JPH08238301A - Drug vial holding assembly and related technology - Google Patents

Abstract

(57) [Summary] [Purpose] To provide a product whose outer surface is efficiently and reliably sterilized by an electron beam without affecting the drug in the drug vial. [Structure] A radiation resistant polypropylene resin thin layer is laminated on the outer surface of the vial 10 and the top surface of the elastic stopper 12. The peripheral portion of the opening of the cap body 14 is bent and airtightly pressed to the top surface of the plug body 12. The elastic annular plate 20 bonded to the annular bottom portion 18a of the tubular portion 18 of the holding body 16 is air-tightly pressed onto the top surface of the cap body 14. The outer peripheral portion of the cap body 14 is held inside the small diameter portion 18b of the tubular portion 18. On the outer peripheral surface of the body of the vial 10, the large diameter portion 18 of the tubular portion 18 is provided.
The inner annular packing 22 attached to the inner peripheral portion of d is airtightly crimped. The electron beam is irradiated from both the axial direction of the drug vial holding assembly 32.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug vial holding assembly whose outer surface is sterilized by an electron beam, a method for manufacturing the same, and a drug vial suitable for sterilizing the outer surface by an electron beam.

[0002]

2. Description of the Related Art Among antibiotics and blood products, some of them are supplied to the medical treatment as solid preparations due to the problem of pharmaceutical stability, and they are dissolved immediately before use and intravenously injected as an injection. Some are administered. The drug dissolving operation at this time has conventionally been performed, for example, by connecting a drug vial and a solution container, which are each sealed with a rubber stopper, with each other by means of a hollow double-ended needle or the like having cutting edges at both ends. If such a communication operation is performed with the rubber stoppers of both containers and the hollow double-ended needle in contact with the outside air,
There is a risk of drug contamination. Therefore, various medical containers (hereinafter referred to as medical kits) have been proposed in which the communication operation between the drug vial and the solution container can be performed in a sealed system. For example, Japanese Patent Publication No. 61-501129 discloses a medical kit in which a capsule containing a drug vial and a flexible dissolution container are connected by a conduit means, and the conduit means is provided with a communicating means. ing. Also,
JP-A No. 2-1277 discloses an improved communication mechanism,
A medical kit has been disclosed in which communication operation can be performed easily and reliably.

As for the medical kit in which the drug vial and the solution container are communicated with each other in a sealed system as described above, microbial contamination in the sealed system at the time of manufacturing is prevented, and sterilization in the sealed system is prevented. Sex must be guaranteed.

In order to prevent microbial contamination in the sealed system of this medical kit, each part of the medical kit is aseptically manufactured, and the assembly process of each part is performed in a clean room where the cleanliness is kept high. It will be possible by using an unmanned integrated production line.

As a method for aseptically manufacturing each component other than a drug vial constituting a medical kit, a physical sterilization method by radiation irradiation or high-pressure steam sterilization, or chemical sterilization by ethylene oxide gas (hereinafter referred to as EOG) or the like is used. Any method can be used. It is important to maintain the sterility of the sterilized product by these methods and to supply it to the assembly process in order to guarantee the sterility of the sealed system.

On the other hand, as an aseptic manufacturing method for drug vials, a drug is aseptically filled in a vial that has been sterilized by dry heat, and a rubber stopper processed by radiation sterilization such as gamma ray sterilization or high-pressure steam sterilization is filled with the drug. After aseptically fitting the mouth of the finished drug vial and sealing the mouth, an aluminum cap sterilized by radiation sterilization such as gamma ray sterilization, gas sterilization such as EOG sterilization, or high pressure steam sterilization. A possible method is to externally fit the portion of the drug vial extending from the neck portion to the rubber stopper, and tighten it. The inner surface of the drug vial manufactured in this manner is aseptic when completed.

However, in the medical kit,
Sterility is also required on the outer surface of the drug vial.
The sterilized aluminum cap described above may be exposed to microorganisms from the operator or the external environment when unpacking and supplying it to the drug vial manufacturing apparatus. It is necessary to sterilize the surface of the cap after it is supplied to the drug vial manufacturing apparatus and before the tightening process. However, it is difficult to incorporate a sterilizer for the purpose of sterilizing only the surface of the cap into the drug vial manufacturing apparatus because of a large cost increase. The method of sterilizing adherent bacteria on the surface of the aluminum cap using a powerful UV lamp in the preceding step of the winding step is considered to be the most advantageous in terms of cost, but sterilization by an ultraviolet irradiation device causes dust on the surface. If such a substance is attached, the part cannot be sterilized, so complete sterilization cannot be expected. UV irradiation is included in the category of sterilization. Unlike sterilization, sterility is not guaranteed.

Further, when the above-mentioned medical kit cannot be manufactured in an integrated manner, for example, the drug vial production line and the medical kit assembly line are separated from each other, or the drug vial manufacturer and the medical kit manufacturer are different from each other, that is, medical If the drug kit manufacturer receives drug vials from a drug vial manufacturer for use in medical kits, even if the drug vial's inner and outer surface sterility is guaranteed at the time of completion, it will not be transported or unpacked. In such a case, the surface of the drug vial and the gap between the cap and the vial and the rubber stopper may be contaminated by microorganisms from the operator or the external environment.

Even in the case where the parts other than the drug vial among the parts making up the medical kit are subjected to gamma ray sterilization, EOG sterilization, etc. in a consignment relationship, the steps of transportation and unpacking are added as described above. Therefore, the worker or the external environment may contaminate the outer surface of the drug vial with microorganisms during the transportation period or during the unpacking operation.

In any case, the problem can be solved by sterilizing the outer surface of the drug vial and other necessary parts during or after the drug vial is supplied to the process of assembling the medical kit. .

As a sterilization method in that case, it is conceivable to adopt EOG sterilization, radiation sterilization, high-pressure steam sterilization, etc., which are typical sterilization methods currently used for medicines and medical instruments.

However, in the case of EOG sterilization, the toxicity of ethylene oxide poses a problem, so EO in the rubber stopper for sealing the drug vial and other components of the medical kit is used.
It is necessary to perform chemical tests and biological tests on secondary products with a high residual amount of G and highly toxic substances to ensure that they have no effect on the human body. Also, in EOG sterilization, in order to prevent microbial contamination by workers, it is necessary to perform unattended batch processing of sterilization, residual gas removal operations, etc. Therefore, in order to inline the production line, maintain the production environment. Therefore, the total equipment cost will increase.

Recently, radiation sterilization has been widely used as an alternative method to EOG sterilization. Normally, gamma ray sterilization with cobalt 60 is used to sterilize medical instruments and the like. The absorbed dose is usually 25 kGy in Japan. If each component that makes up the medical kit is made of polymer material, sterilize with this absorbed dose, and with gamma rays,
Since polymer chains will be decomposed and cross-linked and the material will be deteriorated, physical, chemical and biological tests must be carried out to guarantee the functionality after gamma irradiation and the safety to the human body. In addition, gamma rays penetrate the vial and irradiate the internal drug, which may adversely affect the active ingredients of the drug. It is necessary to re-apply to the Ministry of Health and Welfare at the same level as in the above, and to guarantee that the active ingredients are not chemically affected. Furthermore, since the vial is colored or discolored by converting the ionic valence in the vial, it cannot be used for a transparent vial. In terms of manufacturing equipment, if the gamma-ray sterilization facility is connected to the above-mentioned assembly line, it can be in-lined, but the gamma-ray sterilization facility is extremely expensive, which causes an increase in the cost of the medical kit.

