A pre-filled syringe vacuum filling and vacuum stoppering system and a control method thereof

Abstract

The application discloses a pre-filled syringe vacuum filling and vacuum stoppering system and a control method thereof. The system comprises a filling vacuum cavity in communication with the syringe; a filling vacuum pumping unit in communication with the filling vacuum cavity and used for pumping the syringe; a filling hose used for filling the syringe with liquid medicine; a stoppering vacuum cavity in communication with the syringe; a stoppering vacuum pumping unit in communication with the stoppering vacuum cavity and used for pumping the syringe; a rubber plug feeding module used for stoppering the syringe; a vacuum breaking unit in communication with the filling vacuum cavity and the stoppering vacuum cavity; a first valve and a first sterilization filter arranged on a pipeline of the filling vacuum pumping unit and the filling vacuum cavity; a second valve and a second sterilization filter arranged on a pipeline of the stoppering vacuum pumping unit and the stoppering vacuum cavity; a third valve and a third sterilization filter arranged on a pipeline of the vacuum breaking unit and the filling vacuum cavity; and a fourth valve and a fourth sterilization filter arranged on a pipeline of the vacuum breaking unit and the stoppering vacuum cavity.

Description

Technical Field

[0001] This invention relates to the field of pre-filled syringe technology, specifically a pre-filled syringe vacuum filling and vacuum stoppering system and its control method. Background Technology

[0002] Currently, traditional injectable medications are typically stored in ampoules. To administer the medication, the ampoule is opened, and the medication is drawn from the ampoule using a disposable syringe. However, this method requires breaking the ampoule before drawing the medication, which is cumbersome. Furthermore, there is a risk of airborne bacteria entering the medication during the drawing process, posing a potential hazard to the patient. Additionally, breaking the ampoule carries the risk of glass shards being generated and mixed into the medication.

[0003] To address these issues, pre-filled syringes are increasingly being developed for drug storage. A pre-filled syringe is a device that allows injectable drugs to be directly filled into a syringe, combining the syringe and the original drug storage container into one. Drugs can be administered directly through the pre-filled syringe, eliminating the traditional process of breaking open the ampoule and drawing the medication with a disposable syringe. This simplifies the process and avoids the risk of bacteria entering the medication when drawing it from the ampoule, as well as the risk of glass fragments contaminating the medication when breaking the ampoule.

[0004] Although pre-filled syringes offer many advantages for directly storing medication, the urgent problem to be solved is how to automate the filling of medication into pre-filled syringes and seal them after filling. Summary of the Invention

[0005] The purpose of this invention is to address the problem of how to automatically fill pre-filled syringes with liquid medicine and seal them after filling. A vacuum filling and vacuum stoppering system for pre-filled syringes is designed to achieve the functions of automatically filling pre-filled syringes with liquid medicine and automatically sealing them after filling.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solution:

[0007] This invention designs a pre-filled syringe vacuum filling and vacuum stoppering system. This system is used for vacuum filling of pre-filled syringes and for vacuum stoppering of the pre-filled syringes after vacuum filling. The pre-filled syringe is provided with an inlet for vacuum filling and vacuum stoppering. The system includes the following structural configuration:

[0008] A filling vacuum chamber, which is configured to communicate with the inlet of the pre-filled syringe;

[0009] A filling vacuum unit is connected to the filling vacuum chamber, and the filling vacuum unit is used to evacuate the interior of the pre-filled syringe through the filling vacuum chamber;

[0010] A filling tube is used to fill the pre-filled syringe with liquid medicine after the internal vacuum has been evacuated, i.e., vacuum filling.

[0011] A stoppered vacuum chamber is configured to communicate with the inlet of the pre-filled syringe during vacuum stoppering;

[0012] A stopper vacuum unit is provided, which is connected to the stopper vacuum chamber. The stopper vacuum unit is used to vacuum the pre-filled syringe that has completed vacuum filling (medication liquid filling) through the stopper vacuum chamber.

