JP2022145664A - Method for manufacturing multi-chamber container - Google Patents

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 The present invention relates to a method of manufacturing a multi-chamber container using a specific resin and through specific steps.

In the medical field, it is common practice to administer a mixture of multiple drug components at the time of treatment. Various methods have been adopted depending on the combination of drug components to be mixed, and in some cases the drug is mixed immediately before administration for prevention of denaturation.
When combining a solid drug with an infusion solution, the drug solution should be prepared by placing the infusion solution and the solid drug in separate containers such as vials, mixing and dissolving them in an aseptic state using a syringe or the like to form a mixed solution. They are put back into vials or soft bags.
However, these methods are time-consuming and involve the step of taking out part of the infusion solution, so there is a possibility of contact with a contaminated atmosphere or equipment, and there is a risk of bacterial contamination or foreign matter contamination.

In order to solve these problems, a multi-chamber container having a partition inside has been proposed.
A multi-chamber container is a container having a partition formed therein, and is formed by bag-making a resin film or sheet by heat-sealing.
However, at the stage of attaching a drug solution discharge port and a mixed injection port to a bag-shaped container, and further at the step of filling the formed multiple chamber with a drug solution, the film of the non-welded part is peeled off, and the port attachment part, It is necessary to open the portion corresponding to the liquid medicine filled portion. In particular, when a solid medicine is filled after filling an infusion and performing sterilization, blocking of the non-welded portion of the film may prevent filling of the solid medicine. In the case of a multi-chamber container as described above, it is necessary that blocking of the film does not occur during sterilization.
As a method for suppressing blocking, a method of embossing disclosed in Japanese Patent Application Laid-Open No. 2008-125836 (Patent Document 1) and Japanese Patent Application Laid-Open No. 6-178804 (Patent Document 2) is known. However, the method of applying embossing requires a step of applying embossing during film molding or after molding, and the increase in the number of steps reduces productivity.
As another method for suppressing blocking during sterilization, as described in Japanese Patent Application Laid-Open No. 8-215285 (Patent Document 3), two bags are prepared and fused while creating liquid communication in post-processing. However, this method increases the number of steps and deteriorates productivity.
Further, Japanese Patent Application Laid-Open No. 2007-222292 (Patent Document 4) discloses a method of suppressing blocking by mixing two or more specific polyethylene resins obtained by polymerizing a seal layer with a single-site catalyst. Although described, this method only claims to suppress blocking when the amount of liquid is small, and furthermore, the sterilization temperature is only as low as 105°C.

JP 2008-125836 A JP-A-6-178804 JP-A-8-215285 JP 2007-222292 A

Under such circumstances, the object of the present invention is to provide a multi-chamber container such as an infusion bag that is sterilized at a temperature of 110 ° C. or higher, even if the film is in contact with each other without anything in the container, the inner surface can be melted. To provide a method for manufacturing a multi-chamber container having a heat-seal layer having an adhesion 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-sealing temperature of 160° C. or less. That's what it is.
Another object of the present invention is to provide a multi-chamber container obtained by such a manufacturing method, and a resin composition used for the heat seal layer.

In order to solve the above problems, the present inventors have combined a low melting point polypropylene resin and a high melting point polypropylene resin in a specific range as the polypropylene resin used for the sealant layer (heat seal layer), and further these polypropylenes By adding a specific polyethylene to the system resin, even when the films are sterilized while the films are in contact with each other without putting anything in the room, the inner surface fusion of more than 0.1 N / 15 mm does not occur, and the temperature is 160 ° C or less. The inventors discovered a heat-sealing resin composition capable of forming a strong seal of 20 N/15 mm width at a typical heat-sealing temperature, and completed the present invention.

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

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

Moreover, according to the third invention of the present invention, there is provided a multi-chamber container manufactured by the manufacturing method of the first invention.

Further, according to a fourth invention of the present invention, there is provided the resin composition described in the first invention, which is used for a multi-chamber container manufactured by the manufacturing method of the first invention. be done.

Further, according to the fifth invention of the present invention, there is provided a method of using the multiple-chamber container according to the third invention, wherein the drug put in the step (ii) of the first invention is The method of use is provided, which is used by mixing with.

According to the manufacturing method of the present invention, in a multi-chamber container such as an infusion bag that is sterilized at a temperature of 110° C. or higher, even if nothing is put in the chamber and the films are in contact with each other, the 0.1 N/15 mm It is possible to provide a multi-chamber container having a heat-seal layer that does not cause inner surface fusion beyond the width and that can form a strong seal of 20 N/15 mm width at a practical heat-sealing temperature of 160° C. or less.

