A continuous washing and sterilizing device for blow-fill-seal equipment

Abstract

The utility model relates to blow -fill -seal equipment technical field, and disclose a kind of cleaning and sterilization device of continuous blow -fill -seal equipment, comprising: filling unit, the filling unit is separately provided with cleaning and sterilization mechanism and blowdown mechanism, and filling unit is separately provided with needle outer wall cleaning and sterilization pipeline and needle inner wall cleaning and sterilization pipeline;Cleaning and sterilization mechanism includes buffer tank and pipe embryo gas filter.The cleaning and sterilization device of continuous blow -fill -seal equipment, by setting needle outer wall cleaning and sterilization pipeline, first three-way pipeline and second three-way pipeline, first three-way pipeline and second three-way pipeline are connected by hose to form needle outer wall cleaning passage;First three-way pipeline branch is equipped with diaphragm valve two, and second three-way pipeline branch is equipped with diaphragm valve one linkage, synchronously clean needle inner wall and outer wall and extrusion die gap, thoroughly eliminate secondary pollution risk caused by outer wall attached impurities.

Description

Technical Field

[0001] This utility model relates to the field of blow-fill-seal equipment technology, specifically a cleaning and sterilization device for continuous blow-fill-seal equipment. Background Technology

[0002] Blow-Fill-Seal (BFS) technology requires that the production process be carried out in accordance with the requirements for sterile pharmaceuticals in GMP. It must meet the quality and intended use requirements of the corresponding pharmaceutical products. Referring to the 2022 edition of EU GMP, it specifies the requirements for the environment related to sterility assurance, the selection of plastic granules, the design and production requirements of pharmaceutical packaging containers, and the confirmation and validation of process parameters. Therefore, online sterilization devices and methods make this sterilization process more compliant with regulatory requirements and are applied in the fields of cosmetics, pharmaceutical packaging, and medical equipment.

[0003] Blow-fill-seal equipment must possess online cleaning (CIP) and online sterilization (SIP) functions to ensure aseptic conditions during production. After online CIP / SIP, the system is protected by positive pressure, making the filling system equivalent to a sterile closed system. Conventional continuous blow-fill-seal equipment's sterilization devices only clean and sterilize the inner wall of the filling needle. However, in actual production, as the filling needle passes through the extruded plastic preform, paraffin wax and other impurities adhere to its outer wall. After prolonged use, the outer surface and inner hole of the filling needle will yellow, eventually turning black at the bottom of the extruder and on the surface of the filling needle. The extruder die supplies clean, sterile air to the preform through the gap between the filling needle and the die's needle hole, ensuring the preform is supported. When the filling needle passes through the extrusion die and moves up and down relative to the plastic guide sleeve, tiny particles generated by friction can adhere to the surface of the filling needle. These particles, when inserted into the preform during production, pose a risk of secondary contamination. Utility Model Content

[0004] To address the shortcomings of existing technologies, this invention provides a cleaning and sterilization device for a continuous blow-fill-seal equipment, solving the problems mentioned in the background.

[0005] This utility model provides the following technical solution: a cleaning and sterilization device for a continuous blow-fill-seal equipment, comprising:

[0006] The filling unit is equipped with a cleaning and sterilization mechanism and a sewage discharge mechanism. The filling unit is also equipped with a cleaning and sterilization pipeline for the outer wall of the filling needle and a cleaning and sterilization pipeline for the inner wall of the filling needle.

[0007] The cleaning and sterilization mechanism includes a buffer tank and a tube preform gas filter. The filling unit is equipped with a first three-way pipe, and the front end of the air inlet hose of the tube preform gas filter is equipped with a second three-way pipe. The first three-way pipe and the second three-way pipe are connected by a hose to form a cleaning channel on the outer wall of the filling needle. A second diaphragm valve is provided on a branch of the first three-way pipe, and a first diaphragm valve is provided on a branch of the second three-way pipe.

