Automatic sterility inspection system and method for radiopharmaceuticals

Abstract

The invention discloses an automatic sterility inspection system and method for radiopharmaceuticals, and the system comprises a feeding module which is used for placing medicine bottles, culture bottles and injectors; the bottle opening mechanism is used for opening the medicine bottle; a sample transfer device and an injector control device are arranged on the moving device; the sample transferring device is used for moving the medicine bottles and the culture bottles; the injector control device is used for being connected with an injector and driving a push rod on the injector to move so as to achieve extraction and injection of medicine. The culture detection module is used for placing a culture bottle and culturing the medicine; the culture detection module is provided with a camera for photographing and detecting the medicine in the culture bottle; and a waste box. High automation of the detection process is achieved, opening of medicine bottles and injection and transfer of medicine are all automatically completed in the closed machine body, harm caused by medicine radiation to personnel is effectively avoided, the whole process is high in automation degree, and operation complexity is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of radioactive drug detection, and in particular to an automated sterility inspection system and inspection method for radioactive drugs. Background Art

[0002] Radiopharmaceuticals refer to radionuclide preparations or labeled drugs used for clinical diagnosis or treatment, including medical radionuclide generators and their supporting kits, positron-type radiopharmaceuticals, radioactive implants, immediate labeled radiopharmaceuticals, radioimmunoassay kits, other reactor and accelerator radiopharmaceuticals, etc. Radiopharmaceuticals have important clinical application value, but they also have certain safety risks and require strict quality control and management.

[0003] Sterility testing of radioactive drugs is an important part of radioactive drug quality control. Its purpose is to ensure that radioactive drugs do not contain microorganisms that can reproduce and prevent infection to patients. At present, the sterility testing of radioactive drugs mainly relies on manual operation, which has the following problems:

[0004] During the sterile inspection process, operators need to directly contact radioactive drugs and are prone to radiation damage, especially for drugs containing short-half-life radionuclides, which have a high radiation intensity and pose a greater health hazard to operators. In addition, during the sterile inspection process, operators need to take out sample culture bottles many times to observe the turbidity of the culture solution and determine whether there is microbial growth. This not only increases the complexity and error of the operation, but also increases the operator's radiation exposure time and degree. Summary of the invention

[0005] The purpose of the present invention is to solve the deficiencies in the prior art and to provide an automated sterility inspection system and method for radioactive drugs.

[0006] The object of the present invention is to achieve the following technical solution: an automated sterility inspection system for radioactive drugs, comprising:

[0007] Loading module, used to place medicine bottles, culture bottles and syringes;

[0008] A bottle opening mechanism, used to open the medicine bottle;

[0009] A moving device, on which a sample moving device and a syringe control device are provided; the sample moving device is used to move medicine bottles and culture bottles; the syringe control device is used to connect with the syringe and drive the push rod on the syringe to move so as to extract and inject the medicine;

[0010] The culture detection module is used to place the culture bottle and culture the medicine; the culture detection module is provided with a detection device for judging whether the culture bottle is sterile;

[0011] Waste bin for collecting vials, culture bottles and syringes.

[0012] Preferably, it further comprises a body, a drawer is arranged on the body, and the loading module is arranged on the drawer; and an inlet and outlet corresponding to the drawer are arranged on the outer shell.

[0013] Preferably, the bottle opening mechanism includes a bottle opening component and a telescopic driving component, the bottle opening component is connected to the medicine bottle, and a connecting mechanism is provided between the bottle opening component and the telescopic driving component, and the connecting mechanism is used to control the connection or disconnection between the bottle opening component and the telescopic driving component; when the medicine bottle is opened, the telescopic driving component is connected to the bottle opening component through the connecting mechanism, and the bottle opening component is driven to move by the telescopic mechanism to open the medicine bottle.

