Temperature control method and control system for large volume parenteral water bath type sterilizer

Through the phased temperature increase control method and circulating water-heat exchange, the problems of slow temperature increase and long exposure time of high temperature in traditional water bath sterilizers are solved, and rapid temperature increase and product temperature reduction are achieved, product quality is improved and production costs are reduced.

CN120371047APending Publication Date: 2025-07-25SICHUAN KELUN PHARMA CO LTD
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Patent Information

Application Number
CN202510144185.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-10
Publication Date
2025-07-25

AI Technical Summary

Technical Problem

Traditional water bath sterilizers are slow to heat up, and the product is exposed for a long time in the high temperature stage, resulting in unstable quality of thermally sensitive products, and existing improvements increase costs or have high risk of sterility.

Method used

The phased temperature increase control method is adopted, combined with the control of steam and cooling water valves, and the heating time is shortened and the product temperature in the high temperature stage is reduced through circulating water heat exchange and intermittent cooling.

Benefits of technology

It shortens the heating time and high temperature exposure time of the product, reduces the temperature in the product, reduces the F0 value, improves the stability of the product quality, and reduces energy consumption and production costs.

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Abstract

The invention discloses a temperature control method and a temperature control system for a large volume parenteral water bath type sterilizer, and relates to the technical field of water bath type sterilizers, and the temperature control method comprises the following steps: in the temperature rise process of sterilization, adopting a staged temperature rise mode, and setting different upper limit values of outlet water temperature of a heat exchanger in each stage; when the temperature of a product in the sterilizer reaches a preset temperature value, the steam valve is firstly closed, heat exchange is carried out between heat accumulated by circulating water and the product in the sterilizer chamber, and then the cooling water valve is discontinuously opened, so that the temperature of the circulating water in the sterilizer chamber is reduced; and when the temperature of the product in the sterilizer reaches the sterilization set temperature, the sterilization control program enters a heat preservation stage, and the cooling water valve is continuously and discontinuously opened in the heat preservation stage. The temperature rising time of the product and the exposure time in the high-temperature stage are shortened, meanwhile, the overall temperature of the product is reduced, the F0 value is reduced, and the problems that the temperature rising speed is high, and the temperature in the product is too high easily are solved.
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Description

Technical Field

[0001] The present invention relates to the technical field of water-bath sterilizers, and particularly relates to a temperature control method and control system for a large-volume infusion water-bath sterilizer. Background Art

[0002] A large-volume infusion water-bath sterilizer is used in the pharmaceutical field to sterilize large-volume infusion products, so as to make the products reach a certain aseptic guarantee level. The water-bath sterilizer uses superheated water as the sterilization medium, which has the advantages of uniform heating, precise temperature control, and no absolute hot spots and cold spots, and is being widely used. The water-bath sterilizer is a key production equipment for ensuring the product quality in the production process of large-volume injections, and plays a very important role in the aseptic guarantee of products produced by using the final sterilization process.

[0003] The sterilizer generally consists of a sterilizer main body, a heat exchange system, a control system, a sterilization cart, etc. The sterilizer main body is the container where the products are sterilized. The products to be sterilized are sealed in the sterilizer chamber, and the infusion products are sterilized by means of high-temperature superheated water spraying during the sterilization stage. The heat exchange system heats or cools the circulating water in the sterilizer, and the circulating water exchanges heat with the products through the spraying and water distribution device in the sterilizer to realize the heating and cooling of the products. The control system automatically controls the pressure and temperature in the sterilizer chamber according to the set sterilization parameters (sterilization temperature, sterilization time, F0 value) program, can realize the automatic calculation of the F0 value, and monitors the sterilization process in real time.

[0004] The temperature control method of the traditional water-bath sterilizer has a slow heating rate. After switching to the holding stage and entering the sterilization stage, the temperature inside the product is high, and the exposure time of the product at the high-temperature stage is long. Especially for heat-sensitive products, impurities are easily generated, which affects the product quality and the medication safety of patients.

[0005] Currently, there are mainly the following two production methods for heat-sensitive products:

[0006] Production Method 1: Use a small-volume water-bath sterilizer for production, but the production batch is small. Or by adding heat standby hardware, such as increasing the heat exchange area of the heat exchanger, but for a production line with multi-variety production, these will increase energy consumption and production costs. Currently, there are relatively few heat-sensitive products among the terminal large-volume infusion products, and most of the products are non-heat-sensitive products. The above two methods will increase the production costs.

