JPH11137636A - Production of medical container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a process for producing a medical container which allows the sterile and simple connection of a medicine housing device, etc., to the cylindrical part of the container without the execution of retransfer, filling, etc., of a medicine. SOLUTION: This process for producing the medical container 1 consists in forming an adhesive region 3 formed by thermal welding of the inside walls of the cylindrical part 2 peelably to each other in part of the flat cylindrical part 2 formed of a flexible resin wall, forming through-holes 4 in the adhesive region 3, adhering a resin sealing cap 5 to the outside wall surface of the adhesive region 3 to hermetically cover one of the through-holes 4 and adhering the medicine housing device 6 made of a resin to the other outside wall surface of the adhesive region 3, thereby hermetically connecting the same to the other of the through-holes 4.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for manufacturing a medical container, and more particularly, to aseptically and simply connecting a container for aseptically filled medicine to an ordinary plastic infusion container or the like. The present invention relates to a method for manufacturing a medical container that can be used. In addition, easily deteriorated by moisture or oxygen,
The present invention relates to a method for manufacturing a medical container capable of sufficiently protecting an easily-altered drug from discoloration during the preservation period when the easily-altered drug that changes color is stored in a medicine container.

[0002]

2. Description of the Related Art In general, medical containers include infusion containers and the like, which are used for separating easily degenerate drugs such as antibiotics and liquids for dissolving the drugs, and aseptically mixing them when used. For example, a peelable sealing strip is formed on the body of the container, and the inside of the container is divided into two chambers, one containing an antibiotic and the other containing a lysing solution. (JP-A-4-364850, JP-A-4-364851, JP-A-6-149)
No. 75). Since freeze-dried products such as antibiotics dislike water and oxygen, only the room for containing antibiotics is packaged with a moisture or gas barrier packaging material.

[0003]

Conventionally, when a dry drug such as an antibiotic is put in one storage chamber of a container, the drug is exposed to the outside and the freeze-dried container is transferred to one chamber of the infusion container. This is done by transfer work. Further, the barrier wrapping material completely covers the entire room. SUMMARY OF THE INVENTION The present invention provides a method for manufacturing a medical container capable of easily and aseptically connecting a medicine container or the like to a body of a container without performing transfer filling of the medicine. In addition, in order to prevent the deterioration of easily deteriorated drugs, only a part of the container or the trunk is covered with a cover to make the drying space or oxygen elimination space as small as possible to maintain the function of the desiccant and oxygen scavenger for a long time. It is intended to provide a method for producing a medical container that can be made to work.

[0004]

According to the present invention, an adhesive region is formed on a part of a flat body formed of a flexible resin wall by heat welding so that inner walls of the body can be separated from each other. Then, a through hole is formed in the bonding region, and a resin sealing lid is bonded to one outer wall surface of the bonding region to airtightly cover one of the through holes and to the other outer wall surface of the bonding region. Another object of the present invention is to provide a method of manufacturing a medical container characterized in that a resin container made of resin is bonded to the other of the through holes in an airtight manner by bonding.

In the method for manufacturing a medical container according to the present invention, the body is made of a flexible resin wall and is formed flat. For this reason, the container body is made of blown film,
It is formed from tubes, sheets and films, extruded, injection-molded or blow-molded. Polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin,
It is a general-purpose resin such as a polyvinyl alcohol-based resin, a polyacrylonitrile-based resin, a polyacrylic acid-based resin, and a polyamide-based resin. Further, the resin container may be formed in a single layer or a multilayer. The innermost layer that comes into contact with the drug in the container is preferably a resin layer that does not affect the drug and does not generate elutes. As such a resin, a polyolefin-based resin is desirable, and examples thereof include low olefin resins such as low-, medium-, and high-density polyethylene and polypropylene, cyclic polyolefins, and copolymers of two or more of these.

In the method for manufacturing a medical container according to the present invention,
An adhesive region is formed in a part of the body portion so that the inner wall surfaces are heat-welded so as to be peelable from each other. The area of the bonding region may be any area as long as the through hole can be formed and the peelable bonding region exists around the through hole. The bonding area partitions the inside of the body, and the inside of the container, to which the bonding area is peeled off and attached, is used to communicate with the inside of the body during use. Examples of the bonding region include bonding by external heating such as heat sealing and impulse sealing, and bonding by internal heating such as ultrasonic bonding and high-frequency bonding. The bonding area is a peelable seal portion. The peelable seal portion is usually called a peel seal portion or a weak seal portion, and a seal portion which can be peeled off when a chamber or a container is pressed from the outside and the inside thereof is brought into a constant pressure rising state, or a container outer wall. It is a seal or the like that can be peeled off when each is gripped and pulled. The peel strength of the peel seal portion is desirably such that the pressure in the body portion is peeled at a pressure of 0.01 to 1.0 kgf / cm ² , particularly 0.05 to 0.5 kgf / cm ² . If the strength is lower than the above range, the safety for maintaining an isolated state at the time of production, transportation, storage and the like is lacking. If the strength exceeds the above range, the communication operation may not be easily performed at the time of use.

