Clean room wall penetration using aseptic connection device

Abstract

The utility model relates to the field of pharmaceutical technology, concretely is a sterile connecting device for clean area through wall, including external seal, wallboard, protective sleeve, internal seal cover, pipeline and fastener, the pipeline passes through wallboard and is sealedly connected with wallboard, and the both ends of pipeline protrude outward in the left and right sides of wallboard, external seal and internal seal cover are sealedly connected with the left and right ends of pipeline respectively, and the inside of external seal is sealedly provided with hose, the protective sleeve is sleeved in the outside of hose, and the left end of protective sleeve inserts into external seal, the right end of protective sleeve inserts into internal seal cover, the utility model discloses through multiple sealing design of external seal, internal seal cover, pipeline and protective sleeve etc. parts, can effectively block the airflow exchange and pollutant transmission channel between different levels clean area, prevents the cross -contamination risk of different levels clean area.

Description

Technical Field

[0001] This utility model relates to the field of pharmaceutical technology, specifically to a sterile connection device for through-wall use in clean areas. Background Technology

[0002] For the pharmaceutical industry, transporting solutions or products across different cleanroom levels is unavoidable and a necessary routine operation. This is especially true for systems using flexible connections, such as silicone tubing, for transferring solutions or products between different cleanroom levels. Firstly, during transport, contact between the tubing and the external environment, as well as airflow exchange between different cleanroom areas, can easily lead to contamination of the transported solutions or products, severely impacting drug quality and potentially causing batch product scrapping, resulting in significant economic losses for the company. Secondly, connecting different cleanrooms through a transport channel disrupts the independent sealing environment of each cleanroom, leading to contamination and fluctuations in pressure difference. If the pressure difference exceeds acceptable limits, the cleanroom level will fail to meet standards, thus affecting the compliance of the entire production process.

[0003] Therefore, developing a connection device that enables sterile fluid transport between pharmaceutical equipment in different rooms, achieves mutual isolation between equipment in different rooms with different cleanliness requirements, and effectively reduces the risk of environmental contamination of related equipment has become a pressing technical problem for the pharmaceutical industry. Utility Model Content

[0004] The purpose of this invention is to provide a sterile connection device for through-wall use in clean areas, which can effectively prevent the risk of cross-contamination between clean areas of different levels, thereby solving the technical problems in the background art.

[0005] A sterile connection device for through-wall use in clean areas, applicable to fluid transfer scenarios in areas with different cleanliness levels, includes external seals, wall panels, protective sleeves, internal sealing sleeves, pipes, and fasteners;

[0006] The pipe passes through the wall panel and is sealed to the wall panel, with both ends of the pipe protruding outwards on the left and right sides of the wall panel;

[0007] The external seal and the internal sealing sleeve are respectively sealed to the left and right ends of the pipe, and the external seal is internally sealed with a flexible hose.

[0008] The protective sleeve is fitted over the outside of the hose, with the left end of the protective sleeve inserted into the outer seal and the right end of the protective sleeve inserted into the inner sealing sleeve.

[0009] Fasteners are provided on both the left and right sides of the wall panel, which are used to fasten the external seal and the internal sealing sleeve to both ends of the pipe.

[0010] Furthermore, V-shaped sealing grooves are provided at both ends of the pipe; annular sealing rings are provided on the end of the external sealing element and the internal sealing sleeve near the pipe, and the cross-section of the annular sealing rings is triangular; the annular sealing rings are engaged in the V-shaped sealing grooves to form a sealing structure.

[0011] Furthermore, the fastener has a snap-fit ​​structure;

[0012] When the fastener is a snap-fit ​​structure, it includes a snap-fit ​​seat and a snap-fit ​​fastener fixed to the wall panel. The snap-fit ​​seat is fixed to the wall panel by bolts, and the snap-fit ​​fastener engages with the outer surface of the external seal and the inner sealing sleeve, pressing and fastening the external seal and the inner sealing sleeve to both ends of the pipe.

[0013] Furthermore, the external seal has a through hole at the left end of the axial position for the hose to pass through, and the outer wall of the hose is sealed to the external seal; the end of the hose is connected to a Luer connector.

[0014] Furthermore, the inner sealing sleeve has a receiving cavity inside for accommodating the right end of the protective sleeve; the outer wall of the protective sleeve has a cylindrical structure; a plurality of sealing rings are provided on the inner wall of the receiving cavity; when the protective sleeve is inserted into the inner sealing sleeve, it forms a sealing structure with the receiving cavity of the inner sealing sleeve.

[0015] Beneficial effects

[0016] This invention employs a multi-seal design, including external seals, internal sealing sleeves, pipes, and protective sleeves, to effectively block airflow exchange and contaminant transmission channels between clean areas of different levels. This prevents the risk of cross-contamination between clean areas of different levels while ensuring the sterility of the transmitted solutions and products, significantly improving the product quality and safety in the pharmaceutical manufacturing process.

[0017] This invention enables rapid fixing and sealing of various components using fasteners, reducing the installation difficulty and operational complexity of the device and improving user convenience. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this utility model. For those skilled in the art, other drawings can be obtained based on these drawings.

