Sterility test culture device suitable for membrane filtration method

Abstract

The utility model provides a sterility test culture device applicable to a membrane filtration method, which comprises a shell, a constant-temperature culture room and a bacteria collection incubator, an information input device is arranged on one side of the shell, a display device is arranged in front of the shell, the constant-temperature culture room is arranged in the shell, and a temperature control device and an information acquisition device are arranged in the constant-temperature culture room. A liquid inlet is formed in the top end of the bacteria collecting culture device, a bacteria collecting culture device cup bottom is arranged at the bottom of the bacteria collecting culture device, a bottom sealing plug is arranged in the bacteria collecting culture device cup bottom, and a chromaticity sensor is arranged above the bottom sealing plug. And a microorganism growth state trend chart in the whole detection process can be provided.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and particularly to a sterile inspection and culture device suitable for the membrane filtration method. Background Art

[0002] The Chinese Pharmacopoeia stipulates that the membrane filtration method should be preferentially adopted if possible. The membrane filtration method is the preferred method for the sterility test.

[0003] The inoculation amount of the membrane filtration method is larger than that of the direct inoculation method, which is helpful for detecting large-volume samples; the membrane filtration method can eliminate or at least reduce the presence of compounds with antibacterial properties by rinsing, which can ensure the recovery of slowly growing microorganisms; filtering and enriching microorganisms in the sample can ensure that only live microorganisms are detected and the results are reliable. Content of the Utility Model

[0004] The utility model provides a sterile inspection and culture device suitable for the membrane filtration method, which has the characteristics of short time for detecting microbial contamination, high sensitivity, high automation degree, accurate detection result, and the ability to provide a trend chart of the growth state of microorganisms during the whole detection process.

[0005] In order to achieve the above purpose, the technical solution provided by the utility model is as follows:

[0006] A sterile inspection and culture device suitable for the membrane filtration method includes a housing, a constant temperature culture chamber and a bacteria collection and culture device. An information input device is provided on one side of the housing, a display device is provided in front of the housing, a constant temperature culture chamber is provided inside the housing, a temperature control device and an information collection device are provided in the constant temperature culture chamber. The top of the bacteria collection and culture device is provided with a liquid inlet, and the bottom is provided with the bottom of the bacteria collection and culture device cup. A bottom plug is provided inside the bottom of the bacteria collection and culture device cup, and a chromaticity sensor is provided above the bottom plug. The fully automatic sterile inspection and culture device is an intelligent instrument dedicated to the sterility test of drugs. Its principle is based on the CO2 generated by the respiration of microorganisms, which causes the color change of the sensor on the culture container. The visual camera of the device continuously scans the sensor image and the corresponding two-dimensional code, and the computer device performs visual analysis and converts it into a growth signal. The sterility test result is judged according to the trend analysis and a dedicated algorithm.

[0007] Preferably, a filter membrane is provided between the bacteria collection and culture device and the bottom of the bacteria collection and culture device cup. A drainage groove is provided between the bottom of the bacteria collection and culture device cup and the filter membrane. A magnetic bar is provided inside the bacteria collection and culture device. The filter membrane can filter microorganisms, the drainage groove guides the culture solution onto the sensor, the inside of the bacteria collection and culture device is filled with a liquid culture medium, the liquid culture medium provides a growth environment and nutrients for microorganisms, and the magnetic bar makes the bacteria collection and culture device fully shaken by magnetic stirring to promote the growth of microorganisms.

[0008] Preferably, an electromagnetic lock is provided on the constant temperature cultivation chamber, and an electromagnetic lock tongue is provided on the incubator placement tray. The electromagnetic lock on the constant temperature cultivation chamber is connected and matched with the electromagnetic lock tongue on the incubator placement tray.

[0009] Preferably, guide rails are provided at both ends inside the constant temperature cultivation chamber, and linear guide rails are provided on both sides of the incubator placement tray. The guide rails are adapted to the linear guide rails.

[0010] Preferably, heat dissipation ventilation holes are provided on both sides of the outer wall of the housing, an indicator light is provided at the front end of the housing, and a buzzer is provided on the back of the housing.

