Vacuum filling and plugging machine for pre-filling glass injector
By designing a vacuum filling and plugging machine for pre-filled glass syringes, the shortcomings of the prior art in sterility guarantee and process continuity are solved, and efficient and safe filling and plugging processes are achieved, improving the yield rate of the product and the reliability of the sterile environment.
Patent Information
- Application Number
- CN202510042414.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-01-10
- Publication Date
- 2025-04-11
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The prior art needs to be improved in terms of sterility assurance, and it is difficult to complete the two steps of filling and plugging in an isolated environment, affecting the continuity of the process and increasing the risk of pollution.
A vacuum filling and plugging machine for pre-filled glass syringes is designed, using a sealed chamber as the filling execution space, and a built-in automated filling and plugging mechanism can be used to continuously complete the filling and plugging process. In addition, the reliability of the sterile environment is improved through the ozone sterilization module and the booster module.
It effectively improves the reliability of the sterile environment, ensures the continuity and safety of the filling process, reduces the risk of pollution, and improves the yield rate of the product.
Smart Images
Figure CN119796598A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of prefilled syringes, in particular to a vacuum filling and stoppering machine for prefilled glass syringes. Background Art
[0002] Prefilled syringes, also known as prefilled syringes or prefilled needles, are syringes that are pre-filled with drugs in a polymer or glass barrel in a sterile environment. They are not medical devices, but a new type of drug packaging system, mainly composed of drugs, syringes, rubber stoppers, needle caps and push rods, which combine the two functions of storing drugs and injection.
[0003] Prefilled syringes are subject to ISO11040 series standards internationally, which cover the requirements for finished products and test methods of prefilled syringes as well as the requirements for various components. The standard YBB00112004-2015 "Prefilled Syringe Assembly (with Injection Needle)" is implemented, which cites the separate standards for various accessories of prefilled syringes, such as YBB00062004-2015 "Chlorobutyl Rubber Piston for Prefilled Syringes", YBB00082004-2015 "Brominated Butyl Rubber Piston for Prefilled Syringes", etc. In addition, the technical indicators of prefilled syringe assemblies are required, such as the compatibility of the piston and the push rod, the lubricity of the piston, the sliding performance of the piston, the connection force between the needle and the needle seat, the extraction force of the needle and the protective cap, the tightness of the body, the residual amount of the syringe needle tube, the accuracy of the graduation capacity, the amount of silicone oil in the piston, the insoluble particles, the residual amount of ethylene oxide, bacterial endotoxins, sterility and biological tests.
[0004] Good sealing is a necessary condition to ensure the safety and effectiveness of prefilled syringe products, and leakage problems will lead to serious product defects. Leakage may cause product losses such as evaporation of the perfusate and liquid seepage, and may also cause contamination of the filling components and loss of sterility, and may also cause contact injuries to product handling personnel. For prefilled syringes, leakage usually occurs in component cracks, component pinholes, seal defects, etc. Therefore, the sealing verification of the product should run through the processes of packaging development verification, routine production, and monitoring of marketed products, covering the entire life cycle of the product. When conducting sealing verification, the appropriate verification method can be comprehensively selected based on the syringe material, structure, and maximum allowable leakage. In addition, attention should also be paid to the lateral, axial and positive pressures on the prefilled syringe, as well as the possibility of leakage at the piston or sealing ring under negative pressure conditions.
