Gas sterilization resistance detection device and detection method during zero-rise period of gas concentration

Abstract

The present application relates to a gas sterilization resistance detection device and method for zero-rise gas concentration. The device comprises: a first chamber provided with an external sealing door; a second chamber connected to the first chamber; an internal isolation door disposed between the first chamber and the second chamber, which is driven by a drive mechanism to achieve on-off control between the first chamber and the second chamber; a sample holder capable of moving back and forth between the first chamber and the second chamber along with the internal isolation door; an atomization device disposed on the second chamber; a vaporization device disposed on the second chamber; a hydrogen peroxide sensor disposed on the second chamber; and a temperature sensor disposed within the second chamber. The present application can achieve zero-rise gas sterilization, with the concentration and temperature of the first chamber remaining consistent with those of the second chamber, resulting in good test results. Furthermore, after the test, only the first chamber can be drained, making the operation easy.

Description

Technical Field

[0001] The present application relates to a testing device, and in particular to a gas sterilization resistance detection device and a detection method thereof during a zero-rise period of gas concentration. Background Art

[0002] In industries like pharmaceutical production and healthcare, hydrogen peroxide sterilization is a common sterilization method, with users choosing between atomization and vaporization. Hydrogen peroxide biological indicators are used to verify the effectiveness of sterilization equipment, with the D value being a recognized validation parameter.

[0003] Current equipment for measuring the D-value of vaporized hydrogen peroxide sterilization biological indicators, whether tested under normal pressure or vacuum, cannot directly measure the distribution concentration of vaporized hydrogen peroxide; instead, it is calculated using pressure conversion. However, hydrogen peroxide itself is very unstable and easily decomposes, making accurate concentration values ​​difficult to obtain. To achieve a vapor phase that meets testing requirements, the chamber requires a long stabilization time, which also extends the sterilization ramp-up period.

[0004] Currently, the primary testing method involves performing all operations within a chamber, inserting an indicator carrier, and providing a qualified pressure or concentration test. During recovery, the chamber must be opened only after all vapors within it have been vented to a safe level. This results in low vapor utilization during sterilization testing and can lead to significant contamination. Alternatively, indicator recovery may be abandoned.

[0005] Therefore, there is an urgent need for a gas sterilization resistance detection device and a detection method with a zero-rise period of gas concentration to solve the problems existing in the prior art. Summary of the Invention

[0006] The purpose of this application is to address the above-mentioned problems existing in the prior art and to provide a gas sterilization resistance detection device and a detection method for the gas concentration zero rise period.

[0007] In order to achieve the above application objectives, the present application adopts the following technical solutions: The gas sterilization resistance detection device in the zero-rise period of gas concentration includes:

[0008] The first cabin is provided with an outer sealed door and is used to place the test indicator and the sample to be tested;

[0009] A second cabin, connected to the first cabin, for performing a sterilization test;

[0010] The internal isolation door is provided between the first cabin and the second cabin, and is driven by a driving mechanism to realize on-off control between the first cabin and the second cabin;

[0011] The sample holder is detachably connected to the internal isolation door and can be moved from the first cabin to the second cabin along with the internal isolation door, so that the sample to be tested enters the second cabin for sterilization testing; after the sterilization test, the sample holder can be moved from the second cabin to the first cabin along with the internal isolation door to remove hydrogen peroxide from the first cabin and the surface of the indicator;

[0012] an atomizing device, provided on the second cabin, for atomizing hydrogen peroxide and spraying it into the second cabin;

[0013] a vaporization device, provided on the second cabin, for vaporizing hydrogen peroxide and transporting it into the second cabin;

[0014] a hydrogen peroxide sensor, provided on the second cabin, for monitoring the concentration of hydrogen peroxide in the second cabin in real time;

[0015] The temperature sensor is arranged in the second cabin and is used to detect the temperature of each point in the second cabin in real time.

[0016] Furthermore, the device also includes a fan, located within the second chamber, to accelerate fluid flow within the chamber. The addition of the fan improves gas flow and distribution within the chamber, increasing the consistency and efficiency of the sterilization effect. This helps ensure that the sample being tested is fully exposed to the sterilant, improving the reliability and effectiveness of the sterilization process.

