Valve assembly and sterile transfer container

Abstract

The utility model relates to the field of biopharmaceutical technology, disclose a valve assembly, including valve body and sealing washer, wherein the valve body is equipped with the sealing washer installation groove for installing sealing washer, is equipped with one -way exhaust structure in sealing washer installation groove, it includes the air vent and elastic protective sheath, the air vent intercommunication sealing washer installation groove with elastic protective sheath, elastic protective sheath covers air vent in its inside, when the inside pressure of elastic protective sheath is greater than the outside pressure, elastic protective sheath is pressed and occurs expansion, its outer diameter is larger and exceeds the boss outer diameter, forms the gap between with boss outer wall, air vent opens, gas is discharged to the outside through the gap, realizes the pressure reduction inside container, when the inside pressure of elastic protective sheath is less than or equal to the outside pressure, elastic protective sheath contracts, sticks boss outer wall, closes side wall hole, air vent closes, prevents the outside gas or pollutant to enter the inside container, the utility model realizes the demand of equipment sterile transmission through one -way exhaust structure.

Description

Technical Field

[0001] This utility model relates to the field of biopharmaceutical technology, and in particular to valve components and sterile transfer containers. Background Technology

[0002] In the pharmaceutical industry, the valve assembly of aseptic transfer containers is a crucial production component, used to achieve precise transfer and sealing of materials in a sterile environment, thereby ensuring the sterility, safety, and compliance of pharmaceutical production.

[0003] Currently, aseptic material transfer scenarios are becoming increasingly frequent in biopharmaceutical manufacturing. These materials typically undergo high-temperature steam sterilization before and after transfer to completely eliminate any potential microorganisms and ensure their sterility. However, the sealing performance of valve components faces severe challenges in this crucial process. Currently available aseptic transfer containers frequently experience sealing ring detachment during high-temperature steam sterilization, directly compromising the integrity of the container and failing to effectively guarantee sterility. Once this occurs, not only may the material be contaminated, but the entire production batch may also face the risk of being scrapped, resulting in significant economic losses for the company and posing a serious threat to medication safety.

[0004] With the continuous development of pharmaceutical technology, the market demand for high-end drugs such as biological agents, sterile raw materials, and injections continues to rise. The production process of drugs is highly dependent on sterile barrier systems, and the sealing problem of valve components of traditional sterile transfer containers is becoming increasingly prominent.

[0005] This traditional aseptic transfer container has significant technical shortcomings. Aseptic transfer containers are not only fundamental equipment for ensuring the stability of drug quality, but also an important support for promoting the upgrading of drug production processes and achieving aseptic control throughout the entire process, occupying an irreplaceable position in the modern drug production system.

[0006] To address the aforementioned issues, existing technologies urgently need improvement. Utility Model Content

[0007] The purpose of this invention is to provide a valve assembly that aims to solve the problem of sealing ring detachment during the high-temperature steam sterilization process of aseptic transfer containers.

[0008] To solve the above-mentioned technical problems, this utility model provides a valve assembly, including:

[0009] Valve body and sealing ring, wherein the valve body is provided with a sealing ring mounting groove and a one-way exhaust structure;

[0010] The sealing ring is disposed in the sealing ring mounting groove, and the one-way venting structure includes a vent hole and an elastic protective sleeve. One end of the vent hole communicates with the internal space of the sealing ring mounting groove, and the other end of the vent hole is tightly attached to the inner wall of the elastic protective sleeve.

[0011] When the inner pressure of the elastic protective sleeve is greater than the outer pressure, the elastic protective sleeve expands and separates from the other end of the vent hole to open the vent hole; when the inner pressure of the elastic protective sleeve is less than or equal to the outer pressure, the elastic protective sleeve fits into the other end of the vent hole to close the vent hole.

[0012] Optionally, the one-way exhaust structure further includes a boss, which is integrated with the valve body, the exhaust port passes through the boss, and the elastic protective sleeve is fitted onto the boss.

[0013] Optionally, the vent hole includes a through hole and a side wall hole. The side wall hole is formed on the side wall of the boss. The through hole is arranged along the axis of the central through hole of the boss and communicates with the sealing ring mounting groove and the side wall hole.

[0014] Optionally, the one-way exhaust structure further includes barbs, which are provided on the outer side wall of the boss to prevent the elastic protective sleeve from moving relative to the boss.

