JP2784501B2 - Medical container and manufacturing method thereof - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container such as an infusion bag used for infusion and the like, and a method for producing the same. The present invention relates to a medical container that can be added to water and a method for producing the same.

[0002]

2. Description of the Related Art In general, medical containers such as bags and containers for infusions and the like used for instillation injection are resin containers having a flexible wall and having no fixed shape and free of eluted substances.
Such a resin container is also used as a drug connection kit container having a connection port for connecting a drug, a drug solution vial, and the like. Various types of connection ports for drug containers have been proposed. For example, a connection port is generally provided with a communication needle made of metal or resin as a communication means, and the communication needle may be pierced into a vial stopper to communicate with the flexible container. Also, in order to achieve aseptic connection, the connecting port side of the flexible container and the stopper side of the vial are aseptically accommodated with a communication needle with a flexible member such as a bellows, and the communication needle is movable therein. Medical containers have also been proposed.

[0003]

The flexible container of a medical container is usually sterilized by autoclave. On the other hand, the medicine in the vial, which is a medicine container, is weak to heat and may not be autoclaved in some cases. A vial is prepared and manufactured by filling a container with a drug solution passed through a sterilization filter, and then directly or freeze-drying and sealing with a rubber stopper. Therefore, the flexible container and the vial are not connected and autoclaved together. On the other hand, in order to aseptically connect the container and the vial via the connection port during use, the communication needle must be aseptically treated and maintained aseptically until use. Conventionally, sterilization of the communication needle in the connection port is performed by gamma irradiation sterilization or chemical gas sterilization.In order to maintain sterilization of the communication needle, the communication needle is sealed and stored in a flexible member in a state where bacteria do not permeate. ing.

However, irradiation sterilization or gas sterilization of the communication needle after storing the communication needle with the flexible member has many manufacturing defects. For example, a flexible member becomes brittle due to γ-ray irradiation, has a reduced mechanical strength, and remains uneasy in maintaining long-term sterilization of a communication needle. In addition, the γ-ray irradiation needs to be performed only on the connection port, and such partial irradiation complicates the shielding procedure of other parts. In chemical gas sterilization, a part of a flexible member must be provided with a wall having sufficient gas permeation, which is also troublesome, and if the gas permeability is not sufficient, sterilization treatment of the communication needle is required. May not be completely performed. It has also been proposed to sterilize the communicating needle, house it in a flexible member by aseptic operation, and hermetically attach the flexible member to the rubber stopper or to the connection port. But,
It is not easy to maintain aseptic condition by hermetically mounting, and there is a possibility that aseptic reliability cannot be guaranteed. Conventionally, as a medical container for maintaining the aseptic connection of the communication means, a flexible container is provided with a communication port, a flexible member is provided in the communication port, and a communication needle accommodated therein is provided. After sterilizing the vial, the distal end of the flexible member and the rubber stopper surface of the vial are connected with a melted thermoplastic resin, and as a result, the vial and the flexible container are aseptically connected. (Japanese Patent Publication No. 59-500600). In such medical containers, although the sterility of the communication means is surely maintained, there is a problem in terms of manufacturing equipment and economical efficiency, since it is performed using a liquid thermoplastic material. In addition, since the connecting needle penetrates the connecting resin during use, the piercing resistance is large. Accordingly, it is an object of the present invention to provide a medical container and a method of manufacturing the same, which can easily and reliably perform aseptic treatment at the time of production and maintain sterility until use at the connection port between the flexible container and the medicine container.