[0013] A rubber stopper feeding module is used to insert a rubber stopper into the inlet of the pre-filled syringe after the vacuum is completed, i.e., vacuum stoppering;

[0014] And a vacuum breaking unit, which is connected to the filling vacuum chamber and the stoppering vacuum chamber respectively, is used to break the vacuum environment after vacuum filling and vacuum stoppering are completed, thereby realizing the separation of the filling vacuum chamber and the stoppering vacuum chamber from the pre-filled syringe respectively;

[0015] The filling vacuum unit is connected to the filling vacuum chamber via a pipeline equipped with a first valve and a first sterilization filter located near the filling vacuum chamber. The stoppering vacuum unit is connected to the stoppering vacuum chamber via a pipeline equipped with a second valve and a second sterilization filter located near the stoppering vacuum chamber. The vacuum breaking unit is connected to the filling vacuum chamber via a pipeline equipped with a third valve and a third sterilization filter located near the filling vacuum chamber. The vacuum breaking unit is connected to the stoppering vacuum chamber via a pipeline equipped with a fourth valve and a fourth sterilization filter located near the stoppering vacuum chamber.

[0016] Furthermore, a pre-filled syringe vacuum filling and vacuum stoppering system is provided: the filling tubing is connected to the filling vacuum chamber, and after the filling vacuum chamber is connected to the pre-filled syringe, the filling tubing can extend into the pre-filled syringe.

[0017] Furthermore, a pre-filled syringe vacuum filling and vacuum stoppering system: the rubber stopper is disposed in the stoppering vacuum chamber and pushed into the pre-filled syringe by the rubber stopper feeding module.

[0018] Furthermore, a pre-filled syringe vacuum filling and vacuum stoppering system: the system further includes a first vacuum probe disposed on the pipeline connecting the first valve and the first sterile filter.

[0019] Furthermore, a pre-filled syringe vacuum filling and vacuum stoppering system: the system further includes a second vacuum probe disposed on the pipeline connecting the second valve and the second sterile filter.

[0020] Furthermore, a pre-filled syringe vacuum filling and vacuum stoppering system: the system further includes a third vacuum probe, which is disposed on the pipeline between the vacuum breaking unit and the third valve and the fourth valve respectively.

[0021] Furthermore, a pre-filled syringe vacuum filling and vacuum stoppering system: the vacuum breaking unit is used to provide nitrogen gas for vacuum breaking.

[0022] The present invention also provides a control method for a pre-filled syringe vacuum filling and vacuum stoppering system, the method comprising controlling the system to perform vacuum filling of the pre-filled syringe, and controlling the system to perform vacuum stoppering of the pre-filled syringe after vacuum filling is completed;

[0023] I. Vacuum filling:

[0024] 1) Before vacuum filling, ensure that the filling vacuum chamber is tightly fitted to the inlet of the pre-filled syringe to achieve communication;

[0025] 2) Adjust the first valve and the first sterilization filter to be open, and close the other valves and sterilization filters. The filling vacuum unit evacuates the pre-filled syringe, and at the same time, the filling tubing fills the pre-filled syringe with the drug solution.

[0026] 3) After filling is completed, adjust the valve and the third sterilization filter to open, and close the other valves and sterilization filters. The vacuum breaking unit provides nitrogen gas to the pre-filled syringe through the filling vacuum chamber to break the vacuum, thereby separating the filling vacuum chamber from the pre-filled syringe.

[0027] II. Vacuum plugging:

[0028] 1) Before vacuum plugging, ensure that the plugging vacuum chamber is tightly fitted to the inlet of the pre-filled syringe to achieve communication;

[0029] 2) Adjust the valve to open the second valve and the second sterilization filter, and close the other valves and sterilization filters. The vacuuming unit evacuates the pre-filled syringe, and then the rubber stopper feeding module pushes the rubber stopper set in the vacuuming chamber into the pre-filled syringe.

[0030] 3) After the stopper is inserted, the fourth valve and the fourth sterilization filter are opened, while the other valves and sterilization filters are closed. The vacuum breaking unit supplies nitrogen gas to the pre-filled syringe through the stoppering vacuum chamber to break the vacuum, thereby separating the stoppering vacuum chamber from the pre-filled syringe. This completes the vacuum filling and vacuum stoppering process of the pre-filled syringe (the pre-filled syringe is sealed after stoppering).