[0017] Furthermore, a sealing ring is provided at the point where the internal isolation door contacts the first compartment. This prevents gas leakage and contamination spread, controls environmental conditions, and enhances device safety. This helps improve the performance and reliability of the gas sterilization resistance detection device.

[0018] Furthermore, the outer sealed door is opened and locked by a locking device. Opening and locking the outer sealed door by the locking device provides tightness, restricts access, enhances security, and provides operational control. This helps ensure the proper operation and safety of the gas sterilization resistance detection device during the zero-rise period of gas concentration.

[0019] Furthermore, a sealing ring is provided where the outer sealing door contacts the first compartment. This prevents gas leakage and contamination spread, provides mechanical stability, reduces noise and vibration, and enhances device safety. This helps maintain the stability, reliability, and safety of the equipment.

[0020] Furthermore, the inner surface of the second chamber is sprayed with PTFE. This treatment provides a non-stick surface, corrosion resistance, ease of cleaning, high-temperature resistance, and excellent physical properties. This helps improve the performance, reliability, and service life of the equipment, and facilitates cleaning and maintenance.

[0021] Furthermore, the drive mechanism is a pneumatic, electric, or hydraulic cylinder. Selecting a pneumatic, electric, or hydraulic cylinder as the drive mechanism allows for motion control, power transmission, programmability, feedback control, and energy selection. This helps ensure accurate operation, reliability, and adaptability of the device, meeting the requirements of a gas sterilization resistance detection device with a zero gas concentration rise period.

[0022] Furthermore, the sample holder includes multiple fixing rods, each with positioning grooves spaced evenly along its length. These positioning grooves help locate and evenly distribute samples, prevent sample movement, and facilitate operation and sample identification. This helps ensure test accuracy, reliability, and consistency, while simplifying sample handling.

[0023] Furthermore, the first and second compartments are aligned. This aligning of the first and second compartments simplifies operation, saves space, facilitates maintenance, improves data accuracy, and ensures process consistency. This helps improve the availability, efficiency, and ease of operation of the equipment.

[0024] A method for detecting a zero-rise period gas sterilization resistance device is used to detect the sterilization effect of hydrogen peroxide using the above-mentioned gas concentration zero-rise period gas sterilization resistance detection device, specifically comprising the following steps S00: placing a test indicator into a first cabin, mounting a sample to be tested on a sample holder, closing an outer sealing door, and keeping the inner isolation door closed; and simultaneously pre-preparing a test sterilization medium in a second cabin;

[0025] S10, after the second cabin reaches the test condition, the internal isolation door is opened by the driving mechanism so that the sample holder and the sample to be tested are located in the second cabin;

[0026] S20, real-time monitoring of the hydrogen peroxide concentration and temperature in the second cabin;

[0027] S30, after the test is completed, the internal isolation door is closed by the driving mechanism, so that the sample holder and the sample to be tested are located in the first chamber, and the hydrogen peroxide in the first chamber and on the surface of the indicator is removed;

[0028] S40, open the outer sealed door and take out the sample holder and the sample to be tested, and complete the test.

[0029] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention places the test indicator in the first compartment and can quickly transfer it to the second compartment by opening the internal isolation door through a driving mechanism, thereby achieving zero-rise period sterilization while maintaining the concentration and temperature consistent with those in the first compartment; and after the test is completed, the sample is transferred to the first compartment through the internal isolation door, and the test sample can be recovered after only the residue in the first compartment is drained (the hydrogen peroxide in the first compartment and on the surface of the indicator is removed), which makes the operation more convenient;

[0030] 2. This application integrates atomization and vaporization into one, which can cover the entire range of vapor phase sterilization. The second cabin can also produce both normal pressure and negative pressure environments.

[0031] 3. The internal isolation door of the present application can be opened and closed quickly and stably through a driving mechanism, ensuring that the first cabin is placed and the second cabin is tested, and the internal isolation door can effectively isolate the first cabin and the second cabin, and ensure that the first cabin and the second cabin are independent spaces. In this way, the test sterilization medium can be pre-made separately in the second cabin, and the sample can be placed in the first cabin. When the second cabin reaches the test conditions, that is, the gaseous hydrogen peroxide is stable in the second cabin, the internal isolation door opens, and the indicator to be tested enters the second cabin from the first cabin for sterilization. Because there is no gas flow problem, theoretically there is no process for the gas concentration to rise from zero to the target concentration. Therefore, the concentration rise time can basically be considered to be 0s, which is the true gas concentration zero rise period. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is a schematic diagram of the structure of this application;

[0033] Figure 2 is a perspective view of the present application;

[0034] Figure 3 It is a diagram of the internal structure of this application;

[0035] Figure 4 It is a cross-sectional view of this application.