[0005]

According to the present invention, there is provided a drug container having a connection port disposed opposite to a stopper at the mouth of the drug container, and the inside of which is filled with a solution or diluent of the drug. A flexible container, wherein the connection port is sterilized in an autoclave together with the flexible container in advance, and stores therein a communication needle aseptically therein, and has a non-deformed portion at the tip and an easily deformable portion. And the outer peripheral surface of the non-deformed portion is directly on the elastic plug,
Alternatively, the storage material and the plug are aseptically connected to each other by being tightly attached to the elastic packing attached to the plug, and when the medicine container is relatively moved toward the flexible container, The object has been achieved by providing a medical container characterized in that the easily deformable portion is deformed so that the communication needle penetrates the distal end portion and the plug of the storage material. . In the medical container according to the present invention,
The non-deformed portion of the storage material is provided with an engagement projection or engagement for connection. In the medical container according to the present invention, the connection port is a port member communicating with the inside, the storage material attached to the port member, and the drug container provided between the drug container and the port member. A support member that guides and supports when moving, the support member is provided so as to be relatively movable in the axial direction with respect to the medicine container, and is provided so as to be relatively rotatable at the connection port. It is characterized by the following.

In the method for manufacturing a medical container according to the present invention, the connection port is attached to the flexible container, and the solution is filled with the solution or diluent and then sterilized in an autoclave.
Thereafter, when directly or indirectly aseptically connecting the non-deformed tip of the storage material of the connection port to the stopper of the drug container, the medical container is characterized by being aseptically connected using hydrogen peroxide. The object has been achieved by providing a manufacturing method.

[0007]

In the medical container, the flexible container has a connection port, and a communication needle is accommodated in a storage material of the connection port. The communicating needle is steam sterilized with the lysing or diluting solution in a flexible container. Since the end of the storage material is a non-deformed portion, the non-deformed portion is fitted into a hole formed in the plug or a hole of an elastic packing provided in the plug, and the outer peripheral surface of the non-deformed portion and the hole of the plug or The elastic inner peripheral surface of the packing can be brought into close contact and connected. Therefore, if the outer peripheral surface and the elastic inner peripheral surface of the non-deformed portion are connected by exposing them to an atmosphere of a chemical sterilizing agent such as hydrogen peroxide, a portion through which the communication needle passes at the time of piercing is aseptic, and aseptically. Is maintained. Therefore, it is possible to easily sterilize up to the stopper following the connection port of the medical container by steam sterilization and chemical sterilization such as hydrogen peroxide. If it is limited to the outer surface, the sterilization of the connection port can be sufficiently achieved. Therefore, the sterilization of the connection port can be reliably and easily performed.

[0008]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the medical container and the method for producing the same according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a front sectional view of a first embodiment of the medical container according to the present invention. FIG. 2 is an exploded sectional view of the connection port used in the first embodiment. FIGS. 3A to 3D are cross-sectional views showing a process of assembling the connection port used in the first embodiment. FIG.
(A)-(c) is a top view which shows the assembly and function of the stopper member attached to the connection port used for 1st Example. FIG. 5 is a sectional view showing an assembled state of the vial and the holding capsule used in the first embodiment. FIG. 6 is a sectional view showing a docking assembly state of the flexible container and the vial used in the first embodiment. FIG. 7 is a sectional view showing an assembled state in which the support cylinder is connected to the connection port after the docking assembly of FIG. 8 (a) to 8 (c) are lines II in FIG.
It is sectional drawing along the I-II line and the III-III line. FIG. 9 is a cross-sectional view showing a state where the support cylinder is rotated when the medical container of the first embodiment is used. FIG. 10 is a cross-sectional view showing a state in which the vial is pressed and moved toward the flexible container after rotating the medical container of the first embodiment.

As shown in FIGS. 1 to 10, a medical container 1 according to a first embodiment of the present invention is disposed to face a rubber stopper 3 (plug) at the mouth of a vial 2 (drug container). Connection port 5
And a flexible container 6 filled with a solution 7 of the drug 4 therein, wherein the connection port 5 is
Is autoclaved, and the communication needle 11 is aseptically accommodated therein, and the connecting member 13 at the tip (non-deformable member)
And a flexible cap 14 (easily deformable member). The outer peripheral surface of the connecting member 13 has an inner peripheral surface 15 of an elastic packing 15 attached to the rubber stopper 3.
A, the storage material 12 and the rubber stopper 3 are aseptically connected to each other, and when the vial 2 is relatively moved toward the flexible container 6, the flexible cap 14 is deformed and communicated. The needle 11 is configured to penetrate the distal end portion of the storage material 12 and the rubber stopper 3.

