JPH1080465A - Vessel for medical treatment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a vessel for medical treatment which easily and sterilely connects a vial, etc., for medicines. SOLUTION: This vessel 1 for medical treatment is a resin vessel 2 which has plural cells and is obtd. by forming at least part of an isolating line part 5 between the cell and the cell of a peel sealing part or weak sealing part openable from the outer side. A medicinal liquid 7 is housed in the first cell 3 and a vessel 22 for packing the medicine 8 to be mixed with this medicinal liquid 7 is sterilely connected to at least the other second cell 4.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container, and more particularly, to a medical container capable of easily and aseptically connecting a container filled with a drug to a resin container, particularly to a medical container. The present invention relates to a medical container for storing an infusion solution to be used, a dialysate used for a circulatory system, or an organ preservative such as a transplanted organ.

[0002]

2. Description of the Related Art Medical containers such as bags and containers for infusions, dialysis solutions, organ preservation solutions and the like used for infusion are generally resin containers. Some infusions are mixed with antibiotics or the like at the time of use and injected by infusion. Conventionally, a syringe is used for such mixing, and the lysate is placed in the vial containing the antibiotic via the syringe. The antibiotic and the lysis solution are mixed, and the mixture is drawn from the vial with a syringe. Then, the syringe is pierced through the outlet of the infusion container, and the mixed solution is filled in the infusion container. Recently, an infusion container and a vial have been proposed. Such an infusion container is provided with a connection port, and a vial is connected to the connection port with its rubber stopper opposed. A communication needle is provided between the connection port and the vial, and the communication needle pierces the rubber stopper during use, so that the inside of the vial and the inside of the infusion container can be aseptically communicated. These structures are derived from the fact that drugs such as antibiotics are unstable and cannot withstand storage when dissolved in an infusion, and that antibiotics and other drugs cannot be sterilized by high-pressure steam as in infusion. Recently, an infusion container called a double bag has been proposed.
The storage room for the amino acid agent and the storage room for the sugar are divided. A part or the whole of the isolation strip or the isolation wall between the chambers is formed as a peel seal or a weak seal, and is an isolation strip which can be opened from the outside when used. For this reason, in such a double bag, an amino acid and a sugar that react with each other during production and storage are separated and stored, so that they can be easily mixed aseptically when used.

[0003]

However, conventional medical containers such as infusion containers or peritoneal dialysis containers having drug vials have the following problems. The conventional medical container requires a communication needle in the vial support capsule and the connection port, and the connection mechanism is extremely complicated, so that manufacturing is not easy. Aseptic connection of vials and the like is difficult. In a conventional medical container, an operation of piercing a communication needle is required for the operation, and coring contamination may occur from a rubber stopper in the piercing operation. In view of this, there has recently been provided one in which a second chamber utilizing a double bag is directly aseptically filled with a freeze-dried product (JP-A-5-3904, etc.). This prevents the freeze-dried product from sticking to the container wall and hindering the dispensing of a fixed amount. However, such medical containers do not completely eliminate the risk of contamination during the aseptic filling operation. In addition, a method of dispensing a large amount of lyophilized product into a filling chamber using a predetermined quantitative spoon can be considered, but in such a method, the cake of the lyophilized product is necessarily distributed while maintaining a uniform titer. Not necessarily. Accordingly, an object of the present invention is to provide a medical container in which a vial of a medicine is simply and aseptically connected.

[0004]

SUMMARY OF THE INVENTION The present invention has a plurality of chambers, and at least a part of a separation strip between the chambers is formed by a peel seal or a weak seal which can be opened from the outside. A medical container characterized in that a medical solution is stored in a first chamber, and a filling container for a drug mixed with the medical solution is aseptically connected to at least another second chamber. The object has been achieved by providing a container for use.

[0005] The chemical solution contained in the medical container is generally an electrolyte solution. Examples thereof include Ringer's solution containing lactic acid, acetic acid, bicarbonate and the like, high calorie infusion containing sugar, amino acid, peptide, fat, etc., dialysate, organ preservation solution and the like.
The chemical may be a simple solution or dilution of the lyophilized drug, and the chemical may be simple sterile water. The chemical solution is subjected to steam sterilization after being housed in a resin container in a liquid-tight manner. The resin container is a non-constant volume container having at least a flexible wall. The resin container is formed from a sheet or a film, directly blow-molded, or injection-molded. The resin used for the container is a general-purpose resin such as a polyolefin resin, a vinyl chloride resin, and a polyester resin. In particular, polyolefin resins, for example, linear low-density polyethylene, high-density polyethylene, polypropylene, ethylene-vinyl acetate Copolymers and the like.

