A stem cell storage management system and method

By designing a stem cell storage management system, including cell storage quality assessment and condition adjustment modules, the problems of inaccurate stem cell storage quality assessment and unreasonable storage condition management in the existing technology are solved, and efficient and accurate stem cell storage management is achieved, ensuring that Cell quality and safety.

CN118985592BActive Publication Date: 2025-02-14JILIN UNIVERSITY
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Patent Information

Application Number
CN202411491149.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-10-24
Publication Date
2025-02-14
Estimated Expiration
2044-10-24

AI Technical Summary

Technical Problem

The existing stem cell storage management system has shortcomings in monitoring and review, and cannot detect changes in cell activity in a timely manner, resulting in inaccurate storage quality assessment, increasing experimental costs and risks, and failing to effectively manage the storage conditions of the overall repository, resulting in stem cell quality. deterioration.

Method used

A stem cell storage management system was designed, including cell storage quality evaluation module, cell storage condition acquisition module, cell storage condition adjustment module and repository storage management evaluation module. By monitoring cell activity, purity and microbial contamination of cell samples, it evaluates Cell storage quality, timely adjust storage conditions, and evaluate the rationality of storage management.

Benefits of technology

Realize timely monitoring and evaluation of stem cell storage quality, reduce experimental costs and risks, avoid the continuous deterioration of stem cell quality, improve overall storage efficiency and quality, ensure the quality and safety of stem cells, and at the same time enhance the credibility of the repository. and image.

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Abstract

The present invention relates to the technical field of stem cell storage management, and specifically discloses a stem cell storage management system and method. The system comprises: a cell storage quality assessment module, a cell storage condition acquisition module, a cell storage condition adjustment module, a database and a storage repository storage management assessment module. The present invention assesses the cell storage quality corresponding to each liquid nitrogen tank in each monitoring time period. When the cell storage quality is unqualified, the reason for the unqualified cell storage quality is promptly confirmed, and the cell storage condition is adjusted according to the reason for the unqualified cell storage quality. Finally, whether the storage management of the target cell storage repository is reasonable is assessed. If it is unreasonable, feedback is given, thereby improving the accuracy of cell storage quality assessment, promptly confirming and adjusting storage conditions to avoid continuous deterioration of stem cell quality, improving overall storage efficiency and overall storage quality, and ensuring the quality and safety of stem cells during storage.
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Description

Technical Field

[0001] The present invention belongs to the technical field of stem cell storage management, and relates to a stem cell storage management system and method. Background Art

[0002] Stem cells have broad application prospects in the medical field because of their ability to repair, restore, replace and regenerate cells in the body. However, there are problems such as safety, insufficient monitoring and risk of abuse in the storage process of stem cells. The storage management system in the existing technology often has defects such as incomplete monitoring and unprofessional review mechanism. Therefore, in order to effectively ensure the quality and safety of stem cells, it is necessary to monitor and analyze the storage management of stem cells.

[0003] For example, the Chinese patent publication number CN112101829B discloses a high-security stem cell storage management system and method, including: an account registration module, a storage application module, a storage application review module, a stem cell storage module, a use application module and an application review module, wherein the account registration module is used for users to submit personal information and register accounts, the storage application module is used for users to submit applications for stem cell storage, the storage application review module is used to review applications for stem cell storage submitted by users, the stem cell storage module is used to collect, transport and inspect stem cells after the stem cell storage application is reviewed and approved, and store the stem cells in a freezer after passing the inspection, the use application module is used to submit applications for stem cell use, and the application review module is used for a review panel to review the use application and determine whether the use application is approved.

[0004] The above existing technologies still have the following problems: 1. Cell activity, cell purity and microbial contamination monitoring are not performed on stem cells simultaneously, that is, the cell quality data corresponding to the stem cells in each monitoring time period are not monitored in real time, and changes in stem cell activity cannot be discovered in time, which reduces the accuracy of cell storage quality assessment and increases the cost and risk of stem cell experiments.

[0005] 2. When the storage quality of stem cells is unqualified, the reasons for the unqualified cell storage quality are not confirmed in time, and the cell storage conditions are not adjusted in time according to the reasons for the unqualified cell storage quality, which increases the risk of stem cell cross-contamination. Failure to confirm and adjust the storage conditions in time will lead to continuous deterioration of stem cell quality, and it may take longer to recover or re-cultivate the cells, thereby delaying the progress of scientific research. At the same time, it is impossible to provide a basis for tracing the causes of abnormal cell storage.