The medical container 1 according to the present embodiment will be described in more detail. As shown in FIG. 1, a flexible container 6 of the medical container 1 is a tubular sheet formed by inflation molding of a linear low-density polyethylene. , And the cut ends 6A and 6B are fixedly sealed by heat welding. A discharge port member 101 is attached to the end 6A. The opening of the port member 101 is closed in a liquid-tight manner by an elastic plug 102, and the elastic plug 102 is closed by a stopper 103.
Stopped at one. The connection port 5 is attached to the end 6B. As shown in FIGS. 2 and 3, the connection port 5 includes a connection port member 10, a communication needle 11, and a storage material 12, and the connection port member 10 is formed of a resin molded product and has a cylindrical body with a flange 10 </ b> C formed on a top surface. Has become. A connection needle 11 made of resin and a storage material 12 are inserted into the connection port member 10, and the communication needle 11 is
Has a piercing portion 11A formed at the distal end and a mounting flange 11B formed at the proximal end. As shown in FIG. 3C, the mounting flange 11B is liquid-tightly mounted to the connection port member 10 by heat welding, and the piercing portion 11A of the communication needle 11 is stored in the storage material 12. As shown in FIG. 3A, the storage member 12 includes a cylindrical connecting member 13 and a flexible cap 14, and the connecting member 13 is formed of a resin molded product that does not easily deform. It is formed of a flexible resin molded product that deforms into a flexible shape. The inner surface of the connection member 13 and the outer peripheral surface of the distal end of the flexible cap 14 are liquid-tightly joined to each other by heat welding. The engagement protrusion 1 is provided on the outer peripheral surface of the connection member 13.
3A is formed, and the engagement protrusion 13A is engaged with an engagement hole 21A formed in a connection port of the holding capsule 21 described later. A flange 14 is formed at the proximal end of the flexible cap 14, and the flange 14 is connected to the connection port member 10 and the communication needle 1.
It is liquid-tightly mounted between the first mounting flange 11A. Further, as shown in FIG. 3C, the outer diameter (s) of the receiving flange portion 13B of the connection member 13 is formed smaller than the inner diameter (S) of the opening 10D of the connection port member 10, and
Can be accommodated in the connection port member 10 when deformed and contracted due to the side wall of the flexible cap 14.

As shown in FIGS. 3D and 4, a pair of stoppers 1 are provided on the top surface of the flange 10C of the connection port member 10.
6, 16 are attached. A pivot stop hole 10A and a temporary stop hole 10B are formed on the top surface of the flange 10C, and a pivot stop protrusion 16A and a breakable temporary stop protrusion 16B are formed on the stopper 16.
Are formed. The stopper 16 has a pivoting projection 16A and a temporary fixing projection 16B having a pivoting hole 10A and a temporary fixing hole 10 on the top surface.
B and attached to the top surface of the flange 10C. The stopper 16 is formed with an eccentric inner circumference,
As shown in FIG. 4B, when pressed in the direction of arrow A, the temporary fixing projection 16B breaks and rotates 45 degrees around the pivoting locking projection 16A, and as a result, the peripheral edge of the opening of the connection port member 10 is moved. The eccentric inner circumference of the stopper 16 that has been covered is shifted so that the opening 10D of the connection port member 10 is completely opened as shown in FIG. 4C.

As shown in FIG. 5, a vial 2 contains a lyophilized drug 4 (antibiotic), and a rubber stopper 3 is provided at the mouth of the vial 2 to seal the mouth in a liquid-tight manner. ing. The vial 2 is housed in a holding capsule 21 made of resin, and the holding capsule 21 has a resin lid 22 attached to the top surface. The lid 22 is joined to the holding capsule 21 via a cooperating portion (not shown), and the used vial 2 can be extracted from the capsule 21 by breaking the cooperating portion. Therefore, disposal of glass vials and the like after use is facilitated. Capsule 2
An elastic packing 15 made of rubber is attached to the outer peripheral edge of the rubber stopper 3 of the vial 2 in a liquid-tight manner. A part 15 A of the elastic packing 15 liquid-tightly seals a part of the inner peripheral wall of the connection port of the capsule 21. Covering.

