Aerosol challenge instrument
By designing an aerosol challenger including sealed chambers, aerosol generators and air source pump systems, the problem that the prior art cannot directly test the performance of microbial barriers at the seals of the multi-dose eye drop bottle packaging system is solved, and aerosol challenge experiments with high accuracy and repeatability are achieved.
Patent Information
- Application Number
- CN202421824869.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-07-30
- Publication Date
- 2025-06-06
- Estimated Expiration
- 2034-07-30
AI Technical Summary
The prior art cannot directly test the microbial barrier performance at the sealed area of the multi-dose eye drop bottle packaging system, and the aerosol challenger cannot achieve real-time testing of aerosol concentration and opening and closing of the sprayer, which affects the accuracy and repeatability of the experimental results.
An aerosol challenger was designed, including a sealed compartment, an aerosol generator, a first gas source pump, a capsule high-efficiency filter and a second gas source pump. These components were used to achieve aerosol challenge tests under vacuum or pressurized states in the sealed compartment, and aerosol concentration and test conditions were controlled through the capsule high-efficiency filter and gas source pump system.
Direct testing of the performance of microbial barriers at the seal of the packaging system is achieved, ensuring the accuracy and repeatability of the test results, and being able to simulate pressure changes during actual storage and transportation, enhancing the rigor and sensitivity of the experiment.
Smart Images
Figure CN222948330U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical device performance testing, in particular to an aerosol challenge instrument. Background Art
[0002] Due to the large packaging volume, multi-dose eye drops are usually used for 20-30 days. During repeated use, microbial contamination is prone to occur. In order to maintain the sterility of the drug and extend the shelf life of the drug after opening, multi-dose eye drops mostly use preservatives to inhibit the growth of microorganisms in the sample. It is well known that preservatives are cytotoxic to the surface of the eye and may cause eye damage. The side effects of preservatives have always been a problem that manufacturers and users are concerned about. Over the years, the risk of side effects of preservatives in topical medication formulations has been widely concerned, and preservative-free is gradually developing into a trend for topical medication. The physical bacteria-blocking system of multi-dose eye drop bottles uses physical methods to block bacteria without adding preservatives, which can maintain the sterility of multi-dose eye drops without the side effects of preservatives.
[0003] The physical bacteria-blocking system of multi-dose eye drop bottles is a multiple-volume container that uses a physical barrier to block microbial contamination of the contents. It has a liquid channel and a return air channel. The liquid channel uses a loaded spring to control the sealing of the drop hole, so that the liquid and contaminated liquid cannot flow back; the return air channel uses a sterile filter element to filter the air to prevent microorganisms from entering the package through the return air channel.
[0004] The multi-dose eye drop bottle with a physical bacteria barrier system is a new type of eye drop packaging. Although eye drops are external medications, they are directly applied to the eyes and are high-risk local medications. The sterility requirements for them have always been the same as those for injections. The biggest risk of its physical bacteria barrier system is that microorganisms contaminate the liquid channel and the return air channel during use. Therefore, the bacteria barrier performance of the liquid channel and the return air channel of the multi-dose eye drop bottle to ensure that there is no microbial invasion inside the package is the key performance of the physical bacteria barrier system of the multi-dose eye drop bottle.
[0005] The sealing of the packaging system, also known as the container sealing integrity, refers to the ability of the packaging system to prevent the loss of contents, the invasion of microorganisms, and the entry of gases (oxygen, air, water vapor, etc.) or other substances, to ensure that the drug continues to meet safety and quality requirements. Leakage of sterile drug and medical device packaging systems and contamination of contents by microorganisms will pose a major risk to patients' medication safety. Foreign drug regulatory agencies have successively issued standards and specifications requiring that sterile drug packaging systems should be able to ensure the sterility of products within the shelf life, and the sealing of sterile drug packaging systems is increasingly becoming its key quality attribute. In the prior art, the test of the sealing of the packaging system of multi-dose eye drop bottles is to use an instrument to generate a pressure difference between the inside and outside of the sample by vacuuming, thereby observing the gas escape and shape recovery of the sample, and then judging the sealing performance of the sample. The disadvantage is that it is impossible to directly test the microbial barrier performance of the seal, but only the physical strength of the seal is tested.