[0007] Production Method 2: Change the sterilization conditions and adopt the sterilization conditions of 121°C F0(8). The final F0 value of the product is about 10, but at present, the supervision does not tend to this method, and the aseptic risk of the product is relatively high. Summary of the Invention

[0008] Based on the problems of slow temperature rise in the current temperature control method of water-bath sterilizers, high temperature inside the product after switching to the heat preservation stage and entering the sterilization stage, and long exposure time of the product at the high temperature stage, the purpose of the present invention is to provide a temperature control method and control system for a large-volume infusion water-bath sterilizer, which shortens the temperature rise time of the product and the exposure time at the high temperature stage, while reducing the overall temperature of the product, reducing the F0 value, and solving the problems of fast temperature rise and easy overheating of the product inside.

[0009] The present invention is realized through the following technical solutions:

[0010] In the first aspect, the present application provides a temperature control method for a large-volume infusion water-bath sterilizer, including the following steps:

[0011] Set the temperature rise program: During the temperature rise process of sterilization, adopt a staged temperature rise method, and set different upper limit values of the heat exchanger outlet water temperature for each stage;

[0012] When the temperature of the product in the sterilizer reaches the preset temperature value, first close the steam valve, and perform heat exchange between the heat accumulated by the circulating water itself and the product in the sterilizer chamber, and then intermittently open the cooling water valve to reduce the temperature of the circulating water in the sterilizer chamber;

[0013] Set the heat preservation program: When the temperature of the product in the sterilizer reaches the sterilization set temperature, the sterilization control program enters the heat preservation stage, and the cooling water valve continues to be intermittently opened during the heat preservation stage.

[0014] Further, during the temperature rise process, the opening degree of the control valve is adjusted to increase the temperature rise speed.

[0015] Further, the staged temperature rise includes a method of rising in four stages.

[0016] Further, the upper limit value of the heat exchanger outlet water temperature set for each stage is:

[0017] In the first stage, the upper limit value of the heat exchanger outlet water temperature is set to 125.0 °C to 126.5 °C;

[0018] In the second stage, the upper limit value of the heat exchanger outlet water temperature is set to 123.4 °C to 125.0 °C;

[0019] In the third stage, the upper limit value of the heat exchanger outlet water temperature is set to 123.4 °C to 124.0 °C;

[0020] In the fourth stage, the upper limit value of the heat exchanger outlet water temperature is set to 122.0 °C to 123.0 °C.

[0021] Further, in the first stage, by fully opening the steam valve of the heat exchanger, the heat exchanger outlet water temperature is increased, so that the temperature of the circulating water in the sterilizer quickly rises to the set temperature value;

[0022] In the second stage, after one or more of the product temperatures in the sterilizer reach the set temperature value, the outlet water temperature of the heat exchanger is reduced;

[0023] In the third stage, after one or more of the product temperatures in the sterilizer reach the set temperature value, the steam valve is closed;

[0024] In the fourth stage, after one or more of the product temperatures in the sterilizer reach the set temperature value, the cooling water is intermittently turned on.

[0025] Furthermore, in the heating-up program, the preset temperature value for each stage is as follows:

[0026] The preset temperature value for the first stage is 114 °C;

[0027] The preset temperature value for the second stage is 117 °C;

[0028] The preset temperature value for the third stage is 120 °C;

[0029] The preset temperature value for the fourth stage is 120.6 °C.

[0030] Furthermore, in the heat preservation program, the outlet water temperature of the heat exchanger is between 121.4 °C and 121.8 °C, and the inlet water temperature of the heat exchanger is between 121.3 °C and 121.5 °C. If the outlet water temperature of the heat exchanger is lower than 121.4 °C or / and the inlet water temperature of the heat exchanger is lower than 121.3 °C, the steam valve is opened for heating; if the outlet water temperature of the heat exchanger is higher than 121.8 °C or / and the inlet water temperature of the heat exchanger is higher than 121.5 °C, the cooling water valve is opened.

[0031] In a second aspect, the present application provides a control system for a large-volume infusion water-bath sterilizer. The water-bath sterilizer includes a heating device, a sterilizer, and a control system. The control system includes a processor and a memory storing program instructions. The processor is configured to execute the above temperature control method when running the program instructions.