[0008] Preferably, when diaphragm valve one is closed and diaphragm valve two is open, the buffer tank is connected to the outer wall cleaning and sterilization pipeline and the inner wall cleaning and sterilization pipeline of the filling needle, respectively; when diaphragm valve one is open, the buffer tank is connected to the tube preform gas filter.

[0009] The bottom end of the filling unit is connected to an extrusion die, and the bottom end of the extrusion die is connected to a sterilization cup assembly. The sterilization cup assembly has a receiving cavity, and the lower end of the filling needle is inserted into the receiving cavity during cleaning.

[0010] Preferably, the filling unit includes a liquid inlet vent valve block, and a first three-way pipe is disposed between the liquid inlet vent valve block and the buffer tank;

[0011] The bottom of the liquid inlet vent valve block is connected to the filling needle assembly. The filling needle assembly is connected to the filling needle cleaning and sterilization sealing cover. The bottom end of the filling needle cleaning and sterilization sealing cover is connected to the filling needle cleaning and sterilization return water plate. The bottom end of the filling needle cleaning and sterilization return water plate is connected to the filling head support. The top end of the filling head support is equipped with an air seal mounting plate, and the air seal mounting plate is connected to the surface of the filling needle cleaning and sterilization return water plate. The bottom end of the filling head support is connected to an extrusion die. The sterilization cup assembly has a receiving cavity, and the lower end of the filling needle body is inserted into the receiving cavity.

[0012] Preferably, the injection needle assembly includes an injection needle mounting plate and an injection needle body installed within the injection needle mounting plate, the injection needle mounting plate being installed at the bottom of the drug inlet vent valve block.

[0013] Preferably, the air seal mounting plate has an installation groove, and the inner wall of the installation groove is connected to an inflatable sealing ring. The surface of the air seal mounting plate has an installation hole that communicates with the installation groove, and the inner wall of the installation hole is connected to an air seal pressure plate. The air nozzle of the inflatable sealing ring is located on the inner wall of the air seal pressure plate, and the inner side of the inflatable sealing ring has a serrated structure.

[0014] Preferably, the sewage discharge mechanism includes a main sewage discharge pipeline, a diaphragm valve three is provided on the connecting pipeline between the main sewage discharge pipeline and the sterilization cup assembly, a diversion pipeline is provided on the connecting pipeline, and a diaphragm valve four is provided on the diversion pipeline.

[0015] Preferably, the sterilization cup assembly includes a sterilization cup body, the sterilization cup body having a receiving cavity, and the dispensing needle is inserted into the receiving cavity as it descends;

[0016] The adjustment mechanism includes a sterilization cup adjusting rod, a sterilization cup guide seat, a sterilization cup guide block, an adjusting rod fixing block, and a sterilization cup mounting seat installed on the surface of the sterilization cup body. The sterilization cup guide seat is fixed on the sterilization cup mounting seat. The adjusting rod fixing block is installed on the side of the sterilization cup guide seat. The sterilization cup adjusting rod is installed on the adjusting rod fixing block. The surface of the sterilization cup adjusting rod is threadedly connected to the inner wall of the sterilization cup guide block. The sterilization cup guide block is installed inside the sterilization cup guide seat. The top of the sterilization cup guide block is provided with a first inclined surface, and the bottom of the sterilization cup body is provided with a second inclined surface. The first inclined surface and the second inclined surface are in contact.

[0017] The sterilization cup body is equipped with an adjustment mechanism and a sealing ring that contacts the extrusion die. When the sterilization cup adjustment rod is rotated, the sterilization cup guide block moves laterally along the screw structure. Through the cooperation of the first inclined surface and the second inclined surface, the sterilization cup body is pushed vertically up and down. When the sterilization cup body moves upward, it presses the sealing ring and forms a seal with the bottom of the extrusion die. One end of the sterilization cup adjustment rod passes through the adjustment rod fixing block, and an elastic retaining ring is installed on the surface of the sterilization cup adjustment rod. The elastic retaining ring is located on the side of the adjustment rod fixing block near the sterilization cup guide block. The sealing surface of the sterilization cup body is provided with a dovetail groove, and the sealing ring is installed in the dovetail groove.