[0006] 3. Currently, the focus is only on the storage quality of individual stem cells, and no attention is paid to whether the overall storage management of the stem cell repository is reasonable, which reduces the overall storage efficiency and overall storage quality, and damages the reputation and image of the stem cell repository. Summary of the invention

[0007] In view of this, in order to solve the problems raised in the above background technology, a stem cell storage management system and method are now proposed.

[0008] The purpose of the present invention can be achieved through the following technical solutions: In a first aspect, the present invention provides a stem cell storage management system, including: a cell storage quality assessment module, which is used to randomly select a number of cell samples from each liquid nitrogen tank in a target cell storage library in each monitoring time period, count the number of randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, and perform cell activity monitoring, cell purity monitoring and microbial contamination monitoring on the randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, obtain cell monitoring data corresponding to each liquid nitrogen tank in each monitoring time period, and evaluate the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period.

[0009] The cell storage condition acquisition module is used to determine whether the cell storage quality of each liquid nitrogen tank corresponding to each monitoring time period is qualified. If unqualified, the monitoring time period in which the cell storage quality is unqualified is recorded as an abnormal time period, and the liquid nitrogen tank level, storage temperature in the tank and storage humidity in the tank at each monitoring time point in each abnormal time period are extracted.

[0010] The cell storage condition adjustment module is used to confirm the reasons for the unqualified cell storage quality of each liquid nitrogen tank corresponding to each abnormal time period, and adjust the cell storage conditions according to the reasons for the unqualified cell storage quality.

[0011] The database is used to store the liquid level that needs to be maintained in the liquid nitrogen tank, the storage temperature range and the storage humidity range set in the liquid nitrogen tank, the required amount of liquid nitrogen replenishment corresponding to the unit liquid level stability deviation, and the optimal storage temperature and optimal storage humidity in the tank corresponding to the compliance of each storage environment.

[0012] The storage management evaluation module of the repository is used to count the number of abnormal time periods, liquid nitrogen replenishment times and storage environment adjustment times corresponding to each liquid nitrogen tank, and evaluate whether the storage management of the target cell repository is reasonable. If it is unreasonable, feedback is provided.

[0013] A second aspect of the present invention provides a stem cell storage management method, comprising: S1, cell storage quality assessment: randomly selecting a number of cell samples from each liquid nitrogen tank in a target cell storage storage during each monitoring time period, counting the number of randomly selected cell samples corresponding to each liquid nitrogen tank during each monitoring time period, and performing cell activity monitoring, cell purity monitoring and microbial contamination monitoring on the randomly selected cell samples corresponding to each liquid nitrogen tank during each monitoring time period, obtaining cell monitoring data corresponding to each liquid nitrogen tank during each monitoring time period, and evaluating the cell storage quality coefficient corresponding to each liquid nitrogen tank during each monitoring time period.

[0014] S2. Cell storage condition collection: Determine whether the cell storage quality of each liquid nitrogen tank in each monitoring time period is qualified. If unqualified, the monitoring time period in which the cell storage quality is unqualified is recorded as an abnormal time period, and extract the liquid nitrogen tank level, storage temperature in the tank, and storage humidity in the tank at each monitoring time point in each abnormal time period.

[0015] S3. Adjustment of cell storage conditions: confirm the reasons for unqualified cell storage quality corresponding to each liquid nitrogen tank in each abnormal time period, and adjust the cell storage conditions according to the reasons for unqualified cell storage quality.

[0016] S4. Storage management evaluation of the repository: Count the number of abnormal time periods, liquid nitrogen replenishment times, and storage environment adjustment times corresponding to each liquid nitrogen tank, and evaluate whether the storage management of the target cell repository is reasonable. If not, provide feedback.

[0017] Compared with the prior art, the embodiments of the present invention have at least the following advantages or beneficial effects: (1) The present invention obtains cell monitoring data by performing cell activity monitoring, cell purity monitoring and microbial contamination monitoring on cell samples, and evaluates the cell storage quality corresponding to each liquid nitrogen tank in each monitoring time period. It can timely detect changes in stem cell activity, improve the accuracy of cell storage quality assessment, and reduce the cost and risk of stem cell experiments.

