JPH0910283A - Container for medical treatment with juncture for easy sterilization - Google Patents

Abstract

PURPOSE: To make it possible to easily sterilize the juncture of a container and a container by forming the resin end extended from the peelable sealing part which is disposed in part of a container body and is unsealable from the outer side as a juncture for easy sterilization, subjecting this juncture for easy sterilization to sterilization by irradiation with UV rays and specifying the thickness of the resin end to a specific value. CONSTITUTION: A dissolving liquid 3 for medicines is filled into the plastic container body 2 of the container 1 for medical treatment with the juncture for easy sterilization. The container 1 for medical treatment is constituted by forming the peelable sealing part 11 which is unsealable from the outer side of the container body 2 at the container body 2 via a cylindrical sheet 10 and connecting the juncture 5 for easy sterilization of the extended resin end extended further from the thinly formed part 11 of the seal so as to communicate liquidtightly with the inside of another medicine container 21 and is subjected to the sterilization by the irradiation with the UV rays. The resin end is formed to a thickness of 100 to 10μm and the cylindrical sheet 10 is formed of a polyolefin resin which has UV transmittance of >=60% at a wavelength of 250nm and a thickness of 10μm and a resin density of 0.95 to 0.85g/cm<3> .

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container with a communication passage for easy sterilization and a method for sterilizing the same, and more specifically, when aseptically adjusting two or more drugs immediately before use. The present invention relates to a medical container with a connecting portion including a communication portion or a connecting portion.

[0002]

2. Description of the Related Art Bags for infusions and the like used for intravenous injection,
Medical containers such as containers are generally resin containers. In addition, some medical containers are connected to vials or the like of drugs such as antibiotics that cannot be sterilized under high-pressure steam, and others are separately stored until immediately before use, and the containers are connected or communicated during use. Further, in the former case, there is one in which a medical container and a drug vial are connected in advance, and there is a proposal of a drug kit or the like in which a communication part between the drug container and the medical container body is sterilized. Further, in the latter, there is a proposal to store the drug solution separately, such as one in which the medical container is divided into two or more chambers by a so-called peelable seal portion.

In addition to the above-mentioned peelable seal portion (peel seal portion) that makes two chambers into one chamber, there have been proposed a number of communication means capable of communicating from the outside. For example, a so-called click chip (Japanese Patent Publication No. 63-20550) provided with a mechanism that is formed from a closed-type resin tubular material and is capable of communicating inside the tubular material by breaking it off inside the container, inside the communication passage. Which has a closing mechanism provided on a communicating needle that pierces a rubber stopper such as a drug vial, and the closing mechanism is opened when the communicating needle is pierced (Japanese Utility Model Publication No. 3-73307), which is communicated within the container body Various things have been proposed, such as one in which a needle is held and a container is communicated with each other by piercing a rubber stopper or the like of a drug vial by an operation from outside the container (JP-A-6-254136).

Further, in a medical container in which two chambers are formed into one chamber by a peel seal portion, it is impossible to sterilize the inside of the communication passage, but a kit type medical container for connecting a drug vial which is commercially available in the past In the container, it is necessary to sterilize or sterilize the inside of the communication passage. Examples of such sterilization treatment of the communication passage include gas sterilization of ethylene oxide, chemical agent sterilization with hydrogen peroxide, ultraviolet ray and gamma ray sterilization, and heat sterilization. Further, as a recent technique, a sterilization method using an electron beam to sterilize the surface of a syringe has been proposed (JP-A-7-16286). This is one in which ozone is generated by an electron beam to enhance the bactericidal effect.

Regarding the drug kit, there has been proposed a one-bag type medical container having no communication passage that makes two chambers aseptically one chamber (9th Pharmaceutical Packaging Symposium: Abstracts). This is because the middle of the bag is divided into two chambers with a peel seal part, one chamber is first filled with a solution and subjected to high-pressure steam sterilization, and then the other upper chamber is sterilized by freeze-drying a drug such as an antibiotic. It is to be filled. Since such a medical container has no communication passage, there is no concern about sterilization of the communication passage.