[0006] Microbial challenge method plays a key role in the study of the sealing of packaging systems. The container sealing system of sterile products should be able to prevent microbial invasion. When direct evidence of the ability to prevent microbial invasion is needed, microbial challenge testing is most useful. The aerosol challenge method is to place the packaging system in a challenge instrument containing a specific concentration of microbial aerosol for a certain period of time. The challenge instrument is a sealed system that can set vacuum and pressurization test conditions to simulate the pressure changes that the packaging system may encounter during actual storage and transportation. The package contains liquid or solid culture medium. After the challenge, culture and observe whether there is microbial growth in the culture medium. Ordinary aerosol challenge boxes cannot be manually operated during the aerosol challenge process. Once the aerosol challenge test begins, each bottle of sample needs to be replaced after the test, so the aerosol challenge box needs to be equipped with sealed gloves for operation. Existing aerosol challenge instruments cannot realize real-time testing of aerosol concentration and the opening and closing of the sprayer, and cannot guarantee the stability of aerosol concentration, which affects the accuracy and repeatability of the experimental results.
[0007] There is currently no aerosol challenge device in the prior art that can perform aerosol challenge experiments on multi-dose eye drop bottles. Utility Model Content
[0008] The purpose of the utility model is to solve the technical problems existing in the prior art and provide an aerosol challenge instrument. The utility model first completes the construction of a test device, which can form a test device for testing the physical bacteria barrier system of a multi-dose eye drop bottle, thereby forming material conditions for subsequent product testing.
[0009] To achieve the above-mentioned purpose, the utility model adopts the following technical scheme: an aerosol challenge instrument, comprising a sealed cabin, an aerosol generator, a first air source pump, a capsule high-efficiency filter and a second air source pump, the sealed cabin is provided with a first sealed door and / or a second sealed door, the first sealed door is completely sealed, the second sealed door is equipped with safety gloves, and the sealed cabin is used for microbial challenge test of test samples; the aerosol generator is used to generate microbial aerosol, and one end of the aerosol generator is connected to the top of the sealed cabin; one end of the first air source pump is connected to the other end of the aerosol generator, and the other end of the first air source pump is connected to the bottom of the sealed cabin, and gas is taken out from the sealed cabin to generate the air source for aerosol, and the first air source pump transports the aerosol generated by the aerosol generator into the sealed cabin; the capsule high-efficiency filter is used to filter and clean the gas entering and leaving the sealed cabin, and one end of the capsule high-efficiency filter is connected to the sealed The top of the cabin is internally connected, one end of the second air source pump is connected to the other end of the capsule high efficiency filter, and the other end of the second air source pump is connected to the bottom of the sealed cabin. The second air source pump is used for vacuuming and pressurizing the sealed cabin; the top of the sealed cabin is also connected to the third pipe, and the bottom of the sealed cabin is also connected to the fourth pipe. The third pipe and the fourth pipe are both provided with a third valve. The fourth pipe is connected to a sampling instrument or a particle counter. The sampling instrument is an air microbial sampler. The third pipe is connected to the filter. The third pipe is used for sampling the inlet pipe, and the fourth pipe is used for sampling the outlet pipe. Under normal pressure, the running time of the aerosol generator and the generated microbial aerosol particles, as well as the time that the concentration of the microbial aerosol can be maintained are verified. At this time, sampling is performed using the sampling port, and the sampling instrument or the particle counter collects microbial aerosols from the sealed cabin through the sampling outlet. The sampling inlet, in order to maintain the air pressure balance of the sealed cabin, can open the valve when the instrument is used at normal pressure, and is connected to the pipeline with a filter; a pressure sensor is arranged on the top of the sealed cabin, and the pressure sensor is used to measure the pressure in the sealed cabin; a stacking bracket is also arranged inside the sealed cabin, and the stacking bracket is used to place the test samples, which are stacked according to the sample size and can be applied to samples of different volumes; a fan is arranged at the bottom of the sealed cabin, and a temperature sensor is also arranged in the sealed cabin, and the fan is used to ensure the uniformity of the microbial aerosol and the repeatability and accuracy of the test results; the top of the sealed cabin is also connected to the first safety valve and the second safety valve, the first safety valve is a positive pressure relief valve, and the second safety valve is a negative pressure safety valve, and the first safety valve and the second safety valve are used for safe pressure relief to avoid excessive pressure in the sealed cabin and potential safety hazards. When the pressure exceeds a certain set pressure of the sealed cabin, the first safety valve and the second safety valve are opened to release the pressure.
