JPH09285522A - Chemical vessel - Google Patents

Abstract

PROBLEM TO BE SOLVED: To safely and surely disinfect or sterilize the surface of a rubber plug just before connection by covering the surface to be pierced of the rubber plug with a protecting film pierceyble with a communicating needle, and separating the surface to be pierced of the rubber plug from the protecting film in a specified dimension at a point of time when the communicating needle pierces. SOLUTION: The surface 71 to be pierced of the rubber plug 7 of a chemical vial (chemical vessel) 5 is covered with a protecting film 81 pierceable with a communicating needle, and the surface of the protecting film 81 is sterilized. The surface 71 to be pierced of the rubber plug 7 is separated from the protecting film 81 by 0.7mm or more at a point of time when the communicating needle pierces. The protecting film 81 is arranged with a space from the surface 71 to be pierced, and the protecting film 81, which is formed of aluminum or stainless, is formed thickly excluding the part for covering the surface 71 to be pierced, and also forms a part of a caulking cap 8 for fixing the rubber plug 7 to an opening part 51. The sterilization of the surface of the protecting film 81 is performed by chemical sterilization with aqueous hydrogen peroxide.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a container in which a medicine is contained, an opening of the container is sealed with a rubber stopper, and a communication needle is provided with a rubber to secure a communication passage from the outside of the container to the inside of the container. A drug container used by piercing a stopper, wherein at least the pierced surface of the rubber stopper is covered with a protective film piercable by the communication needle, and the surface of the protective film is sterilized. It is about.

[0002]

2. Description of the Related Art In general, a medicine container contains a powder medicine such as an antibiotic or an anticancer agent or a lyophilized agent, and is formed of a vial whose opening is sealed with a rubber stopper. On the other hand, medical containers such as bags and containers for infusions and the like used for intravenous injections are flexible containers having a flexible wall and having no eluate or the like. Such a flexible container has a connection port, and the medicine container such as the above-mentioned vial is connected through the connection port. Communication between the flexible container and the medicine container is generally performed by a communication needle arranged at the connection port.
For example, in general, a communication needle made of metal or resin is provided at the connection port as communication means, and a communication needle communicating with the inside of the flexible container is pierced into a rubber stopper of the medicine container to communicate therewith.

[0003]

A conventional drug-containing container enclosing a powdered drug such as an antibiotic or an anticancer drug or a lyophilized agent has a rubber stopper that seals the opening of the container. Water vapor and gas are easier to permeate than the glass part of the container, and the drug is degraded by the water or gas. Sterilization failed. For this reason, EOG sterilization and sterilization with a hydrogen peroxide solution are made possible by covering at least a part of the rubber stopper of the container containing the medicine with a protective film. That is, the surface of the rubber stopper is covered with a protective film, and the protective film covering the pierced surface allows the communication needle to penetrate. By contacting the surface of this protective film with EOG sterilization or hydrogen peroxide solution, the surface of the protective film is sterilized or sterilized. Further, the protective film has extremely little gas and liquid permeation as compared with the rubber material and does not deteriorate, so that the protective film does not affect the rubber material or the medicine in the container.
In addition, it is also possible to generate an eddy current by applying magnetic lines of force to the protective film by high frequency induction or the like, and heat only the protective film to sterilize the surface of the protective film by heating. In addition, the protective film protects the surface of the rubber stopper from the electron beam and prevents its deterioration.

However, the protection of the rubber stopper by such a protective film has the following problems. The metal is malleable, and when the communicating needle is pierced through the membrane or foil, the film or foil at the contact portion extends by malleability due to the sliding contact of the side wall of the communicating needle, and then the rubber plug is pierced. Dragged into the puncture hole. For this reason, there is a possibility that the metal piece may pass through the medicine container and contaminate the medicine. Such a phenomenon is observed in a portion such as an aluminum foil or a stainless film which is formed to be thin and malleable. Therefore, according to the present invention, when the flexible containers are aseptically connected, the surface of the rubber stopper can be sterilized or sterilized safely and reliably immediately before the connection, and the contamination of the medicine or the like at the time of the insertion of the communication needle can be achieved. It is to provide a drug container that does not occur.

