Sterile connector

Abstract

To provide a sterile connector for connecting tubes, which has a simplified configuration and can achieve high sterility.SOLUTION: A sterile connector includes first and second connectors 1 of the same shape including: a first (second) body portion 11 including a first (second) joining surface 111; a first engaging member 12; and a first (second) fitting portion fitting with the first (second) tube, which is provided on a back surface side of the first (second) joining surface 111 of the first (second) body portion 11 and which has a tip end portion for tightening the first (second) tube. An end face 21 of the first (second) tube is configured to be positioned to project beyond the first (second) joining surface 111. The sterile connector is configured such that, when the first connector 1 and the second connector 1 are engaged such that the first joining surface 111 faces the second joining surface 111, the end face of the first tube 2 and the end face of the second tube 2 are compressed with each other.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present invention relates to a sterile connector for connecting tubes (tubes for passing fluids) to each other. [Background technology]

[0002] Biopharmaceuticals are manufactured through various steps, such as culturing cells or microorganisms, purifying the culture medium, inactivating cells, concentrating the culture medium, and storing the manufactured drug substance. Each step uses a container optimized for that step, which makes it necessary to transfer liquid between containers. However, in the field of biopharmaceuticals, the manufacturing process must be performed aseptically, and the transfer of liquid between containers must also be performed aseptically. In order to meet this requirement, technology has been developed to aseptically connect two containers in a general environment, and various sterile connectors have been proposed. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent Publication No. 2021-37035 Summary of the Invention [Problem to be solved by the invention]

[0004] The sterile connector in Patent Document 1 is intended to reduce the number of parts and improve manufacturing efficiency (paragraphs 0007 and 0008). However, there are multiple parts (main body 3, elastic membrane 5, elastic member 21, flow hole member 20) between the connecting tubes (pipes for circulating fluids), and there is a demand for the development of a simpler sterile connector.

[0005] In view of the above, an object of the present invention is to provide a sterile connector for connecting tubes, which has a simpler configuration and can achieve high sterility. [Means for solving the problem]

[0006] (Configuration 1) A sterile connector comprising a first connector attached to a first tube and a second connector attached to a second tube, wherein the first connector comprises a first body portion having a first mating surface, a first engagement member for engaging with the second connector, and a first fitting portion for fitting with the first tube, the first fitting portion being provided on a back side of the first mating surface of the first body portion and having a tip portion for clamping the first tube; and the second connector comprises a second body portion having a second mating surface, a second engagement member for engaging with the first connector, and a tip portion for clamping the second tube, the second fitting portion being provided on a back side of the second mating surface of the second body portion. and a second fitting portion that fits with the second tube, wherein the first connector and the second connector have the same shape, the first connector is attached to the first tube so that an end face of the first tube is positioned protruding beyond the first joint surface, or the second connector is attached to the second tube so that an end face of the second tube is positioned protruding beyond the second joint surface, and the first connector and the second connector are configured so that the end face of the first tube and the end face of the second tube are pressed together when the first connector and the second connector are engaged with each other so that the first joint surface and the second joint surface face each other.

[0007] (Configuration 2) 2. A sterile connector as described in configuration 1, wherein the first fitting portion has a first space portion that does not clamp the first tube, and the second fitting portion has a second space portion that does not clamp the second tube.

[0008] (Configuration 3) A sterile connector as described in configuration 2, wherein the first tube has a first thick-diameter portion whose outer diameter increases toward the first main body portion in the first space portion, and the second tube has a second thick-diameter portion whose outer diameter increases toward the second main body portion in the second space portion.

[0009] (Configuration 4) A sterile connector according to any one of configurations 1 to 3, wherein an end face of the first tube has a convex curve in a cross section along the longitudinal direction of the first tube, or an end face of the second tube has a convex curve in a cross section along the longitudinal direction of the second tube.

[0010] (Configuration 5) 5. A sterile connector according to any one of configurations 1 to 4, wherein the tip of the first tube and the tip of the second tube are configured in a flange shape.

[0011] (Configuration 6) 6. A sterile connector as described in any one of configurations 1 to 5, configured so that the inner diameters of the first tube and the second tube do not change.

