JP7415574B2 - Sterilization method and sterilization equipment - Google Patents

Description

The present invention relates to a sterilization method and a sterilization apparatus for sterilizing objects using a sterilizing agent such as steam.

Patent Document 1 describes an apparatus that sterilizes objects placed in a sterilization tank by supplying a sterilizing agent such as steam into the sterilization tank.

Japanese Patent Application Publication No. 2018-46879

By the way, the sterilization apparatus as disclosed in Patent Document 1 needs to determine whether the object has been sterilized. When making a determination, a sample is placed in a sterilization tank and the BI index of the sample is evaluated. In this case, it will take time to determine the evaluation result. Furthermore, when physical parameters such as temperature and pressure are used, the usage conditions also affect the sterilization results, making it difficult to make reliable decisions.

An object of the present invention is to provide a sterilization method and a sterilization apparatus that can quickly and accurately detect the possibility of sterilization failure.

The present invention is a sterilization method for sterilizing an object by filling a sterilization chamber with a sterilizing agent, and the sterilization operation data unit includes a plurality of sterilization operation data that are operation data during sterilization processing for sterilizing the object. a data extraction step of extracting a success data unit including sterilization success data, which is a case in which sterilization was successful, from the sterilization operation data unit; A standard case generation step that generates the worst reference data, which is the data that is most likely to fail, a current data acquisition step that acquires the current operation data that is the operation data for the sterilization process of the current object, and a current data acquisition step that A sterilization method is provided, including a determination step of comparing the worst reference data to determine whether the current sterilization of the object is successful.

Preferably, the sterilization operation data includes at least one of a sterilization chamber pressure, temperature, biological indicator, and chemical indicator.

It is preferable that the reference case generation step extracts one piece of sterilization operation data and generates worst reference data.

It is preferable that the reference case generation step generates worst reference data by combining a plurality of sterilization operation data.

Preferably, in the determination step, it is determined that the sterilization process is successful when the evaluation target parameter of the current operation data is equal to or greater than the value of the evaluation target parameter of the worst reference data.

The sterilization processing method includes a step of extracting a failure data unit including sterilization failure data other than when sterilization is successful from the sterilization operation data unit, and a step of extracting a failure data unit including sterilization failure data other than when sterilization is successful; If the data is less than the value of the parameter to be evaluated, it is preferable to determine that sterilization is defective.

The present invention provides a sterilization chamber filled with a sterilizing agent to sterilize objects, an operation data acquisition unit that acquires current operation data of the sterilization process in the sterilization chamber, and an operation data acquisition unit that acquires the current operation data of the sterilization process in the sterilization chamber. A storage unit that stores the worst reference data that is the closest data, and a comparison between the current operation data acquired by the operation data acquisition unit and the worst reference data to determine whether the sterilization process of the current object is successful. a determination unit, wherein the worst reference data is a case in which sterilization is successful, extracted from a sterilization operation data unit that includes a plurality of sterilization operation data that are operation data during sterilization processing for sterilizing an object. To provide a sterilization device whose data is created based on a success data unit including sterilization success data.

According to the present invention, the results of sterilization can be determined more accurately and quickly.

FIG. 1 is a diagram showing a sterilization system according to this embodiment. FIG. 2 is a schematic diagram showing the functions of the processing device and the state monitoring device. FIG. 3 is a flowchart showing an example of a processing procedure for storing sterilization operation data of the sterilization system. FIG. 4 is a flowchart illustrating an example of a processing procedure for creating criteria data for a sterilization system. FIG. 5 is a flowchart illustrating an example of a processing procedure for determining sterilization processing of the sterilization system. FIG. 6 is a flowchart showing another example of the processing procedure for determining sterilization processing of the sterilization system.

Embodiments according to the present invention will be described below with reference to the drawings, but the present invention is not limited thereto. The components of the embodiments described below can be combined as appropriate. Furthermore, some components may not be used.

