Microorganism detection system, method thereof and device for manufacturing and filling containers

Abstract

The embodiment of the invention provides a microbiological detection system, a microbiological detection method and equipment for manufacturing and filling a container. The microbiological detection system comprises a functional channel assembly and a microbiological detection device, the functional channel assembly is provided with a butt joint channel and a drainage pipeline, the microbiological detection device is provided with a first inlet and a first outlet, and the microbiological detection device is internally provided with a microbiological collection and detection part and a first medium conveying part; when the butt joint channel, the first inlet, the first medium conveying part, the first outlet and the drainage pipeline are communicated in sequence, the butt joint channel and the first medium conveying part are cleaned, sterilized and dried; when the butt joint channel, the first inlet, the first medium conveying part and the microorganism detection device are sequentially communicated, microorganism detection is carried out on the butt joint channel.

Description

Technical Field

[0001] The present invention relates to the field of biopharmaceutical technology, and in particular to a microorganism detection system, a device for manufacturing and filling containers, and a microorganism detection method. Background Art

[0002] Continuous blow-fill-seal technology is the continuous blowing, filling and sealing under aseptic conditions. Taking filling as an example, when filling inside a closed tube embryo, the filling area is surrounded by supporting air. This area uses compressed air that has passed through a sterilizing filter and is transported to the inside of the tube embryo through a pipe. During the aseptic production process, the tube embryo has always been in a closed state, and the air inside the tube embryo (ie, supporting air) cannot be detected online. However, Annex 1 of the 2022 EU GMP states that "for rotary equipment used for aseptic filling, the packaging material is usually closed from the environment once blow molded. The design and maintenance of the filling environment inside the packaging material should meet the static and dynamic microorganisms and suspended particle counts to meet Class A requirements" in order to verify that the supporting air meets Class A requirements.

[0003] For pipes with sterility requirements, sterile gas can be blown into the sterilized pipes and the microbial content in the gas blown out of the pipes can be detected to determine whether the pipes meet the sterility requirements. In the existing solution, the pipes that transmit gas need to be sterilized offline and then assembled, and there is a risk of contamination during the assembly process.

[0004] Therefore, there is an urgent need for a solution to detect the microbial content in the supporting air, that is, the planktonic bacteria content. Summary of the invention

[0005] Therefore, in order to overcome at least some of the defects and shortcomings in the prior art, embodiments of the present invention provide a microorganism detection system, an apparatus for manufacturing and filling containers, and a microorganism detection method.

[0006] Specifically, on the one hand, an embodiment of the present invention provides a microorganism detection system, including: a functional channel component and a microorganism detection device, the functional channel component is provided with a docking channel and a drainage pipe, the microorganism detection device is provided with a first inlet and a first outlet, and the microorganism detection device is provided with a microorganism collection and detection component and a first medium conveying component; when the docking channel, the first inlet, the first medium conveying component, the first outlet and the drainage pipe are connected in sequence, they are used to clean, sterilize and dry the docking channel and the first medium conveying component; when the docking channel, the first inlet, the first medium conveying component and the microorganism detection device are connected in sequence, they are used to perform microbial detection on the docking channel.

[0007] On the other hand, an embodiment of the present invention also provides an apparatus for manufacturing and filling containers, which includes the above-mentioned microbial detection system, and the functional channel assembly includes: a blowing, filling and sealing machine, a sterilization cup and the drainage pipe, the sterilization cup is detachably connected to the blowing, filling and sealing machine, and the sterilization cup is connected to the first inlet.

[0008] In a specific embodiment of the present invention, the microorganism detection device is a sterile cart, the first outlet is detachably connected to the drainage pipe, and the sterilization cup has a discharge outlet; the equipment for manufacturing and filling containers also includes: a second medium conveying member, one end of which is connected to the discharge outlet and the other end of which is detachably connected to the first inlet or the drainage pipe of the microorganism detection device.

[0009] In a specific embodiment of the present invention, the blowing, filling and sealing machine includes: a liquid medicine buffer tank; a filling head connected to the liquid medicine buffer tank; a filling needle connected to the filling head; an extrusion die, the extrusion die having a second inlet and a second outlet, the filling needle can pass through the extrusion die through the second inlet and the second outlet, a gas channel connecting the second inlet and the filling needle is provided in the extrusion die, the second outlet is connected to the sterilization cup; and a supporting air input device connected to the second inlet, the supporting air input device is used to filter the compressed air and output the filtered supporting air to the sterilization cup through the gas channel.

