Ethylene oxide sterilization pre-treatment moist heat equilibration control method

Abstract

The application discloses an ethylene oxide sterilization pretreatment humid heat balance control method, and relates to the technical field of sterilization equipment control. In the system operation, the humid heat time sequence data of each humidity sampling position in the pretreatment cabin is acquired, the target humidity interval is recognized to enter the migration, withdrawal migration and re-entry migration process, the humid heat migration event element is generated, and the accurate identification of the humidity change process is realized. The humid heat throughput image element is formed by associating the continuous migration event element, the characteristic representation of the single humid heat change process is realized, the humid heat throughput image element is aggregated according to the humidity sampling position and the time relationship, the same position throughput sub-cluster and the cross position throughput sub-cluster are formed, the humid heat throughput state is biased and layered, the back connection branch is established, the humid heat back connection domain is formed, and the continuous tracking of the humid heat change process is realized. When each humidity sampling position forms the back connection relationship and there is no unassociated humid heat throughput image element, the humid heat balance closed core is formed, and the pretreatment completion signal is output.

Description

Technical Field

[0001] This invention relates to the field of sterilization equipment control technology, specifically a method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization. Background Technology

[0002] Ethylene oxide sterilization is widely used for the sterilization of medical devices, hygiene consumables, and other heat-sensitive products. Before the ethylene oxide release stage of the sterilization process, the contents and packaging materials inside the sterilization chamber typically undergo moist heat pretreatment to achieve a suitable moist heat state, thus providing the appropriate moist heat conditions for the diffusion, penetration, and sterilization reaction of ethylene oxide gas. Therefore, the control of moist heat equilibrium during the pretreatment stage is a crucial control step in the ethylene oxide sterilization process.

[0003] In actual pretreatment processes, humidity changes in different areas are often asynchronous due to variations in the absorption and release of moisture and heat across different loading zones, packaging materials, and stacking positions. Existing control methods often determine the completion of pretreatment based on whether the measured values ​​from one or more humidity sampling locations enter or remain within the target humidity range for a preset time. This type of method primarily focuses on the current state or duration of humidity readings, making it difficult to further determine whether each humidity sampling location repeatedly enters or exits the target humidity range, and also fails to reflect the sequence and temporal continuity of changes between different humidity sampling locations.

[0004] Therefore, even when the measured values ​​at some humidity sampling locations have reached the target humidity range, the damp-heat response of different loading areas and packaging materials may not yet have stabilized, leading to localized humidity retreat or continuous damp-heat exchange. If the pretreatment completion signal is output solely based on whether the humidity measurement value meets the standard or the duration of compliance, the timing of pretreatment completion may be inaccurate, resulting in differences in the damp-heat conditions underlying the subsequent ethylene oxide sterilization process. This affects the consistency of the sterilization process and the reliability of batch control. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a method for controlling the humidity and heat balance during ethylene oxide sterilization pretreatment, thus solving the problems mentioned in the background section.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a method for controlling the moisture and heat balance during ethylene oxide sterilization pretreatment, comprising the following steps: S1: Acquire the pretreatment wet heat time series data of each pretreatment in the ethylene oxide sterilization pretreatment chamber, and identify the entry migration, withdrawal migration and re-entry migration corresponding to each humidity sampling location according to the target humidity range, and generate wet heat migration event elements. S2: Correlate the damp heat migration event elements by associating the entry migration event elements, retreat migration event elements, and re-entry migration event elements that are formed consecutively in time sequence within the same humidity sampling location to form a damp heat throughput pixel characterizing a single damp heat throughput process. S3: Aggregate the humidity and heat throughput pixels according to the humidity sampling location and time relationship. Group the humidity and heat throughput pixels formed continuously within the same humidity sampling location into the same-position throughput sub-cluster. Group the humidity and heat throughput pixels with time overlap or time continuity between different humidity sampling locations into the cross-position throughput sub-cluster. The humidity and heat throughput cluster is formed by the same-position throughput sub-cluster and the cross-position throughput cluster. S4: Based on the humidity throughput state of each humidity sampling location in the humidity throughput cluster, bias layering is performed to form a humidity bias layer, and a back-loop branch is established based on the temporal continuity relationship between the humidity throughput pixels corresponding to each humidity sampling location in the humidity bias layer to form a humidity back-loop domain. S5: When each humidity sampling location of the overheated throughput pixel has a corresponding return branch, and there are no overheated throughput pixels not included in the return branch in the overheated return domain, a overheated equilibrium closure kernel is formed, and an ethylene oxide sterilization pretreatment completion signal is output according to the overheated equilibrium closure kernel.

[0007] Preferably, the formation of the humid heat migration element includes: The preprocessed humid heat time series data is divided into sampling segments according to a preset sampling period to form multiple humid heat sampling segments; Each of the aforementioned humid heat sampling segments and the target humidity range is assigned to a range, forming sampling segments within the range and sampling segments outside the range; Identify the interval assignment transition position between sampling segments within adjacent intervals and sampling segments outside the interval, and combine adjacent damp heat sampling segments containing one interval assignment transition with their corresponding humidity sampling positions and time ranges to form damp heat migration event elements.

[0008] Preferably, the humid heat migration event element includes an entry migration event element, a retreat migration event element, and a re-entry migration event element; The damp heat migration event element formed by the conversion from the sampling segment outside the interval to the sampling segment inside the interval is defined as the entry migration event element; the damp heat migration event element formed by the conversion from the sampling segment inside the interval to the sampling segment outside the interval is defined as the withdrawal migration event element; the damp heat migration event element that is located after the withdrawal migration event element in time sequence and is formed by the conversion from the sampling segment outside the interval to the sampling segment inside the interval is defined as the re-entry migration event element.

[0009] Preferably, the formation of the humid heat throughput pixel includes: Sort the damp heat migration event elements corresponding to the same humidity sampling location according to the time of occurrence; Entering migration event elements, retreating migration event elements, and re-entering migration event elements that are sequentially adjacent in time are defined as a continuous migration event sequence, wherein there are no other humid heat migration event elements corresponding to the humidity sampling position between two adjacent humid heat migration event elements; The humidity sampling location, migration direction sequence, start and end time, and migration duration corresponding to the continuous migration event sequence are combined to form a humid heat throughput pixel.