As described above, in the method of sterilizing the drug vial and other parts constituting the medical kit by using EOG or gamma ray, the development cost and the equipment cost increase, and the cost of the medical kit increases. Invite up.

In the case of electron beam sterilization using an electron beam as radiation, the cost can be relatively suppressed even if the device is made in-line, and the inside of the drug vial is prevented while avoiding irradiation of the drug inside through the vial. The surface can be sterilized. Even in the portion shaded from the irradiation direction and in the gap, it is possible to sterilize a certain amount by wrapping around or reflecting the electron beam. However, it is difficult to sufficiently sterilize the gap between the aluminum cap and the rubber stopper and the outer peripheral surface of the vial. In addition, at the absorbed dose that kills the bacteria adhering to the outer surface of the drug vial, theoretically, the electron beam does not penetrate into the drug vial, but by irradiation with the electron beam,
It is possible that the valence of the ions in the vial is converted and the vial is discolored or colored, and the rubber stopper is deteriorated.

A method of sterilizing the surface of the drug vial by high-pressure steam sterilization, which is relatively inexpensive, can be considered. According to this method, it is possible to sterilize the gap between the aluminum cap, the rubber stopper and the outer peripheral surface of the vial. The thermal deterioration of the drug in the vial due to the high temperature treatment can sufficiently occur.
In particular, since many drugs used in medical kits are likely to be thermally deteriorated, this method cannot be adopted.

Besides, a chemical sterilization method using hydrogen peroxide or the like or a physical sterilization method using ultraviolet irradiation can be considered.
With respect to the sterilization method using chemicals such as hydrogen peroxide, residual chemicals and highly toxic secondary products may pose a problem.For the sterilization method using ultraviolet irradiation, the aluminum cap and rubber stopper attached to the chemical vial and the outer surface of the vial can also be used. There may be a shadow in the gap between the and to reduce the bactericidal effect. Furthermore, since these sterilization methods are included in the category of sterilization, even the parts sterilized by these methods in the integrated production line cannot always guarantee sterility.

The present invention has been made in view of the above-mentioned problems existing in the prior art, and its object is to prevent the drug in the drug vial from being affected by the electronic surface. Drug vial holding assembly sterilized efficiently and reliably by means of a wire, a manufacturing method capable of manufacturing the drug vial holding assembly reliably and efficiently, and an effective sterilization using an electron beam. To provide a suitable drug vial.

[0019]

A drug vial holding assembly according to the present invention is an assembly in which a drug vial is held by a holding body, and the drug vial has a mouth made of a stopper made of an elastic material. It is sealed and wound by a cap body so as to cover at least an outer peripheral portion of the top surface of the stopper body to a constricted portion of the outer peripheral surface of the drug vial while leaving an exposed portion on at least a part of the top surface of the stopper body. The sealed state of the plug body is maintained by the sealing member, and the peripheral portion of the exposed portion of the cap body is airtightly pressed against the top surface of the plug body, and the holding body is located outside the exposed portion. A first annular sealing portion that is airtightly crimped to the cap body over the entire circumference thereof, and a second annular sealing portion that is airtightly crimped to the outer peripheral surface of the drug vial on the bottom side of the cap body at least A cylindrical portion that covers the entire circumference of the drug vial from the annular seal portion to the second annular seal portion, and all outer surfaces of the assembly are sterilized by an electron beam, and a cap body and The gap between the outer peripheral surface of the drug vial and the stopper, and the portion sealed between the first annular seal portion and the second annular seal portion are not sterilized by an electron beam.

Another drug vial holding assembly of the present invention is an assembly in which a drug vial is held by a holding body, and the mouth of the drug vial is sealed by a stopper made of an elastic material. Further, the cap body is wound so as to cover at least an outer peripheral portion of the top surface of the stopper body to a constricted portion of the outer peripheral surface of the drug vial while leaving an uncovered portion on at least a part of the top surface of the stopper body. The sealed state of the plug body is maintained by the holding body, and the holding body has a first annular sealing portion that is hermetically pressure-bonded to the uncovered portion while leaving an exposed portion in at least a part of the uncovered portion, A second annular sealing portion that is airtightly pressure-bonded to the outer peripheral surface of the drug vial on the bottom side of the cap body, and at least the outside of the drug vial from the first annular sealing portion to the second annular sealing portion over the entire circumference. A cylindrical portion, and all outer surfaces of the assembly are sterilized by an electron beam, a gap between the cap body and the outer peripheral surface of the drug vial and the stopper body, and a first annular sealing portion. The portion sealed between the second annular sealing portions is not sterilized by an electron beam.

In the medical container of the present invention, the drug vial holding assembly sterilized by an electron beam, the solution container having a sealed connection port, and the stopper of the drug vial holding assembly are exposed. Means for hermetically sealing the space between the portion and the connection port of the dissolution liquid container to the outside, and a communication means for communicating the inside of the drug vial with the inside of the dissolution liquid container in the space sealed by the sealing means. Be equipped with.

Next, in the method for manufacturing a drug vial holding assembly according to the present invention, the mouth is sealed with a stopper made of an elastic material, and the stopper is left with an exposed portion on at least a part of the top surface of the stopper. The sealing state of the plug body is maintained by being tightened by the cap body so as to cover at least the outer peripheral portion of the top surface of the medicine bottle to the constricted portion of the outer peripheral surface of the drug vial, and the exposed portion of the cap body A method for manufacturing an assembly, in which a drug vial whose peripheral portion is airtightly bonded to the top surface of a stopper is held by a holder and the outer surface is sterilized, the first annular sealing portion of the holder. Is airtightly crimped to the cap body over the entire circumference outside the exposed portion, and the second annular sealing portion of the holding body is airtightly crimped over the outer peripheral surface of the drug vial on the bottom side of the cap body. Let , The tubular portion of the holder covers at least the outside of the drug vial from the first annular seal portion to the second annular seal portion over the entire circumference, thereby sealing between the first annular seal portion and the second annular seal portion. Holding the drug vial with the holding body in the above state, and sterilizing all the outer surface of the assembly in which the drug vial is held with the holding body with an electron beam, the outer periphery of the cap body and the drug vial. The gap between the surface and the plug, and the portion sealed between the first annular sealing portion and the second annular sealing portion are not sterilized by an electron beam.

