Double-butterfly-valve sterile medicine transfer system

Abstract

The utility model discloses a double-butterfly-valve sterile medicine transfer system, and relates to the technical field of pharmacy. Comprising a turnover medicine storage tank, a driving butterfly valve, a driven butterfly valve, a powder storage tank and a sterile liquid medicine storage bag, a discharging port of the turnover medicine storage tank is connected with the driving butterfly valve through a first connecting piece, and the driving butterfly valve is connected with the driven butterfly valve through a second connecting piece; the passive butterfly valve is connected with a feeding port of a powder storage tank through a third connecting piece, a first diaphragm valve is arranged at a discharging port of the powder storage tank, and the discharging port of the powder storage tank is connected with a sterile liquid medicine storage bag; by adopting the design of double butterfly valves, sterile connection is established between the turnover medicine storage tank and the powder storage tank, the reliability of hoop connection is high, the structure is simple, the operation complexity is low, the universality is high, the flexibility is high, and the cost is low.

Description

Technical Field

[0001] The utility model relates to the technical field of pharmaceutical manufacturing, in particular to a double butterfly valve aseptic drug transfer system. Background Art

[0002] In the pharmaceutical industry, existing aseptic production technologies enable the safe transfer of sterile drugs from one sterile container to another in a non-sterile background environment (such as a Grade C environment). Commonly used closed aseptic connection technologies in the industry include SUS (Single Use System), SART system, AB valve system, and vacuum suction system.

[0003] Both the SUS system and the SART system are disposable systems, which not only have high material costs but also increase processing costs. In addition, the research on extractables and leachables (E&L) of disposable systems is relatively complex, and there are certain quality risks and compliance challenges. They are only suitable for the closed transfer of sterile liquid medicines. The AB valve system is designed with specific dimensions and is highly complex to operate. In the case of large-scale production, the risk of errors also increases accordingly. It is also expensive and costly, and is only suitable for the closed transfer of sterile powders. The vacuum suction system is designed with many pipelines and valve connections and a complex structure. During the powder discharging process, a large amount of adhesion occurs at the pipes and valves, resulting in large discharge residues and low product yield. It is only suitable for the closed transfer of sterile powders.

[0004] Therefore, the closed transfer system of sterile drugs in the prior art has the defects of low versatility, high operation complexity, high cost, and large discharge residue. Based on this, a double butterfly valve sterile drug transfer system is now provided. Utility Model Content

[0005] The utility model is intended to solve the technical problems of low versatility, high operational complexity, high cost and large discharge residue in the closed transfer system of sterile drugs in the prior art. The utility model aims to provide a double butterfly valve sterile drug transfer system, which adopts a double butterfly valve design to establish a sterile connection between a reversible drug storage tank and a powder storage tank. The clamp is used as a connecting part to ensure the connection reliability. The utility model has a simple structure and low operational complexity. It can be applied to the sterile transfer of powders and liquids at the same time, and has strong versatility, high flexibility and low cost.

[0006] The utility model is achieved through the following technical solutions:

[0007] A double butterfly valve sterile drug transfer system, comprising a reversible drug storage tank, an active butterfly valve, a passive butterfly valve, a powder storage tank, and a sterile liquid drug storage bag;

[0008] The discharge port of the reversible drug storage tank is connected to the active butterfly valve via a first connecting piece, the active butterfly valve is connected to the passive butterfly valve via a second connecting piece, and the passive butterfly valve is connected to the feed port of the powder storage tank via a third connecting piece;

[0009] The discharge port of the powder storage tank is provided with a diaphragm valve 1, and the discharge port of the powder storage tank is connected to the sterile liquid medicine storage bag.

[0010] Furthermore, the first connecting member is a clamp.

[0011] Furthermore, the second connecting member includes a first clamp, a connector and a second clamp, the first clamp clamps the active butterfly valve and the connector together, and the second clamp clamps the connector and the passive butterfly valve together.

[0012] Furthermore, the third connecting member is a clamp.

[0013] Furthermore, the discharge port of the powder storage tank is connected to the sterile liquid medicine storage bag through a sterile liquid medicine transfer pipeline.

[0014] Furthermore, the discharge port of the powder storage tank is also connected to a steam discharge pipeline.

[0015] Furthermore, a second diaphragm valve is provided at the inlet end of the steam exhaust pipeline.

[0016] Furthermore, the discharge port of the powder storage tank is connected to the inlet of a three-way joint, and the two outlets of the three-way joint are respectively connected to the sterile liquid transfer pipeline and the steam exhaust pipeline.

[0017] Furthermore, the three-way connector adopts a disposable three-way connecting tube.

[0018] Furthermore, the discharge port of the reversible medicine storage tank is located at the upper part of the reversible medicine storage tank.