[0018] Preferably, the sterilization cup assembly further includes two sterilization cup locking plates, which are respectively fixed to both sides of the sterilization cup mounting base.

[0019] Preferably, the sterilization cup assembly further includes an indexing pin and a sterilization cup guide groove;

[0020] The end of the sterilization cup locking plate is connected to the inner wall of the sterilization cup guide groove. The indexing pin is set on the sterilization cup guide groove and has an internal spring reset structure for quickly positioning the sterilization cup body. The lower end of the indexing pin is provided with a pull ring, which can be pulled and rotated 90 degrees to retract the internal pin and release the restriction on the sterilization cup body.

[0021] Preferably, a sterilization cup adapter is installed on the surface of the sterilization cup body, one end of the sterilization cup adapter is equipped with a quick connector, and one end of the quick connector is equipped with a quick pagoda connector, the quick connector and the quick pagoda connector forming a quick-connect connector structure.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] 1. The cleaning and sterilization device of this continuous blow-fill-seal equipment is equipped with a cleaning and sterilization pipeline for the outer wall of the filling needle, a first three-way pipeline, and a second three-way pipeline. The first three-way pipeline and the second three-way pipeline are connected by a hose to form a cleaning channel for the outer wall of the filling needle. A second diaphragm valve is installed on a branch of the first three-way pipeline, and a first diaphragm valve is installed on a branch of the second three-way pipeline. They work together to simultaneously clean the inner and outer walls of the filling needle and the gap of the extrusion die, completely eliminating the risk of secondary contamination caused by impurities attached to the outer wall.

[0024] 2. The cleaning and sterilization device of this continuous blow-fill-seal equipment has a sewage discharge mechanism. The sewage discharge of the cleaning process is set up with two main sewage discharge lines. Diaphragm valve three and diaphragm valve four are opened at the same time to perform a rough cleaning of the main sewage discharge lines, which can shorten the cleaning time of the entire system.

[0025] 3. The cleaning and sterilization device of this continuous blow-fill-seal equipment adopts a split structure design for the filling air seal mounting plate. Normally, the air inlet connector of the inflation seal ring is installed inside the filling air seal mounting plate. Now, the filling air seal mounting plate is carved out and the mounting hole is embedded in the air seal pressure plate, which reduces the processing accuracy requirements and installation requirements, thereby improving economic efficiency. At the same time, it is convenient to replace the inflation seal ring and facilitate maintenance.

[0026] 4. The cleaning and sterilization device of this continuous blow-fill-seal equipment has an inflatable sealing ring installed on the air seal mounting plate. The outer side of the inflatable sealing ring is equipped with a limiting structure to limit the sealing ring. At the same time, the inner wall of the inflatable sealing ring has a serrated structure. Compared with conventional inner wall inflatable sealing rings, when inflated, the inflatable sealing ring can form a better seal with the cleaning and sterilization return water plate of the filling needle. At the same time, when the inflatable sealing ring is depressurized and contracted, it reduces the contact area between the inflatable sealing ring and the cleaning and sterilization return water plate of the filling needle, avoiding friction or wear and extending service life. Attached Figure Description

[0027] Figure 1 This is a schematic diagram illustrating the cleaning and sterilization principle of this utility model.

[0028] Figure 2 This is a side sectional view of the present invention.

[0029] Figure 3 This utility model Figure 2 Enlarged structural diagram at position A in the middle;

[0030] Figure 4 This is a schematic diagram of the installation structure of the inflatable sealing ring and the air-sealing pressure plate of this utility model;

[0031] Figure 5 This is a side sectional view of the sterilization cup assembly of this utility model;

[0032] Figure 6 This utility model Figure 5Enlarged structural diagram at position B in the middle;

[0033] Figure 7 This is a top view of the sterilization cup assembly of this utility model.