[0011] Preferably, an automatic operation structure and a plurality of magnetic stirrers are provided on the constant temperature cultivation chamber. The diameter of the magnetic stirrer is adapted to the diameter of the bottom of the bacteria collection incubator cup, and the magnetic stirrer gives power to the magnetic bar inside the bacteria collection incubator.

[0012] Preferably, an information collection device and a magnetic stirrer are provided on the automatic operation mechanism. The magnetic stirrer periodically acts on the stirring rod inside the bacteria collection incubator to promote the growth of microorganisms. The CO2 generated by the growth of microorganisms in the incubator reacts with the sensor and causes the color of the sensor to change.

[0013] Preferably, the temperature control device includes a refrigeration module, an air duct and a temperature sensor. An incubator placement tray is provided inside the constant temperature cultivation chamber, and a heat preservation layer is provided on the outer layer of the constant temperature cultivation chamber.

[0014] Preferably, an automatic robot transfer mechanism is provided inside the constant temperature cultivation chamber. The automatic robot transfer mechanism has at least one axis, and the automatic robot transfer mechanism moves along the axis.

[0015] The advantages of the present utility model are that the detection time of microbial contamination is short, the sensitivity is high, the degree of automation is high, the detection result is accurate, and it can provide a trend chart of the growth state of microorganisms in the whole detection process. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is the front view of the present utility model;

[0017] Figure 2 is the side view of the present utility model;

[0018] Figure 3 is the rear view of the present utility model;

[0019] Figure 4 is the front view of the placement tray of the present utility model;

[0020] Figure 5 is the side view of the placement tray of the present utility model;

[0021] Figure 6This is the front view of the constant temperature incubator of the present utility model;

[0022] Figure 7 This is the structural schematic diagram of the constant temperature incubator of the present utility model;

[0023] Figure 8 This is the structural schematic diagram of the bacteria collection incubator of the present utility model;

[0024] Figure 9 This is the cross-sectional view of the bacteria collection incubator of the present utility model.

[0025] In the figure: 1. Bacteria collection incubator, 11. Chromaticity sensor, 12. Bottom of the bacteria collection incubator cup, 13. Filter membrane, 14. Drainage groove, 15. Liquid culture medium, 16. Bottom plug, 17. Liquid inlet, 18. Respirator, 19. Magnetic bar, 2. Constant temperature incubator, 20. Magnetic stirrer, 21. Refrigeration module, 22. Information collection device, 23. Temperature sensor, 24. Automatic operation mechanism, 25. Air duct, 26. Guide rail, 27. Electromagnetic lock, 3. Incubator placement tray, 31. Linear guide rail, 32. Culture bottle placement seat, 33. Electromagnetic lock tongue, 4. Housing, 41. Information input device, 42. Display device, 43. Indicator light, 44. Adjustable caster, 45. Heat dissipation ventilation hole, 46. Removable drawer, 47. Power switch, 48. Buzzer. Detailed implementation manners

[0026] The embodiments of the present utility model will be described in detail below. The examples of the embodiments are shown in the drawings, where the same or similar reference numerals indicate the same or similar elements or elements with the same or similar functions from beginning to end. The embodiments described below by referring to the drawings are exemplary and are only used to explain the present utility model and should not be construed as a limitation to the present utility model.

[0027] Embodiment 1, as Figure 1 and 2As shown in FIGS. 3, the sterile inspection culture device applicable to the membrane filtration method provided by the utility model includes a housing 4, a constant temperature culture chamber 2, and a bacteria collection incubator 1. An information input device 41 is installed on one side of the housing 4, and a display device 42 is installed in front of the housing 4. A constant temperature culture chamber 2 is installed inside the housing 4. The constant temperature culture chamber 2 is equipped with a temperature control device and an information collection device 22. A liquid inlet 17 is installed at the top of the bacteria collection incubator 1, and a bottom of the bacteria collection incubator cup 12 is installed at the bottom. A bottom plug 16 is installed inside the bottom of the bacteria collection incubator cup 12, and a chromaticity sensor 11 is installed above the bottom plug 16. The fully automatic sterile inspection culture device is an intelligent instrument dedicated to the sterile inspection of drugs. Its principle is based on the CO2 generated by the respiration of microorganisms, which causes the color change of the sensor on the culture container. The visual camera of the device continuously scans the sensor image and the corresponding two-dimensional code, and the computer device performs visual analysis and converts it into a growth signal. The sterile inspection result is judged based on the change trend analysis and a dedicated algorithm.