[0014] Preferably, when the medicine bottle is a vial, the bottle opening component is provided with a bottle opening chute, one end of the bottle opening chute is the inlet end, and the other end is the bottle opening end; wedge-shaped protrusions are symmetrically provided on both sides of the bottle opening chute, and an inclined surface is provided on the wedge-shaped protrusion, the end of the inclined surface close to the inlet end is the low end, and the end of the inclined surface far from the inlet end is the high end; a cap storage groove is provided above the high end of the inclined surface; an injection hole is provided above the bottle opening end; the bottle cap on the vial is stuck in the bottle opening chute;

[0015] When opening the vial, the telescopic driving member drives the bottle opening component to move so that the bottle cap on the vial moves in the bottle opening chute along the bottle opening end direction; when the bottle cap moves from the low end on the inclined surface to the high end, the bottle cap moves upward relative to the bottle body and enters the cap storage groove, and the bottle cap is separated from the bottle body;

[0016] When the medicine bottle is an ampoule bottle, the bottle opening component is provided with a bottle mouth groove and an injection hole, and the lower end of the bottle mouth groove is provided with a cutting portion corresponding to the bottleneck of the ampoule bottle.

[0017] Preferably, the loading module is provided with a medicine bottle positioning hole for placing a medicine bottle, a syringe positioning hole for placing a syringe, and a culture bottle positioning hole for placing a culture bottle.

[0018] Preferably, the syringe control device includes a mounting plate, on which a fixed part and a lifting drive mechanism are provided, on which a movable part is provided, and the lifting drive mechanism drives the movable part to move up and down, the fixed part is provided with a first insertion gap for inserting the syringe barrel baffle on the syringe, and the movable part is provided with a second insertion gap for inserting the push rod baffle on the syringe.

[0019] Preferably, the fixed part includes a first upper pressing plate and a first lower pressing plate, and a first insertion gap is formed between the first upper pressing plate and the first lower pressing plate; the movable part includes a second upper pressing plate and a second lower pressing plate, and a second insertion gap is formed between the second upper pressing plate and the second lower pressing plate.

[0020] Preferably, the culture detection module includes a culture box body, an opening is provided at the upper end of the culture box body, and an openable and closable door panel is provided at the opening; a temperature module for adjusting the culture temperature is provided on the culture box body; a culture bottle turntable is provided in the culture box body, and the culture bottle turntable is connected to the first rotating drive device; a plurality of culture bottle placement positions are provided on the culture bottle turntable, and the culture bottle placement positions are provided with detection through holes.

[0021] Preferably, the sample transfer device comprises a second rotation drive device, and the second rotation drive device is provided with a clamping claw.

[0022] An automated sterility inspection method for radioactive drugs comprises the following specific steps:

[0023] Step 1: Place the culture bottle, medicine bottle and syringe on the loading module, and place the bottle opening component on the medicine bottle;

[0024] Step 2: Open the medicine bottle by using the bottle opening mechanism;

[0025] Step 3: The mobile device drives the syringe control device to move to the position of the syringe and connects with the syringe, and the mobile device drives the syringe to move and controls the extraction and injection of the syringe; the syringe extracts the medicine from the medicine bottle and injects the medicine into the culture bottle, and then the culture bottle is grabbed by the sample transfer device and placed in the culture detection module for culture, and one of the culture bottles on the loading module is left in place as a positive control culture bottle; after the preset culture time is reached, the culture bottle in the culture detection module is detected by the detection device;

[0026] Step 4: Take out the positive control culture bottle from the loading module and transfer it to the positive inoculation room for inoculation; after the inoculation is completed, put the positive control culture bottle back to the loading module; grab the positive control culture bottle through the sample transfer device and put it into the culture detection module for culture detection;

[0027] Step 5: After all the culture bottles are cultured and tested, the transfer device grabs all the culture bottles and puts them into the waste box.

[0028] The beneficial effects of the present invention are as follows: the present invention realizes a high degree of automation in the detection process, the opening of the medicine bottle, the injection and transfer of the medicine are all completed automatically, and are all carried out in a closed body, effectively avoiding the harm of medicine radiation to personnel, and the whole process has a high degree of automation, which greatly reduces the complexity of the operation, and also reduces the human errors caused by manual operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a schematic diagram of the external structure of the present invention.

[0030] Figure 2 It is a schematic diagram of the internal structure of the invention.

[0031] Figure 3 It is a schematic diagram of the back structure of the invention.

[0032] Figure 4 It is a structural diagram of the feeding module.