FIG. 1 is a diagram showing a sterilization system according to this embodiment. FIG. 2 is a schematic diagram showing the functions of the processing device and the state monitoring device. A sterilization system (sterilization device) 100 shown in FIG. 1 includes a plurality of processing devices (sterilization device main body) 1, a computer 6, and a mobile It includes a communication terminal device 7 and a status monitoring device 10. The condition monitoring device 10 monitors the operation of the processing device 1 . The computer 6 and the mobile communication terminal device 7 communicate with the condition monitoring device 10 and provide the received information to the operator.

In the sterilization system 100, the processing device 1, the mobile communication terminal device 7, and the condition monitoring device 10 can communicate with each other via the communication line 3. Further, the sterilization system 100 is capable of communicating via the communication line 3 with a computer 6 provided at a management base that manages processing equipment in which the processing device 1 is provided.

In this embodiment, a plurality of processing devices 1a, 1b, . is transmitted to the status monitoring device 10. Note that the sterilization system 100 may include a plurality of processing apparatuses 1 as shown in FIG. 1, or may include one processing apparatus. Furthermore, the number of mobile communication terminal devices 7 included in the sterilization system 100 may be plural or single. In the following, when the processing apparatuses 1a, 1b, . Further, although the sterilization system 100 of this embodiment includes the computer 6 and the mobile communication terminal device 7, it may not include the computer 6 and the mobile communication terminal device 7. When the computer 6 and the mobile communication terminal device 7 are not included, the status monitoring device 10, a device provided in the processing device 1 for notifying an operator, and a device for inputting operations are used.

The communication line 3 is a telephone line or a LAN (Local Area Network) installed within the facility. In this embodiment, the condition monitoring device 10 is connected to the communication line 3 by wiring, but it may be connected to the communication line 3 via a wireless communication device. A computer 6 and mobile communication terminal devices 7A and 7B are connected to the communication line 3. In the following, when the mobile communication terminal devices 7A and 7B are not distinguished, they will be referred to as the mobile communication terminal device 7 as appropriate.

The computer 6 is connected to the communication line 3 by wiring. A wireless communication base 4 for a mobile communication terminal device 7 is connected to the communication line 3 . The mobile communication terminal device 7 is connected to the communication line 3 via the wireless communication base 4. The mobile communication terminal device 7 is, for example, a PHS (Personal Handy-phone System) or a so-called mobile phone. When the facility where the processing device 1 is used is a hospital, a PHS is used as the mobile communication terminal device 7. If the facility where the processing device 1 is used is other than a hospital, the mobile communication terminal device 7 may be a so-called mobile phone. Note that the mobile communication terminal device 7 is not limited to a PHS and a mobile phone.

The processing apparatus 1 stores objects to be processed in a container and sterilizes the objects. The sterilization process handled by the processing device 1 is performed in one or more steps, and at least one of the steps proceeds based on a change in a physical quantity, and the processing time of the step changes. This is the process of obtaining. Such a sterilization process includes, for example, any one of heating, pressurization, decompression, and cooling, or a combination thereof. Since such sterilization processing includes steps that proceed based on changes in physical quantities, the time from the start of operation to completion varies and cannot be determined uniquely.

In order to perform such sterilization processing, the processing device 1 has an operation program in which the process progresses based on changes in physical quantities, for example. For example, the above-mentioned sterilization process may be performed by a control microcomputer incorporated in the processing device 1 executing an operating program as a computer program. Furthermore, the processing device 1 may perform the sterilization process using an electronic circuit that implements the above-described operation program.

