A sterile filling machine for the preparation of antibody drugs

Abstract

The utility model discloses an antibody drug preparation is with aseptic filling machine, include: base, the upper surface intercommunication installation of base is separated ring, the separated ring is linked together with the base between intercommunication, the feeding sterilization mechanism is rotatably installed in the base, and the feeding inlet and the discharge port are installed in the both ends intercommunication of base respectively, make the feeding inlet and the discharge port can butt joint with the conveyer belt, and the medicine bottle that will be driven rotation supply into the aseptic chamber through the feeding inlet into the feeding sterilization mechanism, and the aseptic chamber is composed of the sealing plate and the frame board interfit, and the frame board intercommunication installation is in the upper surface department of base, and the sealing plate is fixedly installed in the frame board and is connected with the upper surface of the separated ring. The application is through the design of feeding sterilization mechanism, and the medicine bottle is automatically carried out all -round sterilization operation before being filled with medicine, and then can reduce the risk of microbial contamination medicine to the maximum extent, ensures that medicine is always in highly sterile state before filling and during filling.

Description

Technical Field

[0001] This utility model relates to the field of filling machine technology, specifically to an aseptic filling machine for antibody drug preparation. Background Technology

[0002] Antibody drugs, as an important component of biotechnology drugs, play an irreplaceable role in the treatment of tumors, autoimmune diseases, and other areas due to their high specificity and significant efficacy. However, the unique characteristics of antibody drugs dictate that their production process must meet stringent quality standards, with aseptic filling being a crucial line of defense for ensuring drug safety and efficacy. Even slight negligence can lead to drug contamination by external microorganisms and impurities, causing not only significant economic losses but also threatening the lives and health of patients.

[0003] For example, the national authorized patent announcement number CN115385285B discloses a capping system for an aseptic filling machine. This system includes a lifting mechanism, a servo motor assembly below the lifting mechanism, a transition wheel assembly connected to the servo motor assembly, and a capping mechanism connected to the transition wheel assembly. Air-feeding guide assemblies are located on both sides of the capping mechanism. This invention solves the problem of poor isolation in existing capping devices. By setting up a lifting mechanism and a capping mechanism to perform the capping process, and cooperating with the servo motor assembly and transition wheel assembly, along with the air-feeding guide assemblies, the invention maintains a sterile environment within the system. The system of this invention has good isolation performance and a light system load.

[0004] However, the aforementioned aseptic filling machine capping system cannot automatically sterilize both the outer surface and the inside of the medicine bottle before filling. This can lead to bacteria being introduced into the sterile room during the conversion process, contaminating the medicine and affecting its quality and safety. Utility Model Content

[0005] The purpose of this invention is to provide an aseptic filling machine for antibody drug preparation, so as to solve the problem mentioned in the background art that it is not possible to automatically sterilize both the outer surface and the inside of the medicine bottle before filling.

[0006] To achieve the above objectives, this utility model provides the following technical solution:

[0007] An aseptic filling machine for antibody drug preparation includes: a base, a separator ring connected to the upper surface of the base, the separator ring being connected to the base, a feeding sterilization mechanism rotatably mounted inside the base, an inlet and an outlet connected to both ends of the base respectively, allowing the inlet and outlet to connect with a conveyor belt, and a vial entering the feeding sterilization mechanism through the inlet being rotated and fed into a sterile chamber, the sterile chamber being composed of a sealing plate and a frame plate assembled together, the frame plate being connected to the upper surface of the base, and the sealing plate being fixedly installed inside the frame plate and connected to the upper surface of the separator ring, thereby creating a sealed environment inside the sterile chamber.

[0008] Preferably, an electric push rod is fixedly installed on the upper surface of the frame plate, and the piston rod of the electric push rod slides through the sealing plate in a sealed manner within the sterile chamber, and a capping filling head is fixedly installed on the lower surface of the piston rod that slides through the sterile chamber.

[0009] Preferably, one end of the sealing plate is connected to two sets of ball valves, and both sets of ball valves are connected to the sterile chamber, so that nitrogen gas can be injected into one set of ball valves to replace the air originally in the sterile chamber and discharge it to the outside through the other set of ball valves.

