Method for manufacturing a multi-chamber container

Abstract

To provide a method for manufacturing a multi-chamber container, wherein the multi-chamber container such as an infusion bag to be sterilized at a temperature of 110°C or more, including a heat seal layer, even when being sterilized, with the chamber containing nothing and with the films in contact with each other, having an inner surface fusion strength of 0.1 N / 15 mm or less and capable of forming a strong seal of 20 N / 15 mm width at a practical heat seal temperature of 160°C or less.SOLUTION: A method for manufacturing a multi-chamber container including a layer formed of a resin composition including 30 to 95 pts.wt. of polypropylene resin (A) component and 5 to 70 pts.wt. of polypropylene resin (B) component, and further including 5 to 50 pts.wt. of a polyethylene resin (C) component relative to the total of 100 pts.wt. of the polypropylene resin (A) component and polypropylene resin (B) component, the manufacturing method for manufacturing the multi-chamber container through the steps (i) to (ii).

Description

[Technical Field]

[0001] The present invention relates to a method for producing a multi-chamber container using a specific resin and through a specific process. [Background technology]

[0002] In medical practice, it is common to administer a mixture of multiple pharmaceutical ingredients at the time of treatment. Various methods are used depending on the combination of pharmaceutical ingredients to be mixed, and in some cases, the ingredients are mixed just before administration to prevent denaturation. When combining a liquid infusion with a solid drug, the liquid is prepared by preparing the liquid infusion and the solid drug in separate containers such as vials, mixing and melting them in a sterile environment using a syringe or other device to form a mixed solution, and then returning the mixture to the vial or soft bag. However, these methods are time-consuming and involve a step in which part of the infusion solution is removed, which can lead to contact with contaminated air or equipment, posing the risk of bacterial contamination or foreign matter contamination.

[0003] In order to solve these problems, a multi-chamber container having a partition formed inside has been proposed. A multi-chamber container is a container with a partition formed inside, and is made by making a bag from a resin film or sheet by heat sealing. However, when attaching a drug solution discharge port and a drug solution mixing port to the bag-shaped container and when filling the formed multiple chambers with drug solution, it is necessary to peel off the film in the non-welded portion to open the portion corresponding to the port attachment portion and drug solution filling portion. In particular, when filling a solid drug after filling with an infusion solution and sterilization, blocking of the film in the non-welded portion can occur, making it impossible to fill the solid drug. In the case of the above-mentioned multiple chamber container, it is necessary to prevent blocking of the film during sterilization. Known methods for suppressing blocking include embossing, as disclosed in Japanese Patent Laid-Open No. 2008-125836 (Patent Document 1) and Japanese Patent Laid-Open No. 6-178804 (Patent Document 2). However, embossing requires an embossing step during or after film formation, and the additional steps reduce productivity. Another method for suppressing blocking during sterilization is described in JP-A-8-215285 (Patent Document 3), in which two bags are produced and then fused together in post-processing while creating fluid communication between them. However, this method requires additional steps and reduces productivity. Furthermore, Japanese Patent Laid-Open Publication No. 2007-222292 (Patent Document 4) describes a method of suppressing blocking by using a mixture of two or more specific polyethylene resins obtained by polymerization with a single-site catalyst in the sealing layer. However, this method only claims to suppress blocking when the liquid volume is small, and furthermore, the sterilization temperature is only a low 105°C. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2008-125836 [Patent Document 2] Japanese Patent Application Publication No. 6-178804 [Patent Document 3] Japanese Patent Application Publication No. 8-215285 [Patent Document 4] Japanese Patent Application Laid-Open No. 2007-222292 Summary of the Invention [Problem to be solved by the invention]

[0005] Under these circumstances, an object of the present invention is to provide a method for producing a multi-chamber container, such as an infusion bag, which is sterilized at a temperature of 110°C or higher, having a heat seal layer that has an inner fusion strength of 0.1 N / 15 mm or less even when sterilized with the films in contact with each other without placing anything in the chambers, and that can form a strong seal of 20 N / 15 mm width at a practical heat seal temperature of 160°C or less. Another object of the present invention is to provide a multi-chamber container obtained by the above production method, and a resin composition used in the heat seal layer. [Means for solving the problem]

[0006] In order to solve the above problems, the present inventors discovered a heat-sealing resin composition that combines a low-melting point polypropylene resin and a high-melting point polypropylene resin in a specific range as the polypropylene resin used in the sealant layer (heat-sealing layer), and further adds a specific polyethylene to these polypropylene resins.This composition prevents inner surface fusion of more than 0.1 N / 15 mm even when sterilized in an empty chamber with the films in contact with each other, and also enables the formation of strong seals of 20 N / 15 mm width at a practical heat-sealing temperature of 160°C or less, thereby completing the present invention.