Further, according to another method for manufacturing a drug vial holding assembly of the present invention, the mouth is sealed with a stopper made of an elastic material, and an uncoated portion is provided on at least a part of the top surface of the stopper. The drug vial in which the sealed state of the stopper body is maintained by being wound around the cap body so as to cover at least the outer peripheral portion of the top surface of the stopper body to the constricted portion of the outer peripheral surface of the drug vial is a holding body. And a first annular sealing portion of the holding body, the outer surface of which is sterilized, and the outer surface of the holding body is sterilized. Airtightly crimp,
The second annular sealing portion of the holding body is airtightly pressure-bonded to the outer peripheral surface of the drug vial on the bottom side of the cap body over the entire circumference, and the tubular portion of the holding body allows at least the second annular sealing portion from the second annular sealing portion. A step of holding the drug vial by a holding body in a state where a space between the first annular seal part and the second annular seal part is sealed by covering the outside of the drug vial reaching the annular seal part over the entire circumference; Sterilizing all outer surfaces of the assembly held by the body with an electron beam, the gap between the cap body and the outer peripheral surface of the drug vial and the stopper body, and the first annular sealing portion and the second annular shape. The portion sealed between the sealing portions is not subjected to electron beam sterilization.

Furthermore, the drug vial of the present invention is a drug vial whose mouth is sealed with a stopper made of an elastic material, and a radiation resistant resin composition layer is laminated on the surface of the exposed portion of the stopper. It was done.

Further, another drug vial of the present invention has a radiation resistant resin composition layer laminated on the outer surface thereof.

In the present specification, sterilization means that a sterilization rate of a sterilization assurance level of 6D value (10 ⁻⁶ ) can be guaranteed. D value (decimal reduction va
lue) is a value that reduces the number of microorganisms existing before sterilization to 1/10 after sterilization, in other words, the number of microorganisms is 9
It is a sterilization unit (absorption dose) required to kill 0%.

Since the electron beam is a kind of radiation, Bacillus pumi which is an indigenous bacterium showing the strongest resistance to radiation is used as an indicator bacterium for observing the bactericidal effect.
lus (spores) is used. The D value of this indicator bacterium is 1.7 kGy. For example, if the number of viable bacteria adhering to one product before sterilization is 10 ² , it can be sterilized by 1.7 kGy × (2 + 6) = 1
An absorbed dose of 3.6 kGy is required.

However, this is an absorbed dose that guarantees a 6D value for the indicator bacteria adhering to the surface. For example, in the case of an ordinary drug vial, a 6D value can be guaranteed for the indicator bacteria attached to the surface of microorganisms attached to the inside of a slight gap between the aluminum cap, the rubber stopper and the outer surface of the vial. It was found that the bacteria cannot be sterilized by irradiating the absorbed dose from above and below the drug vial. The absorbed dose for guaranteeing the 6D value for the top surface portion of the rubber stopper including the portion covered with the aluminum cap is 300 kGy at the acceleration voltage value of 250 kV, and the rubber stopper used for a usual drug vial melts.

Even in the assembly in which the drug vial of the present invention is held by the holding body, a portion or a gap where the electron beam is not directly irradiated is generated, and an indicator bacterium attached to the surface of such a portion is also used. In order to ensure the 6D value, it is necessary to make the acceleration voltage value relatively high and the absorbed dose relatively large. The preferred ranges of absorbed dose and accelerating voltage for the object to be sterilized in the present invention are 50 kGy to 500 kGy and 150 kV to 5 respectively.
It is MV. This is because the outer surface of the drug vial and the drug vial holding assembly can be sterilized while sufficiently avoiding the penetration of the electron beam into the drug vial.
A more preferable range is that the absorbed dose is 250 kGy to 40
The acceleration voltage is 0 kGy, and is 150 kV to 500 kV as a range in which X-ray shielding can be performed by the apparatus itself.

When the surface of a drug vial sealed with a stopper made of an elastic material such as rubber is irradiated with an electron beam, the top surface of the stopper is punctured (covered by the cap and the first annular elastic portion). The exposed portion that is not exposed and is to be punctured by the hollow needle in order to lead out the drug inside) may be deteriorated by the electron beam. The deterioration state of the puncture portion depends on the absorbed dose and the acceleration voltage value, but if the deterioration is severe, the puncture portion on the top surface of the plug may also melt. Therefore, as in the case where the radiation-resistant resin composition is laminated on the top surface of the stopper or the radiation-resistant medical rubber parts described in JP-A-62-176455, the stopper itself is not resistant to radiation. It is desired to use a material formed of an elastic material.

Examples of elastic materials that can be used to form the plug of the present invention include natural rubber, isoprene rubber,
Examples thereof include crosslinked rubbery elastic materials such as butadiene rubber, styrene-butadiene rubber, isobutylene / isoprene copolymer, halogenated rubber, and thermoplastic elastomer.

In order to form the plug according to the present invention by laminating the radiation resistant resin composition on the surface of the plug made of a crosslinked rubber-like elastic material, a thin film of polyethylene resin or polypropylene resin having radiation resistance is formed as thin as possible. Is preferably laminated, or polystyrene rubber is preferably laminated. When the resin film is laminated, if it is too thick, it may be difficult to puncture the stopper if the hollow needle for drawing out the drug inside the vial is made of synthetic resin. Further, when a thin film of a resin having low radiation resistance is laminated, the thin layer may be crosslinked or deteriorated by electron beam irradiation. Since the resin strength of the crosslinked product increases, it may be difficult to puncture the plug when the hollow needle is made of synthetic resin. Further, when the deterioration progresses, there is a risk that the thin layer will be peeled off when the hollow needle is punctured into the stopper, and will be mixed as a foreign substance in the drug vial.

For laminating the resin film on the surface of the crosslinked rubber-like elastic body, for example, known techniques as listed below can be used. That is, a technique for laminating a polypropylene film on a vulcanized rubber (Jpn.
51, 44-27753), a plug formed by coating the entire surface with a fluororesin having excellent characteristics (Jitsuko Sho 45-1).
No. 7831), a rubber stopper in which the chemical liquid surface is wrapped with trifluoroethylene resin (Japanese Utility Model Publication No. Sho 49-21246), and a method for manufacturing a rubber stopper in which the surface of the rubber stopper, especially the chemical liquid surface is laminated with a fluororesin film (special Japanese Patent Publication No. 52-1355, 54
No. 9119, No. 57-53184, JP-A No. 61-272134, and JP-A No. 2-23961), a rubber stopper formed by laminating fluororubber on an isobutylene / isoprene copolymer (Japanese Patent Publication No. 63-63). -4310,
Japanese Utility Model Laid-Open No. 55-47850), a rubber plug whose surface is wrapped with an ultra-high molecular weight polyethylene sheet (JP-A-3-14344).
6, gazette 3-270928 gazette, and 3-9632 gazette.
No. 8) and the like.

A drug vial means a drug contained in a vial.

In order to laminate a radiation-resistant resin composition layer made of polyethylene resin or polypropylene resin having radiation resistance on the outer surface of a drug vial, for example, a method of applying a polymer liquid on the outer surface of a glass bottle (special Kaisho 5
No. 3-49586), a method of treating the surface of a glass bottle with an aqueous solution of a fluoride that corrodes glass, and then performing plastic coating (JP-A-54-54124), and glass bottle plastic coating by electrostatic powder coating. Mouth protection method in JP-A-54-11
A known technique such as Japanese Patent No. 3639) can be used.

