresponding first and second raw materials from the first raw material bag and the second raw material bag, and transport them to the mixing... In the mixing bag; according to the preset mixing rules, the mixing section is controlled within a specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements; according to the preset second calibration rules, the flow rate of the second pipeline in the dispensing stage is calibrated; according to the preset pre-filling rules, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to pre-fill the pipeline between the third and fifth solenoid valves; according to the preset dispensing rules, the state of the solenoid valves in the dispensing section is adjusted, and a peristaltic pump is used to transport the target cell solution in the mixing bag to the first dispensing container and the second dispensing container respectively.

[0307] The memory 1303 can be used to store the corresponding instruction program.

[0308] In this embodiment, the network communication port 1301 can be a virtual port bound to different communication protocols, thereby enabling the sending or receiving of different data. For example, the network communication port can be a port responsible for web data communication, a port responsible for FTP data communication, or a port responsible for email data communication. Furthermore, the network communication port can also be a physical communication interface or communication chip. For example, it can be a wireless mobile network communication chip, such as GSM or CDMA; it can also be a Wi-Fi chip; or it can be a Bluetooth chip.

[0309] In this embodiment, the processor 1302 can be implemented in any suitable manner. For example, the processor can take the form of a microprocessor or processor and a computer-readable medium storing computer-readable program code (e.g., software or firmware) executable by the (micro)processor, logic gates, switches, application-specific integrated circuits (ASICs), programmable logic controllers, and embedded microcontrollers, etc. This specification is not limiting.

[0310] In this embodiment, the memory 1303 may include multiple layers. In a digital system, anything that can store binary data can be a memory. In an integrated circuit, a circuit with storage function but no physical form is also called a memory, such as RAM, FIFO, etc. In a system, a storage device with a physical form is also called a memory, such as a memory stick, TF card, etc.

[0311] This specification also provides a computer-readable storage medium based on the above-described formulation mixing and dispensing method. The computer-readable storage medium stores computer program instructions that, when executed, perform the following steps: According to preset self-test rules, by adjusting the state of relevant solenoid valves and combining a peristaltic pump and a pressure sensor, detect whether the tubing and clamps meet preset requirements; if the tubing and clamps meet the preset requirements, calibrate the first tubing flow rate during the liquid inlet stage according to a preset first calibration rule; according to the preset liquid inlet rule, by adjusting the state of the solenoid valves in the liquid inlet section and combining a peristaltic pump and a corresponding gravity sensor, sequentially inlet the first original liquid... The corresponding first and second stock solutions are drawn from the first and second stock solution bags and transported to the mixing bag. According to the preset mixing rules, the mixing section is controlled within a specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements. According to the preset second calibration rules, the flow rate of the second pipeline in the dispensing stage is calibrated. According to the preset pre-filling rules, the state of the fifth solenoid valve is adjusted and a peristaltic pump is used to pre-fill the pipeline between the third and fifth solenoid valves. According to the preset dispensing rules, the state of the solenoid valves in the dispensing section is adjusted and a peristaltic pump is used to transport the target cell solution in the mixing bag to the first dispensing container and the second dispensing container, respectively.

[0312] In this embodiment, the storage medium includes, but is not limited to, Random Access Memory (RAM), Read-Only Memory (ROM), cache, hard disk drive (HDD), or memory card. The memory can be used to store computer program instructions. The network communication unit can be an interface configured according to the standards specified in the communication protocol for network connection communication.

[0313] In this embodiment, the specific functions and effects implemented by the program instructions stored in the computer-readable storage medium can be explained in comparison with other embodiments, and will not be repeated here.

[0314] This specification also provides a computer program product, comprising at least a computer program, which, when executed by a processor, performs the following method steps: Based on preset self-test rules, by adjusting the state of relevant solenoid valves and combining a peristaltic pump and a pressure sensor, respectively detect whether the pipeline and clamp meet preset requirements; if the pipeline and clamp meet the preset requirements, calibrate the first pipeline flow rate during the liquid inlet stage according to a preset first calibration rule; based on preset liquid inlet rules, by adjusting the state of the solenoid valve in the liquid inlet section and combining a peristaltic pump and a corresponding gravity sensor, sequentially draw corresponding amounts of liquid from the first stock solution bag and the second stock solution bag. The first and second stock solutions are transported into a mixing bag; according to a preset mixing rule, the mixing unit is controlled within a specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements; according to a preset second calibration rule, the flow rate of the second pipeline in the dispensing stage is calibrated; according to a preset pre-filling rule, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to pre-fill the pipeline between the third and fifth solenoid valves; according to a preset dispensing rule, the state of the solenoid valve in the dispensing unit is adjusted, and a peristaltic pump is used to transport the target cell solution in the mixing bag to the first dispensing container and the second dispensing container respectively.

[0315] See Figure 14 As shown in the embodiments of this specification, a formulation mixing and dispensing device is also provided, which may specifically include the following structural modules:

[0316] The self-test module 1401 can be used to check whether the pipeline and pipe clamp meet the preset requirements by adjusting the state of the relevant solenoid valves and combining the peristaltic pump and the air pressure sensor according to the preset self-test rules.

[0317] The first calibration module 1402 can be used to calibrate the first pipeline flow rate during the liquid inlet stage according to the preset first calibration rule, provided that the pipeline and clamp meet the preset requirements.

[0318] The liquid inlet module 1403 can be used to, under the condition that the pipeline and clamp meet the preset requirements, according to the preset liquid inlet rules, adjust the state of the solenoid valve of the liquid inlet section, and combine the peristaltic pump and the corresponding gravity sensor to sequentially draw the corresponding first liquid and second liquid from the first liquid bag and the second liquid bag and transport them to the mixing bag.

[0319] The mixing module 1404 can be used to control the mixing unit to mix the cell fluid in the mixing bag within a specified temperature range according to the preset mixing rules, so as to obtain the target cell fluid that meets the requirements.

[0320] The second calibration module 1405 can be used to calibrate the flow rate of the second pipeline during the dispensing stage according to the preset second calibration rules.

[0321] The pre-filling module 1406 can be used to pre-fill the pipeline between the third and fifth solenoid valves by adjusting the state of the fifth solenoid valve and using a peristaltic pump according to a preset pre-filling rule.

[0322] The dispensing module 1407 can be used to transport the target cell fluid in the mixing bag to the first dispensing container and the second dispensing container respectively by adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump according to the preset dispensing rules.

[0323] In some embodiments, the device may further include an exhaust module, which is specifically used to exhaust the first and second dispensing containers by adjusting the state of the solenoid valve of the dispensing section according to a preset exhaust rule, and by using a peristaltic pump and a pressure sensor.

[0324] In some embodiments, when the self-test module 1401 is specifically implemented, it can detect whether the third connecting pipeline meets the preset requirements in the following manner: according to the preset self-test rules, the state of the third solenoid valve and the fourth solenoid valve is set to the open state, and the state of the dispensing valve, the first solenoid valve, and the second solenoid valve is set to the closed state; the peristaltic pump is controlled to run counterclockwise at a specified speed for a first detection period and then stop, and the state of the third solenoid valve and the fourth solenoid valve is set to the closed state; the pipeline air pressure value is collected using an air pressure sensor for a second detection period; the pipeline air pressure change data for the second detection period is determined based on the pipeline air pressure value for the second detection period; the pipeline air pressure change data for the second detection period is detected to match the preset air pressure change reference data; if the pipeline air pressure change data for the second detection period is determined to match the preset air pressure change reference data, the third connecting pipeline is determined to meet the preset requirements.

