A sterilization evaluation method for moist heat sterilizer

Abstract

The present application discloses a sterilization evaluation method for a moist heat sterilizer, which relates to the technical field of sterilization. The sterilization evaluation method for a moist heat sterilizer in the present application comprises the following steps: S1, setting a plurality of detection components in a sterilization chamber, each detection component being set in a different area of ​​the sterilization chamber, detecting the sterilization effect of sterilizing steam in different areas of the sterilization chamber by the detection components, obtaining a detection result, and transmitting the detection result of the detection component to a control module; S2, analyzing the detection result transmitted by each detection component by the control module, analyzing whether the detection result with the worst sterilization effect meets the sterilization requirements, and if so, stopping sterilization; otherwise, continuing to introduce sterilizing steam for sterilization. The present application has the effect of reducing sterilization time while meeting the sterilization requirements.

Description

Technical Field

[0001] The present application relates to the technical field of sterilization, and in particular to a sterilization evaluation method for a moist heat sterilizer. Background Art

[0002] Moist heat sterilization is a sterilization method that uses high-temperature and high-pressure steam as a medium. It utilizes the high latent heat and strong penetrating power of steam to denature or coagulate proteins and ultimately kill microorganisms. Moist heat sterilization is the most commonly used sterilization method in the production process of pharmaceutical preparations.

[0003] Currently, when using a moist heat sterilizer for sterilization, in order to ensure the sterilization effect and meet the sterilization requirements specified in the production process, sterilizing steam is usually used to sterilize the sterilization chamber for 50 minutes, which is time-consuming and has low sterilization efficiency.

[0004] However, if the sterilization time is directly reduced, it is easy for the sterilization requirements to not be met, affecting subsequent production work. Summary of the Invention

[0005] In order to meet the sterilization requirements and reduce the sterilization time, the present application provides a sterilization evaluation method for a moist heat sterilizer.

[0006] This application provides a sterilization evaluation method for a moist heat sterilizer, which adopts the following technical solution:

[0007] A sterilization evaluation method for a moist heat sterilizer comprises the following steps:

[0008] S1. Multiple detection components are provided in the sterilization chamber, each detection component being provided in a different area of ​​the sterilization chamber. The detection components detect the sterilization effect of the sterilization steam in different areas of the sterilization chamber, obtain the detection results, and transmit the detection results of the detection components to the control module;

[0009] S2. The control module analyzes the test results transmitted from each test piece and analyzes whether the test result with the worst sterilization effect meets the sterilization requirements. If the sterilization requirements are met, sterilization is stopped; otherwise, sterilization continues by introducing sterilizing steam.

[0010] By adopting the above technical solution, the control module analyzes the test results transmitted by each test piece, selects the test result with the worst sterilization effect, and determines whether the test result with the worst sterilization effect meets the sterilization requirements. When the test result with the worst sterilization effect also meets the sterilization requirements, it means that the sterilization of the entire sterilization room has met the sterilization requirements. At this time, sterilization is stopped, so that while meeting the sterilization requirements, the sterilization time is reduced, the sterilization efficiency is improved, and the sterilization cost is reduced.

[0011] Optionally, the detection element includes a temperature detection element, and the control module The F0 value of each test piece is cumulatively calculated and compared with the preset value. When F0 is greater than the preset value, it means that the sterilization requirements are met; where T is the sterilization steam temperature measured by the temperature detection piece, and Δt is the time interval between two tests of the temperature detection piece.

[0012] By adopting the above technical solution, the control module calculates F0 through the sterilization steam temperature transmitted by the detection part and the cumulative time of transmission, and compares F0 with the preset value to determine whether the sterilization requirements are met at each detection part, which facilitates the control module to automatically analyze and process the test results transmitted by the detection part and control the sterilization process.

[0013] Optionally, the preset value of F0 is greater than 8 minutes.

[0014] By adopting the above technical solution, the sterilization time is reduced and the sterilization effect is improved by controlling the preset value of F0.

[0015] Optionally, the time interval between two tests of the test piece is 0.5 minutes to 1.5 minutes.

[0016] By adopting the above technical solution and setting the time for two inspections of the inspection piece, it is possible to control the sterilization time by accumulating and calculating F0, while reducing the amount of calculation of the control module and lowering the failure rate during the operation of the control module.

[0017] Optionally, when T is greater than or equal to 121° C., F0 is cumulatively calculated.