[0031] The beneficial effects of this invention are:

[0032] (1) The vacuum filling and vacuum stoppering system for pre-filled syringes designed in this invention can realize the automatic filling of pre-filled syringes with medicine and the automatic stoppering (sealing) function after the medicine filling is completed, which greatly improves the filling efficiency of medicine in pre-filled syringes.

[0033] (2) The vacuum filling and vacuum plugging system for the pre-filled syringe designed in this invention can achieve simultaneous vacuuming and filling of medicine through the setting of a filling vacuum chamber, a filling vacuum unit and a filling hose. This can effectively control the air bubbles remaining at the bottom and side wall of the pre-filled syringe, thereby ensuring the consistency of the filling amount of medicine in each pre-filled syringe in the same batch when filling medicine in batches.

[0034] (3) The pre-filled syringe vacuum filling and vacuum stoppering system designed in this invention can ensure sterility during the filling and stoppering process. Attached Figure Description

[0035] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0036] Figure 1 This is a schematic diagram of a pre-filled syringe vacuum filling and vacuum stoppering system designed according to Embodiment 1 of the present invention;

[0037] Figure 2 A schematic diagram illustrating vacuum filling using a pre-filled syringe controlled by a system according to Embodiment 1 of the present invention;

[0038] Figure 3 A schematic diagram illustrating vacuum plugging of a pre-filled syringe controlled by the system of Embodiment 1 of the present invention;

[0039] Figure 4 A schematic diagram of a pre-filled syringe vacuum filling and vacuum stoppering system designed for Comparative Example 1.

[0040] The diagram shows the following labels: 1-Pre-filled syringe, 2-Filling vacuum chamber, 3-Filling vacuum unit, 4-Filling tubing, 5-Stopping vacuum chamber, 6-Stopping vacuum unit, 7-Plug feed module, 8-Plug, 9-Vacuum breaking unit, 10-Inlet, 11-First valve, 12-First sterilization filter, 13-Second valve, 14-Second sterilization filter, 15-Third valve, 16-Third sterilization filter, 17-Fourth valve, 18-Fourth sterilization filter, 19-First vacuum probe, 20-Second vacuum probe, 21-Third vacuum probe. Detailed Implementation

[0041] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit the present invention or its application or use. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0042] In the description of this invention, it should be understood that the terms "upper," "lower," "left," "right," "top," and "bottom," etc., indicating orientation or positional relationships, are merely for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first" and "second" may explicitly or implicitly include one or more of that feature. Moreover, the terms "first," "second," etc., are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein.

[0043] Example 1

[0044] like Figures 1-3 As shown, this embodiment 1 designs a pre-filled syringe vacuum filling and vacuum stoppering system. The system is used for vacuum filling (medication filling) of the pre-filled syringe 1 and for vacuum stoppering (sealing) the pre-filled syringe 1 after vacuum filling. The pre-filled syringe 1 is provided with an inlet 10 for vacuum filling and vacuum stoppering, that is, the pre-filled syringe 1 is filled with medicine and stoppered from the inlet 10.

[0045] The system includes the following specific structural configurations:

[0046] A filling vacuum chamber 2 is configured to communicate with the inlet 10 of the pre-filled syringe 1 during vacuum filling (medication filling) of the pre-filled syringe 1.

[0047] A filling vacuum unit 3 is connected to the filling vacuum chamber 2. The filling vacuum unit 3 is used to evacuate the interior of the pre-filled syringe 1 through the filling vacuum chamber 2.

[0048] A filling tube 4 is connected to the filling vacuum chamber 2, and after the filling vacuum chamber 2 is connected to the pre-filled syringe 1, one end of the filling tube 4 can extend into the pre-filled syringe 1. The filling tube 4 is used to fill the pre-filled syringe 1 with liquid medicine after the vacuum is completed, that is, to perform vacuum filling.

