A comprehensive drug stability test box sterilization control method and system

Abstract

The present invention relates to the field of ultraviolet radiation sterilization technology, and more specifically to a sterilization control method and system for a comprehensive drug stability test chamber. The present invention analyzes historical ultraviolet sterilization records to determine a baseline irradiation intensity and a basic sterilization duration. Furthermore, during the sterilization process under sterilization control conditions corresponding to the baseline irradiation intensity and the basic sterilization duration, the present invention analyzes microbial metabolism to evaluate the sterilization effect. The present invention then dynamically adjusts the sterilization control conditions based on the real-time sterilization effect, thereby improving the sterilization effect of the comprehensive drug stability test chamber.

Description

Technical Field

[0001] The present invention relates to the technical field of ultraviolet radiation sterilization, and in particular to a sterilization control method and system for a comprehensive drug stability test box. Background Art

[0002] Comprehensive drug stability test chambers are primarily used to simulate the storage conditions of different drugs under varying environmental conditions to assess their long-term stability. To ensure the accuracy and reliability of test results, sterilization is required before drug stability testing to prevent microbial contamination from the chamber and potentially impact the results. Ultraviolet (UV) sterilization is one of the sterilization methods used in comprehensive drug stability test chambers. UV sterilization destroys microbial cell structures, effectively reducing the risk of drug contamination.

[0003] In the existing technology, sterilization is performed by setting standard conditions such as ultraviolet radiation intensity and irradiation time. However, due to factors such as the structure of the comprehensive drug stability test chamber, different areas may have different degrees of microbial contamination, and standard ultraviolet radiation conditions may lead to incomplete sterilization; but blindly extending the ultraviolet radiation time or increasing the irradiation intensity may lead to excessive irradiation, which in turn leads to a decline in the performance of the comprehensive drug stability test chamber or affects the properties of the drug; therefore, determining the appropriate ultraviolet radiation intensity and irradiation time for sterilization is a technical problem that needs to be solved urgently. Summary of the Invention

[0004] In order to solve the technical problem that the existing technology cannot accurately determine the ultraviolet irradiation intensity and irradiation time of the comprehensive drug stability test chamber, thereby resulting in poor sterilization control effect, the purpose of the present invention is to provide a comprehensive drug stability test chamber sterilization control method and system. The technical solution adopted is as follows:

[0005] The present invention proposes a comprehensive drug stability test chamber sterilization control method, the method comprising:

[0006] Obtain all ultraviolet sterilization records of the comprehensive drug stability test chamber, each of which includes at least the irradiation intensity, irradiation duration, and the drug to be tested of the corresponding historical sterilization process;

[0007] Obtain the sterilization selectivity of each irradiation intensity for each drug to be tested based on the frequency of occurrence of each irradiation intensity in all historical sterilization processes for each drug to be tested, and the type of drug to be tested for each irradiation intensity in all historical sterilization processes; determine the baseline irradiation intensity for each drug to be tested based on the sterilization selectivity; and determine the basic sterilization duration based on the irradiation duration in all ultraviolet sterilization records;

[0008] Based on the benchmark irradiation intensity and the basic sterilization time, and in combination with the type of drug currently to be tested, the comprehensive drug stability test chamber is sterilized with ultraviolet light, and during the current sterilization process, a monitoring curve of each measuring point in the comprehensive drug stability test chamber under each microbial metabolic indicator is obtained; based on the fluctuation difference of the monitoring curve under the same microbial metabolic indicator at different measuring points, a sterilization failure coefficient of the current sterilization process is obtained;

[0009] According to the sterilization defect coefficient of the current sterilization process, combined with the benchmark irradiation intensity and the basic sterilization time, ultraviolet sterilization control is performed on the comprehensive drug stability test box.

[0010] Furthermore, the method for obtaining the sterilization selectivity includes:

[0011] In all ultraviolet sterilization records, each irradiation intensity in all sterilization processes corresponding to each drug to be tested shall be used as the candidate irradiation intensity;

[0012] The normalized result of the product of the occurrence frequency of each candidate irradiation intensity in all sterilization processes for each drug to be tested and the total number of types of drugs to be tested in all sterilization processes corresponding to each candidate irradiation intensity is used as the usage extensiveness of each candidate irradiation intensity for each drug to be tested;

[0013] The occurrence frequency of each candidate irradiation intensity for each drug to be tested is weighted according to the usage breadth, and the weighted result is used as the sterilization selectivity of each candidate irradiation intensity for each drug to be tested.

[0014] Furthermore, the method for obtaining the reference irradiance intensity includes:

[0015] Among all the candidate irradiation intensities for each drug to be tested, the irradiation intensity corresponding to the candidate irradiation intensity with the greatest sterilization selectivity is used as the benchmark irradiation intensity for the drug to be tested.

[0016] Furthermore, the method for obtaining the basic sterilization time includes:

[0017] In all ultraviolet sterilization records, the minimum irradiation time among all irradiation times is used as the basic sterilization time.

