A nitrogen filling needle structure for a penicillin bottle

By designing the structure of the nitrogen filling needle for vials and using a cap and annular rubber ring to seal the neck of the vial, the airtightness of the nitrogen filling process was achieved, solving the problem of drug contamination and improving the drug qualification rate and filling safety.

CN117622601BActive Publication Date: 2026-05-26WUXI YAOMING HELIAN BIOTECHNOLOGY CO LTD +2
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
WUXI YAOMING HELIAN BIOTECHNOLOGY CO LTD
Filing Date
2023-12-28
Publication Date
2026-05-26

AI Technical Summary

Technical Problem

In the current nitrogen filling process for vials, the liquid medicine is easily contaminated, especially due to the high risk of contamination caused by the filling needle directly contacting the liquid medicine or by an incompletely sealed production environment.

Method used

A nitrogen filling needle structure for vials is designed, which uses a cap and annular rubber ring to seal the neck of the vial. Nitrogen filling is achieved through a lifting structure, avoiding direct contact between the filling needle and the liquid medicine. The annular rubber ring seals the vial mouth to ensure the airtightness of the filling process.

Benefits of technology

This effectively prevents the liquid medicine from being contaminated during the filling process, improves the pass rate of the liquid medicine and the safety of the filling process, and reduces the risk of contamination of the liquid medicine.

✦ Generated by Eureka AI based on patent content.

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Abstract

This invention provides a nitrogen filling needle structure for vials, comprising a filling needle body, a first through hole penetrating its upper and lower end faces, and a filling needle body gas chamber inside the filling needle body; a top connector communicating with the first through hole at the upper end of the filling needle body; a second through hole penetrating its bottom end face at the bottom of the filling needle body, communicating with the filling needle body gas chamber; a first vent hole on the filling needle body, through which high-pressure gas passes sequentially via the top connector, the first through hole, the second through hole, and the first vent hole; a cap is fixedly installed on the bottom end face of the filling needle body at the top, with an opening at the bottom of the cap, and an annular rubber ring is provided on the inner wall of the cap, the annular rubber ring communicating with the interior of the filling needle body. This invention provides a nitrogen filling needle structure for vials, which can effectively prevent contamination of the liquid inside the vial during nitrogen filling, thereby improving the yield of finished products.
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Description

Technical Field

[0001] This invention relates to the field of biopharmaceutical filling equipment technology, and more specifically, to a nitrogen filling needle structure for vials. Background Technology

[0002] In the pharmaceutical industry, raw materials such as active pharmaceutical ingredients (APIs), inactive ingredients, and other chemicals that may be sensitive to oxygen need to be kept in an inert atmosphere to prevent exposure to oxygen and subsequent deterioration due to oxidation. Since nitrogen makes up 78% of the air, it is often used as a protective gas in vials, and the vials must be kept in a safe environment throughout the filling process to avoid contamination.

[0003] There are currently two methods for filling vials with nitrogen: one is to insert a filling needle into the liquid and continuously fill it with gas until saturation; the other is to let the vials enter a nitrogen "gas curtain" one by one, that is, to continuously blow nitrogen gas from the top of the vials until they are sealed.

[0004] However, both of the above methods leave the top of the vial open. Even in strict production environments, some of the liquid in the vial can still be contaminated by contact with the filling components. Based on the above problems, we designed a nitrogen filling needle structure for vials that can seal the top opening of the vial during the nitrogen filling process, while avoiding direct contact between the filling needle and the liquid, thus reducing the risk of contamination. Summary of the Invention

[0005] To overcome the problem mentioned in the background art that the medicine solution is easily contaminated when filling vials with nitrogen, the present invention provides a nitrogen filling needle structure for vials.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0007] A nitrogen filling needle structure for vials includes a filling needle body, wherein a first through hole penetrating its upper and lower end faces is provided inside the filling needle body, and a filling needle body gas chamber is provided inside the filling needle body; a top connector communicating with the first through hole is provided at the upper end of the filling needle body; a second through hole penetrating its bottom end face is provided at the bottom of the filling needle body, and the second through hole communicating with the filling needle body gas chamber; a first vent is also provided on the filling needle body, and high-pressure gas passes through the top connector, the first through hole, the second through hole, and the first vent in sequence;

[0008] It also includes a cap, the top of which is fixedly installed on the bottom end face of the filling needle body and the bottom of the cap is open. An annular rubber ring is provided on the inner wall of the cap and the annular rubber ring is connected to the interior of the filling needle body.