[0325] In some embodiments, when the self-test module 1401 is specifically implemented, it can detect whether the tube clamp set on the dispensing container meets the preset requirements in the following manner: according to the preset self-test rules, the state of the third solenoid valve, the fourth solenoid valve, and the first dispensing valve is set to the open state, and the state of the first solenoid valve, the second solenoid valve, and the second dispensing valve is set to the closed state; the peristaltic pump is controlled to run counterclockwise at a specified speed for a third detection period; and the pipeline air pressure value is collected using an air pressure sensor during the third detection period; the pipeline air pressure increase during the third detection period is calculated based on the pipeline air pressure value during the third detection period; the pipeline air pressure increase during the third detection period is detected to be less than a preset threshold value; if it is determined that the pipeline air pressure increase during the third detection period is less than the preset threshold value, the tube clamp set on the first dispensing container meets the preset requirements.

[0326] In some embodiments, when the first calibration module 1402 is specifically implemented, the first pipeline flow rate during the liquid inlet stage can be calibrated according to the following preset first calibration rules: according to the preset first calibration rules, the states of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve are set to the open state, and the state of the second liquid inlet valve is set to the closed state; the initial gravity value of the first raw material bag is collected using the first gravity sensor; after controlling the peristaltic pump to run clockwise at a specified speed for a calibration period, the peristaltic pump is stopped; the final gravity value of the first raw material bag is collected using the first gravity sensor; based on the initial gravity value and the final gravity value of the first raw material bag, and the calibration period, the calibrated first pipeline flow rate corresponding to the specified speed of the peristaltic pump during the liquid inlet stage is determined.

[0327] In some embodiments, when the above-described liquid inlet module 1403 is specifically implemented, it can be carried out in the following manner: according to a preset liquid inlet rule, by adjusting the state of the solenoid valve of the liquid inlet section, and by combining a peristaltic pump and a corresponding gravity sensor, the corresponding first and second raw liquids are sequentially drawn from the first raw liquid bag and the second raw liquid bag and transported to the mixing bag: according to the preset liquid inlet rule, the states of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve are set to the open state, and the states of the third solenoid valve and the second liquid inlet valve are set to the closed state; the peristaltic pump is controlled to run clockwise at a specified speed, and the gravity value of the first raw liquid bag is monitored using the first gravity sensor; when the gravity value of the first raw liquid bag is detected to have decreased by the first gravity value, the peristaltic pump is controlled to stop running; the state of the second liquid inlet valve is set to the open state, and the state of the first liquid inlet valve is set to the closed state; the peristaltic pump is controlled to run clockwise at a specified speed, and the gravity value of the second raw liquid bag is monitored using the second gravity sensor; when the gravity value of the second raw liquid bag is detected to have decreased by the second gravity value, the peristaltic pump is controlled to stop running.

[0328] In some embodiments, when the above-described mixing module 1404 is specifically implemented, it can control the mixing unit to mix the cell fluid in the mixing bag within a specified temperature range according to a preset mixing rule in the following manner to obtain the target cell fluid that meets the requirements: according to the preset mixing rule, the current volume parameters of the mixing bag and the current temperature parameters of the cooling plate are obtained; according to the current volume parameters of the mixing bag, matching control parameters are generated; and based on the control parameters, the pressing speed and / or pressing amplitude of the moving body driving the mixing plate to press the mixing bag are adjusted by the motor; it is detected whether the current temperature parameters of the cooling plate are higher than a preset temperature threshold; if it is determined that the current temperature parameters of the cooling plate are higher than the preset temperature threshold, the cooling module is activated to cool and lower the temperature of the cooling plate.

[0329] In some embodiments, when the second calibration module 1405 is specifically implemented, the second pipeline flow rate during the dispensing stage can be calibrated according to the preset second calibration rule in the following manner: according to the preset second calibration rule, the states of the second solenoid valve and the fourth solenoid valve are set to the open state, and the states of the fifth solenoid valve, the first solenoid valve, and the third solenoid valve are set to the closed state; the peristaltic pump is controlled to run counterclockwise at a specified speed, and the first time when the second bubble sensor detects a change value and the second time when the third bubble sensor detects a change value are monitored and recorded; based on the volume of the first metering tube, the first time, and the second time, the calibrated second pipeline flow rate corresponding to the specified speed of the peristaltic pump during the dispensing stage is determined.

[0330] In some embodiments, when the pre-filling module 1406 is specifically implemented, it can perform a pre-filling operation on the pipeline between the third and fifth solenoid valves by adjusting the state of the fifth solenoid valve and using a peristaltic pump according to a preset pre-filling rule: according to the preset pre-filling rule, the states of the fifth and second solenoid valves are set to the open state, and the states of the third and fourth solenoid valves are set to the closed state; the peristaltic pump is controlled to run counterclockwise at a specified speed so that the pipeline between the third and fifth solenoid valves is pre-filled with target cell fluid.

[0331] In some embodiments, when the above-described dispensing module 1404 is specifically implemented, it can be carried out in the following manner: according to a preset dispensing rule, by adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump, the target cell fluid in the mixing bag is transported to the first dispensing container and the second dispensing container respectively: according to the preset dispensing rule, the states of the second dispensing valve, the second solenoid valve, and the fourth solenoid valve are set to the open state; and the peristaltic pump is controlled to run counterclockwise at a specified speed for a dispensing time period, so as to fill the pipeline between the third solenoid valve and the second dispensing container in the third connecting pipeline with the corresponding target cell fluid; wherein, the duration of the dispensing time period is determined according to the specified volume of the target cell fluid to be dispensed in the dispensing container and the flow rate of the second pipeline; the state of the first dispensing valve is set to the open state, and the state of the second dispensing valve is set to the closed state; and the peristaltic pump is controlled to run counterclockwise at a specified speed for a dispensing time period. The process involves several steps: First, the target cell solution is fed into the first dispensing container. The fifth and second solenoid valves are set to open, while the first and third dispensing valves are set to closed. A peristaltic pump is controlled to rotate clockwise at a specified speed to introduce air, which then pushes the target cell solution in the tubing between the third solenoid valve and the mixing bag back into the mixing bag. Next, the third, fourth, and second dispensing valves are set to open, while the fifth and second solenoid valves are set to closed. The peristaltic pump is controlled to rotate counter-clockwise at a specified speed to feed the target cell solution into the second dispensing container. Finally, the first dispensing valve is set to open, and the second dispensing valve is set to closed. The peristaltic pump is controlled to rotate counter-clockwise at a specified speed to feed the target cell solution from the first dispensing tubing into the first dispensing container.