[0018] By adopting the above technical solution, when T is less than 121 degrees Celsius, the sterilization effect of the sterilization steam is weakened, and the cumulative calculation of F0 is not applicable. The cumulative calculation of F0 should start from T being greater than 121°C. When T is lower than 121°C, you should wait until T is higher than 121°C again before recalculating F0.

[0019] Optionally, the detection element further includes a pressure detection element, which is used to detect the pressure in the sterilization chamber during the sterilization process.

[0020] By adopting the above technical solution, the detection component can detect the pressure, making it easier to judge the sterilization effect from multiple dimensions of temperature and pressure.

[0021] Optionally, the detection results transmitted by the detection component to the control module also include the pressure measured by the pressure detection component. During the cumulative calculation of F0, the pressure at the time corresponding to T should be maintained at 13psi-30psi, otherwise the cumulative calculation of F0 will be restarted, where 1psi=0.006895MPa.

[0022] By adopting the above technical solution, the control module further judges the sterilization effect of the sterilization steam from the perspective of pressure, so that the sterilization steam can effectively sterilize, thereby making the control module more accurate in judging whether the sterilization requirements are met.

[0023] Optionally, the detection element further includes a biological detection element, and the sterilization evaluation method of the moist heat sterilizer further includes: S3, culturing the biological detection element after sterilization is completed to verify the sterilization result.

[0024] By adopting the above technical solution, after the sterilization is completed, the biological detection parts are further verified to see whether the sterilization requirements are met, so that the sterilization result in the sterilization chamber can be judged more accurately.

[0025] Optionally, the control module can record the sterilization time during the sterilization process, and the control module can set the sterilization time and perform sterilization according to the set sterilization time.

[0026] By adopting the above technical solution, the sterilization time of the initial sterilization is recorded by the control module. In the subsequent sterilization process, the sterilization time can be set according to the initial sterilization time, thereby reducing the sterilization time and reducing the operation of the control module.

[0027] In summary, this application has at least one of the following beneficial effects:

[0028] 1. The cumulative calculation of F0 can evaluate the sterilization condition of the sterilization chamber by the sterilization steam, thereby shortening the sterilization time and improving the sterilization efficiency while meeting the sterilization requirements;

[0029] 2. During the initial sterilization, the control module can record the sterilization time. In the subsequent sterilization process, the sterilization time can be set according to the initial sterilization time, thereby reducing the sterilization time and reducing the operation of the control module. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is a flow chart of Example 1 of the present application;

[0031] Figure 2 This is a flow chart of Example 2 of the present application;

[0032] Figure 3 This is a schematic diagram of the test results of the pressure detector used in Example 2 of the present application;

[0033] Figure 4 This is a schematic diagram of the detection results of the temperature detector used in Example 2 of the present application. DETAILED DESCRIPTION

[0034] The following is combined with Figure 1-4 This application is described in further detail.

[0035] Example 1:

[0036] The sterilization evaluation method of a moist heat sterilizer disclosed in the embodiment of the present application is as follows: Figure 1 ,include:

[0037] Detection: Detect the temperature of the sterilization steam through the temperature detection element on the detection piece;

[0038] Calculation: The temperature detection element transmits the sterilization steam temperature to the control module. The control module calculates the F0 at each detection element based on the temperature and detection time detected by each temperature detection element, and selects the minimum value of F0. Among them: F0 is the equivalent sterilization time of the reference temperature of 121℃, T is the sterilization steam temperature measured by the temperature detection element, Δt is the time interval between two detections by the temperature detection element, Δt may be 0.5 minutes to 1.5 minutes, and in the embodiment of the present application, Δt may be 1 minute; in other embodiments of the present application, Δt may be a time interval of variable length, for example, alternating between 0.5 minutes and 1 minute, thereby reducing the operation of the control module and the sterilization time;

[0039] Comparison: The control module compares the minimum value of F0 with the preset value of F0. The preset value of F0 is 8 minutes or more. In the embodiment of the present application, the preset value of F0 can be 12 minutes, thereby enhancing the sterilization effect while reducing the sterilization time.

[0040] Control: When the minimum value of F0 is greater than the preset value of F0, it means that the sterilization requirement is met. At this time, the control module stops the introduction of sterilization steam and completes the sterilization.