[0033] Figure 5 It is a schematic diagram of the structure of the bottle opening component when the medicine bottle is a syringe bottle.

[0034] Figure 6 It is a schematic diagram of the structure of the bottle opening component when the medicine bottle is an ampoule bottle.

[0035] Figure 7 It is a schematic diagram of the bottle opening component and the ampoule bottle when they are in cooperation.

[0036] Figure 8 It is a schematic diagram of the structure when the medicine bottle is a screw-cap bottle.

[0037] Fig. 9 Schematic diagram of the structure of the culture detection module.

[0038] Fig.10 A cross-sectional view of the culture detection module.

[0039] Fig.11 This is a schematic diagram of the structure of the culture bottle turntable.

[0040] Fig.12 A schematic diagram of the structure of a syringe.

[0041] Fig.13 It is a schematic diagram of the structure of the syringe control device.

[0042] Fig.14 It is a schematic diagram of the syringe control device connected to the controller.

[0043] Fig.15 Schematic diagram of the structure of the sample transfer device.

[0044] In the figure: 1, body, 1-1, observation window, 2, loading module, 2-1, medicine bottle positioning hole, 2-2, syringe positioning hole, 2-3, culture bottle positioning hole, 3, culture detection module, 3-1, culture box, 3-2, opening, 3-3, door panel drive member, 3-4, door panel, 3-5, door panel limit plate, 3-6, first rotation drive device, 3-7, culture bottle turntable, 3-8, detection device, 3-10, Peltier module, 3-11, culture bottle placement position, 3-12, detection through hole, 4, waste box, 6, moving device, 7, syringe control device, 7-1, mounting plate, 7-2, lifting drive mechanism, 7-3, fixing member, 7-3a, first upper pressing plate, 7-3 b. first lower pressing plate, 7-4. movable part, 7-4a. second upper pressing plate, 7-4b. second lower pressing plate, 8. sample transfer device, 8-1. second rotary drive device, 8-2. clamping claw, 9. culture bottle, 10. medicine bottle, 11. syringe, 11-1. syringe barrel baffle, 11-2. push rod baffle, 12. drawer, 13. telescopic drive member, 14. bottle opening component, 14-1. bottle opening slide, 14-2. wedge-shaped protrusion, 14-3. cover storage groove, 14-4. injection hole, 14-5. bottle mouth groove, 14-6. cutting part, 15. electromagnet, 16. armature, 17. air inlet blower, 18. air inlet static pressure chamber, 19. exhaust blower, 20. exhaust static pressure chamber. DETAILED DESCRIPTION

[0045] The following will be combined with the accompanying 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 belong to the scope of protection of the present invention.

[0046] Those skilled in the art should understand that, in the disclosure of the present invention, the orientation or position relationship indicated by the terms "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc. are based on the orientation or position relationship shown in the drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation. Therefore, the above terms should not be understood as limiting the present invention.

[0047] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the element may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0048] like Figures 1 to 15As shown, a radioactive drug automated sterility inspection system comprises:

[0049] A loading module 2, used for placing medicine bottles 10, culture bottles 9 and syringes 11;

[0050] A bottle opening mechanism, used to open the medicine bottle 10;

[0051] The moving device 6 is provided with a sample transfer device 8 and a syringe control device 7; the sample transfer device 8 is used to move the medicine bottle 10 and the culture bottle 9; the syringe control device 7 is used to connect with the syringe 11 and drive the push rod on the syringe 11 to move so as to extract and inject the medicine;

[0052] The culture detection module 3 is used to place the culture bottle 9 and culture the medicine; the culture detection module 3 is provided with a detection device 3-8 for judging whether the culture bottle is sterile, and the detection device is a camera as an example;

[0053] The waste box 4 is used to collect medicine bottles 10, culture bottles 9 and syringes 11.