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

(1) polypropylene resin (A)
The polypropylene resin (A) consists of one or more polypropylene polymers, and when it consists of two or more components, the following requirements (A-1) to (A- 2) should be satisfied.

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

The polypropylene resin (A) can be appropriately selected from commercially available propylene homopolymers and propylene-α-olefin copolymers. Specifically, the trade name "Novatec PP" manufactured by Japan Polypropylene Corporation, the trade name "Wintec", and the trade name "Wellnex" can be mentioned.

Moreover, the catalyst for producing the polypropylene resin (A) is not particularly limited, but the polypropylene resin (A) is preferably polymerized with a metallocene catalyst.

It is known that molecular weight, molecular weight distribution, branched structure, and other structural characteristics of ethylene-based polymers and propylene-based polymers can be controlled by selecting a catalyst. It is also possible to distinguish between types, for example, an ethylene polymer or a propylene polymer polymerized with a metallocene catalyst is called a metallocene ethylene polymer or a metallocene propylene polymer, or a catalyst other than a metallocene catalyst is called a metallocene polymer. The ethylene-based polymer and propylene-based polymer polymerized in are sometimes referred to as non-metallocene-based ethylene-based polymer and non-metallocene-based propylene-based polymer.

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

(A-2) Melting peak temperature by differential scanning calorimetry (DSC) The melting peak temperature (by DSC) of the polypropylene resin (A) is 110°C or higher and lower than 145°C, preferably 115°C or higher and lower than 145°C. more preferably 120° C. or higher and 140° C. or lower, and particularly preferably 125° C. or higher and 140° C. or lower. Note that the melting peak temperature may also be referred to as the melting point. If the melting peak temperature is 110° C. or higher, the heat-sealing film obtained by combining with the polypropylene resin (B) is heat-sealed with each other during sterilization at a high temperature of 121° C. for 30 minutes, for example. It is difficult for unintended fusion of parts that are not in contact with each other. Further, when the melting peak temperature is less than 145° C., it is easy to obtain a wide heat sealing temperature range in which the heat sealing strength becomes 2.9 to 9.8 N/15 mm width by combining with the polypropylene resin (B).

(2) polypropylene resin (B)
The polypropylene-based resin (B) consists of one or more propylene-based polymers, and when it consists of two or more components, the following requirements (B-1) to (B- 2) should be satisfied.

Polypropylene-based resin (B) is selected from one or more propylene homopolymers, copolymers of propylene and α-olefins having 2 to 12 carbon atoms (excluding 3 carbon atoms), preferably propylene homopolymer. It is a coalescence.

The polypropylene-based resin (B) can be appropriately selected from commercially available propylene homopolymers and propylene-α-olefin copolymers. Specifically, the trade name "Novatech PP" manufactured by Japan Polypropylene Corporation and the trade name "Wintech" can be mentioned.

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

(B-2) Melting peak temperature by differential scanning calorimetry (DSC) The melting peak temperature (by DSC) of the polypropylene resin (B) is 145°C or higher, preferably 150°C or higher, more preferably 155°C or higher. , particularly preferably 160° C. or higher. When the melting peak temperature is 145° C. or higher, it is easy to obtain a wide heat sealing temperature range in which the heat sealing strength of the heat sealing film obtained by combining with the polypropylene resin (A) is 10 to 15 N/15 mm width. Although the upper limit of the melting peak temperature of the polypropylene-based resin (B) is not particularly limited, it is preferably 170° C. or less, for example.

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

(3) polyethylene resin (C)
The polyethylene-based resin (C) is composed of one or more ethylene-based polymers, and when it is composed of two or more components, it may satisfy the following requirement (C-1) as a mixture of two or more components. .

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

Also, the density of the polyethylene-based resin (C) is not particularly limited, but is preferably 0.911 g/cm ³ or more. If the density is 0.911 g/cm ³ or more, unintentional fusion of the non-heat-sealed portions of the films hardly occurs during sterilization at a high temperature of 121° C. for 30 minutes, for example. Further, the density of polyethylene-based polymers is generally 0.990 g/cm ³ or less. Incidentally, the density is a value measured by D method (density tube method) according to JIS K7112.