[0332] In some embodiments, when the above-described exhaust module is specifically implemented, it can perform exhaust treatment on the first and second sub-containers according to the following method based on preset exhaust rules: by adjusting the state of the solenoid valve of the sub-container and using a peristaltic pump and a pressure sensor; setting the states of the first sub-container valve, the second sub-container valve, and the third solenoid valve to the open state according to preset exhaust rules; controlling the peristaltic pump to run clockwise at a specified speed to perform exhaust operation on the first and second sub-containers; using a pressure sensor to monitor the pressure value of the third connecting pipe; and stopping the operation of the peristaltic pump when the pressure value of the third connecting pipe is less than or equal to a preset pressure threshold.

[0333] It should be noted that the units, devices, or modules described in the above embodiments can be implemented by computer chips or physical entities, or by products with certain functions. For ease of description, the above devices are described by dividing them into various modules according to their functions. Of course, in implementing this specification, the functions of each module can be implemented in one or more software and / or hardware, or the module that implements the same function can be implemented by a combination of multiple sub-modules or sub-units, etc. The device embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and there may be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection between the devices or units shown or discussed can be through some interfaces, and the indirect coupling or communication connection between devices or units can be electrical, mechanical, or other forms.

[0334] As can be seen from the above, the formulation mixing and dispensing device provided in the embodiments of this specification can realize the automatic mixing and dispensing of cell fluid formulations with relatively high efficiency and accuracy; and effectively reduce the damage and contamination of cell fluid during the mixing and dispensing process, and reduce the consumption and waste of cell fluid.

[0335] In a specific scenario example, the formulation mixing and dispensing system and method provided in this manual can be used to construct a fully enclosed, high-precision formulation dispensing system. For detailed implementation procedures, please refer to the following content.

[0336] In this scenario example, the constructed fully enclosed high-precision formulation dispensing system includes: fully enclosed disposable consumable tubing (e.g., first connecting tubing, second connecting tubing, third connecting tubing, fourth connecting tubing, dispensing tubing, liquid inlet tubing, etc.), a system self-test device, a calibration device, a sample injection device (e.g., liquid inlet section), a mixing device (e.g., mixing section), a temperature control device, a high-precision dispensing control (e.g., dispensing section), an automatic venting device, and a complete set of software control programs. It can automatically complete the entire dispensing process—system self-test, formulation injection, mixing, dispensing, and venting—within the fully enclosed tubing. Compared to manual cell fluid dispensing, it offers higher product precision, more reliable quality, and faster production efficiency. (See also...) Figure 15 As shown.

[0337] Based on the aforementioned fully enclosed high-precision formulation dispensing system, the fully enclosed consumable tubing is first installed, and the cell stock solution bag, mixing solution bag, and dispensing solution bag are welded using a sterile connector. After a self-inspection confirms that the consumables are installed correctly, the injection device pumps multiple cell stock solutions sequentially into the mixing bag using a peristaltic pump according to a specified order, speed, and volume. The mixing device presses the mixing bag to thoroughly mix the cell stock solutions. Then, through high-precision dispensing control, the cell solutions are precisely dispensed into each dispensing solution bag according to the set values. Finally, the residual air in the dispensing solution bags is purged by an automatic venting device, and the heat-sealed dispensing solution bags can be directly cryopreserved as cell therapy products for clinical use.

[0338] In practice, firstly, fully enclosed disposable consumables can be used in conjunction with equipment such as aseptic connectors and heat sealers to ensure that the cell fluid is not in contact with the outside during the entire process of cell fluid dispensing, thus avoiding cell fluid contamination and making cell processing safer.

[0339] Next, the system self-test device can be used to self-test and verify the installation and airtightness of disposable consumables, including airtightness testing after sterile connection.

[0340] This is because most consumables for fully enclosed pipelines require manual installation, which inevitably leads to errors. The system self-test can detect the airtightness of the pipeline consumables and the on / off status of the clamp valves in advance through the status of each sensor. If any abnormality occurs, an alarm will be triggered in time, prompting manual correction.

[0341] For specific self-check instructions, please refer to... Figure 16 As shown, it may include the following:

[0342] 1) Perform an airtightness test: Close the solenoid valve, and the peristaltic pump will rotate counterclockwise at the set speed for a certain period of time and then stop, so that high pressure is formed in the pipeline. The air pressure sensor monitors the change of air pressure value in the main pipeline in real time. If the air pressure value is constant within a certain range, it indicates that the pipeline is airtight; if the air pressure value continues to decrease, it indicates that the pipeline is leaking and the airtightness is poor.

[0343] 2) Perform tube clamp opening detection: Open solenoid valve No. 1, and the peristaltic pump will rotate counterclockwise at a set speed for a certain period of time, causing air flow in the pipeline. A certain amount of air will enter the main pipeline. Monitor the pressure value of the air pressure sensor. If the air pressure increases beyond the set threshold, it means that air has not entered bag No. 1, and the tube clamp of bag No. 1 has not opened. This process can be repeated to check whether the tube clamps of dispensing containers No. 1, 2, and 3 are open, allowing for early detection of potential risks during cell dispensing.

[0344] Then, the calibration device is calibrated. The flow rate of the cell fluid is calculated by measuring the difference in the value of the high-precision gravity sensor per unit time when the cell stock solution is injected.

[0345] For specific calibration procedures, please refer to [link / reference]. Figure 17 As shown, it may include the following:

[0346] Calibration using a gravity sensor: Before injecting the specific cell stock solution, the value G1 in the liquid bag of the gravity sensor is read. The peristaltic pump starts rotating and stops after a set time T. The value G2 in the liquid bag of the gravity sensor at this moment is read, and the liquid flow rate can be calculated. The flow rate is then calibrated by averaging multiple calculations.

[0347] For specific calibration instructions, please refer to [link / reference]. Figure 18 As shown, it may include the following:

[0348] When calibrating using a metering tube (e.g., a second metering tube), a peristaltic pump can be controlled to pump liquid into the metering tube at a set speed. The volume of the metering tube is v. Bubble sensor 1 (e.g., a second bubble sensor) monitors in real time, and the time when liquid enters the metering tube is recorded as t1. Liquid continues to enter the metering tube, and bubble sensor 2 (e.g., a third bubble sensor) monitors in real time. The time when liquid fills the metering tube is recorded as t2. By calculation, when the peristaltic pump operates at this speed, the liquid flow rate is s = v / (t2-t1).

[0349] Next, the sample introduction device can be used to execute the sample introduction process (i.e., the liquid introduction process) to control the volume, rate, and sequence of the cell stock solution introduced. For example, it can support the introduction of three different stock solutions.

[0350] For specific sample injection procedures, please refer to [link / reference]. Figure 19 As shown, it may include the following:

[0351] Opening the designated solenoid valve causes the peristaltic pump to rotate clockwise, injecting the cell culture medium into the mixing bag. The injection volume can be determined by real-time readings of the gravity sensor. The injection flow rate can be controlled by adjusting the peristaltic pump speed, and the injection sequence can be controlled by the opening sequence of the solenoid valves. Setting the injection parameters in the software program allows the cell culture medium to enter the mixing bag in a set ratio and order.

