Double butterfly valve-based sterile medicine transfer system and sterile medicine transfer method
The aseptic drug transfer system, with its dual butterfly valve design and clamp connection, solves the problems of low versatility, complex operation, high cost, and large residue in existing aseptic drug transfer systems. It achieves aseptic transfer of liquid and powder drugs, improving efficiency and reducing costs.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SICHUAN KELUN PHARMA CO LTD
- Filing Date
- 2025-10-17
- Publication Date
- 2026-05-21
AI Technical Summary
Existing sterile drug closed transfer systems suffer from low versatility, high operational complexity, high cost, and large amounts of residue in the output.
The system employs a dual-butterfly valve design, utilizing the aseptic connection between the tiltable drug storage tank and the powder storage tank. The active butterfly valve, passive butterfly valve, and discharge port are connected by clamps. Combined with the use of steam sterilization and compressed air, aseptic transfer of liquid and powder drugs is achieved.
It enables aseptic transfer of liquid and powder drugs, reduces operational complexity, improves versatility and flexibility, reduces discharge residue, and lowers production costs.
Smart Images
Figure CN2025128383_21052026_PF_FP_ABST
Abstract
Description
A dual-butterfly valve aseptic drug transfer system and aseptic drug transfer method Technical Field
[0001] This invention relates to the field of pharmaceutical technology, specifically to a dual-butterfly valve aseptic drug transfer system and a method for aseptic drug transfer. Background Technology
[0002] In the pharmaceutical industry, existing aseptic manufacturing technologies enable the safe transfer of sterile drugs from one sterile container to another in non-sterile environments (such as Class C environments). Commonly used closed-loop aseptic connection technologies in the industry include SUS (single-use system), SART system, AB valve system, and vacuum suction system.
[0003] Both the SUS and SART systems are single-use systems, which not only have high material costs but also increase processing costs. Furthermore, the research on extractables and leachates (E&L) of single-use systems is relatively complex, posing certain quality risks and compliance challenges. They are only suitable for the closed transfer of sterile pharmaceutical solutions. The AB valve system is designed with specific dimensions, has a high degree of operational complexity, and the risk of errors increases accordingly in large-scale production. It is also expensive and has high costs, making it only suitable for the closed transfer of sterile powders. The vacuum suction system has a complex structure with many pipeline and valve connections. During the powder discharge process, a large amount of material adheres to the pipelines and valves, resulting in large discharge residues and low product yield. It is only suitable for the closed transfer of sterile powders.
[0004] Therefore, existing closed transfer systems for sterile drugs have drawbacks such as low versatility, high operational complexity, high cost, and large residues after discharge. Based on this, a dual-butterfly valve sterile drug transfer system and a sterile drug transfer method are provided. Summary of the Invention
[0005] This invention aims to address the technical problems of existing sterile drug closed transfer systems, such as low versatility, high operational complexity, high cost, and large residue in the discharge. The goal is to provide a double-butterfly valve sterile drug transfer system and method. The double-butterfly valve design establishes a sterile connection between a tiltable drug storage tank and a powder storage tank. Clamps serve as connecting components, ensuring reliable connection. The system is simple in structure, has low operational complexity, and can be applied to the sterile transfer of both powders and liquids. It offers strong versatility, high flexibility, and low cost.
[0006] This invention is achieved through the following technical solution:
[0007] The first objective of this invention is to provide a dual-butterfly valve aseptic drug transfer system, comprising a reversible drug storage tank, an active butterfly valve, a passive butterfly valve, a powder storage tank, and a sterile drug liquid storage bag.
[0008] The discharge port of the reversible drug storage tank is connected to the active butterfly valve through the first connector, the active butterfly valve is connected to the passive butterfly valve through the second connector, and the passive butterfly valve is connected to the inlet of the powder storage tank through the third connector.
[0009] The powder storage tank is equipped with a diaphragm valve at its outlet, and the outlet of the powder storage tank is connected to a sterile drug storage bag.
[0010] Furthermore, the first connecting component is a clamp.
[0011] Furthermore, the second connector includes a first clamp, a connector head, and a second clamp. The first clamp engages the active butterfly valve with the connector head, and the second clamp engages the connector head with the passive butterfly valve.