[0036]

In the first and second aspects of the invention, it is difficult to sterilize the gap between the cap body, the outer peripheral surface of the drug vial and the stopper body by the electron beam.

However, according to the first aspect of the invention, the peripheral portion of the exposed portion of the cap body is airtightly pressed against the top surface of the plug body, and the first annular sealing portion of the holding body is entirely surrounded outside the exposed portion. Airtightly crimping to the cap body over the entire circumference of the outer peripheral surface of the drug vial on the bottom side of the cap body with the second annular sealing portion of the holding body,
Since the tubular portion of the holding body covers at least the outside of the drug vial extending from the first annular seal portion to the second annular seal portion over the entire circumference, the gap is sealed to the outside and the inside of the drug vial. Has become. Therefore, when the entire outer surface of the assembly is sterilized by the electron beam, it is not necessary to sterilize the gap and the portion sealed between the first annular seal portion and the second annular seal portion.

Further, in the invention of claim 2, the first annular sealing portion of the holding body is airtightly pressure-bonded to the uncoated portion of the stopper, leaving an exposed portion in at least part of the uncoated portion,
The second annular sealing portion of the holding body is airtightly pressure-bonded to the outer peripheral surface of the drug vial on the bottom side of the cap body over the entire circumference, and the tubular portion of the holding body is at least the first annular sealing portion to the second annular sealing portion. Since the outside of the drug vial up to the above is completely covered, the gap is in a sealed state with respect to the outside and the inside of the drug vial. Therefore, when the entire outer surface of the assembly is sterilized by the electron beam, it is not necessary to sterilize the gap and the portion sealed between the first annular seal portion and the second annular seal portion.

According to the third aspect of the present invention, when the medical container is manufactured in a sterilized state, at least all the outer surfaces of the drug vial holding assembly should be such that the drug vial is held by the holding body. It can be easily sterilized by electron beam. If the inside of the drug vial and the inside of the solution container are communicated by the communication means in the space sealed by the sealing means in the sterilized medical container, the drug in the drug vial can be kept in the solution container while maintaining the sterility. Can be mixed with the lysate.

In the fourth aspect of the present invention, it is difficult to sterilize the gap between the cap body, the outer peripheral surface of the drug vial and the stopper body by the electron beam.

However, the peripheral portion of the exposed portion of the cap body is airtightly pressure-bonded to the top surface of the stopper body, and therefore the first annular sealing portion of the holding body is entirely surrounded outside the exposed portion. Airtightly crimping the cap body over the entire circumference of the second annular sealing portion of the holding body to the outer peripheral surface of the drug vial on the bottom side of the cap body, and by the tubular portion of the holding body. , A drug vial with a holding body covering at least the outside of the drug vial from the first annular seal part to the second annular seal part over the entire circumference so that the first annular seal part and the second annular seal part are sealed. By holding the gap, the gap is sealed to the outside and the inside of the drug vial.

Therefore, it is not necessary to sterilize the gap and the portion sealed between the first annular sealing portion and the second annular sealing portion. Therefore, sufficient sterilization can be achieved by electron beam sterilization of all outer surfaces of the assembly.

In the fifth aspect of the present invention, it is difficult to sterilize the gap between the cap body, the outer peripheral surface of the drug vial and the stopper body by the electron beam.

However, the first annular sealing portion of the holder is airtightly pressure-bonded to the uncovered portion of the stopper, leaving an exposed portion in at least part of the uncovered portion of the stopper, and the second annular seal portion of the holder. Is airtightly pressure-bonded to the outer peripheral surface of the drug vial on the bottom side of the cap body over the entire circumference, and the tubular portion of the holding body causes at least the first annular sealing portion to reach the second annular sealing portion of the drug vial. By holding the drug vial by the holding body in a state where the first annular sealing part and the second annular sealing part are sealed by covering the entire circumference, the gap is sealed to the outside and the inside of the drug vial. It will be in the state of being.

Therefore, it is not necessary to sterilize the gap and the portion sealed between the first annular sealing portion and the second annular sealing portion. Therefore, sufficient sterilization can be achieved by electron beam sterilization of all outer surfaces of the assembly.

In the invention of claim 6, since the radiation resistant resin composition layer is laminated on the surface of the exposed portion of the stopper made of an elastic material which seals the mouth of the drug vial, the layer is sealed by the stopper. The radiation-resistant resin composition layer prevents deterioration of the plug when the drug vial is irradiated with an electron beam, and the radiation-resistant resin composition layer itself is deteriorated or strength is increased by crosslinking. Too much is prevented.

In the invention of claim 7, since the radiation resistant resin composition layer is laminated on the outer surface, even if the outer surface of the drug vial whose mouth is sealed with a stopper is irradiated with an electron beam, The radiation resistant resin composition layer prevents the drug vial from discoloring or coloring.

[0048]

Embodiments of the present invention will be described with reference to the drawings.

1 and 2 show a drug vial holding assembly as an embodiment of the present invention, in which FIG. 1 is a partially crushed assembly view, and FIG. 2 is a drug showing an electron beam irradiation state. It is a partially crushed front view of a vial holding assembly.

The drug vial 10 is a glass vial containing a drug (a powder formulation, a solid formulation such as a freeze-drying agent, and other formulations). The outer peripheral portion of the vial 10 continues from the outer peripheral portion of the mouth portion to the bottom portion through the constricted portion 10a, the shoulder portion, and the body portion, and has a substantially rotationally symmetrical shape about the vertical axis in FIG. On the outer surface of the vial 10, a thin layer made of polypropylene resin having radiation resistance is laminated.

The mouth of the vial 10 is sealed by a plug 12 made of an elastic material (eg isoprene rubber). The plug 12 includes a fitting portion 12a that fits in the mouth portion,
Disc-shaped portion 1 that projects radially outward from the fitting portion 12a
It consists of 2b. On the top surface of the stopper 12, a thin layer 12c made of polypropylene resin having radiation resistance is laminated.

The cap body 14 made of aluminum leaves the central portion of the top surface of the plug body 12 as an exposed portion 12d, and
2 is wound so as to cover a portion from the outer peripheral portion of the top surface of the second via the side peripheral surface of the disk-shaped portion 12b to the constricted portion 10a of the outer peripheral surface of the drug vial 10, thereby maintaining the sealed state of the stopper 12. Has been done. The peripheral edge of the opening 14a of the cap body 14 for exposing the exposed portion 12d of the plug body 12 is bent toward the plug body 12 side over the entire circumference, and is airtight in a state that it bites into the top surface of the plug body 12. Is crimped.

The holding member 16 has a tubular portion 18 and an elastic annular plate 20 which has an annular shape which substantially coincides with the top surface of the cap member 14.
(First annular sealing portion), inner annular packing 22 (second annular sealing portion), two outer annular packings 24 and 26,
It comprises a flange portion 28 and a pair of collar portions 30. Tubular part 1
The material of 8, flange portion 28 and collar portion 30 is preferably hard plastic or rubber. The material of the elastic annular plate 20, the inner annular packing 22, and the outer annular packings 24 and 26 is preferably a rubber-like elastic material such as silicon rubber, butadiene rubber or isoprene rubber.