[0010] A further solution of the utility model is that the aerosol generator is connected to the sealed cabin via a second pipeline, and a second valve is provided on the second pipeline; the aerosol generator is connected to the first air source pump via an eighth pipeline, and a first flow controller is provided on the eighth pipeline; the first air source pump is connected to the sealed cabin via a fifth pipeline, and a fifth valve is provided on the fifth pipeline.
[0011] A further solution of the utility model is that the capsule high efficiency filter is connected to the sealed cabin through a first pipeline, and a first valve is arranged on the first pipeline; the capsule high efficiency filter is connected to the sealed cabin through a sixth pipeline, and a second flow controller, a seventh valve and a sixth valve are arranged on the sixth pipeline in sequence; the second air source pump is connected in parallel with the seventh valve; a first branch pipe connected to the outside is also arranged on the first pipeline, a fourth valve is arranged on the first branch pipe, a second branch pipe connected to the outside is arranged between the node where the sixth valve is connected in parallel with the seventh valve and the second air source pump on the sixth pipeline, and the An eighth valve is provided on the second branch pipe; when pressurizing, the eighth valve of the second branch pipe is opened, the second air source pump is turned on, the pressurization size is controlled by the second flow controller, and the external air source opens the first valve after passing through the capsule-type high-efficiency filter to enter the sealed cabin; when vacuuming, the sixth valve is opened, the second air source pump is turned on, the vacuuming size is controlled by the second flow controller, and the internal air source passes through the capsule-type high-efficiency filter, and the fourth valve is opened to discharge out of the sealed cabin; when quickly releasing pressure, the sixth valve is locked, the seventh valve is opened, the pressure relief size is controlled by the second flow controller, and the internal air source passes through the capsule-type high-efficiency filter, and the fourth valve is opened to directly discharge out of the sealed cabin.
[0012] A further solution of the utility model is that the first sealing door and the sealing cabin are fixed by a sealing hand wheel.
[0013] A further solution of the utility model is that the second sealing door is fixed to the sealing cabin by screws.
[0014] A further solution of the utility model is that a distribution box is arranged on the side of the sealed cabin, and a display screen control system is arranged on the top of the distribution box.
[0015] A further solution of the utility model is that the pressure sensor, the first flow controller, the second flow controller, the first valve, the second valve, the fourth valve, the fifth valve, the sixth valve, the seventh valve and the eighth valve are all communicatively connected with the display screen control system, and the display screen control system obtains the pressure data of the pressure sensor, the flow data of the first flow controller and the second flow controller and controls the opening and closing of each valve.
[0016] A further solution of the utility model is that casters are arranged at the bottom of the sealed cabin and the distribution box.
[0017] Through the above technical scheme, the sterilized and dried test sample is first placed in a sealed cabin, and the sealed cabin is closed; then a capsule high-efficiency filter is used to flush the sealed cabin; the test parameters are set on the control panel of the sealed cabin, including the operation cycle of the aerosol generator (during the instrument verification, confirm the aerosol concentration generated by the cyclic operation of the aerosol generator and the time the aerosol can maintain this concentration), the test vacuum pressure and maintenance time, the test pressurization and maintenance time, the test normal pressure and maintenance time, then, the test is run, the aerosol generator generates microbial aerosol and transports it to the sealed cabin; the air source pump performs vacuum or pressurization treatment, etc.