[0049] The stoppered vacuum chamber 5 is configured to communicate with its inlet 10 when vacuum stoppering is performed after vacuum filling of the pre-filled syringe 1;

[0050] A stoppering vacuum unit 6 is connected to the stoppering vacuum chamber 5. The stoppering vacuum unit 6 is used to vacuum the pre-filled syringe 1 that has been vacuum-filled through the stoppering vacuum chamber 5.

[0051] The rubber stopper feeding module 7 is used to insert a rubber stopper 8 into the inlet 10 of the pre-filled syringe 1 after the vacuum is completed, that is, to perform vacuum plugging; specifically, the rubber stopper 8 is disposed in the plugging vacuum chamber 5 and is pushed into the pre-filled syringe 1 by the rubber stopper feeding module 7.

[0052] And a vacuum breaking unit 9, which is connected to the filling vacuum chamber 2 and the stoppering vacuum chamber 5 respectively. The vacuum breaking unit 9 is used to provide nitrogen gas to break the vacuum environment after the pre-filled syringe 1 completes vacuum filling and vacuum stoppering, thereby realizing the separation of the filling vacuum chamber 2 and the stoppering vacuum chamber 5 from the pre-filled syringe 1 respectively.

[0053] The filling vacuum unit 3 and the filling vacuum chamber 2 are connected by a first valve 11 and a first sterilization filter 12 located close to the filling vacuum chamber 2. A first vacuum probe 19 is also provided on the pipeline connecting the first valve 11 and the first sterilization filter 12.

[0054] The stopper vacuum unit 6 and the stopper vacuum chamber 5 are connected by a second valve 13 and a second sterilization filter 14 located close to the stopper vacuum chamber 5. A second vacuum probe 20 is also provided on the pipeline connecting the second valve 13 and the second sterilization filter 14.

[0055] The pipeline connecting the vacuum breaking unit 9 to the filling vacuum chamber 2 is provided with a third valve 15 and a third sterilization filter 16 located near the filling vacuum chamber 2. The pipeline connecting the vacuum breaking unit 9 to the stoppering vacuum chamber 5 is provided with a fourth valve 17 and a fourth sterilization filter 18 located near the stoppering vacuum chamber 5. A third vacuum probe 21 is also provided on the pipeline connecting the vacuum breaking unit 9 to the pipelines connected to the third valve 15 and the fourth valve 17.

[0056] Example 2

[0057] This embodiment 2 provides a control method for a pre-filled syringe vacuum filling and vacuum stoppering system. The method includes controlling the system of embodiment 1 to perform vacuum filling on the pre-filled syringe 1, and controlling the system to perform vacuum stoppering on the pre-filled syringe 1 after vacuum filling is completed.

[0058] I. Vacuum filling:

[0059] 1) Before vacuum filling, ensure that the filling vacuum chamber 2 and the inlet 10 of the pre-filled syringe 1 are tightly fitted together to achieve communication (e.g., Figure 2 As shown in (a));

[0060] 2) Adjust the valve to open the first valve 11 and the first sterilization filter 12, and close all other valves and sterilization filters. Then, the filling vacuum unit 3 evacuates the inside of the pre-filled syringe 1 (e.g., Figure 2 (b) As shown, the filling tube 4 then fills the pre-filled syringe 1 with the drug solution (such as...). Figure 2 (c) and 2(d) are shown), so that the drug is filled while vacuuming is performed. This can effectively control the air bubbles remaining at the bottom and side wall of the pre-filled syringe 1, thereby ensuring the consistency of the drug filling volume in each pre-filled syringe 1.