Examples of the processing device 1 include, for example, a steam sterilizer that uses steam as a sterilizing agent, an EOG gas sterilizer that uses ethylene oxide gas (EOG) and steam as a sterilizing agent, and a peroxidizer that uses hydrogen peroxide as a sterilizing agent. Sterilizers include hydrogen gas low-temperature sterilizers, low-temperature steam formaldehyde sterilizers that use formaldehyde and water vapor as sterilants, plasma sterilizers that generate plasma to sterilize, sterilizers such as retort sterilizers, formalin sterilizers, etc. It will be done. Such equipment includes a depressurization process, a steam supply process, a water supply process, etc. In order to advance these processes to the next process, a step is performed when a change in physical quantity, that is, pressure or temperature, etc. reaches a set value. It has a driving program that advances the Moreover, such devices necessarily include treatments such as heating, including pressurization by supplying steam, depressurization for air removal or cooling, and water supply to the storage tank. The operating time of these processes varies depending on external factors, such as steam supply equipment, water supply equipment, water temperature, etc.

The processing device 1 includes a control device 1C and an operation panel. The control device 1C is a device for controlling the operation of the processing device 1, and is, for example, a microcomputer. The operation panel includes an input device for inputting commands to the processing device 1 and a monitor for displaying the status of the processing device 1 and the like. The monitor may be a touch panel so that it also serves as an input device. The status monitoring device 10 is connected to the control device 1C, and receives information about the processing device 1 from the control device 1C.

The control device 1C transmits each piece of information about the process being executed to the condition monitoring device 10 as sterilization operation data. Sterilization operation data includes the temperature, pressure, etc. of steam, electricity, gas, pure water, and compressed air obtained during sterilization processing, as well as the bacterial lethality calculated based on the operation data. This is an index indicating, for example, the F value. Further, the control device 1C also transmits a signal indicating information such as device information and abnormality information to the state monitoring device 10, for example. The device information is information regarding the normal completion of the operation of the processing device 1. The abnormality information is information regarding an abnormality that has occurred in the processing device 1.

Next, with reference to FIG. 2, the configurations of the processing device 1 and the status monitoring device 10 described above will be described. In the following description, similar components are given the same reference numerals. Furthermore, duplicate explanations may be omitted.

As shown in FIG. 2, the control device 1C of the processing device 1 includes a control section 51 and an input/output section 53. The control unit 51 is, for example, a combination of a CPU (Central Processing Unit) and a memory, and may use a microcomputer. A pressure sensor 54 , a temperature sensor 55 , and a supply valve 56 are electrically connected to the control unit 51 .

The pressure sensor 54 and the temperature sensor 55 are pressure sensors and temperature sensors provided in the container of the processing device 1, the supply line, and the equipment in which the processing device 1 is provided. The pressure sensor 54 and the temperature sensor 55 output signals indicating the detected pressure and temperature to the control unit 51. The supply valve 56 is a supply valve provided in the equipment in which the supply line and the processing device 1 are provided. The supply valve 56 outputs a signal indicating the open/closed state of the valve to the control unit 51. The control unit 51 acquires sterilization operation data based on signals input from the pressure sensor 54, the temperature sensor 55, the supply valve 56, and the like.

The input/output section 53 is connected to the control section 51 and the input/output section 13 of the condition monitoring device 10 . The input/output unit 53 outputs information from the control unit 51 to the status monitoring device 10. The input/output unit 53 receives various types of information output from the status monitoring device 10 and outputs the information to the control unit 51.

The state monitoring device 10 includes a processing section 11 , a storage section 12 , and an input/output section 13 . The processing unit 11 includes an information collection unit 11A, a state determination unit 11B, and an information transmission unit 11C. The processing unit 11 is, for example, a combination of a CPU (Central Processing Unit) and a memory, and may be a microcomputer. The processing unit 11 executes a computer program for transmitting the above-mentioned sterilization operation data, and transmits the sterilization operation data received from the processing device 1 to the mobile communication terminal device 7 etc. via the communication line 3.