[0018] Compared with the prior art, the beneficial effects of the utility model are:
[0019] The utility model provides an aerosol challenge instrument. By designing a first sealing door and a second sealing door, the first sealing door can realize an aerosol challenge test in a highly sealed state of vacuum or pressurization, and the second sealing door can realize an aerosol challenge test in a relatively well sealed state; the generation and transportation of aerosols are realized by a first air source pump and its pipeline, the severity of test conditions is increased, and the sensitivity of the test method is increased; the vacuuming, pressurization and rapid pressure relief functions in a sealed cabin are realized by a second air source pump and its pipeline, the test conditions of vacuuming and pressurization can be set, and the pressure changes that may be encountered by a packaging system during actual storage and transportation are simulated; by setting a pressure sensor, when the pressure value deviates from the set value, the central control system controls the air source pump to maintain the stability of the pressure; the sampling inlet and the sampling outlet are connected with a sampling instrument or a particle counter to realize the operation time of the aerosol generator, the generated microbial aerosol particles, and the time that the concentration of the microbial aerosol can be maintained under normal pressure. The aerosol challenge instrument can also be used for the integrity test of the sterile barrier system of sterile breathable packaging such as medicines, foods, and sterilization wraps of medical institutions. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.
[0021] Figure 1 The overall structure of the aerosol challenge instrument of the utility model is three-dimensional Figure 1 ;
[0022] Figure 2The overall structure of the aerosol challenge instrument of the utility model is three-dimensional Figure 2 ;
[0023] Figure 3 The internal structure of the aerosol challenger of the utility model is shown in FIG. Figure 1 ;
[0024] Figure 4 The internal structure of the aerosol challenger of the utility model is shown in FIG. Figure 2 ;
[0025] Figure 5 The internal structure of the aerosol challenger of the utility model is shown in FIG. Figure 3 ;
[0026] Figure 6 This is a schematic diagram of the installation of the second sealing door of the aerosol challenger of the utility model;
[0027] Figure 7 This is a schematic diagram of pipeline connection of the testing device of the utility model.
[0028] In the figure: 1, sealed cabin, 2, distribution box, 3, casters, 4, first sealed door, 5, sealed handwheel, 6, display screen control system, 7, aerosol generator, 8, pressure sensor, 9, first pipeline, 10, second pipeline, 11, third pipeline, 12, fourth pipeline, 13, first safety valve, 14, second safety valve, 15, third valve, 16, second valve, 17, first valve, 18, first branch pipeline, 19, fourth valve, 20, capsule high efficiency filter, 21, first air source pump, 22, second air source pump, 23, fifth pipeline, 24, sixth pipeline, 25, fifth valve, 26, sixth valve, 27, seventh pipeline, 28, eighth pipeline, 29, seventh valve, 30, second branch pipe, 31, eighth valve, 32, second flow controller, 33, first flow controller, 34, stacking bracket, 35, temperature sensor, 36, fan, 37, second sealed door, 38, safety gloves. DETAILED DESCRIPTION
[0029] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.
[0030] Example 1
[0031] like Figure 1-7As shown, an aerosol challenge instrument includes a sealed cabin 1, an aerosol generator 7, a first air source pump 21, a capsule high efficiency filter 20 and a second air source pump 22.
[0032] The sealed cabin 1 is provided with a first sealed door 4. Specifically, the first sealed door 4 and the sealed cabin 1 are fixed by a sealing handwheel. The first sealed door 4 is completely sealed. The sealed cabin 1 is used for microbial challenge tests of test samples.