[0007] That is, according to the first aspect of the present invention, there is provided a method for producing a multi-chamber container comprising a layer made of a resin composition containing 30 to 95 parts by weight of the following polypropylene-based resin (A) component, 5 to 70 parts by weight of the following polypropylene-based resin (B) component, and 5 to 50 parts by weight of the following polyethylene-based resin (C) component per 100 parts by weight of the total of the polypropylene-based resin (A) and the polypropylene-based resin (B), the method comprising the following steps (i) to (ii): Component (A): A polypropylene resin that satisfies the following requirements (A-1) and (A-2). (A-1) The melt flow rate (JIS K7210, temperature 230°C, 2.16 kg load) is 0.5 g / 10 min or more and 30 g / 10 min or less. (A-2) The melting peak temperature measured by DSC is 110°C or higher and lower than 145°C. Component (B): Polypropylene resin that satisfies the requirements of (B-1) and (B-2) below. (B-1) The melt flow rate (230°C, 2.16 kg load) is 0.5 g / 10 min or more and 100 g / 10 min or less. (B-2) The melting peak temperature measured by DSC is 145°C or higher. Component (C): A polyethylene resin that satisfies the requirements of (C-1) below. (C-1) The melt flow rate (190°C, 2.16 kg load) is 0.01 g / 10 min or more and 50 g / 10 min or less. Step (i): A step of heat sterilizing the layers in contact with each other in at least one chamber of a multi-chamber container at a temperature of 110°C or higher. Step (ii): A step of opening the chamber that has been sterilized with the layers in contact with each other during the heat sterilization in step (i), adding a drug, and then sealing it to create a chamber again.

[0008] Furthermore, according to a second aspect of the present invention, there is provided a method for producing a multi-chamber container according to the first aspect, wherein the polypropylene resin (A) is a polypropylene resin polymerized using a metallocene catalyst.

[0009] Furthermore, according to a third aspect of the present invention, there is provided a multi-chamber container manufactured by the manufacturing method of the first aspect of the present invention.

[0010] Furthermore, according to a fourth aspect of the present invention, there is provided a resin composition as described in the first aspect, which is used for a multi-chamber container manufactured by the manufacturing method of the first aspect.

[0011] Furthermore, according to the fifth aspect of the present invention, there is provided a method for using the multi-chamber container described in the third aspect, in which the chemical placed in step (ii) of the first aspect is mixed with the chemical in another chamber and used. [Effects of the Invention]

[0012] According to the manufacturing method of the present invention, a multi-chamber container such as an infusion bag that is sterilized at a temperature of 110°C or higher can be provided that has a heat seal layer that does not cause inner surface fusion of more than 0.1 N / 15 mm width even when sterilized with the films in contact with each other without placing anything in the chambers, and that can form a strong seal of 20 N / 15 mm width at a practical heat seal temperature of 160°C or lower. DETAILED DESCRIPTION OF THE INVENTION

[0013] [Resin composition] The resin composition used as the heat-sealable layer of the multi-chamber container in the method for producing a multi-chamber container of the present invention contains 30 to 95 parts by weight of a polypropylene resin (A) component, 5 to 70 parts by weight of a polypropylene resin (B) component, and 5 to 50 parts by weight of a polyethylene resin (C) component per 100 parts by weight of the total of the polypropylene resins (A) and (B) (hereinafter, this resin composition will also be referred to as the "resin composition of the present invention" or the "heat-sealable resin composition of the present invention"). Details of the polypropylene resin (A), the polypropylene resin (B), and the polyethylene resin (C) component will be described later.

[0014] (1) Polypropylene resin (A) The polypropylene resin (A) is composed of one or more polypropylene polymers, and when it is composed of two or more components, it is sufficient that the mixture of the two or more components satisfies the following requirements (A-1) to (A-2).

[0015] The polypropylene-based resin (A) is selected from one or more types of propylene homopolymers and copolymers of propylene and an α-olefin having 2 to 12 carbon atoms (excluding 3 carbon atoms), and is preferably a propylene-ethylene copolymer or a propylene-ethylene-1-butene copolymer.

[0016] The polypropylene resin (A) can be appropriately selected from commercially available propylene homopolymers and propylene-α-olefin copolymers, specifically those under the trade names "Novatec PP," "Wintec," and "Wellnex," all of which are manufactured by Japan Polypropylene Corporation.

[0017] The catalyst for producing the polypropylene-based resin (A) is not particularly limited, but the polypropylene-based resin (A) is preferably one polymerized with a metallocene catalyst.