[0012] (Configuration 7) 7. The sterile connector of any one of configurations 1 to 6, wherein the first connector comprises a first protective sheet covering the first joint surface and the end surface of the first tube, the second connector comprises a second protective sheet covering the second joint surface and the end surface of the second tube, the first body portion and the second body portion are made of polypropylene, the first protective sheet and the second protective sheet are made of polyethylene, the first protective sheet and the second protective sheet are fixed to the first body portion and the second body portion by thermal welding, and are removed after the first connector and the second connector are engaged.

[0013] (Configuration 8) 7. A sterile connector as described in any one of configurations 1 to 6, wherein the first connector comprises a first protective sheet covering the first joint surface and the end surface of the first tube, the second connector comprises a second protective sheet covering the second joint surface and the end surface of the second tube, the first body portion and the second body portion are made of polycarbonate, the first protective sheet and the second protective sheet are made of polyethylene, the first protective sheet and the second protective sheet are fixed to the first body portion and the second body portion via an adhesive, and are removed after the first connector and the second connector are engaged. Effect of the Invention

[0014] According to the aseptic connector of the present invention, it is possible to provide a aseptic connector that has a simpler configuration and is capable of achieving high sterility. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view showing a sterile connector (one of a pair of connectors having the same shape) according to an embodiment of the present invention; [Diagram 2] FIG. 2 is another perspective view showing the sterile connector of the embodiment. [Diagram 3] FIG. 1 is a front view showing a sterile connector according to an embodiment; [Figure 4] Cross-sectional view of an embodiment of a sterile connector [Diagram 5] FIG. 1 is a cross-sectional view showing a connection state of a sterile connector according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings. Note that the following embodiment is one form for embodying the present invention, and is not intended to limit the scope of the present invention.

[0017] Fig. 1 is a perspective view showing a sterile connector according to an embodiment of the present invention (a first connector which is one of a pair of connectors having the same shape) as viewed from the mating surface side, and Fig. 2 is a perspective view as viewed from the back side. Also, Fig. 3 is a front view of the sterile connector according to this embodiment (one of a pair of connectors having the same shape), and Fig. 4 is a cross-sectional view (Fig. 4(a): a cross-sectional view taken along line AA in Fig. 3, and Fig. 4(b): a cross-sectional view taken along line BB in Fig. 3, respectively). The sterile connector of this embodiment is used to connect two tubes, which are pipes for circulating fluids, and is a sterile connector configured to prevent the intrusion of germs and the like through the joint. That is, the first tube and the second tube are joined in a sterile manner by engaging a first connector attached to the end of one tube (the first tube) with a second connector attached to the end of the other tube (the second tube). The first connector (including the first protective sheet) and the second connector (including the second protective sheet) of the sterile connector of this embodiment, as well as the first tube and the second tube, are of the same shape (hermaphrodite). The configuration of one connector (first connector 1) and one tube (first tube 2) will be described below.

[0018] The first connector 1, as shown in Figs. A first body portion 11 having a first bonding surface 111; an engagement protrusion 12 which is a first engagement member for engaging with a second connector (having the same configuration as the first connector 1); an engagement hole 13 that engages with a second engagement member (same type as the engagement protrusion 12) of the second connector; a first fitting portion 14 that is provided on the rear side of the first joint surface 111 of the first main body portion 11 and has a tip portion 141 that fastens the first tube 2 and fits with the first tube 2; Boss 15 for alignment, a boss hole 16 for receiving a boss of the second connector; It is equipped with: As shown in Figures 3-5, the first connector is provided with a first protective sheet 3 that covers the end surface 21 of the first tube 2. The first protective sheet 3 is removed after the first connector and the second connector are engaged with each other. Figures 4 and 5 are schematic diagrams that are somewhat exaggerated (e.g., the thickness of the first protective sheet 3 is thick) from the viewpoint of ease of viewing.

[0019] The first main body portion 11 is a roughly disk-shaped plate-like member, and the first joint surface 111 is formed flat except for the members for engagement (the engagement projection 12, the boss 15, etc.). A hole for inserting the first tube 2 is formed in the center of the first main body portion 11, and a countersunk (recessed) portion for receiving the flange portion 22 of the first tube 2 is formed on the first joint surface 111 side of this hole. The first main body portion 11 of the present embodiment is made of polypropylene. In this embodiment, the first main body portion has an outer shape that is generally disk-shaped, but the outer shape of the first main body portion may be any shape.

