JPH1043271A - Medical container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To simplify aspetic connection by providing a medical fluid storing chamber and a chamber for mixing a medical fluid with a medicine, and aseptically a filling container filled with a medicine to the mixing chamber. SOLUTION: This medical container 1 is formed by a resin container 2 provided with plural chambers 3, 4 which are opened from the outside and separated from each other by a separating bar part 5. A medical fluid 7 is accommodated in the chamber 3. A filling container 22 filled with a medicine 8 mixed with the medical fluid 7 is aseptically connected to the chamber 4. The filling container 22 is provided with a communicating means 25 for aseptic communication with the interior of the chamber 4. At the time of use, a rod 27 is pushed down to remove a tap member 29, thus communicating the filling container 22 with the chamber 4. Subsequently, the chamber 3 is pressed to separate the separating bar part 5 to unseal. Thus, the medical fluid 7 is poured into the filling container 22 to dissolve the medicine 8. Subsequently, the dissolved solution is returned to the container 2, and the medical container 1 is applied to a drip- infused patient. Thus, factor is accurate, and aseptic communication is surely possible.

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 device capable of easily aseptically mixing a drug solution in a resin container and a drug in a filling container when used. TECHNICAL FIELD The present invention relates to a medical container capable of simply and aseptically joining a resin container and a filling container to each other.

[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. Also, a method of dispensing a predetermined amount from a large amount of freeze-dried product into the second chamber using a measuring spoon can be considered, but in such a method, the cake of the freeze-dried product is not 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 resin container, wherein a chemical solution is contained in the first chamber, and a filling container for a drug mixed with the chemical solution is aseptically joined to at least another second chamber, and the used filling container is used for the filling container. In this case, the above object has been achieved by providing a medical container provided with a communicating means for aseptically communicating the inside of the filling container and the second chamber.

[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 filling container is required to be joined 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 joining resin member, and it 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 bonded 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 is provided with communication means. The communication means is a means for opening a joint wall or a joint surface between the second chamber and the filling container when used, and aseptically communicating means that the inside of the filling container and the second chamber are kept liquid-tight. In this state, the filling container and the second chamber are communicated. The filling container sterilized in the sterile room and the second room sterilized by the autoclave are aseptically joined.
Aseptic bonding may generally be performed in a sterile room. In addition, in order to ensure sterility assurance, various sterilization processes may be performed on the joint surface of the filling container and the second chamber before joining.

[0008] In the medical container constructed as described above, first, when using the medical container, the communication means connects the second chamber and the inside of the filling container. Then, pressure is applied to the inside of the resin container to open the isolation strip. Thereby, the inside 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 outer wall surface of the filling container joined to the second chamber can be easily maintained aseptic, so that the filling container can be easily aseptically joined, and can be heat-sterilized, chemically sterilized, or γ-ray or electron beam. , And sterilization by irradiation with ultraviolet rays, etc., can be easily performed. 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. In addition, since the medicine in the filling container is not transferred and charged into the resin container, the freeze-dried product 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 predetermined amount from a large amount of freeze-dried product into a filling chamber using a measuring spoon.

A medical container according to a second aspect of the present invention is intended to specifically provide means for communicating a filling container in the medical container according to the first aspect,
3. The medical container according to claim 2, wherein the filling container has a connection port with the second chamber, and the communication means includes:
A plug member for covering the connection port, and an operation bar connected to the plug member, the operation bar being pressed from outside the filling container, and pressing the operation bar to close the connection port with the plug member. It is characterized by being open to the public. By providing a connection port in the filling container, disposing a plug member of the communication means in the connection port, and arranging the operation bar of the communication means so that the operation bar can be operated from outside the filling container, the inside of the filling container and the second chamber to the outside world. The plug member can be removed from the connection port by operating the operation bar without opening the plug member. Therefore, at the time of use, the inside of the filling container and the second chamber can be aseptically communicated.

