A liquid adding device

Abstract

This application relates to a liquid dispensing device for injecting a pharmaceutical solution into a preparation tank. The dispensing device includes a bottle body and a sterile component. The bottle body includes a receiving cavity for holding the solution, and an outlet port communicating with the receiving cavity is provided on the bottle body. The sterile component is detachably installed on the outlet port, allowing the solution to flow from the receiving cavity into the sterile component. The sterile component includes a solution filter, the inlet end of which is connected to the outlet port, enabling sterilization of the solution within the sterile component. The outlet end of the solution filter is provided with a liquid collection structure to inject the sterilized solution into the preparation tank. The sterile component is detachably installed on the bottle body, and by filtering the solution in the receiving cavity through the sterile component, the solution injected into the preparation tank is a sterile solution. This reduces the number of sterilization-requiring components in the dispensing device, thereby reducing the risk of contamination during the preparation of sterile solutions.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical technology, and in particular to a liquid dispensing device. Background Technology

[0002] In the pharmaceutical manufacturing process, raw materials, intermediates, and finished products need to be prepared and transported in a sterile environment to reduce the possibility of contamination. Currently, sterile solution preparation systems require online sterilization of pipelines and dispensing tanks before use, the installation of sterile solution filters, and the use of pumps to pressurize the sterile solution into the filter. After sterile filtration, the solution enters the sterile preparation tank. To ensure that the solution dispensing and preparation process is carried out in a sterile environment, steam sterilization pipelines, filtration systems, stainless steel dispensing tanks, pump systems, CIP pipelines, etc., need to be installed on the sterile preparation tank. The risk of contamination during sterile solution preparation is high. Utility Model Content

[0003] This application provides a liquid dispensing device to address the problem of high risk of bacterial contamination in sterile solutions.

[0004] This application provides a liquid adding device, the liquid adding device comprising:

[0005] The bottle body includes a receiving cavity containing a solution, and the bottle body is provided with a liquid outlet, which is connected to the receiving cavity;

[0006] A sterile component, which is detachably installed at the liquid outlet, allowing the solution to flow into the sterile component from the receiving cavity;

[0007] The aseptic component includes a solution filter, the inflow end of which is connected to the outlet interface to perform aseptic treatment on the solution within the aseptic component, and the outlet end of the solution filter is provided with a liquid collection structure.

[0008] In one possible embodiment, a first connecting pipe is provided between the solution filter and the liquid extraction structure, and a second connecting pipe is provided between the solution filter and the liquid outlet. Both the first connecting pipe and the second connecting pipe are made of silicone.

[0009] In one possible embodiment, the sterile component includes a first cut-off element that is sleeved on the first connecting tube.

[0010] In one possible embodiment, the sterile assembly includes a second cut-off element that is sleeved on the second connecting tube.

[0011] In one possible embodiment, the bottle body is provided with a liquid outlet tube, one end of which is connected to the liquid outlet interface, and the other end extends into the solution.

[0012] In one possible embodiment, the bottle body includes a liquid inlet port that communicates with the receiving cavity.

[0013] In one possible embodiment, the liquid dispensing device includes a seal that is detachably mounted on the liquid inlet to block the liquid inlet.

[0014] In one possible embodiment, the bottle body includes a vent port that communicates with the receiving cavity.

[0015] In one possible embodiment, the liquid dispensing device includes an air filter installed at the vent.

[0016] In one possible embodiment, the bottle body includes a bottle body and a bottle cap, the bottle cap being detachably installed on the bottle body, the bottle body having the receiving cavity, and the liquid outlet being located on the bottle cap.