[0028] The information input device 41 of the utility model is used to scan the two-dimensional code at the bottom of the bacteria collection incubator for input. The display device 42 displays and can operate and observe the operation status of the device. The frame shell is used for the device frame and appearance. The indicator light 43: facilitates observing the operation status of the device. The constant temperature culture chamber 2: independent temperature control supports high and low temperature cultivation. The adjustable casters 44: can move / fix and adjust the device level. The heat dissipation ventilation holes 45: for device heat dissipation. The detachable drawer 46: facilitates maintenance and installation. The power switch 47: the device start-up and power-on button. The buzzer 48: the device alarm emits an alarm prompt sound.

[0029] Example 2, as Figure 4 and 5 As shown in FIGS. 6 and 7, the utility model provides a constant temperature culture chamber. The utility model installs an electromagnetic lock 27 on the constant temperature culture chamber 2, and an electromagnetic lock tongue 33 is installed on the culture vessel placement tray 3 of the utility model. The electromagnetic lock 27 and the electromagnetic lock tongue 33 are connected and matched with each other. Guide rails 26 are installed at both ends inside the constant temperature culture chamber 2, and linear guide rails 31 are installed on both sides of the culture vessel placement tray 3. The guide rails 26 and the linear guide rails 31 are mutually adapted. Refrigeration modules 21 are arranged on the left and right sides of the constant temperature culture chamber 2. The energy after heating or refrigeration is evenly distributed and delivered into the constant temperature culture chamber 2 through the air outlet of the air duct 25. A temperature sensor 23 is installed at the air inlet of the air duct to detect the temperature inside the constant temperature culture chamber 2 in real time. An information collection device 22 and six magnetic stirrers 20 corresponding to the tray positions are installed on the automatic operation mechanism 24 to sequentially detect the test articles on the culture vessel placement tray 3. At the same time, the magnetic stirrers 20 work to rotate the magnetic rods 19 to stir the culture solution to promote the growth of microorganisms.

[0030] The test sample is input into the device through the information input device 41. The bacteria collection incubator 1 is placed in the three-layer independent temperature-controlled constant temperature incubator 2 for cultivation. The cultivation data is set through the display operation device, and the device is controlled to perform automatic cultivation judgment. The three-layer constant temperature incubator 2 is placed on the rack housing. The device is provided with an indicator light 43 to facilitate observing the operation status of the device. Each layer of the constant temperature incubator 2 is provided with a detachable drawer 46, and the bacteria collection incubator 1 is placed on the incubator placement tray 3.

[0031] Example 3, as Figure 8 and 9 shown, a bacteria collection incubator 1 provided by the present utility model. A liquid inlet 17 is installed at the top of the bacteria collection incubator 1, and a bacteria collection incubator cup bottom 12 is installed at the bottom. A bottom plug 16 is arranged in the bacteria collection incubator cup bottom 12, and a chromaticity sensor 11 is arranged above the bottom plug 16. The cross-section of the bacteria collection incubator 1 is set as a frustum of a cone. A filter membrane 13 is installed between the bacteria collection incubator 1 and the bacteria collection incubator cup bottom 12. A drainage groove 14 is arranged between the bacteria collection incubator cup bottom 12 and the filter membrane 13. A magnetic bar 19 is installed in the bacteria collection incubator. The special chromaticity sensor 11 is fixed in the bacteria collection incubator cup bottom 12. The bottom of the bacteria collection incubator 1 contains a filter membrane 13. The test sample passes through the filter membrane 13. If the test sample contains microorganisms, the microorganisms can be intercepted on the filter membrane 13, and a liquid culture medium 15 suitable for the growth of microorganisms is added. Microorganisms such as bacteria and fungi will produce CO2 during the growth process. The chromaticity sensor 11 can sensitively detect the weak change of CO2, can react with the CO2 generated during the growth process of microorganisms, and can change from the original color to another significant color (such as changing from gray to yellow).