[0018] It is known that structural characteristics such as molecular weight, molecular weight distribution, and branched structure of ethylene polymers and propylene polymers can be controlled by selecting a catalyst, and a person skilled in the art can also distinguish between types of polymers depending on the type of catalyst. For example, ethylene polymers and propylene polymers polymerized using a metallocene catalyst may be referred to as metallocene-based ethylene polymers or metallocene-based propylene polymers, and ethylene polymers and propylene polymers polymerized using a catalyst other than a metallocene catalyst may be referred to as non-metallocene-based ethylene polymers or non-metallocene-based propylene polymers.

[0019] (A-1) Melt flow rate (230℃, 2.16kg load) The melt flow rate of the polypropylene resin (A) (230°C, 2.16 kg load) is 0.5 g / 10 min or more and 30 g / 10 min or less, preferably 0.5 to 25 g / 10 min, more preferably 0.5 to 15 g / 10 min, and particularly preferably 1.0 to 15 g / 10 min. If the melt flow rate is 0.5 g / 10 min or more, the load during molding of the heat-sealable film does not increase, and molding of the laminate itself becomes easy. If the melt flow rate is 30 g / 10 min or less, molding stability during molding of the heat-sealable film is good.

[0020] (A-2) Melting peak temperature measured by differential scanning calorimetry (DSC) The melting peak temperature (measured by DSC) of the polypropylene resin (A) is 110°C or higher but lower than 145°C, preferably 115°C or higher but lower than 145°C, more preferably 120°C or higher but lower than 140°C, and particularly preferably 125°C or higher but lower than 140°C. The melting peak temperature is sometimes referred to as the melting point. When the melting peak temperature is 110°C or higher, the heat-sealable film obtained by combining it with the polypropylene resin (B) is less likely to unintentionally fuse together at unheat-sealed portions of the film when sterilized at a high temperature, for example, at 121°C for 30 minutes. Furthermore, when the melting peak temperature is lower than 145°C, a wide heat-sealing temperature range is easily achieved by combining it with the polypropylene resin (B), resulting in a heat-sealing strength of 2.9 to 9.8 N / 15 mm width.

[0021] (2) Polypropylene resin (B) The polypropylene resin (B) is composed of one or more propylene polymers, and when it is composed of two or more components, it is sufficient that the mixture of the two or more components satisfies the following requirements (B-1) to (B-2).

[0022] The polypropylene resin (B) is selected from one or more types of propylene homopolymers and copolymers of propylene and α-olefins having 2 to 12 carbon atoms (excluding 3 carbon atoms), and is preferably a propylene homopolymer.

[0023] The polypropylene resin (B) can be appropriately selected from commercially available propylene homopolymers and propylene-α-olefin copolymers, specifically, those under the trade names "Novatec PP" and "Wintec" manufactured by Japan Polypropylene Corporation.

[0024] (B-1) Melt flow rate (230°C, 2.16 kg load) The melt flow rate of the polypropylene resin (B) (230°C, 2.16 kg load) is 0.5 g / 10 min or more and 100 g / 10 min or less, preferably 0.5 to 20 g / 10 min, more preferably 0.5 to 15 g / 10 min, and particularly preferably 1.0 to 15 g / 10 min. If the melt flow rate is 0.5 g / 10 min or more, the load during molding of the heat-sealable film does not increase, and molding of the film itself becomes easy. If the melt flow rate is 100 g / 10 min or less, molding stability during molding of the heat-sealable film is good.

[0025] (B-2) Melting peak temperature measured by differential scanning calorimetry (DSC) The melting peak temperature (measured by DSC) of the polypropylene resin (B) is 145°C or higher, preferably 150°C or higher, more preferably 155°C or higher, and particularly preferably 160°C or higher. If the melting peak temperature is 145°C or higher, it is easy to widen the heat sealing temperature range in which the heat seal strength of the heat-sealable film obtained by combining it with the polypropylene resin (A) is 10 to 15 N / 15 mm width. There is no particular upper limit to the melting peak temperature of the polypropylene resin (B), but it is preferably 170°C or lower, for example.

[0026] In the present invention, from the viewpoint of ensuring a wide sealing temperature range, the difference between the melting peak temperature of the polypropylene-based resin (A) and the melting peak temperature of the polypropylene-based resin (B) is preferably 5°C or more, more preferably 10°C or more, and particularly preferably 20°C or more.

[0027] (3) Polyethylene resin (C) The polyethylene resin (C) is composed of one or more ethylene polymers, and when it is composed of two or more components, it is sufficient that the mixture of two or more components satisfies the following requirement (C-1).