[0010] Preferably, the nitrogen gas filling the sterile chamber is used to remove air, reduce the incidence of oxidation reactions, and prevent the drug from deteriorating or microorganisms from being damaged by oxidation.

[0011] Preferably, a first ultraviolet irradiation lamp is fixedly installed at both ends of the sterile chamber, and the two sets of the first ultraviolet irradiation lamps are positioned opposite each other and opposite to the capping filling head and the feeding sterilization mechanism located in the sterile chamber.

[0012] Preferably, the feeding sterilization mechanism includes a turntable that rotates between a base and a partition ring. The outer surface of the turntable has four sets of filling ports, and each set of filling ports can be rotated to be flush with the feed inlet and the discharge outlet, and one end of the turntable rotates in a sealed environment within the sterile chamber.

[0013] Preferably, the lower surface of the turntable has an annular groove, and the motor is placed in the annular groove. The motor is fixedly installed on the upper surface of the base, and the output shaft of the motor is fixedly connected to the turntable.

[0014] Preferably, this causes the turntable to rotate 90° counterclockwise by the motor, which in turn causes the filling port on the outer surface to be perpendicular to the air tube and the capping filling head in sequence. The air tube is fixedly installed inside the sealing cylinder, and the sealing cylinder is fixedly installed on the inner ring wall of the separator ring and slides against the upper surface of the turntable, so that it can be flush with the rotating filling port and connected and sealed.

[0015] Preferably, the upper end of the trachea extends through the upper surface of the separator ring and is able to be filled with compressed sterile air. The trachea can deliver the compressed sterile air into the medicine bottle flush with the filling port, thereby purging and replacing the air inside the bottle. The replaced air is discharged to the outside through the air port and the air filter. The air port is connected to one end of the outer surface of the separator ring and located inside the sealed cylinder, while the air filter is connected to the other end of the air port.

[0016] Preferably, each of the filling ports is equipped with a second ultraviolet irradiation lamp embedded in it.

[0017] Compared with the prior art, the beneficial effects of this utility model are:

[0018] 1. The design incorporates a base, separator ring, electric push rod, sealing plate, sterile chamber, capping filling head, first ultraviolet irradiation lamp, and feeding sterilization mechanism. During use, the conveyor belt transporting the medicine bottles is connected to the inlet and outlet respectively. The conveyor belt then transports the medicine into the feeding sterilization mechanism. Each time the feeding sterilization mechanism rotates 90° counterclockwise, it sequentially aligns the medicine bottle with the sterilization end and capping filling head within the feeding sterilization mechanism. The sterilization end then injects compressed sterile air at high speed into the medicine bottle, rapidly replacing the original air inside and expelling any microorganisms or impurities. The air-replaced medicine bottle is then rotated into the sterile chamber, perpendicular to the capping filling head. At this point, the electric push rod on the upper surface of the frame plate activates according to a preset program, its piston rod sliding through the sealing plate, causing the capping filling head to descend smoothly. When it reaches the precise filling height, the capping filling... The filling head opens, rapidly and stably injecting a measured amount of antibody solution into the vial. After filling, the electric push rod controls the capping head to continue pressing down, using mechanical pressure to tightly press the cap onto the vial opening, completing the capping operation and ensuring a tight seal to prevent leakage and external contamination. Subsequently, the electric push rod drives the capping head to rise and reset, waiting for the next vial to enter the filling position. Then, with the continuous rotation of the feeding sterilization mechanism, another drug is conveyed to be level with the capping head, while the sealed drug is brought to be level with the discharge port, allowing the conveyor belt connected to the discharge port to carry it away. While the feeding sterilization mechanism drives the drug to rotate, it continuously sterilizes the outer surface of the vial with ultraviolet light, thus automatically performing a comprehensive sterilization operation on the vial before filling, minimizing the risk of microbial contamination and ensuring that the drug remains in a highly sterile state before and during filling.