[0054] Among them, the function of the loading module 2 is to carry the medicine bottle 10, the culture bottle 9 and the syringe 11. The process of placing the medicine bottle 10, the culture bottle 9 and the syringe 11 on the loading module 2 can be completed manually. The medicine bottle 10, the culture bottle 9 and the syringe 11 are all disposable items and are discarded after the detection is completed, avoiding cross-use and contamination. The culture detection module 3 can simultaneously realize the cultivation and photo detection of the medicine bottle 10. During the detection, the medicine bottle 10 is photographed and detected by the camera, and the photo of the culture solution is obtained. The turbidity of the culture solution is analyzed through the photo to determine whether there is microbial growth; during the detection process, the problem of radiation caused to personnel by close contact with the culture solution is avoided.

[0055] The present invention realizes a high degree of automation in the detection process. The opening of the medicine bottle 10, the injection and transfer of the medicine are all completed automatically and are all carried out in the closed body 1, effectively avoiding the harm of the medicine radiation to personnel. The whole process has a high degree of automation, which greatly reduces the complexity of the operation and also reduces the human errors caused by manual operation.

[0056] The present invention further comprises a body 1 , on which a drawer 12 is arranged, and a loading module 2 is arranged on the drawer 12 ; and an inlet and outlet corresponding to the drawer 12 are arranged on the outer shell.

[0057] The drawer 12 can be pulled out. When it is necessary to place the medicine bottle 10, the culture bottle 9 and the syringe 11 on the loading module 2, the drawer 12 can be pulled outward so that the drawer 12 is in the discharge position. At this time, the loading module 2 is located outside the fuselage 1, which is convenient for the placement of the medicine bottle 10, the culture bottle 9 and the syringe 11; when the placement is completed, the drawer 12 is pushed into the fuselage 1 and the drawer 12 is located in the feed position. At this time, the drawer 12 is sealed with the inlet and outlet through an inflatable sealing ring.

[0058] The outer wall panel of the fuselage 1 adopts a three-layer metal plate structure, the outermost and innermost layers are stainless steel plates, and the middle layer is a lead plate. This structure can effectively avoid radiation leakage.

[0059] The fuselage 1 is provided with an observation window 1 - 1 through which the internal operating conditions can be observed.

[0060] The bottle opening mechanism includes a bottle opening component 14 and a telescopic driving component 13. The bottle opening component 14 is connected to the medicine bottle 10. A connecting mechanism is provided between the bottle opening component 14 and the telescopic driving component 13. The connecting mechanism is used to control the connection or disconnection between the bottle opening component 14 and the telescopic driving component 13. When the medicine bottle 10 is opened, the telescopic driving component 13 is connected to the bottle opening component 14 through the connecting mechanism, and the bottle opening component 14 is driven to move by the telescopic mechanism to open the medicine bottle 10. The connecting mechanism includes an electromagnet 15 arranged on the telescopic driving component 13, and an armature 16 arranged on the bottle opening component 14 and corresponding to the electromagnet 15. When the drawer 12 is pushed in and is in the feeding position, the armature 16 on the bottle opening component 14 is close to the electromagnet 15, and the electromagnet 15 is opened and the armature 16 is sucked so that the telescopic driving component 13 and the bottle opening component 14 remain connected. In this embodiment, the telescopic driving component 13 is an electric cylinder.

[0061] Among them, when the medicine bottle 10 is a syringe bottle, the bottle opening component 14 is provided with a bottle opening slot 14-1, one end of the bottle opening slot 14-1 is the entrance end, and the other end is the bottle opening end; wedge-shaped protrusions 14-2 are symmetrically provided on both sides of the bottle opening slot 14-1, and an inclined surface is provided on the wedge-shaped protrusion 14-2, the end of the inclined surface close to the entrance end is the low end, and the end of the inclined surface away from the entrance end is the high end; a cap storage groove 14-3 is provided above the high end of the inclined surface; an injection hole 14-4 is provided above the bottle opening end; the bottle cap on the syringe bottle is stuck in the bottle opening slot 14-1.

[0062] When opening the vial, the telescopic drive member 13 drives the bottle opening member 14 to move so that the bottle cap on the vial moves along the bottle opening end direction in the bottle opening chute 14-1; when the bottle cap moves from the low end on the inclined plane to the high end, the bottle cap moves upward relative to the bottle body and enters the cap storage groove 14-3, and the bottle cap is separated from the bottle body.