[0020] A first fitting portion 14 is joined to the back surface side of the first main body portion 11 (the side opposite to the first joining surface 111). The first fitting portion 14 functions as a holding portion that fits with and holds the first tube 2, and in this embodiment, as shown in Figures 2, 4, etc., has a configuration in which two cylindrical members with different diameters are joined together. The tip portion 141 is formed so that its inner diameter is slightly smaller than the outer diameter of the first tube 2, and is configured so as to fasten the first tube 2 (so as to come into contact with at least the outer periphery of the first tube 2) when attached to the first tube 2. Note that the "tip" of the tip portion 141 is the "base end" when the end of the first tube 2 (the end to which the first connector 1 is attached) is considered to be the tip side. On the other hand, the expanded diameter portion 142 is formed so that its inner diameter is larger than the outer diameter of the first tube 2 (first large diameter portion 23) (same as the outer diameter at the maximum diameter location of the first large diameter portion 23), and is configured to form therein a first space portion S. As a modified example, it is also possible to form the expanded diameter portion so that its inner diameter is the same as the outer shape of the first large diameter portion 23 or smaller than the first large diameter portion (so that the inner surface of the expanded diameter portion and the first large diameter portion 23 come into contact).

[0021] The first tube 2 is a tube having flexibility, elasticity and softness, such as a fluororesin tube or a silicon tube, and can be selected according to the object. As shown in FIG. 4, the first tube 2 has a first large diameter portion 23 whose outer diameter increases toward the first main body portion 11 in the first space portion S in the expanded diameter portion 142. As shown in FIG. 4, the first tube 2 has a flange portion 22 that is thick-walled (flange-shaped) at the tip of the first tube 2, and the end face 21 of the first tube 2 has a convex curve ("downward convex" in FIG. 3).

[0022] The first connector 1 and the first tube 2 are configured so that, when the first connector 1 is attached to the first tube 2, the end face 21 of the first tube is positioned to protrude beyond the first joint surface 111, as shown in Fig. 4. This allows the end face 21 of the first tube 2 and the end face of the second tube (the end face of the second tube having a similar structure to the first tube 2) to be pressed against each other when the first connector 1 and the second connector are engaged so that the first joint surface 111 and the second joint surface (the joint surface of the second connector having a similar structure to the first tube 2) face each other. As shown in FIG. 4, even when the first connector 1 is attached to the first tube 2, the inner diameter of the first tube 2 does not change substantially.

[0023] The first protective sheet 3 is fixed to the first joint surface 111 of the first main body portion 11 so as to cover the end surface 21 of the first tube 2. The first protective sheet 3 aseptically seals the inside and tip portion (end surface 21) of the first tube 2, making it possible to maintain the inside of the sterile connector 1 in a sterile state even in a general environment. The first protective sheet 3 in this embodiment is made of polyethylene. Specifically, Tyvek (registered trademark) can be used as the first protective sheet 3. First protective sheet 3 is configured to extend beyond first main body portion 11 so as to be removable after the connector is engaged (see FIG. 3), and is fixed to first main body portion 11 by thermal welding. First protective sheet 3 is configured to be removable by pulling the portion protruding outward after the connector is joined. In detail, the first protective sheet 3 has a sealing part 3-1 that aseptically seals the first tube, a pulling part 3-3 that the user pulls to remove after the connectors are joined, and a folded part 3-4 that is folded back between the sealing part 3-1 and the pulling part 3-3. With this configuration, even when the sterile connectors are joined and the protective sheet is tightly sandwiched between the end faces of the tubes, the protective sheet can be removed by pulling the pulling part 3-3 in the direction of the arrow 3-5 (see FIG. 5), making it possible to connect the sterile connectors in a sterile and liquid-tight manner. In the present embodiment, the sealing portion 3-1 is fixed to the first joint surface 111 of the first main body portion 11 so as to cover the end surface of the first tube 2, and the fixing method can be selected as the most suitable method depending on the application and material. For example, when the first connector 1 is made of polypropylene, the two can be fixed by thermal welding. Alternatively, when the first connector 1 is made of polycarbonate, the two can be fixed via an adhesive. In either case, the first protective sheet 3 is fixed to the first joint surface 111 so that the fixing region 3-2 fixed to the first joint surface 111 surrounds the end surface 21 of the first tube 2. In this way, by fixing the first protective sheet 3 to the first joint surface 111 in the region outside the end surface 21, it is possible to maintain the inside of the connector in a sterile state.