[0019] 2. The design incorporates a motor, turntable, second ultraviolet irradiation lamp, filling port, sealing cylinder, air tube, and air filter. When the medicine bottle is conveyed into the filling port by the conveyor belt, the embedded second ultraviolet irradiation lamp immediately activates, irradiating the outer surface of the bottle with ultraviolet light to sterilize it, destroying the DNA or RNA structure of microorganisms and rendering them inactive. Subsequently, the motor can be activated to rotate the turntable 90° counterclockwise, aligning the filling port and the medicine bottle perpendicularly with the air tube fixed inside the sealing cylinder. Compressed sterile air then rushes in from the top of the air tube, quickly entering the medicine bottle. This powerful airflow rapidly replaces the existing air inside the bottle, carrying away any microorganisms and impurities that may be present, and expelling them through the air outlet. The air filter connected to the air inlet filters the exhaust gas, preventing contaminants from spreading to other areas of the filling machine. Simultaneously, the second ultraviolet lamp inside the filling port continues to operate, providing secondary ultraviolet sterilization to the inside of the vial during the air exchange process, further ensuring a sterile environment. The turntable is then driven by the motor to rotate 90° counterclockwise, guiding the filling port containing the air-exchanged and secondary-sterilized vials into the sterile chamber. It rotates to a position perpendicular to the capping filling head. Because one end of the turntable rotates within the sterile chamber, the sealed environment of the chamber is maintained. During this process, the first ultraviolet lamps, positioned opposite each other at both ends of the sterile chamber, continuously irradiate the outside of the vials. The surface is irradiated to further enhance the sterilization effect, ensuring that the vials remain highly sterile before entering the filling stage. Then, the electric pusher is activated according to a preset program. Its piston rod slides through the sealing plate, smoothly lowering the capping filling head. When the capping filling head reaches the precise filling height, it opens and rapidly and stably injects a measured amount of antibody solution into the vial. After filling, the electric pusher controls the capping filling head to continue pressing down, using mechanical pressure to tightly press the cap onto the vial opening, completing the capping operation and ensuring a tight seal to prevent leakage and external contamination. Subsequently, the electric pusher drives the capping filling head back up to its original position, awaiting the next vial to enter the filling position. The turntable can then be driven back in reverse. Rotating the clockwise 90°, the filled and capped vials are brought to the same level as the discharge port. The conveyor belt connected to the discharge port then transports the finished vials out of the filling machine and into subsequent packaging, quality inspection, and other production stages. The vials undergo initial sterilization using a second ultraviolet lamp, followed by a second ultraviolet irradiation sterilization during air exchange. This, combined with sterile air exchange, achieves comprehensive microbial elimination from the outside in, using both physical and chemical methods. The first ultraviolet lamp in the sterile chamber further enhances the sterilization of the outer surface. This multi-layered and continuous sterilization process minimizes the risk of microbial contamination, effectively ensuring the sterility and quality safety of antibody drugs, reducing drug waste due to microbial contamination, and improving drug qualification rates. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the overall structure of this utility model;

[0021] Figure 2 This is a schematic diagram of the structure of the sterile room of this utility model;

[0022] Figure 3 This is a schematic diagram of the structure of the turntable and filling port of this utility model;

[0023] Figure 4 This is a schematic diagram of the feeding and sterilization mechanism of this utility model.

[0024] In the diagram: 1. Base; 101. Separator ring; 102. Frame plate; 103. Electric push rod; 104. Sealing plate; 105. Ball valve; 106. Feed inlet; 107. Discharge outlet; 108. Aseptic chamber; 109. Capping filling head; 110. First ultraviolet irradiation lamp; 2. Feeding sterilization mechanism; 201. Turntable; 202. Air pipe; 203. Filling port; 204. Second ultraviolet irradiation lamp; 205. Sealing cylinder; 206. Air inlet; 207. Air filter; 208. Motor. Detailed Implementation

[0025] 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.

[0026] Please see Figures 1-4 This utility model provides a technical solution:

[0027] like Figures 1-2 As shown, an aseptic filling machine for antibody drug preparation includes: a base 1, a separator ring 101 connected to the upper surface of the base 1, the separator ring 101 being connected to the base 1, a feeding sterilization mechanism 2 rotatably installed inside the base 1, and an inlet 106 and an outlet 107 respectively connected to both ends of the base 1, so that the inlet 106 and the outlet 107 can be connected to the conveyor belt. The medicine bottles entering the feeding sterilization mechanism 2 through the inlet 106 are rotated and fed into the sterile chamber 108. The sterile chamber 108 is composed of a sealing plate 104 and a frame plate 102 assembled together. The frame plate 102 is connected to the upper surface of the base 1, while the sealing plate 104 is fixedly installed inside the frame plate 102 and connected to the upper surface of the separator ring 101, thereby forming a sealed environment inside the sterile chamber 108.