The tubular portion 18 has an annular bottom portion 18a having an opening portion which substantially coincides with the opening portion 14a of the cap body 14 at the lower end in FIGS. 1 and 2, and an outer peripheral portion of the cap body 14 on the upper side thereof. It has a small diameter portion 18b which is fitted on the outside and holds the neck portion of the drug vial 10, and the enlarged diameter portion 18b is provided above the small diameter portion 18b.
It has a large diameter portion 18d sandwiching c.

An elastic annular plate 20 is bonded to the upper surface of the annular bottom portion 18a in FIGS. 1 and 2 coaxially with the annular bottom portion 18a. A flange portion 28 is provided on the outer periphery of the upper portion of the small diameter portion 18b, and the flange portion 28 has four ventilation holes 2 in the axial direction (vertical direction in FIGS. 1 and 2).
8a is provided. An outer annular packing 24 is attached to the outer peripheral portion of the flange portion 28. An inner annular packing 22 is attached to the lower inner peripheral portion of the large diameter portion 18d, and an outer annular packing 26 is attached concentrically to the outer peripheral portion of the large diameter portion 18d. Further, a pair of notches 18d1 of an upper opening are provided on the upper portion of the large diameter portion 18d, the pair of remaining portions 18d2 has an axial projection ridge 18d3 on the outer peripheral surface thereof, and a flange is provided at the upper end of the remaining portion 18d2. Part 30
Have.

When the drug vial 10 is fully inserted into the tubular portion 18 from the large-diameter portion 18d side of the holding body 16 with the mouth side as the leading end, as shown in FIG. Is almost exactly airtightly crimped to the upper side of the elastic annular plate 20, the outer peripheral portion of the cap body 14 is held inside the small diameter portion 18b, and the outer peripheral surface of the body portion of the vial 10 is entirely covered by the inner annular packing 22. The drug vial holding assembly 32 is completed by being held in a state of being hermetically crimped over the circumference.

As shown in FIG. 2, the outer surface of the drug vial holding assembly 32 is sterilized by an electron beam accelerating device 34 from both sides in the axial direction of the drug vial holding assembly 32 at the same time or sequentially on each side. , Drug vial holding assembly 32
On the other hand, it can be performed by uniformly irradiating the electron beam in the axial direction.

The gap between the cap body 14 and the outer peripheral surface of the drug vial 10 and the stopper body 12 is difficult to sterilize with an electron beam. However, the peripheral edge of the opening of the cap body 14 is airtightly pressure-bonded to the top surface of the plug body 12 over the entire circumference, and the inner annular packing 22 of the holding body 16 is entirely formed on the outer peripheral surface of the body portion of the drug vial 10. Airtightly crimp over the circumference,
The tubular portion 18 of the holding body 16 covers the outside of the drug vial 10 from the elastic annular plate 20 to the inner packing over the entire circumference. As described above, since the gap between the cap body 14 and the outer peripheral surface of the drug vial 10 and the stopper body 12 is in a sealed state with respect to the outside and the inside of the drug vial 10, it is necessary to sterilize the gap. There is no. Further, including the gap, the elastic annular plate 20 and the inner annular packing 22
It is not necessary to sterilize the part sealed between the two. Therefore, the drug vial 10, the stopper body 12, the cap body 14, and the holding body 16 cannot pass through, and the drug vial 10, the stopper body 1
2, the material of the cap body 14 and the holder 16 and the electron beam to the extent that the drug in the drug vial 10 is not deteriorated or deteriorated are irradiated as shown in FIG. The outer surface of the can be reliably sterilized. Since the radiation resistant polypropylene resin thin layer is laminated on the outer surface of the vial 10 and the top surface of the elastic stopper 12, the stopper 12 is deteriorated by an electron beam, and the vial 1
Discoloration or coloring of 0 is prevented. Flange 28
The outer surface of the portion shaded by the outer annular packings 24 and 26 is also sterilized by irradiating the electron beam from both axial directions of the drug vial holding assembly 32 so that the electron beam wraps around. In this way, all the outer surfaces were sterilized by the electron beam and sealed between the cap body 14 and the outer peripheral surface of the drug vial 10 and the stopper body 12, and between the elastic annular plate 20 and the inner annular packing 22. The part is a drug vial holding assembly 32 which has not been sterilized by an electron beam.
Can be obtained. After the drug vial 10 is held by the holder 16, it can be sterilized by an electron beam, which is more efficient than performing sterilization separately and aseptically assembling.

FIG. 3 is a partially fragmented front view showing an electron beam irradiation state of another embodiment of the drug vial holding assembly according to the present invention.

In this embodiment, instead of the elastic annular plate 20 in the embodiment of FIGS. 1 and 2, a bottomed cylindrical elastic body 36 having an annular bottom portion 36a which substantially coincides with the top surface of the cap body 14 is used. ing. That is, the annular bottom portion 36 a of the bottomed cylindrical elastic body 36 is bonded to the upper surface of the annular bottom portion 18 a of the tubular portion 18 coaxially with the annular bottom portion 18 a of the tubular portion 18, and the bottomed cylindrical elastic body 36 is provided. The outer peripheral surface of the peripheral wall 36b is bonded to the inner peripheral surface of the small diameter portion 18b of the holding body 16. The top surface of the cap body 14 of the drug vial 10 is airtightly and press-fitted substantially tightly to the upper side of the annular bottom portion 18a of the bottomed cylindrical elastic body 36, and the outer peripheral portion of the cap body 14 has a bottomed cylindrical elastic body 36. Since it is pressure-held inside the peripheral wall 36b, the outer peripheral portion of the cap body 14 is more strongly held. Therefore, the drug vial 10 is held by the holding body 16 in a state in which the gap between the cap body 14 and the outer peripheral surface of the drug vial 10 and the plug body 12 is sealed between the bottomed cylindrical elastic body 36 and the inner annular packing 22. But it becomes more certain. As the material of the bottomed cylindrical elastic body 36, the same material as that of the elastic annular plate 20 can be preferably used.

Except for the above, this embodiment is similar to FIG. 1 and FIG.
This is substantially the same as the embodiment described above. The common parts are given the same numbers and their explanations are omitted.

FIG. 4 is a partially fragmented front view showing an electron beam irradiation state of still another embodiment of the drug vial holding assembly according to the present invention.

In this embodiment, the cap body 38 has an opening 38a for leaving the central portion of the top surface of the plug 12 as an uncovered portion, and the peripheral portion of the opening 38a is a plug body. Although it is in contact with the top surface of No. 12, it is not particularly pressure-bonded.

The opening of the annular bottom portion 18a of the tubular portion 18 is
It is formed to be slightly smaller than the opening 38a of the cap body 38. An elastic annular plate 40 is adhered to the upper surface of the annular bottom portion 18a so that the inner peripheral edges thereof are substantially aligned with each other. The inner peripheral portion of the elastic annular plate 40 is erected toward the stopper 12 and is airtightly pressure-bonded to the top surface of the stopper 12 inward from the opening of the cap 38. In this way, the opening 38 a of the cap body 38
Even if is not air-tightly attached to the stopper 12, the gap between the cap 38, the outer peripheral surface of the drug vial 10 and the stopper 12 is sealed between the elastic annular plate 40 and the inner annular packing 22.