[0006] Further, an isolation strip formed by a peel seal portion or a weak seal portion between the walls of the resin container may be formed on the entire isolation wall, or may be formed on a part thereof.
The isolation strip can be formed by a conventionally well-known method. For example, in a resin container molded from a polyethylene sheet having specific properties, using a heat seal bar, the sealing region forming temperature is set to 110 ° C. to 12 ° C.
There is a method in which the pressure is set in the range of 5 ° C. and the pressing force is set at 4 kg / cm ² for 1 second (Japanese Patent Laid-Open No. 5-68702). The isolation strip thus formed has a container internal pressure of 10
It is said to be peeled off at a pressure of from about 100 g / cm ² to about 100 g / cm ² . Further, the kneaded composition of linear polyethylene and polypropylene is used as the inner wall layer of the resin container, the peripheral seal forming temperature for forming the container is in the range of 150 to 170 ° C, and the area of the weak seal portion is 130 to 150 ° C. As a range, a method for manufacturing an infusion container having a plurality of chambers has also been proposed. In the present invention, such a conventional method is employed for forming the isolation strip, and the separation strength of the isolation strip is determined by adjusting the internal pressure of the container to 0.02 to 0.
It is desirable to peel off when the pressure is increased in the range of 15 kgf / cm ² . In such a range, there is no possibility that the inside of the container is opened when the filling container is attached, and the wall can be easily separated from the outside during use.

The filling container may be a so-called vial or the like. Therefore, it may be made of glass or resin. The opening of the filling container is required to be connected to and connected to the second chamber of the resin container. For this reason, the filling container is different if it is made of resin, but if it is made of glass, there is a connecting resin member, and the filling container is connected to the second chamber via such a resin member. Therefore, if the vial or the like is made of resin, the main body of the vial or the like becomes a resin member and can be directly connected to the resin wall of the second chamber by thermal welding. The drug in the filling container may be a lyophilized product in addition to powder and granules. Examples of the drug include relatively unstable drugs such as antibiotics and anticancer drugs, and electrolytes such as bioactive substances, vitamins, and bicarbonates. Most of these are aseptically adjusted. The filling container that has been aseptically adjusted in the aseptic chamber and the second chamber that has been sterilized by the autoclave are aseptically connected. The aseptic connection may generally be established in a sterile room. In addition, in order to ensure the sterility assurance, the connection portion of the filling container may be subjected to various sterilization treatments before the connection.

In the medical container constructed as described above, when using the medical container, first, pressure is applied to the inside of the resin container to open the isolation strip. Thereby, the opening of the filling container communicates with the inside of the medical container. The chemical liquid enters the filling container and dissolves the chemical to form a mixed solution. Then, the mixed solution is infused from the outlet. In this case, the connection part of the filling container can easily be aseptically connected, and can be easily sterilized by heat sterilization, chemical sterilization, or irradiation sterilization with γ-rays, electron beams, and ultraviolet rays. Can be easily done. In particular, electron beam irradiation sterilization is desirable because it does not require a large-scale facility like γ-ray irradiation sterilization, and has a higher probability of sterilization than ultraviolet irradiation sterilization. Furthermore, in aseptic mixing of a drug solution and a drug, the number of parts, operability, and the like are superior to those of the related art. Further, since the filling container is directly connected to the inside of the resin container, the freeze-dried material does not stick to the wall of the freeze-drying container as in the related art, and does not hinder the dispensing of the fixed amount. There is no need to worry about a uniform titer distribution as in the method of dispensing a large amount of freeze-dried product into a filling chamber using a predetermined measuring spoon.

A medical container according to a second aspect of the present invention aims to easily and liquid-tightly connect a connecting portion of the filling container in the medical container according to the first aspect by heat welding. In the medical container according to claim 2, a connection port is formed in the second chamber, and a peripheral edge of the connection port and a resin connection flange formed in the filling container are heat-sealed in a liquid-tight manner. It is characterized by being. By forming the resin connection flange in the filling container, it can be fitted to the connection port of the second chamber, and can be easily and liquid-tightly mounted by ultrasonic welding. In the medical container according to the third aspect of the present invention, the connection portion of the filling container in the medical container according to the first aspect is connected in a liquid-tight manner using an elastic material, and the filling container is easily detached after use. do it,
A medical container according to claim 3, wherein a connection port is formed in the second chamber, and a peripheral port of the connection port is made of an elastic material. Wherein the mouth of the filling container is detachably engaged with the peripheral edge of the connection port while pressing the seal member. The elastic material is, for example, a rubber packing, a rubber ring, or the like. The rubber also includes silicon rubber and the like. The mouth portion is engaged with the periphery of the connection port so as to be detachably engaged while pressing the seal member, for example, has a hook portion or the like having resin elasticity at the periphery, and the mouth portion of the filling container is forcibly applied to such a hook portion. The sealing member is inserted in such a manner that the sealing member is pressed at the time of the insertion, and the resin hook portion or the like is broken when the filling container is removed.