[0018] Furthermore, the method for obtaining the sterilization failure coefficient includes:

[0019] Under each microbial metabolism index, according to the difference in the time corresponding to the extreme point in the monitoring curve at different measuring points, the first metabolic difference coefficient of the microorganisms at different measuring points is obtained;

[0020] Under each microbial metabolism indicator, according to the difference in the change characteristics of the data points in the monitoring curve at different measuring points, the second metabolic difference coefficient of the microorganisms at different measuring points is obtained;

[0021] The first metabolic difference coefficient and the second metabolic difference coefficient of microorganisms at different measuring points under all microbial metabolic indicators are integrated to obtain a sterilization failure coefficient.

[0022] Furthermore, the method for obtaining the first metabolic difference coefficient includes:

[0023] The time corresponding to the extreme point in the monitoring curve at each measuring point is used as a sequence element to construct an extreme time sequence;

[0024] The variance of the corresponding moments of the sequence elements with the same sequence number in the extreme value time sequence at all measuring points under each microbial metabolic index is used as the fluctuation difference parameter, and the mean of the fluctuation difference parameters under all the same sequence numbers is used as the first metabolic difference coefficient.

[0025] Furthermore, the method for obtaining the second metabolic difference coefficient includes:

[0026] The normalized result of the accumulated sum of the indicator differences at all adjacent moments in the monitoring curve at each measuring point is used as the fluctuation trend parameter of the monitoring curve;

[0027] Under each microbial metabolism indicator, a second metabolic difference coefficient is obtained according to the difference in the fluctuation trend parameter of the monitoring curve at all different measuring points.

[0028] Furthermore, the method for ultraviolet sterilization of the comprehensive drug stability test box includes:

[0029] When the sterilization failure coefficient is less than a preset threshold, the ultraviolet sterilization is terminated; when the sterilization failure coefficient is greater than or equal to the preset threshold, a new round of ultraviolet sterilization is continued on the comprehensive drug stability test chamber based on the benchmark irradiation intensity and the basic sterilization time, and the sterilization failure coefficient of the new round of sterilization process is obtained;

[0030] The process continues to iterate until the sterilization failure coefficient of the latest sterilization process is less than a preset threshold.

[0031] Furthermore, the microbial metabolism index includes at least temperature and humidity.

[0032] The present invention also proposes a comprehensive drug stability test chamber sterilization control system, comprising a memory, a processor, and a computer program stored in the memory and runnable on the processor. When the processor executes the computer program, the steps of the comprehensive drug stability test chamber sterilization control method are implemented.

[0033] The present invention has the following beneficial effects:

[0034] The present invention first obtains all ultraviolet sterilization records of the comprehensive drug stability test box, and each ultraviolet sterilization record includes at least the irradiation intensity, irradiation time and the drug to be tested in the corresponding historical sterilization process, so as to prepare for the subsequent determination of the ultraviolet irradiation conditions in the sterilization control plan; according to the occurrence frequency of each irradiation intensity in all historical sterilization processes corresponding to each drug to be tested, and the type of drug to be tested in all historical sterilization processes corresponding to each irradiation intensity, the sterilization selectivity of each irradiation intensity for each drug to be tested is obtained, and the sterilization selectivity reflects the suitability of each irradiation intensity for the sterilization of the drug to be tested; then, according to the sterilization selectivity, the baseline irradiation intensity of each drug to be tested is determined; according to the irradiation time in all ultraviolet sterilization records, the basic sterilization Duration; Based on the benchmark irradiation intensity and basic sterilization duration, combined with the type of the current drug to be tested, the comprehensive drug stability test box is sterilized by ultraviolet light, and in the current sterilization process, the monitoring curve of each measuring point in the comprehensive drug stability test box under each microbial metabolism index is obtained, so as to provide data preparation for the subsequent analysis of the microbial metabolism at different measuring points; According to the fluctuation difference of the monitoring curves of different measuring points under the same microbial metabolism index, the difference in microbial metabolism at different measuring points is evaluated. The greater the difference, the more uneven the sterilization, so that the sterilization defect coefficient of the current sterilization process can be obtained; and then according to the sterilization defect coefficient of the current sterilization process, combined with the benchmark irradiation intensity and basic sterilization duration, the comprehensive drug stability test box is subjected to ultraviolet sterilization control. The present invention determines the benchmark irradiation intensity and basic sterilization duration by analyzing historical ultraviolet sterilization records, and then analyzes the microbial metabolism during the sterilization process under the sterilization control conditions corresponding to the benchmark irradiation intensity and basic sterilization duration, thereby evaluating the sterilization effect, and then dynamically adjusting the sterilization control conditions according to the real-time sterilization effect to improve the sterilization control effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the technical solutions and advantages of the embodiments of the present invention or the prior art, the following briefly introduces the drawings required for use in the embodiments or the prior art descriptions. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0036] Figure 1 A flow chart of a comprehensive drug stability test chamber sterilization control method provided by one embodiment of the present invention;