When the peelable seal portion is formed by thermal welding, it is desirable that the innermost layer of the container or the like is a blend of different resins. In particular, different resins are hot melt onset temperature,
Alternatively, it is desirable to use a resin blend having a different picad softening point and little compatibility. By having such a blended material layer, it is possible to easily set the sealing temperature conditions for peel seal bonding. Seal strength required for peel seal adhesion, that is, easy peelability due to external force during use,
The relationship with the seal strength that does not cause peeling during storage can be strictly set. When a resin having different compatibility is melt-mixed in the inner layer and formed into a sheet, the inner layer surface can be microscopically separated into portions having different thermal adhesiveness. Then, by determining the thermal fusibility of the microscopic portion between the surfaces of the sheet at an arbitrary temperature, the strength of the sealing strength is accurately provided, and the above-mentioned effect is easily achieved.

In the method for manufacturing a medical container according to the present invention, a through-hole is formed in the bonding area. The through-hole may be formed before the formation of the above-mentioned bonding region. The through hole can be easily formed with a punch or the like. After forming the bonding area and the through-hole, one of the through-holes is airtightly covered by bonding a resin sealing lid to one outer wall surface of the bonding area.
The seal lid may be a thin film or sheet, or may be a thick molded product. The seal lid is made of resin, but may have a metal layer such as an aluminum layer or a silica vapor deposition layer. Since the seal lid is made of resin, it can be easily adhered to the outer wall surface of the resin body. Such bonding is performed by a non-peelable fixed seal, in which at least one of the bonded parts is substantially broken when it is peeled. As the fixed sealing method, a liquid-tight secure seal via an adhesive, a heat seal, or the like can be used. As the adhesive, a solvent adhesive such as a ketone solvent, an ester solvent, an ether solvent, a hydrocarbon solvent, a halogenated hydrocarbon solvent, or a resin adhesive such as a modified olefin or a hot melt is used. There are hermetic seals and the like. Examples of the heat-sealing seal include bonding by external heating such as heat sealing and impulse sealing, and bonding by internal heating such as ultrasonic bonding and high-frequency bonding. In the case of the fixed sealing method by heat welding, the sealing temperature and the sealing time are set so as not to impair the function of the bonding region because the bonding region overlaps with the peelable bonding region. In addition, the wall of the body may be formed in two or more layers so that such adhesion can be easily performed. That is, the resin layer on the body wall is selected so that the melting start temperature of the outermost layer resin material forming the fixed seal is lower than the melting start temperature of the innermost layer resin material forming the peelable bonding region. hand,
It is desirable that the outer layer be set so as to be completely fixedly sealed even under low-temperature sealing conditions.

After forming the above-mentioned bonding region and through-hole,
By bonding a resin container made of resin to the other outer wall surface of the bonding area, it is airtightly connected to the other of the through holes. The medicine container is made of resin and injection molding, blow molding, vacuum molding,
It may be formed in a cup shape by another method, and preferably, a mounting flange is formed in the opening. By firmly sealing the mounting flange to the peripheral surface of the through-hole, the medicine container can be easily airtightly connected to the through-hole. In the method for manufacturing a medical container according to the present invention, the medicine component filled in the entire body and the medicine in the container are easily mixed by peeling the adhesive area by an external operation during use. it can. Therefore, a medical container having the function of a conventional multi-chamber container can be easily manufactured. In addition, since aseptic filling of the medicine in the container, filling of the medicine component in the body portion, and high-pressure steam sterilization can be performed individually, the management and production of multi-drug management filling becomes easy. Further, the connection between the container and the through-hole of the body can be easily carried into the clean area in a sterile atmosphere.