[0032] The thin film filtration method is used to concentrate microorganisms into the bacteria collection incubator 1 for cultivation. The bottom of the bacteria collection incubator 1 is provided with a chromaticity sensor 11 for detecting the growth of internal microorganisms. The CO2 generated by the growth of microorganisms in the bacteria collection incubator 1 reacts with the sensor and causes a significant color change in the chromaticity sensor 11. The operator inputs the information of a batch of filled bacteria collection incubators 1 by scanning the two-dimensional code at the bottom and places them into the sterility inspection culture device, and sets the temperature of each constant temperature incubator.

[0033] The advantages of the present utility model are that the time for detecting microbial contamination is short, the sensitivity is high, the automation degree is high, the detection result is accurate, and it can provide a trend chart of the growth status of microorganisms in the whole detection process.

[0034] Example 4, as Figures 1-9As shown in the figure, a bacteria collection incubator 1 provided by the present utility model has the following overall connection relationships of the equipment: The housing 4 serves as the main framework, connecting and supporting the constant temperature incubation chamber 2, the information input device 41, the display device 42, the indicator light 43, the adjustable casters 44, the heat dissipation ventilation holes 45, the detachable drawer 46, the power switch 47, and the buzzer 48. The constant temperature incubation chamber 2 is built inside the housing 4 and is connected to the temperature control device, the information collection device 22, the refrigeration module 21, the automatic operation mechanism 24 (including the magnetic stirrer 20), the air duct 25 and its temperature sensor 23, as well as the electromagnetic lock 27 and the guide rail 26. The constant temperature incubation chamber 2 is adaptively connected to the linear guide rail 31 of the incubator placement tray 3 through the guide rail 26, and the bacteria collection incubator 1 is placed on the incubator placement tray 3. The electromagnetic lock 27 cooperates with the electromagnetic lock tongue 33 on the incubator placement tray 3 to realize the locking and unlocking of the incubator placement tray 3.

[0035] The internal connection relationships of the bacteria collection incubator 1 are as follows: The top of the bacteria collection incubator 1 is connected to the liquid inlet 17, and the bottom is connected to the bottom of the bacteria collection incubator cup 12. A bottom plug 16 is built inside the bottom of the bacteria collection incubator cup 12, and the chromaticity sensor 11 is fixed above. A filter membrane 13 is installed between the bacteria collection incubator 1 and the bottom of the bacteria collection incubator cup 12, and a drainage groove 14 is provided below the filter membrane 13. A magnetic bar 19 is also installed inside the bacteria collection incubator 1, and the magnetic bar 19 is rotated by the magnetic stirrer 20 through external control to stir the culture solution.

[0036] In addition, the information input device 41 scans the QR code at the bottom of the bacteria collection incubator 1 and inputs the information into the system. The display device 42 displays the operating status of the equipment and allows the operator to make settings and observations. The temperature control device receives the setting instructions and controls the temperature inside the constant temperature incubation chamber 2. The information collection device 22 collects the data inside the constant temperature incubation chamber, including the data of the temperature sensor 23 and the color change information of the chromaticity sensor 11. The automatic operation mechanism 24 performs automatic control of the culture process according to the settings, including the start and stop of the magnetic stirrer 20. The equipment status is displayed through the indicator light 43, and when abnormal, the buzzer 48 emits an alarm prompt sound.

[0037] The entire sterility test culture device realizes the full automation from sample input, constant temperature incubation, microbial growth monitoring to result interpretation through a series of precise physical connections and intelligent controls, and has the characteristics of high efficiency, sensitivity, and accuracy.

[0038] When the sterility test culture device with the above structure starts dynamic operation, its various parts will work together according to the preset programs and logics. The following is a detailed description of the dynamic operation process:

[0039] The operator inputs or selects culture conditions, such as temperature, culture time, etc., through the interface on the display device 42. The operator uses the information input device 41 to scan the QR code at the bottom of the bacteria collection incubator 1 and enters the sample information into the system. The system initializes the temperature control device and the automatic operation mechanism 24 of the constant temperature culture chamber 2 according to the input information and the preset parameters. The bacteria collection incubator 1 is placed on the incubator placement tray 3, and through the adaptation of the guide rail 26 and the linear guide rail 31, stable placement is ensured. The electromagnetic lock 27 is activated and cooperates with the electromagnetic lock tongue 33 on the incubator placement tray 3 to lock the bacteria collection incubator 1 in place, preventing it from moving or falling off during the culture process.