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 filling container is manufactured by aseptically joining 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 filling container having a filling port and a connection port is prepared. A plug member of the communication means is attached to the connection port in a liquid-tight manner, and the plug member is provided so as to be removable from the connection port to the outside. The solution of the drug is passed through a sterilization filter and filled into a sterilized or aseptic-filled filling container through a filling port. Next, the stopper is attached to the filling port 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. The plug has a structure that allows operation of an operation bar or the like of the communication means. 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 joined under an aseptic atmosphere. First, the connection port portion of the filling container and the outer surface of the plug member are maintained in an aseptic state, and the connection port is inserted into the second chamber in a heel state to join the second chamber and the filling container. At the time of joining, the members can be joined in a liquid-tight manner by thermal welding of the resins. In such a manufacturing method, the second chamber, the inside of the filling container and the mouth thereof can be easily and easily maintained in a sterile 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 joint of the filling container can be made in a preferable form, simple and liquid-tight joining with a reduced number of parts can be achieved. In addition, at the time of joining, chemical sterilization, heat sterilization, irradiation sterilization, and the like, which will be described later, can be locally performed, so that the assurance of sterilization of such a joint can be further improved.

[0012] According to a fourth aspect of the present invention,
It is an object of the present invention to sufficiently assure sterility when the filling container and the second chamber are joined in the production method according to the third aspect. That is, in the manufacturing method according to the fourth aspect, at least one of a chemical sterilization process, a heat sterilization process, and an irradiation sterilization process is performed on the joint portion of the filling container or the resin container. 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 is performed at a temperature of 110 ° C. or higher for a predetermined period of time. However, the heat sterilization process has a drawback that it takes a long time because the heating temperature is limited because the joint is a resin member. For this reason,
If the resin member has considerable heat resistance, it will be an effective sterilization process. The irradiation sterilization process is a process using irradiation beams such as γ-rays, ultraviolet rays, and electron beams.

According to a fifth aspect of the present invention, there is provided a manufacturing method comprising:
When the filling container and the second chamber are joined in the manufacturing method according to the third aspect, the sterility of the second chamber may not be completely guaranteed. Things. That is, in the manufacturing method according to the fifth aspect, the second chamber after the joining of the filling container is sterilized by irradiation. Irradiation rays include gamma rays, ultraviolet rays, electron beams, and the like. The production method according to claim 6 of the present invention aims to provide a sterilization method capable of performing a large-scale line processing with simple equipment, out of the irradiation sterilization treatment in the production method according to claim 5. is there. That is, the manufacturing method according to claim 6 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 13000μm a thickness of water (specific gravity 1g / m ^2). 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 and low energy type 1 MeV or less,
In particular, a low-energy type accelerating voltage device of 500 KV or less is desirable.
g / m ^2, for about 800 g / m ² of low energy type is the limit, the thickness of the electron beam transmittance in the resin material 1600μ
m, especially 800 μm, is the optimum limit. From this, electron beam sterilization is performed if the accelerating voltage is less than 1 MeV, especially if the low energy type is 500 KV to 50 KV.
While a certain permeability of the electron beam can be obtained, there is almost no emission of X-rays or the like, so that no shielding facility is required and the device can be arranged compactly on a production line. That is, the permeability of the electron beam at an acceleration voltage of 500 KV is about 800 g / m ^2.
In the following, sufficient permeability can be obtained particularly in a thin resin portion of 800 μm or less.

Therefore, in the case where the irradiation part is directly sterilized by irradiation or the irradiation part is sterilized through the container wall of the second chamber, the thickness of the filling container is considered in consideration of the effect of the medicine in the filling container. Is much larger than the above range, especially 3 mm or more, and the thickness of the resin container wall is preferably smaller than the above range. In the sterilization of microorganisms,
As described in Japanese Patent Application Laid-Open No. 7-16286, B. pumilus (spores) E-601 which is an indicator for
It has a D value of Mrad (2 kGy). 1 cm ² per Although bacteria typically 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) has a survival rate of 10 ^-6 %. Therefore, the electron beam irradiation device 50 in the present embodiment has the filling container 22 or the second chamber of 6 × 0.2 Mr.
The amount of electricity and the conveyor speed are adjusted so that sterilization is performed at a rate of at least ad, preferably at least 8 × 0.2 Mrad.

