Medicine sterility test culture device

Abstract

The medicine sterility test culture device comprises a sterile operation cabin, a sterility test inoculation device is arranged in the sterile operation cabin, a culture box is arranged on the side edge of the sterile operation cabin, a sealing door is arranged between the culture box and the sterile operation cabin, a culture device is arranged in the culture box, and a detection device is arranged on the side edge of the culture device. The whole sampling and inoculating process can be completed without manual operation. The problems of puncture sampling and puncture inoculation of the penicillin bottle are solved; due to full-automatic replacement of the sampling needle cylinder, the efficiency is improved. The sampling bottle and the inoculation bottle are bound in relation, traceability is achieved, and management is more convenient; the penicillin bottle plastic cap can be automatically opened, manual operation is saved, a full-automatic culture technology is adopted, and manual inspection is not needed.

Description

Technical Field

[0001] The invention relates to the technical field of radioactive medicine and nuclear medicine, and in particular to a medicine sterility inspection and culture device. Background Art

[0002] Radiopharmaceuticals, also known as nuclear medicines, are radionuclide preparations or labeled compounds used in nuclear medicine for clinical diagnosis or treatment that contain radionuclides. They are currently widely used in tumor diagnosis and treatment, myocardial imaging, early detection of neurodegenerative diseases, and inflammatory tissue imaging and diagnosis. Radiopharmaceuticals can use the biological characteristics of the carriers they are labeled with to reflect the diseased genes, molecules, metabolism, and functional status, and can provide earlier and more specific insights into the molecular level of the disease. At the same time, they can also use the radiation energy of radionuclides to accurately kill tumors. They have become a powerful means for early diagnosis and precision treatment of diseases. Radiopharmaceuticals are generally divided into diagnostic radiopharmaceuticals (including in vitro radioimmunodiagnostic drugs) and therapeutic radiopharmaceuticals according to their use, and are divided into gamma-nuclide, beta-nuclide, and alpha-nuclide labeled drugs according to the type of nuclide.

[0003] Radioactive drugs, as the name implies, are radioactive in themselves. Therefore, drug operators and dispensers should not come into direct contact with radioactive drugs. Operators cannot perform direct contact operations on radioactive drugs and need to operate in a shielded hot chamber. In the operation process, the operating equipment commonly used are sword-type manipulators and master-slave manipulators, but these two methods are too cumbersome to operate, require high manual labor intensity, and have high requirements on operators. In order to circumvent the above-mentioned unfavorable factors, this patent proposes an automated inoculation device that can be placed inside a hot chamber for sampling and inoculation of radioactive drugs. Summary of the invention

[0004] The purpose of the present invention is to solve the problems existing in the above-mentioned prior art and to provide a drug sterility inspection and culture device to solve the problems of vial puncture sampling and puncture inoculation, and to adopt automatic culture technology without manual inspection.

[0005] The technical solution of the present invention is as follows: A drug sterility inspection and culture device comprises a sterile operation cabin, a sterile inspection inoculation device is arranged in the sterile operation cabin, a culture box is arranged on the side of the sterile operation cabin, a sealed door is arranged between the culture box and the sterile operation cabin, a culture device is arranged in the culture box, and a detection device is arranged on the side of the culture device.

[0006] Preferably, the sterility inspection inoculation device comprises a horizontal transplanting device, on which an inoculation bottle setting seat and a sampling bottle setting seat are provided, and a cover opening device is provided on one side, and the sampling bottle setting seat and the inoculation bottle setting seat are in the same straight line.

[0007] Preferably, the sterility inspection and vaccination device also includes a puncture sampling device, which includes a first mounting plate, a syringe clamp is provided at one end of the first mounting plate, and a vertical transfer device is provided at the other end, the syringe clamp is connected with a syringe through the first mounting plate, a second mounting plate is provided between the syringe clamp and the vertical transfer device, a syringe piston clamping device is provided on the second mounting plate, a guide shaft is provided under the second mounting plate, a pushing device is provided under the first mounting plate, the pushing device is located on the side of the guide shaft, and a code scanning device is provided on the side of the vertical transfer device.