[0036] In the figure, 1. first cabin; 2. second cabin; 3. internal isolation door; 4. driving mechanism; 5. sample holder; 6. atomizing device; 7. vaporizing device; 8. hydrogen peroxide sensor; 9. temperature sensor; 10. fan; 11. external sealing door; 12. locking device. DETAILED DESCRIPTION

[0037] The following will be combined with the accompanying drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field are within the scope of protection of this application.

[0038] Those skilled in the art should understand that, in the disclosure of this application, the terms "longitudinal", "transverse", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the above terms cannot be understood as limiting this application.

[0039] Example 1

[0040] like Figure 1-4 As shown, the gas sterilization resistance detection device for the zero-rise period of gas concentration includes:

[0041] The first cabin 1 is provided with an outer sealing door 11 for placing the test indicator and the sample to be tested;

[0042] In this embodiment, the size of the first cabin 1 is smaller than that of the second cabin 2 (that is, the first cabin 1 can be called a small cabin, and the second cabin 2 can be called a large cabin). The two cabins are located in the same straight line, and the first cabin 1 and the second cabin 2 can be customized according to a special proportion. The setting of the first cabin 1 can enable the opening and loading of the carrier (carrying the sample) to be completed in the small cabin, which can shorten the time for the sample to eliminate residual disinfectant and the time for the cabin to stabilize.

[0043] Preferably, the outer sealed door 11 is opened and closed by a locking device 12, and a sealing ring is provided at the point where the outer sealed door 11 contacts the first cabin 1. The locking device 12 is a conventional lock, and may be provided with reinforcing ribs for increased strength and aesthetics. The specific structure is not limited, but the purpose is to enable rapid opening, closing, and locking, and its principle and structure are not further described here.

[0044] The second cabin 2 is connected to the first cabin 1 and is used for sterilization testing;

[0045] In this embodiment, the inner surface of the second cabin 2 is sprayed with PTFE (polytetrafluoroethylene) to avoid the decomposition of hydrogen peroxide and ensure the decomposition and adsorption of hydrogen peroxide during the test. Among them, polytetrafluoroethylene (PTFE) is a synthetic polymer with high chemical stability and corrosion resistance. It exhibits excellent performance in high temperature and chemical environment, and is therefore widely used in non-stick coatings, seals, insulating materials, etc. Hydrogen peroxide (H2O2) is a strong oxidant with strong oxidizing and corrosive properties. If under certain conditions, hydrogen peroxide comes into contact with inappropriate materials, it may trigger a decomposition reaction and release oxygen, leading to a dangerous situation. The chemical stability of PTFE enables it to withstand the decomposition reaction of hydrogen peroxide. Therefore, in some cases, applying PTFE to the inner surface coating can effectively avoid the problem of hydrogen peroxide decomposition.

[0046] Of course, other materials that can achieve the same effect may also be used, such as polyimide coatings and fluorinated polymer coatings.

[0047] The internal isolation door 3 is provided between the first cabin 1 and the second cabin 2 and is driven by the driving mechanism 4 to realize the on-off control between the first cabin 1 and the second cabin 2;

[0048] In this embodiment, a sealing ring is installed at the point where the internal isolation door 3 contacts the first compartment 1, secured by a sealing ring pressure plate. The drive mechanism 4 is a pneumatic, electric, or hydraulic cylinder. This preferably utilizes the advantages of a pneumatic or electric cylinder for rapid actuation, ensuring independent sealing of the large and small compartments, and guaranteeing safety and reliability.

[0049] The sample holder 5 is detachably connected to the internal isolation door 3 and can be moved into the second cabin 2 along with the internal isolation door 3 so that the sample to be tested enters the second cabin 2 for testing;

[0050] In this embodiment, the sample holder 5 includes a plurality of fixing rods, each of which is provided with positioning grooves evenly spaced along the length of the fixing rod. The sample can be loaded on a carrier, which is fixed to the fixing rod via the positioning grooves.