[0018] (2) The present invention reduces the risk of stem cell cross-contamination by promptly identifying the cause of unqualified cell storage quality when the cell storage quality is unqualified, and adjusting the cell storage conditions according to the cause of unqualified cell storage quality. The storage conditions are promptly identified and adjusted to avoid continuous deterioration of stem cell quality, thereby avoiding the need for longer time to recover or re-cultivate cells, and providing a basis for tracing the cause of abnormal cell storage.

[0019] (3) The present invention evaluates whether the storage management of the target cell storage library is reasonable by counting the number of abnormal time periods, liquid nitrogen replenishment times, and storage environment adjustment times corresponding to each liquid nitrogen tank. If it is unreasonable, feedback is provided, thereby improving the overall storage efficiency and overall storage quality, ensuring the quality and safety of stem cells during the storage process, and improving the reputation and image of the stem cell storage library. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0021] Figure 1 It is a schematic diagram of the system structure connection of the present invention.

[0022] Figure 2 It is a schematic diagram of the method steps of the present invention. DETAILED DESCRIPTION

[0023] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0024] See also Figure 1 As shown, the first aspect of the present invention provides a stem cell storage management system, including: a cell storage quality assessment module, a cell storage condition acquisition module, a cell storage condition adjustment module, a database and a repository storage management assessment module.

[0025] The cell storage quality assessment module is connected to the cell storage condition acquisition module, the cell storage condition acquisition module is connected to the cell storage condition adjustment module, both the cell storage condition acquisition module and the cell storage condition adjustment module are connected to the repository storage management assessment module, and the cell storage condition adjustment module is connected to the database.

[0026] The cell storage quality assessment module is used to randomly select a number of cell samples from each liquid nitrogen tank in the target cell storage library in each monitoring time period, count the number of randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, and perform cell activity monitoring, cell purity monitoring and microbial contamination monitoring on the randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, obtain the cell monitoring data corresponding to each liquid nitrogen tank in each monitoring time period, and evaluate the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period.

[0027] It should be noted that the specific method of cell activity monitoring is: monitoring the cell activity of the cell sample by using the trypan blue staining method, wherein the cell membrane of the living cells is intact and can exclude the trypan blue dye. The cell membrane of the dead cells is damaged and will be stained with trypan blue. The cell activity can be determined by calculating the proportion of cells that are not stained.

[0028] It should be noted that the specific method of monitoring the cell purity is to monitor the cell purity of the cell sample by using flow cytometry, wherein fluorescently labeled antibodies are combined with specific markers on the cell surface or inside the cell, and the proportion of cells with different fluorescent signals is detected by flow cytometry to determine the purity of the stem cells.

[0029] It should be noted that the specific method of the microbial contamination monitoring is: by using the culture method to monitor the microbial contamination of cell samples, the stem cell sample is inoculated into an appropriate culture medium, cultured under certain conditions for a period of time, and regularly observed whether there is colony growth on the culture medium. If there is colony growth, it is necessary to further identify the type and number of microorganisms.

[0030] In a specific embodiment of the present invention, the cell monitoring data includes the number of unstained cells, the number of target stem cells, the number of microbial species and the number corresponding to each type of microorganism.

[0031] In a specific embodiment of the present invention, the specific process of evaluating the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period is as follows: A1, extracting the number of unstained cells, the number of target stem cells, the number of microbial species, and the number corresponding to each type of microorganism from the cell monitoring data corresponding to each liquid nitrogen tank in each monitoring time period, and recording them as , as well as and ,in, Indicates the number of the liquid nitrogen tank. , Indicates the number of the monitoring time period. , Indicates the microbial species number, .

[0032] A2. Record the number of randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period as .

[0033] A3. Calculate the cell activity of each liquid nitrogen tank in each monitoring time period , .

[0034] A4. Calculate the cell purity of each liquid nitrogen tank in each monitoring time period , .

[0035] A5. Calculate the severity of microbial contamination for each liquid nitrogen tank during each monitoring period .