[0015] Optionally, the sidewall hole is located between the barb and the top of the sidewall of the boss.

[0016] Optionally, it also includes a valve cover, which has a groove on the side facing the valve body. The valve body has a central through hole and a plurality of snap-fit ​​platforms are provided on the inner side wall of the valve body. The valve cover cooperates with the snap-fit ​​platforms of the valve body through the groove to press the sealing ring to achieve a seal.

[0017] This utility model provides a sterile delivery container, including an inner bag, an outer bag, and a valve assembly as described above;

[0018] The valve assembly has an annular flange on the bottom surface of the valve body. Both the inner bag and the outer bag have an open end. The open end of the outer bag is fixedly connected to the annular flange of the valve body by welding. The open end of the inner bag extends out of the outer bag through the central through hole of the valve body. The closed end of the inner bag is located inside the outer bag and is fixedly connected to the closed end of the outer bag by welding.

[0019] Optionally, both the inner bag and the outer bag are welded together from two opposing plastic films. The open end of the outer bag is formed in one of the plastic films, and the open end of the inner bag is formed by combining the open edges of the two plastic films.

[0020] Through the above technical solution, this utility model has the following beneficial effects:

[0021] The one-way venting structure of this invention effectively prevents the sealing ring from falling off, ensuring the integrity and sterility of the sterile container. Through a rational structural design, especially the setting of the sealing ring mounting groove, a stable installation space is provided for the sealing ring, reducing the risk of it falling off during high-temperature steam sterilization and other processes. This ensures that the sealing performance of the sterile container is not compromised, maintaining its internal sterile environment.

[0022] In addition, the combination of the vent and the elastic protective sleeve enables one-way venting. The elastic protective sleeve covers the vent inside. When the pressure inside is greater than that outside, the outer diameter of the elastic protective sleeve increases and opens the vent, making it easier to release the gas inside the container. When the pressure inside is less than or equal to that outside, the elastic protective sleeve fits against the outer wall of the boss and seals the vent, which can effectively prevent external gas or contaminants from entering and ensure the one-way venting and the reliability of the seal. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of the aseptic delivery container in an embodiment of the present invention;

[0024] Figure 2 This is a cross-sectional view of the aseptic delivery container in an embodiment of the present invention. Figure 1 ;

[0025] Figure 3 This is a cross-sectional view of the aseptic delivery container in an embodiment of the present invention. Figure 2 ;

[0026] Figure 4 This is a schematic diagram of the unidirectional exhaust structure in an embodiment of the present invention;

[0027] Figure 5 This is a schematic diagram of the card slot structure in an embodiment of the present invention;

[0028] Figure 6 This is a schematic diagram of the valve body in an embodiment of the present invention;

[0029] Figure 7 This is a schematic diagram of the bag body in an embodiment of the present invention.

[0030] In the diagram, 1. Valve cover; 2. Sealing ring; 3. Valve body; 4. Through hole; 5. Side wall hole; 6. Barb; 7. Elastic protective sleeve; 8. Inner bag; 9. Outer bag; 10. Snap-in groove; 11. Sealing ring mounting groove; 12. Center through hole; 13. Snap-in platform; 14. Flange. Detailed Implementation

[0031] The present invention will now be described with reference to the accompanying drawings, which illustrate preferred embodiments of the present invention. It should be understood that those skilled in the art can modify the present invention described herein while still achieving its advantageous effects. Therefore, the following description should be understood as being of general knowledge to those skilled in the art and is not intended to limit the present invention.

[0032] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages). In the description of this utility model, it should be understood that the terms "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this utility model and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0033] In this utility model, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0034] The present invention will be described in more detail below by way of example with reference to the accompanying drawings. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention.

[0035] Please refer to Figure 1 - Figure 3This embodiment provides a valve assembly, including: a valve body 3 and a sealing ring 2, wherein the valve body 3 is provided with a sealing ring mounting groove 11 and a one-way venting structure; the sealing ring 2 is disposed in the sealing ring mounting groove 11, and the one-way venting structure includes a vent hole and an elastic protective sleeve 7, one end of the vent hole is connected to the internal space of the sealing ring mounting groove 11, and the other end of the vent hole is tightly attached to the inner wall of the elastic protective sleeve 7; when the inner pressure of the elastic protective sleeve 7 is greater than the outer pressure, the elastic protective sleeve 7 expands and separates from the other end of the vent hole to open the vent hole; when the inner pressure of the elastic protective sleeve 7 is less than or equal to the outer pressure, the elastic protective sleeve 7 is attached to the other end of the vent hole to close the vent hole.