[0019] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0020] 1. The transfer device of the utility model adopts a clamp as a connecting piece, connecting 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 through the clamp. Since the clamp has a strong clamping force and good sealing performance, the connection reliability is guaranteed, and the structure is simple and the operation complexity is low.

[0021] 2. The double butterfly valve design of the utility model establishes a sterile connection between the reversible drug storage tank and the powder storage tank, thereby avoiding contamination by human operation and environmental microorganisms.

[0022] 3. The powder storage tank of the utility model is used as a storage tank when transferring powder and as a transfer pipeline when transferring liquid medicine. It is suitable for the aseptic transfer of powder and liquid at the same time. It has strong versatility and high flexibility, reduces the dependence on a specific type of transfer system, enhances the efficiency and reliability of aseptic transfer, and reduces production costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions of the exemplary embodiments of the present invention, the following briefly introduces the drawings required for use in the examples. It should be understood that the following drawings only illustrate certain embodiments of the present invention and should not be considered as limiting the scope. A person of ordinary skill in the art can also derive other relevant drawings based on these drawings without inventive effort. In the drawings:

[0024] Figure 1 This is a schematic diagram of the structure of the transfer system of the utility model;

[0025] Figure 2 This is a schematic diagram of the connection structure between the second connecting piece and the powder storage tank of the utility model;

[0026] Figure 3 for Figure 2 Middle AA section view;

[0027] Figure 4 Schematic diagram of the structure of the second connecting member.

[0028] Markings and corresponding parts names in the accompanying drawings:

[0029] 1-reversible drug storage tank, 101-discharge port, 2-first connecting piece, 3-active butterfly valve, 4-second connecting piece, 401-first clamp, 402-connector, 403-second clamp, 5-passive butterfly valve, 6-third connecting piece, 7-powder storage tank, 8-diaphragm valve 1, 9-tee connector, 10-sterile drug solution transfer pipeline, 11-sterile drug solution storage bag, 12-diaphragm valve 2, 13-steam discharge pipeline. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solutions and advantages of the present invention more clear, the technical solutions in the embodiments of the present invention are clearly and completely described below in combination with the embodiments and drawings. Obviously, the schematic implementation methods of the present invention and their descriptions are only used to explain the present invention and are not intended to limit the present invention.

[0031] In the following description, numerous specific details are set forth to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that these specific details are not necessarily required to practice the present invention. In other embodiments, well-known structures, circuits, materials, or methods are not described in detail to avoid obscuring the present invention.

[0032] Throughout this specification, references to "one embodiment," "an embodiment," "an example," or "an example" mean that a particular feature, structure, or characteristic described in conjunction with the embodiment or example is included in at least one embodiment of the present invention. Therefore, the phrases "one embodiment," "an embodiment," "an example," or "an example" appearing in various places throughout this specification do not necessarily refer to the same embodiment or example. In addition, the particular features, structures, or characteristics may be combined in one or more embodiments or examples in any suitable combination and / or subcombination. Furthermore, it will be understood by those of ordinary skill in the art that the figures provided herein are for illustrative purposes only and are not necessarily drawn to scale. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0033] In the description of the present invention, the indicated orientation or position relationship is based on the orientation or position relationship shown in the accompanying drawings, or is the orientation or position relationship in which the product of the application is usually placed when in use, or is the orientation or position relationship commonly understood by those skilled in the art. It is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0034] At the same time, the terms "dispose," "assemble," "connect," and "connect" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to direct connections, indirect connections through an intermediary, or internal connections between two components. Those skilled in the art will understand the specific meanings of these terms in this utility model based on specific circumstances.

[0035] The technical solution of the present utility model is further described in detail below in conjunction with the embodiments.

[0036] It should be noted that the experimental methods used in the examples are conventional methods unless otherwise specified. The materials, reagents, methods and instruments used are conventional materials, reagents, methods and instruments in the art, unless otherwise specified, and can be obtained from commercial channels by those skilled in the art.

[0037] Example 1

[0038] A double butterfly valve sterile drug transfer system, see Figures 1-4, including 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.

[0039] The reversible drug storage tank 1 has a discharge port 101, which is arranged 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, and the connection between the active butterfly valve 3 and the discharge port 101 of the reversible drug storage tank 1 is realized through the first connecting member 2.

[0040] The active butterfly valve 3 is connected to the passive butterfly valve 5 through a second connecting member 4. Specifically, the second connecting member 4 includes a first clamp 401, a connecting head 402 and a second clamp 403. The first clamp 401 clamps the active butterfly valve 3 and the connecting head 402 together, and the second clamp 403 clamps the connecting head 402 and the passive butterfly valve 5 together. The connection between the active butterfly valve 3 and the passive butterfly valve 5 is achieved through the second connecting member 4.