[0017] The bottle body includes a receiving cavity for holding the solution. The bottle body has a liquid outlet communicating with the receiving cavity. A sterile assembly is detachably installed on the liquid outlet, allowing the solution to flow from the receiving cavity into the sterile assembly. The sterile assembly includes a solution filter. The inlet end of the solution filter is connected to the liquid outlet, enabling sterilization of the solution within the sterile assembly. The outlet end of the solution filter has a liquid-collecting structure, allowing the sterilized solution to be injected into the preparation tank. The detachable installation of the sterile assembly on the bottle body, and its filtration of the solution within the receiving cavity, ensures that the solution injected into the preparation tank is sterile. This reduces the need for sterilization procedures in the dispensing device, thereby lowering the risk of contamination during sterile solution preparation. Attached Figure Description

[0018] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the liquid addition device provided in an embodiment of this application.

[0020] Figure label:

[0021] 1-Bottle body;

[0022] 11-Bottle body;

[0023] 111 - Receiving cavity;

[0024] 12-Bottle cap;

[0025] 121 - Liquid outlet port;

[0026] 122 - Liquid inlet port;

[0027] 123 - Ventilation port;

[0028] 2-Sterile components;

[0029] 21-Solution filter;

[0030] 22-Liquid extraction structure;

[0031] 23-First cut-off piece;

[0032] 24 - Second cut-off piece;

[0033] 25 - First connecting pipe;

[0034] 26 - Second connecting pipe;

[0035] 3-Discharge tube;

[0036] 4-Seals;

[0037] 5-Air filter. Detailed Implementation

[0038] To better understand the technical solution of this application, the embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0039] It should be understood that the described embodiments are merely some, not all, of the embodiments in this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0040] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise.

[0041] It should be understood that the term "and / or" used in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, the character " / " in this article generally indicates that the preceding and following related objects have an "or" relationship.

[0042] In the formulation process of pharmaceuticals and biotechnology, the formulation tank needs to maintain a sterile environment to reduce the possibility of contamination of the finished product. For example... Figure 1 As shown in the illustration, this application provides a liquid dispensing device for injecting a pharmaceutical solution into a preparation tank. The dispensing device includes a bottle body 1, which comprises a bottle body 11 and a bottle cap 12. The bottle body 11 is a wide-mouth bottle made of glass and polypropylene, with an internal receiving cavity 111 for holding the solution. The bottle cap 12, made of polypropylene, is fastened to the bottle body 11 to seal the receiving cavity 111. The bottle cap 12 has a liquid outlet 121 communicating with the receiving cavity 111. The bottle cap 12 is detachably mounted on the bottle body 11 to facilitate adding the solution into the receiving cavity 111.

[0043] The liquid addition device also includes a sterile component 2, which is detachably installed on the liquid outlet 121, allowing the solution to flow from the receiving cavity 111 into the sterile component 2. The sterile component 2 includes a solution filter 21, the inlet end of which is connected to the liquid outlet 121, and is capable of sterilizing the solution in the sterile component 2. The outlet end of the solution filter 21 is provided with a liquid collection structure 22 to inject the sterilized solution into the preparation tank.

[0044] The sterile component 2 is made of a material that can be sterilized and can be sterilized by a steam sterilizer to make the inside of the sterile component 2 a sterile environment. The sterilized sterile component 2 is installed on the bottle 1. After the solution in the bottle 1 flows into the sterile component 2, it is sterilized by the solution filter 21 so that the solution injected into the preparation tank through the sterile component 2 is a sterile solution.

[0045] The aseptic component 2, after sterilization, is detachably installed on the bottle body 1. The solution inside the bottle body 1 does not need to be kept sterile. The aseptic component 2 filters the solution in the receiving chamber 111, ensuring that the solution injected into the preparation tank is sterile. This reduces the need for sterilization in the dispensing device, thereby lowering the risk of contamination during sterile solution preparation. If the solution in the bottle body 1 needs to be injected into the preparation tank again, the aseptic component 2 can be replaced, allowing the solution in the bottle body 1 to be added to the preparation tank multiple times or to different preparation tanks, reducing the possibility of solution waste.