[0024] The attachment of the first connector 1 to the first tube 2 generally comprises the following steps. A step of fitting the first body portion 11 to the first tube 2 A step of inserting the first tube 2 into the first fitting portion 14. A step of joining (by adhesion, heat welding, etc.) the first fitting portion 14 to the first main body portion 11 A step of fixing the first protective sheet 3 to the first bonding surface 111 of the first main body portion 11. Through the above steps, the first connector 1 is brought into an attached state as shown in Figures 1 to 4 (first protective sheet 3 is not shown in Figures 1 and 2). As can be seen from the above, the first connector 1 can be brought into an attached state through relatively easy and simple operations.

[0025] The sterile connector manufactured as described above is used in a state where the tip of the first tube 2 (the tip opposite to the end surface 21) is connected to various containers. Examples of containers to which the sterile connector is connected include, but are not limited to, containers for culture, containers for transporting (supplying) culture media, containers for purification and concentration, and containers for storage. By sterilizing (for example, gamma ray sterilization or electron beam sterilization) the containers and the sterile connector in a state where they are connected to these containers, it becomes possible to sterilize the containers and the sterile connector to a level required for their intended use (for example, for the manufacture of biopharmaceuticals, etc.). In particular, since the end surface 21 of the first tube 2 is blocked by the first protective sheet 3, the sterile connector maintains a sterile state inside even when placed in a general environment after sterilization. Since the sterile connectors are configured to be aseptically connected to each other in a general environment, it becomes possible to aseptically transfer a fluid from one container to another. As a specific example, a use can be envisaged in which culture medium is supplied to a culture vessel in a general environment by engaging (sterile connection) a sterile connector connected to a culture vessel with a sterile connector connected to a culture medium supplying container.

[0026] A second connector is also attached to the second tube, which is the other tube to be connected. As described above, the second tube and the second connector have the same configuration as the first tube 2 and the first connector 1 (hereinafter, the first tube and the first connector are distinguished from the second tube and the second connector by adding "second" to each configuration (the same reference numerals are used). The first tube and the second tube are each connected to different containers (containers between which fluid transfer is planned). The procedure for connecting the paired sterile connectors will be described below. The first connector 1 and the second connector 1 attached to each tube are butted together so that their first mating surfaces 111 and second mating surfaces 111 face each other (see FIG. 5(a)), and the first engagement protrusion 12 and the second engagement hole 13, and the second engagement protrusion 12 and the first engagement hole 13 are engaged with each other. This fixes the first connector 1 and the second connector 1 (the sterile connectors to each other). Thereafter, the protruding portions (pulling portions 3-3) of the first protective sheet 3 and the second protective sheet 3 are pulled together, thereby removing the first protective sheet 3 and the second protective sheet 3 at the same time. This results in the connected state as shown in FIG. 5(b) (a schematic cross-sectional view showing the connected state of the connector). The end surface 21 of the first (second) tube 2 protrudes from the first (second) joining surface 111, and when the first connector 1 and the second connector 1 are engaged, the end surface 21 of the first tube and the end surface 21 of the second tube are pressed against each other via the first protective sheet 3 and the second protective sheet 3. Thereafter, the first protective sheet 3 and the second protective sheet 3 are simultaneously removed, so that the first tube 2 and the second tube 2 are joined in a sterile and liquid-tight manner. The first (second) tube 2 is a member having flexibility, elasticity, and softness, such as a silicon tube, and the first (second) flange portion 22 is pressed against each other, resulting in a connected state as shown in FIG. 5(b). In this embodiment, the end face 21 of the first tube and the end face 21 of the second tube have a convex curve in their cross-section (cross-section along the longitudinal direction of the first tube 2) (FIG. 3), and the end face 21 of the first tube and the end face 21 of the second tube come into line contact, improving the degree of sealing between them, thereby improving the sterility and liquid-tightness between them. However, the present invention is not limited to this, and it is preferable to make the cross-sectional shape of the end face 21 of the first tube and the end face 21 of the second tube a shape that provides a higher degree of sealing in accordance with the amount of protrusion of the end face 21 of the first tube and the end face 21 of the second tube, the hardness and material of the tubes, etc.