[0028] An electric push rod 103 is fixedly installed on the upper surface of the frame plate 102. The piston rod of the electric push rod 103 slides through the sealing plate 104 in a sealed manner and is located in the sterile chamber 108. A capping filling head 109 is fixedly installed on the lower surface of the piston rod that slides through the sterile chamber 108.

[0029] Two sets of ball valves 105 are connected to one end of the sealing plate 104, and both sets of ball valves 105 are connected to the sterile chamber 108, so that nitrogen gas can be injected into one set of ball valves 105 to replace the air originally in the sterile chamber 108 and discharge it to the outside through the other set of ball valves 105.

[0030] The nitrogen gas filling the sterile chamber 108 is used to remove air, reduce the incidence of oxidation reactions, and prevent drug deterioration or oxidative damage to microorganisms.

[0031] The sterile chamber 108 has two sets of first ultraviolet irradiation lamps 110 fixedly installed at both ends. The two sets of first ultraviolet irradiation lamps 110 are opposite to each other and are opposite to the capping filling head 109 and the feeding sterilization mechanism 2 located inside the sterile chamber 108.

[0032] Through the design of the base 1, separator ring 101, electric push rod 103, sealing plate 104, sterile chamber 108, capping filling head 109, first ultraviolet irradiation lamp 110, and feeding sterilization mechanism 2, in use, the conveyor belt for transporting medicine bottles is connected to the inlet 106 and outlet 107 respectively. The conveyor belt then transports the medicine into the feeding sterilization mechanism 2. Each time the feeding sterilization mechanism 2 is rotated 90° counterclockwise, it sequentially drives the medicine bottle to the sterilization end of the feeding sterilization mechanism 2 and the capping filling head 109 respectively. The filling head 109 is flush with the sterilization end, which then injects compressed sterile air at high speed into the bottle. This powerful airflow rapidly replaces the existing air inside the bottle, carrying away any microorganisms or impurities that may be present. The bottle, after undergoing air replacement, is rotated into the sterile chamber 108, perpendicular to the capping filling head 109. At this point, the electric push rod 103 on the upper surface of the frame plate 102 is activated according to a preset program. Its piston rod slides through the sealing plate 104, causing the capping filling head 109 to descend smoothly. When it reaches the precise filling point... When filling to the required height, the capping filling head 109 opens, rapidly and stably injecting a measured amount of antibody solution into the vial. After filling, the electric push rod 103 controls the capping filling head 109 to continue pressing down, using mechanical pressure to tightly press the cap onto the vial opening, completing the capping operation and ensuring the vial is tightly sealed to prevent leakage and external contamination. Subsequently, the electric push rod 103 drives the capping filling head 109 to rise and reset, waiting for the next vial to enter the filling position. Then, with the continuous rotation of the feeding sterilization mechanism 2, another vial can be filled. The medicine is conveyed to the level of the capping filling head 109, and the sealed medicine is driven to be level with the discharge port 107, so that the conveyor belt connected to the discharge port 107 can carry it away. At the same time, the feeding sterilization mechanism 2 drives the medicine to rotate and continuously irradiates the outer surface of the medicine bottle with ultraviolet light to sterilize it. This allows the medicine bottle to be automatically sterilized in all aspects before filling, thereby minimizing the risk of microbial contamination of the medicine and ensuring that the medicine is in a highly sterile state before and during filling.

[0033] like Figures 3-4 As shown, the feeding sterilization mechanism 2 includes a turntable 201, which rotates between the base 1 and the partition ring 101. The outer surface of the turntable 201 is provided with four sets of filling ports 203, and each set of filling ports 203 can be driven to rotate to be flush with the feed port 106 and the discharge port 107 respectively. One end of the turntable 201 is sealed and rotates in the sterile chamber 108.