[0352] To begin sample injection, open valves 0 and 1, and record the initial reading A1 on scale 1. The peristaltic pump rotates clockwise at the set speed, and the cell stock solution from bag 1 begins to enter the mixing bag. Monitor the scale 1 reading in real time. When the injected volume reaches the set volume ΔA, the scale 1 reading becomes A2 (A2 = A1 - ΔA). The peristaltic pump stops rotating, the injection of solution 1 is complete, and valve 1 closes. Next, open valves 0 and 2, and record the initial reading B1 on scale 2. The peristaltic pump rotates clockwise at the set speed, and the cell stock solution from bag 2 begins to enter the mixing bag. Monitor the scale 2 reading in real time. When the injected volume reaches the set volume ΔB, the scale 2 reading becomes B2 (B2 = B1 - ΔB). The peristaltic pump stops rotating, the injection of solution 2 is complete, and valve 2 closes. Open valves 0 and 3, record the reading C1 on scale 3 for the first time, the peristaltic pump rotates clockwise at the set speed, and the cell stock solution in bag 3 begins to enter the mixing bag. Monitor the change of scale reading C in real time. When the injection reaches the set liquid volume ΔC, the scale 3 reading is C2 (C2 = C1 - ΔC), the peristaltic pump stops rotating, the injection of liquid 3 is completed, and valve 3 is closed.

[0353] Then, a mixing device can be used to press the outside of the mixing bag with a mixing plate to fully mix the injected cell stock solution, thereby ensuring the uniformity of cell density in each dispensing container after the cell solution is dispensed.

[0354] For details, please refer to Figure 2 As shown, the mixing plate is powered by a motor and moves back and forth at a set speed. The displacement of the mixing plate exerts pressure on the mixing bag. When the mixing plate moves toward the bag, it presses the liquid bag to provide kinetic energy, causing the liquid inside the bag to flow. At the same time, the liquid level in the bag rises, and some of the kinetic energy is converted into gravitational potential energy. When the mixing bag moves away from the bag, it releases the liquid bag, causing the liquid level in the bag to drop and releasing gravitational potential energy. This cycle repeats, thereby causing the liquid inside the bag to flow and producing a mixing effect.

[0355] During the mixing process, it is also important to use a temperature control device for temperature control. Specifically, temperature control is achieved by turning the refrigeration equipment on and off to keep the temperature in the mixing zone between 2-8℃, effectively protecting the cells and ensuring that the cell viability meets the requirements after aliquoting.

[0356] For details, please refer to Figure 3 As shown, it includes the following:

[0357] 1) Cooling through heat conduction. The system reads the temperature sensor value in real time. If the temperature is higher than the target temperature, the cooling fan turns on, the airflow carries away the heat, and the cooling metal plate cools down. This allows the heat of the cell fluid in the mixing bag to be conducted to the metal plate through the contact surface between the mixing bag and the metal plate, thereby reducing the temperature of the cell fluid in the mixing bag.

[0358] 2) The automatic on / off switching of the refrigeration equipment is controlled by a temperature control switch, ensuring that the temperature remains within a preset range. After the temperature control system is activated, a temperature sensor monitors the real-time temperature of the mixing zone. If the detected temperature exceeds the set upper temperature limit T1℃, the refrigeration unit automatically turns on to rapidly cool the mixing zone. When the temperature sensor detects that the mixing zone temperature is below the set lower temperature limit T2℃, the refrigeration unit automatically turns off, and cooling ceases. After cooling stops, the mixing zone gradually heats up. When the temperature reaches the set upper temperature limit T1℃, the refrigeration unit automatically turns on again to rapidly cool the mixing zone. This cycle repeats, ensuring that the mixing zone temperature remains within the set temperature range T1-T2 through the constant on / off switching of the refrigeration unit.

[0359] Next, a high-precision dispensing device is used for dispensing. Based on high-precision dispensing control, the flow rate of cell fluid can be calculated by measuring the difference in the value of a high-precision gravity sensor per unit time, thereby controlling the high-precision dispensing of cell fluid. Furthermore, through specific dispensing logic, the residue of precious cell fluid in the pipeline can be minimized.

[0360] Specifically, the flow rate of the liquid in the tubing can be obtained through a calibration device. By adjusting the rotation direction of the peristaltic pump and specifying the opening and closing of the solenoid valve, the sequence of the liquid bag dispensing containers can be controlled. When the peristaltic pump operates at a specified speed, the flow rate of the liquid in the tubing is constant. By controlling the running time of the peristaltic pump, the amount of liquid entering the dispensing container can be precisely controlled. Experiments have shown that using this method, the accuracy error is within 0.2 ml per 15 ml of liquid dispensed, and after air is introduced, there is no cell fluid residue in the tubing. The dispensing accuracy is high while minimizing waste of cell fluid preparation.

[0361] When specifically repackaging, for example, refer to... Figure 20 As shown, it may include the following:

[0362] 1) After mixing, prefill the tubing before dispensing to determine the starting point of the dispensing liquid: The length of the tubing from the mixing bag outlet to valve 8 is fixed, with a volume of V1. Open valves 9 and 11, and the peristaltic pump runs counterclockwise at the set speed for a certain period of time, pumping up a volume of liquid V2. It is necessary to ensure that V2>=V1. The cell fluid in the mixing bag flows upward, passes below valve 8 (closed), and stops at valve 9. At this moment, the tubing below valve 8 has been completely filled with cell fluid. Close valve 9 and open valve 8. At this moment, the prefilling is completed, and valve 8 is the starting point for dispensing cell fluid.

[0363] 2) Obtain flow rate: Obtain the precise flow rate of cell fluid in the tubing through a calibration device.

[0364] 3) According to the calibration device, when the peristaltic pump operates at the set speed, the liquid flow velocity in the pipeline is S. When the set dispensing volume is V, the calculation shows that the peristaltic pump needs to run for t = V / S after the valve is opened. Dispensing begins, valves 6, 8, and 11 are opened. Taking valve 8 as the starting point, the peristaltic pump runs counterclockwise at the set speed for t seconds. The dispensing volume above valve 8 is V. To keep the dispensing main pipeline full, the liquid is temporarily not pushed into bag 3, and valve 3 is closed. When valve 2 is opened, the peristaltic pump rotates counterclockwise for t seconds at the set speed, using valve 2 as the starting point for liquid dispensing, pumping a volume of V into bag 2. Valve 2 is then closed. When valve 1 is opened, the peristaltic pump rotates counterclockwise for t seconds at the set speed, using valve 1 as the starting point for liquid dispensing, pumping a volume of V into bag 1. Valve 1 is then closed. After dispensing bag 1 is complete, valves 1 and 8 are closed, and valves 9 and 11 are opened. The peristaltic pump rotates clockwise, allowing air to enter and cutting the liquid below valve 8, pushing it back into the mixing bag. At this point, the pipeline below valve 8 contains air, and the pipeline above valve 8 contains liquid. This determines valve 8 as the end point for liquid dispensing. Both the starting and ending points are valve 8, thus achieving precise metering. Valves 9 and 11 are then closed, and air is subsequently introduced.