[0061] 3) After the pre-filled syringe 1 completes the drug filling, the third valve 15 and the third sterilization filter 16 are opened, while all other valves and sterilization filters are closed. Then, the vacuum breaking unit 9 supplies nitrogen gas to the pre-filled syringe 1 through the filling vacuum chamber 2 to break the vacuum, thereby separating the filling vacuum chamber 2 from the pre-filled syringe 1 (e.g., Figure 2 (e) is shown), and then subsequent vacuum plugging is performed;

[0062] II. Vacuum plugging:

[0063] 1) Before vacuum-stopping the pre-filled syringe 1 after the medicine solution has been filled, ensure that the stoppering vacuum chamber 5 is tightly fitted with the inlet 10 of the pre-filled syringe 1 to achieve communication (e.g., Figure 3 (as shown in (a));

[0064] 2) Adjust the valve to open the second valve 13 and the second sterilization filter 14, and close all other valves and sterilization filters. Then, the stopper vacuum unit 6 evacuates the pre-filled syringe 1 (e.g., Figure 3 (b) As shown, the rubber stopper feeding module 7 then pushes the rubber stopper 8, which is located in the stopper vacuum chamber 5, into the pre-filled syringe 1 (as shown). Figure 3 (c) and 3(d) are shown);

[0065] 3) After the stopper is inserted, the fourth valve 17 and the fourth sterilization filter 18 are opened, while all other valves and sterilization filters are closed. Then, the vacuum breaking unit 9 supplies nitrogen gas to the pre-filled syringe 1 through the stoppering vacuum chamber 5 to break the vacuum, thereby separating the stoppering vacuum chamber 5 from the pre-filled syringe 1 (e.g., Figure 3 (e) As shown; complete the vacuum filling and vacuum stoppering process of the pre-filled syringe 1.

[0066] Comparative Example 1

[0067] like Figure 4 As shown, Comparative Example 1 provides a pre-filled syringe vacuum filling and vacuum stoppering system. This system is also used for filling the pre-filled syringe 1 with medicine and for sealing the pre-filled syringe 1 after filling. The pre-filled syringe 1 is provided with an inlet 10 for filling and stoppering.

[0068] The system includes the following specific structural configurations:

[0069] A filling vacuum chamber 2 is configured to communicate with the inlet 10 of the pre-filled syringe 1 during vacuum filling of the pre-filled syringe 1.

[0070] A filling vacuum unit 3 is connected to the filling vacuum chamber 2. The filling vacuum unit 3 is used to evacuate the interior of the pre-filled syringe 1 through the filling vacuum chamber 2.

[0071] A filling tube 4 is connected to the filling vacuum chamber 2, and after the filling vacuum chamber 2 is connected to the pre-filled syringe 1, one end of the filling tube 4 can extend into the pre-filled syringe 1. The filling tube 4 is used to fill the pre-filled syringe 1 with liquid medicine after the vacuum is completed, that is, to perform vacuum filling.

[0072] The stoppered vacuum chamber 5 is configured to communicate with its inlet 10 when vacuum stoppering is performed after vacuum filling (medication filling) of the pre-filled syringe 1;

[0073] A stoppering vacuum unit 6 is connected to the stoppering vacuum chamber 5. The stoppering vacuum unit 6 is used to vacuum the pre-filled syringe 1 that has been vacuum-filled through the stoppering vacuum chamber 5.

[0074] The rubber stopper feeding module 7 is used to insert a rubber stopper 8 into the inlet 10 of the pre-filled syringe 1 after the vacuum is completed, that is, to perform vacuum plugging; specifically, the rubber stopper 8 is disposed in the plugging vacuum chamber 5 and is pushed into the pre-filled syringe 1 by the rubber stopper feeding module 7.

[0075] And a vacuum breaking unit 9, which is connected to the filling vacuum chamber 2 and the stoppering vacuum chamber 5 respectively. The vacuum breaking unit 9 is used to provide nitrogen gas to break the vacuum environment after the pre-filled syringe 1 completes vacuum filling and vacuum stoppering, thereby realizing the separation of the filling vacuum chamber 2 and the stoppering vacuum chamber 5 from the pre-filled syringe 1 respectively.

[0076] The filling vacuum unit 3 and the filling vacuum chamber 2 are connected by a first sterilization filter 12, a first valve 11 and a first vacuum probe 19 in sequence on the pipeline, and the first vacuum probe 19 is located close to the filling vacuum chamber 2.