[0010] In a specific embodiment of the present invention, a supporting air transmission pipeline is further provided between the supporting air input device and the extrusion die head, and the first inlet of the microorganism detection device is detachably connected to the supporting air transmission pipeline.

[0011] In a specific embodiment of the present invention, the drainage pipe has a connecting port, the drainage port of the sterilization cup is higher than the first inlet of the microorganism detection device, the first inlet of the microorganism detection device is higher than the first outlet, and the first outlet of the microorganism detection device is higher than the connecting port.

[0012] In a specific embodiment of the present invention, the equipment for manufacturing and filling containers also includes: a compressed air input pipeline connected to the supporting air input device; the drainage pipeline includes: a main pipeline having a drainage port; a first pipeline connected between the connecting port and the main pipeline, and the first pipeline is provided with a first temperature sensor and a first steam trap; a second pipeline connected between the supporting air transmission pipeline and the main pipeline, and the second pipeline is provided with a second temperature sensor and a second steam trap; and a third pipeline connected between the compressed air input pipeline and the main pipeline, and the third pipeline is provided with a third temperature sensor and a third steam trap.

[0013] On the other hand, an embodiment of the present invention further provides a microorganism detection method, comprising: connecting a first inlet of a microorganism detection device to a docking channel of a functional channel assembly; connecting a first end of a first medium conveying member in the microorganism detection device to the first inlet, and a second end to a first outlet of the microorganism detection device; cleaning, sterilizing and drying the functional channel assembly; removing the second end of the first medium conveying member in the microorganism detection device from the first outlet, and connecting it to a microorganism collection and detection member in the microorganism detection device; inputting filtered supporting air into the functional channel assembly to control sampling and detection of the microorganism collection and detection member.

[0014] In a specific embodiment of the present invention, connecting the first inlet of the microorganism detection device to the docking channel of the functional channel assembly specifically includes: connecting the first inlet of the microorganism detection device to the sterilization cup or supporting air transmission pipeline of the functional channel assembly.

[0015] In a specific embodiment of the present invention, the microorganism detection method further includes: controlling a temperature sensor to monitor the sterilization temperature; and controlling the steam trap to be opened or closed according to the monitoring result of the temperature sensor to control the sterilization temperature to be at a preset temperature.

[0016] As can be seen from the above, the embodiment of the present invention is to configure the microorganism detection system to include a functional channel component and a microorganism detection device, the functional channel component is provided with a docking channel and a drainage pipe, the microorganism detection device is provided with a first inlet and a first outlet, a microorganism collection and detection component and a first medium conveying component, and the first medium conveying component is detachably connected to the microorganism collection and detection component, so that microorganism detection can be performed on the supporting air in the docking channel. By connecting the first medium conveying component to the first outlet, the docking channel and the first medium conveying component can be cleaned, sterilized and dried, and the operation is convenient and the structure is simple. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0018] Figure 1 and Figure 2 A schematic structural diagram of an apparatus for manufacturing and filling containers provided in an embodiment of the present invention.

[0019] Figure 3Another schematic diagram of the structure of the apparatus for manufacturing and filling containers provided in an embodiment of the present invention.

[0020] Figure 4 and Figure 5 Still another schematic structural diagram of an apparatus for manufacturing and filling containers provided in an embodiment of the present invention.

[0021] Figure 6 A schematic diagram of a process for detecting microorganisms provided in an embodiment of the present invention.

[0022] Figure 7 Another schematic diagram of the process of microorganism detection provided by an embodiment of the present invention.

[0023] Main component numbers:

[0024] 10. Equipment for making and filling containers; 11. First valve; 12. Second valve; 13. Third valve; 14. Fourth valve; 15. Fifth valve; 16. Sixth valve; 17. Seventh valve; 18. Eighth valve; 100. BFS; 110. Liquid buffer tank; 120. Filling head; 121. Filling needle; 130. Extrusion die; 131. Second inlet; 132. Second outlet; 140. Sterilization cup; 141. Exhaust outlet; 150. Support air input device; 160. Compressed air input pipeline; 170. Support air transmission Conveying pipeline; 180, sterilizing medium input device; 200, microorganism detection device; 201, first inlet; 202, first outlet; 210, microorganism collection and detection member; 220, first medium conveying member; 300, drainage pipeline; 301, first temperature sensor; 302, first steam trap; 303, second temperature sensor; 304, second steam trap; 305, third temperature sensor; 306, third steam trap; 310, main pipeline; 320, first pipeline; 321, second medium conveying member; 330, second pipeline; 340, third pipeline. DETAILED DESCRIPTION

[0025] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments described in the present invention, all other embodiments obtained by ordinary technicians in this field without creative work belong to the protection scope of the present invention.