Except for the above, this embodiment is different from FIG. 1 and FIG.
This is substantially the same as the embodiment described above. The common parts are given the same numbers and their explanations are omitted.

5 to 8 show one embodiment of the medical container of the present invention. FIG. 5 is an exploded perspective view of a main part, and FIG. 6 is a partial crushing view showing a state before a communicating operation. 7 is a front view of a partial crushing essential portion showing a state during a communicating operation, and FIG. 8 is a front view of a partial crushing essential portion showing a state after completion of the communicating operation.

This medical container has a drug vial holding assembly 32 (shown in FIGS. 1 and 2 above) whose outer surfaces are all sterilized by an electron beam, a case 42, a double-ended needle 44, and It consists of a solution container 46.

A case 42 having a bottomed cylindrical shape has a flange portion at the upper end thereof, and a suspender 44 is rotatably connected to the upper portion of the outer wall. The upper annular groove 42a, the middle annular groove 42b, and the lower annular groove 4 which are radially inwardly opened at the upper portion, the intermediate portion, and the lower portion of the inner peripheral wall of the case 42 respectively over the entire circumference.
2c are provided, and small exhaust holes 47 that communicate the inside and outside of the case 42 are provided at two opposing positions in the middle annular groove 42b.
Is provided. On the lower side of the bottom of the case 42, there is a connecting pipe portion 48 provided with an annular fitting groove 48a of a downward opening, and the inside and outside of the case 42 are connected via the connecting pipe portion 48. A rubber plug 50 is fitted on the connecting pipe portion 48. The rubber plug 50 has a top plate portion 5 whose peripheral portion is raised upward.
0a and the cylindrical portion 50 provided upward on the top plate portion 50a.
The cylindrical portion 50b is fitted in the connecting pipe portion 48, and the peripheral edge portion is fitted in the inner peripheral portion of the annular fitting groove 48a. The material of the case 42 is preferably hard plastic or rubber.

The solution container 46 is a flexible container made of thermoplastic polyolefin resin, soft vinyl chloride resin, ethylene-vinyl acetate copolymer or the like.
The dissolution liquid container 46 has a thin film portion 52 at the upper portion in the drawing.
It has a connecting port portion 52 which is sealed by a and is surrounded by an annular fitting wall 52b. At the bottom of the solution container 46, there is a drug solution outlet (not shown) sealed with a rubber stopper, and the solution is filled inside. The annular fitting wall 52b has an annular protrusion 52b provided on the outer periphery of its upper portion.
1 is fitted in the annular fitting groove 48a in an airtight manner in a state of being fitted with the annular groove portion 48a1 of the radially inner opening which is provided in the upper outer peripheral portion of the annular fitting groove 48a of the case 42, and thereby the case 42 and The dissolution liquid container 46 is connected.

The double-ended needle 44 (communication means) has a piercing depth at the time of piercing the plug body 12 for sealing the mouth portion of the drug vial 10 at the middle portion of the hollow main body having sharp points at both ends. It has a hub 44a for keeping it constant. Several arms 44b that can be bent outward from the hub 44a in the radial direction are provided. By fitting the outer end of the arm portion 44b into the lower annular groove 42c of the case 42, the double-ended needle 44 is held coaxially with the case 42 at the lower portion inside the case 42. A portion of the double-ended needle 44 between the hub 44a and the lower end portion is expanded in diameter to form a liquid leakage prevention portion 44c, and is slidably fitted into the cylindrical portion 50b of the rubber stopper 50. There is. The material of the double-ended needle 44 is preferably stainless steel or hard plastic.

The drug vial holding assembly 32 is fitted and inserted into the case 42 with the annular bottom portion 18a at the top, and both outer annular packings 24 and 26 are fitted into the middle annular groove 42b and the upper annular groove 42a, respectively. The interior wall is sealed. By such a sealing means, the space between the holder 16 and the case 42 and the small exhaust hole 47 are closed, and the connection port portion 52 of the dissolution liquid container 46 connected to the connection pipe portion 48 of the case 42.
And the exposed portion 1 of the stopper 12 of the drug vial holding assembly 32.
2d is sealed to the outside to form an airtight space, and the drug vial holding assembly 3 is attached to the case 42.
2 is positioned. Drug vial holding assembly 32
Excessive gas such as air between the two when it is inserted into the case 42 is discharged to the outside through the small exhaust hole 47 before being closed by the outer annular packing 24. The double-ended needle 44
It is held in the hermetic space.

In this way, the medical container in the state shown in FIG. 6 is completed. After sterilizing the outer surfaces of the case 42, the double-ended needle 44, the rubber stopper 50, and the solution container 46 with an electron beam or the like, the sterilized drug vial holding assembly 32 is also combined to assemble them aseptically. In the state shown in (1), sterility in the airtight space is maintained, and transportation and storage are performed. Double-ended needle 4 at a predetermined position in the case 42
It is possible to sterilize all the surfaces including the inside of the double-ended needle 44 by irradiating the electron beam from both directions of the axial direction while holding 4 and sterilize them separately to assemble them aseptically. Is more efficient than When electron beam sterilization is performed, it is desirable that the case 42, the double-ended needle 44, or the like be formed of a radiation-resistant material or that the surface be laminated with a radiation-resistant material.

In order to communicate the insides of the drug vial 10 and the solution container 46 with each other, the bottom of the drug vial 10 is pressed downward. As a result, as shown in FIG. 7, both outer annular packings 24 and 26 are disengaged from the upper annular groove 42a and the middle annular groove 42b, respectively, and the airtightness between them and the inner wall of the case 42 is maintained. The entire drug vial holding assembly 32 is lowered toward the dissolution liquid container 46 while being maintained by 26. Accordingly, the case 42
Excess air such as air in the inner and lower portions is discharged to the outside of the case 42 through the ventilation hole 28a provided in the flange portion 28 of the holder 16 and the small exhaust hole 47 of the case 42. Therefore, the communication is smoothly performed without the lowering of the drug vial holding assembly 32 being hindered by the gas such as excess air. Therefore, excess gas such as air will not be discharged through the vent holes 28a as described above.
Also, since the air is unilaterally discharged through the small exhaust holes 47, the space inside the case 42 is not contaminated by outside air or the like.

Also, the upper part of the double-ended needle 44 is the drug vial 1
The double-ended needle 44 is pushed downward by the plug body 12 while piercing the exposed portion 12d of the plug body 12 of 0, the arm portion 44b is bent, and the outer end of the arm portion 44b is disengaged from the lower annular groove 42c of the case 42. The leak prevention portion 44c slides in the cylindrical portion 50b of the rubber stopper 50, and the lower portion of the double-ended needle 44 punctures the top plate portion 50a and the thin film portion 52a of the rubber stopper 50.