According to a second aspect of the present invention, in the method for manufacturing a medical container according to the first aspect, after forming the adhesive area, the body is filled with a liquid agent and sealed. In addition, the solution is steam-sterilized at a temperature of 100 ° C to 140 ° C. Some drug components contained in the drug container are weak to heat. For this reason, some medicine components cannot be subjected to high-pressure steam sterilization treatment, and some medicine ingredients are only allowed to be aseptically filled. An infusion container or the like using such a drug component has conventionally been available, and such an infusion container and the like cannot perform the steam sterilization treatment of the drug together with the liquid agent. Therefore, the problem can be easily solved by filling the inside of the body with the liquid agent and sterilizing the body after forming the adhesive region, and then aseptically connecting the container or the like.

According to a third aspect of the present invention, there is provided a method for manufacturing a medical container according to the second aspect, wherein a sealing lid made of resin is provided on one outer wall surface of the bonding area before the steam sterilization. The other of the through-holes is air-tightly covered by air-tightly covering one of the through-holes and releasably adhering a resin-made aseptic maintenance sealing material to the other outer wall surface of the bonding area. It is characterized by. If the periphery of the through hole, which is the connection part of the container, is covered with a sterility maintaining seal before the steam sterilization process, the periphery of the through hole is maintained in a sterilized state by the steam sterilization process. The medical container in such a state is transported to the filling line or filling place of the medicine in the container,
The through-hole is maintained aseptically until immediately before the container is connected to the through-hole, and contamination during the connection operation can be prevented as much as possible.

According to a fourth aspect of the present invention, there is provided a method for manufacturing a medical container according to the second aspect, wherein the medicine container contains an easily deteriorated drug which is degraded or discolored by moisture, and the seal lid is provided. Is formed of a moisture barrier material,
The medicine container is airtightly covered with a cover made of a moisture barrier material, and a desiccant is arranged in the cover. Examples of the vulnerable drug that easily undergoes deterioration or discoloration due to moisture and oxygen include lyophilized antibiotics, bioactive proteins, chemicals, and the like. When the easily deteriorated drug is stored in the drug container, the external water (water vapor) slightly permeates into the container. Such moisture prevents long-term storage of the vulnerable drug. For this reason, if the seal lid is formed of a moisture barrier material and the container is airtightly covered with a moisture barrier cover and a desiccant is placed in the cover, moisture from the outside will be absorbed by the desiccant inside the cover. Therefore, moisture does not permeate into the container. In this case, since the space between the cover and the container can be made as small as possible, the space for the desiccant to be in a dry state can be reduced.

As the moisture barrier material, there are a moisture-impermeable material that does not substantially transmit water vapor and a moisture-impermeable material that hardly transmits water vapor. The moisture-impermeable material has a thickness of 100 μm and a moisture permeability of 5.0 to 0.1.
50 g / m ² · day (temperature: 40 ° C., 90-0% R
H), particularly preferably in the range of 2.00 to 0.50 g / m ² · day (temperature: 40 ° C., 90-0% RH). The moisture-impermeable material has a moisture permeability of 0.40 g / m ² · day at a thickness of 100 μm (temperature: 40
(90 ° C., 90-0% RH) or less. Specific examples of the water-impermeable or non-permeable material include a non-transparent metal layer made of aluminum or the like which transmits little or no moisture, polyvinylidene chloride, polytetrafluoroethylene, polytrifluoroethylene. Deposition of a transparent resin layer with high moisture barrier properties, such as rubber, hydrochloric acid rubber, polyethylene, polypropylene, etc., as well as the deposition of earth metals or metals such as aluminum, silicon, magnesium, titanium, silver, and gold, or oxides thereof. It has a layer and the like. The specific moisture permeability of the wall of the moisture barrier material used in the present invention is 3.00 g /.
m ² · day (temperature: 40 ° C., 90-0% RH) or less,
In particular, 1.20 to 0.00 g / m ² · day (temperature: 4
(0 ° C., 90-0% RH).
If the water content is within the above range, even if water vapor permeates into the cover or the container from the outside, the desiccant can absorb the water at a higher speed, and there is no possibility that the easily deteriorated drug will be deteriorated. The desiccant itself is a substance having a strong hygroscopic property, and may be a chemical desiccant or a physical desiccant. Preferred drying agents include porous structures such as silica gel, activated alumina, calcium chloride, and molecular sieves. In particular, the desiccant is desirably capable of drying the moisture remaining in 1 L of air to 5 × 10 ⁻³ mg or less.
With such a desiccant, the absolute humidity can be reduced to the above range.