[0041] The passive butterfly valve 5 is connected to the feed port of the powder storage tank 7 via a third connecting piece 6 . Specifically, the third connecting piece 6 is a clamp, and the connection between the passive butterfly valve 5 and the feed port of the powder storage tank 7 is achieved via the third connecting piece 6 .

[0042] The discharge port 101 of the powder storage tank 7 is provided with a diaphragm valve 8, which is connected to the three-way joint 9 through a clamp. The three-way joint 9 adopts a disposable three-way connecting pipe. The two outlets of the three-way joint 9 are respectively connected to the sterile liquid transfer pipeline 10 and the steam discharge pipeline 13; the sterile liquid transfer pipeline 10 is connected to the sterile liquid storage bag 11 for transferring the sterile liquid into the sterile liquid storage bag 11; the inlet end of the steam discharge pipeline 13 is provided with a diaphragm valve 2 12, and steam is discharged from the steam discharge pipeline 13 during sterilization to ensure the sterility effect of the sterilization system.

[0043] When the transfer system of the present invention is in use, the active butterfly valve 3, the passive butterfly valve 5 and the diaphragm valve 1 8 must first be opened, and steam must be introduced into the system so that the steam can flow between the reversible drug storage tank 1 and the sterile drug liquid storage bag 11 to perform steam sterilization on the entire system. In addition, the diaphragm valve 2 12 must also be opened for online sterilization and steam discharge.

[0044] When the transferred drug is liquid, the active butterfly valve 3, the passive butterfly valve 5 and the diaphragm valve 1 8 are opened, the diaphragm valve 2 12 is closed, and the powder storage tank 7 acts as a transfer pipeline. The liquid is transferred to the sterile liquid storage bag 11 through the powder storage tank 7 and the sterile liquid transfer pipeline 10; when the transferred drug is powder, the active butterfly valve 3 and the passive butterfly valve 5 are opened, the diaphragm valve 1 8 and the diaphragm valve 2 12 are closed, and the bottom of the powder storage tank 7 is sealed to prevent the powder in the tank from being contaminated, and the powder is directly transferred to the powder storage tank 7.

[0045] The transfer device of the present invention adopts a clamp as a connecting piece, and connects the active butterfly valve 3 and the passive butterfly valve 5, as well as the active butterfly valve 3 and the discharge port 101, and the passive butterfly valve 5 and the powder storage tank 7 together through the clamp. Since the clamp has a strong clamping force and good sealing performance, the connection reliability is guaranteed, and the structure is simple and the operation complexity is low; at the same time, the double butterfly valve design of the present invention establishes a sterile connection between the flippable drug storage tank 1 and the powder storage tank 7, thereby avoiding contamination by human operation and environmental microorganisms; in addition, the powder storage tank 7 of the present invention is used as a storage tank when transferring powder, and as a transfer pipeline when transferring liquid medicine. It is suitable for the aseptic transfer of powder and liquid, has strong versatility and high flexibility, reduces dependence on a specific type of transfer system, enhances the efficiency and reliability of aseptic transfer, and reduces production costs.

[0046] Example 2

[0047] Based on the transfer system of Example 1, this embodiment provides a method for transferring a sterile liquid medicine, comprising the following steps:

[0048] (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 open the active butterfly valve 3 and the passive butterfly valve 5 switches and perform an online leak test on the system to ensure the integrity of the system connection.

[0049] (2) Maintaining the active butterfly valve 3 and the passive butterfly valve 5 in an open state, steam is introduced into the system so that pure steam can flow between the reversible drug storage tank 1 and the sterile drug storage bag 11. The entire system undergoes online moist heat sterilization (121°C, 30 minutes). After sterilization is completed and leak detection is passed, the system maintains a slightly positive pressure state against the background environment.

[0050] (3) The active butterfly valve 3 and the passive butterfly valve 5 are closed, and 20 kg of sterile liquid medicine prepared by the aseptic production process is transported and stored in the reversible medicine storage tank 1.

[0051] (4) Open the active butterfly valve 3, the passive butterfly valve 5 and the diaphragm valve 8 in sequence, and introduce clean compressed air into the reversible drug storage tank 1 with a pressure of ≤0.20 MPa. The reversible drug storage tank 1 is turned over to discharge the material, and the sterile drug solution is transferred to the sterile drug solution storage bag 11 along the closed sterile channel. After observing the transfer of the sterile drug solution through the sight glass, close the diaphragm valve 8, the passive butterfly valve 5 and the active butterfly valve 3.

[0052] The sterile liquid medicine storage bag 11 of this embodiment receives 19.5 kg of liquid medicine, and the liquid medicine yield is 97.5%.