[0041] By cumulatively calculating F0, the sterilization condition of the sterilization chamber by the sterilization steam can be evaluated, thereby shortening the sterilization time and improving the sterilization efficiency while meeting the sterilization requirements.

[0042] The implementation principle of the sterilization evaluation method for a moist heat sterilizer in an embodiment of the present application is as follows: the sterilization effect of the sterilization steam is detected by setting multiple detection parts, F0 is calculated based on the detection results, the minimum value of F0 at each detection part is selected, and compared with the preset value to determine whether the sterilization requirements are met, so as to stop sterilization in time, thereby reducing the sterilization time and improving the sterilization efficiency.

[0043] Example 2:

[0044] The sterilization evaluation method of a moist heat sterilizer disclosed in the embodiment of the present application is as follows: Figure 2 , including the following steps:

[0045] Detection: The temperature of the sterilization steam is detected by the temperature detection element on the detection element, the pressure in the sterilization chamber is detected by the pressure detection element on the detection element, and the sterilization effect of the sterilization steam is detected by the biological detection element on the detection element;

[0046] Calculation: The temperature detection component transmits the sterilization steam temperature to the control module, and the pressure detection component transmits the pressure in the sterilization chamber to the control module. When the pressure in the sterilization chamber is between 13psi and 30psi, the control module accumulates the F0 at each detection component based on the temperature and detection time detected by each temperature detection component, and selects the minimum F0 value. Where: 1psi = 0.006895Mpa, F0 is the equivalent sterilization time at a reference temperature of 121°C, T is the sterilization steam temperature measured by the temperature detection element, Δt is the time interval between two detections by the temperature detection element, Δt may be 0.5 minutes to 1.5 minutes, and in the embodiment of the present application, Δt may be 1 minute; in other embodiments of the present application, Δt may be a time interval of variable length, for example, alternating between 0.5 minutes and 1 minute, thereby reducing the operation of the control module and the sterilization time;

[0047] Comparison: The control module compares the minimum value of F0 with the preset value of F0. The preset value of F0 is 8 minutes or more. In the embodiment of the present application, the preset value of F0 can be 12 minutes, thereby enhancing the sterilization effect while reducing the sterilization time.

[0048] Control: When the minimum value of F0 is greater than the preset value of F0, it means that the sterilization requirement is met. At this time, the control module stops the introduction of sterilization steam to complete the sterilization and records the sterilization time.

[0049] Verification: Through culture testing of biological test pieces, it is verified whether the sterilization in the sterilization room meets the requirements.

[0050] Setting: Set the subsequent sterilization time according to the sterilization time recorded by the control module in the control step.

[0051] By cumulatively calculating F0, the sterilization status of the sterilization chamber by the sterilization steam can be evaluated, thereby shortening the sterilization time and improving sterilization efficiency while meeting the sterilization requirements. At the same time, during sterilization, the sterilization duration is recorded by the control module, so that in subsequent sterilization processes, the sterilization duration can be set according to the initial sterilization duration, thereby reducing the sterilization time and reducing the operation of the control module. After the sterilization is completed, the sterilization status in the sterilization chamber is verified by the biological detection component, making the sterilization results more accurate.

[0052] Take the sterilization process with 16 temperature detectors numbered TC01-TC16, 16 biological detectors numbered BI01-BI16 and 1 pressure detector numbered Y as an example. The sterilization starts at 9:30 and ends at 9:40. The test results of the pressure detector refer to Figure 3 , the test results of the temperature detector during the sterilization process refer to Figure 4 .

[0053] according to Figure 3 From the data, we can see that in the time interval of 9:30-9:40, the pressure measured by the pressure detector is between 0.11Mpa-0.12Mpa, that is, 15.95psi-17.40psi, which is within the range of 13psi-30psi.

[0054] According to the calculation method in the above "Calculation" step and Figure 4 Based on the data in , calculate the F0 of each temperature detection component at 9:40. Take the F0 calculation of TC01 as an example: F0=1×10^((124.9-121) / 10)+1×10^((124.6-121) / 10)+1×10^((124.7-121) / 10)+1×10^((124.8-121) / 10)+1×10^((125.0-

[0055] 1×10^((124.2-121) / 10)+1×10^((124.5-121) / 10)=26.90. Taking the F0 calculation of TC07 as an example: F0=1×10^((124.2-121) / 10)+1×10^((124.5-121) / 10) )+1×10^((124.3-121) / 10)+1×10^((124.4-121) / 10)+1×10^((124.3-121) / 10)+1×10^((124.4-121) / 10)+1×10^((124.3-121) / 10)+1×10^((124.5-121) / 10)+1×10^((124.4-121) / 10)+1×10^((124.3-121) / 10)+1×10^((124.5-121) / 10)=23.92.