[0036] It should be noted that the formula for calculating the severity of microbial contamination of each liquid nitrogen tank in each monitoring time period is: ,in, and They represent the number of microbial species and the number of microorganisms used as reference, respectively.

[0037] A6. Calculate the cell storage quality coefficient of each liquid nitrogen tank in each monitoring time period ,

[0038] ,in, , and Respectively represent the cell activity, cell purity and severity of microbial contamination of the set reference, Represents a natural constant.

[0039] The embodiment of the present invention obtains cell monitoring data by performing cell activity monitoring, cell purity monitoring and microbial contamination monitoring on cell samples, and evaluates the cell storage quality corresponding to each liquid nitrogen tank in each monitoring time period, so as to timely discover changes in stem cell activity, improve the accuracy of cell storage quality assessment, and reduce the cost and risk of stem cell experiments.

[0040] The cell storage condition acquisition module is used to determine whether the cell storage quality of each liquid nitrogen tank corresponding to each monitoring time period is qualified. If unqualified, the monitoring time period in which the cell storage quality is unqualified is recorded as an abnormal time period, and the liquid nitrogen tank level, storage temperature in the tank and storage humidity in the tank of each liquid nitrogen tank at each monitoring time point in each abnormal time period are extracted.

[0041] In a specific embodiment of the present invention, the specific method of judging whether the cell storage quality corresponding to each liquid nitrogen tank in each monitoring time period is qualified is: comparing the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period with the set reference cell storage quality coefficient; if the cell storage quality coefficient corresponding to a liquid nitrogen tank in a monitoring time period is less than the set reference cell storage quality coefficient, the cell storage quality corresponding to the liquid nitrogen tank in the monitoring time period is recorded as unqualified; otherwise, the cell storage quality corresponding to the liquid nitrogen tank in the monitoring time period is recorded as qualified.

[0042] It should be noted that the liquid nitrogen tank liquid level, the storage temperature in the tank and the storage humidity in the tank of each liquid nitrogen tank at each monitoring time point in each abnormal time period are all extracted from the corresponding liquid nitrogen tank equipment management background.

[0043] The cell storage condition adjustment module is used to confirm the reasons for the unqualified cell storage quality of each liquid nitrogen tank corresponding to each abnormal time period, and adjust the cell storage conditions according to the reasons for the unqualified cell storage quality.

[0044] In a specific embodiment of the present invention, the specific process of confirming the reasons for the unqualified cell storage quality of each liquid nitrogen tank corresponding to each abnormal time period is as follows: B1, based on the liquid nitrogen tank liquid level of each liquid nitrogen tank at each monitoring time point in each abnormal time period, calculating the liquid level stability of each liquid nitrogen tank corresponding to each abnormal time period ,in, Indicates the number of the abnormal time period, .

[0045] In a specific embodiment of the present invention, the specific process of calculating the liquid level stability of each liquid nitrogen tank corresponding to each abnormal time period is as follows: C1, the liquid level of each liquid nitrogen tank at each monitoring time point in each abnormal time period is recorded as ,in, Indicates the number of the monitoring time point, .

[0046] C2. Extract the liquid level that the liquid nitrogen tank needs to maintain from the database and record it as .

[0047] C3. Calculate the liquid level stability of each liquid nitrogen tank during each abnormal time period ,

[0048] ,in, Indicates The liquid nitrogen tank is in The first The liquid level of the liquid nitrogen tank at each monitoring time point, Indicates The liquid nitrogen tank is in The first The liquid level of the liquid nitrogen tank at each monitoring time point, and They respectively represent the liquid level deviation between the reference monitoring time points and the liquid nitrogen tank level deviation. Indicates the number of monitoring time points.

[0049] B2. Calculate the storage environment compliance of each liquid nitrogen tank in each abnormal time period based on the storage temperature and storage humidity in each liquid nitrogen tank at each monitoring time point in each abnormal time period. .

[0050] It should be noted that the specific process of calculating the storage environment compliance of each liquid nitrogen tank corresponding to each abnormal time period is as follows: comparing the tank storage temperature of each liquid nitrogen tank at each monitoring time point in each abnormal time period with the tank storage temperature range set for the liquid nitrogen tank stored in the database; if the tank storage temperature of a liquid nitrogen tank at a monitoring time point in a certain abnormal time period is not within the tank storage temperature range set for the liquid nitrogen tank, then the monitoring time point is recorded as the temperature abnormal time point, and the number of temperature abnormal time points of each liquid nitrogen tank in each abnormal time period is counted and recorded as .