The information collection unit 11A of the processing unit 11 receives sterilization operation data from the processing device 1. Upon receiving the information, the information collecting section 11A transmits the received information to the state determining section 11B. The state determination unit 11B determines whether or not the sterilization in the current sterilization operation data was good, based on the data stored in the storage unit 12 and the current sterilization operation data in the processing device 1 acquired by the information collection unit 11A. Determine if it is true and create a determination result. The state determining unit 11B transmits the determination result to the information transmitting unit 11C. The information transmitting unit 11C transmits various information such as the determination result of the state determining unit 11B to the processing device 1 or wireless communication, in this embodiment, a wireless communication base interposed between the communication line 3 and the mobile communication terminal device 7. 4 to the mobile communication terminal device 7. Note that various processes will be described later.

The storage unit 12 is, for example, a combination of a volatile memory such as a RAM (Random Access Memory) and a nonvolatile memory such as a ROM (Read Only Memory), but is not limited thereto. The storage unit 12 stores collected data 12A, judgment standard data 12B, and judgment program 12C. The storage unit 12 also stores programs for executing each process executed by the state determination unit 11B. The collected data 12A is a collection of data in which sterilization operation data executed by the processing device 1 and sterilization results are associated, that is, a sterilization operation data unit. The sterilization operation data also includes CI (chemical indicator) values and BI (biological indicator) values obtained through inspection after execution of sterilization processing. The determination standard data 12B is data used for determination processing in the state determining section 11B, and includes worst standard data and a database of sterilization failures. The worst reference data is the data closest to failure among the operational sterilization data in which the sterilization process was successful. The determination program 12C is a program that implements the functions of the state determination section 11B.

The input/output section 13 is connected to the processing section 11, the communication line 3, and the control device 1C of the processing device 1. The processing unit 11 receives various information transmitted by the control device 1C via the input/output unit 13, and outputs the information to the communication line 3. When there is only one processing device 1, the control device 1C of the processing device 1 is connected to the input/output section 13. In addition to the processing device 1, when a plurality of processing devices 1a to 1n send various information to the status monitoring device 10, the input/output unit 13 is further connected to control devices 1Ca to 1Cn of the plurality of processing devices 1a to 1n. be done.

Next, an example of a sterilization method of the sterilization system will be explained using FIGS. 3 to 6. FIG. 3 is a flowchart showing an example of a processing procedure for storing sterilization operation data of the sterilization system. FIG. 4 is a flowchart illustrating an example of a processing procedure for creating criteria data for a sterilization system. FIG. 5 is a flowchart illustrating an example of a processing procedure for determining sterilization processing of the sterilization system. FIG. 6 is a flowchart showing another example of the processing procedure for determining sterilization processing of the sterilization system. The sterilization processing method of this embodiment performs sterilization processing multiple times, uses various data acquired in the sterilization processing, extracts the worst case, sets judgment standard data, uses the set worst case standard data, Determine whether the current sterilization process (to be evaluated) was successfully executed.

The sterilization processing method acquires sterilization operation data (step S12). Sterilization operation data is information acquired by various sensors. The parameters of the sterilization operation data include the temperature and pressure inside the processing device 1. Measured values are saved as a time history. Further, the sterilization operation data may include information on the object to be sterilized, the amount of the object, the arrangement thereof, and the like.

The sterilization method acquires the sterilization results of the acquired sterilization operation data (step S14). The sterilization result is at least one of a CI (chemical indicator) value, a BI (biological indicator) value, and an evaluation value confirmed by the operator. The sterilization results do not need to be acquired at the same time as the sterilization operation data, and may be input after each inspection and confirmation is completed. CI (chemical indicator) value and BI (biological indicator) value are evaluated by placing a sample on the processing device 1 during sterilization, collecting the sample after sterilization, and evaluating each value. By doing so, the sterilization process corresponding to the sterilization operation data can be evaluated.

The sterilization method stores the acquired sterilization operation data and sterilization results in association with each other (step S16). Thereby, the sterilization processing method acquires a plurality of data in which the sterilization operation program, sterilization operation data, and sterilization results are associated with each other, and uses the data as collected data. The collected data includes data on successful sterilization and data on failed sterilization.