According to a fifth aspect of the present invention, there is provided a method for manufacturing a medical container, comprising the steps of:
The above-mentioned medicine container accommodates an easily deteriorated drug that is changed or discolored by oxygen, the seal lid is formed of an oxygen barrier material, and the medicine container is air-tightly covered with a cover made of an oxygen barrier material. An oxygen scavenger is provided inside the cover. When the easily deteriorated drug that is easily deteriorated by oxygen is stored in the above-mentioned resin container, oxygen in the outside world slightly permeates into the container. Such oxygen prevents long-term storage of the vulnerable drug. For this reason, if the seal lid is formed of an oxygen barrier material, the container is hermetically covered with an oxygen barrier cover, and the oxygen absorber is disposed inside the cover, oxygen in the outside world will be transferred to the oxygen absorber inside the cover. It is absorbed and oxygen does not penetrate into the container. In this case, since the space between the cover and the container can be made as small as possible, the space for removing the oxygen scavenger can be reduced.

As the oxygen-barrier material, there are an oxygen-impermeable material which does not substantially transmit oxygen, and an oxygen-impermeable material which hardly transmits oxygen. The oxygen-impermeable material has a thickness of 20 μm and a permeability of 40 cc / m ^2.
day · atm (Temperature: 25 ℃, 90% RH) or less, in ^{particular, 10cc / m 2 · day ·} atm or less, and preferably is desired to be in the range of ^{5cc~1cc / m 2 · day · atm} . The oxygen-impermeable material has a transmittance of 0.5 cc / m ² · day ·
Atm or less does not substantially transmit oxygen.
Specific examples of the oxygen-impermeable material and the oxygen-impermeable material include a metal layer such as aluminum having almost no or no gas permeation, polyvinylidene chloride, polyester, nylon, ethylene-vinyl alcohol copolymer,
A resin layer with high gas barrier properties, such as a fluorine-based resin,
Or aluminum, silicon, magnesium, titanium, silver,
It has an earth metal or metal such as gold, or a vapor-deposited layer of an oxide thereof. The specific permeability at the wall of the oxygen barrier material used in the present invention is 1.0.
cc / m ² · day · atm or less, and preferably 0.
It is desirable to be in the range of 5 cc to 0.1 cc / m ² · day · atm. Examples of the oxygen scavenger include organic compounds mainly composed of ascorbic acid and catechol-based compounds, and powdery compounds composed of metals such as iron and metal halides. Specifically, it is commercially available from the trade name “Ageless” (Mitsubishi Gas Chemical Co., Ltd.) or other manufacturers. Examples of the oxygen scavenger include those that only absorb oxygen and those that absorb oxygen to generate carbon dioxide gas.

According to a sixth aspect of the present invention, there is provided the method for manufacturing a medical container according to the second aspect, wherein the medicine container contains an easily-altered drug which is degraded or discolored by moisture in the drug container, and the drug is stored therein. The container is formed of a moisture barrier material, the seal lid is hermetically covered with a cover made of a moisture barrier material, and a desiccant is disposed in the cover.
According to a seventh aspect of the present invention, there is provided the method for manufacturing a medical container according to the second or sixth aspect, wherein the medicine container contains an easily deteriorated drug which is degraded or discolored by oxygen in the drug container. The vessel is made of oxygen barrier material,
The seal lid is air-tightly covered with a cover made of an oxygen barrier material, and an oxygen scavenger is disposed in the cover. In the manufacturing method according to the fourth and fifth aspects, a similar effect can be obtained when the container is made of a material having a moisture or oxygen barrier property instead of the seal lid.

[0017]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the medical container according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a cross-sectional view of the medical container of the manufacturing method according to the first embodiment. FIG.
FIG. 4 is a sectional view of a main part when the medical container of the manufacturing method according to the first embodiment is used. FIG. 3 is a plan view of a molded container in the method for manufacturing a medical container according to the first embodiment. FIG. 4 is a plan view when an adhesive region and a through-hole are formed in a molded container in the method for manufacturing a medical container according to the first embodiment. FIG. 5 is a plan view when the liquid container is filled with the seal lid and the sterility maintaining seal attached to the molded container in the method for manufacturing a medical container according to the first embodiment. FIG. 6 is an exploded cross-sectional view of a vial provided with a medicine container used in the method for manufacturing a medical container according to the first embodiment. FIG. 7 is a sectional view of the vial shown in FIG. FIG. 8 is a plan view when a medicine container is attached to a molded container in the method for manufacturing a medical container according to the first embodiment. FIG. 9 is a plan view of an essential part showing a process of attaching a cover to a molded container in the method for manufacturing a medical container according to the first embodiment. FIG. 10 is a plan view of relevant parts when a cover is attached to a molded container in the method for manufacturing a medical container according to the first embodiment.
FIG. 11 is a cross-sectional view of the medical container of the manufacturing method according to the second embodiment.