[0028] (C-1) Melt flow rate (190℃, 2.16kg load) The polyethylene resin (C) has a melt flow rate (190°C, 2.16 kg load) of 0.01 g / 10 min or more and 50 g / 10 min or less, preferably 0.01 to 20 g / 10 min, more preferably 0.1 to 20 g / 10 min, and particularly preferably 0.1 to 10 g / 10 min. If the melt flow rate is 0.01 g / 10 min or more, fish eyes (FE) are unlikely to occur when mixed with the polypropylene resin (A) and the polypropylene resin (B). If the melt flow rate is 50 g / 10 min or less, molding stability is good when molding a heat-sealable film.

[0029] The density of the polyethylene resin (C) is not particularly limited, but is preferably 0.911 g / cm 3 It is desirable that the density is 0.911 g / cm or more. 3 If the density is equal to or greater than this, unintended fusion of the unheat-sealed portions of the film is unlikely to occur during sterilization at a high temperature, for example, 121°C for 30 minutes. In addition, the density of polyethylene polymers is generally 0.990 g / cm. 3 The density is a value measured by the D method (density gradient tube method) according to JIS K7112.

[0030] The polyethylene used in the polyethylene resin (C) is not particularly limited, but low density polyethylene, linear low density polyethylene, high density polyethylene or a combination thereof can be used.

[0031] (4) Formulation of the Resin Composition of the Present Invention The resin composition of the present invention contains 30 to 95 parts by weight of a polypropylene-based resin (A) component, 5 to 70 parts by weight of a polypropylene-based resin (B) component, and 5 to 50 parts by weight of a polyethylene-based resin (C) component per 100 parts by weight of the total of the polypropylene-based resin (A) and the polypropylene-based resin (B).

[0032] The amount of polypropylene resin (A) component blended is 30 to 95 parts by weight, preferably 40 to 95 parts by weight, more preferably 45 to 90 parts by weight, and even more preferably 50 to 85 parts by weight, per 100 parts by weight of the total of polypropylene resin (A) component and polypropylene resin (B) component. The amount of polypropylene resin (B) component blended is 5 to 70 parts by weight, preferably 5 to 60 parts by weight, more preferably 10 to 55 parts by weight, and even more preferably 15 to 50 parts by weight. When the blending amounts of the polypropylene-based resin (A) component and the polypropylene-based resin (B) component are within the above ranges, it is easy to achieve a wide heat-sealing temperature range in which the heat-seal strength of the resulting heat-sealable layer is 10 to 15 N / 15 mm width. Furthermore, it is possible to prevent the temperature at which the heat-seal strength exceeds 29.4 N / 15 mm width from becoming too high. Therefore, a strong seal can be formed at a practical heat-sealing temperature of 160°C or less.

[0033] The resin composition of the present invention contains 5 to 50 parts by weight of a polyethylene resin (C) component per 100 parts by weight of the total of the polypropylene resin (A) component and the polypropylene resin (B) component.

[0034] The polyethylene resin (C) is blended for the purpose of preventing blocking of the heat seal layer made of the heat-sealable resin composition of the present invention during heat sterilization. Blocking is prevented by roughening the film surface due to the presence of the polyethylene resin (C) in the polypropylene resins (A) and (B). The blending amount of the polyethylene resin (C) component is 5 parts by weight or more and 50 parts by weight or less, preferably 5 parts by weight or more and 40 parts by weight or less, more preferably 5 parts by weight or more and 30 parts by weight or less, even more preferably 10 parts by weight or more and 30 parts by weight or less, and particularly preferably 10 parts by weight or more and 25 parts by weight or less, relative to 100 parts by weight of the total of the polypropylene resin (A) component and the polypropylene resin (B) component. When the blending amount of the polyethylene resin (C) component is 50 parts by weight or less, the resulting heat-sealable layer is likely to form a strong seal. When the blending amount of the polyethylene resin (C) component is 5 parts by weight or more, the film surface is roughened, and unintended fusion of the unheat-sealed portions of the films constituting the multi-chamber container is unlikely to occur during sterilization treatment at a high temperature, for example, 121°C for 30 minutes.

[0035] [Method of producing resin composition] The resin composition of the present invention can be obtained by mixing the polypropylene resin (A), the polypropylene resin (B), and the polyethylene resin (C) in a Henschel mixer (trade name), a V blender, a ribbon blender, a tumbler blender, etc., and then kneading the mixture in a kneader such as a single-screw extruder, a multi-screw extruder, a kneader, a Banbury mixer, etc. Alternatively, the resin composition can be obtained as a pellet mixture in which the polypropylene resin (A), the polypropylene resin (B), and the polyethylene resin (C) are individually mixed in a Henschel mixer (trade name), a V blender, a ribbon blender, a tumbler blender, etc., and then kneaded and pelletized in a kneader such as a single-screw extruder, a multi-screw extruder, a kneader, a Banbury mixer, etc. When other additives are used as optional components, they can be added when the pellet mixture is obtained. Alternatively, the mixture prepared by mixing using a Henschel mixer (trade name) can be used as the pellet mixture as is.