According to the present invention, in the method for manufacturing a medical container according to the first aspect, the isolation strip portion is formed in the resin container, and the chemical solution is accommodated in the first chamber. Autoclave sterilization, after that, by providing a method for manufacturing a medical container, characterized in that the filled container is manufactured by aseptically connected to the second chamber,
The above object has been achieved. First, a resin container is formed. The resin container may be blow molded. Alternatively, the two resin sheets cut to a predetermined size may be formed by stacking the two resin sheets and completely bonding their peripheral edges with each other. The inflation tubular sheet cut to a predetermined size may be formed into a bag shape by completely heat bonding at both ends. In addition, the discharge port (or drip port) and the connection port of the resin container can be formed integrally with the blow molded product by using the blowout port or the extension tip port as such a port. In the case of a seal-like material, it can be formed by attaching a port member at the time of heat-sealing the peripheral edge. One or more isolation strips are formed. The isolation strip is formed by a conventionally known method, and is formed while adjusting the above-mentioned sealing strength. After the formation of the isolation strip, a chemical solution is filled into the resin container from the outlet. The chemical may be filled in a resin container after passing through the sterilization filter. After filling, the outlet is plugged and the port is closed liquid-tight. Then, in order to enhance sterilization assurance, the chemical solution is subjected to autoclave sterilization together with the resin container. The autoclave sterilization temperature is 10
A range of 5 ° C to 140 ° C is desirable, and a range of 105 ° C to 120 ° C is particularly desirable. At a temperature below the above range, the sterilization time becomes longer, and the sterility assurance is reduced. On the other hand, if the temperature exceeds the above range, the function of the resin container and the function of the isolation strip of the container may be adversely affected. After sterilization, the resin container is maintained in a sterile atmosphere.

On the other hand, the filling container is aseptically filled with a drug. For example, in the case of a drug as a freeze-dried product, first, a solution of the drug is passed through a sterilization filter and filled in a sterilized or aseptic filling container. Next, the stopper is attached to the opening of the filling container in a half-stopped state, and the filling container is placed in a dust-free freeze-drying apparatus. The drug solution in the filled container is freeze-dried, and the stopper is completely stoppered in a freeze-dried state. After the filling, the atmosphere in a sterile state where the resin container is placed is maintained. The resin container and the filling container are connected under a sterile atmosphere. First, the plug of the filling container is unplugged, and the mouth opening of the heel is joined to the connection port of the second chamber. At the time of joining, the members are joined in a liquid-tight manner by heat welding between the resins.
In such a manufacturing method, the inside of the second chamber and the filling container and the mouth thereof can be easily and easily maintained in an aseptic state.
For this reason, contamination is less likely to occur when the filling container is connected to the second chamber. Regarding the connection, since the structure of the connection port of the second chamber and the mouth of the filling container can be in a preferable form, simple and liquid-tight connection with a reduced number of parts can be achieved. In addition, at the time of connection, chemical sterilization processing described later,
Since the heat sterilization treatment and the irradiation radiation sterilization treatment can be performed locally, the sterilization assurance of the connection portion can be further improved.

[0012] The manufacturing method according to claim 5 according to the present invention,
It is an object of the present invention to sufficiently guarantee the sterility of the connection between the filling container and the connection port of the second chamber in the production method according to the fourth aspect. That is, in the manufacturing method according to the fifth aspect, in the aseptic connection of the filling container, at least one of a chemical sterilization process, a heat sterilization process, and an irradiation sterilization process is performed on a connection portion of the filling container. It is characterized by the following. The application of such a sterilization process at the connection is easy and enhances sterilization assurance at the connection.
In the chemical sterilization treatment, the connection parts are treated with hydrogen peroxide, formalin, alcohol, ethylene oxide gas, or the like. In particular, it is desirable to use hydrogen peroxide from the viewpoint of sterilization ability, equipment, and waste liquid treatment. The heat sterilization process is performed at a temperature of 110 ° C. or higher for a predetermined period of time. However, the heat sterilization treatment has a drawback that it takes a long time because the heating temperature is limited because the connecting portion is a resin member. For this reason, if the resin member has considerable heat resistance, an effective sterilization process is performed. The irradiation sterilization process is a process using irradiation beams such as γ-rays, ultraviolet rays, and electron beams.