Next, an example of a method for creating determination criterion data will be described using FIG. 4. Note that the process in FIG. 4 may be performed each time the collected data is updated, each time a certain number of sterilization operation data is added, or each time a certain period of time elapses. The sterilization processing method extracts sterilization operation data from the collected data (step S20). That is, the sterilization processing method selects and extracts one sterilization operation data from a plurality of sterilization operation data included in the collected data. Prior to the extraction, the collected data may be narrowed down to approximate collected data that approximates the current sterilization operation data or similar collected data that has a similar sterilization operation program using the least squares method or the like. In the sterilization processing method, it is determined whether the extracted data, that is, the extracted sterilization operation data, is well sterilized (step S22). The sterilization treatment method determines whether sterilization was successful or failed based on the sterilization results.

In the sterilization processing method, if the sterilization of the extracted data is not good (No in step S22), that is, if it is sterilization operation data in which sterilization has failed, the extracted data is stored in a sterilization failure database (step S24). The sterilization method then proceeds to step S30.

In the sterilization processing method, if the sterilization of the extracted data is good (Yes in step S22), that is, the sterilization operation data shows successful sterilization, it is determined whether the data is worse than the worst reference data (step S26). For example, if a sterilization method is judged based on the degree of vacuum attainment based on the pressure inside the processing device 1 during degassing, etc., the degree of vacuum attainment of the extracted data is worse than the worst reference data (the degree of vacuum is low). , which is high as a pressure value), it is determined that the data is worse than the worst reference data. When the sterilization processing method is judged based on the temperature in the processing device 1 based on the temperature increase rate, the temperature increase rate of the extracted data is worse than the worst reference data (the temperature increase rate is large, the reached temperature is low), it is determined that the data is worse than the worst reference data. When determining the sterilization method based on the sterilization time, calculate the time it takes for the temperature and pressure inside the processing device 1 to reach predetermined conditions, and if the sterilization time is shorter than the worst standard data, the worst It is determined that the data is worse than the reference data. When determining the sterilization method using the F value as a standard, if the F value of the extracted data is worse than the worst standard data (bacterial mortality rate is low, there are many surviving bacteria), it is judged that the F value of the extracted data is worse than the worst standard data. It is determined that the data is bad.

In the sterilization processing method, if it is determined that the data is worse than the worst reference data (Yes in step S26), or if there is no worst reference data, the data to be evaluated is set as the worst reference data (step S28). , proceed to step S30. If it is determined that the sterilization method is not worse than the worst reference data (No in step S26), the process directly proceeds to step S30. That is, when it is determined that the data to be evaluated has better conditions than the worst reference data, the worst reference data is maintained.

In the sterilization processing method, after performing the processing in steps S24 and S28, or when the determination is No in step S26, it is determined whether the evaluation of the accumulated data has been completed (step S30). In the sterilization processing method, if the evaluation of the accumulated data has not been completed (No in step S30), that is, if there is sterilization operation data that has not been evaluated, the process returns to step S20 and the above-mentioned sterilization operation data is performed for the sterilization operation data that has not been evaluated. Execute processing. In the sterilization processing method, when it is determined that the evaluation of the accumulated data has been completed (Yes in step S30), this processing ends. In the sterilization processing method, the sterilization operation data that is closest to failure among the operations in which sterilization was successful is extracted from the sterilization operation data as the worst reference data. Further, in the sterilization processing method, by extracting sterilization operation data in which sterilization was successfully performed from the sterilization operation data in step S22, it is possible to sequentially execute the process in step S26 on the successful sterilization operation data. The sterilization processing method can generate a data unit including a plurality of sterilization operation data in which sterilization was successful by repeating the above processing. Further, the sterilization processing method accumulates sterilization operation data in which sterilization has failed in a sterilization failure database. The data created in the process shown in FIG. 4 is stored in the judgment criterion data 12B.