[0005]

SUMMARY OF THE INVENTION According to the present invention, a medicine is stored in a container, an opening of the container is sealed with a rubber stopper, and a communication needle is provided to secure a communication path from the outside of the container to the inside of the container. Is a drug container used by piercing a rubber stopper,
At least the pierced surface of the rubber stopper is covered with a protective film that can be pierced with the communication needle, and the surface of the protective film is sterilized in a drug container. The object has been achieved by providing a medicine container characterized in that the medicine container is separated from the protective film by 0.7 mm or more at the time of piercing of the communication needle.

In the medicine container according to the present invention, the protective film is provided so as to float from the piercing surface. In the drug container according to the present invention, a hole is formed on the surface of the rubber stopper, and the bottom surface of the hole serves as the pierced surface. In the drug container according to the present invention, the protective film is made of aluminum or stainless metal,
The rubber cap is formed thick except for a portion covering the pierced surface, and is a part of a caulking cap for fixing the rubber stopper to the opening. In the drug container according to the present invention, the sterilization treatment is a chemical sterilization treatment. In the medicine container according to the present invention, the medicine container is connected to a flexible container having a communication needle, and the pierced surface of the rubber stopper is separated from the protective film by 以上 or more of the outer diameter L of the communication needle. It is characterized by doing.

[0007]

The inside of the medicine container is communicated with the inside of the flexible container by a communication needle, and a part of the solution in the flexible container is mixed with the medicine in the medicine container. Then, the mixed solution is returned into the flexible container via the communication needle, and is discharged from the flexible container as an infusion solution. In this case, the communication needle is pierced at least through the rubber stopper of the medicine container, but the pierced surface of the rubber stopper is covered with the protective film, and the chemical sterilization is performed safely. Then, when the communication needle pierces the rubber stopper, first, the communication needle pierces the protective film. At this time, the crushed portion of the protective film extends toward the pierced surface by malleability. In this case, when the extended portion reaches the pierced surface of the rubber stopper, it is embedded in the rubber stopper due to the movement of the communication needle. The buried metal part may be torn in the rubber stopper by the movement of the communication needle and the elastic compression of the rubber stopper, and may be fragmented into the medicine container. A so-called coring phenomenon of the protective film may occur. However, in the present invention, the protective film is 0.7 mm
In particular, if the outer diameter of the communicating needle to be pierced is equal to or more than の, it is difficult for the extended portion of the protective film to reach the pierced surface, and the protective film is buried in the rubber stopper. No coring occurs. Therefore, the drug container is safely sterilized in the connection port, and there is no possibility that contaminants or the like will be mixed into the drug container when the communication needle is pierced.

[0008]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of a medicine container according to the present invention will be described below in detail with reference to the accompanying drawings. 1 and 2 are front sectional views of a first embodiment of a medicine container according to the present invention.
3 and 4 are front sectional views when the first embodiment is used.

As shown in FIGS. 1 to 4, a medicine vial (medicine container) 5 according to the first embodiment of the present invention contains a medicine 6, an opening 51 is sealed with a rubber stopper 7, and the medicine is introduced from outside to inside. This is a container used to pierce the rubber stopper 7 with a communication needle to secure a communication passage. In the vial 5, the pierced surface 71 of the rubber stopper 7 is covered with a protective film 81 that can be pierced with a communication needle, and the surface of the protective film 81 is sterilized. And
In the vial 5, the surface 71 to be pierced of the rubber stopper 7 and the protective film 81 are separated from each other by 0.7 mm or more when the communicating needle is pierced. The protective film 81 of the vial 5 is disposed so as to rise from the pierced surface 71, and the protective film 81 is made of stainless steel.
1 is a part of a caulking cap 8 formed to be thick except for a portion covering 1 and fixing the rubber plug 7 to the opening 51. The sterilization of the surface of the protective film 81 in the vial 5 is a chemical sterilization with a hydrogen peroxide solution. Then, as shown in FIG. 2, the flexible container 1 having the communication needle 9 is provided.
0, and the piercing surface 71 of the rubber plug 7 and the protective film 81 are separated from each other by １ ／ or more of the outer diameter L of the communication needle 13.

The vial 5 according to this embodiment will be described in more detail. As shown in FIG. 1, the vial 5 is filled with a freeze-dried drug 6 aseptically, and the vial 5 has an opening 5.
Reference numeral 1 is sealed with a rubber stopper 7. Rubber stopper 7 is pierced surface 7
1, a communication needle made of metal or resin can penetrate the pierced surface 71. A caulking cap 8 is attached to the rubber stopper 7, and the caulking cap 8 is caulked and fixed to the flange 52 of the opening 51. The caulking cap 8 is made of stainless steel and has a thin protective film 81 on the central surface through which the communication needle is pierced by punching and stretching. That is, the protective film 81 covers the pierced surface 71 of the rubber plug 7 and is formed so as to rise from the punctured surface 71. The protective film 81 is formed to have a thickness of 5 μm to 100 μm. The periphery of the protective film 81, particularly the shoulder portion 82 that supports the floating of the protective film 81, is a thick portion that is not easily deformed.