[0037] Figure 2 A flow chart of a method for obtaining sterilization selectivity provided by one embodiment of the present invention;

[0038] Figure 3 A flow chart of a method for obtaining a sterilization defect coefficient provided by one embodiment of the present invention. DETAILED DESCRIPTION

[0039] To further illustrate the technical means and effectiveness of the present invention to achieve its intended purpose, the following, in conjunction with the accompanying drawings and preferred embodiments, describes in detail the specific implementation, structure, features, and effectiveness of a comprehensive pharmaceutical stability test chamber sterilization control method and system proposed by the present invention. In the following description, different references to "one embodiment" or "another embodiment" do not necessarily refer to the same embodiment. Furthermore, specific features, structures, or characteristics of one or more embodiments may be combined in any suitable manner.

[0040] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0041] The specific scheme of the comprehensive drug stability test chamber sterilization control method and system provided by the present invention is described in detail below with reference to the accompanying drawings.

[0042] See also Figure 1 , which shows a flow chart of a comprehensive drug stability test chamber sterilization control method provided by one embodiment of the present invention, specifically including:

[0043] Step S1, obtaining all ultraviolet sterilization records of the comprehensive drug stability test chamber, each ultraviolet sterilization record at least includes the irradiation intensity, irradiation time and the drug to be tested of the corresponding historical sterilization process.

[0044] In one embodiment of the present invention, all ultraviolet sterilization records of the comprehensive drug stability test box, that is, historical sterilization plan records, are first obtained, wherein each ultraviolet sterilization record includes at least the ultraviolet irradiation intensity and irradiation duration set in each historical sterilization process, as well as the test drug to be subjected to the stability test, so as to subsequently evaluate the appropriate sterilization control plan in combination with the historical ultraviolet sterilization records of each test drug.

[0045] It should be noted that the ultraviolet sterilization control of the comprehensive drug stability test chamber in the embodiment of the present invention is determined based on the analysis and evaluation of a large number of historical ultraviolet sterilization records. The ultraviolet irradiation intensity and irradiation duration set in the historical ultraviolet sterilization records are reasonable parameters determined by professional experimenters through biochemical calculations and empirical analysis, and can be an ideal sterilization scheme without affecting the performance of the test chamber and the properties of the drugs. The acquisition of ultraviolet sterilization records is an existing technology well known to those skilled in the art and will not be repeated here.

[0046] Step S2: Obtain the sterilization selectivity of each irradiation intensity for each drug to be tested based on the frequency of occurrence of each irradiation intensity in all historical sterilization processes for each drug to be tested, and the type of drug to be tested for each irradiation intensity in all historical sterilization processes; determine the baseline irradiation intensity for each drug to be tested based on the sterilization selectivity; and determine the basic sterilization time based on the irradiation time in all ultraviolet sterilization records.

[0047] Considering that in all historical ultraviolet sterilization records, the more times a certain irradiation intensity is applied to a certain test drug, the less likely it is that the irradiation intensity will affect the properties of the test drug and the performance of the test chamber, and the more suitable it is for sterilizing the test drug; and considering that the more types of test drugs that a certain irradiation intensity can be applied to sterilize, the wider its scope of use, the less impact it has on the properties of most test drugs, and the more suitable it is for sterilization;

[0048] Based on this, the embodiment of the present invention will obtain the sterilization selectivity of each irradiation intensity for each drug to be tested based on the frequency of occurrence of each irradiation intensity in all historical sterilization processes for each drug to be tested, and the type of drug to be tested for each irradiation intensity in all historical sterilization processes; the sterilization selectivity reflects the suitability of each irradiation intensity for the sterilization of the drug to be tested, and prepares for the subsequent screening of the benchmark irradiation intensity for ultraviolet sterilization of the drug to be tested.

[0049] Preferably, in one embodiment of the present invention, the method for obtaining the sterilization selectivity includes:

[0050] See also Figure 2 , which shows a flow chart of a method for obtaining sterilization selectivity provided by one embodiment of the present invention, specifically including:

[0051] Step S201 : In all ultraviolet sterilization records, each radiation intensity in all sterilization processes corresponding to each drug to be tested is used as a candidate radiation intensity.

[0052] As an example, considering that the irradiation intensity used in the historical sterilization process of the test drug should be given priority for sterilization to ensure the reliability of sterilization; therefore, each irradiation intensity corresponding to each test drug in all sterilization processes is first used as the candidate irradiation intensity, which facilitates subsequent analysis and screening of the optimal baseline irradiation intensity.

[0053] In step S202, the frequency of occurrence of each candidate irradiation intensity in all sterilization processes for each drug to be tested is normalized by the product of the total number of types of drugs to be tested in all sterilization processes corresponding to each candidate irradiation intensity, as the usage prevalence of each candidate irradiation intensity for each drug to be tested.