[0032] In a third aspect, the present application provides a large-volume infusion water-bath sterilizer, characterized by including the above control system.

[0033] In a fourth aspect, the present application provides a computer-readable storage medium storing program instructions, and the program instructions execute the above temperature control method when running.

[0034] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0035] (1) The present invention shortens the heating time of the product, reduces the exposure time of the product at high temperature, and at the same time lowers the overall temperature inside the product, reducing the F0 value, thus solving the problem that the temperature inside the product is prone to be too high due to rapid heating.

[0036] (2) The present invention can keep the number of loading layers of a single sterilization cart unchanged, change the arrangement mode of products inside a single-layer sterilization box, i.e., the loading mode of products, and reduce the loading density to increase the space for the sterilization circulating water to flow downward, enabling the sterilization circulating water to flow downward quickly. For example, for a four-layer sterilization cart, each layer can normally load 22 rows, and each row loads 14 bottles. When producing heat-sensitive products, the products on the 1st and 3rd layers are loaded in 22 rows, and by means of equally spaced bottle separation, the loading is achieved at bottle positions 1, 3, 5, 7, 9, 11, and 13, loading 7 bottles; the products on the 2nd and 4th layers are loaded in 22 rows, and by means of equally spaced bottle separation, the loading is achieved at bottle positions 2, 4, 6, 8, 10, 12, and 14, loading 7 bottles.

[0037] (3) The present invention can reduce the number of loading layers of the sterilization cart. For example, for the sterilization of normal products, each sterilization cart can load 4 layers of products, labeled as 1, 2, 3, and 4 layers from bottom to top. If the traditional temperature control program is used, only one layer can be loaded for the production of heat-sensitive products, and the remaining three layers are empty boxes. By using the control program of the present invention, it is possible to load layers 1, 2, 3 or layers 1, 3 to sterilize heat-sensitive products.

[0038] (4) In the control system of the present application, a frequency converter is used to control the operating frequency of the circulation pump. Compared with the traditional situation without a frequency converter or with a frequency converter but without changing the operating frequency of the circulation pump, the number of circulation times of the circulating water per unit time can be increased, thereby increasing the heating speed. Detailed implementation mode

[0039] To make the objectives, technical solutions, and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below in conjunction with embodiments. The illustrative embodiments and descriptions of the present invention are only used to explain the present invention and are not intended to limit the present invention.

[0040] In the following description, a large number of specific details are set forth in order to provide a thorough understanding of the present invention. However, it is obvious to those of ordinary skill in the art that the present invention does not have to be implemented with these specific details. In other embodiments, well-known materials or methods are not specifically described to avoid obscuring the present invention.

[0041] Throughout the specification, references to "an embodiment", "embodiments", "an example", or "examples" mean that a particular feature, structure, or characteristic described in connection with the embodiment or example is included in at least one embodiment of the present invention. Thus, the phrases "an embodiment", "embodiments", "an example", or "examples" that appear throughout the specification do not necessarily all refer to the same embodiment or example. Furthermore, the particular features, structures, or characteristics may be combined in any suitable combination and / or sub-combination in one or more embodiments or examples. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items. Additionally, without contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0042] The "range" disclosed in this application is defined in the form of a lower limit and an upper limit. A given range is defined by selecting a lower limit and an upper limit, and the selected lower limit and upper limit define the boundary of a particular range. The ranges defined in this way can include the end values or not include the end values, and can be combined arbitrarily, that is, any lower limit can be combined with any upper limit to form a range. For example, if ranges of 60-120 and 80-110 are listed for a specific parameter, ranges of 60-110 and 80-120 are also contemplated. Additionally, if the minimum range values 1 and 2 are listed, and if the maximum range values 3, 4, and 5 are listed, then the following ranges are all contemplated: 1-3, 1-4, 1-5, 2-3, 2-4, and 2-5. In this application, unless otherwise specified, the numerical range "a-b" represents an abbreviated representation of any real number combination between a and b, where a and b are both real numbers. For example, the numerical range "0-5" means that all real numbers between "0-5" have been fully listed herein, and "0-5" is only an abbreviated representation of these numerical combinations. Additionally, when stating that a certain parameter is an integer ≥2, it is equivalent to disclosing that the parameter is, for example, the integers 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc.