According to a sixth aspect of the present invention, there is provided a manufacturing method comprising:
At the time of connection between the filling container and the connection port of the second chamber in the production method according to claim 4, since sterility of the second chamber may not be completely guaranteed, it is necessary to sufficiently ensure such sterility. It is the purpose. That is, in the production method according to claim 6, the second chamber after the connection of the filling container is sterilized by irradiation. Γ for irradiation
Rays, ultraviolet rays, electron beams and the like. Claim 7 of the present invention
The object of the manufacturing method described above is to provide a sterilizing method capable of processing a large number of lines with simple equipment, out of the irradiation sterilization processing in the manufacturing method according to the sixth aspect.
That is, the manufacturing method according to claim 7 is characterized in that the irradiation sterilization is electron beam irradiation sterilization or ultraviolet irradiation sterilization. The irradiation sterilization treatment is irradiation treatment with gamma rays, electron beams, and ultraviolet rays. However, the following electron beam sterilization and ultraviolet irradiation sterilization are desirable from the viewpoint of sterilization certainty, its economy, and mass production adaptability. In the electron beam irradiation sterilization, permeability of an electron beam is determined mainly by the acceleration voltage, a high energy type is the highest 13000 g / m ^2, which is the thickness of the water (specific gravity 1g / m ²⁾ 13000
μm. However, when the accelerating voltage device is increased in size, the X-ray shielding equipment becomes large, and the resin material may be deteriorated. For this reason, medium-low energy 1Me
V or less, especially low-energy type 500KV following acceleration voltage device is desirable, from about 1500 g / m ² in medium energy type in such a device, about 800 g / m ² of low energy type
Is the limit, the thickness of electron beam transmission is 16
00 μm, especially 800 μm, is the optimum limit. From this, electron beam sterilization has an accelerating voltage of less than 1 MeV,
In particular, if it is a low energy type of 500 KV to 50 KV, a predetermined permeability of the electron beam can be obtained, but since there is almost no emission of X-rays or the like, no shielding facility is required,
It can be arranged compactly on the production line. That is,
Approximately 800 g of electron beam penetration at an acceleration voltage of 500 KV
/ M ² or less, in particular, sufficient permeability can be obtained in a resin thin portion of 800 μm or less.

Therefore, in the case where the irradiation of the filling container is directly irradiated with radiation or the irradiation of the opening is performed through the container wall of the second chamber, the filling of the filling container is considered in consideration of the effect of the medicine in the filling container. The thickness of the container is much larger than the above range, especially 3 m
m and the thickness of the resin container wall is desirably less than the above range. In addition, in the disinfection of microorganisms, as described in JP-A-7-16286, a D value of about 0.2 Mrad (2 kGy) is measured with B. pumilus (spores) E-601 which is an indicator for radiation bacteria. Have. 1cm ²
Per, the bacteria usually 10 ⁰ order is attached, if sufficiently considering safety versa assumption that there is attached to the 10 ^two orders. The sterilization assurance level (SAL) in the order of 10 ² is a survival rate of 10 ⁻⁶ %. Therefore,
In the electron beam irradiation apparatus 50 of the present embodiment, the filling container 22 or the second chamber is 6 × 0.2 Mrad or more, preferably 8 × 0.2 Mrad.
The amount of electricity and the conveyor speed are adjusted so that the sterilization is performed at Mrad or more, and the sterilization is performed.

In the ultraviolet irradiation sterilization, direct irradiation sterilization at the mouth of the filling container is a simple method and has no problem. However, irradiation sterilization through the second room is restricted as follows. For example, a resin container material having a wavelength of 250
UV transmittance at 10 nm (at 10 μm thickness) is 60%
As described above, the density is in the range of 0.95 to 0.85 g / cm ³ , and the thickness of the sheet is 100 μm to
The use of a material limited to a range of 10 μm is required.
The ultraviolet irradiation device is provided with a high-power ultraviolet lamp. The high-power UV lamp is a low-pressure mercury lamp having a wavelength of 25
A high radiation intensity around 0 to 260 nm is used. High power UV lamp is 100mWc at the window of irradiation part
m ² or more. Therefore, in order to make the apparatus compact, the ultraviolet lamp should be 200 watts or more.
Those having a range of 1 kW are desirable. The distance from the window surface of the irradiation unit to the object is 25 mm or less, particularly 10 mm or less. If the distance is 25 mm or less, about 70% of the irradiation rate of the window surface is secured. In the disinfection of microorganisms, B. subtilis (spores), which is resistant to ultraviolet rays, is used.
For 9% sterilization, approximately 33.3 mW · sec / cm ²
Irradiation dose is required. After avoiding adherence up to 10 ^-3 order, the survival rate 1 which is the sterilization assurance level (SAL)
0 ^-6 is guaranteed. For example, to sterilize within 30 seconds by ultraviolet irradiation, at least 1.11 mW
It is adjusted so that the amount of ultraviolet light of c / cm ² or more reaches. Therefore, if the irradiation sterilization is γ-ray irradiation, the wall thickness of the resin container is not so limited. If the irradiation sterilization is a simple electron beam irradiation, the thickness is desirably 1600 μm to 10 μm. If the irradiation sterilization is ultraviolet light, the thickness is preferably in the range of 100 μm to 10 μm. Within such a range, sterilization up to the surface of the resin member at the opening can be easily performed, and the way of mass production can be easily opened.