As shown in FIGS. 6 and 7, the connection member 13 of the connection port 5 assembled and attached to the flexible container 6 is inserted into the connection port of the capsule 21. The connection member 13 and the connection port of the capsule 21 are fixed via the engagement protrusion 13A and the engagement hole 21A, and the outer peripheral surface of the connection member 13 is in close contact with the inner peripheral surface 15A of the elastic packing 15 in a liquid-tight manner. . As shown in FIG. 7, a resin support cylinder 23 for guiding is arranged between the capsule 21 and the connection port 5. Support tube 2
A groove 23A for engagement is formed along the circumferential direction on the inner peripheral surface at one end of 3, and the groove 23A is engaged with the outer peripheral edge of the flange 10C of the connection port member 10. Therefore, the support cylinder 23 is rotatable with respect to the connection port member 10.
A flange portion 23B is formed at the other end of the support cylinder 23, and the flange portion 23B serves as a handhold during use. As shown in FIG. 8, four ribs 24 are formed on the outer peripheral surface of the capsule 21 along the axial direction. The ribs 24 are formed on the inner peripheral surface of the support cylinder 23 by eight grooves formed along the axial direction. It is adapted to be engaged with four of the parts 26. Rotating protrusions 25 are formed on the inner peripheral surface of the support cylinder 23 toward the center. The protrusion 25 presses the end of the stopper 16 when the support cylinder 23 rotates with respect to the connection port 5. It is provided to be.

Next, the manufacturing method of the first embodiment of the medical container according to the present invention will be described. First, as shown in FIGS. 2 and 3, the connection port 5 is assembled. The distal end of the flexible cap 14 is inserted into the connecting member 13, the silicon support is inserted into the flexible cap as shown in FIG. 3A, and the inner peripheral surface of the connecting member 13 is heated by an external heating element. And the outer peripheral surface of the flexible cap 14 is fixed in a liquid-tight manner to form the storage material 12. As shown in FIGS. 3B and 3C, the piercing portion 11A of the communication needle 11 is inserted into the storage material 12, and the proximal end 11B of the communication needle 11 is heat-sealed to the connection port member 10 in a liquid-tight manner. . next,
As shown in FIG. 3D, the stopper 16 is
Is mounted on the top surface of the flange 10C. As shown in FIG.
The pivoting projection 16A and the temporary fixing projection 16B of the stopper 16 are inserted into the pivot locking hole 10A and the temporary fixing hole 10B on the surface of the flange 10C, and heat is applied to these portions to adhere. Such an adhesive force is such that the temporary fixing projection is broken when pressed in the direction of arrow A in FIG. 4B, and the pivoting fixing projection 16A is rotatably attached.

On the other hand, a linear low-density polyethylene is formed into a cylindrical sheet having a thickness of 300 μm and a width of 80 mm by inflation molding, and the cylindrical sheet is cut into a predetermined length. A heat sealer is applied to both ends of the cut and heat-sealed, thereby forming the flexible container 6. End 6 of flexible container 6
At the time of heat welding of A, the discharge port member 101 is attached, and the end portion 6B
At the time of thermal welding, the above-described connecting port 5 is attached. Next, a predetermined amount of the solution 7 is filled into the flexible container 6 from the outlet member 101, the opening of the outlet member 101 is sealed with the stopper 102, and the stopper 102 is stopped with the stopper 103.
While the flexible container 6 has the communication needle 11 in the connection port 5,
Autoclave sterilize. This ensures that the dissolving solution 7 and the communication needle 11 in the flexible container 6 are maintained in a sterile state. The temperature of autoclave sterilization is performed in the range of 100 to 130 ° C. Preferably, it is desirably 105 to 125 ° C. in consideration of a resin container.