[0010] Preferably, the formation of the humid heat inhalation cluster includes: The humid heat throughput pixels corresponding to the same humidity sampling location are sorted according to the start time. When the time interval between two adjacent humid heat throughput pixels in time sequence does not exceed the preset co-location threshold, the co-location relationship between the two humid heat throughput pixels is established, and humid heat throughput pixels with direct or indirect co-location relationships are classified into the same co-location sub-cluster. The temporal relationship of the humid heat throughput pixels corresponding to different humidity sampling locations is compared. When the time ranges of two humid heat throughput pixels overlap, or the time interval between two humid heat throughput pixels does not exceed the preset cross-position continuation threshold, the cross-position continuation relationship between the two humid heat throughput pixels is established, and humid heat throughput pixels with direct or indirect cross-position continuation relationships are classified into the same cross-position throughput sub-cluster. Moist heat inhalation clusters are formed by isotopic inhalation clusters and transtopic inhalation clusters.

[0011] Preferably, the formation of the humid heat bias layer includes: Assign co-occurrence sub-clusters containing two or more humid heat throughput pixels within the same humidity sampling location to the continuous bias layer. The cross-pass sub-clusters containing different humidity sampling locations, and whose time interval between adjacent humid heat throughput pixels does not exceed the preset cross-pass continuation duration, are assigned to the transition bias layer. For a humidity sampling location that has formed a humid heat throughput pixel, if no new humid heat throughput pixel is generated after a preset stable sampling period following the termination time of the last humid heat throughput pixel corresponding to the humidity sampling location, the humidity sampling location is assigned to the fading bias layer. A humid-heated bias layer is formed by a continuous bias layer, a transition bias layer, and a fading bias layer.

[0012] Preferably, the return branches in the humid heat return domain include continuous return branches and transition return branches; Connect the humid heat throughput pixels corresponding to the same humidity sampling position in the continuous bias layer according to the time sequence, and determine the fading bias layer corresponding to the humidity sampling position as the branch endpoint to form a continuous loop branch. According to the cross-position connection relationship and time sequence, connect the humidity and heat throughput pixels corresponding to different humidity sampling positions in the transfer bias layer, and determine the fading bias layer corresponding to the next humidity sampling position in the time sequence as the branch endpoint to form the transfer return branch.

[0013] Preferably, the humid heat reconnection domain also includes the set of unconnected pixels; Moisture-heat throughput pixels that are not included in the continuous return branch and are not included in the transfer return branch are included in the non-return pixel set; The humid heat return domain is formed by the continuous return branch, the transfer return branch, and the non-returned pixel set.

[0014] Preferably, the formation of a closed nucleus with thermo-humid equilibrium includes: For each humidity sampling location that forms a humid heat throughput pixel, the path extending from the first humid heat throughput pixel corresponding to that humidity sampling location along the continuous loop branch and / or the transfer loop branch to the corresponding fading offset layer is determined as the closed propagation path. When all humidity sampling locations that form overheated and humidified pixels have corresponding closed propagation paths, and the set of unconnected pixels is empty, a closed core of humidity and heat equilibrium is determined to be formed.

[0015] Preferably, the output control of the ethylene oxide sterilization pretreatment completion signal includes: When a closed nucleus of humid heat equilibrium is formed, a signal indicating completion of ethylene oxide sterilization pretreatment is output. When a closed nucleus of hygrothermal equilibrium has not been formed, no signal indicating completion of ethylene oxide sterilization pretreatment is output. Instead, the ethylene oxide sterilization pretreatment hygrothermal equilibrium process continues, and the updated pretreatment hygrothermal timing data is retrieved.

[0016] This invention provides a method for controlling the moisture and heat balance during ethylene oxide sterilization pretreatment, which has the following beneficial effects: (1) During system operation, to address the problems of uneven distribution of moisture and heat, difficulty in accurately judging local humidity status, and inaccurate identification of the completion status due to reliance on single-point parameters or fixed time in traditional methods during the pretreatment of ethylene oxide sterilization, a control method based on the identification of moisture and heat migration process, correlation of throughput relationship, and determination of equilibrium status is proposed. This method can dynamically analyze the moisture and heat change process at different locations in the pretreatment chamber, avoiding judgment based solely on a single humidity value or overall average status, thereby improving the accuracy and reliability of identifying the completion status of ethylene oxide sterilization pretreatment.

[0017] (2) In the process of identifying the humidity and heat change process, by dividing the preprocessed humidity and heat time series data into sampling segments and combining the target humidity interval to determine the humidity status of different time periods, the change process of humidity from outside the interval to inside the interval, from inside the interval to outside the interval, and re-entering the target interval can be accurately captured, forming humidity and heat migration event elements with directional characteristics and time attributes. On this basis, based on the temporal continuity of migration events within the same humidity sampling location, the entry migration, retreat migration, and re-entry migration are further correlated to form humidity and heat throughput pixels that characterize a single humidity and heat throughput process, thereby transforming the continuous humidity fluctuation process into an identifiable process unit, which helps to reduce the interference of instantaneous fluctuations on the judgment of humidity and heat status and improve the accuracy of humidity and heat change process analysis.

[0018] (3) After obtaining multiple humidity and heat throughput pixels, by combining the temporal overlap and temporal continuity relationships between humidity sampling locations, the humidity and heat change processes at different locations are correlated and analyzed. This allows for the identification of continuous humidity and heat changes within the same location and the humidity and heat transfer processes between different locations, forming a humidity and heat throughput cluster that reflects the overall humidity and heat change characteristics. Simultaneously, bias stratification is performed based on the throughput status of different humidity sampling locations to distinguish between different states such as continuous change, location transition, and state decay. Furthermore, corresponding return branches are established to create a time-correlated tracking relationship between the humidity and heat change processes at each location. This allows for a more comprehensive reflection of the humidity and heat adjustment process inside the pretreatment chamber, avoiding the problem that some locations have reached the required state while other locations still have deviations.