[0063] Among them, after the cillin bottle is placed on the feeding component, it is necessary to put the bottle opening component 14 on the upper end of the medicine bottle 10 and make the bottle cap on the cillin bottle stuck in the bottle opening chute 14-1 on the bottle opening component 14. When the cillin bottle is not opened, the bottle cap is stuck at the entrance end of the bottle opening chute 14-1, and the bottle cap is just located at the low end of the inclined surface at this time; in the process of opening the bottle, the telescopic driving member 13 drives the bottle opening component 14 to move the cillin bottle to the bottle opening end of the bottle opening chute 14-1, and the needle on the syringe 11 can penetrate the cillin bottle through the injection hole 14-4 and extract the medicine in the cillin bottle. In the process of opening the bottle, after the bottle cap moves upward along the inclined surface and separates from the bottle body, the bottle cap is embedded in the cap storage groove 14-3, and when the cillin bottle moves to the bottle opening end, the upper end of the cillin bottle can support one side of the bottle cap so that the bottle cap will not fall.

[0064] When the medicine bottle 10 is an ampoule, the bottle opening component 14 is provided with a bottle mouth groove 14-5 and an injection hole 14-4, and the lower end of the bottle mouth groove 14-5 is provided with a cutting portion 14-6 corresponding to the bottleneck of the ampoule. The cutting portion 14-6 is a circular blade structure. When the ampoule is placed on the loading component, the bottle opening component 14 needs to be placed on the ampoule, and the bottle mouth on the ampoule is inserted into the bottle mouth groove 14-5 on the bottle opening component 14; during the bottle opening process, the bottle opening component 14 is driven to move by the telescopic driving member 13, and the bottleneck of the ampoule is cut by the cutting portion 14-6 and the bottle head of the ampoule is broken off during the movement of the bottle opening component 14; after the bottle head is broken off, the ampoule continues to move to the bottom of the injection port, and the syringe 11 extracts the medicine in the ampoule through the injection hole 14-4.

[0065] The bottle opening mechanism of the present invention can be applied to the automatic opening of two common medicine bottles 10, namely, vials and ampoule bottles.

[0066] The loading module 2 is provided with a medicine bottle positioning hole 2 - 1 for placing the medicine bottle 10 , a syringe positioning hole 2 - 2 for placing the syringe 11 , and a culture bottle positioning hole 2 - 3 for placing the culture bottle 9 .

[0067] The medicine bottle 10, the culture bottle 9, and the syringe 11 are all inserted into the medicine bottle positioning hole 2-1, the culture bottle positioning hole 2-3, and the syringe positioning hole 2-2. The medicine bottle positioning hole 2-1 is provided with a clamping mechanism for clamping the medicine bottle 10, so as to firmly place the medicine bottle 10 in the medicine bottle positioning hole 2-1 to ensure that the medicine bottle 10 will not move during the process of opening the bottle or extracting the medicine liquid. The clamping mechanism can adopt the existing technology.

[0068] The syringe control device 7 includes a mounting plate 7-1, on which a fixing part 7-3 and a lifting drive mechanism 7-2 are provided, on which a movable part 7-4 is provided, and the lifting drive mechanism 7-2 drives the movable part 7-4 to move up and down, and the fixing part 7-3 is provided with a first insertion gap for inserting the syringe baffle 11-1 on the syringe 11, and the movable part 7-4 is provided with a second insertion gap for inserting the push rod baffle 11-2 on the syringe 11.

[0069] Specifically, the fixed member 7-3 includes a first upper pressing plate 7-3a and a first lower pressing plate 7-3b, and a first insertion gap is formed between the first upper pressing plate 7-3a and the first lower pressing plate 7-3b; the movable member 7-4 includes a second upper pressing plate 7-4a and a second lower pressing plate 7-4b, and a second insertion gap is formed between the second upper pressing plate 7-4a and the second lower pressing plate 7-4b.

[0070] When the syringe 11 is connected to the syringe control device 7, the syringe control device 7 is driven by the moving device 6 to move the syringe barrel baffle 11-1 and the push rod baffle 11-2 on the syringe 11 respectively into the first insertion gap and the second insertion gap, and the push rod baffle 11-2 is driven up and down by the lifting and driving movable member 7-4 to move up and down, thereby realizing the operation of the syringe 11. In this embodiment, the lifting and driving mechanism 7-2 is a linear module.