[0077] The pipeline connecting the stopper vacuum unit 6 and the stopper vacuum chamber 5 is provided with a second sterilization filter 14, a second valve 13 and a second vacuum probe 20 in sequence, and the second vacuum probe 20 is located close to the stopper vacuum chamber 5.

[0078] The pipeline connecting the vacuum breaking unit 9 and the filling vacuum chamber 2 is provided with a third sterilization filter 16, a third valve 15, and a first vacuum probe 19 (which shares a first vacuum probe 19 with the filling vacuum unit 3); the pipeline connecting the vacuum breaking unit 9 and the stoppering vacuum chamber 5 is provided with a fourth sterilization filter 18, a fourth valve 17, and a second vacuum probe 20 (which shares a second vacuum probe 20 with the stoppering vacuum unit 6).

[0079] The difference between Comparative Example 1 and Example 1 is that the positions of the first valve 11, the first sterilization filter 12, the second valve 13, the second sterilization filter 14, the third valve 15, the third sterilization filter 16, the fourth valve 17, the fourth sterilization filter 18, the first vacuum probe 19, and the second vacuum probe 20 in Comparative Example 1 are different from those in Example 1, but the rest are the same.

[0080] However, according to GMP and EU aseptic guidelines, the downstream section of the sterilizing filter cartridges must be sterilized offline according to aseptic management requirements, requiring disassembly after filling, and aseptic assembly before filling. The system structure in Example 1 has the following shortcomings: ① The downstream section of the sterilizing filter cartridges (i.e., the first, second, third, and fourth sterilizing filters) contains non-removable, offline sterilization components, such as vacuum probes; ② The components downstream of the sterilizing filter cartridges are relatively complex, making aseptic assembly more complicated, posing a risk of aseptic operation, increasing production time, and reducing efficiency. In contrast, the system structure designed in Example 1 only has connecting tubing downstream of the sterilizing filter cartridges, greatly reducing the number of components and time required for aseptic assembly, and eliminating non-sterilizable components. This significantly improves both production efficiency and aseptic assurance, ensuring both the efficiency of filling and capping the pre-filled syringe 1 with medication and guaranteeing the aseptic requirements of the operation process.

[0081] The above-described preferred embodiments of the present invention are for illustrative purposes only and are not intended to limit the scope of the invention. Any obvious variations or modifications derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims

1. A pre-filled syringe vacuum filling and vacuum stoppering system, characterized in that, The system is used for vacuum filling of pre-filled syringes (1) and for vacuum plugging of the pre-filled syringes (1) after vacuum filling. The pre-filled syringes (1) are provided with an inlet (10) for vacuum filling and vacuum plugging. The system includes the following structural configuration: A filling vacuum chamber (2) is provided for communication with the inlet (10) of the pre-filled syringe (1); A filling vacuum unit (3) is connected to the filling vacuum chamber (2). The filling vacuum unit (3) is used to evacuate the interior of the pre-filled syringe (1) through the filling vacuum chamber (2). A filling tube (4) is used to fill the pre-filled syringe (1) with liquid medicine after the pre-filled syringe (1) has been evacuated, i.e., vacuum filling; A stoppered vacuum chamber (5) is configured to communicate with the inlet (10) of the pre-filled syringe (1) during vacuum stoppering; A stopper vacuum unit (6) is connected to the stopper vacuum chamber (5). The stopper vacuum unit (6) is used to vacuum the pre-filled syringe (1) that has been vacuum-filled through the stopper vacuum chamber (5). The rubber stopper feeding module (7) is used to insert a rubber stopper (8) into the inlet (10) of the pre-filled syringe (1) after the vacuum is completed, i.e., vacuum plugging; And a vacuum breaking unit (9), which is connected to the filling vacuum chamber (2) and the stoppering vacuum chamber (5) respectively, and is used to break the vacuum environment after vacuum filling and vacuum stoppering are completed, so as to separate the filling vacuum chamber (2) and the stoppering vacuum chamber (5) from the pre-filled syringe (1); Among them, a first valve (11) and a first sterilization filter (12) are sequentially arranged on the pipeline connecting the filling vacuum unit (3) and the filling vacuum chamber (2); Among them, a second valve (13) and a second sterilization filter (14) are sequentially arranged on the pipeline connecting the stopper vacuum unit (6) and the stopper vacuum chamber (5); The pipeline connecting the vacuum breaking unit (9) and the filling vacuum chamber (2) is provided with a third valve (15) and a third sterilization filter (16) located near the filling vacuum chamber (2); the pipeline connecting the vacuum breaking unit (9) and the stoppering vacuum chamber (5) is provided with a fourth valve (17) and a fourth sterilization filter (18) located near the stoppering vacuum chamber (5).