[0019] (4) Further, by judging the integrity of the moisture and heat return relationship, the moisture and heat throughput pixels that have not formed an effective association are identified, and the overall moisture and heat equilibrium state is determined by combining the propagation path corresponding to each humidity sampling location. When all locations where moisture and heat changes occur have corresponding return relationships and there are no unrelated moisture and heat change processes, it is determined that a moisture and heat equilibrium closed state has been formed, and a pre-processing completion signal is output. This method can comprehensively evaluate the degree of moisture and heat equilibrium from two dimensions: spatial location and temporal change, making the judgment of completion of ethylene oxide sterilization pre-processing more consistent with the actual moisture and heat transfer law, and improving the accuracy and stability of the sterilization pre-processing control. Attached Figure Description

[0020] Figure 1 This is a block diagram of a method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to the present invention; Figure 2 This is a schematic diagram of the process of forming a closed nucleus of ethylene oxide sterilization pretreatment humidity and heat balance control method according to the present invention. Detailed Implementation

[0021] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0022] Example 1 In Example 1, eight humidity sampling points were set up inside the ethylene oxide sterilization chamber, located at the top, middle, bottom and different areas of the loaded material. Humidity data were collected at each sampling point according to a 5-second sampling cycle, and the target humidity range was set to 45%RH~65%RH.

[0023] This invention provides a method for controlling the moisture and heat balance during the pretreatment of ethylene oxide sterilization. Please refer to [link to relevant documentation]. Figure 1 It includes the following steps: S1: Acquire the pretreatment wet heat time series data of each pretreatment in the ethylene oxide sterilization pretreatment chamber, and identify the entry migration, withdrawal migration and re-entry migration corresponding to each humidity sampling location according to the target humidity range, and generate wet heat migration event elements. S2: Correlate the damp heat migration event elements by associating the entry migration event elements, retreat migration event elements, and re-entry migration event elements that are formed consecutively in time sequence within the same humidity sampling location to form a damp heat throughput pixel characterizing a single damp heat throughput process. S3: Aggregate the humidity and heat throughput pixels according to the humidity sampling location and time relationship. Group the humidity and heat throughput pixels formed continuously within the same humidity sampling location into the same-position throughput sub-cluster. Group the humidity and heat throughput pixels with time overlap or time continuity between different humidity sampling locations into the cross-position throughput sub-cluster. The humidity and heat throughput cluster is formed by the same-position throughput sub-cluster and the cross-position throughput cluster. S4: Based on the humidity throughput state of each humidity sampling location in the humidity throughput cluster, bias layering is performed to form a humidity bias layer, and a back-loop branch is established based on the temporal continuity relationship between the humidity throughput pixels corresponding to each humidity sampling location in the humidity bias layer to form a humidity back-loop domain. S5: When each humidity sampling location of the overheated throughput pixel has a corresponding return branch, and there are no overheated throughput pixels not included in the return branch in the overheated return domain, a overheated equilibrium closure kernel is formed, and an ethylene oxide sterilization pretreatment completion signal is output according to the overheated equilibrium closure kernel.

[0024] Example 2 This embodiment is a further explanation based on Embodiment 1. Please refer to [link / reference]. Figure 1 Specifically: The formation of the damp heat migration event element includes: The preprocessed humid heat time series data is divided into sampling segments according to a preset sampling period to form multiple humid heat sampling segments; Specifically, in the ethylene oxide sterilization pretreatment scenario set in Example 1, multiple fixed humidity sampling locations are set up inside the sterilization chamber. Each humidity sampling location continuously collects humidity data according to the fixed sampling cycle of the humidity sampling device. Each humidity data entry includes at least the humidity sampling location number, sampling time, and corresponding humidity value. During data processing, the actual sampling cycle of the humidity sampling device is used as the preset sampling cycle. The continuously collected pretreatment humid-heat time-series data is sequentially divided into multiple humid-heat sampling segments according to the sampling time order. Each humid-heat sampling segment corresponds to a data record formed within one sampling cycle, providing basic data for subsequent interval assignment determination.

[0025] It should be noted that the preset sampling period is preferably the data output period of the humidity sampling device, so that each humid heat sampling segment corresponds to an actual sampling result; when different models of humidity sampling devices use different sampling frequencies, the preset sampling period is synchronously set to the corresponding actual sampling period to ensure that the humid heat sampling segment can truly reflect the humidity change process.

[0026] Each of the aforementioned humid heat sampling segments and the target humidity range is assigned to a range, forming sampling segments within the range and sampling segments outside the range; Specifically, during data processing, the humidity value corresponding to each humid heat sampling segment is read and compared with the lower and upper limits of the target humidity range. When the humidity value is within the target humidity range, the corresponding humid heat sampling segment is determined as an in-range sampling segment; when the humidity value is lower than the lower limit or higher than the upper limit of the target humidity range, the corresponding humid heat sampling segment is determined as an out-of-range sampling segment, and the corresponding humidity sampling location and sampling time are recorded.

[0027] It should be noted that the target humidity range is preset according to the requirements of the ethylene oxide sterilization process. It can be given directly by the sterilization process parameters, or it can be configured according to the moist heat pretreatment requirements corresponding to different sterilization product types. This embodiment does not limit this.

[0028] Identify the interval assignment transition position between sampling segments within adjacent intervals and sampling segments outside the interval, and combine adjacent damp heat sampling segments containing one interval assignment transition with their corresponding humidity sampling positions and time ranges to form damp heat migration event elements.

[0029] Specifically, during data processing, corresponding time series of humid heat sampling segments are established according to the humidity sampling location, and sorted from earliest to latest according to the sampling time. The interval assignment results of two consecutive humid heat sampling segments are compared. When two consecutive humid heat sampling segments belong to the sampling segment within the interval and the sampling segment outside the interval, respectively, it is determined that there is an interval assignment transition between them. Then, the time of the transition, the direction of the transition, the corresponding humidity sampling location, and the time range of the corresponding humid heat sampling segment are recorded, and the above information is combined to form a humid heat migration event element.

[0030] It should be noted that a humidity migration event element includes at least the humidity sampling location number, migration type, migration occurrence time, corresponding time range, and interval assignment results before and after the migration, which is used to completely record the process of humidity state changing across the boundary of the target humidity interval.

[0031] The damp heat migration event element includes an entry migration event element, a retreat migration event element, and a re-entry migration event element; Specifically, after all the wet and heat migration event elements are generated, the elements are classified according to the interval assignment conversion direction and occurrence order of each element, so that each element corresponds to a unique migration event type, providing a unified data object for the construction of subsequent wet and heat throughput pixels.

