Detection device for evaluating effectiveness of container and package of medical instrument
By designing a detection device including a cabin, a positive and negative pressure control system, an aerosol spray system and a particle counter, the problem of sterility verification of medical device containers and packaging in dynamic environments is solved, and automated sterility verification is achieved, ensuring the safety of medical devices.
Patent Information
- Application Number
- CN202421607702.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-07-09
- Publication Date
- 2025-05-27
- Estimated Expiration
- 2034-07-09
AI Technical Summary
The rigid containers and packaging of medical devices are prone to risk of bacteria entering in dynamic environments, and the temperature difference changes during disinfection process affect the integrity of the sterile barrier system. It is difficult for the prior art to effectively verify its sterility in dynamic environments.
A detection device is designed, including a compartment, a positive and negative pressure control system, an aerosol spray system and a particle counter, which can simulate the state of a medical device container in a dynamic bacterial aerosol environment, and automatically adjust the positive and negative pressure values in the compartment to verify the sterility of the container and packaging.
It realizes automatic verification of the sterility of medical device containers and packaging in a dynamic environment, provides scientific guidance on container and packaging design, and ensures the safety of medical devices.
Smart Images
Figure CN222913046U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of detection equipment, in particular to a detection device for evaluating the effectiveness of containers and packaging of medical devices. Background Art
[0002] Poor design or improper use of rigid containers and packaging for medical devices, or rigid containers and packaging for surgical instruments that have undergone steam sterilization or cooling after high temperatures in an autoclave, changes in temperature differences in rigid containers or packaging, and transportation between departments and hospitals, can cause changes in pressure differences inside and outside the containers and packaging, leading to the risk of bacteria entering the interior of the containers and packaging. In addition, because some instruments need to be sterilized with high-pressure steam or autoclaves, during and after the sterilization process, rigid containers and packaging will experience a rapid heating and cooling process, at which point changes in temperature differences inside and outside the rigid containers or packaging will affect the integrity of their sterile barrier systems. Therefore, how to simulate medical device containers in dynamic bacterial aerosol environments, as well as dynamic environments such as packaging storage and transportation, to automatically verify the effectiveness of rigid containers and packaging for medical devices in maintaining a sterile internal environment is a technical problem that needs to be solved in this field. Utility Model Content
[0003] In view of the shortcomings of the prior art, the utility model proposes a detection device for evaluating the effectiveness of containers and packaging of medical devices, which can simulate the medical device containers in dynamic bacterial aerosol environmental conditions, as well as dynamic environments such as packaging storage and transportation, and automatically verify the effectiveness of rigid containers and packaging of medical devices in maintaining a sterile internal environment.
[0004] To realize the above technical solution, the utility model provides a detection device for evaluating the effectiveness of containers and packaging of medical devices, comprising: a cabin, a cabin door is installed on the front side of the cabin, a positive and negative pressure control system is installed on the outside of the cabin, the positive and negative pressure control system comprises a pressure sensor installed on the top of the cabin and a capsule high efficiency filter installed on the left side of the cabin, a first compressed air pump and a first flow controller, wherein the air inlet of the first compressed air pump is connected to the cabin through a pipeline, the air outlet of the first compressed air pump is connected to the air inlet of the capsule high efficiency filter through a pipeline, the air outlet of the capsule high efficiency filter is connected to the cabin through a pipeline, and the first flow controller is installed on the air outlet of the first compressed air pump. The pressure sensor is electrically connected to the first compressed air pump; an aerosol spray system is installed on the outside of the cabin, and the aerosol spray system includes an aerosol generator, a second compressed air pump and a second flow controller, the aerosol generator is installed on the top of the cabin, the second compressed air pump is installed on the left side of the cabin, the air inlet of the second compressed air pump is connected to the cabin through a pipe, the air outlet of the second compressed air pump is connected to the aerosol generator through a pipe, the second flow controller is installed on the connecting pipe between the second compressed air pump and the aerosol generator, and the air outlet of the aerosol generator extends into the cabin through a pipe; a particle counter is also installed on the top of the cabin, and the particle counter is connected to the cabin through a pipe.