[0365] 4) Air Injection: Open valves 3, 8, and 10. The peristaltic pump rotates counter-clockwise for a set time, allowing air to enter and pushing the liquid above valve 8 into dispensing bag 3. At this point, the liquid volume in dispensing bag 3 is exactly the set dispensing volume V. Close valve 3. Open valve 2. The peristaltic pump rotates counter-clockwise for a set time, allowing air to enter and pushing the liquid below valve 2 into dispensing bag 2. The liquid volume in dispensing bag 2 is exactly the set dispensing volume V. Close valve 2. Open valve 1. The peristaltic pump rotates counter-clockwise for a set time, allowing air to enter and pushing the liquid below valve 1 into dispensing bag 1. The liquid volume in dispensing bag 1 is exactly the set dispensing volume V. Close valve 1. Finally, the liquid volume in all dispensing bags is consistent, all being the set dispensing volume V. Furthermore, the air injection results in minimal residual cell fluid in the consumable tubing, greatly reducing waste caused by residual cell fluid in the tubing.

[0366] Finally, after the dispensing is completed, the automatic venting device removes excess air from the dispensing container. The venting speed and the height of the liquid column after venting are adjustable.

[0367] When performing specific venting operations, for example, refer to... Figure 21 As shown, it may include the following:

[0368] After detecting that the sub-packaging is completed, open the specified solenoid valve, and the peristaltic pump starts to rotate clockwise to expel the air in each sub-packaging container. The air pressure value in the pipeline is monitored in real time. As the air is expelled, the air pressure value will gradually decrease. When it drops to the set air pressure threshold, the peristaltic pump stops running and the solenoid valve closes, and the automatic air exhaust is completed. The device can control the air exhaust speed by adjusting the running speed of the peristaltic pump, and can control the liquid column height in the liquid bag after air exhaust by adjusting the air pressure threshold. The air pressure value in the sub-packaging pipeline is inversely proportional to the liquid column height. The higher the liquid column height H, the lower the air pressure value P.

[0369] Specifically, a dedicated software program can also be constructed to control the various functional components of the high-precision preparation sub-packaging system, including: solenoid valves, peristaltic pump devices, mixing devices, temperature control devices, touch screen control panels, etc., and control the linkage of the various functional components by reading the feedback information of each sensor module, so as to realize the automation of the cell liquid sub-packaging process. For details, please refer to Figure 22 as shown.

[0370] In this scenario example, based on the above ideas and combined with specific sub-packaging requirements, the fully enclosed high-precision preparation sub-packaging system constructed can be referred to Figure 23 as shown. Among them, the circles 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, A, B, and C respectively represent the solenoid valves on the corresponding pipelines. The square box filter represents the filter valve. The above liquid bags 1, 2, 3, 4, 5, and 6 respectively represent the corresponding sub-packaging containers. The stock solutions A, B, and C respectively represent the stock solution bags storing different types of stock solutions. The above scales A, B, and C respectively represent the corresponding gravity sensors. During specific implementation, the following contents can be included.

[0371] S1: Carry out installation and connection.

[0372] Specifically, it can refer to the system in Figure 23 to complete the installation of the disposable fully enclosed sterilized consumables. Secondly, use a sterile pipe welding machine to weld the liquid bags, including three cell stock solution bags A, B, and C, a mixing bag, and 6 sub-packaging containers, and open the filter valve and the air pressure detection interface.

[0373] S2: Conduct system self-check.

[0374] Specifically, it can include:

[0375] S2-1: Pipeline airtightness detection: Open valves 7, 8, and 10, and the peristaltic pump rotates counterclockwise for a certain period of time. A certain amount of air enters the main pipeline. Close all solenoid valves and monitor the pressure value of the air pressure sensor. If the pressure value of the air pressure sensor remains constant within a certain value, it proves that the pipeline airtightness is good. If the pressure value of the air pressure sensor continues to drop, it proves that the pipeline leaks.

[0376] S2-2: Pipeline Valve Opening Detection: Open valves 7, 8, 10, and A. Rotate the peristaltic pump counterclockwise for a certain period of time, allowing a certain amount of air to enter the main pipeline. Monitor the pressure sensor value. If the pressure increases beyond the set threshold, it indicates that air has failed to enter bag A, and the bag A clamp is not open. This process can be used to check whether the clamps of the ABC sample bags and each dispensing container are open, allowing for early detection of potential risks during cell dispensing.

[0377] S3: Perform precision calibration.

[0378] Specifically, this may include: opening valves 7, 11, and C; recording the reading G1 of scale C for the first time; rotating the peristaltic pump clockwise at the set speed for a set time T and then stopping; recording the reading G2 of scale C for the second time; and the volume of liquid output from bag C per unit time is the injection flow rate, S = (G1 - G2) / T.

[0379] S4: Perform temperature control.

[0380] Specifically, this can include: after the temperature control system is turned on, the temperature sensor detects the real-time temperature of the mixing zone. If the detected temperature exceeds the set upper temperature limit T1℃, the cooling device automatically turns on to rapidly cool the mixing zone. When the temperature sensor detects that the temperature of the mixing zone is below the set lower temperature limit T2℃, the cooling device automatically turns off, and the mixing zone stops cooling. After cooling stops, the mixing zone will gradually heat up. When the temperature rises to the set upper temperature limit T1℃, the cooling device automatically turns on again to rapidly cool the mixing zone. This cycle repeats, ensuring that the temperature of the mixing zone is always maintained within the set temperature range T1-T2 through the frequent turning of the cooling device on and off.

[0381] S5: Inject the sample.

[0382] Specifically, the process can include: At the start of sample injection, valves 7, 11, and A are opened. The initial reading A1 of the A scale is recorded. The peristaltic pump rotates clockwise at the set speed, and the cell stock solution from bag A begins to enter the mixing bag. The A scale reading is monitored in real time. When the injected volume reaches the set volume ΔA, the A scale reading becomes A2 (A2 = A1 - ΔA). The peristaltic pump stops rotating, the A solution injection is complete, and valve A is closed. Similarly, valves 7, 11, and B are opened. The initial reading B1 of the B scale is recorded. The peristaltic pump rotates clockwise at the set speed, and the B bag cell stock solution begins to enter the mixing bag. The B scale reading is monitored in real time. When the injected volume reaches the set volume ΔB, the B scale reading becomes B2 (B2 = B1 - ΔB). The peristaltic pump stops rotating, the B solution injection is complete, and valve B is closed. Open valves 7, 11, and C. Record the reading C1 of the C scale for the first time. The peristaltic pump rotates clockwise at the set speed, and the cell stock solution in bag C begins to enter the mixing bag. Monitor the changes in the C scale reading in real time. When the injection reaches the set liquid volume ΔC, the C scale reading is C2 (C2 = C1 - ΔC). The peristaltic pump stops rotating, the injection of C solution is completed, and valve C is closed.

[0383] S6: Mix thoroughly.

[0384] Specifically, this process includes: after sample injection begins, the mixing device is activated, and the mixing motor drives the mixing plate to move back and forth on the slide rail. The mixing plate applies pressure to the mixing bag, pushing the liquid inside and thus achieving cell fluid mixing. The mixing device reads the changes in the inflow and outflow of liquid in the mixing bag in real time. During sample injection, when the inflow volume reaches the set gradient value, the liquid thickness inside the mixing bag increases, and the mixing device automatically adjusts the mixing plate to move away from the mixing bag, ensuring appropriate pressure during mixing. During dispensing, when the outflow volume in the mixing bag reaches the set gradient value, the liquid thickness inside the mixing bag decreases, and the mixing device automatically adjusts the mixing plate to move closer to the mixing bag, ensuring appropriate pressure during mixing. By automatically adjusting the mixing amplitude of the mixing plate according to the changes in the liquid volume in the mixing bag, the fully automated dispensing process ensures that the liquid in the mixing bag is always properly pressed and mixed, effectively guaranteeing the uniformity of cell density in each dispensing bag. It plays a crucial role in the quality of the cell fluid product after repackaging.