[0027] As described above, according to the sterile connector of this embodiment, since it is a connector that directly presses the end faces of the tubes together, it is possible to reduce the number of members interposed between the tubes to be connected. Therefore, it is possible to reduce factors that cause problems with sealing (sterility) and the like as much as possible. In addition, by reducing the number of parts, it is possible to reduce costs and simplify the assembly work. And, since the first connector 1 and the second connector 1 do not come into contact with liquids (liquids do not come into contact with anything other than the tubes), the range of materials to be selected for the connector portion is greatly expanded. For example, by forming the first connector from polypropylene, it is possible to fix the first protective sheet 3 made of polyethylene by heat welding (ultrasonic heat welding). As a result, since there is no need to use an adhesive to fix the two, the two are prevented from peeling off even in an environment of minus 80 degrees Celsius, and it is possible to use it as a container for freezing and storing raw materials and the like. However, separately from this, the first connector can also be formed from polycarbonate, and in this case, it is possible to fix the first protective sheet 3 using an adhesive. As a result, it is possible to fix the two more firmly by using an appropriate adhesive. Alternatively, the first connector can be formed by two-color molding of polycarbonate and polypropylene. That is, by forming the portion where the sterile connectors are fitted together (the region where the engagement protrusions 12 and engagement holes 13 are formed) from polycarbonate, strength is increased, and by forming the region where the protective sheet 3 is fixed (fixing region 3-2) from polypropylene, it becomes possible to fix the protective sheet 3 by thermal welding (without using adhesive). In addition, as can be seen from Fig. 4, the sterile connector of this embodiment is configured so that the inner diameter of the first (second) tube 2 does not change substantially, thereby minimizing loss (pressure loss) in the connector portion during liquid transfer. In particular, as shown in Fig. 5(b), the inner diameters of the first tube and the second tube can be maintained equal even when the first and second connectors are engaged, minimizing the phenomenon of liquid remaining between the tubes.

[0028] Furthermore, according to the sterile connector of this embodiment, the first tube 2 is formed with the first flange portion 22 and the first thick-diameter portion 23, which are configured to sandwich the first main body portion 11. Therefore, in the joined state shown in Figure 5(b), even if an external force is applied to the first (second) tube 2 (such as being pulled), deformation of the end face 21 of the first tube 2 is prevented, contributing to maintaining sterility. Furthermore, since the first tube 2 is clamped at the tip 141 of the fitting portion 14, when the first tube 2 is pulled, the force is prevented from being applied to the end face 21, further contributing to maintaining the sterility of the tubes. In this embodiment, the first (second) space S does not "tighten the first (second) tube 2". The first tube 2 is a flexible, elastic, and pliable tube formed of a fluororesin tube, a silicone tube, or the like, and the first large diameter portion 23 of such a flexible, elastic, and pliable tube deforms in the first space S when an external force acts on the tube (when pulled). Since the first space S does not "tighten the first tube 2", this deformation is not hindered and the first large diameter portion 23 bends in the space S. It is expected that the bending of the first large diameter portion 23 will further reduce the occurrence of a defect in which an external force applied to the first tube 2 reaches the end surface 21 of the first tube 2 and deforms it. However, depending on the material of the first tube 2, etc., it is also possible to configure the fitting portion 14 so as not to have a space S (so that the expanded diameter portion 142 contacts the thick diameter portion 23, or so that the expanded diameter portion 142 tightens the thick diameter portion 23).

[0029] In the embodiment, the first (second) main body portion is made of polypropylene, and the first (second) protective sheet made of polyethylene is heat-welded thereto, but the present invention is not limited to this. For example, the first (second) main body portion may be made of polycarbonate and the first (second) protective sheet may be made of polyethylene, and the first (second) protective sheet may be fixed to the first (second) main body portion via an adhesive.

[0030] In the embodiment, the second tube and the second connector have the same configuration as the first tube 2 and the first connector 1, but the present invention is not limited to this, and the second tube and the second connector may have a different configuration from the first tube 2 and the first connector 1 as long as the concept of the present invention understood from the above description is included. For example, the first connector 1 and the second connector may not be made of the same member because an engagement portion for engaging the first connector 1 and the second connector has an asymmetric shape.