[0034] In the diagram: 1. Drug inlet vent valve block; 2. Filling needle mounting plate; 3. Filling needle cleaning and sterilization sealing cover plate; 4. Filling needle cleaning and sterilization return water plate; 5. Filling needle body; 6. Air seal mounting plate; 7. Filling head support seat; 8. Extrusion die head; 9. Sterilization cup body; 10. Sterilization cup adjusting rod; 11. Indexing pin; 12. Sealing ring; 13. Sterilization cup locking plate; 14. Sterilization cup guide seat; 15. Sterilization cup guide block; 16. Elastic retaining ring; 17. Adjusting rod fixing block; 8. Sterilization cup adapter; 19. Quick connector; 20. Quick pagoda connector; 21. Sterilization cup mounting base; 22. Buffer tank; 23. Diaphragm valve one; 24. Diaphragm valve two; 25. Filling needle outer wall cleaning and sterilization pipeline; 26. Sterilization cup assembly; 27. Diaphragm valve three; 28. Main drain pipeline; 29. ​​Diaphragm valve four; 30. Filling needle inner wall cleaning and sterilization pipeline; 31. Tube blank gas filter; 32. Inflatable sealing ring; 33. Air seal pressure plate; 34. Sterilization cup guide groove. Detailed Implementation

[0035] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0036] Please see Figure 1-7 A cleaning and sterilization device for a continuous blow-fill-seal equipment includes: a filling unit, a cleaning and sterilization mechanism and a sewage discharge mechanism respectively provided on the filling unit, and a cleaning and sterilization pipeline 25 for the outer wall of the filling needle and a cleaning and sterilization pipeline 30 for the inner wall of the filling needle respectively provided in the filling unit.

[0037] The cleaning and sterilization mechanism includes a buffer tank 22 and a tube preform gas filter 31. The filling unit is equipped with a first three-way pipe, and the inlet hose of the tube preform gas filter 31 is connected to a second three-way pipe via a hose to form a cleaning channel for the outer wall of the filling needle. A diaphragm valve 24 is installed on a branch of the first three-way pipe, and a diaphragm valve 23 is installed on a branch of the second three-way pipe. When diaphragm valve 23 is closed and diaphragm valve 24 is open, the buffer tank 22 is connected to both the outer wall cleaning and sterilization pipeline 25 and the inner wall cleaning and sterilization pipeline 30 of the filling needle. The outer wall cleaning and sterilization pipeline 25... 5. The inner wall cleaning and sterilization pipeline 30 of the filling needle is connected to the preform gas filter 31 when the diaphragm valve 23 is opened. The sterilization medium sterilizes the preform gas filter 31. The outer wall cleaning and sterilization pipeline 25, the first three-way pipeline and the second three-way pipeline are connected by a hose to form the outer wall cleaning channel of the filling needle. The branch of the first three-way pipeline is equipped with the second diaphragm valve 24 and the branch of the second three-way pipeline is equipped with the first diaphragm valve 23. The two valves are linked to clean the inner wall and outer wall of the filling needle and the gap of the extrusion die 8 simultaneously, so as to completely eliminate the risk of secondary contamination caused by impurities attached to the outer wall.

[0038] The bottom end of the filling unit is connected to an extrusion die 8, and the bottom end of the extrusion die 8 is connected to a sterilization cup assembly 26. The sterilization cup assembly 26 has a receiving cavity. The lower end of the filling unit is inserted into the receiving cavity. The sterilization cup body 9 has a receiving cavity inside. Unlike the conventional method of inserting a single needle into a single hole of the sterilization cup during sterilization, sterilization is carried out in a single sealed space. The receiving cavity facilitates the insertion of the filling needle into the sterilization cup body 9, which can avoid the situation of needle collision caused by assembly error. At the same time, the overall volume of the receiving cavity is large, which also facilitates the cleaning of the medium and enables rapid sewage discharge.