[0036] The sealing ring mounting groove 11 specially designed on the valve body 3 of the aseptic transfer container provides a stable installation space for the sealing ring 2. The one-way venting structure within the sealing ring mounting groove 11 consists of a vent hole and an elastic protective sleeve 7. One end of the vent hole is directly connected to the sealing ring mounting groove 11, providing a channel for gas flow, while the other end of the vent hole is tightly attached to the inner wall of the elastic protective sleeve 7. The elastic protective sleeve 7 opens and closes the vent hole by changing its own state. Simultaneously, the valve assembly structure is rationally designed, ensuring both the sealing performance of the aseptic transfer container and automatically adjusting the internal pressure through the one-way venting structure, thus meeting the usage requirements of aseptic transfer scenarios.

[0037] Furthermore, the one-way exhaust structure also includes a boss, which is integrated with the valve body 3, and the exhaust port passes through the boss.

[0038] The integrated design of the boss and valve body 3 avoids the connection gaps that may exist in a split structure, preventing gas, liquid, or contaminants from leaking from the joint between the boss and valve body 3. This further ensures the sealing integrity of the aseptic transfer container and maintains the internal aseptic environment. The boss provides stable support and a mounting base for the vent, making the position and orientation of the vent easier to control and enabling precise communication with the sealing ring mounting groove 11 and the elastic protective sleeve 7. Simultaneously, the boss also provides some protection for the vent, reducing the risk of damage or blockage from external factors.

[0039] For further details, please refer to... Figure 4 The vent hole includes a through hole 4 and a side wall hole 5. The side wall hole 5 is formed on the side wall of the boss. The through hole 4 is arranged along the axis of the central through hole 12 of the boss and communicates with the sealing ring mounting groove 11 and the side wall hole 5.

[0040] The vent includes a through hole 4 and a side wall hole 5. The through hole 4 is located along the axis of the central through hole 12 of the boss and communicates with the sealing ring mounting groove 11 and the side wall hole 5. The side wall hole 5 is formed on the side wall of the boss, and its machining position can be precisely positioned by the structural dimensions of the boss to ensure that it matches the coverage area of ​​the elastic protective sleeve 7 and ensures the reliable realization of the one-way venting function. The vent uses a combination of through hole 4 and side wall hole 5. The through hole 4 is located along the axis of the central through hole 12 of the boss and communicates with the sealing ring mounting groove 11 and the side wall hole 5. From the perspective of gas flow efficiency, the through hole 4, located in the central through hole 12 of the boss, can directly and efficiently receive the gas in the sealing ring mounting groove 11, forming a smooth main channel and reducing the resistance of the gas in the initial flow stage. The side wall hole 5, which communicates with the through hole 4, can guide the flowing gas to the inside of the elastic protective sleeve 7, making the venting process smoother and ensuring that the internal pressure of the container can be quickly balanced.

[0041] Furthermore, this structure enhances the anti-interference capability of the exhaust port. The through hole 4 is hidden in the center through hole 12 of the boss, making it less susceptible to direct impact or friction from external collisions; although the side wall hole 5 is located on the side wall of the boss, it is covered by an elastic protective sleeve 7, which reduces the risk of external impurities clogging the channel and extends the service life of the valve assembly.

[0042] Furthermore, the one-way exhaust structure also includes barbs 6, which are provided on the outer side wall of the boss to prevent the elastic protective sleeve 7 from moving relative to the boss.

[0043] Furthermore, the sidewall hole 5 is located between the barb 6 and the top of the sidewall of the boss.

[0044] For further details, please refer to... Figures 5-6 The valve includes a valve cover 1, which has a slot 10 on the side facing the valve body 3. The valve body 3 has a central through hole 12. Several locking platforms 13 are provided on the inner side wall of the valve body 3. The valve cover 1 cooperates with the locking platforms 13 of the valve body 3 through the slot 10 to press the sealing ring 2 to achieve sealing.