[0005] The filling process is one of the core processes in the production process of prefilled syringes. During the filling process, attention should be paid to the filling speed, filling volume, piston assembly method, bubble elimination, etc. Prefilled syringes usually reserve a small amount of air in the syringe filled with the drug solution, and are directly injected during clinical use without the need to expel bubbles. Its main purposes are: ① During clinical use, a small amount of drug solution will remain in the syringe needle and syringe. The reserved bubbles can reduce the residual drug solution during discharge and avoid waste of drug solution; ② A small amount of bubbles is reserved in the syringe. When all the drug solution is injected, bubbles continue to be injected. After the needle is removed, the inertia brings out air, which can effectively reduce the phenomenon of drug solution back-seepage. At the same time, it also prevents the stimulation of tissues by drug leakage after the needle is removed, and relieves the pain of the patient at the local injection site. In the existing technology, conventional filling machines need to be improved in terms of sterility assurance. They only rely on the sterile workshop in which they are located to provide a sterile environment, which affects the yield rate to a certain extent. Moreover, conventional filling machines find it difficult to continuously complete the two steps of filling and stoppering, which not only affects the continuity of the process, but also increases the exposure rate and increases the risk of contamination. Summary of the invention
[0006] The present invention aims to solve the technical defects of the prior art and provide a vacuum filling and stoppering machine for prefilled glass syringes to solve the technical problem that conventional filling machines need to be improved in terms of sterility assurance.
[0007] Another technical problem to be solved by the present invention is how to improve the difficulty of conventional filling machines in continuously completing the two-step process of filling and plugging in an isolated environment.
[0008] In order to achieve the above technical objectives, the present invention adopts the following technical solutions: A vacuum filling and stoppering machine for prefilled glass syringes comprises a machine body, a sealing chamber, a bottom chamber, a first door body, a foot, a turntable, a clamp, a first bracket, a first cylinder, a cross frame, a vacuum filling mechanism, a second bracket, a second cylinder, a stoppering mechanism, a sub-chamber body, a second door body, an ozone input pipe, an ozone generator, a controller, a vent, a compressed gas input pipe, and a booster pipe, wherein a sealing chamber and a bottom chamber are respectively provided at the upper and lower parts of the machine body, a first door body is hinged at the port of the bottom chamber, a plurality of foots are fixedly connected to the bottom end of the machine body, a turntable is rotatably connected in the sealing chamber, a plurality of clamps are provided on the turntable, a first bracket is fixedly connected inside the sealing chamber, and a plurality of clamps are fixed on the first bracket. A first cylinder is connected, a cross frame is fixedly connected to the free end of the first cylinder, a plurality of vacuum filling mechanisms are fixedly connected to the cross frame, a second bracket is fixedly connected inside the sealed chamber, a plurality of second cylinders are fixedly connected to the second bracket, a plugging mechanism is fixedly connected to the free end of the second cylinder, a sub-chamber body is also provided on the machine body, a second door body is hinged at the port of the sub-chamber body, an ozone input pipe is fixedly connected inside the sealed chamber, an ozone generator is fixedly connected to the machine body, the ozone generator is communicated with the ozone input pipe, a controller and a vent are respectively provided on the outer wall of the sub-chamber body, a compressed gas input pipe is fixedly connected to the sub-chamber body, and a booster pipe is fixedly connected inside the sealed chamber.
[0009] Preferably, a manipulator is installed inside the sealing chamber, and the clamp is located within the movement range of the manipulator.
[0010] Preferably, a door opening is provided on the sealed bin, a sealing door is installed at the door opening, a sealing strip is fixedly connected to the inner side of the sealing door, and when the sealing door is closed, the sealing strip is squeezed between the sealing door and the door opening.
[0011] Preferably, a booster pump and an air compressor are respectively installed in the bottom bin, the booster pump is connected to the booster pipe through a pipeline, the air compressor is connected to the compressed gas input pipe through the pipeline, and valves are respectively provided on each of the pipelines.
[0012] Preferably, the compressed gas input pipe enters the sealed chamber through the auxiliary chamber body and is connected to each cylinder.
[0013] Preferably, the auxiliary bin body is located outside the sealed bin, a fan is provided in the auxiliary bin body, and the vents are respectively located on two opposite side walls of the auxiliary bin body.
[0014] Preferably, a slide is provided in the sealed chamber, and the turntable is rotatably connected to the slide.