[0008] Preferably, the inoculation bottle adjusting seat includes an inoculation bottle cylinder located at the bottom, and an inoculation bottle clamp is provided above the inoculation bottle cylinder.

[0009] Preferably, the sampling bottle adjusting seat comprises a sampling bottle cylinder located at the bottom, and a sampling bottle clamp is provided above the sampling bottle cylinder.

[0010] Preferably, the cover opening device comprises a cover opening mounting base, a connecting plate is provided on one side of the cover opening mounting base, a limiting plate is provided on the other side, a push rod is provided between the connecting plate and the cover opening mounting base, and a cover opening vertical plate is provided between the cover opening mounting base and the limiting plate.

[0011] Preferably, an arc-shaped opening is provided on one side of the cover opening mounting base close to the limiting plate, a vial of syringe is provided in the arc-shaped opening, and a cover opening cylinder is installed on the side plate of the cover opening vertical plate, and one end of the cover opening cylinder is connected to the connecting plate.

[0012] Preferably, a robotic arm is further provided in the sterile operation cabin, a syringe holder and a culture bottle holder are provided within the movable range of the robotic arm, and the robotic arm is located between the sterile inspection inoculation device and the culture bottle holder.

[0013] Preferably, the sterility inspection and inoculation device is located on one side of the sterile operation cabin, a planktonic bacteria sampler and a particle counter are provided on the other side of the sterile operation cabin, a sample inspection lead tank is provided on the side of the culture bottle holder, and a waste collection tank is also provided between the sterility inspection and inoculation device and the culture bottle holder, and the waste collection tank is located within the moving range of the robotic arm.

[0014] Preferably, the culture device comprises a rotating main shaft, and a plurality of fixing frames are provided in the circumferential direction of the rotating main shaft.

[0015] The beneficial effect of the present invention is that the entire sampling and inoculation process can be completed without manual operation. The problem of puncture sampling and inoculation of vials is solved. The sampling syringe is fully automatically replaced to improve efficiency. The relationship between the sampling bottle and the inoculation bottle is bound, traceable, and management is more convenient. The automatic opening of the vial plastic cap saves manpower. Fully automatic cultivation technology does not require manual inspection. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a top view schematic diagram of the device of the present invention.

[0017] Figure 2 It is a front view schematic diagram of the device of the present invention.

[0018] Figure 3 It is a schematic structural diagram of the sterility inspection inoculation device of the present invention.

[0019] Figure 4 yes Figure 3 An enlarged schematic diagram of the symbol at A in the middle.

[0020] Figure 5 It is a structural schematic diagram of the inoculation bottle setting seat of the present invention.

[0021] Figure 6 It is a structural schematic diagram of the sampling bottle setting seat of the present invention.

[0022] Figure 7 It is a top view schematic diagram of the cover opening device of the present invention.

[0023] Figure 8 It is a side schematic diagram of the sterility inspection inoculation device of the present invention.

[0024] Fig. 9 It is a structural schematic diagram of the cover opening device of the present invention.