[0016]

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 sectional view of a first embodiment of the medical container according to the present invention. FIG. 2 is a sectional view of the resin container in the medical container of the first embodiment at the time of manufacture. FIGS. 3A and 3B are cross-sectional views of the filling container in the medical container of the first embodiment during manufacturing. FIG.
FIG. 2 is a schematic view of an electron beam device used for the medical container of the first embodiment. FIG. 5 is a sectional view of the medical container of the first embodiment at the time of manufacture. FIG. 6 is a sectional view of the medical container of the first embodiment at the time of use. As shown in FIGS. 1 to 6, the medical container 1 of the present embodiment has a plurality of chambers 3 and 4, and a separating strip 5 between the chambers 3 and 4 is a seal that can be opened from the outside. This is the formed resin container 2. The first chamber 3 accommodates the drug solution 7, and the other at least the second chamber 4 is connected to a filling container 22 of the drug 8 mixed with the drug solution 7 and is connected aseptically.

The infusion container 1 of this embodiment will be described in more detail. The resin container 2 used for the medical container 1 is made of a stretch blow-molded product. The resin container 2 is formed in two colors by using a mixed composition of linear low-density polyethylene and polypropylene as the inner layer and the outer layer as the linear low-density polyethylene (not shown). The mixed composition is composed of linear low-density polyethylene (density: 0.935 g / cm ³ , MI: 1, melting point: 126 ° C.) and polypropylene (density: 0.900 g)
/ Cm ³ , MI: 0.7, melting point: 160 ° C.)
These were mixed at a ratio of 10. The resin container 2 of the present embodiment has a body diameter of 70 mm, a capacity of 150 mL, and a wall thickness of about 200 μm. When the thickness of the container wall is 200 μm, complete irradiation sterilization through an electron beam irradiation device of simple equipment to be described below through the container wall can be performed, and the container can be easily mounted on a mass production line. The resin container 2 has an outlet 9
Is formed, and the plug 9 through which the drip needle is pierced is formed in the outlet 9.
0, it is closed in a liquid-tight manner, and the plug 10 is stopped by a stop member 11 on the ring. An isolation strip 5 is formed in the body of the resin container 2, and a first chamber 3 and a second chamber 4 are formed in the resin container 2 with the isolation strip 5 as a boundary. The separating strip 5 is formed in a peel seal portion or a weak seal portion, and is peeled open when the first chamber 3 reaches 100 g / cm ² . The first chamber 3 is filled with a drug solution 7, and the drug solution 7 is autoclaved together with the resin container 2. The drug solution 7 is a physiological saline solution for dissolving a drug which is a freeze-dried product described later, and the physiological saline solution is passed through a sterilization filter to the first chamber 3.
Is filled.

As shown in FIG. 2, the resin container 2 has a connection port 1.
2 are formed, and a flange portion 13 is formed in the connection port 12. A hanging wire 14 is attached to the flange portion 13, and the wire 14 is made of resin and has both ends at the flange portion 13.
Heat-sealed. A connection port 15 is attached to the connection port 12, and the connection port 15 is formed of a two-color molding port member of polyethylene and polypropylene. A filling container 22 is inserted into the connection port 15, and the filling container 22 is arranged with the mouth 23 placed in the second chamber 4. Filling container 2
Numeral 2 is made of an injection molded product of polypropylene, and a connection flange 24 is formed at the bottom as shown in FIG. Further, the filling container 22 is formed of a transparent container that cuts off ultraviolet rays, and the thickness of the filling container 22 is formed to be 4 mm, and can shield ultraviolet rays and electron beams described later. The inner wall at the distal end of the connection port 15 and the connection flange 24 are fixed to each other by ultrasonic thermal welding, and the fixing container
Is aseptically connected to the second chamber 4 of the resin container 2 in a liquid-tight manner. The thickness of the discharge port 15 is about 400 μm (in FIG. 1, the thickness is emphasized for the sake of explanation). The medicine 8 is filled in the filling container 22, and the medicine 8 is a dry product obtained by freeze-drying a sterile-filled solution.