[0053] Example 3

[0054] Based on the transfer system of Example 1, this embodiment provides a sterile powder transfer method, comprising the following steps:

[0055] (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 open the active butterfly valve 3 and the passive butterfly valve 5 switches and perform an online leak test on the system to ensure the integrity of the system connection.

[0056] (2) Maintaining the active butterfly valve 3 and the passive butterfly valve 5 in an open state, steam is introduced into the system so that pure steam can flow between the reversible drug storage tank 1 and the sterile drug storage bag 11. The entire system undergoes online moist heat sterilization (121°C, 30 minutes). After sterilization is completed and leak detection is passed, the system maintains a slightly positive pressure state against the background environment.

[0057] (3) The active butterfly valve 3 and the passive butterfly valve 5 are closed, and 3 kg of sterile powder prepared by the aseptic production process is transported and stored in the reversible drug storage tank 1.

[0058] (4) Open the active butterfly valve 3 and the passive butterfly valve 5 in sequence, flip the drug storage tank 1 to discharge the material, and transfer the sterile powder to the powder storage tank 7 along the closed sterile channel. After observing the sterile powder transfer through the sight glass, close the passive butterfly valve 5 and the active butterfly valve 3.

[0059] In this embodiment, the weight of the powder received by the powder storage tank 7 is 2.7 kg, and the powder yield is 90%.

[0060] It can be seen from Examples 2 and 3 that after adopting the transfer method of the present invention, the aseptic transfer yield of the drug can reach more than 90%, which is a high yield. The traditional sterile powder discharging method generally adopts a vacuum suction method, which has a large drug residue and a low yield (<70%). Therefore, the discharging transfer method of the present invention can significantly improve the product yield.

[0061] Finally, it should be noted that the above specific embodiments are only used to explain in detail the purpose, technical solutions and beneficial effects of the present invention. It should be understood that the above is only a specific implementation method of the present invention and is not used to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the above specific embodiments, ordinary technicians in this field should understand that it is still possible to modify the technical solutions recorded in the above embodiments, or to replace or improve some or all of the technical features therein. These modifications, equivalent replacements, and improvements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and description of the present invention.

Claims

1. A double butterfly valve sterile drug transfer system, characterized in that: It comprises a reversible medicine storage tank (1), an active butterfly valve (3), a passive butterfly valve (5), a powder storage tank (7) and a sterile medicine liquid storage bag (11); The discharge port (101) of the reversible drug storage tank (1) is connected to the active butterfly valve (3) via a first connecting piece (2), the active butterfly valve (3) is connected to the passive butterfly valve (5) via a second connecting piece (4), and the passive butterfly valve (5) is connected to the feed port of the powder storage tank (7) via a third connecting piece (6); The discharge port (101) of the powder storage tank (7) is provided with a diaphragm valve (8), and the discharge port (101) of the powder storage tank (7) is connected to a sterile liquid medicine storage bag (11).

2. A double butterfly valve sterile drug transfer system according to claim 1, characterized in that: The first connecting member (2) is a clamp.

3. A double butterfly valve sterile drug transfer system according to claim 1, characterized in that: The second connecting member (4) comprises a first clamp (401), a connecting head (402) and a second clamp (403), wherein the first clamp (401) clamps the active butterfly valve (3) and the connecting head (402) together, and the second clamp (403) clamps the connecting head (402) and the passive butterfly valve (5) together.

4. A double butterfly valve sterile drug transfer system according to claim 1, characterized in that: The third connecting member (6) is a clamp.

5. The double butterfly valve sterile drug transfer system according to claim 1, characterized in that: The discharge port (101) of the powder storage tank (7) is connected to the sterile liquid medicine storage bag (11) via a sterile liquid medicine transfer pipeline (10).

6. A double butterfly valve sterile drug transfer system according to claim 5, characterized in that: The discharge port (101) of the powder storage tank (7) is also connected to a steam discharge pipeline (13).

7. A double butterfly valve sterile drug transfer system according to claim 6, characterized in that: A second diaphragm valve (12) is provided at the inlet end of the steam exhaust pipeline (13).

8. The double butterfly valve sterile drug transfer system according to claim 6, characterized in that: The discharge port (101) of the powder storage tank (7) is connected to the inlet of the three-way joint (9), and the two outlets of the three-way joint (9) are respectively connected to the sterile liquid transfer pipeline (10) and the steam discharge pipeline (13).

9. A double butterfly valve aseptic drug transfer system according to claim 8, characterized in that: The three-way connector (9) adopts a disposable three-way connecting pipe.

10. A double butterfly valve sterile drug transfer system according to any one of claims 1 to 9, characterized in that: The discharge port (101) of the reversible medicine storage tank (1) is located at the upper part of the reversible medicine storage tank (1).

Images