[0025] In the figure: 1. Aseptic operation cabin, 2. Aseptic inspection inoculation device, 3. Incubator, 4. Inflatable sealing door, 5. Incubation device, 6. Detection device, 7. Horizontal transplanting device, 8. Inoculation bottle setting seat, 9. Sampling bottle setting seat, 10. Opening device, 11. Puncture sampling device, 12. First mounting plate, 13. Syringe clamp, 14. Vertical transplanting device, 15. Syringe, 16. Second mounting plate, 17. Syringe piston clamping device, 18. Guide shaft, 19. Bearing, 20. Electric push cylinder, 21. Scanning device, 22. Inoculation bottle cylinder, 23. Inoculation bottle clamp, 24. Inoculation bottle, 25. Sampling bottle cylinder, 26. Sampling bottle clip, 27. Sampling bottle, 28. Opening cover mounting base, 29. Connecting plate, 30. Limiting plate, 31. Push rod, 32. Opening cover vertical plate, 33. Syringe bottle, 34. Arc opening, 35. Opening cover cylinder, 36. Robotic arm, 37. Syringe holder, 38. Culture bottle holder, 39. Planktonic bacteria sampler, 40. Particle counter, 41. Inspection lead can, 42. Waste collection can, 43. Rotating spindle, 44. Fixed frame, 45. Operation button, 46. Dosing port, 47. Quick transfer outdoor door, 48. Glove operation port, 49. Observation window, 50. Emergency stop button, A. Enlarged schematic mark. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] Embodiment 1, by Figures 1 to 9 It can be seen that the present invention provides a drug sterility inspection and culture device, from Figure 2 It can be seen that the drug sterility testing and culture device in this embodiment of the present invention is a cabinet. Figure 2 It can be seen that in this embodiment of the present invention, a dosing port 46 is provided on the lower left side of the cabinet, and a quick transfer room outer door 47 is provided on the lower right side of the cabinet, and the dosing port 46 and the quick transfer room outer door 47 are on the same straight line. A glove operation port 48 is provided above the quick transfer room outer door 47 and the dosing port 46, and the glove operation port 48 is divided into a left and a right side. In this embodiment of the present invention, the left and right sides of the glove operation port 48 are symmetrical to each other, and the left and the right can be approximately regarded as a semicircle. An observation window 49 is provided above the glove operation port 48, and an emergency stop button 50 is provided on the right side above the observation window 49. From Figure 2 It can be seen that the cabinet of the present invention can be roughly divided into three layers. The first layer is the bottom layer and is provided with a dosing port 46 and a fast transfer outdoor door 47. The second layer is the operating layer and is provided with a glove operating port 48 and an observation window 49 above the first layer. The third layer is mainly provided with an emergency stop button 50 above the second layer. Figure 1 It can be seen that the drug sterility inspection and culture device provided by the present invention can be divided into two areas inside, one is the sterile operation cabin 1 and the other is the incubator 3. In this embodiment of the present invention, the incubator 3 is provided with two mutually symmetrical incubators 3, and a sealed door is provided between the incubator 3 and the sterile operation cabin 1 for separation, and the sealed door in this embodiment is an inflatable sealed door 4.

[0028] Depend on Figure 1 It can be seen that a single incubator 3 is provided with a culture device 5 and a detection device 6. In this embodiment of the present invention, the detection device 6 is located on a side away from the symmetrical central axis of the two incubators 3. Specifically, Figure 1 It can be seen that the detection device 6 in the left incubator 3 is located on the left side of the culture device 5, and the detection device 6 in the right incubator 3 is located on the right side of the culture device 5. In this embodiment of the present invention, the culture device 5 is composed of a rotating main shaft 43 and a plurality of fixing frames 44, and the fixing frames 44 are distributed along the circumference of the rotating main shaft. Figure 1 It can be seen that the rotating main shaft 43 faces the inflation sealing door 4, and the inflation sealing door 4 faces the syringe support 37. Figure 1It can be seen that in the sterile operation cabin 1, based on the inflatable sealing door 4, a row of syringe racks 37, two rows of culture bottle racks 38, and a test lead tank 41 are arranged in sequence from top to bottom.