[0012] Furthermore, the third connecting component is a clamp.
[0013] Furthermore, the outlet of the powder storage tank is connected to a sterile drug storage bag via a sterile drug transfer pipeline.
[0014] Furthermore, the outlet of the powder storage tank is also connected to a steam discharge pipeline.
[0015] Furthermore, a diaphragm valve is installed at the inlet end of the steam discharge pipeline.
[0016] Furthermore, the outlet of the powder storage tank is connected to the inlet of the tee connector, and the two outlets of the tee connector are respectively connected to the sterile drug transfer pipeline and the steam discharge pipeline.
[0017] A second objective of this invention is to provide a sterile drug transfer method, comprising the following steps:
[0018] Open the active butterfly valve and the passive butterfly valve to introduce steam into the system, allowing steam to flow between the reversible drug storage tank and the sterile drug storage bag. Perform online moist heat sterilization at 120-130℃ for 15-30 minutes. After steam sterilization is completed, keep the system under a slight positive pressure.
[0019] Close the active and passive butterfly valves to deliver sterile drugs into the tiltable drug storage tank.
[0020] When the transferred drug is a sterile drug solution, open the active butterfly valve, passive butterfly valve and diaphragm valve one in sequence to introduce clean compressed air into the reversible drug storage tank at a pressure ≤0.20MPa. The sterile drug solution is transferred to the sterile drug storage bag through the powder storage tank and the sterile drug solution transfer pipeline in sequence. After the transfer is completed, close diaphragm valve one, passive butterfly valve and active butterfly valve.
[0021] When transferring sterile powder, keep the diaphragm valve closed, and then open the active butterfly valve and the passive butterfly valve in sequence to transfer the sterile powder into the powder storage tank. After the transfer is complete, close the passive butterfly valve and the active butterfly valve.
[0022] Furthermore, during steam sterilization, diaphragm valve two is opened to allow steam to be discharged from the steam discharge pipe.
[0023] Compared with the prior art, the present invention has the following advantages and beneficial effects:
[0024] 1. The transfer device of the present invention uses clamps as connecting parts to connect the active butterfly valve and the passive butterfly valve, as well as the active butterfly valve and the discharge port, and the passive butterfly valve and the powder storage tank. Because the clamps have strong clamping force and good sealing performance, the connection reliability is guaranteed, and the structure is simple and the operation is not complicated.
[0025] 2. The double butterfly valve design of the present invention establishes a sterile connection between the reversible drug storage tank and the powder storage tank, thereby avoiding contamination by personnel operation and environmental microorganisms.
[0026] 3. The powder storage tank of the present invention can be used as a storage tank when transferring powder and as a transfer pipeline when transferring liquid medicine. It is suitable for aseptic transfer of both powder and liquid, has strong versatility and high flexibility, reduces dependence on specific types of transfer systems, enhances the efficiency and reliability of aseptic transfer, and reduces production costs. Attached Figure Description
[0027] To more clearly illustrate the technical solutions of the exemplary embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be considered as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort. In the drawings:
[0028] Figure 1 is a schematic diagram of the transfer system of the present invention;
[0029] Figure 2 is a schematic diagram of the connection structure between the second connector of the present invention and the powder storage tank;
[0030] Figure 3 is a cross-sectional view of AA in Figure 2;
[0031] Figure 4 is a schematic diagram of the second connector.
[0032] The attached diagram shows the markings and corresponding component names:
[0033] 1- Reversible drug storage tank, 101- Discharge port, 2- First connector, 3- Active butterfly valve, 4- Second connector, 401- First clamp, 402- Connector, 403- Second clamp, 5- Passive butterfly valve, 6- Third connector, 7- Powder storage tank, 8- Diaphragm valve one, 9- T-connector, 10- Sterile drug transfer pipeline, 11- Sterile drug storage bag, 12- Diaphragm valve two, 13- Steam discharge pipeline. Detailed Implementation
[0034] To make the objectives, technical solutions, and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the illustrative embodiments and descriptions of the present invention are only used to explain the present invention and are not intended to limit the present invention.