Next, an example of a process of evaluating the sterilization operation data executed this time using the worst reference data will be explained using FIG. In the sterilization method, worst reference data is acquired (step S42). Next, the sterilization processing method acquires sterilization operation data to be evaluated (step S44). Specifically, sterilization operation data of the sterilization process executed by the processing device 1 this time is acquired. The processes of step S42 and step S44 may be executed in parallel or in the reverse order. Furthermore, the process in FIG. 4 may be executed during the process in step S42.

The sterilization processing method determines whether the sterilization operation data to be evaluated is better than or equivalent to the sterilization operation data of the worst reference data (step S46). Here, the criteria for determining whether the product is good may be set in advance. The object of judgment may be one or more parameters to be evaluated in the sterilization operation data. Further, the determination target may be all time periods of sterilization treatment or only a part of the time periods. For example, when determining a sterilization method based on the degree of vacuum attainment based on the pressure inside the processing device 1 during degassing, etc., the degree of vacuum attainment of the sterilization operation data to be evaluated is better than the worst reference data ( If the degree of vacuum is high or the pressure value is low), it is determined to be good. When determining the sterilization processing method based on the temperature in the processing device 1 based on the temperature increase rate, the temperature increase rate of the extracted data is better than the worst reference data (the temperature increase rate is small, the reached temperature is high), it is determined to be good. When determining the sterilization method based on the sterilization time, calculate the time it takes for the temperature and pressure inside the processing device 1 to reach predetermined conditions, and if the sterilization time is longer than the worst standard data, it is considered good. It is determined that When judging a sterilization method based on the F value, it is judged to be good if the F value of the extracted data is better than the worst standard data (high bacterial mortality rate, few surviving bacteria). do. Further, the determination of whether they are equivalent is also made by comparing various parameters in the same manner as above.

In the sterilization processing method, the sterilization operation data to be evaluated is not better than or equal to the sterilization operation data of the worst reference data (No in step S46), that is, the sterilization operation data to be evaluated is the sterilization operation data of the worst reference data. If it is determined that the sterilization process is worse than that, it is determined that there is a possibility of sterilization failure (step S48), and the process proceeds to step S52.

In the sterilization processing method, the sterilization operation data to be evaluated is better than the sterilization operation data of the worst reference data (Yes in step S46), that is, the sterilization operation data to be evaluated is better than the sterilization operation data of the worst reference data. If it is determined that the data indicates a good sterilization process, it is determined that the sterilization was successful (step S50), and the process proceeds to step S52. Here, in the sterilization processing method, for example, when the evaluation target parameter of the sterilization operation data is equal to or greater than the value of the evaluation target parameter of the worst reference data, it is determined that the sterilization processing is successful. Further, the sterilization processing method determines that sterilization is successful when the sterilization operation data to be evaluated is equivalent to the sterilization operation data of the worst reference data.

The sterilization method outputs the determination result after executing the processes of steps S48 and S50 (step S52). Specifically, the determination result is output to the computer 6 or mobile communication terminal device 7 and notified to the operator.

As described above, the sterilization system 100 and the sterilization processing method use the sterilization operation data in which sterilization was successful to extract the sterilization operation data in which the conditions were the worst among the successful sterilizations, that is, the sterilization operation data with the highest possibility of failure. By setting the worst reference data and evaluating the sterilization operation data for the evaluation target (currently) based on the worst reference data, it is possible to determine whether sterilization is successful or not, during or immediately after the sterilization process is being performed. It is possible to determine whether the Further, by making a determination based on past results, the accuracy of the determination can be increased. This makes it possible to quickly and accurately determine whether sterilization is necessary again or whether sterilization is complete and the next process can proceed.

Moreover, in this embodiment, sterilization operation data with the worst conditions is extracted from the sterilization operation data in which sterilization was successfully performed, and is used as the worst reference data, so that comparison can be made based on actual data.