[0015] Preferably, a motor is installed in the bottom bin, the turntable is driven by the motor, and a mechanical seal is provided at the position where the motor shaft passes through the bottom surface of the sealing bin.
[0016] Preferably, a lock is provided on the first door body, and the lock is a password lock or a mechanical lock.
[0017] Preferably, there are two positioning points on the rotation stroke of the turntable. When the turntable is located at one of the positioning points, the clamp on the left side of the turntable is located below the vacuum filling mechanism, and the clamp on the right side of the turntable is located below the plugging mechanism. When the turntable is located at the other positioning point, the clamp on the left side of the turntable is located below the plugging mechanism, and the clamp on the right side of the turntable is located below the vacuum filling mechanism.
[0018] In the above technical scheme, the machine body is the main structure of the present invention, the sealed bin is used to construct a sealed environment and serve as a filling execution space, the bottom bin can be used to install equipment such as a booster pump and an air compressor, the first door body is used to close or open the bottom bin, and the feet are used to support and adjust the machine body. Inside the sealed bin, the turntable carrying clamp passes under the vacuum filling mechanism and the plugging mechanism in turn. The clamp is used to clamp the syringe to be filled. The first cylinder on the first bracket drives the cross frame to move longitudinally, so as to complete the filling using the vacuum filling mechanism. When the clamp rotates with the turntable to the bottom of the plugging mechanism, it is driven downward by the second cylinder on the second bracket to complete the plugging process. The auxiliary bin body is used to set some air circuits, controllers, valves and other components, and the second door body can open or close the auxiliary bin body. The ozone generator is used to generate ozone, which is then sent into the sealed chamber through the ozone input pipe to sterilize the sealed chamber before filling. After sterilization, before filling, the booster pump pressurizes the sealed chamber through the booster pipe to a pressure slightly higher than the external atmospheric pressure, so that the inside of the sealed chamber maintains a positive pressure relative to the outside. Therefore, if there are pollutants outside, it is not easy to enter the sealed chamber. The controller is used to control valves and other devices. The vent is used to ventilate and dissipate heat for the auxiliary chamber body. The compressed air input pipe is connected to the air compressor to supply compressed air to each cylinder.
[0019] The present invention provides a vacuum filling and plugging machine for prefilled glass syringes. The technical solution constructs a sealed chamber as a filling execution space, and an automated filling and plugging mechanism is arranged inside the sealed chamber, which can continuously complete the two-step process; on this basis, an ozone sterilization module and a pressurization module are designed for the sealed chamber, which effectively improves the reliability of the sterile environment. The present invention has a reasonable structure, superior technical effects, and outstanding technical advantages. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1 It is a stereogram of the present invention as a whole observed from one viewing angle; Figure 2 is a stereogram of the present invention as a whole observed from another viewing angle; Figure 3 is a three-dimensional diagram of the superstructure of the present invention; Figure 4 It is a first stereoscopic view of the second cylinder and its attached structure in the present invention; Figure 5 It is a second stereoscopic view of the second cylinder and its attached structure in the present invention; Figure 6 It is a three-dimensional diagram of the first cylinder and its attached structures in the present invention; Figure 7 is a stereogram of the present invention as a whole observed from another viewing angle; In the figure: DETAILED DESCRIPTION
[0021] The specific embodiments of the present invention will be described in detail below. In order to avoid too much unnecessary details, the well-known structures or functions will not be described in detail in the following examples. The approximate language used in the following examples can be used for quantitative expression, indicating that the quantity can be allowed to have a certain change without changing the basic function. Unless otherwise defined, the technical and scientific terms used in the following examples have the same meaning as those generally understood by those skilled in the art to which the present invention belongs.