[0032] The damp heat migration event element formed by the conversion from the sampling segment outside the interval to the sampling segment inside the interval is defined as the entry migration event element; Specifically, during the data processing, when the interval assignment result of two consecutive humid heat sampling segments changes from the sampling segment outside the interval to the sampling segment inside the interval, it indicates that the humidity value of the corresponding humidity sampling location has entered the target humidity interval for the first time. Therefore, the corresponding humid heat migration event element is determined as the entry migration event element, and its corresponding entry time and humidity sampling location are recorded.

[0033] The damp heat migration event element formed by the conversion from the sampling segment within the interval to the sampling segment outside the interval is defined as the pullback migration event element; Specifically, when the interval assignment result of two consecutive humid heat sampling segments changes from an in-interval sampling segment to an out-of-interval sampling segment, it indicates that the humidity value at the corresponding humidity sampling location has left the target humidity interval. Therefore, the corresponding humid heat migration event element is determined as a pullback migration event element, and the corresponding pullback time and humidity sampling location are recorded.

[0034] The wet and hot migration event element that is located after the pullback migration event element in time sequence and is formed by the conversion from the sampling segment outside the interval to the sampling segment inside the interval is identified as the re-entry migration event element.

[0035] Specifically, in the time series corresponding to the same humidity sampling location, when a retreat migration event element has already occurred, and a humidity-heat migration event element formed by the transition from the sampling segment outside the interval to the sampling segment inside the interval is detected again, this humidity-heat migration event element is identified as a re-entry migration event element, and its corresponding re-entry time is recorded. By distinguishing between entry migration event elements and re-entry migration event elements, the process of humidity changing repeatedly inside and outside the target humidity interval can be accurately reflected, providing a continuous event basis for subsequent identification of a complete humidity-heat throughput process.

[0036] It should be noted that in this embodiment, the re-entry migration event element is defined as a re-entry event that occurs after the withdrawal migration event element. This is because a complete humid heat throughput process includes at least three continuous change stages: entering the target humidity range, exiting the target humidity range, and re-entering the target humidity range. The above method can fully reflect the recovery process after the absorption and release of humid heat at the same humidity sampling location, thereby improving the accuracy of subsequent humid heat throughput process identification.

[0037] Example 3 This embodiment is an explanation based on Embodiment 1. Please refer to it. Figure 1 Specifically: The formation of the moist heat throughput pixel includes: Sort the damp heat migration event elements corresponding to the same humidity sampling location according to the time of occurrence; Specifically: In the ethylene oxide sterilization pretreatment scenario set in Example 1, eight humidity sampling locations were set up inside the sterilization chamber. Humidity data was collected at each sampling location with a sampling period of 5 seconds, and the target humidity range was set to 45%RH~65%RH. During data processing, the humidity sampling location number and migration occurrence time recorded in each humidity migration event element were first read. The humidity migration event elements were then grouped according to the humidity sampling location number, and then each group of humidity migration event elements was arranged from earliest to latest according to the migration occurrence time, forming a migration event time sequence that corresponds one-to-one with each humidity sampling location.

[0038] It should be noted that when two humid heat migration event elements have the same migration occurrence time, the order is determined according to the sampling time of their corresponding humid heat sampling segments; if two humid heat migration event elements originate from the same pair of adjacent humid heat sampling segments, they are considered as the same humid heat migration event element and are not recorded repeatedly. This sorting method ensures that subsequent entry, withdrawal, and re-entry processes are identified according to their actual occurrence order.

[0039] Entering migration event elements, retreating migration event elements, and re-entering migration event elements that are sequentially adjacent in time are defined as a continuous migration event sequence, wherein there are no other humid heat migration event elements corresponding to the humidity sampling position between two adjacent humid heat migration event elements; Specifically: In the migration event time series corresponding to each humidity sampling location, the migration type is read sequentially starting from the earliest humid heat migration event element. When three consecutively read humid heat migration event elements are, in turn, an entry migration event element, a retreat migration event element, and a re-entry migration event element, these three humid heat migration event elements are determined as a continuous migration event sequence.

[0040] During data processing: to determine whether two humid heat migration event elements are adjacent, their permutation numbers in the same migration event time series are read; when the difference between their permutation numbers is 1, they are determined to be adjacent. Therefore, there are no other humid heat migration event elements corresponding to the same humidity sampling location between the entering migration event element and the withdrawing migration event element, nor between the withdrawing migration event element and the re-entering migration event element.

[0041] It should be noted that when no adjacent retreat migration event occurs after an incoming migration event, or no adjacent re-entry migration event occurs after a retreat migration event, the corresponding events are not combined into a continuous migration event sequence. Instead, the corresponding humid heat migration event is retained and the judgment is made again after subsequent sampling data forms new migration event events.

[0042] In this embodiment, the same humid heat migration event element is only included in one consecutive migration event sequence. After a consecutive migration event sequence is formed, sequential matching continues from the next unused humid heat migration event element after that sequence, so as to avoid the same migration event element being used repeatedly to form multiple humid heat throughput pixels.

[0043] The humidity sampling location, migration direction sequence, start and end time, and migration duration corresponding to the continuous migration event sequence are combined to form a humid heat throughput pixel.

[0044] Specifically: For each continuous migration event sequence, read the humidity sampling location number that is common to the three humid heat migration event elements, and record the migration direction sequence in the order of entry, withdrawal and re-entry; determine the migration occurrence time of the entry migration event element as the start time of the humid heat throughput pixel, determine the migration occurrence time of the re-entry migration event element as the end time of the humid heat throughput pixel, and determine the difference between the end time and the start time as the migration duration.

[0045] In this embodiment, a humid heat throughput pixel includes at least a pixel number, a humidity sampling location number, an entry migration event pixel number, a withdrawal migration event pixel number, a re-entry migration event pixel number, a migration direction sequence, a start time, an end time, and a migration duration. The pixel numbers are set sequentially according to the generation order of the humid heat throughput pixels, and are used to distinguish different humid heat throughput pixels during subsequent aggregation and association processes.

[0046] It should be noted that the migration duration represents the time it takes for the humidity value at the same sampling location to travel from entering the target humidity range, through leaving the target humidity range, and then re-entering the target humidity range. This time reflects the duration required for the corresponding sampling area to complete one cycle of humid heat entry, withdrawal, and re-entry.