The manufacturing method of the medical container 1 according to the first embodiment is as follows. As shown in FIG. 1 to FIG. A bonding area 3 is formed by heat-welding the inner wall surfaces so as to be peelable, a through hole 4 is formed in the bonding area 3, and a resin sealing lid 5 is bonded to one outer wall surface of the bonding area 3 to form a through hole. One of the through holes 4 is hermetically connected to the other of the through-holes 4 by adhering a resin container 6 made of resin to the other outer wall surface of the adhering region 3 while airtightly covering one of the adjoining regions 3. After the formation of the bonding area 3, the body 2
A solution (solution) 7 is filled and sealed, and the solution together with the body 2 is subjected to steam sterilization at a temperature of 100 ° C to 140 ° C. Before the steam sterilization process, a resin-made sealing lid 5 is adhered to one outer wall surface of the adhesive region 3 to airtightly cover one of the through holes 4 and a resin-made seal is attached to the other outer wall surface of the adhesive region 3. The other of the through holes 4 is hermetically covered by bonding the aseptic maintenance sealing material 14 in a releasable manner. The medicine container 6 accommodates an antibiotic (easily deteriorated drug) 10 that changes or discolors due to moisture, the seal lid 5 is formed of a moisture barrier material, and the medicine container 6 is formed of a cover made of a moisture barrier material. The cover 8 is airtightly covered with a desiccant 9 inside the cover 8.

First, the medical container 1 of the manufacturing method according to this embodiment will be described in more detail. The body 2 of the medical container 1 is formed from a sheet having a wall thickness of 200 μm, has a capacity of 160 ml, and has a long length. Is 150 mm and the width is 80 mm. The wall of the body 2 is formed into two layers, an outer layer and an inner layer. The outer layer is a linear low-density polyethylene having a thickness of 150 μm (density: 0.935 g / cm ³ , MI: 2, melting point: 121).
° C). The inner layer is a linear low-density polyethylene having a thickness of 50 μm (density: 0.935 g / cm ³ , melting point: 12
1 ° C) and polypropylene (density: 0.900 g / c)
m ³ , MI: 0.7, melting point: 165 ° C.) in a ratio of 2: 1. A discharge port 20 is attached to the body 2, and the discharge port 20 is sealed with a rubber stopper. A solution 7 is contained in the body 2, and the solution 7 is sterilized together with the container 1.

A bonding area 3 is formed on a part of the body 2 by bonding inner wall surfaces facing each other. The bonding area 3 is formed when the internal pressure in the body 2 is set to about 0.2 kgf / cm ^2. It is formed to have an adhesive strength such that it can be peeled off. A circular through-hole 4 is formed in the bonding area 3, one opening of the through-hole 4 is airtightly covered with a seal lid 5, and the other opening is an antibiotic 10.
Are hermetically connected to each other. The seal lid 5 has an inner layer adhered to the outer wall surface of the body 2 made of linear low-density polyethylene, and has an aluminum foil layer as an intermediate layer. For this reason, the seal lid 5 is made of a water-impermeable material that does not substantially transmit water vapor, and is made of a material that can be thermally welded and sealed to the outer wall surface of the body 2.
The medicine container 6 is made of a material mainly composed of low-density polyethylene, has transparency, and is made of a material that can be heat-sealed and sealed to the outer wall surface of the body 2 and a cover 8 described later. The seal lid 5 is fixed to the outer wall surface of the bonding area 3 near the through hole 4. The medicine container 6 is formed in a cup shape, and a mounting flange 6A is formed at an opening thereof. The mounting flange 6A of the medicine container 6 is fixed to the outer wall surface of the bonding area 3 near the through hole 4.

The outside of the medicine container 6 is airtightly covered with a cover 8, and the cover 8 is made of a moisture barrier material.
The cover 8 is made of a transparent multilayer resin film, the inner layer and the outer layer are formed of a sealant layer made of low-density polyethylene, and has a polyethylene terephthalate layer on which silica is deposited as an intermediate layer. For this reason, the moisture permeability of the wall of the cover 8 is 0.05 g / m ² · day (temperature: 40 ° C., 90-0)
% RH) or less, and the oxygen permeability is 0.1 cc / m ^2.
· Day · atm (temperature: 25 ° C, 90% RH) or less. The cover 8 is formed in a bag shape by sealing portions 8A, 8B, and 8C formed by bending one sheet and heat-sealing the three sides, and an opening 12 through which the container 6 is inserted is formed at a predetermined position of the sheet. . The periphery of the opening 12 is fixed to the mounting flange 6A of the container 6. A desiccant 9 is provided in the cover 8, and the desiccant 9 is composed of 5 g of molecular sieves.