[0046] The solution in the receiving cavity 111 is injected into the preparation tank after passing through the solution filter 21. The solution filter 21 is used to sterilize the solution in the sterile component 2. The solution filter 21 can be a capsule-type solution filter 21 with a pleated filter membrane. It has a large filtration surface area, which can improve filtration efficiency. The filtration accuracy of the solution filter 21 is less than or equal to 0.22μm, thereby improving the purity of the solution injected into the preparation tank.

[0047] In one possible embodiment, the solution filter 21 is made of polypropylene material, free of adhesives and other chemicals, which reduces the possibility of contamination of the solution inside the sterile component 2. Furthermore, the solution filter 21 can be autoclaved to ensure the solution inside the sterile component 2 is in a sterile environment. The solution filter 21 also has radiation resistance, allowing it to be sterilized by radiation.

[0048] like Figure 1 As shown, in one possible embodiment, a liquid outlet pipe 3 is provided inside the bottle body 1. The liquid outlet pipe 3 is located inside the receiving cavity 111, wherein one end of the liquid outlet pipe 3 is connected to the liquid outlet interface 121, and the other end extends into the solution.

[0049] The sterile component 2 and the outlet tube 3 are respectively connected to both ends of the outlet port 121, so that the outlet tube 3 is connected to the sterile component 2. The length of the outlet tube 3 is greater than or equal to the length of the bottle body 11, so that the end of the outlet tube 3 away from the outlet port 121 can extend into the solution. When the solution in the receiving cavity 111 is small, it is convenient for the solution to flow into the sterile component 2. The end of the outlet tube 3 away from the outlet port 121 can be beveled, which can reduce the possibility of the inner wall of the receiving cavity 111 clogging the outlet tube 3.

[0050] In one possible embodiment, the outlet tube 3 can be a platinum-cured silicone tube, which is translucent white, has a temperature resistance range of -51°C to 135°C, and can be sterilized by steam sterilization, radiation sterilization, or gas sterilization. This allows the outlet tube 3 to undergo sterilization before being installed on the outlet interface 121, reducing the possibility of contaminating the solution in the receiving cavity 111. The platinum-cured silicone tube does not contain organic plasticizers, plasticizers, or latex additives, further reducing the possibility of solution contamination. The platinum-cured silicone tube also has a smooth, hydrophobic inner surface, facilitating the flow of solution from the receiving cavity 111 into the sterile component 2 through the outlet tube 3, reducing the possibility of residue buildup on the inner wall of the outlet tube 3.

[0051] like Figure 1 As shown, in one possible embodiment, the sterile component 2 includes a first cut-off element 23, which is located between the solution filter 21 and the liquid extraction structure 22. After a preset volume of solution is injected into the preparation tank, the passage between the solution filter 21 and the liquid extraction structure 22 can be cut off.

[0052] The solution filter 21 and the liquid collection structure 22 are connected by a first connecting tube 25. The first connecting tube 25 is made of silicone. In one possible embodiment, the silicone tube connected to the solution filter 21 and the silicone tube connected to the liquid collection structure 22 can be one or both of platinum vulcanized silicone tube or room temperature vulcanized silicone tube. It has the characteristics of smooth surface, stable chemical properties, high transparency and good flexibility, which makes it easy to inject the solution into the preparation tank and easy to observe the flow of the solution in the silicone tube. The good flexibility also makes the aseptic component 2 suitable for a variety of environments.

[0053] In one possible embodiment, the diameter of the silicone tube connected to the solution filter 21 can be larger than the diameter of the silicone tube connected to the liquid dispensing structure 22, so that the solution can flow from the bottle 1 to the solution filter 21. A straight-through variable diameter structure is provided between the two silicone tubes so that the solution can flow in the two silicone tubes.