[0040] The temperature control device starts the refrigeration module 21 or the heating element (if necessary) according to the set temperature, and evenly sends the conditioned air into the constant temperature culture chamber 2 through the air duct 25. The temperature sensor 23 continuously monitors the temperature inside the constant temperature culture chamber 2 and feeds the data back to the control system to ensure that the temperature is maintained within the preset range. The automatic operation mechanism 24 is started, and the information collection device 22 begins to collect data inside the constant temperature culture chamber, including temperature and the growth situation of microorganisms monitored (through the chromaticity sensor 11). The magnetic stirrer 20 starts to work according to the preset program, driving the magnetic bar 19 to rotate inside the bacteria collection incubator 1 to stir the culture solution, promoting the growth and uniform distribution of microorganisms. The chromaticity sensor 11 continuously monitors the color changes caused by CO2 generated during the growth of microorganisms on the filter membrane 13 and converts these changes into electrical signals and transmits them to the control system.

[0041] The system records and stores all the collected data, including temperature, color changes, etc. The computer device performs visual analysis on the collected images and data, converts them into growth signals, and applies a special algorithm to judge the sterility inspection result. After the culture is completed, the system generates a report according to the analysis result and displays it on the display device 42. The report may include information such as a trend chart of the microbial growth state, the final judgment result, etc.

[0042] The operator takes out the bacteria collection incubator 1 from the incubator placement tray 3 according to the system prompt or the report result for subsequent processing or analysis. The detachable drawer 46 may be opened to clean and maintain the interior of the constant temperature culture chamber 2. The system enters the standby state, waiting for the next culture task.

[0043] Example 5, such as Figures 1-7As shown in the figure, a bacteria collection incubator 1 provided by the utility model mainly includes a housing 4. The housing 4 serves as the support framework of the device, which is stable and integrates multiple functions. On one side of it, an information input device 41 is seamlessly integrated. This device realizes the rapid input of sample information by scanning the QR code at the bottom of the bacteria collection incubator. On the front of the housing, a display device 42 is arranged to display the working status, operation guidelines and detection results of the device in real time, providing an intuitive operation experience for users. The internal space of the housing is effectively utilized, and a constant temperature incubator 2 is installed, which is responsible for providing a temperature environment with precise control for the growth of microorganisms.

[0044] The connection method of its components is that an advanced temperature control device is embedded inside the constant temperature incubator 2. This device can automatically adjust the indoor temperature according to preset parameters to meet the high and low temperature culture requirements. The information collection device 22 is directly installed in the incubator and is responsible for real-time monitoring and recording key data such as temperature and the growth status of microorganisms. To ensure the stability during the culture process, an electromagnetic lock 27 is equipped at the top of the incubator, which closely cooperates with the electromagnetic lock tongue 33 on the incubator placement tray 3 to form a double locking mechanism.

[0045] Guide rails 26 are designed on both sides inside the incubator, which are accurately docked with the linear guide rails 31 on both sides of the incubator placement tray 3 to ensure that the incubator can enter and exit smoothly and its position is stable. The refrigeration modules 21 installed on both sides circulate and convey heated or cooled air through the air duct 25 to ensure that the temperature inside the incubator is uniform. A temperature sensor 23 is provided at the air duct inlet to continuously monitor and feedback the indoor temperature to achieve precise temperature control. The automatic operation mechanism 24 is located inside the incubator, and a plurality of magnetic stirrers 20 are equipped on it. Each stirrer corresponds to a position of the incubator. The magnetic stirrer agitates the culture solution non-contact through a magnetic rod 19 to promote the uniform distribution and growth of microorganisms.

[0046] As the core container for sample processing, the bacteria collection incubator 1 is provided with a liquid inlet 17 at its top for facilitating the addition of culture medium or liquid to be tested. The bottom is designed as the bottom of the bacteria collection incubator cup 12, which is internally provided with a bottom plug 16 and a key chromaticity sensor 11. The chromaticity sensor can sensitively capture the color change caused by CO2 generated during the growth of microorganisms, which is a direct indication of the growth of microorganisms. A fine filter membrane 13 is installed between the bacteria collection incubator and the cup bottom to effectively intercept microorganisms in the sample. A drainage groove 14 is provided below the filter membrane to ensure the smooth discharge of liquid and avoid contamination.