[0071] The culture detection module 3 includes a culture box body 3-1, an opening 3-2 is provided at the upper end of the culture box body 3-1, and an openable and closable door panel 3-4 is provided at the opening 3-2; a temperature module for adjusting the culture temperature is provided on the culture box body 3-1; a culture bottle turntable 3-7 is provided in the culture box body 3-1, and the culture bottle turntable 3-7 is connected to the first rotation drive device 3-6; a plurality of culture bottle placement positions 3-11 are provided on the culture bottle turntable 3-7, and a detection through hole 3-12 is provided at the bottom of the culture bottle placement position 3-11; during the rotation of the culture bottle turntable 3-7, the culture bottles 9 placed on the culture bottle turntable 3-7 pass over the camera in turn.

[0072] Among them, the door panel 3-4 is connected to the door panel driver 3-3, and an inflatable sealing strip is provided on the door panel 3-4. The door panel driver 3-3 drives the door panel 3-4 to move, and the door panel driver 3-3 is fixed to the upper end of the culture box body 3-1. Door panel limit plates 3-5 are respectively provided on both sides of the door panel 3-4, and the movement of the door panel 3-4 is guided by the door panel limit plates 3-5. In this embodiment, the door panel driver 3-3 is an electric cylinder. The culture bottle placement positions 3-11 are arranged in a circular array on the culture bottle turntable 3-7; the culture bottle turntable 3-7 is driven to rotate by the first rotation drive device 3-6. The culture bottle 9 is placed on the culture bottle placement position 3-11. When placing the culture bottle 9 in the culture box body 3-1, the door panel 3-4 is opened first, and then the sample transfer device 8 places the culture bottles 9 one by one on the culture bottle turntable 3-7 in the culture box body 3-1. Each time a culture bottle 9 is placed, the culture bottle turntable 3-7 rotates a certain angle. The temperature module is a Peltier module 3-10, which is used to control the culture temperature in the culture box 3-1. In the present invention, there are two culture detection modules 3, one is a high temperature culture detection module 3, and the other is a low temperature culture detection module 3. The difference between the two is the difference in the internal culture temperature, and the culture temperature is controlled by the temperature module set on the culture box 3-1.

[0073] When a photographic test is required, the culture bottle 9 to be tested is rotated above the camera, and the culture solution in the culture bottle 9 is photographed and an image is obtained by the camera, and the turbidity of the culture solution is determined by the image to determine whether microorganisms are growing. The camera has its own light source to improve the clarity of the shooting.

[0074] The sample transfer device 8 includes a second rotary drive device 8-1, and a clamping claw 8-2 is provided on the second rotary drive device 8-1. The second rotary drive device 8-1 is a reduction motor, and the second rotary drive device 8-1 is used to drive the clamping claw 8-2 to rotate. The clamping claw 8-2 can be an electric clamping claw 8-2. When the medicine bottle 10 is a screw-on cap bottle, the bottle opening component 14 is a screw-on cap rubber ring, and the screw-on cap rubber ring is made of flexible materials such as rubber. The screw-on cap rubber ring is installed on the screw cap on the screw-on cap bottle, and the screw-on cap rubber ring has a gear-like structure; when the screw-on cap bottle is opened, the two sides of the screw-on cap rubber ring are clamped by the clamping claw 8-2, and then the screw-on cap rubber ring is driven to rotate by the second rotary drive device 8-1 to drive the screw-on cap on the screw-on cap bottle to rotate, thereby opening the screw-on cap; after the screw-on cap is opened, the sample transfer device 8 throws the screw-on cap into the waste bin 4.

[0075] An air inlet blower 17 and an air exhaust blower 19 are provided on the back of the fuselage 1. The air inlet blower 17 is connected to an air inlet static pressure chamber 18 in the fuselage 1, and air is introduced into the fuselage 1 through the air inlet blower 17. The air exhaust blower 19 is connected to an air exhaust static pressure chamber 20 in the fuselage 1, and air is extracted from the fuselage 1 through the air exhaust blower 19.