[0035] The following detailed description of embodiments of a double-butterfly valve aseptic drug transfer system and aseptic drug transfer method according to the present invention is provided with appropriate reference to the accompanying drawings. However, unnecessary detailed descriptions may be omitted. For example, detailed descriptions of well-known matters and repetitive descriptions may be omitted. This is to avoid unnecessarily lengthy descriptions and to facilitate understanding by those skilled in the art.
[0036] The "scope" disclosed in this application is defined by a lower limit and an upper limit. A given scope is defined by selecting a lower limit and an upper limit, which define the boundaries of the specific scope. Unless otherwise specified, all embodiments and optional embodiments of this application can be combined to form new technical solutions.
[0037] Unless otherwise specified, all technical features and optional technical features of this application may be combined to form new technical solutions.
[0038] Unless otherwise specified, the terms "comprising" and "including" as used in this application can be open-ended or closed-ended. For example, "comprising" and "including" can mean that other substances not listed may also be included, or that only the listed substances may be included.
[0039] Unless otherwise specified, all steps of this application may be performed sequentially or randomly, but sequentially is preferred.
[0040] The technical solution of the present invention will be further described in detail below with reference to the embodiments.
[0041] It should be noted that, unless otherwise specified, the experimental methods used in the embodiments are conventional methods. Unless otherwise specified, the materials, reagents, methods, and instruments used are all conventional materials, reagents, methods, and instruments in the art, and can be obtained commercially by those skilled in the art. Example 1
[0042] A dual-butterfly valve aseptic drug transfer system includes a reversible drug storage tank 1, an active butterfly valve 3, a passive butterfly valve 5, a powder storage tank 7, and a sterile drug liquid storage bag 11.
[0043] The reversible drug storage tank 1 has a discharge port 101, which is located at the upper part of the reversible drug storage tank 1. The discharge port 101 is connected to the active butterfly valve 3 through a first connecting member 2. Specifically, the first connecting member 2 is a clamp, which is used to connect the active butterfly valve 3 to the discharge port 101 of the reversible drug storage tank 1.
[0044] The active butterfly valve 3 is connected to the passive butterfly valve 5 through the second connecting member 4. Specifically, the second connecting member 4 includes a first clamp 401, a connector 402, and a second clamp 403. The first clamp 401 clamps the active butterfly valve 3 and the connector 402 together, and the second clamp 403 clamps the connector 402 and the passive butterfly valve 5 together. The connection between the active butterfly valve 3 and the passive butterfly valve 5 is realized through the second connecting member 4.
[0045] The passive butterfly valve 5 is connected to the inlet of the powder storage tank 7 via a third connector 6. Specifically, the third connector 6 is a clamp, which is used to connect the passive butterfly valve 5 to the inlet of the powder storage tank 7.
[0046] The discharge port 101 of the powder storage tank 7 is equipped with a diaphragm valve 8, which is connected to a three-way connector 9 via a clamp. The three-way connector 9 is a disposable three-way connecting pipe, and its two outlets are respectively connected to a sterile drug solution transfer pipeline 10 and a steam discharge pipeline 13. The sterile drug solution transfer pipeline 10 is connected to a sterile drug solution storage bag 11 to transfer sterile drug solution into the sterile drug solution storage bag 11. The inlet end of the steam discharge pipeline 13 is equipped with a second diaphragm valve 12, and steam is discharged from the steam discharge pipeline 13 during sterilization to ensure the sterilization effect of the system.
[0047] When using the transfer system of the present invention, the active butterfly valve 3, the passive butterfly valve 5 and the diaphragm valve 8 should be opened first to introduce steam into the system, so that the steam can flow between the reversible drug storage tank 1 and the sterile drug storage bag 11 to perform steam sterilization treatment on the entire system. The diaphragm valve 12 should also be opened for online sterilization and steam discharge.
[0048] When the transferred drug is a liquid, the active butterfly valve 3, the passive butterfly valve 5, and the first diaphragm valve 8 are opened, and the second diaphragm valve 12 is closed. The powder storage tank 7 acts as a transfer pipeline, and the liquid drug is transferred to the sterile liquid drug storage bag 11 through the powder storage tank 7 and the sterile liquid drug transfer pipeline 10. When the transferred drug is a powder, the active butterfly valve 3 and the passive butterfly valve 5 are opened, and the first diaphragm valve 8 and the second diaphragm valve 12 are closed, sealing the bottom of the powder storage tank 7 to prevent the powder inside the tank from being contaminated. The powder is directly transferred to the powder storage tank 7.