[0039] The filling unit includes a liquid inlet vent valve block 1, and a first three-way pipe is located between the liquid inlet vent valve block 1 and the buffer tank 22;

[0040] The bottom of the liquid inlet vent valve block 1 is connected to the filling needle assembly. The filling needle assembly is connected to the filling needle cleaning and sterilization sealing cover plate 3. The bottom end of the filling needle cleaning and sterilization sealing cover plate 3 is connected to the filling needle cleaning and sterilization return water plate 4. The bottom end of the filling needle cleaning and sterilization return water plate 4 is connected to the filling head support seat 7. The top end of the filling head support seat 7 is equipped with an air seal mounting plate 6, and the air seal mounting plate 6 is connected to the surface of the filling needle cleaning and sterilization return water plate 4. The bottom end of the filling head support seat 7 is connected to the extrusion die head 8. The sterilization cup assembly 26 has a receiving cavity. The lower end of the filling needle body 5 is inserted into the receiving cavity.

[0041] The filling needle assembly includes a filling needle mounting plate 2 and a filling needle body 5 installed within the filling needle mounting plate 2. The filling needle mounting plate 2 is installed at the bottom of the liquid inlet exhaust valve block 1. An air seal mounting plate 6 has a mounting groove, and an inflation sealing ring 32 is connected to the inner wall of the mounting groove. An installation hole communicating with the mounting groove is opened on the surface of the air seal mounting plate 6, and an air seal pressure plate 33 is connected to the inner wall of the installation hole. The air nozzle of the inflation sealing ring 32 is located on the inner wall of the air seal pressure plate 33. The inner side of the inflation sealing ring 32 has a serrated structure. The filling air seal mounting plate 6 adopts a split structure design. Usually, the air inlet connector of the inflation sealing ring 32 is installed inside the filling air seal mounting plate 6. Now, the filling air seal mounting plate 6 is drilled and the installation hole is embedded. The air seal plate 33 reduces the requirements for processing precision and installation, thereby improving economic efficiency. It also facilitates the replacement of the inflatable sealing ring 32 and makes maintenance easier. The inflatable sealing ring 32 is installed on the air seal mounting plate 6. The outer side of the inflatable sealing ring 32 is provided with a limiting structure, which can limit the sealing ring ring 12. At the same time, the inner wall of the inflatable sealing ring 32 is provided with a serrated structure. Compared with the conventional inner wall inflatable sealing ring 32, when it is inflated, it can form a better seal between the inflatable sealing ring 32 and the needle cleaning and sterilization return water plate 4. At the same time, when the inflatable sealing ring 32 is depressurized and contracted, it reduces the contact area between the inflatable sealing ring 32 and the needle cleaning and sterilization return water plate 4, avoids friction or wear, and extends the service life.

[0042] The sewage discharge mechanism includes a main sewage discharge line 28. A diaphragm valve 3 27 is installed on the connecting pipe between the main sewage discharge line 28 and the sterilization cup assembly 26. A diversion pipe is provided on the connecting pipe, and a diaphragm valve 4 29 is installed on the diversion pipe. The sewage discharge of the cleaning process is set up with two main sewage discharge lines 28. Diaphragm valves 3 27 and 4 29 are opened at the same time to perform a rough cleaning of the main sewage discharge line 28, which can shorten the cleaning time of the entire system.

[0043] Please see Figure 5-7 The sterilization cup assembly 26 includes a sterilization cup body 9, which has a receiving cavity, and the dispensing needle is inserted into the receiving cavity as it descends.

[0044] The adjustment mechanism includes a sterilization cup adjustment rod 10, a sterilization cup guide seat 14, a sterilization cup guide block 15, an adjustment rod fixing block 17, and a sterilization cup mounting seat 21 installed on the surface of the sterilization cup body 9. The sterilization cup guide seat 14 is fixed on the sterilization cup mounting seat 21. The adjustment rod fixing block 17 is installed on the side of the sterilization cup guide seat 14. The sterilization cup adjustment rod 10 is installed on the adjustment rod fixing block 17. The surface of the sterilization cup adjustment rod 10 is threadedly connected to the inner wall of the sterilization cup guide block 15. The sterilization cup guide block 15 is installed inside the sterilization cup guide seat 14. The top of the sterilization cup guide block 15 is provided with a first inclined surface, and the bottom of the sterilization cup body 9 is provided with a second inclined surface. The first inclined surface and the second inclined surface are in contact.