[0047] The formation of the moist heat inhalation cluster includes: The humid heat throughput pixels corresponding to the same humidity sampling location are sorted according to the start time. When the time interval between two adjacent humid heat throughput pixels in time sequence does not exceed the preset co-location threshold, the co-location relationship between the two humid heat throughput pixels is established, and humid heat throughput pixels with direct or indirect co-location relationships are classified into the same co-location sub-cluster. Specifically: First, the humidity sampling pixels are grouped according to their sampling location numbers. Then, each group of humidity sampling pixels is arranged from earliest to latest according to its start time. For adjacent humidity sampling pixels in the arrangement order, the start time of the latter pixel is subtracted from the end time of the former pixel to obtain the co-location time interval between the two humidity sampling pixels.

[0048] When the time interval between co-occurrences is less than or equal to the preset co-occurrence continuation threshold, a co-occurrence relationship is established between the two wet and hot throughput pixels; when the time interval between co-occurrences is greater than the preset co-occurrence continuation threshold, no co-occurrence relationship is established, and the next wet and hot throughput pixel is used as the starting pixel of the new co-occurrence throughput sub-cluster.

[0049] In the scenario set in Example 1: the preset co-location continuity threshold is preferably set to 60s, which is equivalent to 12 sampling cycles. When the interval between two consecutive humidity and heat throughput pixels at the same humidity sampling location does not exceed 60s, it indicates that the two humidity and heat throughput processes occur continuously in time, which can be regarded as a continuous humidity and heat fluctuation in the same sampling area.

[0050] It should be noted that the preset co-location continuity threshold is determined based on the humidity sampling period, the humidity sensor response time, and the humidity adjustment response time within the pre-processing chamber. In actual setup, multiple normal pre-processing batches can be tested first to calculate the time interval between adjacent humidity throughput pixels within the same humidity sampling location caused by the same continuous humidity fluctuation. The upper limit covering this time interval is then set as the preset co-location continuity threshold. The preset co-location continuity threshold is adjusted accordingly when the sampling period or humidity adjustment response speed changes.

[0051] Specifically: When a wet / hot throughput pixel A establishes a co-location relationship with a wet / hot throughput pixel B, they have a direct co-location relationship. When a wet / hot throughput pixel A establishes a co-location relationship with a wet / hot throughput pixel B, and a wet / hot throughput pixel B establishes a co-location relationship with a wet / hot throughput pixel C, even if a wet / hot throughput pixel A and a wet / hot throughput pixel C do not have a direct co-location relationship, they still have an indirect co-location relationship through a wet / hot throughput pixel B. All wet / hot throughput pixels that can be interconnected through one or more co-location relationships are grouped into the same co-location sub-cluster.

[0052] During data processing: an initial sub-cluster can be created for each wet and hot throughput cell that has not yet been clustered, and then the co-location relationship between adjacent wet and hot throughput cells can be checked in turn; if the co-location relationship exists, the initial sub-clusters of the two cells are merged until all co-location relationships are judged, thereby obtaining each co-location throughput sub-cluster.

[0053] The temporal relationship of the humid heat throughput pixels corresponding to different humidity sampling locations is compared. When the time ranges of two humid heat throughput pixels overlap, or the time interval between two humid heat throughput pixels does not exceed the preset cross-position continuation threshold, the cross-position continuation relationship between the two humid heat throughput pixels is established, and humid heat throughput pixels with direct or indirect cross-position continuation relationships are classified into the same cross-position throughput sub-cluster. Specifically: Two moisture-heat throughput pixels are selected from the moisture-heat throughput pixels corresponding to different humidity sampling locations, and their start and end times are read. When the start time of the first moisture-heat throughput pixel is not later than the end time of the second moisture-heat throughput pixel, and the start time of the second moisture-heat throughput pixel is not later than the end time of the first moisture-heat throughput pixel, it is determined that the time ranges of the two moisture-heat throughput pixels overlap, and a cross-position continuation relationship is established between them.

[0054] During data processing: When the time ranges of two humidified heat throughput pixels do not overlap, the humidified heat throughput pixel with the later start time is designated as the subsequent humidified heat throughput pixel, and the humidified heat throughput pixel with the earlier start time is designated as the preceding humidified heat throughput pixel. The start time of the subsequent humidified heat throughput pixel is subtracted from the end time of the preceding humidified heat throughput pixel to obtain the span time interval. When the span time interval is less than or equal to a preset span continuation threshold, a span continuation relationship is established between the two humidified heat throughput pixels; when the span time interval is greater than the preset span continuation threshold, no span continuation relationship is established.

[0055] In the scenario set in Example 1: the preset cross-location continuity threshold is preferably set to 120s, which is equivalent to 24 sampling cycles. There are usually differences in the distance of heat transfer, the degree of obstruction by the loading, and the moisture absorption rate of the packaging material between different humidity sampling locations. Therefore, the allowable continuity time for cross-location heat response is usually greater than the continuity time within the same humidity sampling location. In this example, the preset cross-location continuity threshold is set to twice the preset same-location continuity threshold to accommodate the time delay caused by the transfer of heat from one sampling area to another.

[0056] It should be noted that the preset cross-position continuity threshold can be determined through no-load humidity response tests and loaded humidity response tests in the pre-treatment chamber. During the specific test, a humidification process is performed inside the pre-treatment chamber, and the time it takes for each humidity sampling location to enter the target humidity range is recorded. The response time difference between different humidity sampling locations is calculated, and the upper limit of the response time difference under normal loading conditions is set as the preset cross-position continuity threshold. If the loading type, packaging material, chamber volume, or humidity sampling location changes, the above test can be re-executed and the preset cross-position continuity threshold updated.

[0057] Specifically: When a cross-location connection is established between humidity-heat sampling pixel A and humidity-heat sampling pixel B at different humidity sampling locations, they have a direct cross-location connection. When a cross-location connection is established between humidity-heat sampling pixel A and humidity-heat sampling pixel B, and a cross-location connection is established between humidity-heat sampling pixel B and humidity-heat sampling pixel C, humidity-heat sampling pixel A and humidity-heat sampling pixel C are determined to have an indirect cross-location connection. Humidity-heat sampling pixels that can be interconnected through one or more cross-location connection relationships are grouped into the same cross-location throughput sub-cluster.