[0049] The transfer device of this invention uses clamps as connectors to connect the active butterfly valve 3 and the passive butterfly valve 5, as well as the active butterfly valve 3 to the discharge port 101 and the passive butterfly valve 5 to the powder storage tank 7. The clamps provide strong clamping force and excellent sealing performance, ensuring reliable connection. The device also features a simple structure and low operational complexity. Furthermore, the dual butterfly valve design establishes a sterile connection between the tiltable drug storage tank 1 and the powder storage tank 7, preventing contamination from personnel and environmental microorganisms. In addition, the powder storage tank 7 functions as a storage tank for powder transfer and as a transfer pipeline for liquid transfer, making it suitable for aseptic transfer of both powder and liquid. This versatility and flexibility reduce dependence on specific transfer systems, enhance the efficiency and reliability of aseptic transfer, and lower production costs. Example 2
[0050] Based on the transfer system of Example 1, this example provides a method for transferring sterile drug solution, including the following steps:
[0051] (1) Before production, check the integrity and sealing of the system connection to ensure that the entire system forms a closed sterile channel when connected. Then, turn on the active butterfly valve 3 and the passive butterfly valve 5 to perform an online leak test on the system to ensure the integrity of the system connection.
[0052] (2) After the leak test is passed, keep the active butterfly valve 3 and the passive butterfly valve 5 in the open state, and introduce steam into the system so that pure steam can flow between the reversible drug storage tank 1 and the sterile drug storage bag 11. The whole system is sterilized online by moist heat (121℃, 30min). After sterilization, the system maintains a slightly positive pressure state against the background environment.
[0053] (3) Close the active butterfly valve 3 and the passive butterfly valve 5, and transport and store the 20kg sterile drug solution prepared by the aseptic production process in the invertible drug storage tank 1.
[0054] (4) Turn on the active butterfly valve 3, passive butterfly valve 5 and diaphragm valve 8 in sequence to introduce clean compressed air into the tiltable drug storage tank 1 with a pressure ≤0.20MPa. The tiltable drug storage tank 1 will tilt and discharge the sterile drug solution along the closed sterile channel to the sterile drug storage bag 11. After observing through the sight glass that the sterile drug solution has been transferred, turn off the diaphragm valve 8, passive butterfly valve 5 and active butterfly valve 3.
[0055] In this embodiment, the sterile drug storage bag 11 receives 19.5 kg of drug solution, and the drug solution recovery rate is 97.5%. Example 3
[0056] Based on the transfer system of Example 1, this example provides a sterile powder transfer method, including the following steps:
[0057] (1) Before production, check the integrity and sealing of the system connection to ensure that the entire system forms a closed sterile channel when connected. Then, turn on the active butterfly valve 3 and the passive butterfly valve 5 to perform an online leak test on the system to ensure the integrity of the system connection.
[0058] (2) After the leak test is passed, keep the active butterfly valve 3 and the passive butterfly valve 5 in the open state, and introduce steam into the system so that pure steam can flow between the reversible drug storage tank 1 and the sterile drug storage bag 11. The whole system is sterilized online by moist heat (121℃, 30min). After sterilization, the system maintains a slightly positive pressure state against the background environment.
[0059] (3) Close the active butterfly valve 3 and the passive butterfly valve 5, and transport and store the 3kg sterile powder prepared by the aseptic production process in the invertible drug storage tank 1.
[0060] (4) Turn on the active butterfly valve 3 and the passive butterfly valve 5 in sequence. The flip-top drug storage tank 1 will turn over to discharge the sterile powder along the closed sterile channel to the powder storage tank 7. After observing through the sight glass that the sterile powder has been transferred, turn off the passive butterfly valve 5 and the active butterfly valve 3.
[0061] In this embodiment, the powder storage tank 7 receives 2.7 kg of powder, with a powder yield of 90%.
[0062] As can be seen from Examples 2 and 3, the aseptic transfer yield of the drug using the transfer method of the present invention can reach more than 90%, which is a high yield. In contrast, the traditional aseptic powder discharge method generally uses vacuum suction, which results in larger drug residues and a lower yield (<70%). Therefore, the discharge and transfer method of the present invention can significantly improve the product yield.