The drug vial holding assembly 32 is attached to the case 42.
When completely pushed down inside, as shown in FIG. 8, the upper and lower portions of the double-ended needle 44 are completely pierced into the drug vial 10 and the solution container 46, respectively, and the insides of both are communicated by the double-ended needle 44. It Further, since both outer annular packings 24 and 26 are fitted in the lower annular groove 42c and the middle annular groove 42b, respectively, and the small exhaust holes 47 are closed, the lower portion of the case 42 is resealed and the drug vial holding assembly is attached. The solid 32 is held at that position in the case 42. At that time, the protrusion 18d3 of the holder 16 is pushed inward by the inner wall surface of the case 42, and the pair of remaining portions 18d2 hold the drug vial 10 inward.

After the drug vial 10 and the inside of the solution container 46 are communicated with each other, they are leveled or the solution container 46 is lifted above the drug vial 10 and the wall surface of the solution container 46 is pressed. The solution is transferred into the drug vial 10 to dissolve the drug. After completely dissolving the drug, the solution is returned to the solution container 46, the suspending tool 44 is hung on the hook of the infusion stand, the infusion set is attached to the drug solution outlet port 54 of the solution container 46, and the patient is drip instilled. Note. Of course, other usage methods can also be implemented.

After using the medical container of this embodiment, the drug vial holding assembly 32 is attached to the case 4 by the collar portion 30.
2 can be taken out. From the drug vial holding assembly 32 that has been taken out, the body of the drug vial 10 exposed from the cutout portion 18d1 is grasped and the drug vial 10 is held.
Can be taken out from the holder 16.

[Electron beam sterilization confirmation test] 1. Preparation of culture vessel (FIG. 9) One opening of the cylindrical body 80 made of polypropylene is about 20.
A culture container was prepared by sealing with a nylon resin film 82 (having a high electron beam transparency) having a thickness of μm. Adhesion of the nylon resin film 82 to one end of the cylindrical body 80 was performed using a vinyl chloride adhesive.

Among the objects of the sterilization test, a is a vial in which the peripheral portion of the opening of the aluminum cap body is in contact with the top surface of the stopper body, but is not pressure-bonded particularly in an airtight manner, b is a vial in which the peripheral edge portion of the opening of the aluminum cap body is bent toward the stopper body over the entire circumference and is hermetically pressure-bonded to the top surface of the stopper body in a biting state, c
Is a holding body, d is a vial holding assembly holding the vial by the holding body, e is a holding head with a double-ended needle at a predetermined position in the case, f is a rubber stopper, and g is a melter. It is a cut on the side of the connection port portion 52 of the liquid container 46.

Each object, the cylindrical body 80, the nylon resin film 84 having a thickness of about 20 μm for sealing the other end of the cylindrical body 80, and the sealing tape described later are irradiated with 25 kGy of γ-rays. Was sterilized and the initial number of bacteria was set to 0. 2. Preparation of bacterial solution (stock solution) Bacillus pumilus was mass-cultured on SCD agar medium (7 days), and sporophyte (spore)
s) was formed.

A certain amount of the cultivated cells in a large amount was suspended in sterilized distilled water and heated at 65 ° C. for 30 minutes,
After centrifugation, the supernatant was discarded.

After repeating the operation 3 times, sterile distilled water was added and the mixture was heated at 65 ° C. for 30 minutes, and the number of bacteria in this solution was confirmed (SCD medium: 3 days), which was used as a bacterial stock solution. 3. Sample preparation (attachment of bacterial cells) Dilute the bacterial stock solution with sterile distilled water to 1000 cells / 50μ
A bacterial solution having a bacterial concentration of 1 was prepared.

In the clean bench, 50 μl of the bacterial solution for each object was applied (the number of adherent bacteria: about 1000).

After the applied bacterial solution is dried, each object is housed in each culture container so that its axis is parallel to the axis of the cylindrical body 80, and the other opening of the culture container is opened. A sample was prepared by sealing with the nylon resin film 84 using a vinyl chloride adhesive. 4. Electron Beam Irradiation An electron beam accelerating device 86 was used to irradiate the sample with an electron beam giving the absorbed dose shown in the same table at the accelerating voltage value shown in Table 1 in this order from above and below in the axial direction. (FIG. 9). 5. Sterilization test After sterilizing the outer surface of the culture vessel with a bactericide, put it in a sterile room (class 1000), and in a clean bench in the sterile room, use a connecting pipe for infusion into a culture medium in a liquid medium (thioglycolic acid medium). ) Was aseptically filled, and after filling, the filling hole was closed with the above-mentioned sterilized paper tape.

This was cultured in an incubator at 30 ° C. for 3 days, and when it became cloudy (+), when the color of the medium was the same as when it was filled, it was judged as (−). In Table 1, it was described as (-) only when all (-) was repeated three times under the same condition, and as (+) otherwise.

[0086]

[Table 1]

[0087]

In the drug vial holding assembly according to claims 1 and 2, it is difficult to perform electron beam sterilization, and the gap between the cap body and the outer peripheral surface of the drug vial and the plug body, and the first aspect.
It is not necessary to sterilize the portion sealed between the annular sealing portion and the second annular sealing portion. Therefore, the entire outer surface of the assembly can be reliably sterilized with an electron beam that does not cause deterioration or alteration of the materials of the drug vial, stopper, cap and holder, and the drug. Since the assembly holding the drug vial by the holder can be easily sterilized by an electron beam, the sterilization process can be performed once compared with the case where the drug vial and the holder are sterilized individually. Not only can it be carried out, but also the assembly process of both in a clean room after sterilization can be omitted, and as a whole, extremely sterilized and reliable sterilization can be performed.

In the medical container according to the third aspect, at least at all outer surfaces of the drug vial holding assembly, after the drug vial is held by the holder to form an assembly, deterioration or deterioration of each material or drug is prevented. It is possible to surely sterilize with an electron beam that does not occur. Therefore, it is possible to efficiently manufacture the medical container in a sterilized state.

According to the manufacturing method of the drug vial holding assembly of claims 4 and 5, by holding the drug vial by the holding body, the gap between the cap body and the outer peripheral surface of the drug vial and the plug body is external. Further, since the inside of the drug vial is sealed, it is not necessary to sterilize the gap and the portion sealed between the first annular seal portion and the second annular seal portion. Therefore, after the drug vial is held by the holder to form an assembly, all the outer surfaces of the drug vial are sterilized with an electron beam that does not cause deterioration or deterioration of each drug or drug, so that the drug is sufficiently sterilized. The vial holding assembly can be reliably and efficiently manufactured.

In the drug vial of claim 6, even if the outer surface of the drug vial whose mouth is sealed by the plug is irradiated with an electron beam, the plug is deteriorated by the radiation resistant resin composition layer. To be prevented. Also, the radiation-resistant resin composition layer itself is prevented from deteriorating and peeling off the layer, or cross-linking to prevent excessive increase in strength, so that when a hollow needle for drug delivery is pierced into the stopper, It is possible to avoid the risk of the exfoliated substance entering the drug vial as a foreign substance and the difficulty of puncturing the hollow needle. Therefore, it is suitable for efficiently sterilizing the outer surface of the drug vial whose mouth is sealed by the stopper using the electron beam. The same applies to a cap that is wound around with a cap while leaving an exposed portion on at least a part of the top surface of the plug, or a drug vial held by a holder.