[0054] As an example, the formula for calculating usage breadth is:

[0055] ; Wherein, m is the serial number of the drug to be tested; n is the serial number of the selected irradiation intensity for each drug to be tested; is the usage frequency of the nth selected irradiation intensity for the mth tested drug; is the frequency of occurrence of the nth selected irradiation intensity in all sterilization processes corresponding to the mth tested drug; The total number of drug types to be tested in all sterilization processes corresponding to the nth selected irradiation intensity for the mth drug to be tested; is a linear normalization function.

[0056] In the calculation formula for the breadth of use, the higher the frequency of occurrence of each candidate irradiation intensity in all sterilization processes for each test drug, the lower the possibility that the irradiation intensity will affect the properties of the test drug; the greater the total number of types of test drugs corresponding to each irradiation intensity in all historical sterilization processes, the wider the application range of the irradiation intensity; the two are multiplied and combined to comprehensively evaluate the breadth of use of each candidate irradiation intensity for each test drug. The wider the use of the candidate irradiation intensity, the more likely it is to be used as the benchmark irradiation intensity.

[0057] In step S203 , the occurrence frequency of each candidate irradiation intensity for each drug to be tested is weighted by the corresponding usage breadth, and the weighted result is used as the sterilization selectivity of each candidate irradiation intensity for each drug to be tested.

[0058] As an example, the ratio of the occurrence frequency of each candidate irradiation intensity for each drug to be tested to the total number of ultraviolet sterilization records is used as its occurrence frequency. The occurrence frequency indirectly reflects the relative frequency of application of the candidate irradiation intensity among all irradiation intensities in the ultraviolet sterilization records. The more frequently the candidate irradiation intensity is used, the lower the impact of the candidate irradiation intensity on the drug properties and test chamber performance when used as the benchmark irradiation intensity.

[0059] The frequency of occurrence of each candidate irradiation intensity for each experimental drug was then multiplied by the corresponding usage breadth, and the product was used as the sterilization selectivity of each candidate irradiation intensity for each experimental drug. The sterilization selectivity comprehensively evaluated the possibility of the candidate irradiation intensity as a benchmark irradiation intensity from two perspectives: the scope of use of the candidate irradiation intensity and the relative frequency of use.

[0060] After obtaining the sterilization selectivity of each irradiation intensity for each drug to be tested, the irradiation intensity that is most suitable for the drug to be tested can be screened from all irradiation intensities based on the sterilization selectivity, that is, the benchmark irradiation intensity for the drug to be tested.

[0061] Preferably, in one embodiment of the present invention, among all candidate irradiation intensities for each drug to be tested, the irradiation intensity corresponding to the maximum sterilization selectivity is used as the benchmark irradiation intensity for the drug to be tested.

[0062] Taking into account that irradiation time is also an important parameter in the sterilization control scheme, a reasonable sterilization time can obtain an ideal sterilization effect, thereby ensuring the accuracy of the drug stability test results; and taking into account the irradiation time in all historical ultraviolet sterilization records, a certain analysis reference basis can be provided; therefore, the embodiment of the present invention will determine the basic sterilization time based on the irradiation time in all ultraviolet sterilization records; the basic sterilization time is the preliminary sterilization operation time, so that the sterilization effect can be analyzed and evaluated in real time during the corresponding sterilization operation process, so as to reasonably determine the sterilization control scheme according to the real-time sterilization effect to determine whether it is necessary to carry out the next round of sterilization operation until the ideal sterilization effect is achieved.

[0063] Preferably, in one embodiment of the present invention, considering that in historical ultraviolet sterilization records, the shortest irradiation time can also ensure the ultraviolet sterilization effect, the shortest irradiation time among all irradiation times in all ultraviolet sterilization records is used as the basic sterilization time.

[0064] In other embodiments of the present invention, the implementer may also use the irradiation duration corresponding to the mode of all irradiation durations in all ultraviolet sterilization records as the basic sterilization duration.

[0065] Step S3, based on the benchmark irradiation intensity and basic sterilization time, combined with the type of drug currently to be tested, the comprehensive drug stability test box is sterilized by ultraviolet light, and during the current sterilization process, the monitoring curve of each measuring point in the comprehensive drug stability test box under each microbial metabolic indicator is obtained; based on the fluctuation difference of the monitoring curves of different measuring points under the same microbial metabolic indicator, the sterilization defect coefficient of the current sterilization process is obtained.

[0066] After obtaining the baseline irradiation intensity and basic sterilization time, we can start ultraviolet sterilization of the comprehensive drug stability test chamber in combination with the type of drug currently to be tested, and obtain the monitoring curve of each measuring point in the test chamber under each microbial metabolic indicator during the current sterilization process, so as to subsequently analyze the monitoring curve and evaluate the sterilization effect of the current sterilization process.

[0067] It should be noted that the drugs to be tested in the embodiments of the present invention should be drugs that have been sterilized in the past during ultraviolet sterilization.