[0036] Additives such as antioxidants that can be added to polypropylene resins can be appropriately blended as long as they do not impair the effects of the present invention. Specifically, 2,6-di-t-butyl-p-cresol (BHT), tetrakis[methylene-3-(3,5-di-t-butyl-4-hydroxyphenyl)propionate]methane (trade name "IRGANOX 1010" manufactured by BASF Japan Ltd.), and n-octadecyl-3-(4-hydroxy-3,5-di-t-butylphenyl)propionate (trade name "IRGANOX 1010" manufactured by BASF Japan Ltd.) 1076"), phosphite stabilizers such as bis(2,4-di-t-butylphenyl)pentaerythritol diphosphite and tris(2,4-di-t-butylphenyl)phosphite, lubricants such as higher fatty acid amides, such as oleic acid amide and erucic acid amide, higher fatty acid esters, and silicone oils, antistatic agents such as glycerin partial esters of fatty acids with 8 to 22 carbon atoms, sorbitan acid esters, and polyethylene glycol esters, sorbitol nucleating agents (for example, "Gelall MD" manufactured by New Japan Chemical Co., Ltd.), aromatic phosphate esters (for example, "ADEKA STAB NA-21" and "ADEKA STAB NA-11" manufactured by ADEKA Corporation), and Nucleating agents such as those manufactured by Milliken Chemical Co., Ltd. under the trade name "Millad" series, those manufactured by Milliken Corporation under the trade name "Hyperform" series, those manufactured by New Japan Chemical Co., Ltd. under the trade name "N-Jester NU-100", talc, and high-density polyethylene, molecular weight modifiers and crosslinking aids such as antiblocking agents such as silica, calcium carbonate, and talc, and organic peroxides, neutralizing agents such as higher fatty acid metal salts such as calcium stearate and hydrotalcites, light stabilizers, ultraviolet absorbers, metal deactivators, peroxides, fillers, antibacterial and antifungal agents, antibacterial agents, bacteriostatic agents, fluorescent brighteners, antifogging agents, flame retardants, colorants, pigments, natural oils, synthetic oils, waxes, and organic or inorganic flame retardants may also be added depending on the application, in appropriate amounts.

[0037] [film] The resin composition of the present invention can be suitably used for heat-sealable films containing one or more heat-sealable layers of the resin composition, and can be suitably used for heat-sealable films that can form strong seal strength at 160°C or less, have a wide temperature range for forming weak seals, and have excellent blocking resistance. The film of the present invention is a film consisting of one or more layers including at least a heat seal layer, and is characterized in that the heat seal layer is made of the above-mentioned heat-sealable resin composition of the present invention.

[0038] The film of the present invention may be a single layer or a multilayer film, but is preferably a multilayer film from the viewpoint of ease of handling during heat sealing.

[0039] The thickness of the film of the present invention is not particularly limited, but in the case of a single-layer film, a film of about 10 to 500 μm is suitably used as a sealant. In the case of a multilayer film, the thickness of the entire multilayer film is about 10 to 500 μm, and the thickness of the heat seal layer made of the heat-sealable resin composition of the present invention is preferably about 5 to 100 μm, more preferably 10 to 60 μm, and even more preferably about 20 to 50 μm.

[0040] Examples of multilayer films include two-layer films having a heat-sealing layer made of the heat-sealing resin composition of the present invention and an outer layer adjacent to it; three-layer films having a heat-sealing layer made of the heat-sealing resin composition of the present invention, an intermediate layer adjacent to it, and an outer layer adjacent to the intermediate layer; and five-layer films having a heat-sealing layer made of the heat-sealing resin composition of the present invention, an adhesive layer adjacent to it, a gas barrier layer adjacent to the adhesive layer, an adhesive layer adjacent to the gas barrier layer, and an outer layer adjacent to the adhesive layer.However, the multilayer film is not limited to these and can have any configuration as long as the heat-sealing resin composition of the present invention is used as the heat-sealing layer. Examples of methods for producing the multilayer film include coextrusion, extrusion lamination, and dry lamination, with the coextrusion being preferred from the standpoint of economy.

[0041] The gas barrier layer may be made of, for example, a mixture of a polyolefin resin and an ethylene-vinyl alcohol copolymer, or a composition in which a layered silicate such as montmorillonite or mica is blended with a polyolefin resin.