[0009] In the above embodiments, the filling needle structure is connected to the lifting structure of the filling machine via a top connector and is also connected to the gas tank. During use, it can move up and down with the lifting structure to fill vials with nitrogen gas. Specifically,

[0010] When the vial moves below this structure in the filling machine, the lifting mechanism moves the filling needle body downwards. When the lifting mechanism stops, the annular rubber ring is located at the neck of the vial. At this time, the valve is opened, allowing nitrogen gas to enter through the first through-hole and continuously fill the vial with nitrogen until it is saturated. During this process, the air inside the vial is discharged through the second through-hole and the first vent. Since the annular rubber ring and the gas chamber of the filling needle body are connected, some gas enters the annular rubber ring during the filling process and inflates it until the annular rubber ring expands and seals the neck of the vial. The annular rubber ring effectively prevents impurities in the air from entering the liquid medicine. Compared with traditional filling operations, this structure does not require the needle to be inserted into the liquid medicine during filling, and there is no need for the needle to come into contact with the liquid medicine, thus reducing the risk of contamination. The entire filling process is highly safe.

[0011] In the above steps, the annular rubber ring and the main air chamber of the filling needle can be directly connected through a hose, or the annular rubber ring can be connected to the first through hole or the top connector.

[0012] Preferably, the bottom end of the filling needle body is fixedly connected to an air outlet pipe that communicates with the first through hole, and the second through hole is located inside the air outlet pipe.

[0013] The vent tube design allows for a further reduction in the height between the bottom of the filling needle body and the bottom of the vial, enabling the outlet to be more precisely aligned with the vial opening for filling, thus quickly saturating the vial with the medication and improving efficiency.

[0014] In a further preferred embodiment, a bottom connector is fixedly connected to the bottom end face of the filling needle body, and the vent tube is located inside the bottom connector; the sealing cap is fixedly connected to the filling needle body through the bottom connector.

[0015] More preferably, both the top and bottom connectors have external threads on their outer side walls, and the top of the cap is threadedly connected to the bottom connector.

[0016] Preferably, multiple first vent holes are evenly arranged around the side of the filling needle body.

[0017] More preferably, an air valve structure is also provided at the external opening of the first air outlet, the air valve structure including a slider, a sealing cover, a second air outlet, and a third air outlet;

[0018] The slider sidewall is installed against the inner wall of the first vent hole, and the slider is slidably installed inside the first vent hole; the slider is provided with a second vent hole facing the opening of the filling needle body air chamber, and a third vent hole is also provided on the side wall of the slider away from the filling needle body air chamber, and the third vent hole is connected to the second vent hole; a sealing cap is also connected to the slider located on the side of the third vent hole, and the sealing cap is embedded in the side wall of the filling needle body; the air valve structure is also provided with a reset component for resetting.

[0019] More preferably, the reset component includes a guide rod, a guide groove, and a spring;

[0020] The guide groove is located on the side wall of the filling needle body;

[0021] A guide rod is slidably installed inside the guide groove, and one end of the guide rod is connected to a spring, while the other end of the spring is fixedly connected to the end of the inner wall of the guide groove.

[0022] The other end of the guide rod is fixedly connected to the sealing cover, and multiple reset components are arranged around the axis of the sealing cover.

[0023] Preferably, the sealing cap is provided with multiple rubber ring air inlet channels. One end of the rubber ring air inlet channel is connected to the inside of the annular rubber ring, and the other end is connected to the inside of the air chamber of the filling needle body through a third through hole.

[0024] More preferably, the cap is shaped like a flared bell with openings at both ends, and the inner diameter of the bottom opening of the cap is larger than the inner diameter of the top opening of the cap.

[0025] Compared with the prior art, the beneficial effects of the technical solution of the present invention are:

[0026] This invention provides a nitrogen filling needle structure for vials, which, compared with traditional nitrogen filling devices for vials, can effectively prevent contaminants from entering the vial body during filling. At the same time, it avoids contact between the filling needle and the liquid during filling, reducing direct contact between the filling needle and the liquid, lowering the risk of infection, and improving the qualified rate of the liquid. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the overall cross-sectional structure of the present invention during nitrogen purging;

[0028] Figure 2 This is a schematic diagram of the overall cross-sectional structure of the present invention during reset;

[0029] Figure 3 This is a top view of the internal structure of the filling needle body of the present invention;

[0030] Figure 4 For the present invention Figure 2 Enlarged structural diagram at point A in the middle;