[0076] An automated sterility inspection method for radioactive drugs comprises the following specific steps:

[0077] Step 1: Place the culture bottle 9, medicine bottle 10 and syringe 11 on the loading module 2, and place the bottle opening component 14 on the medicine bottle 10;

[0078] Before step 1, it is necessary to prepare and inspect the consumables (syringes, culture bottles, etc.), and after the drawer is pulled out, the culture bottles 9, medicine bottles 10, and syringes 11 are placed on the loading module 2, and then the drawer is pushed in, and the inflatable sealing ring on the door panel is inflated to achieve sealing of the door panel;

[0079] After the drawer is pushed in, the photoelectric sensor arranged on the loading module 2 detects whether the culture bottle 9, the medicine bottle 10 and the syringe 11 are placed in place. After they are placed in place, the sterilization device inside the automated sterility inspection system for radioactive drugs is used to sterilize the area inside the cabin where the loading module is located to make it reach a sterile state.

[0080] Step 2: Open the medicine bottle 10 by using the bottle opening mechanism;

[0081] Step 3: The mobile device 6 drives the syringe control device 7 to move to the position of the syringe 11 and connects with the syringe 11. The mobile device 6 drives the syringe 11 to move and controls the extraction and injection of the syringe 11; the syringe 11 extracts the medicine from the medicine bottle 10 and injects the medicine into the culture bottle 9, then the sample transfer device 8 grabs the culture bottle 9 and puts the culture bottle 9 into the culture detection module 3 for culture, and one of the culture bottles 9 on the loading module 2 is left in place as a positive control culture bottle 9; after the preset culture time is reached, the culture bottle 9 in the culture detection module 3 is photographed and detected by the camera;

[0082] Step 4: Take out the positive control culture bottle 9 from the loading module 2 and transfer it to the positive inoculation chamber for inoculation; after the inoculation is completed, put the positive control culture bottle 9 back on the loading module 2; grab the positive control culture bottle 9 through the sample transfer device 8 and put it into the culture detection module 3 for culture detection;

[0083] Step 5: After the culture test of all the culture bottles 9 is completed, all the culture bottles 9 are grabbed by the transfer device and placed into the waste box 4.

[0084] The detection device can also be a photoelectric sensor or a spectral sensor. The photoelectric sensor is arranged at the bottom of the culture bottle placement position, and the spectral sensor is arranged at the side of the culture bottle placement position.

[0085] The present invention is not limited to the above-mentioned optimal implementation mode. Anyone can derive other various forms of products under the inspiration of the present invention. However, no matter what changes are made in the shape or structure, all technical solutions that are the same or similar to those of the present application fall within the protection scope of the present invention.

Claims

1. An automated sterility inspection system for radioactive drugs, characterized in that: include: Loading module, used to place medicine bottles, culture bottles and syringes; A bottle opening mechanism, used to open the medicine bottle; A moving device, on which a sample moving device and a syringe control device are provided; the sample moving device is used to move medicine bottles and culture bottles; the syringe control device is used to connect with the syringe and drive the push rod on the syringe to move so as to extract and inject the medicine; A culture detection module is used to place culture bottles and culture drugs; The culture detection module is provided with a detection device for judging whether the culture bottle is sterile; Waste bin for collecting vials, culture bottles and syringes.

2. The radioactive drug automated sterility inspection system according to claim 1, characterized in that: The utility model also comprises a body, a drawer is arranged on the body, a loading module is arranged on the drawer; and an inlet and outlet corresponding to the drawer are arranged on the shell.

3. The automated sterility inspection system for radioactive drugs according to claim 1, characterized in that: The bottle opening mechanism includes a bottle opening component and a telescopic driving component. A connecting mechanism is provided between the bottle opening component and the telescopic driving component. The connecting mechanism is used to control the connection or disconnection between the bottle opening component and the telescopic driving component. When opening the medicine bottle, the telescopic driving component is connected to the bottle opening component through the connecting mechanism, and the bottle opening component is driven to move by the telescopic mechanism to open the medicine bottle.

