JP7380215B2 - Container packaging and its manufacturing method - Google Patents

Description

The present invention relates to a package capable of packaging a container, for example, a pharmaceutical container such as a prefilled syringe, an ampoule, or a vial, and a method for manufacturing the same.

In the medical field, syringes called prefilled syringes, which are prefilled with drugs, have come into use. By using a prefilled syringe, there is no need to refill the drug into the syringe as with conventional syringes, so there is no risk of infection or foreign matter contamination during refilling, and prompt administration is possible in emergencies, making it easier for medical professionals to contribute to improving labor productivity. Moreover, by filling a pre-filled syringe with a predetermined amount of drug, an accurate amount can be administered. This also contributes to simplifying drug management.

Strict quality control is required for pharmaceutical products, and in recent years, quality control has been extended not only to the manufacturing process but also to storage and transportation processes during the distribution process. Good Distribution Practices (GDP), which serves as a basic guideline for quality assurance in the distribution process, requires control of vibration and shock in addition to temperature control. Therefore, it has become necessary for pharmaceutical packaging bodies to be able to absorb vibrations and shocks during the distribution process.

Regarding prefilled syringe packaging, we use a blister-integrated packaging as a packaging container that allows the prefilled syringe to be properly fixed without moving or vibrating within the packaging container, and that can be easily loaded into the packaging container even by machine. There is a blister packaging container for storing a prefilled syringe, which is a container and includes a lock portion that is squeezed and shaped to match the outer diameter of the prefilled syringe, and in which a portion of the prefilled syringe is fixed by the lock portion (Patent Document 1).

Japanese Patent Application Publication No. 2011-006154

In the blister packaging container for storing a prefilled syringe described in Cited Document 1, the prefilled syringe is fixed to the packaging container, so that the prefilled syringe is prevented from excessive vibration within the packaging container during transportation. However, the lock part is a part that is squeezed and molded to fit a part of the prefilled syringe, and there is a gap between it and the outer shape of the prefilled syringe, so minute vibrations may occur in this gap. The packaging container could not completely prevent the prefilled syringe from vibrating within the packaging container.

Furthermore, in the blister packaging container of Cited Document 1, when vibrations or shocks are applied to the blister packaging container from the outside, the vibrations or shocks are transmitted to the prefilled syringe without being substantially attenuated. Therefore, it was not sufficient to buffer vibrations and shocks during the distribution process. Furthermore, when used by medical personnel, it has not been sufficient to dampen vibrations and shocks that may occur when handling a blister packaging container containing a prefilled syringe.

The present invention advantageously solves the above-mentioned problems, and provides a packaging body for containers capable of absorbing vibrations and impacts on pharmaceutical containers containing drugs, such as prefilled syringes, ampoules, and vials, and the production thereof. The purpose is to provide a method.

The present inventors fixed the container to the lid material with a skin pack, and covered the fixed skin pack with blisters at intervals, thereby causing the container to vibrate and move within the package due to the tight fixation of the skin pack. We have discovered that the space between the skin pack and the blister can act as a cushioning material to buffer against external vibrations and shocks, leading to the present invention.

The container packaging body of the present invention based on the above knowledge is a packaging body for accommodating a container filled with liquid, and includes a lid material, the container is housed between the lid material, and the container is arranged according to the outer shape of the container. A skin pack film that is deformed and tightly fixed to the lid material, and a bulge portion is formed, and the container and the deformed portion of the skin pack film are accommodated in the bulge portion, and the skin pack film is tightly fixed to the lid material or the lid material. and a blister closely fixed to the skin pack film, the bulge of the blister being spaced apart from the deformed portion of the skin pack film.

In the container package of the present invention, the blister is preferably a soft blister. Further, one of the skin pack film and the blister and the lid material may include a barrier layer. Furthermore, the structure may be such that the lid material and the skin pack film are provided with easy-to-open means. The container package of the present invention is suitable as a package for accommodating pharmaceutical containers.

In the method for manufacturing a container package of the present invention, after a container is skin-packed and fixed to a lid material, a blister formed so as to separate a space from a deformed part of the skin pack to which the container is fixed is attached to the lid. It is characterized in that it is closely fixed to the skin pack film which is closely fixed to the material or the lid material.

According to the container package of the present invention, it is possible to buffer the vibration impact of a container containing a drug, such as a prefilled syringe, ampoule, or vial.

FIG. 1 is a schematic perspective view of an embodiment of a container package of the present invention. FIG. 2 is a sectional view of the container packaging shown in FIG. 1. FIG. It is a typical perspective view of another embodiment of the package for containers of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS It is a schematic diagram explaining one Embodiment of the manufacturing method of the package for containers of this invention. FIG. 2 is a schematic diagram of main parts of a skin pack packaging machine.