[0006]

However, the conventional medical containers have the following problems. When the communication passage is treated with ethylene oxide gas or treated with hydrogen peroxide or the like, the treatment agent remains in the communication passage, which causes problems such as removal of the treatment agent. Since the communication passage has conventionally been a thick resin communication passage, even if the communication passage is sterilized with ultraviolet light,
The sterilization guarantee may not be obtained sufficiently. When gamma-ray sterilization is performed on the communication passage, the equipment becomes large-scale, and local treatment of the communication passage also involves difficulty.
Furthermore, since it is a batch type, it cannot be flowed on the production line. When the communication passage is subjected to heat sterilization, the operation during the treatment is complicated, and quality control on equipment is difficult. Further, in recent electron beam irradiation sterilization, even if the sterilization treatment is simply used, since a communication needle or the like is used in the communication portion, sterilization of only the surface such as a conventional syringe becomes insufficient. Further, since the conventional communication passage is a resin molded product and has a wall thickness of about 3 mm, the electron beam cannot penetrate into the communication passage.

[0007] Further, in the medicine kit in which the two chambers are made into one room and the communication passage is unnecessary, there is a problem that the equipment is duplicated and it is difficult to manage the filling of the medicine container in manufacturing. For example, a penicillin antibiotic and a cephalosporin antibiotic cannot be filled and sealed in a drug container at the same place. This is because if such different drugs are filled in the same building or the like, there is a risk of causing contamination and the like, and it becomes impossible to manage resistant bacteria when used in a hospital. Therefore, in a drug kit having two chambers as one chamber, different antibiotics must be manufactured in separate buildings, and a complete filling and manufacturing facility must be individually provided depending on the type of drug.

Therefore, the object of the present invention is to facilitate the sterilization of the connecting portion between the containers and to control the production of each drug container connected at the time of production, thus requiring a great deal of duplicate equipment. Not to propose a medical container with a connection part for easy sterilization.

[0009]

According to the present invention, a plastic container main body is filled with a dose, and another drug container is connected or communicated with the drug, and the dose is mixed with the other drug at the time of use. In a medical container, at least a part of the container body has a peelable seal portion that can be opened from the outside, and a resin end portion further extending from the peelable seal portion has a connection portion for easy sterilization. The connection part for easy sterilization is connected so as to be in fluid-tight communication with the inside of the other drug container, irradiation sterilization is performed with ultraviolet rays, and the thickness of the resin end part is 100 μm to 10 μm. By providing a characteristic medical container with a connection part for easy sterilization,
The above object has been achieved.

In the medical container with an easily sterilizable connecting portion of the present invention, the resin of the easily sterilizing connecting portion has an ultraviolet transmittance at a wavelength of 250 nm of 60% or more at a thickness of 10 μm and a density of 0.95 to 0. It is characterized by being a polyolefin resin in the range of 0.85 g / cm ³ . In the medical container with a connection part for easy sterilization of the present invention, a resin member or a resin layer which is not heat-sealed during the communication connection is provided in the resin end part of the connection part for easy sterilization. . In the medical container with a connection part for easy sterilization of the present invention, the peelable seal part is formed in a tubular or tubular thin resin member provided in communication with the container body, and the thin resin member is It is characterized in that it is connected so as to communicate with the inside of the other drug in a liquid-tight manner.

The present invention also relates to sterilization of a medical container in which a plastic container main body is filled with a dosage substance, another drug container is connected or communicated with the drug product, and the drug is mixed with the other drug at the time of use. In the method, at least a part of the container body is formed with a peelable seal portion that can be opened from the outside, and a resin end portion is present at a position further extending from the peelable seal portion, A connection part for easy sterilization, characterized in that the resin end part is adhered so as to communicate with the inside of the other drug container in a liquid-tight manner, and the resin end part extending from the peelable seal part is subjected to ultraviolet irradiation sterilization. The above object is achieved by providing a method for sterilizing an attached medical container.

The sterilization method of the present invention is characterized in that the resin end portion is subjected to ultraviolet irradiation sterilization by a high power ultraviolet sterilizer of 200 w to 1 kw. In the sterilization method of the present invention, the resin end face is irradiated at a distance within 25 mm from the irradiation window of the high-power ultraviolet sterilizer.