[0034] A ring groove is provided on the lower surface of the turntable 201, and a motor 208 is placed in the ring groove. The motor 208 is fixedly installed on the upper surface of the base 1, and the output shaft of the motor 208 is fixedly connected to the turntable 201.

[0035] This causes the turntable 201 to rotate 90° counterclockwise each time it is driven by the motor 208, which in turn causes the filling port 203 on the outer surface to be perpendicular to the air tube 202 and the capping filling head 109. The air tube 202 is fixedly installed inside the sealing cylinder 205, and the sealing cylinder 205 is fixedly installed on the inner ring wall of the separating ring 101 and slides against the upper surface of the turntable 201, so that it can be flush with the rotating filling port 203 and connected and sealed.

[0036] The upper end of the trachea 202 extends through the upper surface of the separator ring 101 and can be filled with compressed sterile air. The trachea 202 can deliver the compressed sterile air into the medicine bottle inside the filling port 203, which is flush with it, thereby purging and replacing the air inside the bottle. The replaced air is discharged to the outside through the air port 206 and the air filter 207. The air port 206 is connected to one end of the outer surface of the separator ring 101 and located inside the sealing cylinder 205, while the air filter 207 is connected to the other end of the air port 206.

[0037] Each filling port 203 is equipped with a second ultraviolet irradiation lamp 204 installed in an embedded manner.

[0038] Through the design of the motor 208, turntable 201, second ultraviolet irradiation lamp 204, filling port 203, sealing cylinder 205, air tube 202, and air filter 207, when the medicine bottle is conveyed by the conveyor belt into the feed port 106 and filled into the filling port 203, the second ultraviolet irradiation lamp 204, which is embedded in the filling port 203, is immediately activated to irradiate and sterilize the outer surface of the medicine bottle with ultraviolet light, destroying the DNA or RNA structure of microorganisms and rendering them inactive. Subsequently, the motor 208 can be activated to drive the turntable 201 to rotate 90° counterclockwise, so that the filling port 203 and the medicine bottle are perpendicularly aligned with the air tube 202 fixed in the sealing cylinder 205. Then, compressed sterile air can be rushed in from the top of the air tube 202 and quickly enter the inside of the medicine bottle through the air tube 202. A strong airflow rapidly replaces the original air inside the bottle, carrying away any microorganisms and impurities that may be present, and expelling them through the air inlet 206. The air filter 207, connected to the air inlet 206, filters the exhaust gas to prevent contaminants from spreading to other areas of the filling machine. Simultaneously, the second ultraviolet lamp 204 inside the filling port 203 continues to operate, providing secondary ultraviolet sterilization to the inside of the bottle during the air replacement process, further ensuring a sterile environment. Then, the turntable 201 is driven by the motor 208 to rotate 90° counterclockwise, guiding the filling port 203, containing the air-replaced and secondary-sterilized bottle, into the sterile chamber 108, and rotating it to a position perpendicular to the capping filling head 109. Furthermore, since one end of the turntable 201 rotates in a sealed manner within the sterile chamber 108, the sealed environment of the sterile chamber 108 is not disrupted. During this process, the first ultraviolet irradiation lamps 110, which are positioned opposite each other at both ends within the sterile chamber 108, continuously irradiate the outer surface of the vial, further enhancing the sterilization effect and ensuring that the vial remains in a highly sterile state before entering the filling stage. Subsequently, the electric push rod 103 can be activated according to the preset program. Its piston rod slides through the sealing plate 104, driving the capping filling head 109 to descend smoothly. When the capping filling head 109 descends to the precise filling height, it opens and injects a quantitative amount of antibody solution quickly and stably into the vial. After filling is completed, the electric push rod 103 controls the capping filling head 109 to continue pressing down. Mechanical pressure is used to tightly press the bottle cap onto the bottle neck, completing the capping operation and ensuring a tight seal to prevent leakage and external contamination. Then, the electric push rod 103 drives the capping filling head 109 to rise and reset, awaiting the next bottle to enter the filling position. The turntable 201 is then rotated 90° counterclockwise, bringing the filled and capped bottle level with the discharge port 107. The conveyor belt connected to the discharge port 107 transports the finished bottle out of the filling machine for subsequent packaging, quality inspection, and other production stages. The bottle's outer surface is initially sterilized by a second ultraviolet lamp 204, followed by a second ultraviolet sterilization during air replacement. This, combined with aseptic air replacement, utilizes a combination of physical and chemical methods from the outside in.The sterilization process comprehensively eliminates microorganisms, while the first ultraviolet irradiation lamp 110 in the sterile room 108 further enhances the sterilization of the outer surface. This multi-layered and continuous sterilization method minimizes the risk of microbial contamination, effectively ensuring the sterility and quality safety of antibody drugs, reducing drug spoilage due to microbial contamination, and improving the drug qualification rate.