[0068] In one embodiment of the present invention, after the drug to be tested is placed in a comprehensive drug stability test chamber, the ultraviolet irradiation conditions are set to the corresponding baseline irradiation intensity and basic sterilization time, and then sterilization begins; the comprehensive drug stability test chamber is usually equipped with several measuring points, and a corresponding microbial metabolic indicator monitoring sensor is installed at each measuring point to monitor the microbial metabolism in real time during the sterilization process;

[0069] Among them, considering that if sterilization is not thorough, the residual microbial metabolism may release additional heat, causing temperature changes. At the same time, microbial metabolism is accompanied by the generation of water, which will also cause humidity changes. Therefore, the microbial metabolism indicators include at least temperature and humidity. It is necessary to deploy temperature sensors and humidity sensors at each measuring point to obtain the temperature change curve and humidity change curve at each measuring point during the current sterilization process.

[0070] As an example, measuring points are set at least at the corners of the inner walls of the comprehensive drug stability test box, and at locations near the test box door that are prone to breeding bacteria and other microorganisms; the acquisition frequency of all sensors is set to 50HZ, and after setting the ultraviolet irradiation conditions of the comprehensive drug stability test box, each sensor collects temperature data and humidity data from the start of irradiation, and constructs a monitoring curve for the collected data in chronological order, that is, obtains the temperature change curve and humidity change curve at each measuring point in the current sterilization process.

[0071] In other embodiments of the present invention, the implementer may also define the layout of the measurement points in the comprehensive drug stability test chamber, such as uniform layout, etc.; the implementer may also evaluate and set other types or quantities of microbial metabolic indicators, such as additionally setting the carbon dioxide concentration and other products of other microbial metabolic reactions as microbial metabolic indicators, which will not be repeated here.

[0072] Considering that if there are differences in the same microbial metabolic indicators at the same time at different measuring points in the comprehensive drug stability test box, it means that there may be different degrees of microbial metabolic reactions at different measuring points in the comprehensive drug stability test box, further indicating that the sterilization effect in the comprehensive drug stability test box is poor; therefore, the embodiment of the present invention obtains the sterilization failure coefficient of the current sterilization process based on the fluctuation differences of the monitoring curves of different measuring points under the same microbial metabolic indicators; the sterilization failure coefficient determines whether further sterilization is required in the future to perform precise sterilization control.

[0073] Preferably, in one embodiment of the present invention, the method for obtaining the sterilization failure coefficient includes:

[0074] See also Figure 3 , which shows a flow chart of a method for obtaining a sterilization failure coefficient provided by an embodiment of the present invention, specifically comprising:

[0075] Step S301 : Under each microbial metabolism index, first metabolic difference coefficients of microorganisms at different measuring points are obtained according to the differences in the corresponding moments of the extreme points in the monitoring curves at different measuring points.

[0076] Considering that extreme points can usually help evaluate the fluctuation characteristics of a curve, when there are differences in the appearance time of extreme points in different monitoring curves, it means that there are differences in fluctuations; therefore, one embodiment of the present invention is based on this to evaluate the first metabolic difference coefficient of microorganisms at different measuring points; the first metabolic difference coefficient uses extreme points to evaluate the fluctuation difference, reflecting the difference in the metabolic reaction of microorganisms at different measuring points, preparing for the subsequent evaluation of the sterilization effect.

[0077] In a preferred embodiment of the present invention, the method for obtaining the first metabolic difference coefficient includes:

[0078] The time corresponding to the extreme point in the monitoring curve at each measuring point is used as a sequence element to construct an extreme time sequence;

[0079] In the extreme value time series at all measuring points under each microbial metabolic index, the variance of the corresponding moments of the sequence elements with the same sequence number is used as the fluctuation difference parameter, and the mean of the fluctuation difference parameters under all the same sequence numbers is used as the first metabolic difference coefficient.

[0080] It should be noted that obtaining extreme points is an existing technology well known to those skilled in the art and will not be described in detail here. The total number of extreme points in different monitoring curves may be inconsistent. Therefore, when comparing the corresponding moments of sequence elements with the same sequence number, the extreme time sequence with the least total number of extreme points is used as the benchmark. For example, there are three extreme time sequences, namely {10, 21, 56, 78, 101}, {8, 11, 25, 36, 49, 66, 77, 98, 50, 19}, and {10, 25, 65, 78}, where the sequence length of the shortest extreme time sequence is 4. In this case, it is only necessary to compare the variances of the corresponding moments of the first four sequence elements with the same sequence number in all extreme time sequences.

[0081] As an example, the calculation formula of the first metabolic difference coefficient is:

[0082] ; Wherein, x is the type number of the microbial metabolism indicator; is the first metabolic difference coefficient of microorganisms at different measuring points under the xth microbial metabolic index; c is the sequence number of the sequence element in the extreme value moment sequence; is the length of the shortest sequence among all extreme value time sequences at different measuring points under the x-th microbial metabolism index;

[0083] z is the measuring point number; Z is the total number of measuring points; is the time corresponding to the cth sequence element in the extreme value time sequence at the zth measuring point under the xth microbial metabolism index; It is the variance of the moment corresponding to the cth sequence element in the extreme value moment sequence of all measuring points under the xth microbial metabolism index, and is also the fluctuation difference parameter.