[0005] Preferably, a high-pressure safety valve and a vacuum safety valve are installed on the cabin body, and the high-pressure safety valve and the vacuum safety valve are electrically connected to the first compressed air pump and the second compressed air pump.
[0006] Preferably, the capsule high efficiency filter is provided with a first air outlet and a second air outlet respectively connected to the cabin body, a second solenoid valve is installed at the first air outlet, and a fourth solenoid valve is installed at the second air outlet.
[0007] Preferably, an eighth solenoid valve is installed on the pipe connecting the air inlet of the first compressed air pump and the cabin, and the air inlet of the second compressed air pump is connected to the cabin through three pipes, and the first solenoid valve, the third solenoid valve and the fifth solenoid valve are respectively installed on the three pipes.
[0008] Preferably, the particle counter is connected to the top of the cabin through a first connecting pipe, a sixth solenoid valve is installed on the first connecting pipe, and the particle counter is connected to the right side of the cabin through a second connecting pipe, a seventh solenoid valve is installed on the second connecting pipe.
[0009] Preferably, a ninth solenoid valve is installed on the pipe connecting the air outlet of the aerosol generator and the cabin.
[0010] Preferably, temperature and humidity sensors are installed on the side walls of the cabin.
[0011] Preferably, a plurality of evenly spaced handwheel handle clamping devices are installed on the four upper, lower, left and right end edges of the hatch.
[0012] Preferably, a sample rack is installed in the cabin.
[0013] Preferably, a stirring fan is installed in the cabin.
[0014] The beneficial effects of a detection device for evaluating the effectiveness of containers and packaging of medical devices provided by the utility model are as follows: the detection device for evaluating the effectiveness of containers and packaging of medical devices has a simple structure, a reasonable design, and is easy to operate. It can simulate the medical device container under dynamic bacterial aerosol environmental conditions, as well as dynamic environments such as packaging storage and transportation, and automatically adjust the positive and negative pressure values required for the cabin experiment, and automatically verify the effectiveness of the rigid container and packaging of the medical device in maintaining a sterile internal environment. It can provide scientific guidance for the container and packaging design of medical device manufacturers, and provide a reference for standardized use for users such as hospitals. BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Figure 1 It is a three-dimensional structural schematic diagram of the utility model.
[0016] In the figure: 1. cabin; 2. cabin door; 3. sample rack; 4. temperature and humidity sensor; 5. stirring fan; 6. pressure sensor; 7. high-pressure safety valve; 8. vacuum safety valve; 9. aerosol generator; 10. particle counter; 11. capsule high-efficiency filter; 12. pipeline; 13. handwheel handle clamping device; 21. first solenoid valve; 22. second solenoid valve; 23. third solenoid valve; 24. fourth solenoid valve; 25. fifth solenoid valve; 26. sixth solenoid valve; 27. seventh solenoid valve; 28. eighth solenoid valve; 29. ninth solenoid valve; 31. first compressed air pump; 32. second compressed air pump; 41. first flow controller; 42. second flow controller. DETAILED DESCRIPTION
[0017] 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. All other embodiments obtained by ordinary personnel in this field without creative work are within the scope of protection of the utility model.
[0018] Embodiment: A detection device for evaluating the effectiveness of containers and packaging of medical devices.
[0019] Reference Figure 1As shown, a detection device for evaluating the effectiveness of containers and packaging of medical devices comprises: a cabin 1, wherein the cabin is welded with a 6 mm thick stainless steel groove to ensure air tightness and rigidity, a sample rack 3 is installed in the cabin 1, the sample rack 3 is used to place the sample to be detected, a stirring fan 5 is installed on one side of the sample rack 3, the stirring fan 5 is used to stir the gas in the cabin 1 evenly, a temperature and humidity sensor 4 is installed on the side wall of the cabin 1, and is used to monitor the temperature and humidity in the cabin 1 in real time, a cabin door 2 is installed on the front side of the cabin 1, and a plurality of evenly spaced handwheel handle clamping devices 13 are installed on the four end edges of the upper, lower, left and right sides of the cabin door 2, and the cabin 1 and the cabin door 2 are evenly locked with a high-performance sealing strip between the two through the handwheel handle clamping device 13 to ensure the sealing requirements of the cabin 1.