[0058] During data processing: each humidity throughput pixel can be treated as a node, and the cross-position connection relationship can be used as an edge connecting two nodes. Traversal is performed according to the connection relationship between nodes. All nodes that can be reached from a given node through one or more edges are grouped into the same cross-position throughput sub-cluster. When a humidity throughput pixel does not have a cross-position connection relationship with any humidity throughput pixel corresponding to other humidity sampling positions, the humidity throughput pixel is not separately identified as a cross-position throughput sub-cluster, but is still retained in the corresponding same-position throughput sub-cluster.

[0059] Moist heat inhalation clusters are formed by isotopic inhalation clusters and transtopic inhalation clusters.

[0060] Specifically: After dividing the sub-clusters into in-situ and cross-situational throughput sub-clusters, a unique sub-cluster number is assigned to each sub-cluster, and the sub-cluster type, the included wet and heat throughput pixel numbers, the corresponding humidity sampling location, the sub-cluster start time, and the sub-cluster end time are recorded. The sub-cluster start time is the start time of the earliest wet and heat throughput pixel within that sub-cluster, and the sub-cluster end time is the end time of the latest wet and heat throughput pixel within that sub-cluster.

[0061] In this embodiment: all in-situ throughput sub-clusters and cross-situ throughput sub-clusters formed within the same preprocessing batch are aggregated to form the corresponding wet heat throughput cluster for that preprocessing batch. A wet heat throughput pixel can be assigned to one in-situ throughput sub-cluster, and simultaneously assigned to one cross-situ throughput sub-cluster when the cross-situ continuity condition is met; the in-situ throughput sub-cluster is used to record the wet heat throughput process that occurs continuously within the same humidity sampling location, and the cross-situ throughput sub-cluster is used to record the wet heat throughput process that overlaps or continues in time between different humidity sampling locations.

[0062] It should be noted that a humid heat throughput cluster includes at least a humid heat throughput cluster number, a preprocessing batch number, a set of in-situ throughput sub-clusters, a set of cross-situation throughput sub-clusters, a set of humid heat throughput pixels it contains, and a set of corresponding humidity sampling locations. This data organization method clearly preserves the humid heat throughput correlation results within the same humidity sampling location and between different humidity sampling locations, providing a directly readable data foundation for the subsequent formation of a humid heat bias layer.

[0063] Example 4 This embodiment is an explanation based on Embodiment 1. Please refer to it. Figure 1 Specifically: The formation of the humid heat bias layer includes: Assign co-occurrence sub-clusters containing two or more humid heat throughput pixels within the same humidity sampling location to the continuous bias layer. Specifically: In the application scenario set in Example 1, each isotopic throughput sub-cluster formed in Example 3 is read, and the number of humid heat throughput pixels contained in each isotopic throughput sub-cluster is counted. When the number of humid heat throughput pixels in an isotopic throughput sub-cluster is not less than 2, the isotopic throughput sub-cluster is determined as a continuous bias layer, and the corresponding humidity sampling position and the humid heat throughput pixels contained therein are recorded.

[0064] It should be noted that the number of humidity throughput pixels is set to no less than 2 because a single humidity throughput pixel only represents one humidity throughput process, which is insufficient to reflect continuous humidity fluctuations. Two or more consecutive humidity throughput pixels can characterize the existence of a continuous humidity throughput state at the same humidity sampling location.

[0065] The cross-pass sub-clusters containing different humidity sampling locations, and whose time interval between adjacent humid heat throughput pixels does not exceed the preset cross-pass continuation duration, are assigned to the transition bias layer. Specifically: Read the humidity and heat sampling pixels contained in each span-passage sub-cluster, sort them according to the start time, and calculate the time interval between adjacent humidity and heat sampling pixels in the time sequence. When a span-passage sub-cluster contains two or more different humidity sampling locations, and the time interval between adjacent humidity and heat sampling pixels does not exceed the preset span-passage continuity duration, the span-passage sub-cluster is determined as the transition offset layer.

[0066] It should be noted that the preset cross-location connection time is set using the cross-location connection threshold in Example 3, and is determined according to the time required for normal heat and humidity transfer between different humidity sampling locations. When the sampling period or loading method changes, it can be reset.

[0067] For a humidity sampling location that has formed a humid heat throughput pixel, if no new humid heat throughput pixel is generated after a preset stable sampling period following the termination time of the last humid heat throughput pixel corresponding to the humidity sampling location, the humidity sampling location is assigned to the fading bias layer. Specifically: The last formed humidity and heat throughput pixel at each humidity sampling location is read, and its termination time is used as the starting point for stable monitoring. The humidity data collected at that sampling location is continuously received. If no new humidity and heat throughput pixel is formed after a preset stable sampling period, the corresponding humidity sampling location is determined as the fading offset layer.

[0068] It should be noted that the preset stable sampling period is determined based on the time required for the humid and hot state to stabilize during normal preprocessing, and should be greater than the preset same-position continuation threshold and the preset cross-position continuation duration, so as to ensure that no new humid and hot throughput pixels are formed subsequently.

[0069] A humid-heated bias layer is formed by a continuous bias layer, a transition bias layer, and a fading bias layer.

[0070] Specifically: After completing the allocation of continuous bias layers, transition bias layers, and fading bias layers, the three types of layers are associated according to the same preprocessing batch to form corresponding humid heat bias layers, and the correspondence between each layer is saved to provide basic data for the subsequent establishment of the humid heat reconnection domain.

[0071] The return branches in the humid heat return domain include continuous return branches and transition return branches; Specifically: Read the correlation between each offset layer position in the humidity and heat offset layer, take the connection relationship formed within the same humidity sampling position as the continuous back-loop branch, take the connection relationship formed between different humidity sampling positions as the transfer back-loop branch, and record the corresponding humidity and heat throughput pixel connection order respectively.

[0072] Connect the humid heat throughput pixels corresponding to the same humidity sampling position in the continuous bias layer according to the time sequence, and determine the fading bias layer corresponding to the humidity sampling position as the branch endpoint to form a continuous loop branch. Specifically: according to the formation time of the wet and hot throughput pixels, connect the wet and hot throughput pixels with the same humidity sampling position with the same positional succession relationship in sequence from early to late. When connecting to the last wet and hot throughput pixel, take the fading offset layer of the corresponding humidity sampling position as the end point of the branch, thus forming a continuous loop branch.