[0385] S7: Perform high-precision packaging.

[0386] Specifically, this may include:

[0387] 1) Prefilling of tubing: After mixing, valves 9 and 11 are opened, and the peristaltic pump runs counterclockwise at the set speed for a certain period of time. The cell fluid in the mixing bag flows upward and stops at valve 9. At this moment, the tubing below valve 8 has been completely filled with cell fluid.

[0388] 2) Quantitative Dispensing: The calibration device indicates that when the peristaltic pump operates at the set speed, the liquid flow velocity in the pipeline is S. When the set dispensing volume is V, the calculation shows that the peristaltic pump needs to run for t = V / S after the valves are opened. Dispensing begins with valves 6, 8, and 11 opened. Starting from valve 8, the peristaltic pump rotates counterclockwise at the set speed for t seconds. The dispensing volume above valve 8 is V. To keep the main dispensing pipeline full, liquid is temporarily not pushed into bag 6, and valve 6 is closed. When valve 5 is opened, the peristaltic pump rotates counterclockwise for t seconds at the set speed, using valve 5 as the starting point for liquid dispensing, pumping a liquid volume of V into bag 5, and then closing valve 5; when valve 4 is opened, the peristaltic pump rotates counterclockwise for t seconds at the set speed, using valve 4 as the starting point for liquid dispensing, pumping a liquid volume of V into bag 4, and then closing valve 4; when valve 3 is opened, the peristaltic pump rotates counterclockwise for t seconds at the set speed, using valve 5 as the starting point for liquid dispensing, pumping a liquid volume of V into bag 3, and then closing valve 3; and so on, after dispensing bag 1, valves 1 and 8 are closed, valves 9 and 11 are opened, the peristaltic pump rotates clockwise, air enters, cutting the liquid below valve 8 and pushing it back into the mixing bag, and then valves 9 and 11 are closed.

[0389] 3) Air Injection: Open valves 6, 8, and 10. The peristaltic pump rotates counter-clockwise for the set time, allowing air to enter and pushing the liquid above valve 8 into dispensing container 6. At this point, the liquid volume in dispensing container 6 is exactly the set dispensing volume V. Close valve 6. Open valve 5. The peristaltic pump rotates counter-clockwise for the set time, allowing air to enter and pushing the liquid below valve 5 into dispensing container 5. The liquid volume in dispensing container 5 is exactly the set dispensing volume V. Close valve 5. Open valve 4. The peristaltic pump rotates counter-clockwise for the set time, allowing air to enter and pushing the liquid below valve 4 into dispensing container 4. The liquid volume in dispensing container 4 is exactly the set dispensing volume V. Close valve 4. Open valve #3, and the peristaltic pump rotates counterclockwise for the set time, allowing air to enter and pushing the liquid below valve #3 into dispensing container #3. The volume of liquid entering dispensing container #3 is exactly the set dispensing volume V. Then close valve #3. Continue this process, pushing the liquid below valves #1 and #2 into their corresponding dispensing containers, ensuring that the dispensing volume in dispensing containers #1 and #2 is V. Finally, the dispensing volume in all containers is consistent, all being the set dispensing volume V. Furthermore, the introduction of air minimizes residual cell fluid in the consumable tubing, significantly reducing waste caused by residual cell fluid in the tubing.

[0390] S8: Performs automatic exhaust.

[0391] Specifically, this process may include: During the dispensing process, after the liquid is pushed in with air, some air remains in the dispensing bag. To ensure that the cryopreservation of cells is not affected, the air in the dispensing container must be completely expelled. Once quantitative dispensing is detected as complete, the automatic venting device is activated, valves 1-6, 8, and 10 open, and the peristaltic pump rotates clockwise at a set speed. Air in the six dispensing containers begins to be expelled from the filter valves. During the venting process, the air pressure in the dispensing containers and dispensing pipelines is monitored in real time by a pressure sensor. As the venting time increases, the amount of air in the dispensing containers and pipelines decreases, and the air pressure gradually decreases. When the air pressure drops to a set threshold, the peristaltic pump stops operating, valves 1-6, 8, and 10 close, and the air in each dispensing container is emptied, thus venting is terminated. The dispensing bag is then removed using a heat sealer and packaged for cryopreservation.

[0392] The above scenario examples verify that the formulation mixing and dispensing system and method provided in this manual do indeed have the following beneficial effects: by ensuring that cells are not contaminated through fully enclosed consumables, precise sample injection control, thorough mixing, efficient temperature control, and high-precision dispensing methods and automatic exhaust systems, the cell dispensing process can be automated. Compared with manual cell dispensing, it can make cell products more accurate, more standardized in quality, and greatly improve production efficiency.

[0393] While this specification provides the steps of operation for the methods described in the embodiments or flowcharts, more or fewer steps may be included based on conventional or non-inventive means. The order of steps listed in the embodiments is merely one possible order of execution among many steps and does not represent the only possible order. In actual device or client product execution, the methods shown in the embodiments or drawings may be executed sequentially or in parallel (e.g., in a parallel processor or multi-threaded processing environment, or even a distributed data processing environment). The terms "comprising," "including," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, product, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, product, or apparatus. Without further limitations, the presence of other identical or equivalent elements in a process, method, product, or apparatus that includes said elements is not excluded. The terms "first," "second," etc., are used to denote names and do not indicate any particular order.

[0394] Those skilled in the art will also know that, besides implementing the controller using purely computer-readable program code, the same functions can be achieved by logically programming the method steps, making the controller function as logic gates, switches, application-specific integrated circuits (ASICs), programmable logic controllers (PLCs), and embedded microcontrollers. Therefore, such a controller can be considered a hardware component, and the devices within it used to implement various functions can also be considered structures within that hardware component. Alternatively, the devices used to implement various functions can be considered as both software modules implementing the method and structures within a hardware component.

[0395] This specification can be described in the general context of computer-executable instructions that are executed by a computer, such as program modules. Generally, program modules include routines, programs, objects, components, data structures, classes, etc., that perform a specific task or implement a specific abstract data type. This specification can also be practiced in distributed computing environments, where tasks are performed by remote processing devices connected via a communication network. In distributed computing environments, program modules can reside in local and remote computer-readable storage media, including storage devices.

[0396] As can be seen from the above description of the embodiments, those skilled in the art can clearly understand that this specification can be implemented by means of software plus necessary general-purpose hardware platforms. Based on this understanding, the technical solutions of this specification can essentially be embodied in the form of a software product. This computer software product can be stored in a storage medium, such as ROM / RAM, magnetic disk, optical disk, etc., and includes several instructions to cause a computer device (which may be a personal computer, mobile terminal, server, or network device, etc.) to execute the methods described in the various embodiments or some parts of the embodiments of this specification.