[0054] The first cut-off piece 23 can be a metal tube sleeved outside the first connection 25 tube. The inner diameter of the metal tube is the same as the outer diameter of the silicone tube, so that the metal tube can be fixed to the silicone tube. When the worker squeezes the metal tube, the metal tube deforms, and then squeezes the silicone tube, so that the passage between the solution filter 21 and the liquid taking structure 22 is broken.

[0055] After the solution in the sterile component 2 is injected into the preparation tank by the liquid extraction structure 22, the pipeline of the sterile component 2 is connected to the preparation tank. The first cut-off component 23 cuts off the passage between the solution filter 21 and the liquid extraction structure 22, thereby disconnecting the sterile component 2 from the preparation tank. This can reduce the possibility of the solution flowing back into the sterile component 2 due to the high pressure in the preparation tank.

[0056] like Figure 1 As shown, in one possible embodiment, the aseptic component 2 includes a second cut-off member 24, which is installed between the filter and the liquid outlet 121. After a preset volume of solution is injected into the preparation tank, the passage between the solution filter 21 and the liquid outlet 121 can be cut off.

[0057] The solution filter 21 and the outlet port 121 can be connected via a second connecting pipe 26, which is made of silicone. The second cut-off piece 24 can be a metal tube fitted onto the second connecting pipe 26. When the operator squeezes the metal tube, it deforms, thereby squeezing the silicone tube and disconnecting the passage between the solution filter 21 and the outlet port 121. After the aseptic device is removed from the bottle 1, the possibility of residual solution leaking out of the aseptic component 2 is reduced, and the liquid within the aseptic component 2 can be preserved to retain samples of the solution injected into the preparation tank, thus meeting production regulatory requirements.

[0058] In one possible embodiment, the liquid sampling structure 22 can be a sampling needle. When injecting solution into the preparation tank, the sampling needle can pierce the sealing structure of the preparation tank, making it easier to inject solution into the preparation tank.

[0059] like Figure 1 As shown, in one possible embodiment, the bottle body 1 includes a liquid inlet 122 communicating with the receiving cavity 111, and the liquid inlet 122 is disposed on the bottle cap 12.

[0060] A solution can be added to the receiving cavity 111 through the liquid inlet 122. The solution added to the receiving cavity 111 through the liquid inlet 122 can be the same as the existing solution in the receiving cavity 111 to replenish the amount of solution in the receiving cavity 111, or it can be different from the existing solution in the receiving cavity 111 to form the solution required in the preparation tank after mixing with the solution in the receiving cavity 111. For example, the solution injected into the receiving cavity 111 through the liquid inlet 122 can be hydrochloric acid, sodium hydroxide, etc., to adjust the pH value of the solution in the receiving cavity 111.

[0061] like Figure 1 As shown, in one possible embodiment, a sealing element 4 is provided on the cover, and the sealing element 4 is detachably installed on the liquid inlet 122 to block the liquid inlet 122.

[0062] The seal 4 can reduce external environmental pollution of the solution in the receiving cavity 111. The seal 4 is detachably installed on the liquid inlet 122, making it easy to remove the seal 4 and add solution into the receiving cavity 111.

[0063] In one possible embodiment, the seal 4 is installed on the inlet port 122 via a pipe made of thermoplastic elastomer (TPE) material. One end of the TPE pipe is connected to the inlet port 122, and the seal 4 is installed on the end of the TPE pipe away from the inlet port 122. The TPE pipe protrudes from the surface of the bottle cap 12 for easy installation of the seal 4. The TPE pipe has good resistance to various chemicals such as acids, alkalis, and solvents, and can reduce the possibility of corrosion of the TPE pipe when a solution is injected into the receiving cavity 111.

[0064] like Figure 1 As shown, in one possible embodiment, the bottle body 1 includes a vent 123, which is disposed on the bottle cap 12 and communicates with the receiving cavity 111.