[0042] Examples of adhesives that constitute the adhesive layer include polyurethane adhesives, vinyl acetate adhesives, hot melt adhesives, or adhesive resins such as maleic anhydride-modified polyolefins and ionomer resins. When an adhesive layer is included in the layer configuration, the main layers such as the inner layer, intermediate layer, and outer layer can be laminated by co-extrusion with these adhesives.

[0043] The method for producing the film of the present invention is not particularly limited, and the film can be produced by a known method using the above resin composition, for example, by a known technique such as extrusion molding using a T-die or a circular die. Among these, the water-cooled inflation molding method using a circular die is preferred from the viewpoint of transparency.

[0044] The film of the present invention includes a heat seal layer made of the heat-sealable resin composition of the present invention described above, and therefore can form a weak seal strength of 10 to 15 N / 15 mm width over a wide temperature range, and can even form a strong seal strength of 20 N / 15 mm width without using extremely harsh conditions.Furthermore, unintended fusion of films is unlikely to occur even during heat treatment processes such as sterilization and pasteurization, making the film suitable for multi-chamber packaging bags for heat treatment, particularly small multi-chamber bags for infusion solutions.

[0045] [Multi-chamber container and its manufacturing method] The method for producing a multi-chamber container of the present invention includes a step (step (i)) of heat-treating a multi-chamber container containing the resin composition of the present invention as one or more heat-sealable layers at a temperature of 110°C or higher in a state where the heat-sealable layers are in contact with each other for at least one chamber. The heat treatment temperature is 110° C. or higher, preferably 115° C. or higher, and more preferably 121° C. or higher. If the heat treatment temperature is 110° C. or higher, a sterilization effect is exhibited during the heat treatment. The method for producing a multi-chamber container of the present invention further includes a step (step (ii)) of opening the chamber that has been subjected to the heat treatment step, placing a drug inside, and then sealing it again to form a chamber. In the method for producing a multi-chamber container of the present invention, a multi-chamber container is produced through the above steps (i) and (ii), and the multi-chamber container obtained by this production method is also referred to as the multi-chamber container of the present invention.

[0046] The multi-chamber container of the present invention can be used by mixing the chemical placed in the above step (ii) with the chemical placed in the other chamber.

[0047] The multi-chamber container of the present invention has at least one chamber (storage chamber) for storing a drug solution, and the storage chamber is made of the above-mentioned film of the present invention.

[0048] In the multi-chamber container of the present invention, after the drug is placed in step (ii), when the container is sealed again to form a chamber, the easily peelable seal portion that separates the chambers is formed by fusing the heat seal layers of the film of the present invention together. The seal strength of the easily peelable seal portion is 10N / 15mm width to 15N / 15mm width.

[0049] The seal strength of the easily peelable seal portion is adjusted by the seal temperature (heating temperature of the heat seal bar), seal pressure, and seal time. Usually, the seal pressure and seal time are fixed, and the seal temperature is adjusted so as to obtain the desired seal strength. There are no particular restrictions on the seal pressure and seal time, but usually the seal pressure is 1 to 6 kg / cm. 2 (0.098~0.59MPa), and the sealing time is set in the range of 0.5~8 seconds.

[0050] The peripheral edge of the multi-chamber container of the present invention may be formed by a conventional method. For example, when a film formed by a coextrusion multilayer T-die method, dry lamination method, extrusion lamination method, etc. is used as the material, the sealant layers may be overlapped so that they face each other, and then the resulting film may be sandwiched between a pair of heat-sealing bars and uniformly heated and pressurized to achieve heat fusion. When a cylindrical film formed by a water-cooled or air-cooled coextrusion multilayer inflation method is used as the material, only both ends of the film may be heat-sealed; it is not necessary to heat-seal the entire circumference of the container.

[0051] The seal strength of the peripheral edge of the multi-chamber container of the present invention varies depending on the shape and use of the container, but is preferably set within the strength range of 20 to 60 N / 15 mm.

[0052] The multi-chamber container of the present invention can be used for general intravenous infusion bags, such as liquid / liquid mixing bags for amino acid infusions and glucose infusions, and solid (powder) / liquid mixing bags for antibiotics and their dissolving solutions. [Example]

[0053] The present invention will be described in more detail below using examples, but the present invention is not limited thereto as long as it does not deviate from the gist of the invention. The methods for measuring various physical properties and materials used in the examples are as follows.