[0031] In the embodiment, both the end face 21 of the first tube and the end face 21 of the second tube protrude beyond the first (second) joint surface 111, but the present invention is not limited to this. For example, either the end face 21 of the first tube or the end face 21 of the second tube may protrude beyond the first (second) joint surface, and the other may be flush with the first (second) joint surface (as long as the end face of the first tube and the end face of the second tube are pressure welded together when the first connector and the second connector are engaged). In the embodiment, both the end face 21 of the first tube and the end face 21 of the second tube have a convex curve in their cross-sectional shape, but the present invention is not limited to this. For example, either the end face of the first tube or the end face of the second tube may have a convex curve in their cross-sectional shape, and the other may be flat. If the end face of the first tube and the end face of the second tube are in line contact when they start to come into contact during engagement, the contact pressure at the contact point can be increased compared to surface contact between the surfaces, and the degree of sealing can be improved. Note that, if a sufficient degree of sealing can be obtained even in surface contact by pressure contact between the end faces of the first (second) tubes due to the above-mentioned "structure in which the end face of the first (second) tube protrudes from the first (second) joining surface", the end face of the first tube and the end face of the second tube may be in surface contact at the beginning of the contact. [Explanation of symbols]

[0032] 1...First (second) connector 11...First (second) body part 111...1st (2nd) joint surface 12...First engaging member 13...Engagement hole 14...First (second) fitting part 141...Tip 2...First (second) tube 21...end face 22...Flange section 23...1st (2nd) large diameter part 3...First (second) protective sheet S...1st (2nd) space part

Claims

1. 1. A sterile connector comprising a first connector attached to a first tube and a second connector attached to a second tube, The first connector, a first body portion having a first joining surface; a first engagement member for engaging with the second connector; a first fitting portion provided on a rear side of the first joint surface of the first main body portion, the first fitting portion having a tip portion for fastening the first tube, the first fitting portion fitting with the first tube; Equipped with The second connector, a second body portion having a second joining surface; a second engagement member for engaging with the first connector; a second fitting portion provided on a rear side of the second joint surface of the second main body portion, the second fitting portion having a tip portion for fastening the second tube, the second fitting portion fitting with the second tube; Equipped with The first connector and the second connector have the same shape, A sterile connector, wherein the first connector is attached to the first tube so that an end face of the first tube protrudes beyond the first joint surface, or the second connector is attached to the second tube so that an end face of the second tube protrudes beyond the second joint surface, and when the first connector and the second connector are engaged so that the first joint surface and the second joint surface face each other, the end face of the first tube and the end face of the second tube are pressed together.

2. the first fitting portion includes a first space portion that does not clamp the first tube, The sterile connector of claim 1 , wherein the second fitting portion includes a second space portion that does not pinch the second tube.

3. the first tube has a first large diameter portion whose outer diameter increases toward the first main body portion in the first space portion, The sterile connector according to claim 2 , wherein the second tube has a second large diameter portion in the second space portion, the outer diameter of which increases toward the second body portion.

4. The end surface of the first tube has a convex curve in a cross section along the longitudinal direction of the first tube, or 4. The sterile connector according to claim 1, wherein the end face of the second tube has a convex curve in a cross section along the longitudinal direction of the second tube.

5. 4. The sterile connector according to claim 1, wherein the tip of the first tube and the tip of the second tube are configured in a flange shape.

6. 4. The sterile connector according to claim 1, wherein the inner diameters of the first tube and the second tube do not change.

7. the first connector includes a first protective sheet covering the first joint surface and an end surface of the first tube, the second connector includes a second protective sheet covering the second joint surface and an end surface of the second tube, The first body portion and the second body portion are made of polypropylene, the first protective sheet and the second protective sheet are made of polyethylene, A sterile connector as described in any one of claims 1 to 3, wherein the first protective sheet and the second protective sheet are fixed to the first main body portion and the second main body portion by thermal welding, and are removed after the first connector and the second connector are engaged.

8. the first connector includes a first protective sheet covering the first joint surface and an end surface of the first tube, the second connector includes a second protective sheet covering the second joint surface and an end surface of the second tube, The first body portion and the second body portion are made of polycarbonate, the first protective sheet and the second protective sheet are made of polyethylene, A sterile connector as described in any one of claims 1 to 3, wherein the first protective sheet and the second protective sheet are fixed to the first main body portion and the second main body portion via an adhesive, and are removed after the first connector and the second connector are engaged.

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