[0031] The components are as follows: 1. Filling needle body; 2. Top connector; 3. Air outlet pipe; 4. First through hole; 5. Air chamber of filling needle body; 6. Second through hole; 7. Sealing cap; 8. Annular rubber ring; 9. Rubber ring air inlet channel; 10. First air outlet; 11. Bottom connector; 12. Third through hole; 13. Slider; 14. Sealing cap; 15. Second air outlet; 16. Third air outlet; 17. Guide rod; 18. Guide groove; 19. Spring. Implementation

[0032] The accompanying drawings are for illustrative purposes only and should not be construed as limiting the scope of this patent. To better illustrate this embodiment, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual dimensions of the product. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0033] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate embodiments of the present application. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0035] Spatial relation terms such as “below,” “under,” “below,” “below,” “above,” “above,” etc., are used herein to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, an element or feature described as “below,” “below,” or “below” will be oriented “above” the other element or feature. Therefore, the exemplary terms “below” and “under” can include both above and below orientations. Furthermore, the device may also include other orientations (e.g., rotated 90 degrees or other orientations), and the spatial descriptive terms used herein will be interpreted accordingly.

[0036] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising / including” or “having,” etc., specify the presence of the stated features, wholes, steps, operations, components, parts, or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof. Meanwhile, the term “and / or” as used in this specification includes any and all combinations of the associated listed items.

[0037] The technical solution of the present invention will be further described below with reference to the accompanying drawings and embodiments. Example

[0038] Please see Figure 1-4 A nitrogen filling needle structure for vials includes a filling needle body 1, with a first through hole 4 penetrating its upper and lower end faces inside the filling needle body 1, and a filling needle body gas chamber 5 inside the filling needle body 1; a top connector 2 connected to the first through hole 4 is provided at the upper end of the filling needle body 1; a second through hole 6 penetrating its bottom end face is provided at the bottom of the filling needle body 1, and the second through hole 6 is connected to the filling needle body gas chamber 5; a first vent hole 10 is also provided on the filling needle body 1, and high-pressure gas passes through the top connector 2, the first through hole 4, the second through hole 6 and the first vent hole 10 in sequence; it also includes a cap 7, the top of the cap 7 is fixedly installed on the bottom end face of the filling needle body 1 and the bottom of the cap 7 is open, and an annular rubber ring 8 is provided on the inner wall of the cap 7, the annular rubber ring 8 communicating with the interior of the filling needle body 1.

[0039] In the above embodiment, the top connector 2 is connected to the lifting structure of the filling machine and connected to the gas cylinder. During filling, the vial enters below the structure, and the lifting structure drives the structure to move down, so that the annular rubber ring 8 is at the neck of the vial. The specific positioning of the above process can be achieved by the sensor inside the filling machine. This part is the prior art and will not be described in detail in this application.

[0040] Upon reaching the designated location, the gas cylinder valve is opened. Under high pressure, nitrogen gas enters the lower part of the structure through the top connector 2 and the first through hole 4, continuously filling the vial with nitrogen. The air inside the vial enters the gas chamber 5 of the filling needle body through the second through hole 6 and is further discharged through the first vent hole 10. During this process, some high-pressure gas enters the annular rubber ring 8, causing it to expand and seal the neck of the vial. At this time, the filling needle body 1, the cap 7, the annular rubber ring 8, and the top of the vial form a sealed structure, preventing the interior of the structure from mixing with the outside air, which would cause contamination of the liquid inside the vial during filling. After the inert gas inside the vial is saturated, the gas valve is closed, the annular rubber ring 8 is retracted, and the lifting structure is driven to move upward. The filling machine then moves the vial into the next capping process, and the filling process ends.

[0041] Based on the above embodiments, the bottom end of the filling needle body 1 is fixedly connected to an air outlet pipe 3 that communicates with the first through hole 4, and the second through hole 6 is located inside the air outlet pipe 3.

[0042] The vent tube 3 allows for a further reduction in the height between the bottom of the filling needle body 1 and the bottom of the vial, enabling the outlet to be more precisely aligned with the vial opening for filling, thus allowing the liquid inside the vial to be saturated quickly and improving filling efficiency.

[0043] Based on the above embodiments, a bottom connector 11 is also fixedly connected to the bottom end face of the filling needle body 1, and the air outlet tube 3 is located inside the bottom connector 11; the cap 7 is fixedly connected to the filling needle body 1 through the bottom connector 11.

[0044] The above structure facilitates the disassembly and replacement of the cap 7, making maintenance convenient.

