Process control system and method for disposable bioreactor

By designing a process control system for single-use bioreactors, the problem that parameter setting depends on experience and lack of data analysis in the existing technology is solved, and more scientific and accurate parameter control is achieved, which improves the stability of the bioreactor culture process. Sex and efficiency.

CN119491068APending Publication Date: 2025-02-21SHANGHAI TOFFLON MEDICAL EQUIP CO LTD
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Patent Information

Application Number
CN202411509507.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-28
Publication Date
2025-02-21

AI Technical Summary

Technical Problem

The setting and adjustment of parameter values ​​during the existing bioreactor culture process depends on experience, lack of scientificity and accuracy, resulting in inconsistent parameter values, affecting the bioactive parameter values ​​of the final culture product. At the same time, the existing automated control system lacks the analysis and optimization functions of data during the cultivation process, and cannot effectively identify bottlenecks and optimization points.

Method used

A process control system for a disposable bioreactor is designed, including a data acquisition module, a data analysis module, a parameter adjustment module, an automation control module and a visual management module. The system collects and analyzes data in real time, compares parameter trends in different batches, adjusts parameter ranges, and ensures the optimal state of the production process through automated control.

Benefits of technology

It realizes more scientific and precise parameter control of the bioreactor culture process, improves the stability and repetition of the culture process, can effectively identify and optimize bottlenecks and optimization points, and improves the efficiency and quality of the bioreactor culture process.

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Abstract

The invention discloses a process control system for a disposable bioreactor, and the system comprises a data collection module which is used for collecting data in a production process in real time and generating csv files, and each csv file corresponds to a production batch; the data analysis module is used for selecting at least two csv files, selecting at least one parameter for comparison and generating a comparison result and a parameter trend chart; the parameter adjusting module is used for setting different parameter ranges according to different cultures and culture targets and adjusting parameters according to the comparison result to obtain parameter values and time finally set for next culture; and the automatic control module is used for controlling equipment according to the finally set parameter values and time of the next culture so as to ensure the optimal state of the production process. The invention further discloses a process control method of the disposable bioreactor. The method effectively solves the problem that in the prior art, setting of parameter values only depends on personal experience, it cannot be ensured that the production process is in the optimal state, and biological activity parameter values of final culture products are affected.
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Description

Technical Field

[0001] The present invention relates to the technical field of disposable bioreactors, and in particular to a process control system and method for a disposable bioreactor. Background Art

[0002] In the fields of biotechnology, bioengineering and control systems, bioreactors are very important equipment that simulates the environment in the body and provides suitable growth conditions so that microorganisms or cells can grow and reproduce and produce the desired products. Parameter control during the bioreactor culture process is a key factor affecting the value of the biological activity parameters of the final culture product.

[0003] In the existing bioreactor culture process, the method of manually adjusting and controlling parameters is usually adopted, that is, by manually monitoring and adjusting the temperature, pH value, dissolved oxygen concentration, substrate concentration and other parameters in the culture process to maintain the stability of the bioreactor environment, so as to obtain the ideal culture product. In addition, there are some automatic control systems that can automatically adjust and control the parameters in the bioreactor through preset parameter values ​​to achieve optimal control of the culture process.

[0004] However, in the existing bioreactor culture process, the setting and adjustment of parameter values ​​often rely on experience and lack scientificity and precision, which may lead to the consistency (or inconsistency) of parameter values ​​and affect the numerical value of the biological activity parameters of the final culture product. In addition, although the existing automated control system can realize automatic adjustment and control of the culture process, it lacks the function of analyzing and optimizing the data in the culture process, and cannot effectively identify bottlenecks and optimization points, thus limiting its application in the bioreactor culture process.

[0005] Therefore, the problems or shortcomings of the existing technologies in this field are mainly the lack of in-depth analysis and optimization of data during the culture process, and the lack of precise control and optimization of the parameter values ​​of the culture process. Summary of the invention

[0006] The purpose of the present invention is to overcome the existing defects and provide a process control system and method for a disposable bioreactor, which effectively solves the problem that the setting of parameter values ​​in the prior art is based solely on personal experience, which cannot ensure that the production process is in the best state and affects the value of the biological activity parameters of the final culture product.