[0026] It should be noted that all directional indications (such as up, down, left, right, front, back, top, and bottom) in the embodiments of the present invention are only used to explain the relative position relationship, movement, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly. In the embodiments of the present invention, descriptions such as "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features.

[0027] See also Figure 1 and Figure 2 The embodiments of the present invention provide a microorganism detection system, a device for manufacturing and filling containers, and a microorganism detection method. The microorganism detection method can be specifically applied to the microorganism detection system or the device for manufacturing and filling containers.

[0028] Specifically, the microorganism detection system may, for example, include a functional channel component and a microorganism detection device 200. The functional channel component may, for example, be provided with a docking channel and a drainage pipe 300. The microorganism detection device 200 may, for example, be provided with a first inlet 201 and a first outlet 202, and the microorganism detection device 200 may be provided with a microorganism collection detection member 210 and a first medium conveying member 220. The docking channel may, for example, be a functional pipeline of the functional channel component, and the functional pipeline is used to transmit sterilization medium and / or supporting air, etc., and the drainage pipe 300 is used to drain water after the docking pipeline is cleaned and sterilized. The microorganism collection detection member 210 may, for example, be used to collect supporting air and detect the content of microorganisms in the supporting air, and specifically, for example, may detect the content of floating bacteria in the supporting air. The first medium conveying member 220 may, for example, be a hose, or may, for example, be a pipeline of other materials, and the present embodiment is not limited thereto. The first medium conveying member 220 may be, for example, a hose, and the microorganism detection device 200 may be, for example, a sterile trolley. The hose may be bent by means of operating gloves on the sterile trolley so that the hose connects the first inlet 201 and the first outlet 202. The hose is cleaned, disinfected and sterilized synchronously with the functional channel assembly, which is convenient for operation. Moreover, the hose is always located in the sterile trolley, and there is no risk of contamination during the docking process.

[0029] See also Figure 2 When the docking channel, the first inlet 201, the first medium conveying member 220, the first outlet 202 and the drainage pipe 300 are connected in sequence, the docking channel and the first medium conveying member 220 are cleaned, sterilized and dried. Figure 1 When the docking channel, the first inlet 201, the first medium conveying member 220 and the microorganism detection device 200 are connected in sequence, they are used to perform microorganism detection on the docking channel.

[0030] Specifically, the docking channel can be connected to the first inlet 201, one end of the first medium conveying member 220 is connected to the first inlet 201, and the other end can be detachably connected to the microorganism detection device 200 or the first outlet 202, and the first outlet 202 is connected to the drainage pipe 300. When the functional channel assembly needs to be cleaned, sterilized and dried, the other end of the first medium conveying member 220 can be connected to the first outlet 202, and the cleaning medium, the sterilizing medium and the drying medium can be sequentially passed through the docking channel for cleaning, sterilization and drying, and the cleaning medium can be discharged from the drainage pipe 300. When microbial detection is required, the other end of the first medium conveying member 220 can be removed from the first outlet 202 and connected to the microorganism collection detection member 210, so that the microorganism collection detection member 210 can collect the supporting air of the docking channel and detect the supporting air to detect the microbial content of the supporting air passing through the docking channel.

[0031] The embodiment of the present invention configures a microorganism detection system to include a functional channel component and a microorganism detection device 200, wherein the functional channel component is provided with a docking channel and a drainage pipe 300, and the microorganism detection device 200 is provided with a first inlet 201 and a first outlet 202, as well as a microorganism collection and detection component 210 and a first medium conveying component 220. By detachably connecting the first medium conveying component 220 with the microorganism collection and detection component 210, microorganism detection can be performed on the supporting air in the docking channel. By connecting the first medium conveying component 220 with the first outlet 202, the docking channel and the first medium conveying component 220 can be cleaned, sterilized and dried, and the operation is convenient and the structure is simple.