Next, a method for manufacturing the medical container 1 will be described. The resin container 2 is formed by stretch blow molding, and the receiving portion of the stretch blow fitting is formed as the discharge port 9 and the blowout port is formed as the connection port 12 during such forming. An isolation strip 5 is formed on a predetermined body of the resin container 2. The formation of the isolation strip 5 is performed at a heat seal formation temperature of 130 ° C. for 12 seconds. Next, the connection port 15 is connected to the connection port 1 by heat welding.
Attach to 2. Also, as shown in FIG.
Is closed with a lid 16 having gas permeability. Outlet 9
Then, a stopper 10 and a stopper 11 are attached to the outlet 9. Then, the chemical solution 7 is autoclaved together with the resin container 2 at 110 ° C. On the other hand, as shown in FIG. 3, the filling container 22 is filled with the medicine 8 aseptically. First, the drug 8 as a freeze-dried product is filled through the opening 23 by passing a solution of the drug 8 through a sterilization filter. Next, the plug 25 is attached to the opening 23 in a half-plugged state, and the filling container 22 is placed in a dust-free freeze-drying apparatus. The drug solution in the filling container 22 is freeze-dried, and the stopper 25 is completely plugged in a freeze-dried state.

After the filling, the resin container 2 and the filling container 22 are maintained in an aseptic atmosphere. As shown in FIG. 5, the lid 16 of the resin container 2 and the plug 25 of the filling container 22 are removed under aseptic conditions. After removal, the filling container 22 is inserted into the connection port 15, and the inner wall surface at the distal end of the connection boat 15. And the connection flange 23 of the filling container 22 are liquid-tightly fixed to each other by ultrasonic thermal welding. Next, the suspension wire 14 is attached to the flange 13 of the connection port. Thereby, the medical container 1
Is manufactured. When connecting the resin container 2 and the filling container 22, if necessary, the outer surfaces near the lid 16 and the plug 24 are treated with hydrogen peroxide water vapor to sterilize the connection. Such a process achieves sufficient and easy assurance of sterility at the time of connection. When connecting the resin container 2 and the filling container 22, if necessary, the outer surfaces near the lid 16 and the stopper 25 are subjected to a heat treatment to sterilize the connection. Such processing can increase the assurance of sterility at the time of connection. Further, when connecting the resin container 2 and the filling container 22, if necessary, the outer surfaces near the lid 16 and the plug 25 are irradiated with ultraviolet rays to sterilize the connection.
Such processing can increase the assurance of sterility at the time of connection.

When connecting the resin container 2 and the filling container 22, the outer surfaces near the lid 16 and the plug 25 can be sterilized by the above-mentioned electron beam irradiation, if necessary. FIG.
As shown in the figure, the electron beam irradiation device 50 includes a belt conveyor 51.
, A frame 52, a window frame 53 formed in the frame 52, a window foil 54 attached to the window frame 53, and a window frame 5.
The acceleration tube 55 covers an upper part of the electron beam 3 and an electron beam generator 56 provided in a vacuum chamber in the acceleration tube 55. The electron beam generator 56 includes a grid 57, a gun frame 58, and a filament 59. The filament 59 is energized and heated to generate thermoelectrons.
The thermoelectrons are accelerated between the filament 59 to which a predetermined voltage is applied and the grid 57, and are transferred from the window foil 54 to the conveyor 5.
Irradiated on 1 Note that the machine casing 52 is shielded with lead to prevent external leakage of X-rays and the like generated secondary by irradiation with electron beams. Therefore, the irradiation electron dose can be adjusted by the speed of the conveyor 51 and the amount of current supplied to the filament 59, and the permeability of the electron beam can be adjusted by the acceleration voltage. Such a process achieves sufficient and easy assurance of sterility at the time of connection. Further, even after the connection, the electron beam irradiation sterilization can be performed in the first chamber 4 of the resin container 2. By such irradiation sterilization, the inside of the first chamber 4 is sterilized, and the outer surface of the filling container 22 is almost completely sterilized. On the other hand, the electron beam does not reach the inside of the filling container 22,
There is no possibility that the drug 8 is decomposed.

Next, the use of the medical container 1 of the present embodiment will be described. In the medical container 1 of the present embodiment thus configured, the first chamber 3 is pressed during its use as shown in FIG. Then, the separating strip 5 is peeled off and opened, and the drug solution 7 is injected into the filling container 22, and the drug 8 is dissolved with the drug solution 7. The dissolving solution is returned into the container 2, and after dissolving and mixing, the medical container 1 is applied to a drip patient. In this case, in the case of the medicine 8 as a freeze-dried product, so-called bottles are connected, so that the exact titer,
The dissolution volume can be protected, and the accuracy is higher than that in the case where only the freeze-dried product is simply dispensed and filled with a spoon or the like, and the sterilization is sufficiently ensured.