[0073] According to the cross-position connection relationship and time sequence, connect the humidity and heat throughput pixels corresponding to different humidity sampling positions in the transfer bias layer, and determine the fading bias layer corresponding to the next humidity sampling position in the time sequence as the branch endpoint to form the transfer return branch.

[0074] Specifically: Based on the cross-position connection relationship established in Example 3, the wet and heat throughput pixels corresponding to different humidity sampling positions are connected sequentially according to the formation time of the wet and heat throughput pixels, and the fading offset layer of the last humidity sampling position in the time sequence is taken as the end point of the branch to form a transfer return branch.

[0075] The humid reconnection domain also includes the set of unconnected pixels; Specifically: The non-reconnected pixel set is used to store the wet heat throughput pixels that have not yet formed a continuous reconnection branch or a transfer reconnection branch, and is maintained in real time as wet heat data is updated.

[0076] Moisture-heat throughput pixels that are not included in the continuous return branch and are not included in the transfer return branch are included in the non-return pixel set; Specifically: After all continuous loopback branches and transfer loopback branches are established, all currently formed wet and hot throughput pixels are traversed. When a wet and hot throughput pixel does not participate in any continuous loopback branch or transfer loopback branch, the wet and hot throughput pixel is added to the set of unloopback pixels. Subsequently, when the loopback conditions are met, it is removed from the set of unloopback pixels.

[0077] The humid heat return domain is formed by the continuous return branch, the transfer return branch, and the non-returned pixel set.

[0078] Specifically, the continuous reconnection branch, the transfer reconnection branch, and the set of unconnected pixels corresponding to the same preprocessing batch are uniformly associated to form a humid heat reconnection domain. This domain is used to completely preserve the reconnection relationships that have been formed in the current batch's humid heat throughput process and the humid heat throughput pixels that have not yet been reconnected, providing a data basis for the subsequent determination of the humid heat equilibrium closure kernel.

[0079] Example 5 This embodiment is an explanation based on Embodiment 1. Please refer to it. Figure 2 Specifically: The formation of a closed nucleus in a state of thermal equilibrium includes: For each humidity sampling location that forms a humid heat throughput pixel, the path extending from the first humid heat throughput pixel corresponding to that humidity sampling location along the continuous loop branch and / or the transfer loop branch to the corresponding fading offset layer is determined as the closed propagation path. Specifically: In the ethylene oxide sterilization pretreatment scenario set in Example 1, each continuous reconnection branch and transition reconnection branch in the humid heat reconnection domain is read, and the humidity sampling position of each humid heat throughput pixel is read. For each humidity sampling position, the earliest formed humid heat throughput pixel is used as the starting node, and subsequent connection nodes are sequentially searched along the corresponding continuous reconnection branch or transition reconnection branch until the fading bias layer corresponding to the humidity sampling position is connected. All nodes traversed and their connection relationships are determined as the closed propagation path corresponding to the humidity sampling position.

[0080] It should be noted that when a certain humidity sampling pixel has both a continuous return path and a transfer return path, the traversal continues along the corresponding path. If any path can reach the corresponding fading offset layer, it is determined that the humidity sampling location has a closed propagation path.

[0081] When all humidity sampling locations that form overheated and humidified pixels have corresponding closed propagation paths, and the set of unconnected pixels is empty, a closed core of humidity and heat equilibrium is determined to be formed.

[0082] Specifically: Traverse all humidity sampling locations within the current preprocessing batch that have formed humid heat throughput pixels, and determine one by one whether they all correspond to a closed propagation path; at the same time, read the number of humid heat throughput pixels in the unconnected pixel set. When all humidity sampling locations have corresponding closed propagation paths, and there are no humid heat throughput pixels in the unconnected pixel set, it is determined that the current preprocessing batch has formed a humid heat equilibrium closed core.

[0083] In this embodiment: an empty set of unconnected pixels indicates that all wet heat throughput pixels formed in the current preprocessing batch have been assigned to the continuous connection branch or the transfer connection branch, and there is no wet heat throughput process that has not yet completed the connection judgment.

[0084] The output control of the ethylene oxide sterilization pretreatment completion signal includes: When a closed nucleus of humid heat equilibrium is formed, a signal indicating completion of ethylene oxide sterilization pretreatment is output. Specifically: Once the formation of a closed core for moisture and heat equilibrium is confirmed, the controller immediately generates a pretreatment completion status and outputs a signal indicating that the pretreatment for ethylene oxide sterilization is complete. At the same time, the current moisture and heat equilibrium judgment process ends, allowing the sterilization equipment to enter the subsequent ethylene oxide sterilization program.

[0085] It should be noted that the pretreatment completion signal can be an internal status signal of the controller or a control signal sent to the main control unit of the sterilization equipment. This embodiment does not limit this.

[0086] When a closed nucleus of hygrothermal equilibrium has not been formed, no signal indicating completion of ethylene oxide sterilization pretreatment is output. Instead, the ethylene oxide sterilization pretreatment hygrothermal equilibrium process continues, and the updated pretreatment hygrothermal timing data is retrieved.

[0087] Specifically: when there are humidity sampling locations where a closed propagation path has not been formed, or when the non-reconnected pixel set is not empty, the current preprocessing state is maintained, the ethylene oxide sterilization preprocessing completion signal is not output, and new preprocessing humid heat time series data is collected according to the method of Example 1; then, the humid heat migration event element identification, humid heat throughput pixel formation, humid heat throughput cluster aggregation, humid heat bias layer construction, humid heat reconnection domain establishment, and humid heat equilibrium closure kernel judgment are re-executed until the humid heat equilibrium closure kernel formation conditions are met.