[0032] Furthermore, the device 10 for manufacturing and filling containers provided in an embodiment of the present invention may, for example, include the microbial detection system described above. Among them, the functional channel component may, for example, include: a blowing, filling and sealing machine 100, a sterilizing cup 140 and a drainage pipe 300, the sterilizing cup 140 is detachably connected to the blowing, filling and sealing machine 100, and the sterilizing cup 140 is also connected to the first inlet 201. The blowing, filling and sealing machine 100 is used for blowing, filling and sealing in a sterile environment. During the whole process, the plastic container may be, for example, extruded from polymer particles, and then a filling material such as a liquid medicine is filled into the plastic container. By detachably connecting the sterilizing cup 140 to the blowing, filling and sealing machine 100, and connecting the sterilizing cup 140 to the first inlet 201.

[0033] When the BFS machine 100 and the sterilization cup 140 need to be cleaned, sterilized, and dried, the other end of the first medium conveying member 220 can be connected to the first outlet 202, for example, and the cleaning medium, the sterilization medium, and the drying medium can be sequentially passed through the docking channel for cleaning, sterilization, and drying, and the cleaning medium can be discharged from the drainage pipe 300. When microbial detection is required, the other end of the first medium conveying member 220 can be removed from the first outlet 202 and connected to the microbial collection and detection member 210, so that the microbial collection and detection member 210 can collect the supporting air of the sterilization cup 140 and detect the supporting air to detect the microbial content of the supporting air passing through the sterilization cup 140.

[0034] See also Figure 3 In one implementation of the present embodiment, the microorganism detection device 200 may be, for example, a sterile trolley, which is detachably connected to the sterilization cup 140 and movable. Specifically, the first outlet 202 is detachably connected to the drainage pipe 300, and the sterilization cup 140 has a discharge port 141. The device 10 for manufacturing and filling containers also includes: a second medium conveying member 321, one end of which is connected to the discharge port 141, and the other end of which is detachably connected to the first inlet 201 or the drainage pipe 300 of the microorganism detection device 200. The second medium conveying member 321 may be, for example, made of a hose material, or other materials, and the present embodiment is not limited thereto.

[0035] When microbial detection is not required, the microbial detection device 200 may not be placed next to the BFS machine 100, and the sterilization cup 140 is connected to the drainage pipe 300 through the second medium conveying member 321 to clean, sterilize and dry the BFS machine 100 and the sterilization cup 140. When microbial detection is required, the microbial detection device 200 is moved next to the BFS machine 100, the other end of the second medium conveying member 321 is connected to the first inlet 201 of the microbial detection device 200, and the first outlet 202 of the microbial detection device 200 is connected to the drainage pipe to sample and detect the support air.

[0036] Further, the blow-fill-seal integrated machine 100 may, for example, include: a liquid medicine buffer tank 110, a filling head 120, a filling needle 121, an extrusion die 130, and a supporting air input device 150. The liquid medicine buffer tank 110 is used to store liquid medicine. The filling head 120 is connected to the liquid medicine buffer tank 110, and the filling needle 121 is connected to the filling head 120. The extrusion die 130 has a second inlet 131 and a second outlet 132, and the second inlet 131 and the second outlet 132 may, for example, be arranged at opposite ends of the extrusion die 130, and the filling needle 121 may pass through the extrusion die 130 through the second inlet 131 and the second outlet 132, and a gas channel connecting the second inlet 131 and the filling needle 121 is arranged in the extrusion die 130, and the second outlet 132 is connected to the sterilization cup 140. The supporting air input device 150 is connected to the second inlet 131. The supporting air input device 150 may be, for example, a supporting air filter for filtering the compressed air and outputting the filtered supporting air to the sterilization cup 140 through the gas channel. The supporting air passes through the gas channel in the extrusion die 130 and the sterilization cup 140 in sequence.

[0037] In one implementation of this embodiment, the drainage pipe 300 has a connection port, and the discharge port 141 of the sterilization cup 140 may be, for example, higher than the first inlet 201 of the microorganism detection device 200, the first inlet 201 of the microorganism detection device 200 is higher than the first outlet 202, and the first outlet 202 of the microorganism detection device 200 is higher than the connection port. By forming a slope with the discharge port 141, the first inlet 201, the first outlet 202 and the connection port, it is convenient to discharge condensed water, and the discharge efficiency of condensed water can be improved.