[0033] The aerosol generator 7 is used to generate microbial aerosols, and one end of the aerosol generator 7 is connected to the top of the sealed cabin 1; one end of the first air source pump 21 is connected to the other end of the aerosol generator 7, and the other end of the first air source pump 21 is connected to the bottom of the sealed cabin 1, and gas is taken out from the sealed cabin 1 to be used as the gas source for aerosol generation. The first air source pump 21 transports the aerosol generated by the aerosol generator 7 into the sealed cabin 1. A further solution of the utility model is that the aerosol generator 7 is connected to the sealed cabin 1 through a second pipeline 10, and a second valve 16 is provided on the second pipeline 10; the aerosol generator 7 is connected to the first air source pump 21 through an eighth pipeline 28, and a first flow controller 33 is provided on the eighth pipeline 28; the first air source pump 21 is connected to the sealed cabin 1 through a fifth pipeline 23, and a fifth valve 25 is provided on the fifth pipeline 23.
[0034] The capsule high-efficiency filter 20 is used for filtering and cleaning the gas entering and leaving the sealed cabin 1. One end of the capsule high-efficiency filter 20 is connected to the top interior of the sealed cabin 1. One end of the second air source pump 22 is connected to the other end of the capsule high-efficiency filter 20. The other end of the second air source pump 22 is connected to the bottom interior of the sealed cabin 1. The second air source pump 22 is used for vacuuming and pressurizing the sealed cabin 1. A further solution of the utility model is that the capsule high efficiency filter 20 is connected to the sealed cabin 1 through a first pipeline 9, and a first valve 17 is provided on the first pipeline 9; the capsule high efficiency filter 20 is connected to the sealed cabin 1 through a sixth pipeline 24, and a second flow controller 32, a seventh valve 29 and a sixth valve 26 are sequentially provided on the sixth pipeline 24; the second air source pump 22 is connected in parallel with the seventh valve 29; the first pipeline 9 is also provided with a first branch pipe 18 connected to the outside, and a fourth valve 19 is provided on the first branch pipe 18, and a second branch pipe 30 connected to the outside is provided between the node where the sixth valve 26 is connected in parallel with the seventh valve 29 and the second air source pump 22 on the sixth pipeline 24, The second branch pipe 30 is provided with an eighth valve 31; when pressurizing, the eighth valve 31 of the second branch pipe 30 is opened, the second air source pump 22 is turned on, and the pressurization size is controlled by the second flow controller 32. The external air source opens the first valve 17 after passing through the capsule-type high-efficiency filter 20 to enter the sealed cabin 1; when vacuuming, the sixth valve 26 is opened, the second air source pump 22 is turned on, and the vacuuming size is controlled by the second flow controller 32. After the internal air source passes through the capsule-type high-efficiency filter 20, the fourth valve 19 is opened to discharge the air out of the sealed cabin 1; when quickly releasing pressure, the sixth valve 26 is locked, the seventh valve 29 is opened, and the pressure relief size is controlled by the second flow controller 32. After the internal air source passes through the capsule-type high-efficiency filter 20, the fourth valve 19 is opened to discharge the air out of the sealed cabin 1 directly.
[0035] like Figure 2As shown, the top of the sealed cabin 1 is also connected to the third pipe 11, and the bottom of the sealed cabin 1 is also connected to the fourth pipe 12. The third pipe 11 and the fourth pipe 12 are both provided with a third valve 15. The fourth pipe 12 is connected to a sampling instrument or a particle counter, and the third pipe 11 is connected to a filter. The sampling instrument is an air microbial sampler, and the filter is a disposable consumable. The air microbial sampler, the filter and the particle counter are all prior art. The third pipe 11 is used for sampling the inlet pipe, and the fourth pipe 12 is used for sampling the outlet pipe. Under normal pressure, the operation time of the aerosol generator 7 and the generated microbial aerosol particles, as well as the time that the concentration of the microbial aerosol can be maintained are verified. At this time, sampling is performed using the sampling port, and the sampling instrument or the particle counter collects the microbial aerosol from the sealed cabin 1 through the sampling outlet. The sampling inlet, in order to maintain the air pressure balance of the sealed cabin 1, can open the valve when the instrument is used at normal pressure, and the pipeline with the filter is connected.