[0029] In fact, in this embodiment of the present invention, the sterile operation cabin 1 is divided into two areas with the mechanical arm 36 close to the central axis of the sterile operation cabin 1 as the reference line. One is the bracket placement area on the left side, which mainly places some brackets, and the other is the inoculation area on the right side, in which a sterile inspection inoculation device 2 is provided. Another culture bottle bracket 38 is provided directly in front of the mechanical arm 36, and the inspection product lead tank 41 is still in front of the other culture bottle bracket 38. In this embodiment of the present invention, a total of three culture bottle brackets 38 are provided in the sterile operation cabin 1. Furthermore, the bracket placement area on the left side has three columns in this embodiment of the present invention. The first column is closest to the edge of the sterile operating cabin 1 and includes a particle counter 40 located on the side close to the inflatable sealing door 4 and a planktonic bacteria sampler located on the side away from the inflatable sealing door 4; the third column includes a robotic arm 36 close to the central axis of the sterile operating cabin 1, specifically, to the left of the central axis of the sterile operating cabin 1, wherein the robotic arm 36 is close to the side of the inflatable sealing door 4 and another culture bottle holder 38 in front of the robotic arm 36 is away from the side of the inflatable sealing door 4; the second column is located between the first column and the third column, and the second column is facing the inflatable sealing door 4, and a culture bottle holder 38 is provided on the side close to the inflatable sealing door 4, and a sample lead tank 41 is provided on the side away from the inflatable sealing door 4, and a culture bottle holder 38 and another culture bottle holder 38 are respectively provided between the syringe holder 37 and the sample lead tank 41, and one of the culture bottle holders 38 is close to the side of the inflatable sealing door 4. The inoculation area on the right is divided into two columns. One column is close to the central axis of the sterile operation cabin 1. In fact, a waste collection tank 42 is arranged to the right of the central axis of the sterile operation cabin 1. The waste collection tank 42 is within the range of motion of the robot arm 36. Figure 1 It can be seen that the robot arm 36 is processing the waste collection tank 42 at this time, and the sterile inspection inoculation device 2 is placed in the second column of the inoculation area on the right, that is, the column close to the edge of the sterile operation cabin 1.

[0030] Depend on Figure 3 and Figure 4 and Figure 8 It can be seen that the sterility inspection inoculation device 2 includes a horizontal transplanting device 7 and a vertical transplanting device 14, and both of them are controlled by an operation button 45. The horizontal transplanting device 7 is provided with an inoculation bottle setting seat 8 and a sampling bottle setting seat 9. In this embodiment of the present invention, the sampling bottle setting seat 9 is on the left side of the inoculation bottle setting seat 8, and a cover opening device 10 is provided on the right side of the inoculation bottle setting seat 8. A code scanning device 21 is provided on the side of the vertical transplanting device 14. The puncture sampling device 11 is controlled to move up and down by the vertical transplanting device 14. Figure 4It can be known that the puncture sampling device 11 includes a first mounting plate 12, and a syringe clamp 13 is provided at one end of the first mounting plate 12 away from the vertical transfer device 14. The syringe clamp 13 clamps a syringe 15 below the first mounting plate 12, and the syringe clamp 13 is provided with a second mounting plate 16 on the side close to the vertical transfer device 14. The second mounting plate 16 is rectangular in this embodiment of the present invention, and a syringe piston clamping device 17 is provided at each end of its long side. A guide shaft 18 passing through the first mounting plate 12 is provided below the second mounting plate 16, and a bearing 19 is provided at the junction of the guide shaft 18 and the top surface of the first mounting plate 12. A pushing device is provided on the side of the guide shaft 18 close to the vertical transfer device 14. The pushing device of this embodiment is an electric push cylinder 20.

[0031] Depend on Figure 5 and Figure 6 It can be seen that the inoculation bottle setting seat 8 includes an inoculation bottle cylinder 22, and an inoculation bottle clamp 23 is provided above the inoculation bottle cylinder 22. The inoculation bottle clamp of this embodiment is wavy, and the inoculation bottle clamp 23 clamps three inoculation bottles 24. The sampling bottle setting seat 9 includes a sampling bottle cylinder 25, and a sampling bottle clamp 26 is provided above the sampling bottle cylinder 25. The sampling bottle clamp of this embodiment is rectangular as a whole, and the sampling bottle clamp 26 clamps a sampling bottle 27.