Polyethylene used for the polyethylene-based resin (C) is not particularly limited, but any one of low-density polyethylene, linear low-density polyethylene, and high-density polyethylene can be used in combination.

(4) Formulation of the resin composition of the present invention The resin composition of the present invention comprises 30 to 95 parts by weight of polypropylene resin (A) component, 5 to 70 parts by weight of polypropylene resin (B) component, and polypropylene resin ( 5 to 50 parts by weight of the polyethylene resin (C) component is contained with respect to a total of 100 parts by weight of A) and the polypropylene resin (B).

The blending amount of the polypropylene resin (A) component in the total 100 parts by weight of the polypropylene resin (A) component and the polypropylene resin (B) component is 30 to 95 parts by weight, preferably 40 to 95 parts by weight, and more It is preferably 45 to 90 parts by weight, more preferably 50 to 85 parts by weight. The blending amount of the polypropylene resin (B) component is 5 to 70 parts by weight, preferably 5 to 60 parts by weight, more preferably 10 to 55 parts by weight, still more preferably 15 to 50 parts by weight.
If the blending amount of the polypropylene resin (A) component and the polypropylene resin (B) component is within the above range, the heat seal strength of the obtained heat seal layer is 10 to 15 N/15 mm width. Easy to take. Moreover, it is possible to prevent the temperature at which the heat seal strength becomes 29.4 N/15 mm width or more from becoming too high. Therefore, a strong seal can be formed at a practical heat sealing temperature of 160° C. or less.

Further, the resin composition of the present invention contains 5 to 50 parts by weight of the polyethylene resin (C) component with respect to a total of 100 parts by weight of the polypropylene resin (A) component and the polypropylene resin (B) component.

The polyethylene-based resin (C) is blended for the purpose of suppressing blocking during heat treatment sterilization of the heat-sealing layer made of the heat-sealing resin composition of the present invention. Blocking is suppressed by roughening the film surface due to the presence of the polyethylene resin (C) in the polypropylene resin (A) and the polypropylene resin (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, with respect to a total of 100 parts by weight of the polypropylene resin (A) component and the polypropylene resin (B) component. parts by weight to 40 parts by weight, more preferably 5 parts by weight to 30 parts by weight, still more preferably 10 parts by weight to 30 parts by weight, and particularly preferably 10 parts by weight to 25 parts by weight.
If the blending amount of the polyethylene-based resin (C) component is 50 parts by weight or less, the obtained heat seal layer is likely to form a strong seal. If the blending amount of the polyethylene resin (C) component is 5 parts by weight or more, the film surface is roughened and, for example, the films constituting the multi-chamber container are heat-sealed during sterilization at a high temperature of 121° C. for 30 minutes. Unintentional fusion of the untreated portion is less likely to occur.

[Method for producing resin composition]
The resin composition of the present invention is prepared by mixing the polypropylene resin (A), the polypropylene resin (B), and the polyethylene resin (C) with a Henschel mixer (trade name), V blender, ribbon blender, tumbler blender, or the like. and then kneading with a kneader such as a single-screw extruder, a multi-screw extruder, a kneader, or a Banbury mixer. In another form, 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, or a tumbler. After mixing with a blender, etc., kneaded with a kneader such as a single-screw extruder, multi-screw extruder, kneader, Banbury mixer, etc., pelletized, and mixed with a Henschel mixer (trade name), V blender, ribbon blender, tumbler blender, etc. It can also be obtained as a mixed pellet mixture.
When other additives are used as optional components, they can also be added when obtaining the pellet mixture. Alternatively, a mixture obtained by mixing with a Henschel mixer (trade name) can be used as it is as a pellet mixture.