[0043] If there is no special instruction, all steps of this application can be carried out sequentially or randomly, preferably sequentially. For example, the method includes steps (a) and (b), which means that the method may include steps (a) and (b) carried out sequentially, or may also include steps (b) and (a) carried out sequentially. For example, when it is mentioned that the method may further include step (c), it means that step (c) can be added to the method in any order. For example, the method may include steps (a), (b), and (c), or may also include steps (a), (c), and (b), or may also include steps (c), (a), and (b), etc.

[0044] Embodiment 1

[0045] This embodiment provides a temperature control method for a large infusion water bath sterilizer, which is carried out according to the following steps:

[0046] S1. During the heating-up process of sterilization, it is carried out in a way of heating up in four stages. By controlling the opening degree of the valve, the heating-up speed is increased. The upper limit value of the outlet water temperature of the heat exchanger set for each stage is:

[0047] In the first stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 125.0°C to 126.5°C; by controlling the steam valve of the heat exchanger to be fully open, the outlet water temperature of the heat exchanger is increased, so that the temperature of the circulating water in the sterilizer rises rapidly to 114°C;

[0048] In the second stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 123.4°C to 125.0°C; after one or more of the product temperatures in the sterilizer reach 117°C, the outlet water temperature of the heat exchanger is reduced;

[0049] In the third stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 123.4°C to 124.0°C; after one or more of the product temperatures in the sterilizer reach 120°C, the steam valve is closed;

[0050] In the fourth stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 122.0°C to 123.0°C; after one or more of the product temperatures in the sterilizer reach 120.6°C, the cooling water is intermittently opened.

[0051] S2. When the temperature of the product in the sterilizer reaches the preset temperature value, first close the steam valve, and carry out heat exchange between the heat accumulated by the circulating water itself and the product in the sterilizer chamber, and then intermittently open the cooling water valve to reduce the temperature of the circulating water in the sterilizer chamber.

[0052] S3. When the product temperature in the sterilizer reaches the sterilization set temperature, the sterilization control program enters the heat preservation stage. In the heat preservation stage, the cooling water valve is continuously and intermittently opened (opened for 2 seconds, and then opened again after an interval of 15 seconds). In this stage, the outlet water temperature of the heat exchanger is controlled at 121.4°C to 121.8°C, and the inlet water temperature of the heat exchanger is controlled at 121.3°C to 121.5°C. If the outlet water temperature of the heat exchanger is lower than 121.4°C or / and the inlet water temperature of the heat exchanger is lower than 121.3°C, the steam valve is opened for heating; if the outlet water temperature of the heat exchanger is higher than 121.8°C or / and the inlet water temperature of the heat exchanger is higher than 121.5°C, the cooling water valve is opened.

[0053] The temperature control method of the large-volume infusion water-bath sterilizer in this embodiment, during the heating process, by dividing into stages and setting different upper limit values of the heat exchanger outlet water temperature for each stage, controls the opening degree of the steam valve to increase the heating speed. When the product temperature in the sterilizer reaches a certain temperature, the steam valve is closed, and heat exchange is carried out between the heat accumulated by the circulating water itself and the product in the sterilizer chamber; by intermittently opening the cooling water valve, the temperature of the circulating water in the sterilizer chamber is reduced. When the product temperature in the sterilizer reaches the sterilization set temperature, the sterilization control program enters the heat preservation stage. At this time, the heat exchanger outlet water temperature and the heat exchanger inlet water temperature are still relatively high. To further reduce the product temperature, the cooling water valve is continuously and intermittently opened during the heat preservation stage to control the heat exchanger outlet water temperature and the heat exchanger inlet water temperature within a relatively narrow temperature range, so that the product reaches the expected temperature.