[0013]

In the above-mentioned medical container, as shown in FIG. 1, the sheet of the mouth portion of another drug container is inserted into the tubular thin resin sheet of the easily sterilizable connecting portion. The resin end of the tubular sheet, which is the connection portion for easy sterilization, and the mouth (thin resin end) of the drug container are liquid-tightly heat-sealed, and the containers are in communication with each other. In such a connected state, as shown in FIG. 4, the easily sterilizing connection portion is irradiated and sterilized. Irradiation sterilization is ultraviolet irradiation. Since the easy sterilization connection portion is configured as a communication passage formed of a thin sheet or the like, the sterilization of the inside can be surely easily sterilized by ultraviolet sterilization. In ultraviolet sterilization, when the thickness of the resin sheet exceeds 100 μm, most of the ultraviolet rays are blocked by the sheet, but since the thickness is 100 μm or less, it is possible to transmit the ultraviolet rays to the inside of the resin end, and the time and light source position The amount of ultraviolet rays is adjusted to about 35 mW / cm ² or more by adjusting and, and the connection part for easy sterilization can be sterilized in a short time by a high-power ultraviolet device.

Further, in the easily sterilizing connection portion, the filling liquid from the container body does not penetrate due to the existence of the peelable seal portion, and the filled administration liquid is not affected by the irradiation rays. Since the easily sterilizable connection portion is formed of a thin resin sheet or the like as described above, sterilization of the inside is ensured if it has the above-mentioned permeability. Being able to sterilize with irradiation rays is different from conventional gas sterilization, hydrogen peroxide sterilization, heat sterilization, etc.
If the equipment is simple and compact and the UV irradiation device is compact, it can be flowed on the production line. Moreover, it has no effect on the dose in both connected containers. Further, since the building for filling the container body with the dose and the filling of the dosage for other drug containers with the dose building can be done in separate buildings, the drug containers for each product type are manufactured and stored in a separate building, and the container body and the drug container are separated at the time of manufacture. Can be placed on the docking line, so there is no need for duplicate filling equipment for container bodies. In addition, it is easy to manage various drugs.

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A preferred embodiment of a medical container with a connection part for easy sterilization according to the present invention will be described in detail below with reference to the accompanying drawings. FIG. 1 is a sectional view of a first embodiment of a medical container with a connection part for easy sterilization according to the present invention, and FIGS. 2 (A) and 2 (B) are I of FIG.
A cross-sectional view taken along the line -I and a cross-sectional view taken along the line II-II. Fig. 3 is a schematic view of an ultraviolet device for sterilizing the connection part of the medical container with a connection part for easy sterilization of the first embodiment, Fig. 4 Is a plan view showing an irradiation part of the first embodiment, and FIG. 5 is a sectional view showing a state of the first embodiment when in use.

As shown in FIGS. 1 to 5, a medical container 1 with a connection part for easy sterilization of this embodiment is a plastic container body 2
Is filled with the solution 3 of the drug as the administration substance, and another drug container 21 is connected or communicated with the solution 3 and the other drug 22 is mixed with the solution 3 at the time of use. The medical container 1 has a seal portion 11 that can be opened and peeled from the outside of the container body 2.
Is formed on the container body 2 via the tubular sheet 10, and the resin end portion is further extended from the thin-wall forming portion 11 of the peelable seal, and the extended resin end portion is used as the easy sterilization connection portion 5. ,
The easily sterilizing connection portion 5 is connected so as to be fluid-tightly connected to the inside of the other drug container 21 and irradiation sterilization by ultraviolet rays is performed, and the thickness of the resin end portion is 100 μm to 10 μm.

The present embodiment will be further described. The easily sterilizable medical container 1 with a connecting portion according to the present embodiment will be described in more detail. The container body 2 of the medical container 1 is an atypical flexible resin container. Consists of. Specifically, in this embodiment, the container body 2 is formed of two sheets produced by extrusion molding a mixed composition of low density polyethylene and polypropylene. That is, such a sheet is cut into a predetermined length, and its peripheral edge is completely adhered and sealed by heat welding. The discharge port 4 made of a resin molded product and the tubular sheet 10 are attached to the peripheral end seal portion 2A together with heat welding.
In the present embodiment, low-density polyethylene or the like is used as the resin container, but if it is a flexible heat-sealable resin container,
Not limited to such resins, for example, linear low-density polyethylene resin, high-density polyethylene resin, polypropylene resin, soft polyester resin, chlorinated polyethylene resin, vinyl chloride resin, ethylene-vinyl acetate copolymer, etc. A material rich in properties can be used. However, since the container body 2 contains a drug solution 3 such as a drug solution, a mixed drug solution, or an infusion solution, among them, a polyolefin resin such as a low-density polyethylene resin, a linear low-density polyethylene resin, or a polypropylene resin is used. Is preferable because it has excellent chemical resistance, a small amount of eluate in the solution, is inexpensive, and is economical. Incidentally, the resin sheet may be a multi-layer film, in particular, a polyethylene resin layer is multi-layered,
A laminated sheet in which the inner layer is thinner than the outer layer to weaken the strength may be used.