[0020] A positive and negative pressure control system is installed on the outside of the cabin 1, and the positive and negative pressure control system is used to adjust the pressure in the cabin 1 so as to better simulate the usage scenarios under various pressures. The positive and negative pressure control system includes a pressure sensor 6 installed on the top of the cabin 1 and a capsule high-efficiency filter 11, a first compressed air pump 31 and a first flow controller 41 installed on the left side of the cabin 1, wherein the air inlet of the first compressed air pump 31 is connected to the cabin 1 through a pipeline, and the air outlet of the first compressed air pump 31 is connected to the air inlet of the capsule high-efficiency filter 11 through a pipeline. The air outlet of the capsule high efficiency filter 11 is connected to the cabin 1 through a pipeline, the first flow controller 41 is installed on the air outlet of the first compressed air pump 31, and the pressure sensor 6 is electrically connected to the first compressed air pump 31; the capsule high efficiency filter 11 is provided with a first air outlet and a second air outlet which are respectively connected to the cabin 1, a second solenoid valve 22 is installed at the first air outlet, a fourth solenoid valve 24 is installed at the second air outlet, and an eighth solenoid valve 28 is installed on the pipeline connecting the air inlet of the first compressed air pump 31 and the cabin 1. In actual operation, the vacuum value and pressure value in the cabin 1 can be set and adjusted through the positive and negative pressure control system so as to achieve the positive and negative pressure values required for adjusting the experiments in the cabin.
[0021] An aerosol spray system is installed on the outside of the cabin 1, and the aerosol spray system is used to generate small aerosol particles in a simulated environment. The aerosol spray system includes an aerosol generator 9, a second compressed air pump 32 and a second flow controller 42. The aerosol generator 9 is installed on the top of the cabin 1, and the second compressed air pump 32 is installed on the left side of the cabin 1. The air inlet of the second compressed air pump 32 is connected to the cabin 1 through three pipes, and the first solenoid valve 21, the third solenoid valve 23 and the fifth solenoid valve 25 are installed on the three pipes respectively. The air outlet of the second compressed air pump 32 is connected to the aerosol generator 9 through a pipe, and the second flow controller 42 is installed on the connecting pipe between the second compressed air pump 32 and the aerosol generator 9. The air outlet of the aerosol generator 9 extends into the cabin 1 through a pipe, and the ninth solenoid valve 29 is installed on the pipe connecting the air outlet of the aerosol generator 9 and the cabin 1. During actual operation, the aerosol generator 9 filled with the microbial solution is installed in the configuration pipeline, the system is started, and the central processor executes according to the set program, opens the eighth solenoid valve 28 and the ninth solenoid valve 29, and then turns on the stirring fan 5, starts the second compressed air pump 32, and controls the flow rate through the second flow controller 42. The compressed air passes through the aerosol generator 9, and the aerosol generator 9 generates a microbial aerosol that enters the interior of the cabin 1 through the pipeline. The stirring fan 5 evenly distributes the microbial aerosol in the cabin 1, thereby simulating the state of the medical device container under dynamic bacterial aerosol environmental conditions, as well as dynamic environments such as packaging, storage and transportation.
[0022] A particle counter 10 is also installed on the top of the cabin 1, and the particle counter 10 is connected to the top of the cabin 1 through a first connecting pipe, and a sixth solenoid valve 26 is installed on the first connecting pipe. The particle counter 10 is connected to the right side of the cabin 1 through a second connecting pipe, and a seventh solenoid valve 27 is installed on the second connecting pipe. In actual operation, the particle counter 10 can be used to monitor the environmental conditions of bacterial aerosols in the cabin 1, so as to more accurately simulate the environmental conditions of bacterial aerosols in the medical device container in a dynamic state.
[0023] The cabin body 1 is also equipped with a high-pressure safety valve 7 and a vacuum safety valve 8, which are electrically connected to the first compressed air pump 31 and the second compressed air pump 32. The high-pressure safety valve 7 and the vacuum safety valve 8 are respectively used to ensure the safety of the cabin body 1 under high-pressure or vacuum conditions.