[0045] Based on the above embodiments, external threads are provided on the outer side walls of the top connector 2 and the bottom connector 11, and the top of the cap 7 is threadedly connected to the bottom connector 11. Example

[0046] Please see Figure 1-4A nitrogen filling needle structure for vials includes a filling needle body 1, with a first through hole 4 penetrating its upper and lower end faces inside the filling needle body 1, and a filling needle body gas chamber 5 inside the filling needle body 1; a top connector 2 connected to the first through hole 4 is provided at the upper end of the filling needle body 1; a second through hole 6 penetrating its bottom end face is provided at the bottom of the filling needle body 1, and the second through hole 6 is connected to the filling needle body gas chamber 5; a first vent hole 10 is also provided on the filling needle body 1, through which high-pressure gas passes sequentially via the top connector 2, the first through hole 4, the second through hole 6, and the first vent hole 10; it also includes a cap 7, with the top of the cap 7 fixedly installed on the bottom end face of the filling needle body 1 and the bottom of the cap 7 open; an annular rubber ring 8 is provided on the inner wall of the cap 7, and the annular rubber ring 8 connects to the interior of the filling needle body 1; multiple first vent holes 10 are evenly arranged around the side of the filling needle body 1.

[0047] An air valve structure is also provided at the external opening of the first air outlet 10. The air valve structure includes a slider 13, a sealing cover 14, a second air outlet 15, and a third air outlet 16.

[0048] The slider 13 is mounted against the inner wall of the first vent 10, and the slider 13 is slidably mounted inside the first vent 10. The slider 13 is provided with a second vent 15 facing the air chamber 5 of the filling needle body. A third vent 16 is also provided on the side wall of the slider 13 away from the air chamber 5 of the filling needle body. The third vent 16 is connected to the second vent 15. A sealing cap 14 is also connected to the slider 13 located on the side of the third vent 16. The sealing cap 14 is embedded in the side wall of the filling needle body 1. The air valve structure is also provided with a reset component for resetting.

[0049] The difference from Embodiment 1 is that the above embodiment adds a valve structure at the opening of the first vent 10. During filling, due to the air pressure, the slider 13 drives the sealing cap 14 to move outward, allowing the third vent 16 to communicate with the outside. At this time, the gas is discharged from the structure through the second vent 15 and the third vent 16. When the previous vial is filled and reset, the reset component will drive the above valve structure to reset, preventing air from re-entering the structure and further reducing the risk of contamination.

[0050] Based on the above embodiment, the reset component includes a guide rod 17, a guide groove 18, and a spring 19; the guide groove 18 is located on the side wall of the filling needle body 1; the guide rod 17 is slidably installed inside the guide groove 18, and one end of the guide rod 17 is connected to the spring 19, and the other end of the spring 19 is fixedly connected to the end of the inner wall of the guide groove 18; the other end of the guide rod 17 is fixedly connected to the sealing cap 14, and multiple reset components are arranged around the axis of the sealing cap 14.

[0051] When the guide rod 17 moves in the guide groove 18, it can position the entire valve structure. At the same time, the spring 19 connects the guide rod 17 and the inside of the guide groove 18, which can reset the entire valve structure. Example

[0052] Please see Figure 1-2 A nitrogen filling needle structure for vials includes a filling needle body 1. The filling needle body 1 has a first through hole 4 penetrating its upper and lower end faces, and a filling needle body gas chamber 5 is also provided inside the filling needle body 1. A top connector 2, communicating with the first through hole 4, is provided at the upper end of the filling needle body 1. A second through hole 6, penetrating its bottom end face, is provided at the bottom of the filling needle body 1 and communicates with the filling needle body gas chamber 5. A first vent hole 10 is also provided on the filling needle body 1, through which high-pressure gas is sequentially passed. The system includes a top connector 2, a first through hole 4, a second through hole 6, and a first vent hole 10; it also includes a cap 7, the top of which is fixedly installed on the bottom end face of the filling needle body 1 and the bottom of the cap 7 is open; an annular rubber ring 8 is provided on the inner wall of the cap 7 and the annular rubber ring 8 is connected to the inside of the filling needle body 1; multiple rubber ring air inlet channels 9 are provided inside the cap 7, one end of the rubber ring air inlet channel 9 is connected to the inside of the annular rubber ring 8, and the other end is connected to the inside of the air chamber 5 of the filling needle body through the third through hole 12.

[0053] In the above embodiments, during vial filling, the gas sequentially enters the gas chamber 5 of the filling needle body through the top connector 2, the first through hole 4, and the second through hole 6, and then enters the interior of the annular rubber ring 8 through the third through hole 12 and the rubber ring air inlet channel 9, causing it to expand and seal the neck of the vial.