The tubular sheet 10 can be made of the same material as the container body 2, and in this embodiment, the container body 2 is used.
Similar sheets are used. However, the tubular sheet 10 is thinner than the sheet of the container body 2 and has a thickness of 100
It is desirable that the thickness is 10 μm or less, particularly 50 μm or less and 30 μm or more. In the case of ultraviolet irradiation sterilization, the resin sheet is preferably thin because the permeability of the substance is limited. On the other hand, when the sheet is too thin, the sheet may be broken without mechanical strength, and the above range is preferable. In this embodiment, the cylindrical sheet 10 of 30 μm is used to form the communication passage. The ultraviolet transmittance depends on the transmittance of the resin, and the ultraviolet transmittance of the resin of the tubular sheet 10 is preferably 60% or more, particularly 80% or more at a wavelength of 250 nm and a thickness of 10 μm. The resin density is 0.95
A polyolefin resin having a weight ratio of 0.85 g / cm ³ is desirable. As long as the transmittance is maintained, it is easy to put it on the production line without being restricted by the light amount of the ultraviolet irradiation device described later and the distance from the light source. Further, in order to maintain such ultraviolet transmittance, it is desirable that the resin has a low resin density within the above range and does not have a functional group or the like.

The tubular sheet 10 has a complete hermetic seal portion together with the peripheral edge seal portion 2A of the container body 2, and a peelable seal portion 11 in the upper middle portion. Both the peelable seal portion 11 and the end seal portion 2A are formed by thermal bonding. Seal part 1 that can be opened and peeled from the outside
For 1, various known methods can be adopted. For example, as an example, Japanese Patent Application No. 143, 143, 399.
As described in No. 3, the method for producing a medical container having a completely hermetically sealed portion and a peelable seal portion can be referred to.

That is, in this example, linear low-density polyethylene (trade name: Moretec, manufactured by Idemitsu Petrochemical Co., Ltd., density: 0.916 g / cm ³ , MI: 2) and polypropylene (trade name: Chisso Polypro) Manufactured by Chisso Corporation, density: 0.90 g / cm ³ , MI: 0.7) 6:
The mixture is kneaded at a ratio of 4 and inflation-molded and stretched. Then, the tubular sheet 10 having a wall thickness of 30 μm and a folding width of 15 mm is cut into a length of 30 mm.
Is prepared. Next, the tubular sheet 10 is inserted into a part of the container main body 2 and the peripheral end seal portion 2A is applied with an impulse sealer (Fuji Impulse Co., Ltd. auto sealer FA-300-5.
W). Sealing conditions are sealing time 1.5 seconds,
The cooling time is 5 seconds. On the other hand, the peelable seal portion 11
Is sealed from above and below with a heating die for a section of 5 mm width and 15 mm length. The sealing condition is 130 ° C-
It was placed in a pressed state for 12 seconds between 150 ° C. It should be noted that a stopper is provided so that the sealing surface is not completely crushed by the press, and the pressure is adjusted so as not to apply an excessive press pressure.

In the embodiment, the tubular sheet 10 is an inflation-formed tube, but the present invention is not limited to this. For example, not only the extruded sheet that is formed into a tubular seal, the blow-molded or vacuum-molded tube, and the non-standard sheet, but also retains a standard shape to some extent, but the wall is flexible and may be dented. It is also possible to use a cylindrical thin member capable of atypical shape. The width A of the peelable seal part 11 is 2 mm to 30 mm, particularly 3 mm to 20.
mm. If the width A is less than this range, sufficient sealing cannot be performed in a liquid-tight manner, and furthermore, a shield cover 27, which will be described later, may be installed too strictly, which may cause a manufacturing problem. If it exceeds the above range, the peeling operation becomes complicated.