[0007] The technical solution to achieve the above purpose is:

[0008] A process control system for a disposable bioreactor according to one embodiment of the present invention comprises:

[0009] A data acquisition module is used to collect data in the production process in real time and generate csv files, each of which corresponds to a production batch;

[0010] A data analysis module is used to select at least two CSV files, select at least one parameter for comparison, and generate a comparison result and a parameter trend graph;

[0011] A parameter adjustment module is used to set different parameter ranges according to different cultures and culture objectives, and adjust the parameters according to the comparison results to obtain the final parameter values ​​and time set for the next culture;

[0012] The automation control module is used to control the equipment according to the parameter values ​​and time set for the next culture to ensure the best state of the production process;

[0013] Visual management module, used to display real-time data and analysis results of the production process.

[0014] Preferably, in the data acquisition module, the generated csv file is named according to the production batch number.

[0015] Preferably, in the data analysis module, the parameters for comparison are limited to only one or two.

[0016] Preferably, in the data analysis module, the parameters for comparison include but are not limited to temperature, pH value, dissolved oxygen concentration and substrate concentration.

[0017] Preferably, in the visual management module, the displayed content includes real-time data of temperature, pH value, dissolved oxygen concentration, substrate concentration, and a historical trend chart of each parameter.

[0018] A second process control method for a disposable bioreactor according to the present invention comprises:

[0019] Step S1, collect data in the production process in real time and generate csv files, each of which corresponds to a production batch;

[0020] Step S2, select two or more csv files to be compared, select at least one parameter to be compared, and generate a comparison result and a parameter trend graph;

[0021] Step S3, setting different parameter ranges according to different cultures and culture objectives, and adjusting the parameters according to the comparison results to obtain the final parameter values ​​and time set for the next culture;

[0022] Step S4, controlling the equipment according to the parameter values ​​and time finally set for the next cultivation to ensure the optimal state of the production process;

[0023] Step S5, displaying real-time data and analysis results of the production process.

[0024] Preferably, in step S1, the generated csv file is named according to the production batch number.

[0025] Preferably, in step S2, the comparison of parameters to be viewed is limited to one or two parameters; the parameters viewed include but are not limited to temperature, pH value, dissolved oxygen concentration and substrate concentration.

[0026] Preferably, step S3 comprises:

[0027] Step S31, setting the lower limit and upper limit of temperature, pH value, dissolved oxygen concentration and substrate concentration for different culture time periods;

[0028] Step S32, if the parameter value fluctuates during the cultivation process, it is normal as long as the fluctuation range is within the upper and lower limits;

[0029] Step S33, if the duration of the parameter fluctuation exceeds the upper or lower limit, and the final culture product biological index exceeds the normal culture biological index, the duration of the time period and the parameter value will be displayed. During the next culture, it will automatically prompt whether to adjust the parameter value and the duration of the time period.

[0030] The beneficial effects of the present invention are as follows: the present invention realizes the transmission and interaction of data and instructions by setting a data acquisition module, a data analysis module, a parameter adjustment module, an automatic control module and a visual management module;

[0031] The present invention collects data from the production process in real time, conducts in-depth analysis, identifies bottlenecks and optimization points, and can help solve the problem of the influence of the consistency (or inconsistency) of parameter values ​​in the cultivation process of the existing bioreactor on the biological activity parameter values ​​of the final culture product by comparing and analyzing the parameter values ​​of the final culture results of more than two batches. Compared with the lack of comparison and analysis of data in the cultivation process in the prior art, the present invention provides a more comprehensive and scientific comparison and analysis method, which helps to improve the stability and repeatability of the cultivation process.

[0032] The present invention can flexibly select and adjust the parameters to be viewed and the batches to be compared according to different culture requirements and conditions, and has strong flexibility and adaptability. Compared with the fixed and poorly adjustable parameter setting and adjustment methods in the prior art, the present invention provides a more flexible and more adaptable parameter setting and adjustment method, which helps to improve the efficiency and quality of the culture process.