[0045] Please see Figure 6The sterilization cup body 9 is provided with an adjustment mechanism and a sealing ring 12 that contacts the extrusion die 8. When the sterilization cup adjustment rod 10 is rotated, the sterilization cup guide block 15 moves laterally along the screw structure. The first inclined surface and the second inclined surface cooperate to push the sterilization cup body 9 to rise and fall vertically. When the sterilization cup body 9 moves upward, it presses the sealing ring 12 to form a seal with the bottom of the extrusion die 8. One end of the sterilization cup adjustment rod 10 passes through the adjustment rod fixing block 17, and an elastic retaining ring 16 is installed on the surface of the sterilization cup adjustment rod 10. The elastic retaining ring 16 is located on the side of the adjustment rod fixing block 17 close to the sterilization cup guide block 15. The sealing surface of the sterilization cup body 9 is provided with a dovetail groove. The sealing ring 12 is installed in the dovetail groove, and the upper surface of the sealing ring (12) is located outside the dovetail groove.

[0046] Please see Figure 7 The sterilization cup assembly 26 also includes two sterilization cup locking plates 13, which are respectively fixed to both sides of the sterilization cup mounting base 21.

[0047] The sterilization cup assembly 26 also includes an indexing pin 11 and a sterilization cup guide groove 34. The end of the sterilization cup locking plate 13 is connected to the inner wall of the sterilization cup guide groove 34. The indexing pin 11 is located on the sterilization cup guide groove 34 and has an internal spring reset structure for quickly positioning the sterilization cup body 9. The lower end of the indexing pin 11 is provided with a pull ring, which can be pulled and rotated 90 degrees to retract the internal pin and release the restriction on the sterilization cup body 9.

[0048] The surface of the sterilization cup body 9 is equipped with a sterilization cup adapter 18. One end of the sterilization cup adapter 18 is equipped with a quick connector 19, and one end of the quick connector 19 is equipped with a quick pagoda connector 20. The quick connector 19 and the quick pagoda connector 20 form a quick-connect connector structure.

[0049] When the blow-fill-seal equipment needs to be cleaned, first pull down and lock the indexing pin 11 to retract the limit pin shaft, then slide the sterilization cup assembly 26 into the sterilization cup guide groove 34, then extend the limit pin shaft of the indexing pin 11, manually rotate the sterilization cup adjusting rod 10 to move the sterilization cup guide block 15 to the middle position of the adjusting rod, so that the bottom sterilization cup body 9 is pushed upward. At the same time, the sterilization cup mounting seat 21 plays a guiding role, pressing the sealing ring 12 tightly with the bottom of the extruder die head to form a seal.

[0050] The needle cleaning and sterilization sealing cover plate 3 and the needle cleaning and sterilization return water plate 4 rise to the sterilization position. The needle cleaning and sterilization return water plate 4, the needle mounting plate 2 and the needle body 5 descend and press the sealing ring on the needle cleaning and sterilization sealing cover plate 3 to form a seal. At the same time, the needle body 5 descends from inside the extruder die head into the receiving cavity of the sterilization cup body 9.

[0051] At this point, the cleaning medium is introduced into the buffer tank, first passing through the spray ball for cleaning, and then entering the filling system cleaning pipeline. Then, it enters the sterilization pipeline 30 through the drug inlet exhaust valve block 1, the filling drug channel and the inner wall of the filling needle body 5, and finally enters the sterilization cup body 9 and the main drain pipeline 28, thus completing the cleaning of the filling system pipeline and the inside of the filling needle body 5.