[0038] Further, the device 10 for manufacturing and filling containers may, for example, further include: a compressed air input pipeline 160 and a supporting air transmission pipeline 170, wherein the compressed air input pipeline 160 is connected to the supporting air input device 150, and the compressed air can enter the supporting air input device 150 through the compressed air input pipeline 160, and the supporting air transmission pipeline 170 is connected between the supporting air input device 150 and the extrusion die 130, and the supporting air filtered by the supporting air input device 150 is delivered to the extrusion die 130 through the supporting air transmission pipeline 170. The drainage pipeline 300 may, for example, include: a main pipeline 310, a first pipeline 320, a second pipeline 330, and a third pipeline 340. The main pipeline 310 has a drain port; the first pipeline 320 is connected between the connection port and the main pipeline 310, and the first pipeline 320 is provided with a first temperature sensor 301 and a first steam trap 302; the second pipeline 330 is connected between the supporting air transmission pipeline 170 and the main pipeline 310, and the second pipeline 330 is provided with a second temperature sensor 303 and a second steam trap 304; and the third pipeline 340 is connected between the compressed air input pipeline 160 and the main pipeline 310, and the third pipeline 340 is provided with a third temperature sensor 305 and a third steam trap 306. The sterilization medium, such as sterilizing steam, sterilizes the pipeline, valves, and the supporting air input device 150, etc. to maintain the sterile state of the pipeline. Through the setting of the temperature sensor and the steam trap, the temperature sensor can monitor the sterilization temperature, so that the steam trap can be controlled to be opened or closed according to the monitoring result of the temperature sensor, so as to control the sterilization temperature to be at a preset temperature to ensure the sterile state of the pipeline.

[0039] Referring to the figure again, a first valve 11 is arranged between the medicine buffer tank 110 and the filling head 120, a second valve 12 is arranged between the filling head 120 and the filling needle 121, a third valve 13 is arranged near the connecting port of the first pipe 320, a fourth valve 14 is arranged on the supporting air transmission pipe 170, a fifth valve 15 is arranged on the compressed air input pipe 160, a sixth valve 16 is arranged at the connection of the third pipe 340 near the supporting air transmission pipe 170, and a seventh valve 17 is arranged near the compressed air input pipe 160.

[0040] For example, in Figure 1 In the microorganism collection and detection state shown, the fourth valve 14 and the fifth valve 15 can be, for example, in an open state, and the other valves are in a closed state, and the compressed air enters the support air input device 150 through the compressed air input pipeline 160, and the filtered support air is delivered to the extrusion die 130 via the support air transmission pipeline 170, so that the microorganism detection device 200 samples and detects the support air. Figure 2In the cleaning, sterilizing and drying states shown, the fifth valve 15 can be, for example, in a closed state, and the other valves are in an open state, and the sterilizing medium, such as steam, passes through the sterilizing medium input device 180 through the liquid buffer tank 110, and the sterilizing medium passes through the filling head 120, the filling needle 121, the extrusion die 130, the supporting air input device 150 and various pipelines for sterilization. Of course, this is only an example, and the present embodiment is not limited to this. Through the setting of the valve, the switch of the valve can be controlled according to demand to control the flow direction of the supporting air and the sterilizing medium, and then control different working states.

[0041] See also Figure 4 and Figure 5 In one implementation of this embodiment, the first inlet 201 of the microorganism detection device 200 is detachably connected to the supporting air transmission pipeline 170. In this embodiment, the first outlet 202 of the microorganism detection device 200 is connected to the drainage pipeline 300, specifically, for example, connected to the second pipeline 330, and the eighth valve 18 is also provided on the second pipeline 330.

[0042] like Figure 5 As shown, when the BFS machine 100 and the sterilization cup 140 need to be cleaned, sterilized and dried, the first inlet 201 of the microorganism detection device 200 can be connected to the supporting air transmission pipeline 170, one end of the first medium conveying member 220 is connected to the first inlet 201, and the other end is connected to the first outlet 202, and the first outlet 202 is connected to the drainage pipeline 300. Figure 4 As shown, when microorganism detection is required, the other end of the first medium conveying member 220 can be removed from the first outlet 202 and connected to the microorganism collection and detection member 210, and the discharge port 141 of the sterilization cup 140 can be blocked. In this embodiment, the filtered supporting air can enter through the liquid buffer tank 110, enter the filling head 120, the filling needle 121, the gas channel of the extrusion die 130, and the sterilization cup 140 in sequence, and then flow from the sterilization cup 140 to the extrusion die 130 and the supporting air transmission pipeline 170, and then enter the microorganism collection and detection member 210 through the first inlet 201 for microorganism detection, so that the microorganism collection and detection member 210 can collect the supporting air and detect the supporting air.