[0084] In the calculation formula of the first metabolic difference coefficient, the sequence elements under the same sequence number in the extreme value moment sequence at different measuring points, that is, the larger the variance of the moment corresponding to the extreme value point, the more inconsistent the fluctuation change is, and the larger the fluctuation difference parameter is at the sequence number angle; then the mean of the fluctuation difference parameters at all sequence number angles is analyzed, and the first metabolic difference coefficient at different measuring points is comprehensively evaluated. The larger the first metabolic difference coefficient is, the more uneven the sterilization effect is, and there may be residual.

[0085] In other embodiments of the present invention, the implementer may also directly normalize the cumulative sum of the absolute values of the differences between the extreme points with the same serial number at corresponding moments in the monitoring curves at different measuring points, and use the normalized result as the first metabolic difference coefficient.

[0086] Step S302 : Under each microbial metabolism index, according to the difference in the change characteristics of the data points in the monitoring curve at different measuring points, obtain the second metabolic difference coefficient of the microorganisms at different measuring points.

[0087] Considering that the data point change characteristics can usually help evaluate the fluctuation trend of the curve, when there are large differences in the fluctuation trends in different monitoring curves, it means that the degree of microbial metabolic reaction at different measuring points is inconsistent, such as inconsistent bacterial population size or incomplete sterilization caused by reasons such as ultraviolet irradiation angle; therefore, one embodiment of the present invention is based on the differences in data point change characteristics in the monitoring curves at different measuring points to evaluate the second metabolic difference coefficient of microorganisms at different measuring points; the second metabolic difference coefficient also reflects the differences in microbial metabolic reactions at different measuring points, preparing for the subsequent evaluation of the sterilization effect.

[0088] In a preferred embodiment of the present invention, the method for obtaining the second metabolic difference coefficient includes:

[0089] The normalized result of the cumulative sum of the indicator differences at all adjacent moments in the monitoring curve at each measuring point is used as the fluctuation trend parameter of the monitoring curve;

[0090] Under each microbial metabolism indicator, a second metabolic difference coefficient is obtained according to the difference in the fluctuation trend parameters of the monitoring curves at all different measuring points.

[0091] As an example, the calculation formula for the second metabolic difference coefficient is:

[0092] ; Wherein, x is the type number of the microbial metabolism indicator; is the second metabolic difference coefficient of microorganisms at different measuring points under the xth microbial metabolic index; is a linear normalization function; z is the serial number of the measuring point; r is the serial number of the remaining measuring points except the z-th measuring point; Z is the total number of measuring points; is the fluctuation trend parameter of the monitoring curve at the zth measuring point under the xth microbial metabolism index; is the fluctuation trend parameter of the monitoring curve at the rth measuring point except the zth measuring point under the xth microbial metabolism index; is the absolute value symbol;

[0093] The method for obtaining the fluctuation trend parameters includes: ; s is the serial number of the indicator data point in the monitoring curve; is the total number of indicator data points in the monitoring curve; is the sth indicator data point in the monitoring curve at the zth measuring point under the xth microbial metabolism indicator; It is the s+1th indicator data point in the monitoring curve at the zth measuring point under the xth microbial metabolism indicator.

[0094] In the method for obtaining the second metabolic difference coefficient, the fluctuation trend parameter is first evaluated by the absolute value of the difference between the indicator data points at adjacent moments. The larger the absolute value of the difference, the more severe the fluctuation. Then, by comparing the fluctuation trend parameters between all different measuring points, the change difference of the monitoring curve between different measuring points is evaluated. When the change difference is greater, the second metabolic difference parameter is larger, which means that the sterilization effect is more uneven and there may be residues.

[0095] In other embodiments of the present invention, the implementer can also directly use the two-point formula to calculate the slope of each monitoring curve and use the slope as the fluctuation trend parameter; the implementer can also use discrete parameters such as the variance of the fluctuation trend parameters at different measuring points to evaluate the second metabolic difference coefficient. The larger the variance, the larger the second metabolic difference coefficient. These are all commonly used technical means and will not be elaborated here.

[0096] Step S303 , fusing the first metabolic difference coefficient and the second metabolic difference coefficient of the microorganisms at different measuring points under all microbial metabolic indicators to obtain the sterilization failure coefficient.

[0097] As an example, the first metabolic difference coefficient and the second metabolic difference coefficient of microorganisms at different measuring points under each microbial metabolic index are multiplied and combined, and then the cumulative sum of the corresponding products under all microbial metabolic indicators is linearly normalized, and the normalized result is used as the sterilization failure coefficient.