Next, a second embodiment of the medical container according to the present invention will be described in detail with reference to FIGS. FIG. 7 is a sectional view of a second embodiment in which the medical container according to the present invention is packaged with a packaging material. FIG. 8 is a cross-sectional view of the temporary fixing means of the medical container of the second embodiment. FIG. 9 is a front sectional view of the medical container of the second embodiment. The medical container 31 of the second embodiment has substantially the same configuration and members as those of the medical container 1 of the first embodiment. The differences are as follows. As shown in FIG. 9, the resin container 32 of the medical container 31 is formed by cutting an inflation sheet at a predetermined length and completely sealing both ends by heat sealing. The resin container 32 is formed with two separating strips 5 that can be separated from the outside. The resin discharge port 33 and the connection port 34 are attached to the respective ends at the time of complete heat sealing at both ends. The filling container 35 is formed of a glass vial, and is fitted to the capsule 37 except for the mouth 36. A suspension is formed on the capsule 37. Also,
In the connection port 34, a support ring 101 is fixed to the inner wall surface of the port 34 in a liquid-tight manner, and a ring-shaped packing 102 is attached to the support ring 101. Ring packing 1
Reference numeral 02 denotes silicone rubber which is pressed against the opening 36 of the filling container 35. A hook 10 is provided around the connection port 34.
3 is formed, and the mouth portion 36 is engaged with the hook 103. Thus, the opening 36 of the filling container 35 is connected to the connection port 34 in a liquid-tight manner.

The medical container 31 is packaged in a gas barrier package 38, and a temporary fixing means 39 is arranged outside the package 38.
The inside is divided into packaging chambers 43 and 44 and temporarily fixed. And the oxygen absorber 4 together with the filling container 35 is contained in the packaging material 43.
5, 45 are arranged. The vial mouth 36 is aseptically fitted into the connection port 34 and is connected in a liquid-tight manner. The package 38 is formed of a gas barrier sheet obtained by laminating an aluminum foil on a resin sheet, and is formed by heat sealing a predetermined area. The oxygen absorber 45 stored in the packaging chamber 43 is made of a carbon dioxide-generating type oxygen absorber. The temporary fixing means 39 is composed of a holding clip, and is composed of a pair of plastic bars 46 and 47. Bar 46 and Bar 4
7 are rotatably connected to each other via a pivot pin 48 at one end. An engagement hole 61 is formed at the other end of the bar 46, and a locking claw 62 is formed at the other end of the bar 47. Further, a rubber member 63 is attached to each of the bar 46 and the bar 47, and an operation plate 64 is attached to the bar 46. The operation plate 64 is provided with a suspension hole 65.

Next, a method of manufacturing the medical container 31 will be described. First, an inflation molded sheet of linear low density polyethylene having a folding diameter of 75 mm and a thickness of 200 μm is cut into a predetermined length, and both ends are heat-sealed to form a resin container 32. At the time of heat sealing of both ends, the discharge port 33 and the connection port 34 are attached to respective ends. Next, isolation strips 5 and 5 composed of two weak seals are formed at predetermined positions of the resin container 32. Isolation strip 5,
After the formation of 5, the drug solution 7 is filled from the discharge port 33, and the discharge port 33 is closed with a rubber stopper. Next, the resin container 32 is placed in the package 38 having one end 40 sealed, and the temporary fixing means 39 is arranged outside the package 38. The temporary fixing means 39 is disposed so as to be located between the isolation strips 5, 5 of the resin container 32 in the package 38. The autoclave sterilization described above is performed with the provisional fixing means 39 provided. After sterilization, the division chamber 44 of the package 38 is dried, the end 41 is sealed, and the division chamber 44 is sealed.

On the other hand, a capsule 36 is attached to a filling container 35 containing a freeze-dried product, the outside of the filling container 35 is heated and sterilized with hydrogen peroxide gas, and a rubber stopper at the mouth 36 of the filling container 35 is placed in an aseptic atmosphere. Remove with. The end 4 of the package 38
0 is opened again by cutting or the like, and the mouth 36 of the filling container 35 from which the rubber stopper has been removed is liquid-tightly connected to the distal end of the connection port 34. In this case, the mouth portion 36 of the filling container 35 is inserted while expanding the hook 103 on the peripheral edge of the connection port 34 to the outside by elastically deforming the resin, and when the hook 103 is positioned at the neck of the mouth portion 36, the mouth portion 36 is elastically recovered. Lock the neck. At this time, the opening 36 of the filling container 35 is engaged while pressing the packing 102. After the oxygen absorbers 45, 45 are introduced into the divided chamber 43, the end 40 of the package 38 is sealed again to obtain the medical container 31. In such a manufacturing method, the connection port 34 and the second chamber 4 are sterilized by autoclaving, and the divided chamber 43 of the package 38 is
There is an advantage that the sterile state is maintained until the filling container 35 is connected by the sealed state of. Further, during the autoclave treatment, the connection port 34 and the inside of the second chamber 4 of the resin container do not become wet with water vapor or the like, so that drying is unnecessary.