Additives such as antioxidants that can be added to the polypropylene-based resin can be appropriately blended as long as the effects of the present invention are not hindered.
Specifically, 2,6-di-t-butyl-p-cresol (BHT), tetrakis [methylene-3-(3,5-di-t-butyl-4-hydroxyphenyl) propionate] methane (BASF Japan phenol typified by n-octadecyl-3-(4-hydroxy-3,5-di-t-butylphenyl) propionate (manufactured by BASF Japan under the trade name “IRGANOX 1076”) system stabilizers, phosphite stabilizers represented by bis(2,4-di-t-butylphenyl)pentaerythritol diphosphite and tris(2,4-di-t-butylphenyl)phosphite, olein Higher fatty acid amides such as acid amides and erucic acid amides, lubricants typified by higher fatty acid esters and silicone oils, charging typified by glycerin partial esters of fatty acids with 8 to 22 carbon atoms, sorbitan acid esters, polyethylene glycol esters, etc. Inhibitors, sorbitol nucleating agents (e.g. Shin Nippon Rika Co., Ltd. trade name "Gelol MD"), aromatic phosphate esters (e.g. ADEKA trade names "ADEKA STAB NA-21" and "ADEKA STAB NA-11" ), trade name "Millad" series manufactured by Milliken, trade name "Hyperform" series manufactured by Milliken, trade name "Enjester NU-100" manufactured by Shin Nippon Rika Co., Ltd., talc, nucleating agents represented by high-density polyethylene, etc. , Antiblocking agents such as silica, calcium carbonate, and talc; molecular weight modifiers and cross-linking aids such as organic peroxides; higher fatty acid metal salts such as calcium stearate; and hydrotalcites. Neutralizing agents, light stabilizers, ultraviolet absorbers, metal deactivators, peroxides, fillers, antibacterial antifungal agents, antibacterial agents, bacteriostatic agents, fluorescent brighteners, antifogging agents, flame retardants, coloring agents Agents, pigments, natural oils, synthetic oils, waxes, and organic or inorganic flame retardants may also be added depending on the application, and the blending amount is an appropriate amount.

[the film]
The resin composition of the present invention can be suitably used for a heat-sealing film containing one or more layers of such a resin composition as a heat-sealing layer. It can be suitably used for a heat-sealing film having excellent anti-blocking properties.
The film of the present invention is a film comprising one or more layers including at least a heat-sealing layer, and is characterized in that the heat-sealing layer comprises the above-described heat-sealing resin composition of the present invention.

The film of the present invention may be a single-layer film or a multilayer film, but a multilayer film is preferred from the viewpoint of operability during heat sealing.

The thickness of the film of the present invention is not particularly limited, but in the case of a single-layer film, one having a thickness 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 heat seal layer made of the heat seal resin composition of the present invention is preferably about 5 to 100 μm, preferably 10 to 60 μm, more preferably 20 to 50 μm. degree.

As the multilayer film, a two-layer film having a heat-sealing layer made of the heat-sealing resin composition of the present invention and an outer layer adjacent thereto, a heat-sealing layer made of the heat-sealing resin composition of the present invention, and A three-layer film having an adjacent intermediate layer and an outer layer adjacent to the intermediate layer, a heat-sealing layer comprising the heat-sealing resin composition of the present invention, an adhesive layer adjacent thereto, and a gas barrier layer adjacent to the adhesive layer. , a five-layer film having an adhesive layer adjacent to the gas barrier layer, and an outer layer adjacent to the adhesive layer. can be configured.
Methods for producing a multilayer film include a coextrusion method, an extrusion lamination method, a dry lamination method, and the like, and the coextrusion method is preferable from the viewpoint of economy.

As the gas barrier layer, for example, a mixture of a polyolefin resin and an ethylene-vinyl alcohol copolymer, a composition obtained by blending a polyolefin resin with a layered silicate such as montmorillonite or mica, or the like can be used.

Adhesives constituting the adhesive layer include polyurethane adhesives, vinyl acetate adhesives, hot melt adhesives, and adhesive resins such as maleic anhydride-modified polyolefins and ionomer resins. When an adhesive layer is included in the layer structure, the main layers such as the inner layer, the intermediate layer and the outer layer can be laminated by co-extrusion together with these adhesives.

The method for producing the film of the present invention is not particularly limited, but it can be produced by a known method using the above resin composition. For example, it is produced by a known technique such as extrusion using a T-die or circular die.
Among them, a water-cooled inflation molding method using a circular die is preferable from the viewpoint of transparency.

Since the film of the present invention includes a heat-sealing layer made of the above-described heat-sealing resin composition of the present invention, it can form a weak seal strength of 10 to 15 N/15 mm width in a wide temperature range, and further 20 N/15 mm width. It is possible to form a strong seal strength without making extremely severe conditions such as sterilization and sterilization. In particular, it is suitable for a small multi-chamber bag for infusion.

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

The multi-chambered container of the present invention can be used by mixing the drug put in the above step (ii) with the drug in another chamber.

The multi-chamber container of the present invention has at least one chamber (accommodating chamber) for containing a chemical solution, and the accommodating chamber is made of the above-described film of the present invention.