[0032] Depend on Figure 7 and Fig. 9 It can be seen that the cover opening device 10 includes a cover opening mounting base 28. Fig. 9 It can be seen that a connecting plate 29 is provided on the left side of the cover opening mounting base 28 and a limiting plate 30 is provided on the right side. The left side of the cover opening mounting base 28 is connected to the connecting plate 29 through a push rod 31, and the right side of the cover opening mounting base 28 is connected to the limiting plate 30 through a cover opening vertical plate 32. The cover opening mounting base 28 is provided with an arc opening 34 on the side where the cover opening vertical plate 32 is provided. The arc opening 34 is adapted to the vial 33, and the vial 33 is installed in the arc opening 34. A cover opening cylinder 35 is provided on the side of the cover opening device 10 to provide the cover opening power.

[0033] Example 2 is used to illustrate the process of the present invention.

[0034] The first step is preparation, placing the inoculation bottle 24, the disposable syringe for inoculation, the test sample and the tools into the cabin; starting the sterilization of the operation cabin; In the second step, after the sterilization is completed, the disposable syringe is unpacked and placed in the corresponding position, and the positive control culture bottle and the aerobic anaerobic bottle are placed on the corresponding bracket; specifically, the disposable syringe is unpacked and placed on the syringe bracket 37, and the positive control culture bottle is placed on the culture bottle bracket 38; In the third step, the robot arm 36 takes out the sample (the sample is 1 ml and is packaged in a vial 33), the opening device 10 opens the aluminum cap of the vial 33, and uses a syringe to extract the sample in the bottle; In the fourth step, the robot arm 36 injects the sample into three culture bottles respectively; Step 6: The robot arm 36 places the inoculated culture bottle into the incubator 3 for automatic cultivation; In the seventh step, the robot arm 36 places the inoculated positive control culture bottle into the protective tank and covers the tank lid; Step 8: Move the protective tank outside the chamber, and take the protective tank containing the positive control culture bottle to the positive control room for related experiments; Step 9. During the later stage of culture, you can check on the computer whether the culture bottle sample is positive.

[0035] Radiopharmaceuticals are drugs containing one or more radionuclides for medical treatment and therapy. Radiopharmaceuticals are also called nuclear medicines, which are radionuclide preparations or labeled compounds used in nuclear medicine for clinical diagnosis or treatment. They are currently widely used in tumor diagnosis and treatment, myocardial imaging, early detection of neurodegenerative diseases, and inflammatory tissue imaging diagnosis. Radiopharmaceuticals can use the biological characteristics of the carriers they are labeled with to reflect the diseased genes, molecules, metabolism, and functional status, and can provide earlier and more specific insights into the molecular level of the disease. At the same time, they can also use the radiation energy of radionuclides to accurately kill tumors. They have become a powerful means for early diagnosis and precise treatment of diseases. Radiopharmaceuticals are generally divided into diagnostic radiopharmaceuticals (including in vitro radioimmunodiagnostic drugs) and therapeutic radiopharmaceuticals according to their use, and are divided into γ-nuclide, β-nuclide, and α-nuclide labeled drugs according to the type of nuclide.

[0036] Radiopharmaceuticals, as the name implies, are radioactive. So the operators and dispensers of drugs should not come into direct contact with radiopharmaceuticals. According to the investigation and verification of the World Health Organization, the damage of radiation to tissues and (or) organs depends on the dose of radiation received. If the radiation exceeds a certain threshold, it will damage the function of tissues and (or) organs and produce acute effects, such as skin redness, hair loss, radiation burns or acute radiation syndrome. The higher the dose and dose rate, the more serious these effects. If the radiation dose is low and / or achieved through long-term irradiation (low dose rate), the danger will be greatly reduced because the possibility of repairing the damage is greater. However, some long-term effects, such as cataracts or cancer, may still occur, but they may not appear until several years or even decades later. Such effects do not always occur, and their probability is proportional to the radiation dose. According to the regulatory requirements of the drug bottle production management specification, sampling and sterility inspection are required during drug production to confirm whether the drug is compliant. For radiopharmaceuticals, operators cannot perform direct contact operations and must operate in a shielded hot room. In the operation engineering, the operating instruments commonly used are sword-type manipulators and master-slave manipulators. However, these two methods are too cumbersome to operate, with high labor intensity and high requirements for operators. In order to avoid the above-mentioned unfavorable factors, the patent of this invention proposes an automated inoculation device that can be placed inside the hot room for sampling and inoculation of radiopharmaceuticals. Specifically, it is summarized as a drug sterility inspection and culture device.