[0039] Based on the above technical solution, the working steps of this solution are summarized as follows: In use, the conveyor belt for transporting the medicine bottle is connected to the inlet 106 and outlet 107 respectively. The medicine bottle is then transported by the conveyor belt into the inlet 106 and filled into the filling port 203. The second ultraviolet irradiation lamp 204, embedded in the filling port 203, is immediately activated to irradiate and sterilize the outer surface of the medicine bottle with ultraviolet light, destroying the DNA or RNA structure of microorganisms and rendering them inactive. Then, the motor 208 is activated to rotate the turntable 201 counterclockwise by 90°, so that the filling port 203 and the medicine bottle are perpendicularly aligned with the air tube 202 fixed inside the sealed cylinder 205. Compressed sterile air is then allowed to rush in from the top of the air tube 202 and quickly enter through the air tube 202. The airflow enters the medicine bottle, rapidly replacing the existing air and carrying away any microorganisms or impurities through the air inlet 206. The air filter 207, connected to the air inlet 206, filters the discharged air. Simultaneously, the second ultraviolet lamp 204 inside the filling port 203 continuously operates, providing secondary ultraviolet sterilization to the inside of the medicine bottle during the air replacement process. Then, the turntable 201 is driven by the motor 208 to rotate 90° counterclockwise, guiding the filling port 203 containing the air-replaced and secondary sterilized medicine bottle into the sterile chamber 108. The turntable 201 rotates to a position perpendicular to the capping filling head 109, and because one end of the turntable 201 is sealed and rotates within the sterile chamber 108, it ensures... This ensures the sealed environment of the sterile chamber 108 remains intact. During this process, the first ultraviolet irradiation lamps 110, positioned at opposite ends within the sterile chamber 108, continuously irradiate the outer surface of the vial, further enhancing the sterilization effect. Then, the electric push rod 103 is activated according to a preset program. Its piston rod slides through the sealing plate 104, causing the capping filling head 109 to descend smoothly. When the capping filling head 109 descends to the precise filling height, it opens and rapidly and stably injects a measured amount of antibody solution into the vial. After filling, the electric push rod 103 controls the capping filling head 109 to continue pressing down, using mechanical pressure to tightly press the cap onto the vial opening, completing the capping operation and ensuring a tight seal to prevent leakage and external contamination. The electric push rod 103 drives the capping filling head 109 to rise and reset, waiting for the next vial to enter the filling position. Then, the turntable 201 can be driven to rotate 90° counterclockwise again, bringing the filled and capped vials to be flush with the discharge port 107. The conveyor belt connected to the discharge port 107 transports the finished vials out of the filling machine and into subsequent production stages such as packaging and quality inspection. At the same time, the feed port 106 continues to receive a new batch of vials to be filled brought by the conveyor, filling them into a new filling port 203, repeating the above process of ultraviolet irradiation sterilization, air replacement, filling, capping, and output. The motor 208 continuously drives the turntable 201 to operate in a cyclical manner at a rhythm of 90° rotation, realizing continuous, automated aseptic filling production of antibody drugs.

[0040] In summary, by automatically sterilizing the vials before they are filled with medication, the risk of microbial contamination of the medication can be minimized, ensuring that the medication remains in a highly sterile state before and during filling.