[0397] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to interchangeably. Each embodiment focuses on its differences from other embodiments. This specification can be used in numerous general-purpose or special-purpose computer system environments or configurations. Examples include: personal computers, server computers, handheld or portable devices, tablet devices, multiprocessor systems, microprocessor-based systems, set-top boxes, programmable electronic devices, network PCs, minicomputers, mainframe computers, and distributed computing environments including any of the above systems or devices, etc.

[0398] Although this specification has been described by way of examples, those skilled in the art will recognize that many variations and modifications are possible without departing from the spirit of this specification, and it is intended that the appended claims cover such variations and modifications without departing from the spirit of this specification.

Claims

1. A formulation mixing and dispensing system, characterized in that, At least including: The system includes a liquid inlet section, a mixing section, a dispensing section, and a peristaltic pump. The liquid inlet section, mixing section, and dispensing section are connected to the peristaltic pump via a first connecting pipe, a second connecting pipe, and a third connecting pipe, respectively. A first solenoid valve, a second solenoid valve, and a third solenoid valve are respectively installed on the first connecting pipe, the second connecting pipe, and the third connecting pipe. The liquid inlet section includes at least a first stock solution bag and a second stock solution bag; the first stock solution bag and the second stock solution bag are respectively connected to a first connecting pipe through corresponding first liquid inlet pipes and second liquid inlet pipes, and corresponding first liquid inlet valves and second liquid inlet valves are respectively provided on the first liquid inlet pipes and second liquid inlet pipes; the first stock solution bag and the second stock solution bag are also respectively connected to corresponding first gravity sensors and second gravity sensors; the first stock solution bag and the second stock solution bag respectively store first stock solution and second stock solution; the first stock solution bag and the second stock solution bag are also respectively provided with corresponding pipe clamps; a first bubble sensor is also provided on the first connecting pipe; wherein, the first gravity sensor and the second gravity sensor are used to calibrate the flow rate of the first pipe during the liquid inlet stage; The mixing unit includes at least a mixing bag; the mixing bag is connected to a second connecting pipe; the mixing bag is used to temporarily store and mix the cell fluid; the mixing bag is also provided with a corresponding tube clamp. The dispensing section includes at least a first dispensing container and a second dispensing container; the first dispensing container and the second dispensing container are respectively connected to a third connecting pipe through corresponding first dispensing pipes and second dispensing pipes, and corresponding first dispensing valves and second dispensing valves are provided on the first dispensing pipes and second dispensing pipes; a pressure sensor is also provided at the end of the third connecting pipe; the first dispensing container and the second dispensing container are used to store the target cell fluid obtained after mixing; the first dispensing container and the second dispensing container are also provided with corresponding tube clamps; The peristaltic pump is also connected to a filter valve via a fourth connecting pipe, and a fourth solenoid valve is also provided on the fourth connecting pipe; a first metering tube is also provided on the pipe between the filter valve and the fourth solenoid valve; a second bubble sensor is provided between the fourth solenoid valve and the second solenoid valve; a third bubble sensor is provided at a position adjacent to the first metering tube and away from the fourth solenoid valve; wherein, the first metering tube, the second bubble sensor, and the third bubble sensor are used to calibrate the flow rate of the second pipe during the dispensing stage; A fifth connecting pipe is also connected between the fourth connecting pipe and the third connecting pipe; and a fifth solenoid valve is also provided on the fifth connecting pipe. The connection point between the fifth connecting pipe and the fourth connecting pipe is located between the air filter valve and the fourth solenoid valve, and the connection point between the fifth connecting pipe and the third connecting pipe is located between the third solenoid valve and the peristaltic pump; wherein, the fifth solenoid valve is used to control the pre-filling operation of the dispensing stage.

2. The system according to claim 1, characterized in that, The mixing section further includes: a mixing support, a motor, a moving body, and a mixing plate; The mixing bag is mounted on a mixing support; and a cooling plate is provided on the mixing support at a position a first distance away from the mounted mixing bag. The mixing plate is disposed on the moving body; the moving body is connected to the motor; the moving body is configured to move within a specified range opposite to the cooling plate. Furthermore, the cooling plate is equipped with a temperature sensor; the temperature sensor is connected to the cooling module; and the cooling module is connected to the cooling plate through a heat dissipation channel.

3. The system according to claim 1, characterized in that, The packaging section further includes: a third packaging container...the Mth packaging container; where M is an integer greater than or equal to 3; And / or, the liquid inlet section further includes: a third raw liquid bag...an Nth raw liquid bag; wherein, N is an integer greater than or equal to 3.

4. A method for mixing and dispensing a formulation based on the formulation mixing and dispensing system according to any one of claims 1 to 3, characterized in that, include: According to the preset self-test rules, by adjusting the state of the relevant solenoid valves and combining the peristaltic pump and the air pressure sensor, the pipeline and pipe clamp are tested to see if they meet the preset requirements. If the pipeline and clamps meet the preset requirements, calibrate the first pipeline flow rate during the liquid inlet stage according to the preset first calibration rule; According to the preset liquid inlet rules, by adjusting the state of the solenoid valve of the liquid inlet section, and by combining the peristaltic pump and the corresponding gravity sensor, the corresponding first liquid and second liquid are sequentially drawn from the first liquid bag and the second liquid bag and transported to the mixing bag. According to the preset mixing rules, the mixing unit is controlled within a specified temperature range to mix the cell fluid in the mixing bag to obtain the target cell fluid that meets the requirements. According to the preset second calibration rule, calibrate the flow rate of the second pipeline during the dispensing stage; According to the preset pre-filling rules, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to perform a pre-filling operation on the pipeline between the third and fifth solenoid valves. According to the preset dispensing rules, by adjusting the state of the solenoid valve of the dispensing section and using a peristaltic pump, the target cell fluid in the mixing bag is transported to the first dispensing container and the second dispensing container respectively.

5. The method according to claim 4, characterized in that, After adjusting the state of the solenoid valve in the dispensing section and using a peristaltic pump to transport the target cell solution in the mixing bag to the first dispensing container and the second dispensing container respectively, the method further includes: When the first and second dispensing containers are dispensing bags, the state of the solenoid valve of the dispensing section is adjusted according to the preset venting rules, and the peristaltic pump and air pressure sensor are used to vent the first and second dispensing containers. The process involves adjusting the state of the solenoid valve in the dispensing section according to a preset exhaust rule, and using a peristaltic pump and a pressure sensor to exhaust gases from the first and second dispensing containers. According to the preset exhaust rules, the first dispensing valve, the second dispensing valve, and the third solenoid valve are set to the open state, and the peristaltic pump is controlled to run clockwise at a specified speed to exhaust the first dispensing container and the second dispensing container. The air pressure value of the third connecting pipe is monitored using an air pressure sensor; When the air pressure value of the third connecting pipe is detected to be less than or equal to the preset air pressure threshold, the peristaltic pump stops operating.