Next, the method for producing a medical container according to the present invention will be described in detail. As shown in FIG. 3, the above-mentioned inflation sheet is cut into a predetermined length, and the cut end portions 22 and 2 are cut.
4 is hermetically sealed to form a body 2 as a container body.
The discharge port 20 is attached to the cut end 22 at the time of hermetic sealing. The hermetic seal is performed under a seal condition of a temperature of 170 ° C., and the end portions 22 and 24 are fixed stickers that cannot be peeled off. As shown in FIG. 4, a peelable bonding area 3 in which inner wall surfaces are bonded to each other is formed on a part of the body 2. The bonding area 3 has a temperature of 1
The sealing is performed at 40 ° C. A through hole 4 is formed in the bonding region 3. The through hole 4 is formed by a punch. As shown in FIG. 5, the seal lid 5 is adhered to the outer wall surface of the bonding area 3 by a heat-sealing seal to cover one opening of the through hole 4 in an airtight manner. The heat sealing is performed under a sealing condition of a temperature of 130 ° C.
The aseptic maintenance sealing material 14 is adhered to the outer wall surface of the bonding area 3 by a heat-sealing seal, and the other opening of the through hole 4 is air-tightly covered. The heat sealing is performed under a sealing condition of a temperature of 130 ° C. Therefore, even if the above-mentioned sticking process is performed, the peelable sealing function of the bonding region 3 is not lost. Note that the sterility-maintaining sealing material 14 has an inner layer made of a blended resin composed of polyethylene and polypropylene, and has an aluminum deposited layer as an intermediate layer. Next, the solution 7 is filled into the body 2 through the discharge port 20, and the discharge port 20 is sealed with a rubber stopper. After sealing, the container 1 is subjected to high-pressure steam sterilization at a temperature of 110 ° C.

On the other hand, as shown in FIG. 6, a cup-shaped medicine container 6 having a mounting flange 6A by vacuum forming a sheet.
Is molded and placed in the vial 26. The vial 26 includes an upper half 32 having an opening 30 to which a rubber stopper 28 capable of being half-plugged is attached, and a lower half 34 in which the medicine container 6 is disposed. The medicine container 6 is attached to the lower half 34, and then the upper half 32 and the lower half 34 are combined. The freeze-drying solution is filled through the opening 30 of the upper half 32 through a sterilization filter. After filling, the rubber stopper 28 is stoppered into the opening 30 in a half stoppered state, and the vial 26 is carried into the lyophilization container. After the freeze-drying is completed and the antibiotic 10 is produced as a freeze-dried product in the container 6, as shown in FIG.
The rubber stopper 28 is completely plugged into the opening 30. The vial 26 is placed in a clean room in a sterile environment.

The container 1 after the sterilization treatment is carried into the clean room, and the aseptic maintenance sealing material 14 is peeled off from the through hole 4 of the body 2. On the other hand, the upper half 32 of the vial 26 after lyophilization is removed from the lower half 34. Then, the medicine container 6 is aseptically connected to the opening of the through hole 4 as shown in FIG. The connection is performed by firmly sealing the mounting flange 6A to the outer wall surface of the body 2 around the opening. The temperature of the fixed seal is 1
Perform at 30 ° C. As shown in FIG. 9, the medicine container 6 is inserted into the opening 12 of the sheet for the cover 8, and the peripheral edge of the opening 12 is fixed to the mounting flange 6A and the body 2 wall. And
The sheet is folded and the three end portions 8 as shown in FIG.
The overlapping sheets A, 8B, and 8C are fixed to each other to hermetically cover the medicine container 6. When covering, the desiccant 9 is disposed in the cover 8.