[0033] The present invention adjusts and operates the numerical values ​​based on the parameter adjustment results, and the numerical linkage equipment ensures the optimal state of the production process. Compared with the prior art which can only realize automatic adjustment and control and lacks the function of analyzing and optimizing the data in the culture process, the present invention realizes the automatic control and optimization of the culture process, can effectively identify the bottlenecks and optimization points, and improves the efficiency and quality of the bioreactor culture process;

[0034] The present invention provides an intuitive interface to display real-time data and analysis results of the production process, helping managers to make wise decisions. Compared with the prior art which lacks intuitive and easy-to-understand interface displays, the present invention provides a more intuitive and easier-to-understand interface display, making it easier for managers to monitor and manage the cultivation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a module diagram of a process control system of a disposable bioreactor of the present invention;

[0036] Figure 2 It is a flow chart of a process control method of a disposable bioreactor of the present invention;

[0037] Figure 3 It is a specific flow chart of step S3 in the process control method of a disposable bioreactor of the present invention. DETAILED DESCRIPTION

[0038] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0039] The present invention will be further described below in conjunction with the accompanying drawings.

[0040] like Figure 1 As shown, a process control system of a disposable bioreactor includes: a data acquisition module 1, a data analysis module 2, a parameter adjustment module 3, an automatic control module 4 and a visual management module 5.

[0041] The data acquisition module 1 is used to collect data in the production process in real time and generate csv files, each csv file corresponds to a production batch.

[0042] In an embodiment, the generated csv file is named according to the production batch number (for example, A1, A2, B1, B2). When comparing the parameters to be compared (up to two parameters), the csv files with batch numbers A1, A2, B1, B2 can be selected for comparison. The parameters to be compared can be temperature, pH value, dissolved oxygen concentration, substrate concentration, etc.

[0043] The data analysis module 2 is used to select at least two csv files, select at least one parameter for comparison, and generate comparison results and parameter trend graphs, which can effectively solve the problem of lack of analysis and optimization functions for data in the cultivation process in the existing bioreactor cultivation process.

[0044] In the embodiments, the parameters for comparison are limited to only one or two.

[0045] In the examples, the parameters to be compared include, but are not limited to, temperature, pH value, dissolved oxygen concentration, and substrate concentration.

[0046] The parameter adjustment module 3 is used to set different parameter ranges according to different cultures and culture objectives, and adjust the parameters according to the comparison results to obtain the final parameter values ​​and time set for the next culture.

[0047] For example, the lower limit of temperature can be set to 20°C and the upper limit to 30°C, the lower limit of pH value can be set to 6.0 and the upper limit to 8.0, the lower limit of dissolved oxygen concentration can be set to 50% and the upper limit can be set to 80%, and the lower limit of substrate concentration can be set to 1g / L and the upper limit can be set to 5g / L.

[0048] The automatic control module 4 is used to control the equipment according to the parameter values ​​and time finally set for the next culture to ensure the optimal state of the production process. For example, if it is found that the temperature fluctuates too much and exceeds the set parameter range, the power of the heater is automatically controlled to maintain temperature stability. Through this automatic control method, it is possible to effectively solve the problem that the setting and adjustment of parameter values ​​in the existing bioreactor culture process often rely on experience, lack scientificity and accuracy, which may lead to consistency (or inconsistency) of parameter values ​​and affect the value of the biological activity parameters of the final culture product.

[0049] Visual management module 5 is used to display real-time data and analysis results of the production process to help managers make wise decisions. Through this visual management method, the problem that the manual adjustment and control of parameters in the existing bioreactor culture process is inefficient and easily affected by human factors can be effectively solved.

[0050] In the embodiment, the displayed content includes real-time data of temperature, pH value, dissolved oxygen concentration, substrate concentration, and historical trend graph of the parameters.

[0051] like Figure 2 As shown, a process control method for a disposable bioreactor comprises:

[0052] Step S1, collect data in the production process in real time and generate csv files, each csv file corresponds to a production batch.

[0053] In the embodiment, the generated csv files are named in the form of production batch numbers A1, A2, B1, and B2.

[0054] Step S2 selects two or more csv files to be compared, selects at least one parameter for comparison, and generates a comparison result and a parameter trend graph.

[0055] In the embodiment, the csv files for comparison are all csv files of the same culture, and the parameters for comparison are limited to one or two; the parameters for comparison include but are not limited to temperature, pH value, dissolved oxygen concentration and substrate concentration.