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 · s
It is adjusted so that the ultraviolet ray amount of ec / 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 medical container of the first embodiment in use. FIG.
(A) And (B) is sectional drawing of the filling container in the medical container of 1st Example at the time of manufacture. FIG. 4 is a schematic diagram of an electron beam device used for the medical container of the first embodiment. FIG.
As shown in FIG. 4 to FIG. 4, the medical container 1 of the present embodiment has a plurality of chambers 3 and 4, and an isolation strip 5 between the chambers 3 and 4 is formed by a seal that can be opened from the outside. The resin container 2. In the first chamber 3, a drug solution 7 is stored, and in at least the other second chamber 4, a filling container 2 for a drug 8 mixed with the drug solution 7.
2 is aseptically joined, and the filling container 22 is provided with a communicating means 25 for aseptically communicating the inside of the filling container 2 and the inside of the second chamber 4.

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 outlet 9 is provided with a plug 10 through which a drip needle is pierced.
And the stopper 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 off when the pressure in 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 for dissolving a drug which is a freeze-dried product described later, and the physiological saline is filled in the first chamber 3 through a sterilization filter.

A connection port 12 is formed in the resin container 2, and a flange 13 is formed in the connection port 12. A hanging wire 14 is attached to the flange portion 13 and the wire 1
Numeral 4 is made of resin, and both ends are thermally welded to the flange 13. A filling container 22 is joined to the connection port 12, and the filling container 22 is disposed with the lower end portion placed in the second chamber 4. The filling container 22 is made of an injection-molded product of polypropylene.
The bottom is opened as shown in FIG.
Is provided so that it can be removed. 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 filling port 23 is closed by a rubber stopper 24 in a liquid-tight manner. The connecting means 25 includes an operation bar member 26 integrally formed with the above-described plug member 29 and an operation bar member 26.
And a protective cover 28. The tip of the pusher 27 is inserted through the through hole 30 of the rubber plug 24 in a liquid-tight and slidable manner. The presser 27 and the protective cover 28 are joined in a liquid-tight manner, and the protective cover 28 is fitted in the filling port 23 in a liquid-tight manner. The inner wall at the distal end of the connection port 12 and the lower portion of the filling container 22 are fixed to each other by ultrasonic heat welding.
Is liquid-tightly aseptically joined in the second chamber 4. Filling container 2
The medicine 2 is filled in the medicine 2, and the medicine 8 is a dry product obtained by freeze-drying an aseptically 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. The chemical solution 7 is filled from the outlet 9, and the stopper 10 and the 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, first, the plug member 29 is inserted into the connection port on the bottom surface of the filling container 22, and the tip of the operation bar member 26 is protruded. In this state, the filling container 22 is aseptically filled with the medicine 8. Drug 8 as a lyophilized product
First, the solution of the drug 8 is passed through a sterilization filter to open the opening 23.
Fill from. Next, the plug 2 is inserted into the filling port 23 in a half-stopped state.
4, the tip of the operation bar member 26 is aligned with the through hole 30, 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 24 is completely stoppered in a freeze-dried state.

After the filling, the resin container 2 and the filling container 22 are maintained in an aseptic atmosphere. The bottom of the filling container 22 is inserted into the connection port 12 of the resin container 2 and fixed to each other in a liquid-tight manner by ultrasonic thermal welding. Next, the rod 27 is mounted on the mounting hole of the operation bar member 26, and a flexible protective cover 28 is further mounted on the peripheral edge of the base end of the rod 27, so that the outside of the plug 24 is made liquid-tight. Further, the hanging wire 14 is attached to the flange 13 of the connection port. Thereby, the medical container 1
Is manufactured. When joining the resin container 2 and the filling container 22, if necessary, the plug member 29 and the outer surface near the joint are treated with hydrogen peroxide water vapor to sterilize the joint. Such a treatment can sufficiently and easily achieve sterility assurance at the time of joining. When connecting the resin container 2 and the filling container 22, if necessary, the plug member 29 may be used.
Then, the outer surface near the joint is subjected to a heat treatment to sterilize the joint. Such a treatment can increase the sterility assurance at the time of joining. Further, when connecting the resin container 2 and the filling container 22, if necessary, the plug member 29 and the outer surface near the joint are irradiated with ultraviolet rays to sterilize the joint. Such a treatment can increase the sterility assurance at the time of joining.