[0098] In other examples, the implementer may also use basic mathematical operations such as addition or weighted summation or related mapping methods to combine the two, and then normalize the cumulative sum of the fusion results under all microbial metabolic indicators through other normalization methods to obtain the sterilization failure coefficient. These are all existing technical methods and will not be repeated here.

[0099] Step S4: Based on the sterilization failure coefficient of the current sterilization process, combined with the benchmark irradiation intensity and the basic sterilization time, ultraviolet sterilization control is performed on the comprehensive drug stability test box.

[0100] After obtaining the sterilization failure coefficient of the current sterilization process, it is possible to evaluate whether further sterilization operations are needed based on the sterilization failure coefficient of the current sterilization process, and then conduct ultraviolet sterilization control on the comprehensive drug stability test chamber in combination with the benchmark irradiation intensity and basic sterilization time.

[0101] Preferably, in one embodiment of the present invention, the method for ultraviolet sterilization of a comprehensive drug stability test chamber includes:

[0102] When the sterilization failure coefficient is less than the preset threshold, ultraviolet sterilization is terminated; when the sterilization failure coefficient is greater than or equal to the preset threshold, based on the benchmark irradiation intensity and basic sterilization time, a new round of ultraviolet sterilization is continued on the comprehensive drug stability test chamber, and the sterilization failure coefficient of the new round of sterilization process is obtained; it is continuously iterated until the sterilization failure coefficient of the latest round of sterilization process is less than the preset threshold.

[0103] As an example, the preset threshold is set to 0.88, and the implementer can also set it to any value within 0.88-1. When the sterilization failure coefficient of the current sterilization process is higher than 0.88, it means that the sterilization effect of the current drug to be tested is poor in the first sterilization process and the next round of sterilization operation is required. The baseline irradiation intensity is kept unchanged, and the basic sterilization time is extended. That is, after the current sterilization process is completed, the ultraviolet irradiation basic sterilization time is continued, and the monitoring curve of each measuring point in the comprehensive drug stability test box under each microbial metabolic indicator in the new round of basic sterilization period is simultaneously obtained. The sterilization failure coefficient of the new round of sterilization process is obtained according to the method described in step S3. Then, it is calculated to determine whether it is greater than the preset threshold and whether the next round of ultraviolet sterilization is required. The ultraviolet irradiation time is dynamically adjusted, that is, the basic irradiation time is extended until the sterilization failure coefficient of the latest round of ultraviolet sterilization process is less than 0.88, and the sterilization is terminated. The stability experiment related parameters are set to perform the stability experiment of the current drug to be tested.

[0104] The present invention also proposes a comprehensive drug stability test chamber sterilization control system, including a memory, a processor, and a computer program stored in the memory and runnable on the processor. When the processor executes the computer program, the steps of a comprehensive drug stability test chamber sterilization control method described in steps S1-S4 are implemented.

[0105] In summary, the present invention first obtains all ultraviolet sterilization records of the comprehensive drug stability test box, and then analyzes all ultraviolet sterilization records to obtain the sterilization selectivity of each irradiation intensity for each drug to be tested, and then determines the baseline irradiation intensity of each drug to be tested, and determines the basic sterilization time; then based on the baseline irradiation intensity and the basic sterilization time, combined with the type of the current drug to be tested, the comprehensive drug stability test box is sterilized by ultraviolet light, and in the current sterilization process, the monitoring curve of each measuring point in the comprehensive drug stability test box under each microbial metabolism index is analyzed to evaluate the sterilization defect coefficient of the current sterilization process, and then according to the sterilization defect coefficient of the current sterilization process, the comprehensive drug stability test box is subjected to ultraviolet sterilization control. The present invention determines the baseline irradiation intensity and the basic sterilization time by analyzing historical ultraviolet sterilization records, and then analyzes the microbial metabolism in the process of sterilization control conditions corresponding to the baseline irradiation intensity and the basic sterilization time, thereby evaluating the sterilization effect, and then dynamically adjusts the sterilization control conditions according to the real-time sterilization effect to improve the sterilization control effect.

[0106] It should be noted that the order in which the embodiments of the present invention are described above is for illustrative purposes only and does not necessarily represent the superiority or inferiority of the embodiments. The processes depicted in the accompanying drawings do not necessarily require the specific order or sequential order shown to achieve the desired results. In certain embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0107] The various embodiments in this specification are described in a progressive manner, and the same or similar parts between the various embodiments can be referred to each other. Each embodiment focuses on the differences from other embodiments.