[0019] Figure 1 This is a schematic diagram of the overall structure of the aseptic connection device for wall penetration in clean areas according to this utility model;

[0020] Figure 2This is a schematic diagram of the connection structure between the external seal and the protective sleeve in this utility model;

[0021] Figure 3 This is a schematic diagram of the working structure of this utility model;

[0022] Figure 4 This is a schematic diagram of the structure of the protective sleeve and the inner sealing sleeve when they are removed together in this utility model;

[0023] Figure 5 This is a schematic diagram of the wall panel and pipe in this utility model.

[0024] In the diagram: 1. External seal, 2. Wall panel, 3. Protective sleeve, 4. Internal sealing sleeve, 5. Pipe, 6. Luer connector, 7. Hose, 8. V-shaped sealing groove, 9. Annular sealing ring, 10. Sealing ring, 11. Receiving cavity. Detailed Implementation

[0025] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0026] To achieve the above objectives, this utility model provides the following technical solution, such as... Figure 1-5 As shown, a sterile connection device for through-wall use in clean areas is applied to fluid transfer scenarios in areas with different cleanliness levels. In this embodiment, the left side of the wall panel 2 is an ISO8 area (low protection level), and the right side is an ISO5 area (high protection level). The device includes an external seal 1, a wall panel 2, a protective sleeve 3, an internal sealing sleeve 4, a pipe 5, and fasteners.

[0027] A circular through hole is provided on the wall panel 2. The pipe 5 passes through the circular through hole and is sealed to the wall panel 2. Both ends of the pipe 5 protrude outwards on the left and right sides of the wall panel 2. In this embodiment, the pipe 5 is made of stainless steel. The pipe 5 is sealed to the wall panel 2 to prevent airflow from being exchanged through the gap between the pipe 5 and the wall panel 2.

[0028] The external seal 1 is located in ISO 8 zone, and its right end is sealed to the left end of the pipe 5. The external seal 1 contains a hose 7, and both the external seal 1 and the hose 7 are single-use components. The external seal 1 is made of polytetrafluoroethylene polymer material that meets the hygiene standards of the pharmaceutical industry. The left end of the external seal 1 has a through hole for the hose 7 to pass through. The outer wall of the hose 7 is sealed to the external seal 1, and the end of the hose 7 is connected to a Luer connector 6.

[0029] The left end of the inner sealing sleeve 4 is sealed to the right end of the pipe 5. The inner sealing sleeve 4 is made of the same polytetrafluoroethylene polymer material as the outer sealing element 1. The inner sealing sleeve 4 has a receiving cavity 11 for accommodating the right end of the protective sleeve 3. Three sealing rings 10, made of silicone rubber, are installed on the inner wall of the receiving cavity 11 and fixed to the inner wall of the receiving cavity 11 by embedding. When the protective sleeve 3 is inserted into the receiving cavity 11, the sealing rings 10 fit tightly against the outer wall of the protective sleeve 3, forming a multi-layered sealing structure, effectively enhancing the sealing performance between the inner sealing sleeve 4 and the protective sleeve 3. Simultaneously, when the inner sealing sleeve 4 is removed, due to the friction between the sealing rings 10 and the protective sleeve 3, the inner sealing sleeve 4 will pull the protective sleeve 3 out of the outer sealing element 1, enabling convenient disassembly of the protective sleeve 3.

[0030] Fasteners are provided on both the left and right sides of the wall panel 2. In this embodiment, the fasteners adopt a snap-fit ​​structure (not shown in the figure), including a snap-fit ​​seat 8 fixed on the wall panel 2 and a snap-fit ​​fastener that cooperates with the external seal 1 and the internal sealing sleeve 4. The snap-fit ​​seat 8 is fixed to the wall panel 2 by bolts. The snap-fit ​​fastener engages with the outer surface of the external seal 1 and the internal sealing sleeve 4. The pressure generated by the elastic deformation of the snap-fit ​​fastener presses the external seal 1 and the internal sealing sleeve 4 tightly and fastens them to both ends of the pipe 5, ensuring that the sealing connection between the external seal 1 and the internal sealing sleeve 4 and the pipe 5 will not loosen.

[0031] V-shaped sealing grooves 8 are provided on the end faces of both ends of the pipe 5. The depth of the V-shaped sealing grooves 8 is 5mm and the angle is 60 degrees. Correspondingly, annular sealing rings 9 are provided on the end of the external sealing element 1 and the internal sealing sleeve 4 near the pipe 5. The cross-section of the annular sealing ring 9 is triangular and its material is fluororubber. The annular sealing rings 9 are engaged in the V-shaped sealing grooves 8 provided on both ends of the pipe 5. When the external sealing element 1 and the internal sealing sleeve 4 are pressed against the ends of the pipe 5 by fasteners, the annular sealing rings 9 are compressed, and the two sides of its triangular cross-section are tightly fitted with the inner wall of the V-shaped sealing groove 8, forming a reliable sealing structure, which effectively enhances the sealing effect between the external sealing element 1, the internal sealing sleeve 4 and the pipe 5.