[0065] When a solution is injected into the receiving cavity 111 through the liquid inlet 122, the pressure inside the receiving cavity 111 will increase; or when a solution is withdrawn from the receiving cavity 111 through the liquid outlet 121, the pressure inside the receiving cavity 111 will decrease. The vent 123 can keep the pressure inside the receiving cavity 111 stable, so as to facilitate the injection or withdrawal of a solution into or from the receiving cavity 111.

[0066] like Figure 1 As shown, in one possible embodiment, the liquid filling device includes an air filter 5, which is installed in the vent 123.

[0067] When the pressure inside the receiving cavity 111 is high, the gas inside the receiving cavity 111 can be discharged through the air filter 5. When the pressure inside the receiving cavity 111 is low, the gas in the external environment can enter the receiving cavity 111 through the air filter 5, so that the pressure inside the receiving cavity 111 remains stable.

[0068] The air filter 5 is installed on the vent 123 via a TPE tube. The TPE tube used to install the air filter 5 and the TPE tube used to install the seal 4 protrude from the bottle cap 12 at different heights, which can reduce the possibility of interference between the air filter 5 and the seal 4. After removing the seal 4, it is convenient to inject the solution into the receiving cavity 111.

[0069] In one possible embodiment, the air filter 5 has a filtration accuracy of less than or equal to 0.2 μm.

[0070] There are various particles in the external environment. After the particles enter the container cavity 111 with the air, they will contaminate the solution in the container cavity 111. The air filter 5 has a filtration accuracy of less than or equal to 0.2μm. When the gas in the external environment enters the container cavity 111, it can reduce the possibility of particles in the external environment entering the container cavity 111 and causing the solution in the container cavity 111 to be contaminated.

Claims

1. A liquid dispensing device, characterized in that, The liquid addition device includes: Bottle body (1), the bottle body (1) includes a receiving cavity (111), the receiving cavity (111) contains a solution, and the bottle body (1) is provided with a liquid outlet (121), the liquid outlet (121) is connected to the receiving cavity (111); A sterile component (2) is detachably installed on the liquid outlet (121), and the solution can flow into the sterile component (2) from the receiving cavity (111). The sterile component (2) includes a solution filter (21), the inflow end of which is connected to the outlet interface (121) to sterilize the solution in the sterile component (2), and the outlet end of the solution filter (21) is provided with a liquid collection structure (22).

2. The liquid addition device according to claim 1, characterized in that, A first connecting pipe (25) is provided between the solution filter (21) and the liquid collection structure (22), and a second connecting pipe (26) is provided between the solution filter (21) and the liquid outlet (121). Both the first connecting pipe (25) and the second connecting pipe (26) are made of silicone.

3. The liquid addition device according to claim 2, characterized in that, The sterile component (2) includes a first cut-off element (23), which is sleeved on the first connecting tube (25).

4. The liquid addition device according to claim 2, characterized in that, The sterile component (2) includes a second cut-off element (24), which is sleeved on the second connecting tube (26).

5. The liquid addition device according to claim 1, characterized in that, The bottle body (1) is provided with a liquid outlet pipe (3), one end of which is connected to the liquid outlet interface (121), and the other end extends into the solution.

6. The liquid addition device according to claim 1, characterized in that, The bottle body (1) includes a liquid inlet (122) which is connected to the receiving cavity (111).

7. The liquid addition device according to claim 6, characterized in that, The liquid adding device includes a seal (4), which is detachably installed on the liquid inlet (122) to block the liquid inlet (122).

8. The liquid addition device according to claim 1, characterized in that, The bottle body (1) includes a vent (123) which is connected to the receiving cavity (111).

9. The liquid addition device according to claim 8, characterized in that, The liquid filling device includes an air filter (5), which is installed at the vent (123).

10. The liquid dispensing device according to any one of claims 1 to 9, characterized in that, The bottle body (1) includes a bottle body (11) and a bottle cap (12). The bottle cap (12) is detachably installed on the bottle body (11). The bottle body (11) is provided with the receiving cavity (111). The liquid outlet (121) is provided on the bottle cap (12).

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