[0088] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for controlling the moisture and heat balance during pretreatment before ethylene oxide sterilization, characterized in that: Includes the following steps: S1: Acquire the pretreatment wet heat time series data of each pretreatment in the ethylene oxide sterilization pretreatment chamber, and identify the entry migration, withdrawal migration and re-entry migration corresponding to each humidity sampling location according to the target humidity range, and generate wet heat migration event elements. S2: Correlate the damp heat migration event elements by associating the entry migration event elements, retreat migration event elements, and re-entry migration event elements that are formed consecutively in time sequence within the same humidity sampling location to form a damp heat throughput pixel characterizing a single damp heat throughput process. S3: Aggregate the humidity and heat throughput pixels according to the humidity sampling location and time relationship. Group the humidity and heat throughput pixels formed continuously within the same humidity sampling location into the same-position throughput sub-cluster. Group the humidity and heat throughput pixels with time overlap or time continuity between different humidity sampling locations into the cross-position throughput sub-cluster. The humidity and heat throughput cluster is formed by the same-position throughput sub-cluster and the cross-position throughput cluster. S4: Based on the humidity throughput state of each humidity sampling location in the humidity throughput cluster, bias layering is performed to form a humidity bias layer, and a back-loop branch is established based on the temporal continuity relationship between the humidity throughput pixels corresponding to each humidity sampling location in the humidity bias layer to form a humidity back-loop domain. S5: When each humidity sampling location of the overheated throughput pixel has a corresponding return branch, and there are no overheated throughput pixels not included in the return branch in the overheated return domain, a overheated equilibrium closure kernel is formed, and an ethylene oxide sterilization pretreatment completion signal is output according to the overheated equilibrium closure kernel.

2. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 1, characterized in that: The formation of the humid heat migration element includes: The preprocessed humid heat time series data is divided into sampling segments according to a preset sampling period to form multiple humid heat sampling segments; Each of the aforementioned humid heat sampling segments and the target humidity range is assigned to a range, forming sampling segments within the range and sampling segments outside the range; Identify the interval assignment transition position between sampling segments within adjacent intervals and sampling segments outside the interval, and combine adjacent damp heat sampling segments containing one interval assignment transition with their corresponding humidity sampling positions and time ranges to form damp heat migration event elements.

3. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 2, characterized in that: The damp heat migration event element includes an entry migration event element, a retreat migration event element, and a re-entry migration event element; The damp heat migration event element formed by the conversion from the sampling segment outside the interval to the sampling segment inside the interval is defined as the entry migration event element; the damp heat migration event element formed by the conversion from the sampling segment inside the interval to the sampling segment outside the interval is defined as the withdrawal migration event element; the damp heat migration event element that is located after the withdrawal migration event element in time sequence and is formed by the conversion from the sampling segment outside the interval to the sampling segment inside the interval is defined as the re-entry migration event element.

4. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 3, characterized in that: The formation of the moist heat throughput pixel includes: Sort the damp heat migration event elements corresponding to the same humidity sampling location according to the time of occurrence; Entering migration event elements, retreating migration event elements, and re-entering migration event elements that are sequentially adjacent in time are defined as a continuous migration event sequence, wherein there are no other humid heat migration event elements corresponding to the humidity sampling position between two adjacent humid heat migration event elements; The humidity sampling location, migration direction sequence, start and end time, and migration duration corresponding to the continuous migration event sequence are combined to form a humid heat throughput pixel.

5. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 4, characterized in that: The formation of the moist heat inhalation cluster includes: The humid heat throughput pixels corresponding to the same humidity sampling location are sorted according to the start time. When the time interval between two adjacent humid heat throughput pixels in time sequence does not exceed the preset co-location threshold, the co-location relationship between the two humid heat throughput pixels is established, and humid heat throughput pixels with direct or indirect co-location relationships are classified into the same co-location sub-cluster. The temporal relationship of the humid heat throughput pixels corresponding to different humidity sampling locations is compared. When the time ranges of two humid heat throughput pixels overlap, or the time interval between two humid heat throughput pixels does not exceed the preset cross-position continuation threshold, the cross-position continuation relationship between the two humid heat throughput pixels is established, and humid heat throughput pixels with direct or indirect cross-position continuation relationships are classified into the same cross-position throughput sub-cluster. Moist heat inhalation clusters are formed by isotopic inhalation clusters and transtopic inhalation clusters.

6. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 5, characterized in that: The formation of the humid heat bias layer includes: Assign co-occurrence sub-clusters containing two or more humid heat throughput pixels within the same humidity sampling location to the continuous bias layer. The cross-pass sub-clusters containing different humidity sampling locations, and whose time interval between adjacent humid heat throughput pixels does not exceed the preset cross-pass continuation duration, are assigned to the transition bias layer. For a humidity sampling location that has formed a humid heat throughput pixel, if no new humid heat throughput pixel is generated after a preset stable sampling period following the termination time of the last humid heat throughput pixel corresponding to the humidity sampling location, the humidity sampling location is assigned to the fading bias layer. A humid-heated bias layer is formed by a continuous bias layer, a transition bias layer, and a fading bias layer.

7. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 6, characterized in that: The return branches in the humid heat return domain include continuous return branches and transition return branches; Connect the humid heat throughput pixels corresponding to the same humidity sampling position in the continuous bias layer according to the time sequence, and determine the fading bias layer corresponding to the humidity sampling position as the branch endpoint to form a continuous loop branch. According to the cross-position connection relationship and time sequence, connect the humidity and heat throughput pixels corresponding to different humidity sampling positions in the transfer bias layer, and determine the fading bias layer corresponding to the next humidity sampling position in the time sequence as the branch endpoint to form the transfer return branch.

8. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 7, characterized in that: The humid reconnection domain also includes the set of unconnected pixels; Moisture-heat throughput pixels that are not included in the continuous return branch and are not included in the transfer return branch are included in the non-return pixel set; The humid heat return domain is formed by the continuous return branch, the transfer return branch, and the non-returned pixel set.

9. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 8, characterized in that: The formation of a closed nucleus in a state of thermal equilibrium includes: For each humidity sampling location that forms a humid heat throughput pixel, the path extending from the first humid heat throughput pixel corresponding to that humidity sampling location along the continuous loop branch and / or the transfer loop branch to the corresponding fading offset layer is determined as the closed propagation path. When all humidity sampling locations that form overheated and humidified pixels have corresponding closed propagation paths, and the set of unconnected pixels is empty, a closed core of humidity and heat equilibrium is determined to be formed.

10. The method for controlling the moisture and heat balance in the pretreatment of ethylene oxide sterilization according to claim 9, characterized in that: The output control of the ethylene oxide sterilization pretreatment completion signal includes: When a closed nucleus of humid heat equilibrium is formed, a signal indicating completion of ethylene oxide sterilization pretreatment is output. When a closed nucleus of hygrothermal equilibrium has not been formed, no signal indicating completion of ethylene oxide sterilization pretreatment is output. Instead, the ethylene oxide sterilization pretreatment hygrothermal equilibrium process continues, and the updated pretreatment hygrothermal timing data is retrieved.

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