[0024] The working principle and specific steps of the detection device for evaluating the effectiveness of containers and packaging of medical devices are as follows:
[0025] (1) Place the sample to be tested on the sample rack 3 and close the door 2;
[0026] (2) Start the internal circulation purification, open the first solenoid valve 21 and the fourth solenoid valve 24, close the second solenoid valve 22, the third solenoid valve 23, the fifth solenoid valve 25, the eighth solenoid valve 28, and the ninth solenoid valve 29, turn on the stirring fan 5, start the first compressed air pump 31, the first flow control valve 41 controls the flow, the capsule high efficiency filter 11 filters and purifies the air in the cabin 1, open the sixth solenoid valve 26 and the seventh solenoid valve 27, start the particle counter 10, and when the particle count reaches the set value and the purification set time, close the first solenoid valve 21, the fourth solenoid valve 24, the sixth solenoid valve 26, the seventh solenoid valve 27 and the first compressed air pump 31, and the particle counter 10 stops sampling;
[0027] (3) Aerosol generation: Start the system, the central processor executes according to the set program, opens the eighth solenoid valve 28 and the ninth solenoid valve 29, turns on the stirring fan 5, starts the second compressed air pump 32, and the second flow controller 42 controls the flow. The compressed air passes through the aerosol generator 9, and the aerosol generator 9 generates a microbial aerosol that enters the interior of the cabin 1 through the pipeline. The stirring fan 5 evenly distributes the microbial aerosol in the cabin 1. When the set time is reached, the eighth solenoid valve 28 and the ninth solenoid valve 29 and the second compressed air pump 32 are closed;
[0028] (4) Vacuum control: the cabin 1 and the cabin door 2 remain closed, the first solenoid valve 21 and the second solenoid valve 22 are opened, and the other solenoid valves remain closed. The first compressed air pump 31 is started, the pressure sensor 6 monitors the pressure in the cabin 1, the first flow controller 41 controls the vacuum flow, and the capsule high-efficiency filter 11 filters the air discharged during the vacuum process. When the vacuum pressure reaches the set value, the first solenoid valve 21 and the second solenoid valve 22 and the first compressed air pump 31 are closed, and the vacuum safety valve 8 ensures the safety of the equipment during the vacuum process;
[0029] (5) Vacuum pressure relief control: the cabin 1 and the cabin door 2 remain closed, the third solenoid valve 23, the fourth solenoid valve 24 and the fifth solenoid valve 25 are opened, and the other solenoid valves remain closed. The pressure sensor 6 monitors the pressure of the cabin 1, the first flow controller 41 controls the pressure relief flow, and the capsule high efficiency filter 11 filters the air sent into the cabin 1 during the positive pressure process. When the pressure reaches the pressure relief set value, the third solenoid valve 23, the fourth solenoid valve 24 and the fifth solenoid valve 25 are closed;
[0030] (6) Positive pressure control: the cabin 1 and the cabin door 2 remain closed, the third solenoid valve 23 and the fourth solenoid valve 24 are opened, and the other solenoid valves remain closed. The first compressed air pump 31 is started, the pressure sensor 6 monitors the cabin pressure, the first flow controller 41 controls the positive pressure flow, and the capsule high efficiency filter 11 filters the air sent into the cabin 1 during the positive pressure process. When the positive pressure reaches the set value, the third solenoid valve 23, the fourth solenoid valve 24 and the first compressed air pump 31 are closed, and the positive pressure safety valve 7 ensures the safety of the equipment during the vacuum process;
[0031] (7) Positive pressure relief control: the cabin 1 and the cabin door 2 remain closed, the first solenoid valve 21, the second solenoid valve 22 and the third solenoid valve 23 are opened, and the other solenoid valves remain closed. The pressure sensor 6 monitors the cabin pressure, the first flow controller 41 controls the pressure relief flow, and the capsule high efficiency filter 11 filters the air discharged from the cabin 1 during the positive pressure process. When the pressure reaches the pressure relief set value, the first solenoid valve 21, the second solenoid valve 22 and the third solenoid valve 23 are closed;
[0032] (8) Open door 2, take out the test sample, and detect the contamination of the sample by microbial aerosol.