[0047] Based on the disclosure and teachings of the above specification, those skilled in the art to which the present utility model pertains can also make appropriate changes and modifications to the above embodiments. Therefore, the present utility model is not limited to the specific embodiments disclosed and described above, and some modifications and changes to the present utility model should also fall within the protection scope of the claims of the present utility model. In addition, although some specific terms are used in this specification, these terms are only for convenience of description and do not constitute any limitation to the present invention.

Claims

1. A sterile testing and culture device suitable for membrane filtration method, characterized in that: It comprises a housing (4), a constant temperature culture chamber (2) and a bacteria collecting culture device (1); An information input device (41) is provided on one side of the housing (4), a display device (42) is provided in front of the housing (4), and a constant temperature culture chamber (2) is provided inside the housing (4); The constant temperature culture chamber (2) is provided with a temperature control device and an information collection device (22); The top of the bacteria collecting incubator (1) is provided with a liquid inlet (17), and the bottom is provided with a bacteria collecting incubator cup bottom (12). A bottom sealing plug (16) is provided inside the bacteria collecting incubator cup bottom (12), and a colorimetric sensor (11) is provided above the bottom sealing plug (16).

2. A sterile testing and culture device suitable for membrane filtration method according to claim 1, characterized in that: A filter membrane (13) is provided between the bacteria collecting culture device (1) and the bottom (12) of the bacteria collecting culture device cup, a drainage groove (14) is provided between the bottom (12) of the bacteria collecting culture device cup and the filter membrane (13), and a magnetic rod (19) is provided in the bacteria collecting culture device (1).

3. A sterile testing and culture device suitable for membrane filtration method according to claim 1, characterized in that: The constant temperature culture chamber (2) is provided with an electromagnetic lock (27), and the culture vessel placement tray (3) is provided with an electromagnetic lock tongue (33). The electromagnetic lock (27) on the constant temperature culture chamber (2) is connected and matched with the electromagnetic lock tongue (33) of the culture vessel placement tray (3).

4. A sterile testing and culture device suitable for membrane filtration method according to claim 3, characterized in that: Guide rails (26) are provided at both ends of the inner side of the constant temperature culture chamber (2), and linear guide rails (31) are provided on both sides of the culture device placement plate (3), and the guide rails (26) are adapted to the linear guide rails (31).

5. The sterile testing and culture device suitable for membrane filtration method according to claim 1, characterized in that: Heat dissipation ventilation holes (45) are provided on both sides of the outer wall of the shell (4), an indicator light (43) is provided at the front end of the shell (4), and a buzzer (48) is provided at the back of the shell (4).

6. According to claim 2, a sterile inspection and culture device suitable for membrane filtration method, the constant temperature culture chamber (2) is provided with an automatic operation mechanism and a plurality of magnetic stirrers (20), and the diameter of the magnetic stirrer (20) is adapted to the diameter of the bottom (12) of the bacteria collection culture cup.

7. A sterile testing and culture device suitable for membrane filtration method according to claim 6, characterized in that: The automatic operation mechanism (24) is provided with an information collection device (22) and a magnetic stirrer (20).

8. The sterile testing and culture device suitable for membrane filtration method according to claim 1, characterized in that: The temperature control device comprises a refrigeration module (21), an air duct (25) and a temperature sensor (23); a culture device placement tray (3) is provided in the constant temperature culture chamber (2); and a heat preservation layer is provided outside the constant temperature culture chamber (2).

9. The sterile testing and culture device suitable for membrane filtration method according to claim 1, characterized in that: The information collection device (22) is provided with an intelligent camera.

10. According to claim 1 or 3 or 4 or 6, a sterile inspection and culture device suitable for membrane filtration method, an automated robot transfer mechanism is provided in the constant temperature culture chamber (2), and the automated robot transfer mechanism has at least one axis, and the automated robot transfer mechanism moves along the axis.

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