[0037] The so-called hot chamber is described as follows: a hot chamber is a special facility, usually used to handle radioactive toxic and hazardous substances that are harmful to the human body and the environment. It is a closed special facility, usually set up in a thermal laboratory, designed specifically for handling radioactive substances. The hot chamber can perform cleaning, decontamination, packaging and related shielding measures on radioactive materials to ensure that they meet the clean control standards, and then transfer and conventionally transport them, and finally arrive at the landfill site for deep burial treatment. The hot chamber mentioned in the present invention is divided into 1 part, and the first part is a drug sterility inspection culture device referred to in the present invention. That is, a drug sterility inspection culture device is a hot chamber as a whole. The hatches of the hot chamber are all inflated and sealed. The hatch panels are made of tempered glass / stainless steel with a thickness of 15mm. They are opened on the left and right sides, which are convenient and simple to open and close. The fresh air inside the hot chamber comes from the user's indoor air. The top of the isolator is equipped with a 6-inch exhaust interface, and the exhaust interface is connected to the outside separately. The right observation window of the hot chamber is made of ZF6 lead glass, and the built-in radiation detector monitors the dose inside the hot chamber in real time to ensure that the hot chamber door can only be opened when the dose is lower than the preset value (dose rate measurement range: 1μSv / h-1Sv / h). Leakage rate of the hot chamber: the sealing meets the requirements of level 2 sealing, that is, the leakage rate per hour is less than 2.5×10-3; the total power supply voltage is 380V.50Hz, the current is 25A, and the total power is 6.0kW; it needs to be connected to clean compressed air (0.8Mpa≥P≥0.6Mpa), the gas consumption is 300L / min, and the dew point temperature is less than -20℃.

[0038] Example 3 is used to illustrate a certain workflow of the present invention: like Figures 1 to 9 As shown, the overall workflow is as follows: the robot arm 36 puts the syringe on the syringe holder 37 into the sterile inspection inoculation device 2, the robot arm 36 puts the sample vial 33 in the sample lead tank 41 onto the sterile inspection inoculation device 2 to complete the work of opening the cover, scanning the code, puncturing and taking liquid, etc., the robot arm 36 puts the sampled vial 33 back to the sample lead tank 41, the robot arm 36 puts the culture bottle on the culture bottle holder 38 into the sterile inspection inoculation device 2, the sterile inspection inoculation device 2 completes the inoculation work, the robot arm 36 puts the culture bottle back to the culture bottle holder 38, repeats the inoculation twice, and puts the syringe on the sterile inspection inoculation device 2 into the waste collection tank 42; repeat the above operation until the sample at the sample lead tank 41 completes the inoculation. The inflatable sealing door 4 opens automatically, the robot arm 36 puts the culture bottles at the culture bottle holder 38 onto the culture device 5 respectively, and the detection device 6 detects the culture bottles on the culture device 5 at regular intervals.

[0039] like Figures 1 to 9As shown, the overall workflow is as follows: the robotic arm 36 automatically places the syringe into the puncture sampling device 11, and the puncture sampling device 11 is ready. The robotic arm 36 automatically opens the sampled vial 33 at the cap opening device 10, then scans the code at the code scanning device 21, and then places the sampled vial 33 on the sampling bottle setting seat 9, and the sampling bottle setting seat 9 clamps the sampled vial 33. The robotic arm 36 automatically opens the inoculated vial 33 at the cap opening device 10, then scans the code at the code scanning device 21, and then places the inoculated vial on the inoculation bottle setting seat 8, and repeats this three times, and the inoculation bottle setting seat 8 clamps the inoculated vial 33. The horizontal transfer device 7 transfers the sampled vial 33 at the sampling bottle setting seat 9 to the puncture position, and the vertical transfer device 14 drives the puncture sampling device 11 downward to the setting position, so that the needle passes through the sampled vial 33 and extracts a quantitative stock solution. The vertical transfer device 14 ascends to the setting position. The horizontal transfer device 7 moves the inoculated vial 33 at the inoculation bottle setting seat 8 to the puncture position. The vertical transfer device 14 drives the puncture sampling device 11 downward to the setting position, so that the needle passes through the first bottle of inoculated vial 33 and squeezes out the quantitative stock solution. The vertical transfer device 14 drives the puncture sampling device 11 upward to the setting position, and the subsequent two bottles are inoculated again, and then the inoculation work is completed.