EMBODIMENT OF THE INVENTION Hereinafter, embodiment of the package for containers of this invention is concretely described using drawings.
FIG. 1 shows a schematic perspective view of an embodiment of the container package of the present invention, and FIG. 2 shows a sectional view taken along line II-II of the container package of FIG. 1. In FIGS. 1 and 2, a container package 1 shows an embodiment of a package for packaging a prefilled syringe S as an example of a container, and in the drawings, the prefilled syringe S is schematically a simple cylindrical shape. represented. In addition, the container that can be accommodated by the container package 1 is not limited to the prefilled syringe S, but even in the case of a vial V or an ampoule as a pharmaceutical container as shown in FIG. Similar to the case where the syringe S is housed, the effect of alleviating vibration and impact can be obtained. Furthermore, the container package of the present invention can also be used for containers for uses other than medical containers.

In FIGS. 1 and 2, a container package 1 includes a lid 2, a skin pack film 3, and a blister 4. In the illustrated embodiment, the lid material 2 and the skin pack film 3 constitute a skin pack package. The skin pack packaging body has a skin pack film 3 made of thermoplastic resin and a base material (corresponding to the lid material 2 in the present invention), and an object to be packaged, such as a book, placed at a predetermined position on the base material. In the embodiment, the skin pack film 3 softened by heating is closely attached to the prefilled syringe S along the outer shape of the packaged object, and the vacuum package is sealed with a base material. The skin pack film 3 is a film that is compatible with the skin pack, and has thermoplasticity, and has the property of deforming and expanding so as to follow the external shape of the packaged object.

As shown in FIG. 2, the prefilled syringe S is housed between the lid material 2 and the skin pack film 3 and sealed in a vacuum deaerated state. By softening the skin pack film 3 as a skin pack, bringing it into close contact with the prefilled syringe S, and sealing it in a vacuum deaerated state, a reduced pressure state is created between the lid material 2 and the skin pack film 3, and the prefilled syringe S It is fixed in close contact with the skin pack film 3. A preferred fixing position of the prefilled syringe S is preferably approximately the center in the longitudinal direction and approximately the center in the width direction of the lid member 2 when viewed in the plan view of FIG.

The blister 4 has a bulge extending from the planar film on one side. The bulging portion has a size that allows a space to be separated from the outer shape of the prefilled syringe S fixed to the lid member 2 by the skin pack. The shape of the bulge is not particularly limited. Since the prefilled syringe S is generally cylindrical, the bulging portion can be formed to be approximately cylindrical or semicylindrical, or may have other shapes.
The blister 4 is fixed by having its peripheral portion tightly fixed to the lid 2 or the skin pack film 3 that is tightly fixed to the lid 2.

A space is provided between the blister 4 and a portion (deformed portion) where the skin pack film 3 is deformed to follow the outer shape of the prefilled syringe S. This space is filled with air or an inert gas such as nitrogen gas at approximately normal pressure and sealed. Therefore, the skin-packed prefilled syringe S is located across the internal space from the blister 4.

In the container packaging body 1 of this embodiment, since the prefilled syringe S in contact with the lid material 2 is fixed by the skin pack film 3, even if shocks or vibrations are applied to the container packaging body 1 from the outside, There is no unnecessary movement within the container package 1. In addition, since the prefilled syringe S is located apart from the blister 4, even if shock or vibration is applied to the container package 1 from the outside, the gas inside the blister 4 acts as a buffer and absorbs the shock or vibration. Absorb. Therefore, vibrations and impacts of the prefilled syringe S can be buffered.

The container package 1 is not only a container package but also a buffer for the container. In other words, the packaging body and the cushioning body are integrated. This results in an integrated package that has both packaging and cushioning functions. The container package 1 can have a barrier function etc. by further including a functional film serving as a barrier layer, a light shielding layer, etc. in the lid material 2, the skin pack film 3, and the resin film of the blister 4.

Each member will be explained in more detail below.
The lid material 2 is made of a resin film, and may be a single layer or a multilayer of two or more layers. It is preferable that the inner surface layer includes a layer that can be heat-sealed with the skin pack film 3. Specifically, a laminated film having a base layer made of PET, stretched nylon, etc. and a layer made of polyolefin resin on the inner surface layer can be used. The surface layer on the inner layer side made of a polyolefin resin is the layer facing the skin pack film 3 and the blister 4, and the polyolefin resin is used as the surface layer on the inner layer side of the skin pack film 3 and the blister 4. By using the same type of resin as the film, the lid material 2 and the skin pack film 3 or blister 4 can be easily joined by heat sealing. The same type of resin means that, for example, when the outer surface layer of the lid material 2 is a polyethylene resin layer, the outermost layer of the skin pack film 3 and the blister 4 is a polyethylene resin layer.