Next, in FIG. 5, the drug solution is passed through a sterilization filter, filled into the vial 2, and freeze-dried in a sterile atmosphere to obtain a drug solution 4. Then, the mouth of the vial 2 is sealed with a rubber stopper 3 and completely sealed with an aluminum cap. The elastic packing 15 is attached to the outside of the rubber stopper 3 of the vial 2 and inserted into the capsule 21. Elastic packing 15
Is attached to the inner peripheral surface of the connection port of the capsule 21, the lid 22 cooperates with the capsule 21, the bottom of the vial 2 is pressed by the lid 22, and the gap between the rubber stopper 3 and the connection port is removed. It is made liquid-tight by the elastic packing 15. Next, the inside of the connection port of the capsule 21 is exposed to the vapor of hydrogen peroxide, and the outer wall surface of the rubber stopper 3 and the inner wall surface of the elastic packing 15 are sterilized. As shown in FIG. 6, the connection member 13 of the connection port 5 maintained aseptically is docked to the sterilized connection port. The engagement hole 21A of the connection port and the engagement protrusion 1 of the connection member 13 are formed by docking.
3A are engaged and cannot be pulled out from each other. As a result, the outer peripheral surface of the connection member 13 and the inner peripheral surface of the elastic packing 15 come into close contact with each other in a liquid-tight manner, and the space between the distal end of the flexible cap 14 and the rubber stopper 3 is sterilized, thereby maintaining a sterile state for a long time. In this case, since the tip of the storage material 12 is the non-deformable connection member 13,
It can be inserted into the connection port of the capsule 21 without any problem. If the storage material 12 is only the flexible cap 14, the connection port is deformed when inserted, and it is difficult to insert the connection port. In addition, since the non-deformable connection member 13 is held by the stoppers 16 and 16, the flexible cap 14 is deformed and depressed into the connection port member 10 when the connection port is inserted, and the communication needle 11 is moved. There is no danger of penetrating the flexible cap 14. Next, from the state of FIG.
1 along the guide rib 24, and as shown in FIG.
The groove 23A at the end of the support cylinder 23 is rotatably fitted to the periphery of the flange 10C of the connection port member 10. This prevents the connection opening of the capsule 21 from fluctuating, and allows the rotation protruding piece 25 of the support cylinder 23 to be disposed at the pressing position of the stopper 16. Then, the medical container of the present embodiment shown in FIG. 1 can be manufactured. In addition, since the support tube 23 is arranged on the vial 2 side during docking, it does not hinder the docking.

Next, the use of the medical container of the first embodiment will be described with reference to FIGS. 7, 9 and 10. The user holds the connection port 5 of the medical container 1 in the state shown in FIG. 7 and holds the support cylinder 23 to rotate the connection port 5 by 45 degrees. By rotation,
The turning projection 25 of the support cylinder 23 is indicated by an arrow A shown in FIG.
Is pressed in the direction of. By pressing, the temporary fixing projection 16B of the stopper 16 is broken, and the stopper 16 is moved around the pivoting projection 16A until the state shown in FIG.
Rotate 5 degrees. Thereby, the opening 10D of the connection port member 10 is completely opened as shown in FIG. The palm is put on the lid 22 of the medical container 1 in the state shown in FIG. 9 and the finger is put on the flange portion 23B of the support tube 23. In this state, the vial 2 is pushed into the support cylinder 23 by inserting the rib 24 of the capsule 21 into the guide groove 26 of the support cylinder 23. This allows
The connection port of the capsule 21 and the connection member 13 are connected to the connection port member 1.
0 is pushed into the opening 10D. By being pushed in, the connecting needle 11 penetrates the distal end portion of the flexible cap 14 and the rubber stopper 3, and the flexible container 6 and the vial 2 communicate with each other. The medicine 4 is mixed and returned into the flexible container 6 to start infusion. In this case, the connecting needle 11 is kept aseptically in the storage material 12 until it is used, and the space between the storage material 12 and the rubber stopper 3 is also maintained aseptically. Therefore, even during use, the flexible container 6 and the vial 2 can be aseptically communicated.