[0054] Using the control method in this embodiment shortens the heating time of the product, shortens the exposure time of the product in the high-temperature stage, at the same time reduces the overall temperature inside the product, reduces the F0 value, and solves the problem that the temperature inside the product is likely to be too high due to rapid heating. Moreover, it is also possible to keep the number of loading layers of a single sterilization cart unchanged, change the arrangement method of the products in a single-layer sterilization box, that is, the loading method of the products, reduce the loading density, so as to increase the space for the sterilization circulating water to flow downward, enabling the sterilization circulating water to flow downward quickly. For example, for a four-layer sterilization cart, each layer can normally load 22 rows, and each row loads 14 bottles. When producing heat-sensitive products, the products on the 1st and 3rd layers are loaded in 22 rows, and by means of equally spaced bottle separation, the loading is achieved at the bottle positions of 1, 3, 5, 7, 9, 11, and 13, loading 7 bottles; the products on the 2nd and 4th layers are loaded in 22 rows, and by means of equally spaced bottle separation, the loading is achieved at the bottle positions of 2, 4, 6, 8, 10, 12, and 14, loading 7 bottles. Moreover, it is also possible to reduce the number of loading layers of the sterilization cart. For example, for the sterilization of normal products, each sterilization cart can load 4 layers of products, labeled as 1, 2, 3, and 4 layers from bottom to top. If the traditional temperature control program is used, only one layer can be loaded for the production of heat-sensitive products, and the remaining three layers are empty boxes. Using the control program of the present invention, it is possible to load 1, 2, 3 layers or 1, 3 layers to sterilize heat-sensitive products. In addition, in the control system, a frequency converter is used to control the operating frequency of the circulation pump. Compared with the traditional situation without a frequency converter or with a frequency converter but without changing the operating frequency of the circulation pump, it can increase the number of circulation times of the circulating water per unit time, thereby increasing the heating speed.

[0055] Embodiment 2

[0056] This embodiment provides a control system for a large-volume infusion water-bath sterilizer. The water-bath sterilizer includes a heating device, a sterilizer, and a control system. The control system includes a processor and a memory storing program instructions. The processor is configured to execute the temperature control method of a large-volume infusion water-bath sterilizer in the above-mentioned Embodiment 1 when running the program instructions.

[0057] The memory at least includes one type of readable storage medium, and the readable storage medium includes flash memory, hard disk, multimedia card, card-type memory (e.g., SD or D interface display memory, etc.), random access memory (RAM), static random access memory (SRAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), programmable read-only memory (PROM), magnetic memory, magnetic disk, optical disc, etc. In some embodiments, the memory may be an internal storage unit of the computer device, for example, the hard disk or memory of the computer device. In other embodiments, the memory may also be an external storage device of the computer device, such as a plug-in hard disk, Smart Media Card (SMC), Secure Digital (SD) card, FlashCard, etc. equipped on the computer device. Of course, the memory may also include both the internal storage unit of the computer device and external storage devices. In this embodiment, the memory is commonly used to store the operating system installed on the computer device and various application software, such as the program code for running the temperature control method of the large infusion water bath sterilizer. In addition, the memory can also be used to temporarily store various types of data that have been output or will be output.

[0058] In some embodiments, the processor may be a central processing unit (CPU), controller, microcontroller, microprocessor, or other data processing chip. The processor is generally used to control the overall operation of the computer device. In this embodiment, the processor is used to run the program code stored in the memory or process data, such as running the program code for the temperature control method of the large infusion water bath sterilizer.

[0059] Embodiment 3

[0060] This embodiment provides a computer-readable storage medium storing program instructions, and when the program instructions are running, they execute the temperature control method of the large infusion water bath sterilizer in Embodiment 1 above.

[0061] Among them, the computer-readable storage medium stores an interface display program, and the interface display program can be executed by at least one processor, so that the at least one processor executes the steps of the temperature control method of the large infusion water bath sterilizer in Embodiment 1 above.

[0062] Those skilled in the art should understand that the embodiments of the present application can be provided as methods, systems, or computer program products. Therefore, the present application can take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware aspects. Moreover, the present application can take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0063] The computer program instructions in the present application can be implanted into the processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing devices to generate a machine. These computer program instructions can also be loaded onto a computer or other programmable data processing devices, so that a series of operation steps are executed on the computer or other programmable devices to generate computer-implemented processing. Thus, the instructions executed on the computer or other programmable devices provide the functional steps specified in the temperature control method of the present application.

[0064] Through the description of the above embodiments, those skilled in the art can clearly understand that the above implementation methods can be realized by means of software plus a necessary general hardware platform. Of course, it can also be realized by hardware, but in many cases, the former is a better implementation method. Based on such an understanding, the technical solution of the present application, in essence, or the part that contributes to the prior art can be embodied in the form of a software product. This computer software product is stored in a storage medium (such as ROM / RAM, magnetic disk, optical disk), including several instructions for causing a terminal device (which can be a mobile phone, a computer, a server, or a network device, etc.) to execute the methods described in the various embodiments of the present application.