As shown in FIG. 2A, when the container body 2 (resin sheets 12 and 13) and the tubular sheet 10 are hermetically sealed, a heat-resistant polypropylene resin plate for preventing sealing is provided in the tubular sheet 10. 25 is inserted. When the complete hermetic seal portion 2A of the upper portion of the container body 2 is formed with the resin plate 25 arranged, the resin plate 2 is heat-sealed.
No. 5 does not heat-melt, and the inner surfaces of the tubular sheet 10 are not heat-welded to each other. Therefore, the inside of the container body 2 and the inside of the tubular sheet 10 are in a communicable state. Resin plate 25
Is not particularly limited as long as it is a resin that is not heat-sealed when forming the hermetically-sealed peripheral seal portion 2A, but a polyolefin-based resin is preferable because it is in contact with the administration agent in the medical container. Further, the resin plate 25 is not limited to a plate shape, and may be a thin sheet or film as long as it has heat resistance to the temperature of the hermetically sealing portion 2A during heat sealing.

The container body 2 is filled with the solution 3 from the outlet 4, and the outlet 4 is sealed with a rubber stopper, followed by high-pressure steam sterilization. If safety is assured, aseptic filling may be used. The dissolution liquid 3 is a basic administration material for infusion, and dissolves, dilutes or mixes the medicine 22 in the medicine container 21 described later. Specifically, an amino acid solution, a basic solution for high-calorie infusion mainly containing glucose, physiological saline, 5% glucose solution, distilled water for injection, and a solution containing various electrolytes are used. The high-pressure steam sterilization process is performed based on the high-pressure steam sterilization method of the Japanese Pharmacopoeia, and is sterilized while grasping with a clip so that the peelable seal part 11 is not peeled off or completely adhered during the process.

As shown in FIG. 2B, the resin end portion extends from the peelable seal portion 11 of the tubular sheet 10 by about 15 mm, and the resin end portion is attached to the mouth portion of the drug container 21. The thin sheet 23 is inserted. The thin sheet 23 is also tubular and has a thickness similar to that of the tubular sheet 10 described above. The base end of the thin sheet 23 is liquid-tightly attached to the medicine container 21 via the sealant 20, and a peelable seal part 24 is formed near the base end. Therefore, after the medicine 22 is aseptically filled in the medicine container 21, the thin sheet 23 is liquid-tightly attached to the mouth of the medicine container 21. Therefore, from the seal portion 24 to the medicine container 2
The main body part 1 is in a sterile state, and the thin sheet part 23 extending from the seal part 24 from which the connected drug container 21 can also be peeled off serves as a connection part for easy sterilization.

The medicine container 21 is made of a hard plastic vial, and the plastic material used for the vial 32 is, for example, low density or high density polyethylene.
Polypropylene, polyolefins such as polybutadiene-1, polyvinyl chloride, polyvinylidene chloride, vinylidene chloride copolymer, polymethylmethacrylate, polyvinyl alcohol, ethylene-vinyl alcohol copolymer, acrylonitrile copolymer, polyethylene terephthalate and the like. be able to. In particular, polyolefins are preferable from the viewpoint of versatility and no influence on drugs. Furthermore, high cyclic glass transition temperatures of amorphous cyclic olefin copolymers, etc., are 120 ° C. or higher, and specific gravity is 1.00 to 1.10. The thing of is desirable. In particular, the heat distortion temperature (ASTM D648
18 kg / cm ² ) is preferably a polyolefin having a temperature of 115 ° C. or higher. Specific examples of such a resin include polyolefin-based resins such as trade names Zeonex (Nippon Zeon Co., Ltd.) and trade names Apel (Mitsui Petrochemical Industry Co., Ltd.), which are recently used as materials for optical disc substrates, optical lenses, and the like. It is a resin. Although the drug container 21 is a plastic bottle in the present embodiment, it may be a glass bottle or a bottle form, but a bag form similar to the container body 2, a flexible semi-standard bottle form, etc. May be used.