Next, a modification of the main part of the medical container according to the present invention will be described in detail with reference to FIGS. FIG.
(A) And (b) is sectional drawing which shows the modification of the storage material provided in a connection opening. FIG. 12 is a cross-sectional view showing a modification of the communication needle provided in the storage material of the connection port, a modification of the flexible container, and a modification of the connection between the rubber stopper and the storage material. As shown in FIG. 11, the storage material 32 is made of an integrally molded resin having a non-deformable portion 32A and an easily deformable portion 32B. Even such a storage material 32 has the same operation and effect as the storage material 12 of the above-described embodiment. In the present invention, the storage material is not limited to a general flexible resin molded product, but may be made of rubber,
It may be mostly constituted by a flexible member such as a thermoplastic elastomer. As shown in FIG. 12, the communication needle 31 in the storage material 32 does not need to have a piercing portion only at one end as in the above-described embodiment, and may be a double-ended needle-type communication needle in the present invention. In this case, a separator may be provided between the flexible container 61 and the flexible container 61. In the present invention, the communication needle 31
Is a resin molded product, but the material may be any other material such as metal as long as the rubber stopper 3 and the like can be pierced. As shown in FIG. 12, the flexible container 61 may be a blow molded product, or a connection port may be attached to the wall of such a flexible container. In the present invention, the flexible container 61 is provided with an outlet. However, after the mixing operation of the medicine 4 in the connecting port 5, the vial 2 is removed and the connecting port is used as the outlet, and the flexible container 61 is used as a flexible container. It is not necessary to provide a discharge port in 6. As shown in FIG. 12, a connection hole 34 may be provided in the rubber stopper 33 of the vial 2 to directly connect the storage material 12 without elastic packing.

In the above embodiment, a linear low-density polyethylene sheet was used for the resin container. Such a polyolefin-based resin is preferable because it does not affect the filling liquid because it has no functional group. However, the present invention is not limited to this. For example, low density polyethylene resin, high density polyethylene resin, polypropylene resin, soft polyester resin, chlorinated polyethylene resin,
A highly flexible material such as a vinyl chloride resin or an ethylene-vinyl acetate copolymer can be used. The resin sheet may be a multilayer laminate of different resins. In the above example, a tubular inflation molded product or a blow molded product was used for the resin container. In the present invention,
The resin container may be an extruded product, a vacuum molded product, an injection molded product, or the like. In the above embodiment, hydrogen peroxide is used for the aseptic connection between the storage material 12 and the elastic packing 15, but in the present invention, a chemical substance having a sterilizing effect other than hydrogen peroxide may be used. In the above embodiment, the rubber stopper 3 is made of rubber.
Although the elastic packing 15 is used, in the present invention, a thermoplastic elastomer or the like may be used as long as the connecting surface is an elastic member that can be made liquid-tight. In the above embodiment, the flexible container 6
Was filled with the lysis solution. In the present invention, a commonly used infusion solution or the like may be filled as a solution or a diluting solution. In the above embodiment, the vial 2 is filled with the lyophilized product. However, in the present invention, the drug solution may be filled in some cases. Although the vial 2 is made of glass, a resin container may be used in the present invention. In the above-described embodiment, the engagement protrusion is provided on the storage material 12 to connect the capsule 21, but in the present invention, an engagement hole may be used.

[0020]

As described above, in the medical container and the method for manufacturing the same according to the present invention, the connection port is autoclaved in advance together with the flexible container, and the communication needle is aseptically accommodated therein. A storage material having a non-deformable portion and an easily deformable portion at the tip, wherein the outer peripheral surface of the non-deformable portion is directly adhered to the elastic plug or to an elastic packing attached to the plug to form the storage material; And the stopper are aseptically connected, and when the medicine container is relatively moved toward the flexible container, the easily deformable portion is deformed and the communication needle is moved to the distal end of the storage material and Since the plug is configured to be pierced, aseptic treatment at the time of manufacture and aseptic maintenance until use can be easily and reliably performed at the connection port between the flexible container and the drug container.