In the drug vial of claim 7, when the outer surface of the drug vial is irradiated with an electron beam, the radiation resistant resin composition layer prevents the drug vial from being discolored or colored. It is suitable for efficiently sterilizing the outer surface of a drug vial sealed with a stopper using an electron beam. The same applies to the case in which the cap body is wound up and the medicine vial is held in the holding body.

[Brief description of drawings]

FIG. 1 is a partially crushed assembly view of a drug vial holding assembly.

FIG. 2 is a partially fragmented front view of the drug vial holding assembly showing an electron beam irradiation state.

FIG. 3 is a partially fragmented front view showing an electron beam irradiation state of another example.

FIG. 4 is a partially fragmented front view showing an electron beam irradiation state of yet another example.

FIG. 5 is an exploded perspective view of essential parts of the medical container.

FIG. 6 is a front view of a partial crushing essential part showing a state before a communicating operation of the medical container.

FIG. 7 is a front view of a partial crushing essential part showing a state during a communication operation of the medical container.

FIG. 8 is a partially fragmentary front view showing a state after completion of the communication operation of the medical container.

FIG. 9 is an explanatory diagram of an electron beam sterilization confirmation test.

[Description of sign]

 10 vial 12 elastic plug body 14 cap body 16 holding body 18 tubular portion 18a annular bottom portion 18b small diameter portion 18d large diameter portion 20 elastic annular plate 22 inner annular packing 42 case 44 double-headed needle 46 dissolution liquid container 48 connecting pipe portion 50 rubber portion 52 Connection port

Front Page Continuation (72) Inventor Taro Takei, 1-1 Irisatoyama-cho, Gyoda-shi, Saitama Iwasaki Electric Co., Ltd. Saitama Factory

Claims (7)

[Claims] 1. An assembly in which a drug vial is held by a holding body, wherein the drug vial has a mouth portion sealed by a stopper body made of an elastic material, and at least a part of a top surface of the stopper body. The sealed state of the stopper body is maintained by being tightened by the cap body so as to cover at least the outer peripheral portion of the top surface of the stopper body to the constricted portion of the outer peripheral surface of the drug vial, leaving the exposed portion, and A peripheral portion of the exposed portion of the cap body is airtightly pressure-bonded to the top surface of the plug body, and the holding body is airtightly pressure-bonded to the cap body over the entire circumference outside the exposed portion. An annular sealing part, a second annular sealing part that is airtightly pressure-bonded to the outer peripheral surface of the drug vial on the bottom side of the cap body over the entire circumference, and a drug vial extending from at least the first annular sealing part to the second annular sealing part. And a cylindrical portion covering the entire circumference of the assembly, all outer surfaces of the assembly are sterilized by an electron beam, and a gap between the cap body and the outer peripheral surface of the drug vial and the stopper body, and The sealed portion between the first annular sealing portion and the second annular sealing portion is a drug vial holding assembly which is not sterilized by an electron beam. 2. An assembly in which a drug vial is held by a holding body, the mouth of the drug vial being sealed by a stopper made of an elastic material, and at least one of the top surfaces of the stopper. The sealing state of the stopper is maintained by being tightened by the cap body so as to cover at least the outer peripheral portion of the top surface of the stopper body to the constricted portion of the outer peripheral surface of the drug vial while leaving the uncoated portion in the portion. The holding body includes a first annular sealing portion that is hermetically pressure-bonded to the uncoated portion while leaving an exposed portion in at least a part of the uncoated portion, and an outer periphery of the drug vial on the bottom side of the cap body. A second annular sealing portion that is airtightly pressure-bonded to the surface, and a tubular portion that covers at least the outside of the drug vial from the first annular sealing portion to the second annular sealing portion over the entire circumference. , All of the assembly The surface is sterilized by electron beam, and the gap between the cap body, the outer peripheral surface of the drug vial and the stopper body, and the portion sealed between the first annular seal portion and the second annular seal portion are sterilized by electron beam. Unfilled drug vial holding assembly. 3. The drug vial holding assembly according to claim 2, a solution container having a sealed connection port, an exposed portion of the stopper of the drug vial holding assembly, and a connection port part of the solution container. A medical container comprising a sealing means for sealing the space to the outside and a communication means for communicating the inside of the drug vial with the inside of the solution container in the space sealed by the sealing means. 4. A stopper body made of an elastic material is used to seal the mouth portion, and an outer peripheral surface of the drug vial is constricted from at least the outer peripheral portion of the top surface of the stopper body, leaving an exposed portion on at least a part of the ceiling surface. The cap body is maintained in a sealed state by being tightened by the cap body so as to cover the portion reaching the cap portion, and the peripheral portion of the exposed portion of the cap body is airtightly crimped to the top surface of the cap body. A method for manufacturing an assembly in which the held drug vial is held by a holding body and the outer surface is sterilized, wherein the first annular sealing portion of the holding body covers the entire circumference outside the exposed portion. To the outer peripheral surface of the drug vial on the bottom side of the cap body over the entire circumference, and at least by the tubular portion of the holding body. 1 annular seal A step of holding the drug vial by a holding body in a state where a space between the first annular seal part and the second annular seal part is sealed by covering the outside of the drug vial from the second annular seal part to the second annular seal part; Sterilizing all outer surfaces of the assembly in which the vial is held by a holding body with an electron beam, and a gap between the cap body and the outer peripheral surface of the drug vial and the stopper body, and a first annular sealing portion. A method for manufacturing a drug vial holding assembly, wherein a portion sealed between the second annular sealing portions is not sterilized by an electron beam. 5. The outer periphery of the drug vial is sealed from the outer peripheral portion of the top surface of the stopper body while leaving the uncovered portion on at least a part of the top surface of the stopper body by sealing the mouth portion with the stopper body made of an elastic material. Manufacture of an assembly in which the vial is held by the holding body and the outer surface is sterilized by being wound by the cap body so as to cover the constricted part of the surface and the sealed state of the stopper body is maintained. A method, wherein the first annular sealing portion of the holding body is airtightly pressure-bonded to the uncoated portion leaving an exposed portion in at least a part of the uncoated portion, and the second annular sealing portion of the holding body is formed. The drug vial is pressure-bonded to the outer peripheral surface of the drug vial on the bottom side of the cap body over the entire circumference, and the tubular part of the holder at least extends from the first annular sealing part to the second annular sealing part of the outside of the drug vial. Covers the entire circumference The step of holding the drug vial by the holding body in a state where the space between the first annular sealing portion and the second annular sealing portion is sealed, and all outer surfaces of the assembly in which the drug vial is held by the holding body. And a step of sterilizing with an electron beam, wherein the gap between the cap body and the outer peripheral surface of the drug vial and the stopper body, and the portion sealed between the first annular seal portion and the second annular seal portion are exposed to the electron beam. A method of manufacturing a drug vial holding assembly, characterized in that sterilization is not performed. 6. A drug vial having a mouth sealed with a stopper made of an elastic material, wherein a radiation resistant resin composition layer is laminated on a surface of an exposed portion of the stopper. Drug vial. 7. A drug vial having a radiation resistant resin composition layer laminated on the outer surface thereof.