In this embodiment, the second component drug 22 is a powdered anti-substance. However, in this embodiment, the drug 2
It is not necessary to limit 2 to powder, and a liquid agent may be used. A specific liquid agent is glutamic acid, which is a type of amino acid. Particularly, when the aqueous solution of glutamic acid is heated to 100 ° C., it is partially converted into hirolidone and deteriorates, so that high-pressure steam sterilization cannot be performed. Drugs that cannot be sterilized in the state of an aqueous solution are also targeted.

As shown in FIG. 2B, the heat-resistant polypropylene resin plate 25 similar to the above is inserted into the thin sheet 23 of the medicine container 21. With the resin plate 25 arranged, a complete hermetic seal portion 26 of the tubular sheet 10 and the thin sheet 23 is formed. Since the resin plate 25 is not melted by heat in the hermetically sealed portion 26, the inner surfaces of the thin sheets 23 are not heat-welded to each other and the communication state is maintained. FIG.
In the present embodiment, the easily sterilizing connection portion 5 is flat because it is formed only from the flexible resin sheet. The easily sterilizing connection portion 5 is preferably flat, and has a thickness of 25 mm or less, preferably 10 mm, in the direction of ultraviolet ray irradiation.
It is as follows. If the easily sterilizing connection portion 5 is thin, the sterilization process can be performed because the sterilization process can be performed in a state as close to the ultraviolet irradiation as possible. In this embodiment, 10
It is possible to bring the irradiation window of the ultraviolet irradiation device 51, which will be described later, closer to such a distance within a range of mm or less. Then, as shown in FIGS. 3 and 4, irradiation sterilization is performed between the peelable seal portion 11 of the tubular sheet 10 attached to the container body 2 and the peelable seal portion 24 of the thin seal 23.

As shown in FIG. 3, the ultraviolet irradiation device 51 is
The high-power ultraviolet lamp 52 is provided above the belt conveyer 53. The high-power ultraviolet lamp 52 is a low-pressure mercury lamp, and has a high radiation intensity in the wavelength range of 250 to 260 nm. High power UV lamp 5
2 is preferably 100 mW cm ² or more on the window surface of the irradiation part. Therefore, in order to make the apparatus compact, the ultraviolet lamp 52 is preferably in the range of 200 w to 1 kw. The distance B from the window surface of the irradiation section to the belt conveyor is 25 mm or less, and particularly 10 mm or less. If the distance B is 25 mm or less, the irradiation rate of the window surface is 7
About 0% is secured. As shown in FIG. 4, the container body 2
Between the peelable seal portion 11 and the peelable seal portion 24 of the drug container 21 serves as the easy sterilization adhesive portion 5, such a portion is irradiated with ultraviolet rays, and the other portion is covered with the shielding cover 27.
Is shielded by Further, one UV irradiation device 51 (not shown) is provided in the subsequent stage so that the UV irradiation is performed from both sides of the container 1.
It is designed to be flipped 180 degrees above.

In sterilizing microorganisms, an irradiation dose of approximately 33.3 mW · sec / cm ² is required to sterilize 99.9% of B. subtilis (spores) resistant to ultraviolet rays. After avoiding adhesions of the order of 10 ^-3 , a sterility assurance level (SAL) of 10 ^-6 % survival is guaranteed. Therefore, the ultraviolet irradiation device 51 in this embodiment uses
In order to sterilize within a ^second , the high-output ultraviolet irradiation device 51 is arranged so that the ultraviolet ray amount of at least 1.11 mW · sec / cm ² or more reaches the tubular sheet 11 and the thin sheet 23.
Is adjusted.

When using the medical container 1 with a connection part for easy sterilization configured as described above, first, the peelable seal part 11 of the container body 2 and the peelable seal part 24 of the drug container 21 are attached. Open from the outside. Thereby, as shown in FIG. 5, the drug container 21 and the container body 2 communicate with each other, and the solution 3 partially flows into the drug container 21 side by pumping or the like and mixes with the drug 22. After mixing completely, the mixed drug is returned to the container body 2 and a communicating needle or the like is inserted into the discharge port 4 to administer the mixed drug to the patient. Therefore, gas, hydrogen peroxide solution, etc. during sterilization do not remain between the container body 2 and the drug container 21, so that the drug solution can be safely circulated. Also, since the equipment can be made extremely compact by the irradiation of ultraviolet rays, it can be easily and economically installed on the production line. Moreover, sufficient sterilization of the communication passage can be ensured. Furthermore, since the medicine container 21 and the container body 2 can be filled and sealed in separate chambers, it is not necessary to provide duplicate equipment even when a large number of kinds of medicines are connected to the container body 2 and provided.