[0063] Finally, it should be noted that the above specific embodiments are only used to describe the purpose, technical solution, and beneficial effects of the present invention in detail. It should be understood that the above description is only a specific implementation of the present invention and is not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the foregoing specific embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions or improvements can be made to some or all of the technical features. These modifications, equivalent substitutions, and improvements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered within the scope of the claims and specification of the present invention.
Claims
1. A dual butterfly valve aseptic pharmaceutical transfer system, characterized in that, It includes a reversible drug storage tank (1), an active butterfly valve (3), a passive butterfly valve (5), a powder storage tank (7), and a sterile drug liquid storage bag (11); The discharge port (101) of the reversible drug storage tank (1) is connected to the active butterfly valve (3) through the first connecting member (2), the active butterfly valve (3) is connected to the passive butterfly valve (5) through the second connecting member (4), and the passive butterfly valve (5) is connected to the feed port of the powder storage tank (7) through the third connecting member (6). The powder storage tank (7) is equipped with a diaphragm valve (8) at its outlet (101), and the outlet (101) of the powder storage tank (7) is connected to a sterile medicine storage bag (11).
2. The dual butterfly valve aseptic pharmaceutical transfer system of claim 1, wherein, The first connector (2) is a clamp.
3. The dual butterfly valve aseptic pharmaceutical transfer system of claim 1, wherein, The second connector (4) includes a first clamp (401), a connector (402), and a second clamp (403). The first clamp (401) clamps the active butterfly valve (3) together with the connector (402), and the second clamp (403) clamps the connector (402) together with the passive butterfly valve (5).
4. The dual butterfly valve aseptic pharmaceutical transfer system of claim 1, wherein, The third connector (6) is a clamp.
5. The dual butterfly valve aseptic pharmaceutical transfer system of claim 1, wherein, The outlet (101) of the powder storage tank (7) is connected to the sterile drug storage bag (11) through the sterile drug transfer pipeline (10).
6. The dual butterfly valve aseptic pharmaceutical transfer system of claim 5, wherein, The outlet (101) of the powder storage tank (7) is also connected to a steam discharge pipeline (13).
7. The dual butterfly valve aseptic pharmaceutical transfer system of claim 6, wherein, The inlet end of the steam discharge pipeline (13) is equipped with a diaphragm valve (12).
8. The dual butterfly valve aseptic pharmaceutical transfer system of claim 6, wherein, The outlet (101) of the powder storage tank (7) is connected to the inlet of the three-way connector (9), and the two outlets of the three-way connector (9) are respectively connected to the sterile drug transfer pipeline (10) and the steam discharge pipeline (13).
9. A method of aseptic pharmaceutical transfer, comprising: Includes the following steps: Open the active butterfly valve (3) and the passive butterfly valve (5) to introduce steam into the system, so that the steam can flow between the reversible drug storage tank (1) and the sterile drug storage bag (11). Sterilize online in 15-30 minutes at 120-130℃. After steam sterilization is completed, keep the system in a slightly positive pressure state. Close the active butterfly valve (3) and the passive butterfly valve (5) to deliver sterile drugs into the reversible drug storage tank (1); When the transferred drug is a sterile drug solution, open the active butterfly valve (3), passive butterfly valve (5) and diaphragm valve (8) in sequence, and introduce clean compressed air into the reversible drug storage tank (1) with a pressure ≤0.20MPa. The sterile drug solution is transferred to the sterile drug storage bag (11) through the powder storage tank (7) and the sterile drug solution transfer pipeline (10) in sequence. After the transfer is completed, close the diaphragm valve (8), passive butterfly valve (5) and active butterfly valve (3). When transferring sterile powder, keep diaphragm valve 1 (8) closed, and open the active butterfly valve (3) and passive butterfly valve (5) in sequence to transfer the sterile powder into the powder storage tank (7). After the transfer is completed, close the passive butterfly valve (5) and active butterfly valve (3).
10. A method of aseptic pharmaceutical transfer according to claim 9, wherein, During steam sterilization, open diaphragm valve 2 (12) to allow steam to be discharged from steam discharge pipe (13).