The laminated film of the lid material 2 can be provided with a functional layer if necessary. Examples of the functional layer include a light shielding layer (UV cut layer), a gas barrier layer (oxygen barrier layer), and an oxygen absorption layer. Examples of the light-shielding layer include aluminum foil, an aluminum vapor-deposited film, and a layer containing an ultraviolet absorber. Examples of the gas barrier layer include a vapor-deposited layer such as an aluminum vapor-deposited layer, an aluminum oxide vapor-deposited layer, a silicon oxide vapor-deposited layer, a known gas barrier coating layer, a stretched nylon layer, an ethylene vinyl alcohol copolymer (EVOH) layer, and the like.

The vapor-deposited layer of the gas barrier layer may be a transparent vapor-deposited layer or an opaque vapor-deposited layer. Since the vapor deposition layer is a transparent vapor deposition layer, it is possible to impart or improve gas barrier properties that prevent gases such as oxygen gas and water vapor from permeating while maintaining the visibility of the contents. Note that the vapor deposition layer may include two or more layers. When two or more vapor deposited layers are provided, they may have the same composition or different compositions.

The transparent vapor deposition layer may include an inorganic element or an inorganic oxide, such as silicon (Si), aluminum (Al), magnesium (Mg), calcium (Ca), potassium (K), tin (Sn), sodium (Na), It is possible to use a vapor-deposited layer of an inorganic element such as boron (B), titanium (Ti), lead (Pb), zirconium (Zr), yttrium (Y), hafnium (Hf), barium (B) or its oxide. can.

The chemical formula _of an inorganic oxide is, for _example , _MO The range is different.) Note that when the inorganic element is Al, the value of X in the above formula can basically be 0.5 or more, but if X is less than 1.0, Since it is colored and has poor transparency, it is preferable to use one with X=1.0 or more. Moreover, since the material with X=1.5 is in a state where Al and oxygen are completely oxidized, the material up to the upper limit of X=1.5 can be used.

Although the thickness of the transparent vapor deposition layer varies depending on the type of inorganic oxide used, it is desirable to arbitrarily select the thickness within the range of, for example, 50 Å or more and 2000 Å or less, preferably 100 Å or more and 1000 Å or less. For example, in the case of a vapor deposited layer of aluminum oxide or silicon oxide, the thickness is desirably 50 Å or more and 500 Å or less, more preferably 100 Å or more and 300 Å or less.

The vapor deposition layer is formed on the base material layer by, for example, a physical vapor deposition method (PVD method) such as a vacuum evaporation method, a sputtering method, and an ion plating method, or a plasma chemical vapor deposition method, or a thermochemical method. It can be formed by a chemical vapor deposition method (CVD method) such as a vapor deposition method and a photochemical vapor deposition method. More specifically, a vapor deposition layer can be formed on a film forming roller using a roller type vapor deposition film forming apparatus.

The gas barrier coat layer is a coating film that functions as a layer that suppresses permeation of oxygen gas, water vapor, and the like. The gas barrier coating layer has the general formula R ¹ _n M(OR ² ) _m (wherein, R ¹ and R ² represent an organic group having 1 to 8 carbon atoms, M represents a metal atom, and n is , represents an integer of 0 or more, m represents an integer of 1 or more, and n+m represents the valence of M.), a polyvinyl alcohol-based resin, and/or A metal alkoxide containing a water-soluble polymer such as an ethylene/vinyl alcohol copolymer and further polycondensed by a sol-gel method in the presence of a sol-gel method catalyst, an acid, water, and an organic solvent. It consists of a gas barrier composition containing a hydrolyzate or a hydrolyzed condensate of a metal alkoxide. Note that the gas barrier coat layer is preferably transparent. The gas barrier coating layer can be used alone or in layers on the vapor deposited layer. By superimposing a gas barrier coating layer on the vapor deposited layer, it is possible to effectively prevent the occurrence of cracks in the vapor deposited film.

As the alkoxide represented by the above general formula R ¹ _n M(OR ² ) _m , at least one of a partial hydrolyzate of an alkoxide and a condensate of hydrolysis of an alkoxide can be used. In addition, the partial hydrolyzate of the alkoxide described above does not necessarily have to have all the alkoxy groups hydrolyzed, and may be one in which one or more alkoxy groups have been hydrolyzed, or a mixture thereof. As the condensate of alkoxide hydrolysis, a dimer or more of a partially hydrolyzed alkoxide, specifically a dimer to a hexamer, is used.