[0036] like Figure 3 As shown, a pressure sensor 8 is provided on the top of the sealed cabin 1, and the pressure sensor 8 is used to measure the pressure in the sealed cabin 1; a stacking bracket 34 is also provided inside the sealed cabin 1, and the stacking bracket 34 is used to place test samples, which are stacked according to the size of the samples and can be suitable for samples of different volumes. A fan 36 is provided at the bottom of the sealed cabin 1, and a temperature sensor 35 is also provided in the sealed cabin 1. A heater is also provided to adjust the temperature in the sealed cabin, and the fan 36 is used to ensure the uniformity of the microbial aerosol and the repeatability and accuracy of the test results.
[0037] like Figure 2 As shown, the top of the sealed cabin 1 is also connected to a first safety valve 13 and a second safety valve 14, wherein the first safety valve 13 is a positive pressure relief valve and the second safety valve 14 is a negative pressure relief valve. The first safety valve 13 and the second safety valve 14 are used for safe pressure relief to avoid excessive pressure in the sealed cabin 1 and potential safety hazards. When the pressure exceeds a certain set pressure of the sealed cabin 1, the first safety valve 13 and the second safety valve 14 are opened to relieve pressure.
[0038] A further solution of the utility model is that a distribution box 2 is provided on the side of the sealed cabin 1 , and a display screen control system 6 is provided on the top of the distribution box 2 .
[0039] The pressure sensor 8, the first flow controller 33, the second flow controller 32, the first valve 17, the second valve 16, the fourth valve 19, the fifth valve 25, the sixth valve 26, the seventh valve 29 and the eighth valve 31 are all connected to the display screen control system 6 for communication. The display screen control system 6 obtains the pressure data of the pressure sensor 8, the flow data of the first flow controller 33 and the second flow controller 32 and controls the opening and closing of each valve.
[0040] A further solution of the utility model is that casters 3 are provided at the bottom of the sealed cabin 1 and the distribution box 2 .
[0041] Example 2
[0042] This embodiment is based on embodiment 1, and a further solution is as follows: Figure 6 As shown, the sealed cabin 1 is provided with a second sealed door 37 , and the second sealed door 37 is equipped with safety gloves 38 .
[0043] The second sealing door 37 is fixed to the sealed cabin 1 by screws.
[0044] Working principle: Through the above technical solution, firstly, the sterilized and dried test sample is placed in the sealed cabin 1, the appropriate first sealed door 4 or second sealed door 37 is selected, and the sealed cabin 1 is closed; then the capsule high efficiency filter 20 is used to flush the sealed cabin 1; the test parameters are set on the control panel of the sealed cabin 1, including the operation cycle of the aerosol generator 7 (during the instrument verification, confirm the aerosol concentration generated by the cyclic operation of the aerosol generator 7 and the time the aerosol can maintain this concentration), the test vacuum pressure and maintenance time, the test pressurization and maintenance time, the test normal pressure and maintenance time, then, run the test, the aerosol generator 7 generates microbial aerosol and transports it to the sealed cabin 1; the air source pump performs vacuum or pressurization treatment, etc.
[0045] It is obvious to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, the embodiments should be regarded as exemplary and non-restrictive from any point of view, and the scope of the present invention is defined by the appended claims rather than the above description, and it is intended that all changes falling within the meaning and scope of the equivalent elements of the claims be included in the present invention. Any reference numeral in a claim should not be regarded as limiting the claim to which it relates.