Claims

1. A comprehensive drug stability test chamber sterilization control method, characterized in that: The method comprises: Obtain all ultraviolet sterilization records of the comprehensive drug stability test chamber, each of which includes at least the irradiation intensity, irradiation duration, and the drug to be tested of the corresponding historical sterilization process; Obtain the sterilization selectivity of each irradiation intensity for each drug to be tested based on the frequency of occurrence of each irradiation intensity in all historical sterilization processes for each drug to be tested, and the type of drug to be tested for each irradiation intensity in all historical sterilization processes; determine the baseline irradiation intensity for each drug to be tested based on the sterilization selectivity; and determine the basic sterilization duration based on the irradiation duration in all ultraviolet sterilization records; Based on the benchmark irradiation intensity and the basic sterilization time, and in combination with the type of drug currently to be tested, the comprehensive drug stability test chamber is sterilized with ultraviolet light, and during the current sterilization process, a monitoring curve of each measuring point in the comprehensive drug stability test chamber under each microbial metabolic indicator is obtained; based on the fluctuation difference of the monitoring curve under the same microbial metabolic indicator at different measuring points, a sterilization failure coefficient of the current sterilization process is obtained; According to the sterilization failure coefficient of the current sterilization process, combined with the benchmark irradiation intensity and the basic sterilization time, ultraviolet sterilization control is performed on the comprehensive drug stability test chamber; The method for obtaining the sterilization selectivity includes: In all ultraviolet sterilization records, each irradiation intensity in all sterilization processes corresponding to each drug to be tested shall be used as the candidate irradiation intensity; The normalized result of the product of the occurrence frequency of each candidate irradiation intensity in all sterilization processes for each drug to be tested and the total number of types of drugs to be tested in all sterilization processes corresponding to each candidate irradiation intensity is used as the usage extensiveness of each candidate irradiation intensity for each drug to be tested; Weighting the occurrence frequency of each candidate irradiation intensity for each drug to be tested according to the corresponding usage prevalence, and using the weighted result as the sterilization selectivity of each candidate irradiation intensity for each drug to be tested; The method for obtaining the sterilization failure coefficient includes: Under each microbial metabolism index, according to the difference in the time corresponding to the extreme point in the monitoring curve at different measuring points, the first metabolic difference coefficient of the microorganisms at different measuring points is obtained; Under each microbial metabolism indicator, according to the difference in the change characteristics of the data points in the monitoring curve at different measuring points, the second metabolic difference coefficient of the microorganisms at different measuring points is obtained; The first metabolic difference coefficient and the second metabolic difference coefficient of microorganisms at different measuring points under all microbial metabolic indicators are integrated to obtain a sterilization failure coefficient.

2. A comprehensive drug stability test chamber sterilization control method according to claim 1, characterized in that: The method for obtaining the reference irradiance intensity includes: Among all the candidate irradiation intensities for each drug to be tested, the irradiation intensity corresponding to the candidate irradiation intensity with the greatest sterilization selectivity is used as the benchmark irradiation intensity for the drug to be tested.

3. The sterilization control method for a comprehensive drug stability test chamber according to claim 1, characterized in that: The method for obtaining the basic sterilization time includes: In all ultraviolet sterilization records, the minimum irradiation time among all irradiation times is used as the basic sterilization time.

4. A comprehensive drug stability test chamber sterilization control method according to claim 1, characterized in that: The method for obtaining the first metabolic difference coefficient includes: The time corresponding to the extreme point in the monitoring curve at each measuring point is used as a sequence element to construct an extreme time sequence; The variance of the corresponding moments of the sequence elements with the same sequence number in the extreme value time sequence at all measuring points under each microbial metabolic index is used as the fluctuation difference parameter, and the mean of the fluctuation difference parameters under all the same sequence numbers is used as the first metabolic difference coefficient.

5. The sterilization control method for a comprehensive drug stability test chamber according to claim 1, characterized in that: The method for obtaining the second metabolic difference coefficient includes: The normalized result of the accumulated sum of the indicator differences at all adjacent moments in the monitoring curve at each measuring point is used as the fluctuation trend parameter of the monitoring curve; Under each microbial metabolism indicator, a second metabolic difference coefficient is obtained according to the difference in the fluctuation trend parameter of the monitoring curve at all different measuring points.

6. The sterilization control method for a comprehensive drug stability test chamber according to claim 1, characterized in that: The method for performing ultraviolet sterilization on a comprehensive drug stability test box comprises: When the sterilization failure coefficient is less than a preset threshold, the ultraviolet sterilization is terminated; when the sterilization failure coefficient is greater than or equal to the preset threshold, a new round of ultraviolet sterilization is continued on the comprehensive drug stability test chamber based on the benchmark irradiation intensity and the basic sterilization time, and the sterilization failure coefficient of the new round of sterilization process is obtained; The process continues to iterate until the sterilization failure coefficient of the latest sterilization process is less than a preset threshold.

7. The sterilization control method for a comprehensive drug stability test chamber according to claim 1, characterized in that: The microbial metabolism indicators include at least temperature and humidity.

8. A comprehensive drug stability test chamber sterilization control system, characterized in that: The invention comprises a memory, a processor and a computer program stored in the memory and executable on the processor. When the processor executes the computer program, the steps of the sterilization control method of a comprehensive drug stability test chamber as described in any one of claims 1 to 7 are implemented.

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