When joining the resin container 2 and the filling container 22, if necessary, the stopper member 29 and the outer surface near the joint can be sterilized by the above-mentioned electron beam irradiation. As shown in FIG. 4, the electron beam irradiation device 50 is provided above the belt conveyor 51, and includes a machine frame 52, a window frame 53 formed on the machine frame 52, a window foil 54 attached to the window frame 53, and a window frame. 53
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 and a gun frame 5.
8 and a filament 59. Filament 5
9 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 emitted from the window foil 54 onto the conveyor 51. 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 treatment can sufficiently and easily achieve sterility assurance at the time of joining. Furthermore, even after joining, 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 and the medicine 8
There is no risk of decomposition.

Next, the use of the medical container 1 according to the present embodiment will be described. In the medical container 1 according to the present embodiment thus configured, as shown in FIG.
Press down. Thereby, the flexible protective cover 28 is bent, and the operation bar member 26 moves downward. Then, the plug member 29 is withdrawn from the connection port toward the second chamber 4, and the filling container 22 and the second chamber 4 are communicated. next,
The first chamber 3 is pressed to peel off and open the isolation strip portion 5, 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, since the so-called bottle 8 is connected to the freeze-dried drug 8, the accurate titer and dissolution volume can be protected, and only the freeze-dried product is simply dispensed and filled with a spoon or the like. This is more accurate than is the case, and the sterilization assurance is also sufficient due to the simple structure of the joint. Further, the communication means 25 can aseptically and surely communicate the inside of the filling container 22 with the second chamber 4.

Next, a second embodiment of the medical container according to the present invention will be described in detail with reference to FIGS. FIG. 5 is a sectional view of a second embodiment of the medical container according to the present invention. FIG. 6 (A)
And (B) is a sectional view of the filling container of the second embodiment. 7 and 8 are sectional views of the medical container according to the second embodiment in use. 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. 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 36 and 37 by heat sealing. Further, the resin container 32 is formed with an isolation strip 35 that can be peeled from the outside. The resin discharge port 38 and the connection port 39 are provided at both ends 36, 37.
Are attached to the respective ends at the time of complete heat sealing. A protective film 40 is formed in the opening of the connection port 39, and the surface of the protective film 40 can be easily sterilized.

The filling container 41 is a resin vial, and a rubber stopper 44 is liquid-tightly attached to a connection port at the bottom. The communication means 43 includes the plug 44 and the communication needle 45. The plug 44 is pierced by the communication needle 45 during use. The communication needle 45 is disposed so as to be able to move downward in the filling container 41, and its body is supported by a through hole of the rubber plug body 42 of the filling port. The operation base end of the communication needle 45 is covered with a liquid-tight sheath 47 and further surrounded by a safety cap 46. The safety cap 46 is fixed to the filling port of the filling container 41, and a cutout 49 for cutting is formed in the body of the safety cap 46. The surface of the protective film 40 between the surface of the plug 44 of the filling container and the connection port 39 is aseptically connected after being sterilized by the above-described ultraviolet irradiation or electron beam irradiation.

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 at both ends, a discharge port 38 and a connection port 39 are attached to each end. Next, at a predetermined position of the resin container 32, an isolation strip 35 formed of a single weak seal is formed. After the formation of the isolation strip 35, the chemical solution 7 is filled from the discharge port 38, the discharge port 39 is closed with a rubber stopper, and the connection port 39 is closed with the protective film 40. Then, the resin container 32 is subjected to an autoclave sterilization process.