[0051] According to the statistical method of the number of abnormal temperature time points of each liquid nitrogen tank in each abnormal time period, the number of abnormal humidity time points of each liquid nitrogen tank in each abnormal time period is also statistically analyzed and recorded as .

[0052] Calculate the storage environment compliance of each liquid nitrogen tank in each abnormal time period ,

[0053] ,in, and They respectively represent the proportion of abnormal temperature time points and abnormal humidity time points of the set reference.

[0054] B3. Establish a diagnosis model for the reasons for unqualified cell storage quality corresponding to each liquid nitrogen tank in each abnormal time period, and output the reasons for unqualified cell storage quality. The diagnosis model for the reasons for unqualified cell storage quality is expressed as:

[0055] ,in, and The evaluation conditions for the reasons for the failure of each cell storage quality are respectively represented. express , express , express

[0056] ,in, and They respectively represent the liquid level stability and storage environment compliance of the set reference.

[0057] In a specific embodiment of the present invention, the specific process of adjusting the cell storage conditions according to the reasons for the unqualified cell storage quality is as follows: D1. When the reason for the unqualified cell storage quality is the unstable liquid level, the amount of liquid nitrogen required to be supplemented corresponding to the unit liquid level stability deviation is extracted from the database and recorded as , set the amount of liquid nitrogen required to be replenished for each liquid nitrogen tank in each abnormal time period , .

[0058] D2. When the reason for the unqualified cell storage quality is that the storage environment does not meet the requirements, the storage environment compliance of each liquid nitrogen tank in each abnormal time period is compared with the optimal tank storage temperature and the optimal tank storage humidity corresponding to each storage environment compliance stored in the database, and the optimal tank storage temperature and the optimal tank storage humidity corresponding to each liquid nitrogen tank in each abnormal time period are obtained, and the tank storage temperature and the tank storage humidity corresponding to each liquid nitrogen tank in each abnormal time period are adjusted to the optimal tank storage temperature and the optimal tank storage humidity, respectively.

[0059] D3. When the cell storage quality is unqualified due to other reasons, an early warning feedback will be given.

[0060] The embodiments of the present invention can timely identify the reasons for the unqualified cell storage quality when the cell storage quality is unqualified, and adjust the cell storage conditions according to the reasons for the unqualified cell storage quality, thereby reducing the risk of stem cell cross-contamination, and timely identifying and adjusting the storage conditions to avoid continuous deterioration of stem cell quality, thereby avoiding the need for longer time to recover or re-cultivate cells, and providing a basis for tracing the reasons for abnormal cell storage.

[0061] The database is used to store the liquid level that needs to be maintained in the liquid nitrogen tank, store the in-tank storage temperature range and the in-tank storage humidity range set for the liquid nitrogen tank, store the required amount of liquid nitrogen replenishment corresponding to the unit liquid level stability deviation, and store the optimal in-tank storage temperature and the optimal in-tank storage humidity corresponding to the compliance of each storage environment.

[0062] Table 1 is used to list the data sources in the database of this embodiment.

[0063] Table 1

[0064]

[0065] The storage management evaluation module of the storage repository is used to count the number of abnormal time periods, liquid nitrogen replenishment times and storage environment adjustment times corresponding to each liquid nitrogen tank, and evaluate whether the storage management of the target cell storage repository is reasonable. If it is unreasonable, feedback is provided.

[0066] In a specific embodiment of the present invention, the specific process of evaluating whether the storage management of the target cell storage is reasonable is as follows: E1, based on the number of abnormal time periods, the number of liquid nitrogen replenishment times and the number of storage environment adjustment times corresponding to each liquid nitrogen tank, the storage management rationality of the target cell storage is calculated. .

[0067] In a specific embodiment of the present invention, the specific process of calculating the storage management rationality of the target cell storage is as follows: F1, the number of abnormal time periods, the number of liquid nitrogen replenishment times and the number of storage environment adjustment times corresponding to each liquid nitrogen tank are recorded as , and .