[0052] A first three-way pipe is introduced into the filling unit before the liquid medicine inlet. A second diaphragm valve 24 is installed on a branch of the first three-way pipe. To prevent the cleaning medium from flowing back into the tube preform gas filter housing during cleaning, a second three-way pipe is installed at the front end of the air inlet hose of the tube preform gas filter 31. A first diaphragm valve 23 is installed on a branch of the second three-way pipe. The first three-way pipe and the second three-way pipe are connected by a hose to form a cleaning channel for the outer wall of the filling needle. In this way, a new cleaning pipeline is established between the hose and the cleaning and sterilization pipeline 25 for the outer wall of the filling needle. At this time, the first diaphragm valve 23 is closed and the second diaphragm valve 24 is opened. The cleaning medium can enter the gap between the extrusion die 8 and the filling needle body 5 through this new cleaning pipeline to clean the outer wall of the filling needle body 5. Finally, it is discharged to the drain pipeline. Thus, the whole process achieves cleaning of the sterile pipeline and the inner and outer walls of the filling needle, improving the sterility guarantee.

[0053] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A cleaning and sterilization device for a continuous blow-fill-seal system, characterized in that, include: The filling unit is equipped with a cleaning and sterilization mechanism and a sewage discharge mechanism. The filling unit is equipped with a cleaning and sterilization pipeline (25) on the outer wall of the filling needle and a cleaning and sterilization pipeline (30) on the inner wall of the filling needle. The cleaning and sterilization mechanism includes a buffer tank (22) and a tube preform gas filter (31). The filling unit is provided with a first three-way pipe, and the front end of the air inlet hose of the tube preform gas filter (31) is provided with a second three-way pipe. The first three-way pipe and the second three-way pipe are connected by a hose to form a cleaning channel on the outer wall of the filling needle. A second diaphragm valve (24) is provided on a branch of the first three-way pipe, and a first diaphragm valve (23) is provided on a branch of the second three-way pipe.

2. The cleaning and sterilization device according to claim 1, characterized in that, When diaphragm valve one (23) is closed and diaphragm valve two (24) is open, buffer tank (22) is connected to the outer wall cleaning and sterilization pipeline (25) and the inner wall cleaning and sterilization pipeline (30) of the filling needle, respectively; when diaphragm valve one (23) is open, buffer tank (22) is connected to the tube preform gas filter (31); The bottom end of the filling unit is connected to an extrusion die (8), and the bottom end of the extrusion die (8) is connected to a sterilization cup assembly (26). The sterilization cup assembly (26) has a receiving cavity, and the lower end of the filling needle is inserted into the receiving cavity during cleaning.

3. The cleaning and sterilization device according to claim 1, characterized in that, The filling unit includes a liquid inlet vent valve block (1), and a first three-way pipe is located between the liquid inlet vent valve block (1) and the buffer tank (22); The bottom of the liquid inlet exhaust valve block (1) is connected to the injection needle assembly. The injection needle assembly is connected to the injection needle cleaning and sterilization sealing cover plate (3). The bottom end of the injection needle cleaning and sterilization sealing cover plate (3) is connected to the injection needle cleaning and sterilization return water plate (4). The bottom end of the injection needle cleaning and sterilization return water plate (4) is connected to the filling head support seat (7). The top end of the filling head support seat (7) is equipped with an air seal mounting plate (6), and the air seal mounting plate (6) is connected to the surface of the injection needle cleaning and sterilization return water plate (4). The bottom end of the filling head support seat (7) is connected to the extrusion die head (8). The sterilization cup assembly (26) has a receiving cavity. The lower end of the injection needle body (5) is inserted into the receiving cavity.

4. The cleaning and sterilization device according to claim 2, characterized in that, The injection needle assembly includes an injection needle mounting plate (2) and an injection needle body (5) installed inside the injection needle mounting plate (2). The injection needle mounting plate (2) is installed at the bottom of the drug inlet exhaust valve block (1).