[0033] The utility model has the advantages of simple structure, reasonable design, convenient operation, automation of experimental process, intelligent control of bacterial aerosol environment in the device, and can simulate medical device containers under dynamic bacterial aerosol environmental conditions, as well as dynamic environments such as packaging storage and transportation, and automatically adjust the positive and negative pressure values required for the experiment in the cabin, and automatically verify the effectiveness of the rigid containers and packaging of medical devices in maintaining a sterile internal environment. It can provide scientific guidance for the container and packaging design of medical device manufacturers, and provide a reference for standardized use for users such as hospitals.
[0034] The above is only a preferred embodiment of the present invention, but the present invention should not be limited to the contents disclosed in the embodiment and the drawings, so any equivalent or modification completed without departing from the spirit disclosed in the present invention shall fall within the scope of protection of the present invention.
Claims
1. A detection device for evaluating the effectiveness of containers and packaging of medical devices, characterized in that include: A cabin, a cabin door is installed on the front side of the cabin, a positive and negative pressure control system is installed on the outside of the cabin, the positive and negative pressure control system includes a pressure sensor installed on the top of the cabin, a capsule high efficiency filter installed on the left side of the cabin, a first compressed air pump and a first flow controller, wherein the air inlet of the first compressed air pump is connected to the cabin through a pipeline, the air outlet of the first compressed air pump is connected to the air inlet of the capsule high efficiency filter through a pipeline, the air outlet of the capsule high efficiency filter is connected to the cabin through a pipeline, the first flow controller is installed on the air outlet of the first compressed air pump, the pressure sensor The device is electrically connected to the first compressed air pump; an aerosol spray system is installed outside the cabin, and the aerosol spray system includes an aerosol generator, a second compressed air pump and a second flow controller, the aerosol generator is installed on the top of the cabin, the second compressed air pump is installed on the left side of the cabin, the air inlet of the second compressed air pump is connected to the cabin through a pipeline, the air outlet of the second compressed air pump is connected to the aerosol generator through a pipeline, the second flow controller is installed on the connecting pipeline between the second compressed air pump and the aerosol generator, and the air outlet of the aerosol generator extends into the cabin through a pipeline; A particle counter is also installed on the top of the cabin, and the particle counter is connected with the cabin through a pipeline.
2. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 1, characterized in that: A high-pressure safety valve and a vacuum safety valve are installed on the cabin body, and the high-pressure safety valve and the vacuum safety valve are electrically connected to the first compressed air pump and the second compressed air pump.
3. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 2, characterized in that: The capsule high efficiency filter is provided with a first air outlet and a second air outlet which are respectively connected to the cabin body; a second solenoid valve is installed at the first air outlet, and a fourth solenoid valve is installed at the second air outlet.
4. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 3, characterized in that: The eighth solenoid valve is installed on the pipe connecting the air inlet of the first compressed air pump and the cabin body, and the air inlet of the second compressed air pump is connected to the cabin body through three pipes, and the first solenoid valve, the third solenoid valve and the fifth solenoid valve are installed on the three pipes respectively.
5. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 4, characterized in that: The particle counter is connected to the top of the cabin through a first connecting pipe, on which a sixth solenoid valve is installed. The particle counter is connected to the right side of the cabin through a second connecting pipe, on which a seventh solenoid valve is installed.
6. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 5, characterized in that: A ninth solenoid valve is installed on the pipeline connecting the air outlet of the aerosol generator and the cabin.
7. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 1, characterized in that: Temperature and humidity sensors are installed on the side walls of the cabin.
8. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 1, characterized in that: A plurality of evenly spaced hand wheel handle clamping devices are installed on the four end edges of the hatch, namely, the upper, lower, left and right sides.
9. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 1, characterized in that: A sample rack is installed in the cabin.
10. The detection device for evaluating the effectiveness of containers and packaging of medical devices according to claim 1, characterized in that: A stirring fan is installed in the cabin.