[0068] F2. Calculate the storage abnormality index corresponding to each liquid nitrogen tank ,

[0069] ,in, Indicates the number of monitoring time periods. and They respectively represent the proportion of abnormal time periods set as reference and the total number of liquid nitrogen tank equipment adjustments.

[0070] F3. Compare the storage abnormality index corresponding to each liquid nitrogen tank with the storage abnormality index of the set reference. If the storage abnormality index corresponding to a liquid nitrogen tank is greater than the storage abnormality index of the set reference, the liquid nitrogen tank is recorded as an abnormal liquid nitrogen tank. The number of abnormal liquid nitrogen tanks in the target cell storage library is counted and recorded as .

[0071] F4. Calculate the rationality of storage management of the target cell repository , ,in, Indicates the number of liquid nitrogen tanks. Indicates the percentage of abnormal liquid nitrogen tanks in the set reference.

[0072] E2. Compare the storage management rationality of the target cell repository with the storage management rationality of the set reference. If the storage management rationality of the target cell repository is greater than or equal to the storage management rationality of the set reference, it indicates that the storage management of the target cell repository is reasonable. Otherwise, it indicates that the storage management of the target cell repository is unreasonable.

[0073] The embodiment of the present invention evaluates whether the storage management of the target cell storage bank is reasonable by counting the number of abnormal time periods, the number of liquid nitrogen replenishment times, and the number of storage environment adjustment times corresponding to each liquid nitrogen tank. If it is unreasonable, feedback is given, thereby improving the overall storage efficiency and overall storage quality, ensuring the quality and safety of stem cells during the storage process, and improving the credibility and image of the stem cell storage bank.

[0074] Reference Figure 2 As shown, the second aspect of the present invention provides a stem cell storage management method, including: S1, cell storage quality assessment: randomly selecting a number of cell samples from each liquid nitrogen tank in the target cell storage library in each monitoring time period, counting the number of randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, and performing cell activity monitoring, cell purity monitoring and microbial contamination monitoring on the randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, obtaining the cell monitoring data corresponding to each liquid nitrogen tank in each monitoring time period, and evaluating the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period.

[0075] S2. Cell storage condition collection: Determine whether the cell storage quality of each liquid nitrogen tank in each monitoring time period is qualified. If unqualified, the monitoring time period in which the cell storage quality is unqualified is recorded as an abnormal time period, and extract the liquid nitrogen tank level, storage temperature in the tank, and storage humidity in the tank at each monitoring time point in each abnormal time period.

[0076] S3. Adjustment of cell storage conditions: confirm the reasons for unqualified cell storage quality corresponding to each liquid nitrogen tank in each abnormal time period, and adjust the cell storage conditions according to the reasons for unqualified cell storage quality.

[0077] S4. Storage management evaluation of the repository: Count the number of abnormal time periods, liquid nitrogen replenishment times, and storage environment adjustment times corresponding to each liquid nitrogen tank, and evaluate whether the storage management of the target cell repository is reasonable. If not, provide feedback.

[0078] The above contents are merely examples and explanations of the concept of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in a similar manner. As long as they do not deviate from the concept of the invention or exceed the scope defined by the present invention, they shall all fall within the protection scope of the present invention.