The method for creating the worst reference data for the sterilization method is not limited to this, and the sterilization operation data closest to failure may be created by combining a plurality of sterilization operation data in which sterilization was successful, and may be used as the worst reference data. In addition, the worst reference data does not need to be in the same data format as the sterilization operation data; instead, the timing conditions that are used as the criteria for determining the success or failure of sterilization processing are extracted, and the conditions that must be met at the extracted timing are set as the worst reference data. It may also be used as data.

In the sterilization method shown in FIG. 5, the worst reference data was used for the determination, but the sterilization failure database may also be used for the determination. An example of the process will be described using FIG. 6. FIG. 6 is a flowchart showing another example of the processing procedure for determining sterilization processing of the sterilization system.

In the sterilization method, worst reference data is acquired (step S42). Next, the sterilization processing method acquires sterilization operation data to be evaluated (step S44). Specifically, sterilization operation data of the sterilization process executed by the processing device 1 this time is acquired. The processes of step S42 and step S44 may be executed in parallel or in the reverse order. Furthermore, the process in FIG. 4 may be executed during the process in step S42.

The sterilization processing method determines whether the sterilization operation data to be evaluated is better than or equivalent to the sterilization operation data of the worst reference data (step S46). Here, the criteria for determining whether the product is good can be determined in advance by using the various determination methods described above. The object of judgment may be one or more parameters to be evaluated in the sterilization operation data. Further, the determination target may be all time periods of sterilization treatment or only a part of the time periods.

In the sterilization processing method, the sterilization operation data to be evaluated is not better than or equal to the sterilization operation data of the worst reference data (No in step S46), that is, the sterilization operation data to be evaluated is the sterilization operation data of the worst reference data. If it is determined that the sterilization process is worse than the sterilization process, the sterilization operation data to be evaluated is compared with the data in the sterilization failure database (step S62). As a result of the comparison in step S62, the sterilization processing method determines whether there is failure data with better or equivalent conditions, that is, a sterilization operation database of the sterilization failure database, based on the sterilization operation data to be evaluated (step S64). Good conditions are conditions where there is a high possibility that sterilization can be performed. The criteria for determination may be set in advance. For example, conditions can be set to be good if the temperature is high, the pressure of the sterilizing agent is high, the pressure during decompression treatment is low, etc. For the determination based on the comparison between the sterilization operation data to be evaluated and the sterilization failure database, various methods for determining the worst reference data described above can be used.

The sterilization processing method is used when it is determined that there is no failure data with good conditions or equivalent to the sterilization operation data to be evaluated (No in step S64), that is, when the conditions are worse than the worst reference data and the sterilization failure database If the conditions are better than the sterilization operation data, it is determined that there is a possibility of sterilization failure (step S66), and the process proceeds to step S52. In the sterilization processing method, if it is determined that there is failure data with good or equivalent conditions based on the sterilization operation data to be evaluated (Yes in step S64), it is determined that sterilization has failed (step S68), and the process proceeds to step S52.

The sterilization processing method is such that the sterilization operation data to be evaluated is better than or equal to the sterilization operation data of the worst reference data (Yes in step S46), that is, the sterilization operation data to be evaluated is the sterilization operation data of the worst reference data. If it is determined that the data is of a sterilization process that is better than or equivalent to that of the sterilization process, it is determined that the sterilization was successful (step S50), and the process proceeds to step S52.

The sterilization method outputs the determination result after executing the processes of step S50, step S66, and step S68 (step S52). Specifically, the determination result is output to the computer 6 or mobile communication terminal device 7 and notified to the operator.

As shown in Figure 6, the sterilization processing method determines the current sterilization operation data based on the worst reference data and the sterilization operation data in which sterilization failed, which is stored in the sterilization failure database. It is also possible to determine with high accuracy whether or not the process has failed. Thereby, it is possible to classify whether sterilization was successful, whether there is a possibility of failure, or whether sterilization has failed, and appropriate post-processing can be performed for each sterilized object.