[0051] an atomizing device 6 , provided on the second cabin 2 , for atomizing hydrogen peroxide and spraying it into the second cabin 2 ;

[0052] A vaporizing device 7 is provided on the second cabin 2 and is used to vaporize hydrogen peroxide and transport it into the second cabin 2;

[0053] In this embodiment, the specific structures and principles of the atomizing device 6 and the vaporizing device 7 are based on the existing technology. This application integrates the functions of atomizing and vaporizing on the premise of separating the large and small cabins.

[0054] A hydrogen peroxide sensor 8 is provided on the second cabin 2 and is used to monitor the concentration of hydrogen peroxide in the second cabin 2 in real time;

[0055] In this embodiment, it is inserted into the second compartment 2 .

[0056] The temperature sensor 9 is provided in the second cabin 2 and is used to detect the temperature of each point in the second cabin 2 in real time;

[0057] In this embodiment, the temperature sensors 9 are located at different points, and are specifically commercially available products, and their specific principles and structures will not be described in detail here.

[0058] The fan 10 is disposed in the second cabin 2 and is used to accelerate the flow of the fluid in the second cabin 2, thereby achieving a stirring effect.

[0059] In this embodiment, the built-in fan 10 ensures better sterilization uniformity in the cabin. Multiple fans 10 can also be provided to achieve a better stirring effect.

[0060] Example 2

[0061] The method for detecting the gas sterilization resistance device with zero rise period is used to detect the sterilization effect of hydrogen peroxide using the gas sterilization resistance detection device with zero rise period of gas concentration of embodiment 1, and specifically comprises the following steps:

[0062] S00. Place the test indicator into the first cabin 1, install the sample to be tested on the sample holder 5, close the outer sealing door 11, and keep the inner isolation door 3 closed; at the same time, pre-prepare the test sterilization medium in the second cabin 2;

[0063] Among them, the pre-test sterilization medium is basically a process of heating, vacuum emptying and concentration testing to ensure that it can be tested under a stable state.

[0064] For example, the general steps for vaporizing pre-test sterilization media are:

[0065] First, all heaters on the surface of the second cabin 2 (existing equipment), external environment PTC heaters (existing equipment), and circulating fans 10 start working to heat up the system. During this period, the vacuum pump works intermittently to vacuum and empty the second cabin 2, the first cabin 1 and all connecting pipes multiple times to promote temperature stability.

[0066] When the system temperature stabilizes at 50°C, the heating rod in the vaporizer chamber of vaporizer 7 begins operating, rapidly raising the temperature to a stable 90°C. At this point, the entire system is ready for testing. The host control system sets parameters such as the concentration test time and initiates the test. The vacuum pump evacuates the second chamber 2 while closing all valves connecting to the first chamber 1. The peristaltic pump in vaporizer 7 begins injecting a specified amount of liquid hydrogen peroxide into the pre-stored tank. When the pressure in the second chamber 2 reaches the set value, the vacuum system stops operating and all connecting valves close to ensure stable pressure. Vaporizer 7 opens the liquid inlet solenoid valve. Under pressure, the liquid peroxide in the pre-stored tank is drawn into the high-temperature vaporizer chamber and instantly vaporizes into the second chamber 2. After vaporization is complete, the vaporizer system's liquid inlet solenoid valve closes. Once the hydrogen peroxide concentration in the second chamber 2 stabilizes, the indicator can be added for testing.

[0067] The principle of atomized prefabricated test sterilization medium is similar, but the steps are different. They are all routine operations, so the steps are detailed here.

[0068] S10, after the second cabin 2 reaches the test condition, the internal isolation door 3 is opened by the driving mechanism 4, so that the sample holder 5 and the sample to be tested are located in the second cabin 2;

[0069] S20, real-time monitoring of the hydrogen peroxide concentration and temperature in the second cabin 2;

[0070] S30: After the test is completed, the internal isolation door 3 is closed by the driving mechanism 4, so that the sample holder 5 and the sample to be tested are located in the first chamber 1, and the hydrogen peroxide in the first chamber and on the surface of the indicator is removed;

[0071] S40, open the outer sealing door 11, take out the sample holder 5 and the sample to be tested, and complete the test.

[0072] The parts not described in detail in this application are prior art, so this application does not describe them in detail.