[0032] The following are the operating steps for the aseptic connection device used for wall penetration in this clean area:

[0033] In the ISO5 area, ensure that the inner sealing sleeve 4 and the right end face of the pipe 5 remain in a sealed connection to guarantee the initial sterile environment and sealing performance of the ISO5 area side.

[0034] Initially, the protective sleeve 3 is inserted into the outer seal 1, so that the hose and Luer connector inside the outer seal 1 are covered by the protective sleeve 3. At this time, the hose and Luer connector inside the outer seal 1 are in a sterile state, preventing them from being contaminated during subsequent installation.

[0035] The combined external seal 1 is fastened to the left end of the pipe 5, while the right end of the protective sleeve 3 passes through the pipe 5 and enters the receiving cavity 11 inside the internal sealing sleeve 4.

[0036] Then, the snap-fit ​​fastener engages with the outer surface of the external seal 1. Through the cooperation of the snap-fit ​​seat and the snap-fit ​​fastener, the external seal 1 is pressed tightly against the left end of the pipe 5, forming a reliable seal between the external seal 1 and the pipe 5. This prevents airflow and contaminant transfer between different clean areas.

[0037] In the ISO5 zone, remove the inner sealing sleeve 4 from the right end of the pipe 5. This will pull the protective sleeve 3 out from inside the outer seal 1, exposing the hose 7 and Luer connector 6 to the ISO5 environment. Aseptically connect the receiving device in the ISO5 zone to the exposed Luer connector 6. Once connected, the transfer of solutions or products can begin.

[0038] After the transmission operation is completed, reinstall the inner sealing sleeve 4 on the right end of the pipe 5; keep the ISO5 area isolated; and scrap the used outer seal 1, protective sleeve 3, hose 7 and Luer connector 6 to avoid cross-contamination caused by reuse.

[0039] The embodiments of this utility model are given for illustrative and descriptive purposes only, and are not intended to be exhaustive or to limit the utility model to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art. The embodiments were chosen and described in order to better illustrate the principles and practical applications of this utility model, and to enable those skilled in the art to understand this utility model and design various embodiments with various modifications suitable for a particular purpose.

Claims

1. A sterile connection device for through-wall use in clean areas, applicable to fluid transfer scenarios in areas of different cleanliness levels, characterized in that, Includes external seals (1), wall panels (2), protective sleeves (3), internal sealing sleeves (4), pipes (5), and fasteners; The pipe (5) passes through the wall panel (2) and is sealed to the wall panel (2). Both ends of the pipe (5) protrude outward on the left and right sides of the wall panel (2). The external seal (1) and the internal seal sleeve (4) are respectively sealed to the left and right ends of the pipe (5), and the external seal (1) is internally sealed with a flexible hose (7). The protective sleeve (3) is fitted over the outside of the hose (7), with the left end of the protective sleeve (3) inserted into the outer seal (1) and the right end of the protective sleeve (3) inserted into the inner seal (4). Fasteners are provided on both the left and right sides of the wall panel (2), and the external seal (1) and the internal seal sleeve (4) are fastened to the two ends of the pipe (5) by means of the fasteners.

2. The aseptic connection device for through-wall use in clean areas according to claim 1, characterized in that, Both ends of the pipe (5) are provided with V-shaped sealing grooves (8); both the external sealing element (1) and the internal sealing sleeve (4) are provided with annular sealing rings (9) on the end of the pipe (5) near the pipe (5), and the cross section of the annular sealing ring (9) is triangular; the annular sealing ring (9) is snapped into the V-shaped sealing groove (8) to form a sealing structure.

3. The aseptic connection device for through-wall use in clean areas according to claim 1, characterized in that, The fastener has a snap-fit ​​structure; When the fastener is a snap-fit ​​structure, it includes a snap-fit ​​seat and a snap-fit ​​fastener fixed on the wall panel (2). The snap-fit ​​seat is fixed on the wall panel (2) by bolts. The snap-fit ​​fastener engages with the outer surface of the outer seal (1) and the inner seal sleeve (4), pressing the outer seal (1) and the inner seal sleeve (4) together and fastening them to both ends of the pipe (5).

4. The clean room wall penetration using aseptic connection apparatus according to claim 1, wherein The external seal (1) has a through hole at the left end of the axial position for the hose (7) to pass through, and the outer wall of the hose (7) is sealed to the external seal (1); the end of the hose (7) is connected to a Luer connector (6).

5. The clean room wall penetration using aseptic connection apparatus according to claim 1, wherein The inner sealing sleeve (4) has a receiving cavity (11) for accommodating the right end of the protective sleeve (3); the outer wall of the protective sleeve (3) is cylindrical; a number of sealing rings (10) are provided on the inner wall of the receiving cavity (11); when the protective sleeve (3) is inserted into the inner sealing sleeve (4), it forms a sealing structure with the receiving cavity (11) of the inner sealing sleeve (4).

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