[0056] Step S3, setting different parameter ranges according to different cultures and culture objectives, and adjusting the parameters according to the comparison results to obtain the final parameter values ​​and time set for the next culture.

[0057] like Figure 3 As shown, step S3 includes:

[0058] Step S31, setting lower limits and upper limits of temperature, pH value, dissolved oxygen concentration and substrate concentration for different culture time periods.

[0059] Step S32: If the parameters fluctuate during the culture process, it is normal as long as the fluctuation range is within the upper and lower limits.

[0060] Step S33, if the duration of the parameter fluctuation exceeds the upper or lower limit, and the final culture product biological index exceeds the normal culture biological index, the duration of the time period and the parameter value are displayed. During the next culture, it is automatically prompted whether to adjust the parameter value and the duration of the time period.

[0061] Step S4, if yes is selected, the equipment is controlled according to the parameter values ​​and time finally set for the next culture to ensure the optimal state of the production process. In this process, the system can adjust the speed, temperature, gas ventilation, feed amount, etc. of the disposable bioreactor according to the parameter values ​​and time finally set to ensure the uniformity and stability of the culture growth in different growth cycles.

[0062] Step S5, displaying real-time data and analysis results of the production process.

[0063] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions described in the above embodiments may still be modified, or some or all of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A process control system for a disposable bioreactor, characterized in that: include: A data acquisition module is used to collect data in the production process in real time and generate csv files, each of which corresponds to a production batch; A data analysis module is used to select at least two CSV files, select at least one parameter for comparison, and generate a comparison result and a parameter trend graph; A parameter adjustment module is used to set different parameter ranges according to different cultures and culture objectives, and adjust the parameters according to the comparison results to obtain the final parameter values ​​and time set for the next culture; The automation control module is used to control the equipment according to the parameter values ​​and time set for the next culture to ensure the best state of the production process; Visual management module, used to display real-time data and analysis results of the production process.

2. The process control system of the disposable bioreactor according to claim 1, characterized in that: In the data acquisition module, the generated csv file is named according to the production batch number.

3. The process control system of the disposable bioreactor according to claim 1, characterized in that: In the data analysis module, the parameters for comparison are limited to only one or two.

4. The disposable bioreactor process control system according to claim 3, characterized in that: In the data analysis module, the parameters to be compared include but are not limited to temperature, pH value, dissolved oxygen concentration and substrate concentration.

5. The process control system of the disposable bioreactor according to claim 1, characterized in that: In the visual management module, the displayed content includes real-time data of temperature, pH value, dissolved oxygen concentration, substrate concentration, and historical trend chart of each parameter.

6. A process control method for a disposable bioreactor, characterized in that: include: Step S1, collect data in the production process in real time and generate csv files, each of which corresponds to a production batch; Step S2, select two or more csv files to be compared, select at least one parameter to be compared, and generate a comparison result and a parameter trend graph; Step S3, setting different parameter ranges according to different cultures and culture objectives, and adjusting the parameters according to the comparison results to obtain the final parameter values ​​and time set for the next culture; Step S4, controlling the equipment according to the parameter values ​​and time finally set for the next cultivation to ensure the optimal state of the production process; Step S5, displaying real-time data and analysis results of the production process.

7. The process control method of a disposable bioreactor according to claim 6, characterized in that: In step S1, the generated csv file is named according to the production batch number.

8. The process control method of a disposable bioreactor according to claim 6, characterized in that: In step S2, the parameters to be compared are limited to one or two; the parameters to be compared include but are not limited to temperature, pH value, dissolved oxygen concentration and substrate concentration.

9. The process control method of a disposable bioreactor according to claim 6, characterized in that: The step S3 comprises: Step S31, setting the lower limit and upper limit of temperature, pH value, dissolved oxygen concentration and substrate concentration for different culture time periods; Step S32, if the parameter value fluctuates during the cultivation process, it is normal as long as the fluctuation range is within the upper and lower limits; Step S33, if the duration of the parameter fluctuation exceeds the upper or lower limit, and the final culture product biological index exceeds the normal culture biological index, the duration of the time period and the parameter value are displayed. During the next culture, it is automatically prompted whether to adjust the parameter value and the duration of the time period.