[0041] All parts not described in this utility model are the same as or can be implemented using existing technology. Although embodiments of this utility model 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 this utility model, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A sterile filling machine for antibody drug preparation, characterized in that, include: A base (1) has a separator ring (101) installed on its upper surface. The separator ring (101) is connected to the base (1). A feeding sterilization mechanism (2) is rotatably installed inside the base (1). An inlet (106) and an outlet (107) are respectively connected to both ends of the base (1), so that the inlet (106) and outlet (107) can be connected to the conveyor belt. The material enters the conveyor belt through the inlet (106). The medicine bottles in the sterilization mechanism (2) will be rotated and fed into the sterile chamber (108). The sterile chamber (108) is composed of a sealing plate (104) and a frame plate (102). The frame plate (102) is connected to the upper surface of the base (1), while the sealing plate (104) is fixedly installed in the frame plate (102) and connected to the upper surface of the partition ring (101), so as to form a sealed environment in the sterile chamber (108).

2. The aseptic filling machine for antibody drug preparation according to claim 1, characterized in that: An electric push rod (103) is fixedly installed on the upper surface of the frame plate (102). The piston rod of the electric push rod (103) slides through the sealing plate (104) in a sealed manner and is located in the sterile chamber (108). A capping filling head (109) is fixedly installed on the lower surface of the piston rod that slides through the sterile chamber (108).

3. The aseptic filling machine for antibody drug preparation according to claim 1, characterized in that: Two sets of ball valves (105) are connected to one end of the sealing plate (104), and both sets of ball valves (105) are connected to the sterile chamber (108), so that one set of ball valves (105) can be filled with nitrogen gas, thereby replacing the air originally in the sterile chamber (108) and discharging it to the outside through the other set of ball valves (105).

4. The aseptic filling machine for antibody drug preparation according to claim 3, characterized in that: The sterile chamber (108) is fixedly installed with a first ultraviolet irradiation lamp (110) at both ends. The two sets of the first ultraviolet irradiation lamps (110) are opposite to each other and opposite to the capping filling head (109) and the feeding sterilization mechanism (2) located in the part of the sterile chamber (108).

5. The aseptic filling machine for antibody drug preparation according to claim 1, characterized in that: The feeding sterilization mechanism (2) includes a turntable (201), which rotates between the base (1) and the separator ring (101). The outer surface of the turntable (201) is provided with four sets of filling ports (203), and each set of filling ports (203) can be driven to rotate to be flush with the feed inlet (106) and the discharge port (107), and one end of the turntable (201) is sealed and rotates in the sterile chamber (108).

6. The aseptic filling machine for antibody drug preparation according to claim 5, characterized in that: The turntable (201) has an annular groove on its lower surface, and a motor (208) is placed in the annular groove. The motor (208) is fixedly installed on the upper surface of the base (1), and the output shaft of the motor (208) is fixedly connected to the turntable (201).

7. The aseptic filling machine for antibody drug preparation according to claim 6, characterized in that: Each time the turntable (201) is driven by the motor (208) to rotate 90° counterclockwise, the filling port (203) on the outer surface will be driven to be perpendicular to the air tube (202) and the capping filling head (109) in sequence. The air tube (202) is fixedly installed inside the sealing cylinder (205). The sealing cylinder (205) is fixedly installed on the inner ring wall of the separator ring (101) and slides against the upper surface of the turntable (201) so that it can be flush with the rotating filling port (203) and connected and sealed.

8. The aseptic filling machine for antibody drug preparation according to claim 7, characterized in that: The upper end of the trachea (202) extends through the upper surface of the partition ring (101) and can be filled with compressed sterile air. The trachea (202) can deliver the compressed sterile air into the medicine bottle in the filling port (203) flush with it, thereby purging and replacing the air inside the bottle. The replaced air will be discharged to the outside through the air port (206) and the air filter (207).

9. The aseptic filling machine for antibody drug preparation according to claim 8, characterized in that: The air inlet (206) is connected to one end of the outer surface of the separator ring (101) and located inside the sealing cylinder (205), while the air filter (207) is connected to the other end of the air inlet (206).

10. The aseptic filling machine for antibody drug preparation according to claim 9, characterized in that: Each of the filling ports (203) is equipped with a second ultraviolet irradiation lamp (204) embedded in it.

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