On the other hand, a stopper 44 is attached to the filling container 41,
The solution for freeze-drying is filled, and then the rubber stopper 42 having the communication needle 45 inserted through the through-hole is attached to the filling port of the filling container 41 in a half stoppered state as shown in FIG. In this state, the freeze-drying process and the rubber stopper 42 are completely stoppered. In addition, a liquid-tight sheath 47 is previously put on the operation end of the communication needle 45 on the rubber stopper 42, and is attached to the surface of the rubber stopper 42 in a liquid-tight manner. Then, the safety cap 46 is further inserted and set in the filling port of the filling container 41. The electron beam irradiation sterilization process described above is performed on the protective film 40 at the connection port 39 of the resin container 32. Further, the above-mentioned ultraviolet irradiation sterilization treatment is performed on the surfaces of the plugs 44 at the top and bottom of the filling container 41. After such a treatment, the two are joined and joined completely and liquid-tightly by heat welding.

In such a medical container 31, the following remarkable functions and effects are observed in addition to the same functions and effects as those of the medical container 1 of the first embodiment. At the time of its manufacture, the protective film 40 and the filling container 41 which are the joining portions of the resin container 32
Can easily and reliably be joined under sterile or aseptic conditions. In particular, reliable sterilization can be achieved by employing the above-described electron beam or ultraviolet irradiation sterilization method. Also, during storage, there is no adverse effect from the rubber stopper 44 at the joint. In use, as shown in FIG. 7, first, the tip of the safety cap 46 is separated along the cut 49. In this state, the proximal end of the communication needle 45 is moved down through the liquid-tight sheath 47. Thereby, as shown in FIG. 8, the distal end of the communication needle 45 pierces the stopper 44 and the protective film 40, and connects the inside of the filling container 41 and the inside of the second chamber 34. Then, the separating strip 35 is opened, and the drug solution 7 in the resin container 32 and the drug 8 in the filling container 41 are opened.
And mix. Therefore, as in the first embodiment, aseptic communication can be performed, and the number of parts can be relatively reduced. Although the filling port is provided in the filling container in each of the above embodiments, the present invention is not limited to this. With the present invention, the filling port is used as a connecting port, and a communication means having a structure in which an operation port and the like are provided in addition to the communication port is provided. It may be a filled container.

Next, a modification of the filling container used in the second embodiment will be described with reference to FIGS. The filling container 61 shown in FIGS. 9 and 11 has a substantially cylindrical main body 62 made of a transparent resin, and a filling port plug 63 slidably disposed at openings at both ends of the main body. , An operation port plug 64, an operation bar 66 fixed to the insertion hole 65 of the operation port plug 64, and a stopper 67 for preventing the operation port plug 64 from being removed. The main body 62 is a cylindrical body made of a heat-resistant, cyclic olefin-based resin having an ultraviolet blocking effect and having a side wall thickness of 4 mm and a length of 50 mm. The plugs 63 and 64 are made of silicone rubber, have a predetermined elastic force, and are slidably mounted by urging the inner wall surface of the main body 62. When assembling such a filling container 61, as shown in FIG. 9, first, the operation bar 66 is attached to the operation port plug 64, and the operation port plug 64 is attached to the main body 6.
3 is fitted in the operation port in a liquid-tight manner. Next, a stopper 67 for preventing removal is fixed to the main body 62 by heat welding. Body 63
A predetermined amount of a solution for freeze-drying is filled from the filling port of the main body 62, and the filling port is half-plugged with the filling port plug 63 having the operation bar 66. In this state, the filling container 61 is transported to a freeze-drying apparatus, and after freeze-drying, the filling port plug 63 is completely stoppered.