[Brief description of the drawings]

FIG. 1 is a front sectional view of a first embodiment of a medical container according to the present invention.

FIG. 2 is an exploded sectional view of a connection port used in the first embodiment.

FIGS. 3A to 3D are cross-sectional views showing a process of assembling a connection port used in the first embodiment.

FIGS. 4A to 4C are plan views showing assembly and functions of a stopper member attached to a connection port used in the first embodiment.

FIG. 5 is a sectional view showing an assembled state of the vial and the holding capsule used in the first embodiment.

FIG. 6 is a sectional view showing a docking assembly state of the flexible container and the vial used in the first embodiment.

FIG. 7 is a cross-sectional view showing an assembled state in which the support tube is connected to the connection port after the docking assembly of FIG. 6;

8 (a) to 8 (c) are lines II and II-II in FIG.
FIG. 3 is a cross-sectional view taken along line III-III.

FIG. 9 is a cross-sectional view showing a state where the support cylinder is rotated when using the medical container of the first embodiment.

FIG. 10 is a sectional view showing a state in which the vial is pressed and moved toward the flexible container after rotating the medical container of the first embodiment.

FIGS. 11A and 11B are cross-sectional views showing modified examples of a storage material provided at a connection port of a medical container.

FIG. 12 is a cross-sectional view showing a modification of the communication needle provided in the storage material of the connection port of the medical container, a modification of the flexible container, and a modification of the connection between the rubber stopper and the storage material.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical container 2 Vial 3 Rubber stopper 4 Drug 5 Connection port 6 Flexible container 7 Dissolution 10 Connection port member 11 Communication needle 12 Storage material 13 Connection member 14 Flexible cap 15 Elastic packing 16 Stopper 21 Capsule 22 Cap body 23 Support Cylinder 24 Guide Rib 25 Rotating Protrusion 26 Guide Groove Strip

────────────────────────────────────────────────── ─── Continuation of the front page (56) References JP-A-2-1277 (JP, A) JP-A-6-14973 (JP, A) JP-A-6-14976 (JP, A) JP-A-5-14976 176972 (JP, A) JP 6-5633 (JP, U) JP 7-44430 (JP, U) JP 7-44169 (JP, U) (58) Field surveyed (Int. ⁶ , DB name) A61J 1/20 A61L 2/04 A61L 2/16

Claims (4)

(57) [Claims] 1. A flexible container having a connection port arranged opposite to a stopper at a mouth portion of a drug container and filled with a solution or a diluting solution of the drug, The connection port is pre-sterilized with the flexible container in an autoclave and contains a communication needle aseptically therein, and is made of a storage material having a non-deformed portion and an easily deformable portion at the tip. The outer peripheral surface is directly adhered to the elastic plug or the elastic packing attached to the plug, the storage material and the plug are aseptically connected, and the medicine container is directed toward the flexible container. A medical container characterized in that, when relatively moved, the easily deformable portion is deformed so that the communication needle penetrates the distal end portion and the plug of the storage material. 2. The medical container according to claim 1, wherein an engagement protrusion or an engagement hole for connection is provided on the non-deformed portion of the storage material. 3. The connection port according to claim 1, wherein the connection port includes a port member communicating with the inside,
The storage member attached to the mouth member, and a support member provided between the medicine container and the mouth member and guiding and supporting the medicine container when the medicine container is moved, wherein the support member includes the medicine container and a shaft thereof. The medical container according to claim 1, wherein the medical container is provided so as to be relatively movable in a direction, and is relatively rotatably provided in the connection port. 4. The method for manufacturing a medical container according to claim 1, wherein said flexible container is provided with said connection port, and said solution or diluent is filled therein, followed by autoclave sterilization. Then, when the non-deformed portion of the storage material of the connection port is directly or indirectly aseptically connected to the stopper of the medicine container, the medical container is aseptically connected using hydrogen peroxide. Manufacturing method.