5. The cleaning and sterilization device according to claim 3, characterized in that, The gas seal mounting plate (6) has an installation groove, and the inner wall of the installation groove is connected to an inflatable sealing ring (32). The surface of the gas seal mounting plate (6) has an installation hole that communicates with the installation groove, and the inner wall of the installation hole is connected to an air seal pressure plate (33). The air nozzle of the inflatable sealing ring (32) is located on the inner wall of the air seal pressure plate (33), and the inner side of the inflatable sealing ring (32) has a sawtooth structure.

6. The cleaning and sterilization device according to claim 1, characterized in that, The sewage discharge mechanism includes a main sewage discharge pipeline (28), a diaphragm valve three (27) is provided on the connecting pipeline between the main sewage discharge pipeline (28) and the sterilization cup assembly (26), a diversion pipeline is provided on the connecting pipeline, and a diaphragm valve four (29) is provided on the diversion pipeline.

7. The cleaning and sterilization device according to claim 2, characterized in that, The sterilization cup assembly (26) includes a sterilization cup body (9), which has a receiving cavity, and the injection needle is inserted into the receiving cavity as it descends; The adjustment mechanism includes a sterilization cup adjustment rod (10), a sterilization cup guide seat (14), a sterilization cup guide block (15), and an adjustment rod fixing block (17), as well as a sterilization cup mounting seat (21) installed on the surface of the sterilization cup body (9). The sterilization cup guide seat (14) is fixed on the sterilization cup mounting seat (21). The adjustment rod fixing block (17) is installed on the side of the sterilization cup guide seat (14). The sterilization cup adjustment rod (10) is installed on the adjustment rod fixing block (17). The surface of the sterilization cup adjustment rod (10) is threaded to the inner wall of the sterilization cup guide block (15). The sterilization cup guide block (15) is installed inside the sterilization cup guide seat (14). The top of the sterilization cup guide block (15) is provided with a first inclined surface, and the bottom of the sterilization cup body (9) is provided with a second inclined surface. The first inclined surface and the second inclined surface are in contact. The sterilization cup body (9) is provided with an adjustment mechanism and a sealing ring (12) that contacts the extrusion die (8). When the sterilization cup adjustment rod (10) is rotated, the sterilization cup guide block (15) moves laterally along the screw structure. The first inclined surface and the second inclined surface cooperate to push the sterilization cup body (9) vertically up and down. When the sterilization cup body (9) moves upward, it presses the sealing ring (12) and the bottom of the extrusion die (8) to form a seal. One end of the sterilization cup adjustment rod (10) passes through the adjustment rod fixing block (17), and an elastic retaining ring (16) is installed on the surface of the sterilization cup adjustment rod (10). The elastic retaining ring (16) is located on the side of the adjustment rod fixing block (17) close to the sterilization cup guide block (15). The sealing surface of the sterilization cup body (9) is provided with a dovetail groove. The sealing ring (12) is installed in the dovetail groove, and the upper surface of the sealing ring (12) is located outside the dovetail groove.

8. The cleaning and sterilization device according to claim 2, characterized in that, The sterilization cup assembly (26) also includes two sterilization cup locking plates (13), which are fixed to both sides of the sterilization cup mounting base (21).

9. The cleaning and sterilization device according to claim 2, characterized in that, The sterilization cup assembly (26) also includes an indexing pin (11) and a sterilization cup guide groove (34). The end of the sterilization cup locking plate (13) is connected to the inner wall of the sterilization cup guide groove (34). The indexing pin (11) is located on the sterilization cup guide groove (34) and has a spring reset structure inside for quickly positioning the sterilization cup body (9). The lower end of the indexing pin (11) is provided with a pull ring, which can be pulled and rotated 90 degrees to retract the internal pin and release the restriction on the sterilization cup body (9).

10. The cleaning and sterilization apparatus according to claim 7, characterized in that, The surface of the sterilization cup body (9) is equipped with a sterilization cup conversion connector (18), one end of the sterilization cup conversion connector (18) is equipped with a quick connector (19), and one end of the quick connector (19) is equipped with a quick pagoda connector (20). The quick connector (19) and the quick pagoda connector (20) form a quick-connect connector structure.

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