[0040] like Figures 1 to 9 As shown, the working process of the puncture sampling device 11 is as follows: the syringe clamp 13 opens, the mechanical arm 36 automatically puts the syringe 15 in, and the syringe clamp 13 is clamped. The syringe piston clamping device 17 is clamped to clamp the piston rod of the syringe 15. At this time, the piston rod of the syringe 15 is at the lowest position. When the mechanism punctures the syringe bottle 33 and needs to extract liquid, the electric push cylinder 20, under the guidance of the guide shaft 18 and the bearing 19, lifts the piston rod upward so that the liquid in the syringe bottle 33 is extracted. When the piston rod moves to the set position, the syringe 15 extracts the set value of liquid. When the set value of liquid needs to be discharged, the electric push cylinder 20 moves downward by the set value. As shown Figures 1 to 9 As shown, the setting and clamping of the vial 33 is completed by the cylinder driving the clamping piece to move inward. Figures 1 to 9 As shown, the movement process of the cover opening device 10 is as follows: there is a circular bottle placement position at the cover opening mounting base 28, that is, Fig. 9 The robot arm 36 automatically places the vial 33 to be opened at the arc buckle 34 in the opening, and the plastic cover of the vial 33 is placed on the upper surface of the opening plate 32. The metal cover and the bottle body are between the inner surfaces of the two opening plates 32, sliding smoothly with a very small gap. The opening cylinder 35 drives the connecting plate 29 and the push rod 31 to push the vial 33 forward, and the plastic cover of the vial 33 moves along the slope of the opening plate 32, and the bottleneck is clamped. With the help of the lifting force of the slope, the plastic cover is opened.

[0041] In addition, Figures 1 to 9As shown, the sterile operation cabin 1 is used to provide a sterile environment for the inoculation operation of the test sample; the sterile inspection and inoculation device 2 is used to automatically complete the opening, liquid collection and inoculation of the test sample; the incubator 3 is used to perform fully automatic sterile culture and inspection of the inoculated test sample. Figure 1 The sterile operation cabin 1 is connected to the incubator 3 through an inflatable sealing door 4, and the sterile inspection inoculation device 2 is installed in the sterile operation cabin 1. A mechanical arm 36 is arranged in the sterile operation cabin 1. The incubator 3 is characterized in that a rotating main shaft 43 is arranged in the incubator device 5, and a plurality of fixed frames 44 are arranged in the circumference of the rotating main shaft 43. The fixed frame 44 is provided with a plurality of placement frames in the up and down directions, and a driving member drives the rotating main shaft 43 to rotate. Figure 3 , Figure 5 and Figure 6 The inoculation bottle setting seat 8 shown is a fixing mechanism for the inoculation bottle, the sampling bottle setting seat 9 is a fixing mechanism for the sampling bottle, and the puncture sampling device 11 is the main component of the patent. The puncture sampling device 11 is adapted to the syringe specifications as needed, and the syringe clamp 13 is used to clamp the syringe 15, and the power source is not limited to pneumatic or electric. The syringe piston clamping device 17 is not limited to Y-type clamp structure, parallel clamp structure, 180° clamp structure, etc., and the power is not limited to pneumatic or electric. In addition, the electric push cylinder 20 can also use other pushing devices such as cylinders. The opening device 10, the fixation of the syringe bottle 33 during the opening process is not limited to the bottleneck, but also includes bottle body clamping and other methods. Its opening power is not limited to pneumatic or electric. The inoculation bottle setting seat 8 is a fixing mechanism for the inoculation bottle, and the sampling bottle setting seat 9 is a fixing mechanism for the sampling bottle, and its clamping setting force is not limited to pneumatic or electric. The horizontal transplanting device 7 and the vertical transplanting device 14 are not limited to pneumatic or electric. Figure 1 The invention is not limited to the implementation range of the linear transplanting mechanism.