[0054] The above embodiment is only one embodiment in which high-pressure gas enters the annular rubber ring 8. Alternatively, the filling needle body gas chamber 5 and the annular rubber ring 8 can be directly connected through a hose, or the hose can be connected to the top connector 2, the first through hole 4, or the second through hole 6, and the other end can be connected to the annular rubber ring 8.

[0055] Based on any of the above embodiments, the cap 7 is shaped like a flared funnel with openings at both ends, and the inner diameter of the bottom opening of the cap 7 is larger than the inner diameter of the top opening of the cap 7. This shape can prevent the protruding annular rubber ring 8 from contacting the mouth of the vial when the entire structure moves downward, thus reducing the probability of contact between the structure and the vial.

[0056] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A nitrogen filling needle structure for vials, characterized in that, The device includes a filling needle body (1), which has a first through hole (4) penetrating its upper and lower end faces, and a filling needle body air chamber (5) inside the filling needle body (1); a top connector (2) connected to the first through hole (4) is provided at the upper end of the filling needle body (1); a second through hole (6) penetrating its bottom end face is provided at the bottom of the filling needle body (1), and the second through hole (6) is connected to the filling needle body air chamber (5); a first air outlet (10) is also provided on the filling needle body (1), and high-pressure gas passes through the top connector (2), the first through hole (4), the second through hole (6) and the first air outlet (10) in sequence; It also includes a cap (7), the top of which is fixedly installed on the bottom end face of the filling needle body (1) and the bottom of the cap (7) is open. An annular rubber ring (8) is provided on the inner wall of the cap (7) and the annular rubber ring (8) is connected to the inside of the filling needle body (1). The sealing cap (7) is provided with multiple rubber ring air inlet channels (9). One end of the rubber ring air inlet channel (9) is connected to the inside of the annular rubber ring (8), and the other end is connected to the inside of the filling needle body air chamber (5) through the third through hole (12).

2. The vial nitrogen filling needle structure according to claim 1, characterized in that, The bottom end of the filling needle body (1) is fixedly connected to an air outlet pipe (3) that communicates with the first through hole (4), and the second through hole (6) is located inside the air outlet pipe (3).

3. The vial nitrogen filling needle structure according to claim 2, characterized in that, The bottom end face of the filling needle body (1) is also fixedly connected to a bottom connector (11), and the air outlet pipe (3) is located inside the bottom connector (11); the cap (7) is fixedly connected to the filling needle body (1) through the bottom connector (11).

4. The vial nitrogen filling needle structure according to claim 3, characterized in that, Both the top connector (2) and the bottom connector (11) have external threads on their outer side walls, and the top of the cap (7) is threaded to the bottom connector (11).

5. The vial nitrogen filling needle structure according to claim 1, characterized in that, The first vent (10) has multiple vents evenly arranged around the side of the filling needle body (1).

6. The vial nitrogen filling needle structure according to claim 5, characterized in that, The first air outlet (10) is also provided with an air valve structure at its external opening. The air valve structure includes a slider (13), a sealing cover (14), a second air outlet (15), and a third air outlet (16). The slider (13) is installed in contact with the inner wall of the first air outlet (10) and the slider (13) is slidably installed inside the first air outlet (10); the slider (13) is provided with a second air outlet (15) facing the air chamber (5) of the filling needle body, and a third air outlet (16) is also provided on the side wall of the slider (13) away from the air chamber (5) of the filling needle body, and the third air outlet (16) is connected to the second air outlet (15); a sealing cover (14) is also connected to the slider (13) located on the side of the third air outlet (16), and the sealing cover (14) is embedded in the side wall of the filling needle body (1); the air valve structure is also provided with a reset component for resetting.

7. The vial nitrogen filling needle structure according to claim 6, characterized in that, The reset component includes a guide rod (17), a guide groove (18), and a spring (19). The guide groove (18) is located on the side wall of the filling needle body (1); A guide rod (17) is slidably installed inside the guide groove (18), and one end of the guide rod (17) is connected to a spring (19), and the other end of the spring (19) is fixedly connected to the end of the inner wall of the guide groove (18). The other end of the guide rod (17) is fixedly connected to the sealing cover (14), and multiple reset components are arranged around the axis of the sealing cover (14).

8. A vial nitrogen filling needle structure according to any one of claims 1-7, characterized in that, The cap (7) is shaped like a flared bell with openings at both ends, and the inner diameter of the bottom opening of the cap (7) is larger than the inner diameter of the top opening of the cap (7).