The medical container 31 has not only the same functions and effects as those of the medical container 1 of the first embodiment but also the following remarkable functions and effects. Filling container 3
5 is a divided chamber 43 of the package 38 in which the oxygen absorber 45 is enclosed.
Because it is inside, it is not affected by oxygen or water vapor from the outside, so that the drug 8 does not deteriorate or denature during storage. Further, the moisture of the chemical solution 7 passes through the wall of the resin container 38 and exits to the division chamber 44. However, since the temporary fixing means 39 divides the division chamber 44 and the division chamber 43 of the filling container 35 in a liquid-tight manner, the passing moisture Does not affect the medicine in the medicine container 35. Further, in use, since the holding bar 46 of the temporary fixing means 39 is provided with a hanging hole 65 such as a bag, a necessary dose can be set after the chemical solution 6 and the chemical 7 are mixed. That is,
If it is not necessary to inject the whole mixed solution into the patient, first, the temporary fixing means 39 is re-arranged at an appropriate position of the resin container 32, and the resin container 32 is divided into two chambers to mix unnecessary volumes. The liquid is left on the filling container 35 side, the medical container 31 is bent and held by the temporary fixing means 39, and is hung on a drip stand or the like via the hanging hole 65. This allows for adjustment of the dose. It should be noted that a special scale or the like capable of such adjustment can be formed on the resin container 32. In the case of disposal, the filling container 35 which is a glass vial may be torn off by breaking the hook 103. In the above-described embodiment, the gas barrier sheet is a laminate of aluminum foil. However, the present invention is not limited to this. Any sheet that is difficult to transmit water vapor or oxygen gas can be used. Further, such a package 38 can be naturally applied to the first embodiment, and in the second embodiment, it can be sterilized by irradiation with an electron beam, ultraviolet light, or the like in the first embodiment. .

[0027]

As described above, the medical container according to the present invention has a plurality of chambers, and at least a part of the separating strip between the chambers can be opened from the outside. Or a resin container formed by a weak seal portion, a chemical liquid is stored in the first chamber, and a filling container of a chemical mixed with the chemical liquid is aseptically connected to at least the other second chamber. Therefore, it is possible to easily connect drug vials and the like in a state where the sterilization is guaranteed.

[Brief description of the drawings]

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

FIG. 2 is a sectional view of the resin container in the medical container of the first embodiment at the time of manufacture.

FIGS. 3A and 3B are cross-sectional views of a filling container in the medical container of the first embodiment during manufacturing.

FIG. 4 is a schematic view of an electron beam irradiation device used for the medical container of the first embodiment.

FIG. 5 is a sectional view of the medical container of the first embodiment at the time of manufacture.

FIG. 6 is a sectional view of the medical container according to the first embodiment in use.

FIG. 7 is a sectional view showing a medical container according to a second embodiment of the present invention housed in a packaging material.

FIG. 8 is a cross-sectional view of the temporary fixing means in the medical container of the second embodiment.

FIG. 9 is a front sectional view of the medical container of the second embodiment.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1, 31 Medical container 2 Resin container 3 First chamber 4 Second chamber 5 Isolation strip 7 Chemical solution 8 Drug 22 Filling container 101 Support ring 102 Packing 103 Hook

Claims (7)

[Claims] 1. A resin container having a plurality of chambers, wherein at least a part of a separation strip between the chambers is formed by a peel seal portion or a weak seal portion that can be opened from the outside, A medical container, wherein a medical solution is accommodated in one chamber, and a filling container of a drug mixed with the medical solution is aseptically connected to at least another second chamber. 2. A connection port is formed in the second chamber, and a peripheral edge of the connection port and a resin connection flange formed in the filling container are heat-sealed in a liquid-tight manner. Item 7. The medical container according to Item 1. 3. A connection port is formed in the second chamber, and a seal member made of an elastic material is disposed around a periphery of the connection port, and the port of the filling container presses the seal member while pressing the seal member. The medical container according to claim 1, wherein the medical container is detachably engaged with a peripheral edge of the medical container. 4. The method for manufacturing a medical container according to claim 1, wherein the isolation strip portion is formed in the resin container, and a chemical solution is accommodated in the first chamber, and then the chemical solution is autoclaved together with the resin container. Thereafter, the method further comprises aseptically connecting the filling container to the second chamber to manufacture the medical container. 5. The aseptic connection of the filling container, wherein the connecting portion of the filling container has been subjected to at least one of chemical sterilization, heat sterilization, and irradiation sterilization. A method for producing a medical container according to claim 4. 6. The method for manufacturing a medical container according to claim 4, wherein the second chamber after the connection of the filling container is sterilized by irradiation. 7. The method for producing a medical container according to claim 5, wherein the irradiation sterilization is electron beam irradiation sterilization or ultraviolet irradiation sterilization.