[0056] Calculate F0 at each of TC01-TC16, such as Figure 4As shown in , at 9:40, F0 is 26.90 at TC01, 12.07 at TC02, 23.34 at TC03, 12.14 at TC04, 22.90 at TC05, 21.33 at TC06, 23.92 at TC07, 12.50 at TC08, 22.89 at TC09, 13.15 at TC10, 23.24 at TC11, 21.24 at TC12, 23.04 at TC13, 20.99 at TC14, 23.24 at TC15, and 23.19 at TC16.

[0057] According to the calculation results, at 9:40, F0 at TC02 is the smallest and the sterilization effect is the worst. At this time, F0 at TC02 = 12.07 minutes, which is greater than the preset value of 12 minutes. This means that the sterilization requirements have been met and sterilization can be stopped. The sterilization time is 11 minutes.

[0058] After the sterilization was completed, the sterilization effect was verified by culturing and testing a total of 16 biological detectors BI01-BI16. The test results of the 16 biological detectors BI01-BI16 were all negative, that is, there was no sterile growth, indicating that the sterilization requirements had been met.

[0059] This sterilization took 11 minutes, which saved 39 minutes compared to the fixed setting of 50 minutes, a significant improvement.

[0060] The implementation principle of the sterilization evaluation method for a moist heat sterilizer in an embodiment of the present application is: by controlling the pressure during the cumulative calculation of F0, the sterilization effect of the sterilization steam is further guaranteed. At the same time, after the detection is completed, verification is performed through biological detection parts, so that the sterilization result judgment in the sterilization chamber is more accurate.

[0061] The above are all preferred embodiments of the present application, and are not intended to limit the scope of protection of the present application. Therefore, any equivalent changes made based on the structure, shape, and principle of the present application should be included in the scope of protection of the present application.

Claims

1. A sterilization evaluation method for a moist heat sterilizer, characterized in that: The following steps are involved: S1. Multiple detection components are provided in the sterilization chamber, each detection component is provided in a different area of ​​the sterilization chamber, and the detection components detect the sterilization effect of the sterilization steam in different areas of the sterilization chamber, obtain the detection results, and transmit the detection results of the detection components to the control module; S2. Analyze the test results transmitted by each test piece through the control module, and analyze whether the test result with the worst sterilization effect meets the sterilization requirements. If the sterilization requirements are met, stop sterilization; otherwise, continue to pass sterilizing steam; The detection element includes a temperature detection element, and the control module The F0 value of each test piece is cumulatively calculated and compared with the preset value. When F0 is greater than the preset value, it means that the sterilization requirements are met; where T is the sterilization steam temperature measured by the temperature detection piece, and Δt is the time interval between two tests of the temperature detection piece; The detection component also includes a pressure detection component, which is used to detect the pressure in the sterilization chamber during the sterilization process; the detection result transmitted to the control module by the detection component also includes the pressure measured by the pressure detection component. During the cumulative calculation of F0, the pressure at the time corresponding to T should be maintained at 13psi-30psi, otherwise the cumulative calculation of F0 will be restarted, where 1psi=0.006895MPa.

2. The sterilization evaluation method of a moist heat sterilizer according to claim 1, characterized in that: The default value of F0 is greater than 8 minutes.

3. The sterilization evaluation method of a moist heat sterilizer according to claim 1, characterized in that: The time interval between two tests of the test piece is 0.5 minutes to 1.5 minutes.

4. The sterilization evaluation method of a moist heat sterilizer according to claim 1, characterized in that: When T is greater than or equal to 121°C, F0 is cumulatively calculated.

5. The sterilization evaluation method of a moist heat sterilizer according to claim 1, characterized in that: The detection piece also includes a biological detection piece, and the sterilization evaluation method of the moist heat sterilizer further includes: S3, culturing the biological detection piece after the sterilization is completed to verify the sterilization result.

6. The sterilization evaluation method of a moist heat sterilizer according to claim 1, characterized in that: The control module can record the sterilization time during the sterilization process, and the control module can set the sterilization time and perform sterilization according to the set sterilization time.

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