It is desirable that the distance S between the piercing surface 71 of the rubber plug 7 and the protective film 81 is not less than の of the outer diameter L of the communication needle 13. Usually, the communication needle 13 has an outer diameter of 1.4 mm for metal and an outer diameter of resin because the dissolving solution 11 and the mixed solution reciprocate between the vial 5 and the flexible container 10 by pumping or the like. 3.0 mm or more is required. For this reason,
S between the piercing surface 71 and the protective film 81 is 0.7 mm or more,
In particular, it is desirable that they are separated by 1.5 mm or more, more preferably 2.0 mm or more. If it is less than 1/2 of the outer diameter of the communication needle,
When the protective film 81 is broken, the broken portion is
1 and may be caught in the rubber stopper 7 by the communication needle. Further, if the separation S is 2.0 mm or more, it is easy to provide a plurality of passages in the communication needle, so that there is an advantage that the flow of the solution can be smoothed.

As shown in FIG. 2, the vial 5 may be connected to the flexible container 10 in advance. That is, the solution 11 is stored in the flexible container 10, and the connection port 12 is provided. A communication needle 13 is aseptically disposed in the connection port 12 in advance. The flexible container 10 is formed by cutting a tubular sheet obtained by inflation molding of a linear low-density polyethylene into a predetermined length, and fixing and sealing both ends of the cut by heat welding. A discharge port is attached to the end (not shown), and a connection port 12 is attached to the end 10A. The connection port 12 includes a connection port member 14, a communication needle 13, and a storage material 15. The connection port member 14 is a cylindrical body, into which the resin connection needle 13 and the storage material 15 are inserted and housed. A piercing portion 13A is formed and a mounting flange 1 is provided at a base end.
3B is formed. The mounting flange 13 </ b> B is liquid-tightly mounted to the connection port member 14 by heat welding, and the communication needle 13 is stored in the storage material 15. The storage member 15 is formed of a flexible cap, and a connection member 16 is attached to a distal end.

The connection member 16 is supported by a stopper 17 provided on the connection port member 14 and is fitted to a connection port 18A of the capsule 18. Resin capsule 18 made of resin
The vial 5 is housed therein, and the holding capsule 18 has a resin lid 19 attached to the top surface. The lid 19 is joined to the holding capsule 18 via a cooperating portion (not shown), and the used vial 5 can be extracted from the capsule 18 by breaking the cooperating portion. Therefore,
After use, disposal of glass vials and the like is easy. The rubber stopper 7 of the vial 5 and the outer peripheral edge of the caulking cap 8 in the capsule 18 are provided with a rubber elastic packing 2.
0 is mounted in a liquid-tight manner, and a part 20A of the elastic packing 20 liquid-tightly covers a part of the inner peripheral wall of the connection port 18A of the capsule 18. When connecting the connection member 16 and the connection port 18A, the inside of the connection port 18A is chemically sterilized with a hydrogen peroxide solution or the like, and after the connection, the protection film 81 of the caulking cap 8 is connected.
The surface is kept sterile. Capsule 18 and connection 1
2, a resin support cylinder 21 for guiding is provided. The support cylinder 21 guides the capsule 18 to move accurately to the flexible container 10 when the stopper 17 is removed.

Next, the use of the vial as the medicine container of the first embodiment will be described. In the state shown in FIG. 2, the stopper 17 is removed, and the capsule 18 is pushed into the support cylinder 21. Thereby, the connection port 18A and the connection member 16 of the capsule 18 are pushed into the opening of the connection port member 14 (FIG. 3). By being pushed in, the connecting needle 13 pierces the distal end portion of the storage material 15 and the pierced surface 71 of the rubber plug 7,
The flexible container 10 and the vial 5 communicate with each other, and the solution 11 and the medicine 6 in the flexible container 10 are mixed by pumping, and the mixture is returned into the flexible container 10 to start infusion. In this case, as shown in FIG. 4, the crushed portion of the protective film 81 extends toward the pierced surface 71 by malleability. However, the shoulder portion 82 supporting the protective film 81 is thick, and the communication needle 13
Deformation resistance to piercing impact. Therefore, even at the moment when the communication needle 13 is pierced, the protective film 81 and the pierced surface 71
The extended portion of the protective film 81 does not reach the pierced surface 71 of the rubber plug 7, and there is no risk of being buried in the rubber plug 7 by the movement of the communication needle 13. Therefore, a part of the protective film 81 does not scatter in the vial 5 as a fragment.