[0022] Example 1 Vacuum filler and stopper for prefilled glass syringes, e.g. Figure 1 to Figure 7 As shown, it includes a body 1, a sealed bin 2, a bottom bin 3, a first door body 4, a foot 5, a turntable 6, a clamp 7, a first bracket 8, a first cylinder 9, a cross frame 10, a vacuum filling mechanism 11, a second bracket 12, a second cylinder 13, a plugging mechanism 14, a sub-bin body 15, a second door body 16, an ozone input pipe 17, an ozone generator 18, a controller 19, a vent 20, a compressed gas input pipe 21, and a booster pipe 22, wherein the sealed bin 2 and the bottom bin 3 are respectively provided at the upper and lower parts of the body 1, the first door body 4 is hinged at the port of the bottom bin 3, a plurality of foot 5 are fixedly connected to the bottom end of the body 1, a turntable 6 is rotatably connected in the sealed bin 2, a plurality of clamps 7 are provided on the turntable 6, a first bracket 8 is fixedly connected inside the sealed bin 2, and a first cylinder 9 is fixedly connected to the first bracket 8. A cross frame 10 is fixedly connected to the free end of the first cylinder 9, and a plurality of vacuum filling mechanisms 11 are fixedly connected to the cross frame 10, a second bracket 12 is fixedly connected inside the sealed chamber 2, and a plurality of second cylinders 13 are fixedly connected to the second bracket 12, and a plugging mechanism 14 is fixedly connected to the free end of the second cylinder 13, a sub-chamber body 15 is also provided on the machine body 1, and a second door body 16 is hinged at the port of the sub-chamber body 15, an ozone input pipe 17 is fixedly connected inside the sealed chamber 2, an ozone generator 18 is fixedly connected to the machine body 1, and the ozone generator 18 is connected to the ozone input pipe 17, a controller 19 and a vent 20 are respectively provided on the outer wall of the sub-chamber body 15, a compressed gas input pipe 21 is fixedly connected to the sub-chamber body 15, and a booster pipe 22 is fixedly connected inside the sealed chamber 2.
[0023] In the above technical scheme, the body 1 is the main structure of the present invention, the sealed chamber 2 is used to construct a sealed environment and serve as a filling execution space, the bottom chamber 3 can be used to install equipment such as a booster pump and an air compressor, the first door body 4 is used to close or open the bottom chamber 3, and the foot 5 is used to support and adjust the body 1. Inside the sealed chamber 2, the turntable 6 carries the clamp 7 and passes under the vacuum filling mechanism 11 and the plugging mechanism 14 in turn. The clamp 7 is used to clamp the syringe to be filled. The first cylinder 9 on the first bracket 8 drives the cross frame 10 to move longitudinally, so as to complete the filling by using the vacuum filling mechanism 11. When the clamp 7 rotates with the turntable 6 to the bottom of the plugging mechanism 14, it is driven downward by the second cylinder 13 on the second bracket 12 to complete the plugging process. The auxiliary chamber 15 is used to set some gas circuits, controllers 19, valves and other components. The second door body 16 can open or close the auxiliary chamber 15. The ozone generator 18 is used to generate ozone, which is then sent into the sealed chamber 2 through the ozone input pipe 17 to sterilize the sealed chamber 2 before filling; after the sterilization is completed, before the filling begins, the booster pump pressurizes the sealed chamber 2 through the booster pipe 22 to a pressure slightly higher than the external atmospheric pressure, so that the inside of the sealed chamber 2 maintains a positive pressure relative to the outside. Therefore, if there are pollutants outside, it is not easy to enter the sealed chamber 2. The controller 19 is used to control valves and other devices. The vent 20 is used to ventilate and dissipate heat for the auxiliary chamber body 15. The compressed air input pipe 21 is connected to the air compressor to supply compressed air to each cylinder.