In the medical container 1 according to the manufacturing method thus configured, the inside of the body 2 is pressed from the outside similarly to the conventional multi-chamber container, so that the bonding area 3 is easily peeled off.
The antibiotic 10 is aseptically mixed with the lysis solution 7 as shown in FIG. In the medical container 1 manufactured as described above, the formation of the bonding area 3 is simple, the through-hole 4 can be easily formed in the bonding area 3, and the medicine container 6 is aseptically and easily connected. There is an advantage in that it can be performed, which is an advantage in manufacturing. Further, it is suitable for a medical container in the case where an object which cannot be subjected to high-pressure steam sterilization such as the antibiotic 10 in the medicine container 6 is targeted. In manufacturing, during the high-pressure steam sterilization, the opening of the through-hole 4 can be easily aseptically maintained by the aseptic maintenance sealing material 14 or the like. Further, the antibiotic 10 in the medicine container 6
Is easily protected by the function of the desiccant 9 in the cover 8 that hermetically covers the container 6 even if the user does not like water. Since the desiccant 9 can be arranged in a narrow space surrounding only the container 6, the dehumidifying function of the desiccant 9 can be maintained for a long time.

In the above embodiment, the through hole 4 was formed after the formation of the bonding region 3. However, a method in which a ring-shaped bonding region is formed after the formation of the through hole 4 may be used. In the above-described embodiment, the drug component in the drug container 6 contains the easily degradable drug due to moisture. However, when the easily degradable drug due to oxygen is stored, a deoxidizer is provided in the cover 8, and the cover 8 and the seal are sealed. The lid 6 may be made of an oxygen barrier material. Also in this case, the easily-altered drug in the container 6 can be protected from oxygen in the outside world.

Next, a method for manufacturing a medical container according to a second embodiment of the present invention will be described with reference to FIG. The method for manufacturing the medical container according to the second embodiment employs the same method as the first embodiment in the following points. In other words, the method of manufacturing the medical container 41 according to the second embodiment includes a method of manufacturing the medical container 41, as shown in FIG.
A bonding region 3 is formed by heat-welding the inner wall surfaces of the bonding region 3 so as to be peelable, a through hole 4 is formed in the bonding region 3, and a resin sealing lid 46 is bonded to one outer wall surface of the bonding region 3 to penetrate through. One of the holes 4 is airtightly covered and a resin container 42 made of resin is bonded to the other outer wall surface of the bonding area 3 to be airtightly connected to the other of the through holes 4. The bonding area 3
Is formed, the body 2 is filled with a solution (solution) 7 and sealed, and the solution together with the body 2 is subjected to steam sterilization at a temperature of 100 ° C to 140 ° C. Before the steam sterilization process, a resin-made sealing lid 5 is adhered to one outer wall surface of the adhesive region 3 to airtightly cover one of the through holes 4 and a resin-made seal is attached to the other outer wall surface of the adhesive region 3. The other of the through holes 4 is hermetically covered by bonding the aseptic maintenance sealing material 14 in a releasable manner.

The manufacturing method of the medical container 41 of the second embodiment differs from the manufacturing method of the first embodiment in the following points. In the method of manufacturing the medical container 41 according to the second embodiment, the medicine container 42 contains an antibiotic (easily degradable drug) 44 that changes or discolors due to oxygen, and the medicine container 42 is formed of an oxygen barrier material. Then, the seal lid 46 is air-tightly covered with a cover 50 made of an oxygen barrier material, and an oxygen absorber 48 is disposed in the cover 50. The medicine container 42
Consists of an oxygen impermeable material having an aluminum foil layer in the intermediate layer. The seal lid 46 is made of a low-density polyethylene sheet having a thickness of 100 μm. The cover 50 is made of the same material as the cover 8 of the first embodiment, and uses an oxygen barrier material. In the manufacturing method according to the second embodiment configured as described above, in addition to the same operation and effect as the first embodiment, even when the antibiotic 44 in the medicine container 42 dislikes oxygen, It is easily protected by the function of the oxygen scavenger 48 in the cover 50 that hermetically covers the seal lid 46. And
An oxygen absorber 48 is provided in an extremely narrow space surrounding only the seal lid 46.
Therefore, the oxygen scavenging function of the oxygen scavenger 48 can be maintained for a long period of time. In the above-described embodiment, the drug component in the drug container 42 accommodates the easily-altered drug due to oxygen. However, when the easily-altered drug due to moisture is contained as in the first embodiment, the desiccant 9 is placed in the cover 50. The cover 50 and the container 42 may be made of a moisture barrier material. In this case as well, the easily deteriorated drug in the container 42 can be protected from external moisture.