In the multi-chamber container of the present invention, after the medicine is added in step (ii), when the chambers are sealed again to form the chambers, the easily peelable seal portion that separates the chambers is formed by melting the heat-sealed layers of the film of the present invention. Let me wear it.
The easily peelable seal portion has a seal strength of 10 N/15 mm width to 15 N/15 mm width.

The seal strength of the easily peelable seal portion is adjusted by the sealing temperature (heating temperature of the heat seal bar), sealing pressure and sealing time. Adjust for intensity. Here, the sealing pressure and sealing time are not particularly limited, but usually the sealing pressure is set in the range of 1 to 6 kg/cm ² (0.098 to 0.59 MPa) and the sealing time is set in the range of 0.5 to 8 seconds. be.

The peripheral portion of the multi-chamber container of the present invention may be formed according to a conventional method. After superimposing them so that they face each other, they may be sandwiched between a pair of heat seal bars and uniformly heated and pressurized to be heat-sealed. Also, when a cylindrical film formed by a water-cooled or air-cooled co-extrusion multilayer inflation method is used as a material, it is sufficient to heat-seal only both ends of the film, and heat-sealing is not necessarily performed over the entire circumference of the container. It does not have to be applied.

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

The multi-chamber container of the present invention can be used for infusion bags in general. A bag for liquid mixing is mentioned.

The present invention will be described in more detail below using examples, but the present invention is not limited by these as long as it does not deviate from the gist of the invention. Methods for measuring various physical property values and materials used in Examples are as follows.

1. Measurement method (1) MFR (unit: g/10 minutes): Polyethylene resin is measured at 190 ° C. with a load of 2.16 kg in accordance with JIS-K6922-2 appendix, and polypropylene resin is JIS K-7210. , and measured at 230°C and a load of 2.16 kg.
(2) Melting peak temperature: Using a differential scanning calorimeter, a sample amount of 5 mg was taken, held at 200°C for 5 minutes, then crystallized to -10°C at a cooling rate of 10°C/min, and further 10°C/min. The melting peak temperature Tm was measured when the mixture was melted at a heating speed of 10 minutes.
(3) Heat seal strength (unit: N/15 mm width): Using a heat seal bar of 10 mm × 300 mm, a film cut to a length of 210 mm was cut from 105 ° C. to 160 ° C. in increments of 5 ° C., pressure 0.34 MPa. , and sealed perpendicular to the direction of melt extrusion (MD) under heat sealing conditions for 5 seconds. After that, the container filled with 250 ml of water and sealed by impulse sealing on the side opposite to the heat-sealed side was placed in a heat and pressure sterilizer and heat-treated at a temperature of 121° C. for 30 minutes. The impulse seal side was then cut away and the water was removed to dry the film.
A sample was cut so that the heat-sealed portion had a width of 15 mm, and was pulled apart at a tensile speed of 500 mm/min using a tensile tester to determine the heat-seal strength. Plot the relationship between heat seal temperature and heat seal strength, determine the slope from the obtained curve, weak seal start temperature (heat seal strength reaches 10 N / 15 mm width), weak seal end temperature (heat seal strength is 15 N/15 mm width) and strong seal initiation temperature (temperature at which heat seal strength reaches 20 N/15 mm width).
If the heat seal strength is 10 to 15 N/15 mm width, the resin films or sheets of the partition inside the container are difficult to peel off during manufacturing and transportation, and during use (during mixing), it is difficult to peel off by hand or equipment. easily peeled off. It can be said that a weak seal strength can be easily formed if the weak seal temperature range is 2° C. or higher.
Moreover, if the heat seal strength is 20 N/15 mm 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, it can be said that a strong seal can be stably formed without deformation of the film during heat sealing.

(4) Inner surface fusion strength (unit: N/15 mm width): A container was sealed with the heat-sealed layers of the film in close contact with each other without putting the contents using an impulse seal. and heat-treated under conditions of a temperature of 121° C. and a time of 30 minutes. Afterwards, the impulse seal was cut off and the film was dried.
Peel off a part of the heat-seal layers that are in close contact with each other, cut a sample so that it has a width of 15 mm, separate it at a tensile speed of 500 mm / min using a tensile tester, and measure the peel strength of the heat-seal layers that are in close contact with each other. was measured. If the peel strength is 0.1 N/15 mm width or less, it can be said that the film can be easily peeled and no blocking occurs.