Performance Evaluation In the above embodiment, instead of the solution in the container body 2,
After filling the following two types of culture media A and B and sterilizing the container body 2 with high-pressure steam, and sterilizing the inside by emptying the drug container 21, the container body is non-sterile in a place other than the clean room. The cylindrical sheet 10 of No. 2 and the thin sheet 23 of the medicine container 21 were connected by heat sealing, and the easily sterilized connection part was sterilized according to the above-mentioned method. Then, 100 such medical containers 1 are manufactured, the peelable seal portions 11 and 24 of the medical container 1 are opened, once put in the drug container 21 side, and after returning this, a predetermined one week Cultured under the conditions. The fungus did not reproduce on all 100. As a comparative example, a container similar to the above was manufactured. However, the easily sterilized connection part was not irradiated and sterilized as in the example. The peelable seal parts 11 and 24 were opened in the same manner as in the example, and the cells were cultured in the same manner as in the example. As a result, 12 out of 100 bacterium propagated. A medium: Thioglycolic acid medium II (32 ° C., 7 days culture) B medium: glucose / peptone medium (24 ° C., 7 days culture)

FIG. 6 shows a drug container 2 used in the first embodiment.
It is a modification of No. 1. A thin tubesheet 28 is attached. In the tube sheet 28, the inner layer 29 is a polypropylene resin layer having heat resistance, and the outer layer 30 is a polyethylene resin layer. In a portion of the outer layer 30 where the inner layer 29 does not exist, a peelable seal portion 31 is formed at a part of the mouth of the vial 21. Even in such a configuration, the polypropylene layer of the inner layer 29 secures a communication passage when the perfect adhesion seal portion 26 is formed instead of the above-mentioned resin member 25, and the connection portion 5 for easy sterilization after connection with the container body 2 is formed. It can be easily subjected to ultraviolet irradiation sterilization.

FIG. 7 shows a second embodiment.
The medical container 32 with a connection part for easy sterilization of the present embodiment is almost the same as the embodiment of FIG. 1, except for the following points. That is, the drug container (vial) 21 is aseptically filled with the antibiotic 22, and the filling port is completely sealed by the cap 34. The base end of the cap 34 is a flange, and the flange is thermally bonded to the flange of the filling port of the vial 21. The cap 34 is a resin molded product having a tubular shape with one end closed, has a click tip mechanism 35 at the upper end, and can be bent and opened from the outside of the container body 33 as shown in FIG.

As shown in FIG. 7, a peelable seal portion 36 is formed on the container body 33, and the resin sheet end portions 37 and 38 of the container body 33 are further extended from the formed portion. Also. The resin material of the container body 33 is the same as that of the first embodiment, but the thickness is different from 80 μm. In such a configuration, first, the vial 21 is aseptically filled with the antibiotic 22 and freeze-dried, and then the mouth of the vial 21 is aseptically sealed with the cap 34. On the other hand, the container body 33 is already formed with a peelable seal portion 36, and the dissolving liquid 3
Are sterilized and filled. Then, the click tip portion 35 of the cap 34 is inserted into the extended resin end portions 37 and 38 of the container body 33, the end portion 33B of the container body 33 is completely hermetically sealed, and the cap 34 is attached to the container body 33. . Then, from the peelable seal portion 36 to the end portion 33B, sterilization treatment by ultraviolet irradiation is performed as in the embodiment of FIG. Therefore, also in such a medical container 32 of the second embodiment, the sterilization of the portion to be the connection portion can be extremely facilitated.

FIG. 9 is a view showing a modified example of the medical container 41 according to the present embodiment. The medical container 41 has the above-mentioned container body 33 and a similar shape to the container body 33, and is connected to the container body 33. A container body 33 ′ is connected as a drug container having different diameters. With such a configuration, different chemicals can be aseptically filled in different places, then combined in a production line, and then the easy sterilization connection part 5 can be easily UV-sterilized.