[0054] 1.Measurement method (1) MFR (unit: g / 10 min): For polyethylene resins, the measurement was performed in accordance with the JIS-K6922-2 Appendix at 190°C and a load of 2.16 kg. For polypropylene resins, the measurement was performed in accordance with JIS K-7210 at 230°C and a load of 2.16 kg. (2) Melting peak temperature: Using a differential scanning calorimeter, a 5 mg sample was taken, held at 200°C for 5 minutes, crystallized at a temperature drop rate of 10°C / min to -10°C, and then further melted at a temperature increase rate of 10°C / min, and the melting peak temperature Tm was measured. (3) Heat seal strength (unit: N / 15 mm width): Using a 10 mm x 300 mm heat seal bar, a 210 mm length of film was cut and sealed perpendicular to the melt extrusion direction (MD) under heat sealing conditions of 0.34 MPa for 5 seconds at 5°C increments over the range of 105°C to 160°C. The container was then filled with 250 ml of water, and the heat-sealed side and the opposite side were sealed with impulse sealing. The container was then placed in a heated autoclave and heat-treated at 121°C for 30 minutes. The impulse-sealed side was then cut off, the water removed, and the film was dried. The heat-seal strength was measured by cutting a sample into a 15 mm wide heat-sealed section and pulling it apart at a speed of 500 mm / min using a tensile tester. The relationship between heat-seal temperature and heat-seal strength was plotted, and the slope of the resulting curve was calculated to determine the weak seal initiation temperature (the temperature at which the heat-seal strength reached 10 N / 15 mm width), weak seal end temperature (the temperature at which the heat-seal strength reached 15 N / 15 mm width), and strong seal initiation temperature (the temperature at which the heat-seal strength reached 20 N / 15 mm width). If the heat seal strength is 10 to 15 N / 15 mm width, the resin films or sheets in the partitions inside the container are difficult to peel off during manufacturing or transportation, and are easily peeled off by hand or with a tool during use (mixing).It can be said that a weak seal strength can be easily formed if the weak seal temperature range is 2°C or higher. Furthermore, if the heat seal strength is 20N / 15mm width or more, it can be said that the heat seal strength is sufficient to prevent peeling during manufacturing and transportation. If the strong seal initiation temperature is 160°C or less, the film will not deform during heat sealing, and a strong seal can be formed stably.

[0055] (4) Inner surface fusion strength (unit: N / 15 mm width): A sealed container was made using impulse sealing with the heat-sealed film layers tightly attached to each other without any contents inside, and placed in a heated autoclave for 30 minutes at 121°C. The impulse-sealed portion was then cut off and the film was dried. The heat-sealed layers were peeled apart from each other, and a 15 mm wide sample was cut out. The sample was then pulled apart at a tensile speed of 500 mm / min using a tensile tester to measure the peel strength between the heat-sealed layers. If the peel strength was 0.1 N / 15 mm width or less, the heat-sealed layers could be easily peeled, and it can be said that blocking had not occurred.

[0056] 2.Materials used PP1 (propylene-α-olefin random copolymer polymerized with a Ziegler catalyst): Novatec PP FA3KM (trade name) manufactured by Japan Polypropylene Corporation (melting peak temperature Tm: 160°C, MFR: 10 g / 10 min). PP2 (propylene-based elastomer polymerized with a metallocene catalyst): Wellnex RFG4VM (trade name) manufactured by Japan Polypropylene Corporation (melting peak temperature Tm: 130°C, MFR: 7g / 10min). PP3 (propylene homopolymer polymerized with a Ziegler catalyst): Novatec PP FL4 (trade name) manufactured by Japan Polypropylene Corporation (melting peak temperature Tm: 164°C, MFR: 5g / 10 minutes). PP4 (propylene-α-olefin random copolymer polymerized with a metallocene catalyst): Wintec WFW4M (trade name) manufactured by Japan Polypropylene Corporation (melting peak temperature Tm: 135°C, MFR: 7g / 10min). PP5 (propylene-α-olefin random copolymer polymerized with a metallocene catalyst): Wintec WFX4M (trade name) manufactured by Japan Polypropylene Corporation (melting peak temperature Tm: 125°C, MFR: 7g / 10min). PP6 (propylene-α-olefin random copolymer polymerized with a metallocene catalyst): Wintec WSX03 (trade name) manufactured by Japan Polypropylene Corporation (melting peak temperature Tm: 125°C, MFR: 25 g / 10 min). PE1 (Polyethylene): Made by Japan Polyethylene Co., Ltd. Product name: Novatec LD LM360 (density: 0.928 g / cm 3 , Melt index: 0.9g / 10min). PE2 (Polyethylene): Made by Japan Polyethylene Co., Ltd. Product name: Novatec HD HM160 (density: 0.953 g / cm 3 , Melt index: 5.0g / 10min). SEBS1 (styrene-based elastomer): Kraton styrene-based elastomer, product name G1645MO. SEBS2 (styrene-based elastomer): styrene-based elastomer manufactured by Kraton, product name G1657MS.