[0024] Example 2 Vacuum filler and stopper for prefilled glass syringes, e.g. Figure 1 to Figure 7As shown, it includes a body 1, a sealed bin 2, a bottom bin 3, a first door body 4, a foot 5, a turntable 6, a clamp 7, a first bracket 8, a first cylinder 9, a cross frame 10, a vacuum filling mechanism 11, a second bracket 12, a second cylinder 13, a plugging mechanism 14, a sub-bin body 15, a second door body 16, an ozone input pipe 17, an ozone generator 18, a controller 19, a vent 20, a compressed gas input pipe 21, and a booster pipe 22, wherein the sealed bin 2 and the bottom bin 3 are respectively provided at the upper and lower parts of the body 1, the first door body 4 is hinged at the port of the bottom bin 3, a plurality of foot 5 are fixedly connected to the bottom end of the body 1, a turntable 6 is rotatably connected in the sealed bin 2, a plurality of clamps 7 are provided on the turntable 6, a first bracket 8 is fixedly connected inside the sealed bin 2, and a first cylinder 9 is fixedly connected to the first bracket 8. A cross frame 10 is fixedly connected to the free end of the first cylinder 9, and a plurality of vacuum filling mechanisms 11 are fixedly connected to the cross frame 10. A second bracket 12 is fixedly connected to the inside of the sealed chamber 2, and a plurality of second cylinders 13 are fixedly connected to the second bracket 12. A plugging mechanism 14 is fixedly connected to the free end of the second cylinder 13. A secondary chamber body 15 is also provided on the machine body 1, and a second door body 16 is hinged at the port of the secondary chamber body 15. An ozone input pipe 17 is fixedly connected to the inside of the sealed chamber 2, and an ozone generator 18 is fixedly connected to the machine body 1. The ozone generator 18 is connected to the ozone input pipe 17. A controller 19 and a vent 20 are respectively provided on the outer wall of the secondary chamber body 15, a compressed gas input pipe 21 is fixedly connected to the secondary chamber body 15, and a booster pipe 22 is fixedly connected to the inside of the sealed chamber 2. A manipulator is installed inside the sealed chamber 2, and the clamp 7 is located within the range of motion of the manipulator. A door opening is provided on the sealed chamber 2, and a sealed door is installed at the door opening. A sealing strip is conveniently fixedly connected to the inner side of the sealed door. When the sealed door is closed, the sealing strip is squeezed between the sealed door and the door opening. A booster pump and an air compressor are respectively installed in the bottom chamber 3. The booster pump is connected to the booster pipe 22 through a pipeline, and the air compressor is connected to the compressed air input pipe 21 through the pipeline. Valves are respectively provided on each of the pipelines. The compressed air input pipe 21 enters the sealed chamber 2 through the auxiliary chamber body 15 and is connected to each cylinder. The auxiliary chamber body 15 is located outside the sealed chamber 2, and a fan is provided in the auxiliary chamber body 15. The vents 20 are respectively located on two opposite side walls of the auxiliary chamber body 15. A slide is provided in the sealed chamber 2, and a turntable 6 is rotatably connected to the slide. A motor is installed in the bottom chamber 3, and the turntable 6 is driven by the motor. A mechanical seal is provided at the position where the motor shaft passes through the bottom surface of the sealed chamber 2. A lock is provided on the first door body 4, and the lock is a password lock or a mechanical lock.There are two positioning points on the rotation stroke of the turntable 6. When the turntable 6 is located at one of the positioning points, the clamp 7 on the left side of the turntable 6 is located below the vacuum filling mechanism 11, and the clamp 7 on the right side of the turntable 6 is located below the plugging mechanism 14. When the turntable 6 is located at the other positioning point, the clamp 7 on the left side of the turntable 6 is located below the plugging mechanism 14, and the clamp 7 on the right side of the turntable 6 is located below the vacuum filling mechanism 11.
[0025] The embodiments of the present invention are described in detail above, but the contents are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the scope of the present invention shall be included in the protection scope of the present invention.