In addition, the sterilization operation data includes conditions that can be acquired by sensors during operation, such as temperature and pressure, as well as worst reference data and judgment conditions using the worst reference data, using the amount and arrangement of objects to be sterilized. It is preferable to set Thereby, it is possible to make a determination more appropriately depending on changes in the conditions of sterilization treatment, and the accuracy can be further improved.

Although the present embodiment has been described above, the present embodiment is not limited to the content described above. Furthermore, the above-mentioned components include those that can be easily assumed by those skilled in the art, those that are substantially the same, and those that are in a so-called equivalent range. Furthermore, the aforementioned components can be combined as appropriate. Furthermore, various omissions, substitutions, or changes to the constituent elements can be made without departing from the gist of the present embodiment.

For example, in the sterilization system 100 of this embodiment, the sterilization operation data is stored in the condition monitoring device 10, but various data may be stored in the cloud. Furthermore, the sterilization system 100 may execute the functions of the condition monitoring device 10 in the cloud, that is, may be a server installed via a public line.

1, 1a to 1n Processing devices 1C, 1Ca to 1Cn Control device 3 Communication line 4 Wireless communication base 6 Computers 7, 7A, 7B Mobile communication terminal device 10 Status monitoring device 11 Processing unit 11A Information collecting unit 11B Status determining unit 11C Information transmission Section 12 Storage section 12A Collection data 12B Judgment standard data 12C Judgment program 13 Input/output section 100 Sterilization system

Claims (7)

A sterilization method that sterilizes objects by filling a sterilization chamber with a sterilizing agent,
obtaining a sterilization operation data unit including a plurality of sterilization operation data and sterilization results, which are operation data during sterilization processing for sterilizing the object;
a data extraction step of extracting a success data unit including sterilization success data, which is a case where sterilization was successful, from the sterilization operation data unit;
a reference case generation step of generating worst reference data, which is sterilization operation data closest to failure among successful sterilization processes, based on the success data unit;
a current data acquisition step of acquiring current operation data that is operation data for sterilization processing of the current target object;
A sterilization processing method comprising: a determination step of comparing current operation data with the worst reference data to determine whether sterilization of a current target object has been successful. The sterilization processing method according to claim 1, wherein the sterilization operation data includes at least one of sterilization chamber pressure, temperature, biological indicators, and chemical indicators. 3. The sterilization processing method according to claim 1, wherein the reference case generation step extracts one piece of sterilization operation data and generates worst reference data. 3. The sterilization processing method according to claim 1, wherein the reference case generation step generates worst reference data by combining a plurality of sterilization operation data. The determining step determines that the sterilization process is successful when the evaluation target parameter of the current operation data is equal to or greater than the value of the evaluation target parameter of the worst reference data. Sterilization method described in section. extracting a failure data unit containing sterilization failure data other than when sterilization is successful from the sterilization operation data unit;
According to any one of claims 1 to 4, the determining step determines that sterilization is defective when the evaluation target parameter of the current operation data is less than the value of the evaluation target parameter of the sterilization failure data. Sterilization method described. a sterilization chamber filled with a sterilizing agent to sterilize objects;
an operation data acquisition unit that acquires current operation data of sterilization processing in the sterilization room;
a storage unit that stores worst reference data that is sterilization operation data that is most likely to fail among successful sterilization processes;
a determination unit that compares the current operation data acquired by the operation data acquisition unit with the worst reference data to determine whether the sterilization process of the current object is successful;
The worst reference data is sterilization success data, which is a case in which sterilization is successful, extracted from a sterilization operation data unit that includes a plurality of sterilization operation data and sterilization results, which is operation data during sterilization processing for sterilizing objects. Sterilization equipment, which is data created based on the success data unit containing.

Images