[0057] Examples and Comparative Examples The extruder for the outer layer of the tubular film of the three-type three-layer water-cooled inflation molding machine is used to mix the contents thoroughly by shaking the bag up and down and left and right by hand in the weight ratio of the outer layer shown in Table 1, and the extruder for the middle layer of the tubular film of the three-type three-layer water-cooled inflation molding machine is used to mix the contents thoroughly by shaking the bag up and down and left and right by hand in the weight ratio of the middle layer shown in Table 1, and the extruder for the heat-seal layer of the tubular film of the three-type three-layer water-cooled inflation molding machine is used to mix the contents thoroughly by shaking the bag up and down and left and right by hand in the weight ratio of the middle layer shown in Table 1. The contents were mixed thoroughly by shaking the bag up and down and left and right by hand at the inner layer weight ratio shown in Table 1, and the mixture was fed into the extruder. The mixture was melt-extruded from a cylindrical die at an extrusion temperature of 200°C, cooled and solidified in water adjusted to 10°C, and a tubular film 200μm thick and with a folded diameter (the width of the product when the tube is folded flat and wound using the inflation method) of 91mm was produced at a speed of 3m per minute, with a thickness ratio of outer layer (surface layer):middle layer:inner layer (heat seal layer) of 1:8:1. Table 1 shows the results of various evaluations of the film. All of the films in the comparative examples had an inner surface fusion strength of more than 0.1 N / 15 mm width, and can be said to be unsuitable for the multi-chamber container of the present invention.

[0058] [Table 1]

Claims

1. A method for producing a multi-chamber container including a layer made of a resin composition containing 30 to 95 parts by weight of the following polypropylene-based resin (A) component, 5 to 70 parts by weight of the following polypropylene-based resin (B) component, and 5 to 50 parts by weight of the following polyethylene-based resin (C) component per 100 parts by weight of the total of the polypropylene-based resin (A) component and the polypropylene-based resin (B) component, the method comprising producing the multi-chamber container through the following steps (i) to (ii): Component (A): A polypropylene resin that satisfies the following requirements (A-1) and (A-2). (A-1) The melt flow rate (JIS K7210, temperature 230°C, 2.16 kg load) is 0.5 g / 10 min or more and 30 g / 10 min or less. (A-2) The melting peak temperature as measured by DSC is 110°C or higher and lower than 145°C. Component (B): a polypropylene resin that satisfies the following requirements (B-1) and (B-2). (B-1) The melt flow rate (230°C, 2.16 kg load) is 0.5 g / 10 min or more and 100 g / 10 min or less. (B-2) The melting peak temperature measured by DSC is 145°C or higher. Component (C): A polyethylene resin that satisfies the following requirement (C-1). (C-1) The melt flow rate (190°C, 2.16 kg load) is 0.01 g / 10 min or more and 50 g / 10 min or less. Step (i): A step of heat-sterilizing the layers in contact with each other in at least one chamber of the multi-chamber container at a temperature of 110°C or higher. Step (ii): A step of opening the chamber that has been sterilized in a state where the layers are in contact with each other during the heat sterilization in step (i), adding a drug, and then sealing it to create a chamber again.

2. The method according to claim 1, wherein the polypropylene-based resin (A) is a polypropylene-based resin polymerized using a metallocene catalyst.

3. A resin composition comprising 30 to 95 parts by weight of the following polypropylene-based resin (A) component, 5 to 70 parts by weight of the following polypropylene-based resin (B) component, and 5 to 50 parts by weight of the following polyethylene-based resin (C) component per 100 parts by weight of the total of the polypropylene-based resin (A) component and the polypropylene-based resin (B) component, wherein the resin composition is used for a multi-chamber container produced by the production method according to claim 1. Component (A): A polypropylene resin that satisfies the following requirements (A-1) and (A-2). (A-1) The melt flow rate (JIS K7210, temperature 230°C, 2.16 kg load) is 0.5 g / 10 min or more and 30 g / 10 min or less. (A-2) The melting peak temperature as measured by DSC is 110°C or higher and lower than 145°C. Component (B): a polypropylene resin that satisfies the following requirements (B-1) and (B-2). (B-1) The melt flow rate (230°C, 2.16 kg load) is 0.5 g / 10 min or more and 100 g / 10 min or less. (B-2) The melting peak temperature measured by DSC is 145°C or higher. Component (C): A polyethylene resin that satisfies the following requirement (C-1). (C-1) The melt flow rate (190°C, 2.16 kg load) is 0.01 g / 10 min or more and 50 g / 10 min or less.

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