4. The automated sterility inspection system for radioactive drugs according to claim 3, characterized in that: When the medicine bottle is a vial, an opening slot is provided on the opening component, one end of the opening slot is the inlet end, and the other end is the bottle opening end; wedge-shaped protrusions are symmetrically provided on both sides of the opening slot, and an inclined surface is provided on the wedge-shaped protrusion, the end of the inclined surface close to the inlet end is the low end, and the end of the inclined surface away from the inlet end is the high end; a cap storage slot is provided above the high end of the inclined surface; an injection hole is provided above the bottle opening end; the bottle cap on the vial is inserted into the opening slot; when the vial is opened, the telescopic driving member drives the opening component to move so that the bottle cap on the vial moves in the opening slot along the direction of the bottle opening end; when the bottle cap moves from the low end on the inclined surface to the high end, the bottle cap moves upward relative to the bottle body and enters the cap storage slot, and the bottle cap is separated from the bottle body; When the medicine bottle is an ampoule bottle, the bottle opening component is provided with a bottle mouth groove and an injection hole, and the lower end of the bottle mouth groove is provided with a cutting portion corresponding to the bottleneck of the ampoule bottle.

5. The radioactive drug automated sterility inspection system according to claim 1, characterized in that: The loading module is provided with a medicine bottle positioning hole for placing a medicine bottle, a syringe positioning hole for placing a syringe, and a culture bottle positioning hole for placing a culture bottle.

6. The radioactive drug automated sterility inspection system according to claim 1, characterized in that: The syringe control device includes a mounting plate, on which a fixing part and a lifting drive mechanism are provided, on which a movable part is provided, and the lifting drive mechanism drives the movable part to move up and down, the fixing part is provided with a first insertion gap for inserting a syringe barrel baffle on the syringe, and the movable part is provided with a second insertion gap for inserting a push rod baffle on the syringe.

7. The radioactive drug automated sterility inspection system according to claim 6, characterized in that: The fixed part includes a first upper pressing plate and a first lower pressing plate, and a first insertion gap is formed between the first upper pressing plate and the first lower pressing plate; the movable part includes a second upper pressing plate and a second lower pressing plate, and a second insertion gap is formed between the second upper pressing plate and the second lower pressing plate.

8. The radioactive drug automated sterility inspection system according to claim 1, characterized in that: The culture detection module includes a culture box body, an opening is provided at the upper end of the culture box body, and a door panel that can be opened and closed is provided at the opening; a temperature module for adjusting the culture temperature is provided on the culture box body; a culture bottle turntable is provided in the culture box body, and the culture bottle turntable is connected to the first rotating drive device; a plurality of culture bottle placement positions are provided on the culture bottle turntable, and the culture bottle placement positions are provided with detection through holes.

9. The radioactive drug automated sterility inspection system according to claim 1, characterized in that: The sample transfer device comprises a second rotation drive device, and the second rotation drive device is provided with a clamping claw.

10. An automated sterility inspection method for radioactive drugs, based on the automated sterility inspection system for radioactive drugs according to claim 1, characterized in that: The specific steps include: Step 1: Place the culture bottle, medicine bottle and syringe on the loading module, and place the bottle opening component on the medicine bottle; Step 2: Open the medicine bottle by using the bottle opening mechanism; Step 3: The mobile device drives the syringe control device to move to the position of the syringe and connects with the syringe, and the mobile device drives the syringe to move and controls the extraction and injection of the syringe; the syringe extracts the medicine from the medicine bottle and injects the medicine into the culture bottle, and then the culture bottle is grabbed by the sample transfer device and placed in the culture detection module for culture, and one of the culture bottles on the loading module is left in place as a positive control culture bottle; after the preset culture time is reached, the culture bottle in the culture detection module is detected by the detection device; Step 4: Take out the positive control culture bottle from the loading module and transfer it to the positive inoculation room for inoculation; After the inoculation is completed, the positive control culture bottle is placed back on the loading module; the positive control culture bottle is grabbed by the sample transfer device and placed in the culture detection module for culture detection; Step 5: After all the culture bottles are cultured and tested, the transfer device grabs all the culture bottles and puts them into the waste box.

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