Claims

1. A stem cell storage management system, characterized in that: include: The cell storage quality assessment module is used to randomly select a number of cell samples from each liquid nitrogen tank in the target cell storage library in each monitoring time period, count the number of randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, and perform cell activity monitoring, cell purity monitoring and microbial contamination monitoring on the randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, obtain the cell monitoring data corresponding to each liquid nitrogen tank in each monitoring time period, and evaluate the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period; The cell storage condition acquisition module is used to determine whether the cell storage quality of each liquid nitrogen tank corresponding to each monitoring time period is qualified. If unqualified, the monitoring time period in which the cell storage quality is unqualified is recorded as an abnormal time period, and the liquid nitrogen tank level, storage temperature in the tank, and storage humidity in the tank of each liquid nitrogen tank at each monitoring time point in each abnormal time period are extracted; The cell storage condition adjustment module is used to confirm the reasons for the unqualified cell storage quality of each liquid nitrogen tank corresponding to each abnormal time period, and adjust the cell storage conditions according to the reasons for the unqualified cell storage quality; A database is used to store the liquid level that needs to be maintained in the liquid nitrogen tank, the storage temperature range and the storage humidity range set in the liquid nitrogen tank, the required amount of liquid nitrogen replenishment corresponding to the unit liquid level stability deviation, and the optimal storage temperature and optimal storage humidity in the tank corresponding to the compliance of each storage environment; The storage management evaluation module of the storage repository is used to count the number of abnormal time periods, liquid nitrogen replenishment times and storage environment adjustment times corresponding to each liquid nitrogen tank, and evaluate whether the storage management of the target cell storage repository is reasonable. If it is unreasonable, feedback is provided; The specific process of confirming the reasons for the unqualified cell storage quality corresponding to each liquid nitrogen tank in each abnormal time period is as follows: B1. Based on the liquid nitrogen tank level of each liquid nitrogen tank at each monitoring time point in each abnormal time period, calculate the liquid level stability of each liquid nitrogen tank corresponding to each abnormal time period ,in, Indicates the number of the abnormal time period, ; B2. Calculate the storage environment compliance of each liquid nitrogen tank in each abnormal time period based on the storage temperature and storage humidity in each liquid nitrogen tank at each monitoring time point in each abnormal time period. ; B3. Establish a diagnosis model for the reasons for unqualified cell storage quality corresponding to each liquid nitrogen tank in each abnormal time period, and output the reasons for unqualified cell storage quality. The diagnosis model for the reasons for unqualified cell storage quality is expressed as: ,in, and The evaluation conditions for the reasons for the failure of each cell storage quality are respectively represented. express , express , express ,in, and They respectively represent the liquid level stability and storage environment compliance of the set reference; The specific process of calculating the liquid level stability of each liquid nitrogen tank corresponding to each abnormal time period is as follows: C1. Record the liquid level of each liquid nitrogen tank at each monitoring time point in each abnormal time period as ,in, Indicates the number of the monitoring time point, ; C2. Extract the liquid level that the liquid nitrogen tank needs to maintain from the database and record it as ; C3. Calculate the liquid level stability of each liquid nitrogen tank during each abnormal time period , ,in, Indicates The liquid nitrogen tank is in The first The liquid level of the liquid nitrogen tank at each monitoring time point, Indicates The liquid nitrogen tank is in The first The liquid level of the liquid nitrogen tank at each monitoring time point, and They respectively represent the liquid level deviation between the reference monitoring time points and the liquid nitrogen tank level deviation. Indicates the number of monitoring time points; The specific process of adjusting the cell storage conditions according to the reasons for the unqualified cell storage quality is as follows: D1. When the cell storage quality is unqualified due to unstable liquid level, the amount of liquid nitrogen required to be replenished corresponding to the unit liquid level stability deviation is extracted from the database and recorded as , set the amount of liquid nitrogen required to be replenished for each liquid nitrogen tank in each abnormal time period , ; D2. When the reason for the unqualified cell storage quality is that the storage environment does not meet the requirements, the storage environment compliance of each liquid nitrogen tank in each abnormal time period is compared with the optimal tank storage temperature and the optimal tank storage humidity corresponding to each storage environment compliance stored in the database, and the optimal tank storage temperature and the optimal tank storage humidity corresponding to each liquid nitrogen tank in each abnormal time period are obtained, and the tank storage temperature and the tank storage humidity corresponding to each liquid nitrogen tank in each abnormal time period are adjusted to the optimal tank storage temperature and the optimal tank storage humidity respectively; D3. When the cell storage quality is unqualified due to other reasons, an early warning feedback will be given.

2. A stem cell storage management system according to claim 1, characterized in that: The cell monitoring data includes the number of unstained cells, the number of target stem cells, the number of microbial species, and the number corresponding to each type of microorganism.

3. A stem cell storage management system according to claim 2, characterized in that: The specific process of evaluating the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period is as follows: A1. Extract the number of unstained cells, the number of target stem cells, the number of microbial species, and the number of each type of microorganism from the cell monitoring data corresponding to each liquid nitrogen tank in each monitoring time period, and record them as , as well as and ,in, Indicates the number of the liquid nitrogen tank. , Indicates the number of the monitoring time period. , Indicates the microbial species number, ; A2. Record the number of randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period as ; A3. Calculate the cell activity of each liquid nitrogen tank in each monitoring time period , ; A4. Calculate the cell purity of each liquid nitrogen tank in each monitoring time period , ; A5. Calculate the severity of microbial contamination for each liquid nitrogen tank during each monitoring period ; A6. Calculate the cell storage quality coefficient of each liquid nitrogen tank in each monitoring time period , ,in, , and Respectively represent the cell activity, cell purity and severity of microbial contamination of the set reference, Represents a natural constant.