Next, a medicine container according to a second embodiment of the present invention will be described with reference to FIG. 5 of the accompanying drawings. FIG. 5 is a front sectional view of the vial of the second embodiment. The vial 31 of the second embodiment shown in FIG. 5 has substantially the same structure as the vial 5 of the first embodiment, but differs in a rubber stopper 32 and a caulking cap 33. A hole 34 is formed in the center of the rubber plug 32, and the bottom surface 35 of the hole 34 is thinned to form a pierced surface through which a communication needle can be pierced. An aluminum caulking cap 33 is attached to the rubber stopper 32, and a thinned thin portion 36 of the caulking cap 33 is provided on the opening surface of the hole 34.
Are formed. Therefore, the bottom surface 35 of the hole 34, which is the piercing surface, and the thin portion 36, which is the protective film portion, are separated from each other, and the distance is determined by the depth of the hole 34. In the present embodiment, the depth is 0.7 mm or more, specifically, 5.0 mm. Even in such a configuration, when the communication needle is pierced through the rubber stopper 32, coring or the like does not occur as in the vial 5 of the first embodiment.

In the above embodiment, hydrogen peroxide is used for the aseptic connection between the storage material 15 and the elastic packing 20, 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 7 and the elastic packing 20 are used. However, 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 example, the solution 11 was filled in the flexible container 10. 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 5 is filled with the lyophilized substance. However, in the present invention, the drug solution may be filled in some cases. Although the vial 5 is made of glass, a resin container may be used in the present invention. In the above embodiment, the caulking cap is made of stainless steel or aluminum. However, as long as it can sufficiently protect the rubber stopper, it is not limited to a metal film, and a plastic material having deformation resistance may be used.

[0017]

As described above, in the medicine container according to the present invention, since the piercing surface of the rubber stopper and the protective film are separated from each other by 0.7 mm or more at the time of piercing of the communication needle, the medicine container is flexible. When the sex containers are connected aseptically, the surface of the rubber stopper can be safely and reliably sterilized or sterilized immediately before the connection, and no contamination of medicine or the like occurs when the communication needle is pierced.

[Brief description of drawings]

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

FIG. 2 is a cross-sectional view in which a flexible container and a communication needle are previously attached to the first embodiment.

FIG. 3 is a cross-sectional view showing a state in which the medicine container according to the first embodiment and the flexible container are in communication with each other.

FIG. 4 is an enlarged sectional view of a main part of FIG.

FIG. 5 is a front sectional view of the medicine container of the second embodiment.

[Explanation of symbols]

 5, 31 drug vial 6 drug 7 rubber stopper 8 caulking cap 10 flexible container 11 solution

Claims (6)

[Claims] 1. A drug which is contained in a container, the opening of which is sealed with a rubber stopper, and which is used by piercing a rubber stopper with a communication needle to secure a communication path from the outside of the container to the inside of the container. A container, wherein at least the surface to be pierced by the rubber stopper is covered with a protective film that can be pierced by the communication needle, and the surface of the protective film is sterilized. A drug container, wherein the surface to be pierced and the protective film are separated by 0.7 mm or more when the communication needle is pierced. 2. The drug container according to claim 1, wherein the protective film is arranged so as to float above the surface to be penetrated. 3. The drug container according to claim 1, wherein a hole is formed on the surface of the rubber stopper, and the bottom surface of the hole is the surface to be penetrated. 4. The protective film is made of aluminum or stainless metal, is formed thick except for a portion covering the surface to be pierced, and is a caulking cap for fixing the rubber stopper to the opening. The drug container according to claim 1, which is a part. 5. The drug container according to claim 4, wherein the sterilization treatment is chemical sterilization treatment. 6. A flexible container provided with a communicating needle, wherein the pierced surface of the rubber stopper and the protective film are separated from each other by 1/2 or more of the outer diameter L of the communicating needle. The chemical | medical agent container of Claim 1-5 characterized by the above-mentioned.