2. The pre-filled syringe vacuum filling and vacuum stoppering system according to claim 1, characterized in that, The filling tube (4) is connected to the filling vacuum chamber (2), and after the filling vacuum chamber (2) is connected to the pre-filled syringe (1), the filling tube (4) can extend into the pre-filled syringe (1).

3. The pre-filled syringe vacuum filling and vacuum stoppering system according to claim 1, characterized in that, The rubber stopper (8) is placed in the stopper vacuum chamber (5) and pushed into the pre-filled syringe (1) by the rubber stopper feeding module (7).

4. The vacuum filling and vacuum stoppering system for a pre-filled syringe according to claim 1, characterized in that, The system also includes a first vacuum probe (19) disposed on the pipeline connecting the first valve (11) and the first sterilization filter (12).

5. The vacuum filling and vacuum stoppering system for a pre-filled syringe according to claim 1, characterized in that, The system also includes a second vacuum probe (20) disposed on the pipeline connecting the second valve (13) and the second sterilization filter (14).

6. The vacuum filling and vacuum stoppering system for a pre-filled syringe according to claim 1, characterized in that, The system also includes a third vacuum probe (21), which is disposed on the pipeline between the vacuum breaking unit (9) and the third valve (15) and the fourth valve (17).

7. The pre-filled syringe vacuum filling and vacuum stoppering system according to claim 1, characterized in that, The vacuum breaking unit (9) is used to provide nitrogen gas for vacuum breaking.

8. A control method for a pre-filled syringe vacuum filling and vacuum stoppering system according to any one of claims 1 to 7, characterized in that, The method includes controlling the system to vacuum fill the pre-filled syringe (1), and controlling the system to vacuum plug the pre-filled syringe (1) after vacuum filling is completed; I. Vacuum filling: 1) Before vacuum filling, control the filling vacuum chamber (2) to be tightly fitted with the inlet (10) of the pre-filled syringe (1) to achieve communication; 2) Adjust the first valve (11) and the first sterilization filter (12) to be open, and close the other valves and sterilization filters. The filling vacuum unit (3) evacuates the pre-filled syringe (1), and the filling tubing (4) fills the pre-filled syringe (1) with medicine. 3) After filling is completed, adjust the third valve (15) and the third sterilization filter (16) to open, and close the other valves and sterilization filters. The vacuum breaking unit (9) provides nitrogen gas to the pre-filled syringe (1) through the filling vacuum chamber (2) to break the vacuum, thereby separating the filling vacuum chamber (2) from the pre-filled syringe (1). II. Vacuum plugging: 1) Before vacuum plugging, control the plugging vacuum chamber (5) to fit tightly with the inlet (10) of the pre-filled syringe (1) to achieve communication; 2) Adjust the second valve (13) and the second sterilization filter (14) to open, and close the other valves and sterilization filter. The stopper vacuum unit (6) vacuums the pre-filled syringe (1), and then the stopper feeding module (7) pushes the stopper (8) set in the stopper vacuum chamber (5) into the pre-filled syringe (1). 3) After the stopper is inserted, the fourth valve (17) and the fourth sterilization filter (18) are opened, and the other valves and sterilization filters are closed. The vacuum breaking unit (9) supplies nitrogen gas to the pre-filled syringe (1) through the stoppering vacuum chamber (5) to break the vacuum, thereby separating the stoppering vacuum chamber (5) from the pre-filled syringe (1); thus completing the vacuum filling and vacuum stoppering of the pre-filled syringe (1).

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