Claims
1. Vacuum filling and stoppering machine for prefilled glass syringes, characterized in that The invention comprises a machine body (1), a sealing chamber (2), a bottom chamber (3), a first door body (4), a foot (5), a turntable (6), a clamp (7), a first bracket (8), a first cylinder (9), a cross frame (10), a vacuum filling mechanism (11), a second bracket (12), a second cylinder (13), a plugging mechanism (14), a secondary chamber body (15), a second door body (16), an ozone inlet pipe (17), an ozone generator (18), a controller (19), a vent (20), a pressure A compressed air input pipe (21) and a boost pipe (22), wherein a sealed chamber (2) and a bottom chamber (3) are respectively provided at the upper and lower parts of the machine body (1), a first door body (4) is hinged at the port of the bottom chamber (3), a plurality of feet (5) are fixedly connected to the bottom end of the machine body (1), a turntable (6) is rotatably connected in the sealed chamber (2), a plurality of clamps (7) are provided on the turntable (6), a first bracket (8) is fixedly connected inside the sealed chamber (2), and a plurality of clamps (7) are fixedly connected to the first bracket (8). A first cylinder (9) is connected, a cross frame (10) is fixedly connected to the free end of the first cylinder (9), a plurality of vacuum filling mechanisms (11) are fixedly connected to the cross frame (10), a second bracket (12) is fixedly connected inside the sealed chamber (2), a plurality of second cylinders (13) are fixedly connected to the second bracket (12), a plugging mechanism (14) is fixedly connected to the free end of the second cylinder (13), and an auxiliary chamber body (15) is further provided on the machine body (1), A second door body (16) is hingedly connected at the port, an ozone input pipe (17) is fixedly connected inside the sealed chamber (2), an ozone generator (18) is fixedly connected to the machine body (1), the ozone generator (18) is in communication with the ozone input pipe (17), a controller (19) and a vent (20) are respectively provided on the outer wall of the auxiliary chamber body (15), a compressed gas input pipe (21) is fixedly connected to the auxiliary chamber body (15), and a boost pipe (22) is fixedly connected inside the sealed chamber (2).
2. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: A manipulator is installed inside the sealing chamber (2), and the clamp (7) is located within the range of motion of the manipulator.
3. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: A door opening is provided on the sealed bin (2), a sealing door is installed at the door opening, a sealing strip is fixedly connected to the inner side of the sealing door, and when the sealing door is closed, the sealing strip is squeezed between the sealing door and the door opening.
4. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: A booster pump and an air compressor are respectively installed in the bottom bin (3); the booster pump is connected to the booster pipe (22) via a pipeline; the air compressor is connected to the compressed air input pipe (21) via the pipeline; and valves are respectively provided on each of the pipelines.
5. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: The compressed gas input pipe (21) enters the sealed chamber (2) through the auxiliary chamber body (15) and is connected to each cylinder.
6. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: The auxiliary bin body (15) is located outside the sealed bin (2), a fan is provided in the auxiliary bin body (15), and the ventilation openings (20) are respectively located on two opposite side walls of the auxiliary bin body (15).
7. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: A slide is provided in the sealed chamber (2), and a rotating disk (6) is rotatably connected to the slide.
8. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: A motor is installed in the bottom bin (3), the turntable (6) is driven by the motor, and a mechanical seal is provided at a position where the motor shaft penetrates the bottom surface of the sealing bin (2).
9. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: A lock is provided on the first door body (4), and the lock is a password lock or a mechanical lock.
10. The vacuum filling and stoppering machine for prefilled glass syringes according to claim 1, characterized in that: There are two positioning points on the rotation stroke of the turntable (6). When the turntable (6) is located at one of the positioning points, the clamp (7) on the left side of the turntable (6) is located below the vacuum filling mechanism (11), and the clamp (7) on the right side of the turntable (6) is located below the plugging mechanism (14). When the turntable (6) is located at the other positioning point, the clamp (7) on the left side of the turntable (6) is located below the plugging mechanism (14), and the clamp (7) on the right side of the turntable (6) is located below the vacuum filling mechanism (11).