[0042] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions recorded in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the invention should be included in the protection scope of the present invention.

Claims

1. A drug sterility testing and culture device, characterized in that: It comprises a sterile operation cabin, in which a sterile inspection and inoculation device is arranged, a culture box is arranged on the side of the sterile operation cabin, a sealing door is arranged between the culture box and the sterile operation cabin, a culture device is arranged in the culture box, and a detection device is arranged on the side of the culture device.

2. A drug sterility testing and culture device according to claim 1, characterized in that: The sterility inspection inoculation device comprises a horizontal transplanting device, on which an inoculation bottle setting seat and a sampling bottle setting seat are arranged, and a cover opening device is arranged on one side, and the sampling bottle setting seat and the inoculation bottle setting seat are in the same straight line.

3. A drug sterility testing and culture device according to claim 1 or 2, characterized in that: The sterility inspection and vaccination device also includes a puncture sampling device, which includes a first mounting plate, a syringe clamp is provided at one end of the first mounting plate, and a vertical transfer device is provided at the other end, the syringe clamp is connected to a syringe through the first mounting plate, a second mounting plate is provided between the syringe clamp and the vertical transfer device, a syringe piston clamping device is provided on the second mounting plate, a guide shaft is provided under the second mounting plate, a pushing device is provided under the first mounting plate, the pushing device is located on the side of the guide shaft, and a code scanning device is provided on the side of the vertical transfer device.

4. A drug sterility testing and culture device according to claim 2, characterized in that: The inoculation bottle setting seat includes an inoculation bottle cylinder located at the bottom, and an inoculation bottle clamp is arranged above the inoculation bottle cylinder.

5. A drug sterility testing and culture device according to claim 2, characterized in that: The sampling bottle setting seat comprises a sampling bottle cylinder located at the bottom, and a sampling bottle clamp is arranged above the sampling bottle cylinder.

6. A drug sterility testing and culture device according to claim 2, characterized in that: The cover opening device comprises a cover opening mounting base, a connecting plate is provided on one side of the cover opening mounting base, a limiting plate is provided on the other side, a push rod is provided between the connecting plate and the cover opening mounting base, and a cover opening vertical plate is provided between the cover opening mounting base and the limiting plate.

7. A drug sterility testing and culture device according to claim 6, characterized in that: A curved opening is arranged on one side of the cover opening mounting base close to the limiting plate, a vial is arranged in the curved opening, a cover opening cylinder is arranged on the side plate of the cover opening vertical plate, and one end of the cover opening cylinder is connected to the connecting plate.

8. A drug sterility testing and culture device according to claim 1, characterized in that: A mechanical arm is also provided in the sterile operation cabin. A syringe support and a culture bottle support are provided within the movable range of the mechanical arm. The mechanical arm is located between the sterile inspection inoculation device and the culture bottle support.

9. A drug sterility testing and culture device according to claim 8, characterized in that: The sterility inspection and inoculation device is located on one side of the sterile operation cabin, and a planktonic bacteria sampler and a particle counter are provided on the other side of the sterile operation cabin. A lead tank for inspection is provided on the side of the culture bottle holder, and a waste collection tank is also provided between the sterility inspection and inoculation device and the culture bottle holder. The waste collection tank is located within the range of motion of the robotic arm.

10. A drug sterility testing and culture device according to claim 1, characterized in that: The culture device comprises a rotating main shaft, and a plurality of fixing frames are arranged in the circumferential direction of the rotating main shaft.

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