Claims
1. An aerosol challenge instrument, characterized in that: The invention comprises a sealed cabin (1), an aerosol generator (7), a first air source pump (21), a capsule high efficiency filter (20) and a second air source pump (22); the sealed cabin (1) is provided with a first sealed door (4), and the first sealed door (4) is completely sealed; one end of the aerosol generator (7) is connected to the top interior of the sealed cabin (1), one end of the first air source pump (21) is connected to the other end of the aerosol generator (7), and the other end of the first air source pump (21) is connected to the bottom interior of the sealed cabin (1); one end of the capsule high efficiency filter (20) is connected to the top interior of the sealed cabin (1), one end of the second air source pump (22) is connected to the other end of the capsule high efficiency filter (20), and the second air source pump ( The other end of the valve 22 is connected to the bottom interior of the sealed cabin (1); the top interior of the sealed cabin (1) is also connected to the third pipe (11), and the bottom of the sealed cabin (1) is also connected to the fourth pipe (12). The third pipe (11) and the fourth pipe (12) are both provided with a third valve (15). The fourth pipe (12) is connected to a sampling instrument or a particle counter, and the third pipe (11) is connected to a filter; a pressure sensor (8) is provided at the top of the sealed cabin (1), a stacking bracket (34) is also provided inside the sealed cabin (1), a fan (36) is provided at the bottom of the sealed cabin (1), and a temperature sensor (35) is also provided inside the sealed cabin (1).
2. An aerosol challenge instrument according to claim 1, characterized in that: The aerosol generator (7) is connected to the sealed cabin (1) via a second pipeline (10), and a second valve (16) is provided on the second pipeline (10); the aerosol generator (7) is connected to the first air source pump (21) via an eighth pipeline (28), and a first flow controller (33) is provided on the eighth pipeline (28); the first air source pump (21) is connected to the sealed cabin (1) via a fifth pipeline (23), and a fifth valve (25) is provided on the fifth pipeline (23).
3. An aerosol challenge instrument according to claim 2, characterized in that: The capsule high-efficiency filter (20) is connected to the sealed cabin (1) via a first pipeline (9), and a first valve (17) is provided on the first pipeline (9); the capsule high-efficiency filter (20) is connected to the sealed cabin (1) via a sixth pipeline (24), and a second flow controller (32), a seventh valve (29) and a sixth valve (26) are provided on the sixth pipeline (24) in sequence; the second air source pump (22) is connected in parallel with the seventh valve (29); the first pipeline (9) is also provided with a first branch pipe (18) connected to the outside, and a fourth valve (19) is provided on the first branch pipe (18); a second branch pipe (30) connected to the outside is provided between the node where the sixth valve (26) and the seventh valve (29) are connected in parallel with the second air source pump (22) on the sixth pipeline (24), and an eighth valve (31) is provided on the second branch pipe (30).
4. An aerosol challenge instrument according to claim 3, characterized in that: The first sealing door (4) and the sealing cabin (1) are fixed via a sealing hand wheel.
5. An aerosol challenge instrument according to claim 4, characterized in that: The top of the sealed cabin (1) is also connected to a first safety valve (13) and a second safety valve (14), wherein the first safety valve (13) is a positive pressure relief valve and the second safety valve (14) is a negative pressure safety valve.
6. An aerosol challenge instrument according to claim 5, characterized in that: A distribution box (2) is arranged on the side of the sealed cabin (1), a display screen control system (6) is arranged on the top of the distribution box (2), and casters (3) are arranged on the bottom of the sealed cabin (1) and the distribution box (2).
7. An aerosol challenge instrument according to claim 6, characterized in that: The pressure sensor (8), the first flow controller (33), the second flow controller (32), the first valve (17), the second valve (16), the fourth valve (19), the fifth valve (25), the sixth valve (26), the seventh valve (29) and the eighth valve (31) are all connected to the display screen control system (6) for communication. The display screen control system (6) obtains the pressure data of the pressure sensor (8), the flow data of the first flow controller (33) and the second flow controller (32) and controls the opening and closing of each valve.
8. An aerosol challenge instrument according to any one of claims 1 to 7, characterized in that: The sealed cabin is also provided with a second sealed door (37), the second sealed door (37) is equipped with a safety glove (38), and the second sealed door (37) is fixed to the sealed cabin (1) by screws.