[0043] See also Figure 6 The present invention also provides a method for detecting microorganisms, which may include the following steps:

[0044] S10, connecting the first inlet of the microorganism detection device to the docking channel of the functional channel assembly;

[0045] S20, connecting a first end of a first medium conveying member in the microorganism detection device to the first inlet, and a second end thereof to a first outlet of the microorganism detection device;

[0046] S30, cleaning, sterilizing and drying the functional channel assembly;

[0047] S40, removing the second end of the first medium conveying member in the microorganism detection device from the first outlet and connecting it to the microorganism collecting and detecting member in the microorganism detection device;

[0048] S50, inputting the filtered supporting air into the functional channel assembly to control the microorganism collecting and detecting component to perform sampling and detection.

[0049] Wherein, the step 10 of connecting the first inlet of the microorganism detection device to the docking channel of the functional channel assembly specifically includes: connecting the first inlet of the microorganism detection device to the sterilization cup or supporting air transmission pipeline of the functional channel assembly.

[0050] See also Figure 7 , the microbial detection method further comprises:

[0051] S60, controlling the temperature sensor to monitor the sterilization temperature;

[0052] S70, controlling the steam trap to be opened or closed according to the monitoring result of the temperature sensor, so as to control the sterilization temperature to be at a preset temperature.

[0053] The microorganism detection method provided in this embodiment is applied to the microorganism detection system as described above or the device 10 for manufacturing and filling containers.

[0054] Specifically, the first inlet 201 of the microorganism detection device 200 can be connected to the docking channel of the functional channel assembly, specifically, for example, the sterilization cup 140 or the supporting air transmission pipeline 170 can be connected, and then the first end of the first medium conveying member 220 in the microorganism detection device 200 is connected to the first inlet 201, and the second end is connected to the first outlet 202 of the microorganism detection device 200. Then the functional channel assembly is cleaned, sterilized and dried. After the cleaning, sterilization and drying are completed, the second end of the first medium conveying member 220 in the microorganism detection device 200 is disassembled from the first outlet 202 and connected to the microorganism collection detection member 210 in the microorganism detection device 200. Then the filtered supporting air is input to the functional channel assembly, and the microorganism collection detection member 210 is controlled to sample and detect, so as to detect the microorganisms in the supporting air, such as plankton. In the microorganism detection method provided in this embodiment, the work can be controlled, for example, by disassembling and connecting between pipelines and opening and closing of valves, and the specific description of the microorganism detection system and the device 10 for manufacturing and filling containers provided in the above embodiments can be referred to.

[0055] During the sterilization process, for example, the temperature sensor can be controlled to monitor the sterilization temperature, and then the steam trap can be controlled to open or close according to the monitoring result of the temperature sensor to control the sterilization temperature to be at a preset temperature. The sterilization medium, such as sterilizing steam, sterilizes the pipeline, valves, and the supporting air input device 150, etc. to maintain the sterility of the pipeline. Through the setting of the temperature sensor and the steam trap, the temperature sensor can monitor the sterilization temperature, so that the steam trap can be controlled to open or close according to the monitoring result of the temperature sensor to control the sterilization temperature to be at a preset temperature to ensure the sterility of the pipeline.

[0056] In addition, it can be understood that the aforementioned embodiments are only exemplary descriptions of the present invention. Under the premise that the technical features do not conflict, the structures do not contradict, and the purpose of the present invention is not violated, the technical solutions of the various embodiments can be arbitrarily combined and used in combination.

[0057] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A microorganism detection system, characterized in that: include: A functional channel assembly and a microorganism detection device (200), wherein the functional channel assembly is provided with a docking channel and a drainage pipe (300), the microorganism detection device (200) is provided with a first inlet (201) and a first outlet (202), and the microorganism detection device (200) is provided with a microorganism collection and detection component (210) and a first medium conveying component (220); When the docking channel, the first inlet (201), the first medium conveying member (220), the first outlet (202) and the drainage pipe (300) are connected in sequence, the docking channel and the first medium conveying member (220) are cleaned, sterilized and dried; When the docking channel, the first inlet (201), the first medium conveying member (220) and the microorganism detection device (200) are connected in sequence, they are used to perform microorganism detection on the docking channel.