As shown in FIG. 10, the filling container 61 is joined to the connection port 73 of the resin container 72 with the surface of the filling port plug 63 sterilized and sterile. Connection port 7
A holding member 74 is provided in the inside 3, the bottom surface of the holding member 74 is formed as a receiving portion of the filling port plug 63, and communication holes 75, 75 are formed in the side wall surface. The resin container 72
Although not shown, it has substantially the same configuration as the resin container of the medical container of the second embodiment. When connecting the filling container 61 and the connection port 73, first, the filling container 61 and the resin container 72 are maintained in a sterile room, and the surface of the filling port plug 63 of the filling container 61 and the connection port 73 of the resin container 72 are connected. Is aseptic. Before joining, the surface of the filling tip 63 is sterilized with hydrogen peroxide, and the connection port 73 is sterilized by electron beam irradiation. After such sterilization, the holding member 74 is heat-welded to the flange surface of the connection port 73. Further, the flange surface of the filling container 61 is heat-fixed to the upper surface of the holding member 74 in a liquid-tight manner.

In the medical container 61 having such a structure, aseptic joining can be performed easily and easily as in the first and second embodiments. In operation during use, the operation bar 66 is moved downward from the outside of the filling container 61. As a result, the filling port plug 63 at the lower end is pressed, and the filling port is opened. Thereby, the second chamber of the resin container 72 and the inside of the filling container 61 can be communicated via the communication hole 75 and the filling port, and the chemical solution and the chemical can be mixed smoothly. Further, in order to check the sterilization guarantee of the medical container 61, instead of the drug solution 7, a thioglycolic acid medium for sterility test is filled in the first chamber of the resin container and sterilized in an autoclave. Filling container 61 by method
To join. When the isolation strip portion of the medical container 61 was opened and cultured for two weeks, no bacterial growth was observed.

[0031]

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, the first chamber contains a drug solution, and at least another second chamber is aseptically joined with a drug-filled container mixed with the drug solution, Since the filling container is provided with a communicating means for aseptically communicating the inside of the filling container and the second chamber, it is possible to easily and aseptically connect a vial or the like of the medicine.

[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 medical container according to the first embodiment in use.

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 a medical container according to a second embodiment of the present invention.

FIGS. 6A and 6B are cross-sectional views of a filling container in the medical container of the second embodiment at the time of manufacture.

FIG. 7 is a sectional view of a main part of the medical container of the second embodiment at the time of use.

FIG. 8 is a sectional view of the medical container according to the second embodiment in use.

FIG. 9 is a sectional view showing a modified example of the filling container used for the medical container according to the present invention.

FIG. 10 is a sectional view of the filling container of FIG. 9 before operation.

11 is a sectional view of the filling container of FIG. 9 during operation.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1, 31, 61 Medical container 2 Resin container 3 First room 4 Second room 5 Isolation strip 7 Chemical solution 8 Drug 22 Filling container

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁶ Identification number Agency reference number FI Technical display location B65B 55/16 B65D 81/32 D B65D 81/32 A61J 1/00 390P

Claims (6)

[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 medicine solution is contained in one chamber, and a filling container of a medicine mixed with the medicine solution is aseptically joined to the other at least the second chamber, and the filling container and the second chamber are connected to the filling container. A medical container provided with a communicating means for aseptically communicating. 2. A connection port with the second chamber is formed in the filling container, and the communication means includes a plug member covering the connection port, and an operation bar connected to the plug member. The medical container according to claim 1, wherein the operation bar is pressed from outside the filling container, and the connection port is opened from the plug member by pressing the operation bar. 3. 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 stored in the first chamber, and then the chemical solution is autoclaved together with the resin container. Thereafter, the method further comprises aseptically joining the filling container to the second chamber to produce the medical container. 4. The medical device according to claim 3, wherein at least one of a chemical sterilization process, a heat sterilization process, and an irradiation sterilization process is performed on the joint between the filling container and the resin container. Method for manufacturing containers for packaging. 5. The method for producing a medical container according to claim 3, wherein the second chamber after the joining of the filling container is sterilized by irradiation. 6. The method for producing a medical container according to claim 4, wherein the irradiation sterilization is electron beam irradiation sterilization or ultraviolet irradiation sterilization.