[0045] In this embodiment, when the internal temperature of the aseptic transfer container rises, water vapor first enters the sealing ring mounting groove 11, then reaches the inside of the boss through the through hole 4, and then enters the inner side of the elastic protective sleeve 7 through the side wall hole 5. When the pressure inside the elastic protective sleeve 7 is greater than the pressure outside, the elastic protective sleeve 7 expands due to the pressure, its outer diameter increases and exceeds the outer diameter of the boss, forming a gap between it and the outer wall of the boss. The vent hole opens, and the gas is discharged to the outside through this gap, realizing depressurization inside the container. When the internal pressure of the container drops to be equal to or lower than the external pressure, the pressure inside the elastic protective sleeve 7 is less than or equal to the external pressure, the elastic protective sleeve 7 contracts, fits against the outer wall of the boss, and closes the side wall hole 5. The vent hole closes accordingly, preventing external gas or contaminants from entering the container, completing one-way venting.

[0046] Please refer to Figure 7 In this utility model, a sterile delivery container is also provided, including an inner bag 8, an outer bag 9, and a valve assembly as described above; the bottom surface of the valve body 3 of the valve assembly is provided with an annular flange 14, both the inner bag 8 and the outer bag 9 have an open end, the open end of the outer bag 9 is fixedly connected to the annular flange 14 of the valve body 3 by welding; the open end of the inner bag 8 extends out of the outer bag 9 through the central through hole 12 of the valve body 3, the closed end of the inner bag 8 is located inside the outer bag 9, and is fixedly connected to the closed end of the outer bag 9 by welding.

[0047] In this embodiment, the open end of the inner bag 8 extends from the outer bag 9 through the central through-hole 12 of the valve body 3. The bag itself forms a stepless conveying channel, fundamentally eliminating the material removal obstruction caused by steps at the valve port connection of traditional containers, making material conveying smoother. The inner bag 8, as an open bag for storing materials, has a reasonable length design and its opening can be pulled out from the valve assembly opening, allowing materials to be completely removed within the unobstructed channel, effectively avoiding material residue problems. At the same time, the operation process is more convenient and faster, reducing material waste and cleaning costs. The open end of the outer bag 9 is fixed to the annular flange 14 of the valve body 3 by welding, and the closed end of the inner bag 8 is also welded to the closed end of the outer bag 9. This multi-welded structure ensures the tightness of the connection between components and improves the overall stability of the container.

[0048] Furthermore, both the inner bag 8 and the outer bag 9 are welded together from two opposing plastic films. The open end of the outer bag 9 is formed in one of the plastic films, and the open end of the inner bag 8 is formed by combining the open edges of the two plastic films.

[0049] Both the inner bag 8 and the outer bag 9 have four sides. All four sides of the outer bag 9 are welded edges. One side of the inner bag 8 is an open side, and the other three sides are welded edges. The side opposite to the open side is fixed to the outer bag 9. The closed structure formed by welding effectively improves the overall tear resistance and sealing performance, reducing the risk of leakage due to corner cracking. The inner bag 8 has only one open side, and the side fixed to the outer bag 9 is the opposite side, making the opening direction of the inner bag 8 clear and easy to operate. Combined with the design that can be pulled out from the valve assembly opening, it makes it easier to load and unload materials.

[0050] In summary, the valve assembly of this aseptic transfer container achieves efficient sealing and stable one-way venting through the coordinated operation of its components. The sealing ring mounting groove on the valve body provides a stable mounting position for the sealing ring, which forms a basic sealing barrier. In the one-way venting structure, the boss provides stable support and precise positioning for the vent hole, while the vent hole penetrating the boss consists of a through hole and a side wall hole. The through hole guides the gas from the sealing ring mounting groove into the boss, while the side wall hole guides the gas to the inside of the elastic protective sleeve. This not only improves venting efficiency but also enhances anti-interference performance, while the side wall hole is enclosed within the elastic protective sleeve. The barbs on the outer wall of the boss connect to the upper end of the elastic protective sleeve, securing it and preventing it from falling off or shifting. Furthermore, the side wall hole is located at the lower end of the barbs, ensuring unobstructed venting path. The elastic protective sleeve can change its state according to changes in internal and external pressure: when the internal pressure is greater than the external pressure, its outer diameter will increase and create a gap with the boss, thereby opening the vent to balance the pressure; when the internal pressure is less than or equal to the external pressure, the elastic protective sleeve will fit against the outer wall of the boss, sealing the vent and preventing external contaminants from entering. The open end of the inner bag extends through the valve body through-hole, forming a stepless conveying channel, ensuring smooth material removal without residue, convenient operation, and reduced waste and cleaning costs; the multiple welding of the outer bag to the valve body and the inner bag to the closed end, as well as the structure of both the inner and outer bags being welded from two pieces of plastic film, not only improves the tightness of the connection between the components and the overall stability, but also enhances tear resistance and sealing performance, reducing the risk of corner cracking and leakage. At the same time, the design of the inner bag being able to be pulled out from the valve assembly opening facilitates material loading and unloading.