[0036]

As described above, the medical container with a connection part for easy sterilization of the present invention has a seal portion which can be peeled from the outside of the container body, in at least a part of the container body,
Further extending the resin end portion from the thin resin forming portion of the peelable seal to make the extended resin end portion a connection portion for easy sterilization,
The easily sterilizing connection portion is connected so that the resin end portion can communicate with the inside of the other drug container in a liquid-tight manner, and irradiation sterilization by ultraviolet rays is performed, and the resin end portion has a thickness of 100 μm.
Since it is m to 10 μm, sterilization of the connecting portion between the containers can be facilitated, and manufacturing control for each drug container connected at the time of manufacturing can be performed, and a large amount of duplicate equipment is not required.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view of a first embodiment of a medical container with a connection part for easy sterilization according to the present invention.

FIG. 2 is a cross-sectional view taken along line II of FIG.

FIG. 3 is a schematic view of an ultraviolet device for sterilizing a connection part of a medical container with a connection part for easy sterilization of the first embodiment.

FIG. 4 is a plan view showing an irradiation unit of the first embodiment.

FIG. 5 is a sectional view showing a state of using the first embodiment.

6A and 6B are a side sectional view and a top view showing a modified example of the medicine container of the first embodiment.

FIG. 7 is a cross-sectional view of a second embodiment of the medical container with a connection part for easy sterilization according to the present invention.

FIG. 8 is a cross-sectional view showing a state where the container body and the drug container of the second embodiment are communicated with each other.

FIG. 9 is a view showing a modified example of the second embodiment of the medical container with a connection part for easy sterilization according to the present invention.

[Explanation of symbols]

1 Medical container with connection part for easy sterilization 2 Container body 2A Peripheral seal part 3 Dissolution solution (administration agent) 4 Discharge port 5 Connection part for easy sterilization 10 Cylindrical sheet 11 Peelable seal part 12, 13 Resin sheet end part 20 sealant 21 drug container 22 drug (administration agent) 23 thin sheet 24 peelable seal part 26 hermetically sealed part 51 ultraviolet irradiation device 52 high output ultraviolet lamp 53 belt conveyor

Claims (7)

[Claims] 1. A medical container in which a plastic container main body is filled with a dosage substance and another drug container is connected or communicated with the drug product and the other drug is mixed with the dosage product at the time of use. At least a part of which has a peelable seal portion that can be opened from the outside, and a resin end portion which extends further from the peelable seal portion is used as the easy sterilization connection portion. Is connected so as to communicate with the inside of the other drug container in a liquid-tight manner, irradiation sterilization is performed with ultraviolet rays, and the resin end portion has a thickness of 100 μm to 10 μm. With medical container. 2. The resin of the connection part for easy sterilization has a wavelength of 25.
The easy sterilization connection according to claim 1, wherein the ultraviolet ray transmittance at 0 nm is 60% or more at a thickness of 10 μm, and the density thereof is in the range of 0.95 to 0.85 g / cm ^3. Medical container with parts. 3. The easy sterilization according to claim 1 or 2, wherein a resin member or a resin layer which is not heat-welded at the time of the communication connection is provided in a resin end portion of the easy sterilization connection portion. Medical container with a connecting part. 4. The peelable seal portion is formed on a tubular or tubular thin-walled resin member that is provided so as to communicate with the inside of the container body, and the thin-walled resin member is liquid-tight with the other drug volume. The medical container with a connection part for easy sterilization according to any one of claims 1 to 3, wherein the medical container is connected so as to communicate with the. 5. A method for sterilizing a medical container, wherein a plastic container main body is filled with a dose, and another drug container is connected or communicated, and the dose is mixed with the other drug during use. At least a part of the container main body is provided with a seal portion that can be opened from the peelable outside, and a resin end portion is present at a position further extended from the peelable seal portion,
A connection for easy sterilization, characterized in that the resin end is connected to be in fluid-tight communication with the inside of the other drug container, and the resin end extending from the peelable seal part is subjected to ultraviolet irradiation sterilization. Sterilization method for medical containers with parts. 6. The sterilization method according to claim 5, wherein the resin end portion is subjected to ultraviolet irradiation sterilization by a high-power ultraviolet sterilizer of 200 w to 1 kw. 7. The sterilization method according to claim 5, wherein the resin end surface is irradiated at a distance within 25 mm from an irradiation window of the high-power ultraviolet sterilizer.