[0073] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the elements may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0074] Although this document frequently uses terms such as first chamber 1, second chamber 2, internal isolation door 3, drive mechanism 4, sample holder 5, atomization device 6, vaporization device 7, hydrogen peroxide sensor 8, temperature sensor 9, fan 10, outer sealing door 11, and locking device 12, the use of other terms is not excluded. These terms are used solely to more conveniently describe and explain the essence of this application; interpreting them as any additional limitations is contrary to the spirit of this application.

[0075] This application is not limited to the above-mentioned optimal implementation method. Anyone can derive various other forms of products based on the inspiration of this application. However, no matter what changes are made in their shape or structure, any technical solution that is the same or similar to that of this application falls within the scope of protection of this application.

Claims

1. A gas sterilization resistance detection device for a zero-rise period of gas concentration, characterized in that: include: The first cabin is provided with an outer sealed door and is used to place the test indicator and the sample to be tested; a second cabin, connected to the first cabin, for performing a sterilization test; An internal isolation door is provided between the first cabin and the second cabin, and is driven by a driving mechanism to realize on-off control between the first cabin and the second cabin; a sample holder, detachably connected to the internal isolation door, capable of moving from the first cabin to the second cabin along with the internal isolation door, so that the sample to be tested enters the second cabin for sterilization testing; After the sterilization test, the sample holder can be moved from the second cabin to the first cabin along with the internal isolation door to remove the hydrogen peroxide in the first cabin and on the surface of the indicator; an atomizing device, provided on the second cabin, for atomizing hydrogen peroxide and spraying it into the second cabin; a vaporizing device, provided on the second cabin, for vaporizing hydrogen peroxide and transporting it into the second cabin; a hydrogen peroxide sensor, provided on the second cabin, for monitoring the concentration of hydrogen peroxide in the second cabin in real time; The temperature sensor is arranged in the second cabin and is used to detect the temperature of each point in the second cabin in real time.

2. The gas sterilization resistance detection device with zero gas concentration rise period according to claim 1, characterized in that: It also includes a fan, which is arranged in the second cabin.

3. The gas sterilization resistance detection device with zero gas concentration rise period according to claim 1, characterized in that: A sealing ring is provided at the position where the internal isolation door contacts the first cabin body.

4. The gas sterilization resistance detection device with zero gas concentration rise period according to claim 1, characterized in that: The outer sealed door is opened, closed and locked by a locking device.

5. The gas sterilization resistance detection device in the zero-rise period of gas concentration according to claim 4, characterized in that: A sealing ring is provided at the position where the outer sealing door contacts the first cabin body.

6. The gas sterilization resistance detection device with zero gas concentration rise period according to claim 1, characterized in that: The inner surface of the second cabin is sprayed with PTFE.

7. The gas sterilization resistance detection device in the zero-rise period of gas concentration according to claim 1, characterized in that: The driving mechanism is a pneumatic cylinder, an electric cylinder or a hydraulic cylinder.

8. The gas sterilization resistance detection device in the zero-rise period of gas concentration according to any one of claims 1 to 7, characterized in that: The sample holder comprises a plurality of fixing rods, each of which is provided with positioning grooves evenly spaced along the length direction of the fixing rod.

9. The gas sterilization resistance detection device in the zero-rise period of gas concentration according to any one of claims 1 to 7, characterized in that: The first cabin body and the second cabin body are located on the same straight line.

10. A method for detecting a zero-rise period gas sterilization resistance device, characterized in that: The method is used to detect the sterilization effect of hydrogen peroxide by using the gas sterilization resistance detection device in the zero-rise period of gas concentration according to any one of claims 1 to 9, specifically comprising the following steps: S00. Place the test indicator in the first chamber, install the sample to be tested on the sample holder, close the outer sealing door, and keep the inner isolation door closed; at the same time, pre-prepare the test sterilization medium in the second chamber; S10, after the second cabin reaches the test condition, the internal isolation door is opened by the driving mechanism so that the sample holder and the sample to be tested are located in the second cabin; S20, real-time monitoring of the hydrogen peroxide concentration and temperature in the second cabin; S30, after the test is completed, the internal isolation door is closed by the driving mechanism, so that the sample holder and the sample to be tested are located in the first chamber, and the hydrogen peroxide in the first chamber and on the surface of the indicator is removed; S40, open the outer sealed door and take out the sample holder and the sample to be tested, and complete the test.

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