4. A stem cell storage management system according to claim 3, characterized in that: The specific method of judging whether the cell storage quality corresponding to each liquid nitrogen tank in each monitoring time period is qualified is: comparing the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period with the set reference cell storage quality coefficient; if the cell storage quality coefficient corresponding to a certain liquid nitrogen tank in a certain monitoring time period is less than the set reference cell storage quality coefficient, the cell storage quality corresponding to the liquid nitrogen tank in the monitoring time period is recorded as unqualified; otherwise, the cell storage quality corresponding to the liquid nitrogen tank in the monitoring time period is recorded as qualified.

5. A stem cell storage management system according to claim 3, characterized in that: The specific process of evaluating whether the storage management of the target cell storage library is reasonable is as follows: E1. Calculate the rationality of storage management of the target cell storage library based on the number of abnormal time periods, liquid nitrogen replenishment times, and storage environment adjustment times corresponding to each liquid nitrogen tank. ; E2. Compare the storage management rationality of the target cell repository with the storage management rationality of the set reference. If the storage management rationality of the target cell repository is greater than or equal to the storage management rationality of the set reference, it indicates that the storage management of the target cell repository is reasonable. Otherwise, it indicates that the storage management of the target cell repository is unreasonable.

6. A stem cell storage management system according to claim 5, characterized in that: The specific process of calculating the storage management rationality of the target cell storage library is as follows: F1, record the number of abnormal time periods, liquid nitrogen replenishment times and storage environment adjustment times corresponding to each liquid nitrogen tank as , and ; F2. Calculate the storage abnormality index corresponding to each liquid nitrogen tank , ,in, Indicates the number of monitoring time periods. and They respectively represent the percentage of abnormal time periods and the total number of liquid nitrogen tank equipment adjustments set for reference; F3. Compare the storage abnormality index corresponding to each liquid nitrogen tank with the storage abnormality index of the set reference. If the storage abnormality index corresponding to a liquid nitrogen tank is greater than the storage abnormality index of the set reference, the liquid nitrogen tank is recorded as an abnormal liquid nitrogen tank. The number of abnormal liquid nitrogen tanks in the target cell storage library is counted and recorded as ; F4. Calculate the rationality of storage management of the target cell repository , ,in, Indicates the number of liquid nitrogen tanks. Indicates the percentage of abnormal liquid nitrogen tanks in the set reference.

7. A stem cell storage management method, executed by the system according to any one of claims 1 to 6, characterized in that: Includes: S1. Cell storage quality assessment: randomly select a number of cell samples from each liquid nitrogen tank in the target cell storage library in each monitoring time period, count the number of randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, and perform cell activity monitoring, cell purity monitoring and microbial contamination monitoring on the randomly selected cell samples corresponding to each liquid nitrogen tank in each monitoring time period, obtain the cell monitoring data corresponding to each liquid nitrogen tank in each monitoring time period, and evaluate the cell storage quality coefficient corresponding to each liquid nitrogen tank in each monitoring time period; S2. Cell storage condition collection: determine whether the cell storage quality of each liquid nitrogen tank in each monitoring time period is qualified. If unqualified, record the monitoring time period in which the cell storage quality is unqualified as an abnormal time period, and extract the liquid nitrogen tank level, storage temperature and storage humidity of each liquid nitrogen tank at each monitoring time point in each abnormal time period; S3. Adjustment of cell storage conditions: confirm the reasons for the unqualified cell storage quality of each liquid nitrogen tank corresponding to each abnormal time period, and adjust the cell storage conditions according to the reasons for the unqualified cell storage quality; S4. Storage management evaluation of the repository: Count the number of abnormal time periods, liquid nitrogen replenishment times, and storage environment adjustment times corresponding to each liquid nitrogen tank, and evaluate whether the storage management of the target cell repository is reasonable. If not, provide feedback.

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