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

(Examples and Comparative Examples)
In the extruder for the outer layer, which will be the outer side of the tubular film of the three-kind three-layer water-cooled inflation molding machine, the weight ratio of the outer layer in Table 1 is used. The mixture was put into the extruder for the tubular film intermediate layer of the three-kind three-layer water-cooled inflation molding machine, and the bag was shaken up and down and left and right by hand at the weight ratio of the intermediate layer in Table 1. The contents are thoroughly stirred and the mixture is put into the extruder for the heat seal layer, which will be the inner side of the tubular film of the three-kind three-layer water-cooled inflation molding machine, at the weight ratio of the inner layer in Table 1. , The bag was shaken up and down and left and right by hand to fully stir the contents, and the mixture was put in, melted and extruded from a cylindrical die at an extrusion temperature of 200 ° C., and cooled with water adjusted to 10 ° C. A tubular film having a thickness of 200 μm and a folding diameter (the width of the product when the tube is flattened and wound up by the inflation method) of 91 mm was solidified at a speed of 3 m per minute. It was manufactured so that the thickness ratio of the inner layer (heat seal layer) was 1:8:1. Table 1 shows various evaluation results of the film.
All the films of the comparative examples have an inner surface fusion bond 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.

Claims (5)

30 to 95 parts by weight of the following polypropylene resin (A) component, 5 to 70 parts by weight of the following polypropylene resin (B) component, and a total of 100 parts by weight of the polypropylene resin (A) component and the polypropylene resin (B) component On the other hand, a method for producing a multi-chamber container containing a layer made of a resin composition containing 5 to 50 parts by weight of the polyethylene resin (C) component below, wherein the multi-chamber container is produced through the following steps (i) to (ii) The said manufacturing method which manufactures a container.
Component (A): A polypropylene-based resin that satisfies the following requirements (A-1) and (A-2).
(A-1) Melt flow rate (JIS K7210, temperature 230° C., load 2.16 kg) is 0.5 g/10 minutes or more and 30 g/10 minutes or less.
(A-2) The melting peak temperature by DSC is 110°C or more and less than 145°C.
Component (B): Polypropylene resin (B-1) that satisfies the following requirements (B-1) and (B-2): melt flow rate (230°C, 2.16 kg load) of 0.5 g/10 minutes or more , 100 g/30 minutes or less.
(B-2) The melting peak temperature measured by DSC is 145° C. or higher.
Component (C): Polyethylene resin (C-1) melt flow rate (190°C, 2.16 kg load) that satisfies the requirements of (C-1) below is 0.01 g/10 minutes or more and 50 g/10 minutes or less. be.
Step (i): Heat sterilization at a temperature of 110°C or higher in at least one chamber of a multi-chamber container while the layers are in contact with each other.
Step (ii): A step of opening the chamber that has been sterilized with the layers in contact with each other during heat sterilization in step (i), adding a drug, sealing the chamber, and recreating the chamber. The production method according to claim 1, wherein the polypropylene-based resin (A) is a polypropylene-based resin polymerized using a metallocene catalyst. A multi-chamber container manufactured by the manufacturing method according to claim 1. 30 to 95 parts by weight of the following polypropylene resin (A) component, 5 to 70 parts by weight of the following polypropylene resin (B) component, and a total of 100 parts by weight of the polypropylene resin (A) component and the polypropylene resin (B) component On the other hand, a resin composition containing 5 to 50 parts by weight of the following polyethylene-based resin (C) component, which is used for a multi-chamber container manufactured by the manufacturing method according to claim 1.
Component (A): A polypropylene-based resin that satisfies the following requirements (A-1) and (A-2).
(A-1) Melt flow rate (JIS K7210, temperature 230° C., load 2.16 kg) is 0.5 g/10 minutes or more and 30 g/10 minutes or less.
(A-2) The melting peak temperature by DSC is 110°C or more and less than 145°C.
Component (B): Polypropylene resin (B-1) that satisfies the following requirements (B-1) and (B-2): melt flow rate (230°C, 2.16 kg load) of 0.5 g/10 minutes or more , 100 g/30 minutes or less.
(B-2) The melting peak temperature measured by DSC is 145° C. or higher.
Component (C): Polyethylene resin (C-1) melt flow rate (190°C, 2.16 kg load) that satisfies the requirements of (C-1) below is 0.01 g/10 minutes or more and 50 g/10 minutes or less. be. 4. A method of using the multi-chambered container according to claim 3, wherein the drug put in step (ii) according to claim 1 is used by mixing with the drug in another chamber.