[0029]

As described above, in the method for manufacturing a medical container according to the present invention, the inner wall surfaces of the body part are peeled off a part of the flat body part formed of a flexible resin wall. Forming a through-hole in the above-mentioned bonding region by forming a bonding region that is heat-welded as much as possible, and sealing a resin sealing lid to one outer wall surface of the above-mentioned bonding region to hermetically cover one of the above-mentioned through-holes. By adhering a resin container made of resin to the other outer wall surface of the bonding area and airtightly connecting to the other of the through holes, transfer and filling of the drug is not performed, and aseptically and easily. A medicine container or the like can be connected to the body of the container. In addition, in order to prevent the deterioration of easily deteriorated drugs, only a part of the container or the trunk is covered with a cover to make the drying space or oxygen elimination space as small as possible to maintain the function of the desiccant and oxygen scavenger for a long time. Can be done.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view of a medical container of a manufacturing method according to a first embodiment.

FIG. 2 is a sectional view of a main part when the medical container of the manufacturing method according to the first embodiment is used.

FIG. 3 is a plan view of a molded container in the method for producing a medical container according to the first embodiment.

FIG. 4 is a plan view when an adhesive region and a through hole are formed in a molded container in the method for manufacturing a medical container according to the first embodiment.

FIG. 5 is a plan view of a molded container in the method for manufacturing a medical container according to the first embodiment, in which a liquid lid is filled with a seal lid and a sterility maintaining seal attached.

FIG. 6 is an exploded cross-sectional view of a vial provided with a medicine container used in the method for manufacturing a medical container according to the first embodiment.

FIG. 7 is a sectional view of the vial shown in FIG. 6;

FIG. 8 is a plan view when a medicine container is attached to a molded container in the method for manufacturing a medical container according to the first embodiment.

FIG. 9 is a plan view of an essential part showing a process of attaching a cover to the molded container in the method for manufacturing a medical container according to the first embodiment.

FIG. 10 is a plan view of relevant parts when a cover is attached to the molded container in the method for manufacturing a medical container according to the first embodiment.

FIG. 11 is a cross-sectional view of the medical container of the manufacturing method according to the second embodiment.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical container 2 Body 3 Adhesion area 4 Through-hole 5 Seal lid 6 Drug container 7 Dissolution liquid 8 Cover 9 Desiccant

Claims (7)

[Claims] 1. An adhesive region formed by thermally welding the inner wall surfaces of a body portion to be peelable from each other in a part of a flat body portion formed of a flexible resin wall, and a through hole is formed in the adhesion region. To form
By bonding a resin sealing lid to one outer wall surface of the bonding area to airtightly cover one of the through holes and bonding a resin medicine container to the other outer wall surface of the bonding area, A method for manufacturing a medical container, wherein the medical container is hermetically connected to the other of the through holes. 2. After forming the bonding area, the body is filled with a liquid agent and sealed, and the liquid agent and the body are heated at a temperature of 10%.
The method for producing a medical container according to claim 1, wherein the container is subjected to steam sterilization at 0 ° C to 140 ° C. 3. Prior to the steam sterilization treatment, a resin sealing lid is adhered to one outer wall surface of the bonding area to airtightly cover one of the through holes and to the other outer wall surface of the bonding area. 3. The method for manufacturing a medical container according to claim 2, wherein the other of the through holes is air-tightly covered by detachably bonding a resin-made sealant for maintaining sterility. 4. The medicine container contains an easily deteriorated drug which is degraded or discolored by moisture, the seal lid is made of a moisture barrier material, and the medicine container is a cover made of a moisture barrier material. 3. The method for producing a medical container according to claim 2, wherein the medical container is air-tightly covered and a desiccant is disposed in the cover. 5. The medicine container contains an easily deteriorated drug which is degraded or discolored by oxygen, the seal lid is formed of an oxygen barrier material, and the medicine container is a cover made of an oxygen barrier material. The method for manufacturing a medical container according to claim 2 or 4, wherein the cover is hermetically sealed and an oxygen scavenger is disposed in the cover. 6. The medicine container contains therein a drug which easily deteriorates or changes its color due to moisture, the medicine container is formed of a moisture barrier material, and the seal lid is a cover made of a moisture barrier material. 3. The method for producing a medical container according to claim 2, wherein the medical container is air-tightly covered and a desiccant is disposed in the cover. 7. The medicine container contains an easily deteriorated drug that is changed or discolored by oxygen, the medicine container is formed of an oxygen barrier material, and the seal lid is a cover made of an oxygen barrier material. 7. The method for producing a medical container according to claim 2, wherein the cover is air-tightly covered and an oxygen scavenger is disposed in the cover.