2. An apparatus (10) for manufacturing and filling containers, characterized in that It comprises the microorganism detection system as claimed in claim 1, wherein the functional channel component comprises: a blow-fill-seal machine (100), a sterilization cup (140) and the drainage pipe (300), wherein the sterilization cup (140) is detachably connected to the blow-fill-seal machine (100), and the sterilization cup (140) is connected to the first inlet (201).

3. The device (10) for manufacturing and filling containers according to claim 2, characterized in that The microorganism detection device (200) is a sterile cart, the first outlet (202) is detachably connected to the drainage pipe, and the sterilization cup (140) has a discharge outlet (141); the equipment (10) for manufacturing and filling containers also includes: A second medium conveying member (321) has one end connected to the discharge port (141) and the other end detachably connected to the first inlet (201) of the microorganism detection device (200) or the drainage pipe (300).

4. The device (10) for manufacturing and filling containers according to claim 3, characterized in that The blow-fill-seal integrated machine (100) comprises: A liquid medicine buffer tank (110); A filling head (120) connected to the drug solution buffer tank (110); A filling needle (121), connected to the filling head (120); an extrusion die (130), the extrusion die (130) having a second inlet (131) and a second outlet (132), the filling needle (121) can pass through the extrusion die (130) through the second inlet (131) and the second outlet (132), a gas channel connecting the second inlet (131) and the filling needle (121) is arranged in the extrusion die (130), and the second outlet (132) is connected to the sterilization cup (140); and A supporting air input device (150) is connected to the second inlet (131), and the supporting air input device (150) is used to filter the compressed air and output the filtered supporting air to the sterilization cup (140) through the gas channel.

5. The device (10) for manufacturing and filling containers according to claim 4, characterized in that A supporting air transmission pipeline (170) is also provided between the supporting air input device (150) and the extrusion die head (130), and the first inlet (201) of the microorganism detection device (200) is detachably connected to the supporting air transmission pipeline (170).

6. The device (10) for manufacturing and filling containers according to claim 4, characterized in that The drainage pipe (300) has a connecting port, the discharge port (141) of the sterilization cup (140) is higher than the first inlet (201) of the microorganism detection device (200), the first inlet (201) of the microorganism detection device (200) is higher than the first outlet (202), and the first outlet (202) of the microorganism detection device (200) is higher than the connecting port.

7. The device (10) for manufacturing and filling containers according to claim 5, characterized in that Also includes: A compressed air input pipeline (160) connected to the supporting air input device (150); The drainage pipeline (300) comprises: A main pipeline (310) having a drain outlet; A first pipeline (320) connected between the connection port and the main pipeline (310), and a first temperature sensor (301) and a first steam trap (302) are provided on the first pipeline (320); a second pipe (330) connected between the supporting air transmission pipe (170) and the main pipe (310), and the second pipe (330) is provided with a second temperature sensor (303) and a second steam trap (304); and The third pipeline (340) is connected between the compressed air input pipeline (160) and the main pipeline (310), and a third temperature sensor (305) and a third steam trap (306) are arranged on the third pipeline (340).

8. A method for detecting microorganisms, characterized in that: include: Connecting a first inlet of the microorganism detection device to a docking channel of the functional channel assembly; Connecting a first end of a first medium conveying member in the microorganism detection device to the first inlet and a second end thereof to a first outlet of the microorganism detection device; Cleaning, sterilizing and drying the functional channel components; The second end of the first medium conveying member in the microorganism detection device is removed from the first outlet and connected to the microorganism collecting and detecting member in the microorganism detection device; The filtered supporting air is input into the functional channel component to control the sampling and detection of the microorganism collection and detection component.

9. The microorganism detection method according to claim 8, characterized in that: The method of connecting the first inlet of the microorganism detection device to the docking channel of the functional channel assembly specifically includes: The first inlet of the microorganism detection device is connected to the sterilization cup or the supporting air transmission pipeline of the functional channel assembly.

10. The microorganism detection method according to claim 8 or 9, characterized in that: Also includes: Control temperature sensor to monitor sterilization temperature; The steam trap is controlled to be opened or closed according to the monitoring result of the temperature sensor, so as to control the sterilization temperature to be at a preset temperature.

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