[0065] Finally, it should be noted that: through the above specific embodiments, the purpose, technical solution, and beneficial effects of the present invention have been further described in detail. It should be understood that the above is only the specific embodiment of the present invention and is not used to limit the protection scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention. For those skilled in the art, it is obvious that the present application is not limited to the details of the above exemplary embodiments, and can be implemented in other specific forms without departing from the spirit or basic characteristics of the present application. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of the present application is defined by the appended claims rather than the above description. Therefore, it is intended to include all changes falling within the meaning and scope of the equivalent elements of the claims in the present application.

Claims

1. A temperature control method for a large-volume infusion water-bath sterilizer, characterized in that, It includes the following steps: Set the heating program: During the heating process of sterilization, a staged heating method is adopted, and the upper limit value of the outlet water temperature of the heat exchanger is set for each stage. When the temperature of the product in the sterilizer reaches the preset temperature value, first close the steam valve, perform heat exchange between the heat accumulated by the circulating water itself and the product in the sterilizer chamber, and then intermittently open the cooling water valve to reduce the temperature of the circulating water in the sterilizer chamber. Set the heat preservation program: When the temperature of the product in the sterilizer reaches the sterilization set temperature, the sterilization control program enters the heat preservation stage, and the cooling water valve continues to be intermittently opened during the heat preservation stage.

2. The temperature control method of a large-volume infusion water-bath sterilizer according to claim 1, wherein During the heating process, the heating speed is increased by controlling the opening degree of the valve.

3. The temperature control method of a large-volume infusion water-bath sterilizer according to claim 1, characterized in that, The staged heating includes a heating method with four stages.

4. The temperature control method of a large-volume infusion water-bath sterilizer according to claim 3, characterized in that, The upper limit value of the outlet water temperature of the heat exchanger set for each stage is: In the first stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 125.0°C - 126.5°C; In the second stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 123.4°C - 125.0°C; In the third stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 123.4°C - 124.0°C; In the fourth stage, the upper limit value of the outlet water temperature of the heat exchanger is set to 122.0°C - 123.0°C.

5. A temperature control method for a large infusion water bath sterilizer according to claim 4, characterized in that In the first stage, by fully opening the steam valve of the heat exchanger, the outlet water temperature of the heat exchanger is increased, so that the temperature of the circulating water in the sterilizer quickly rises to the set temperature value; In the second stage, after one or more of the product temperatures in the sterilizer reach the set temperature value, the outlet water temperature of the heat exchanger is reduced; In the third stage, after one or more of the product temperatures in the sterilizer reach the set temperature value, the steam valve is closed; In the fourth stage, after one or more of the product temperatures in the sterilizer reach the set temperature value, the cooling water is intermittently opened.

6. The temperature control method of a large-volume infusion water-bath sterilizer according to claim 3, characterized in that, In the heating program, the preset temperature value for each stage is: The preset temperature value for the first stage is 114°C; The preset temperature value for the second stage is 117°C; The preset temperature value for the third stage is 120°C; The preset temperature value for the fourth stage is 120.6°C.

7. The temperature control method of a large-volume infusion water-bath sterilizer according to claim 1, characterized in that, In the heat preservation program, the outlet water temperature of the heat exchanger is between 121.4°C and 121.8°C, and the inlet water temperature of the heat exchanger is between 121.3°C and 121.5°C. If the outlet water temperature of the heat exchanger is lower than 121.4°C or / and the inlet water temperature of the heat exchanger is lower than 121.3°C, the steam valve is opened for heating; if the outlet water temperature of the heat exchanger is higher than 121.8°C or / and the inlet water temperature of the heat exchanger is higher than 121.5°C, the cooling water valve is opened.

8. A control system for a large-volume infusion water-bath sterilizer, characterized in that, The water bath sterilizer includes a heating device, a sterilizer and a control system. The control system includes a processor and a memory storing program instructions. The processor is configured to execute the temperature control method according to any one of claims 1 - 7 when running the program instructions.

9. An infusion water-bath sterilizer, characterized in that, It includes the control system according to claim 8.

10. A computer-readable storage medium storing program instructions, characterized in that, When the program instructions are running, the temperature control method according to any one of claims 1 - 7 is executed.