[0051] In summary, this aseptic delivery container has a reasonable structure and reliable function. It not only ensures the sealing of the aseptic delivery container, but also automatically adjusts the internal pressure. The design of the inner and outer bags fully meets the usage requirements of aseptic delivery scenarios.

[0052] Obviously, those skilled in the art can make various modifications and variations to this utility model without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this utility model and their equivalents, this utility model also intends to include these modifications and variations.

Claims

1. A valve assembly, characterized by It includes a valve body (3) and a sealing ring (2), wherein the valve body (3) is provided with a sealing ring mounting groove (11) and a one-way exhaust structure; The sealing ring (2) is disposed in the sealing ring mounting groove (11). The one-way exhaust structure includes an exhaust hole and an elastic protective sleeve (7). One end of the exhaust hole is connected to the internal space of the sealing ring mounting groove (11), and the other end of the exhaust hole is tightly attached to the inner wall of the elastic protective sleeve (7). When the inner pressure of the elastic protective sleeve (7) is greater than the outer pressure, the elastic protective sleeve (7) expands and separates from the other end of the vent hole to open the vent hole; when the inner pressure of the elastic protective sleeve (7) is less than or equal to the outer pressure, the elastic protective sleeve (7) fits against the other end of the vent hole to close the vent hole.

2. The valve assembly of claim 1, wherein, The one-way exhaust structure also includes a boss, which is integrated with the valve body (3). The exhaust hole passes through the boss, and the elastic protective sleeve (7) is fitted on the boss.

3. The valve assembly of claim 2, wherein, The exhaust port includes a through hole (4) and a side wall hole (5). The side wall hole (5) is opened on the side wall of the boss. The through hole (4) is arranged along the axis of the central through hole (12) of the boss and communicates with the sealing ring mounting groove (11) and the side wall hole (5).

4. The valve assembly according to claim 3, characterized in that, The one-way exhaust structure also includes barbs (6), which are provided on the outer side wall of the boss to prevent the elastic protective sleeve (7) from moving relative to the boss.

5. The valve assembly according to claim 4, characterized in that, The sidewall hole (5) is located between the barb (6) and the top of the sidewall of the boss.

6. The valve assembly according to claim 1, characterized in that, It also includes a valve cover (1), which has a slot (10) on the side facing the valve body (3). The valve body (3) has a central through hole (12), and a plurality of locking platforms (13) are provided on the inner side wall of the valve body (3). The valve cover (1) cooperates with the locking platforms (13) of the valve body (3) through the slot (10) to press the sealing ring (2) to achieve sealing.

7. A sterile transfer container, characterized in that, It includes an inner bag (8), an outer bag (9), and a valve assembly as described in any one of claims 1 to 6; The valve body (3) of the valve assembly is provided with an annular flange (14) on its bottom surface. The inner bag (8) and the outer bag (9) both have an open end. The open end of the outer bag (9) is fixedly connected to the annular flange (14) of the valve body (3) by welding. The open end of the inner bag (8) extends out of the outer bag (9) through the central through hole (12) of the valve body (3). The closed end of the inner bag (8) is located inside the outer bag (9) and is fixedly connected to the closed end of the outer bag (9) by welding.

8. The aseptic transfer container according to claim 7, characterized in that, Both the inner bag (8) and the outer bag (9) are welded together from two oppositely arranged plastic films. The open end of the outer bag (9) is opened in one of the plastic films, and the open end of the inner bag (8) is formed by combining the open edges of the two plastic films.

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