6. The method according to claim 4, characterized in that, According to preset self-test rules, by adjusting the state of relevant solenoid valves and combining a peristaltic pump and a pressure sensor, the system checks whether the pipeline and pipe clamps meet preset requirements, including: To check whether the third connecting pipe meets the preset requirements, follow these steps: According to the preset self-test rules, the state of the third solenoid valve and the fourth solenoid valve is set to the open state, and the state of the first dispensing valve, the second dispensing valve, the first solenoid valve, and the second solenoid valve is set to the closed state. The peristaltic pump is controlled to run counterclockwise at a specified speed for the first detection period and then stops, and the states of the third and fourth solenoid valves are set to the closed state. The pipeline air pressure value was collected using a pressure sensor during the second detection period; Based on the pipeline air pressure value during the second detection period, determine the pipeline air pressure change data during the second detection period; Check whether the changes in pipeline air pressure during the second detection period match the preset air pressure change reference data; If the pipeline pressure change data during the second detection period matches the preset pressure change reference data, then the third connecting pipeline is determined to meet the preset requirements.

7. The method according to claim 4, characterized in that, According to preset self-test rules, by adjusting the state of relevant solenoid valves and combining a peristaltic pump and a pressure sensor, the system checks whether the pipeline and pipe clamps meet preset requirements, including: The following method is used to check whether the tube clamps installed on the first dispensing container meet the preset requirements: According to the preset self-test rules, the states of the third solenoid valve, the fourth solenoid valve, and the first dispensing valve are set to the open state, and the states of the first solenoid valve, the second solenoid valve, and the second dispensing valve are set to the closed state. Control the peristaltic pump to run counterclockwise at a specified speed during the third detection period; and use a pressure sensor to collect the pipeline pressure value during the third detection period. Calculate the increase in pipeline air pressure during the third testing period based on the pipeline air pressure value during the third testing period. The test checks whether the increase in pipeline air pressure during the third test period is less than a preset threshold. If the increase in pipeline air pressure during the third detection period is less than the preset threshold, the clamp installed on the first dispensing container is determined to meet the preset requirements.

8. The method according to claim 4, characterized in that, According to the preset first calibration rule, the first pipeline flow rate during the liquid inlet stage is calibrated, including: According to the preset first calibration rule, the states of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve are set to the open state, and the state of the second liquid inlet valve is set to the closed state. The initial gravity value of the first raw material bag was obtained using the first gravity sensor; After controlling the peristaltic pump to run clockwise at a specified speed for a calibration period, stop the peristaltic pump. The final gravity value of the first raw material bag was obtained using the first gravity sensor; Based on the initial and final gravity values ​​of the first raw material bag, as well as the calibration time period, the calibrated first pipeline flow rate corresponding to the specified speed of the peristaltic pump during the liquid inlet stage is determined.

9. The method according to claim 4, characterized in that, According to the preset liquid inlet rules, by adjusting the state of the solenoid valve of the liquid inlet section, and using a peristaltic pump and a corresponding gravity sensor, the corresponding first and second stock solutions are sequentially drawn from the first and second stock solution bags and transported to the mixing bag, including: According to the preset liquid inlet rules, the states of the first solenoid valve, the second solenoid valve, and the first liquid inlet valve are set to the open state, and the states of the third solenoid valve and the second liquid inlet valve are set to the closed state. The peristaltic pump is controlled to run clockwise at a specified speed, and the gravity value of the first raw material bag is monitored using the first gravity sensor; When the gravity value of the first raw material bag decreases from the first gravity value, the peristaltic pump is stopped; and the state of the second inlet valve is set to open, and the state of the first inlet valve is set to closed. The peristaltic pump is controlled to run clockwise at a specified speed, and the gravity value of the second stock solution bag is monitored using a second gravity sensor; When the gravity value of the second raw material bag decreases from the second gravity value, the peristaltic pump is controlled to stop running.

10. The method according to claim 4, characterized in that, According to preset mixing rules, the mixing unit is controlled within a specified temperature range to mix the cell solution in the mixing bag to obtain the target cell solution that meets the requirements, including: According to the preset mixing rules, obtain the current volume parameters of the mixing bag and the current temperature parameters of the cooling plate; Based on the current volume parameters of the mixing bag, generate matching control parameters; and based on these control parameters, adjust the pressing speed and / or pressing amplitude of the moving body driving the mixing plate to press the mixing bag using a motor. Check whether the current temperature parameter of the cooling plate is higher than the preset temperature threshold; If the current temperature parameters of the cooling plate are determined to be higher than the preset temperature threshold, the cooling module is activated to cool the cooling plate.

11. The method according to claim 4, characterized in that, According to the preset second calibration rule, the flow rate of the second pipeline during the dispensing stage is calibrated, including: According to the preset second calibration rule, the states of the second solenoid valve and the fourth solenoid valve are set to the open state, and the states of the fifth solenoid valve, the first solenoid valve, and the third solenoid valve are set to the closed state. Control the peristaltic pump to run counterclockwise at a specified speed, monitor and record the first time when the second bubble sensor detects a change in value, and the second time when the third bubble sensor detects a change in value; Based on the volume of the first metering tube, the first time, and the second time, the calibrated second pipeline flow rate corresponding to the specified speed of the peristaltic pump during the dispensing stage is determined.

12. The method according to claim 4, characterized in that, According to the preset pre-filling rules, the state of the fifth solenoid valve is adjusted, and a peristaltic pump is used to perform a pre-filling operation on the pipeline between the third and fifth solenoid valves, including: According to the preset pre-filling rule, the state of the fifth solenoid valve and the second solenoid valve is set to the open state, and the state of the third solenoid valve and the fourth solenoid valve is set to the closed state. Control the peristaltic pump to run counterclockwise at a specified speed so that the pipeline between the third and fifth solenoid valves is pre-filled with target cell fluid; The process involves adjusting the state of the solenoid valve in the dispensing section according to preset dispensing rules, and using a peristaltic pump to transport the target cell solution in the mixing bag to the first dispensing container and the second dispensing container, respectively. According to the preset dispensing rules, the states of the second dispensing valve, the second solenoid valve, and the fourth solenoid valve are set to the open state; and the peristaltic pump is controlled to run counterclockwise at a specified speed for a dispensing period, so as to fill the pipeline between the third solenoid valve and the second dispensing container in the third connecting pipeline with the corresponding target cell fluid; wherein, the duration of the dispensing period is determined according to the specified volume of the target cell fluid to be dispensed in the dispensing container and the flow rate of the second pipeline. Set the first dispensing valve to the open state and the second dispensing valve to the closed state; and control the peristaltic pump to run counterclockwise for a specified dispensing period at a specified speed to input the corresponding target cell fluid into the first dispensing container; Set the fifth and second solenoid valves to the open state, and set the first dispensing valve and the third solenoid valve to the closed state; and control the peristaltic pump to run clockwise at a specified speed to fill in air, and use the filled air to push the target cell fluid in the pipeline between the third solenoid valve and the mixing bag back into the mixing bag. Set the third, fourth, and second solenoid valves to the open state, and the fifth and second solenoid valves to the closed state; and control the peristaltic pump to run counterclockwise at a specified speed to input the corresponding target cell fluid into the second dispensing container; Set the first dispensing valve to the open state and the second dispensing valve to the closed state; and control the peristaltic pump to run counterclockwise at a specified speed to input the target cell fluid in the first dispensing pipeline into the first dispensing container.

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