In the alkoxide represented by the above general formula R ¹ _n M(OR ² ) _m , silicon, zirconium, titanium, aluminum, and the like can be used as the metal atom represented by M. Preferred metals include, for example, silicon and titanium. Furthermore, in the present invention, alkoxides can be used alone or in combination of two or more alkoxides of different metal atoms in the same solution.

Further, in the alkoxide represented by the above general formula R ¹ _n M (OR ² ) _m , specific examples of the organic group represented by R ¹ include, for example, a methyl group, an ethyl group, an n-propyl group, an i Examples include alkyl groups such as -propyl group, n-butyl group, i-butyl group, sec-butyl group, t-butyl group, n-hexyl group, n-octyl group, and others. Further, in the alkoxide represented by the above general formula R ¹ _n M(OR ² ) _m , specific examples of the organic group represented by R ² include, for example, a methyl group, an ethyl group, an n-propyl group, an i -propyl group, n-butyl group, sec-butyl group, and others. Note that these alkyl groups in the same molecule may be the same or different.

Examples of metal alkoxides satisfying the above general formula include tetramethoxysilane (Si(OCH ₃ ) ₄ ), tetraethoxysilane Si(OC ₂ H ₅ ) ₄ ), and tetrapropoxysilane (Si(OC ₃ H ₇ ) ₄ ). , tetrabutoxysilane (Si(OC ₄ H ₉ ) ₄ ), and the like.

When preparing the above gas barrier composition, for example, a silane coupling agent or the like may be added. As the silane coupling agent, known organoalkoxysilanes containing organic reactive groups can be used. In this embodiment, organoalkoxysilane having an epoxy group is particularly preferably used, and specifically, for example, γ-glycidoxypropyltrimethoxysilane, γ-glycidoxypropylmethyldiethoxysilane, β -(3,4-epoxycyclohexyl)ethyltrimethoxysilane and the like can be used. The above silane coupling agents may be used alone or in combination of two or more.

As the water-soluble polymer, polyvinyl alcohol and ethylene-vinyl alcohol copolymer are preferable, and from the viewpoint of oxygen barrier properties and water vapor barrier properties, it is preferable to use these in combination.

The content of the water-soluble polymer in the gas barrier coating layer is preferably 5 parts by mass or more and 500 parts by mass or less based on 100 parts by mass of the metal alkoxide. By setting the content of the water-soluble polymer in the gas barrier coating layer to 5 parts by mass or more based on 100 parts by mass of metal alkoxide, the oxygen barrier properties and water vapor barrier properties of the base material can be further improved. Further, by controlling the content of the water-soluble polymer in the gas barrier coat layer to 500 parts by mass or less based on 100 parts by mass of the metal alkoxide, the film formability of the gas barrier coat layer can be improved.

The thickness of the gas barrier coating layer is preferably 0.01 μm or more and 100 μm or less, more preferably 0.1 μm or more and 50 μm or less. This makes it possible to further improve oxygen barrier properties and water vapor barrier properties while maintaining recyclability. By setting the thickness of the gas barrier coating layer to 0.01 μm or more, the oxygen barrier properties and water vapor barrier properties of the base material can be improved. Moreover, when it is provided adjacent to a deposited film made of an inorganic oxide, it is possible to prevent cracks from occurring in the deposited film.

The gas barrier coating layer is prepared by applying a composition containing the above-mentioned materials by conventionally known means such as roll coating using a gravure roll coater, spray coating, spin coating, dipping, brush, barcode, or applicator. It can be formed by polycondensing by a sol-gel method.

As the sol-gel method catalyst, acid or amine compounds are suitable. As the amine compound, tertiary amines that are substantially insoluble in water and soluble in organic solvents are suitable, such as N,N-dimethylbenzylamine, tripropylamine, tributylamine, tripentyl Examples include amines. Among these, N,N-dimethylbenzylamine is preferred.

The sol-gel method catalyst is preferably used in a range of 0.01 parts by mass or more and 1.0 parts by mass or less, and 0.03 parts by mass or more and 0.3 parts by mass or less, per 100 parts by mass of metal alkoxide. It is more preferable.
By setting the amount of the sol-gel method catalyst to be 0.01 parts by mass or more per 100 parts by mass of metal alkoxide, the catalytic effect can be improved. Further, by controlling the amount of the sol-gel method catalyst to be 1.0 parts by mass or less per 100 parts by mass of the metal alkoxide, the thickness of the formed gas barrier coat layer can be made uniform.

The gas barrier composition may further contain an acid. Acids are used as catalysts in the sol-gel process, mainly for the hydrolysis of alkoxides, silane coupling agents, and the like.
As the acid, mineral acids such as sulfuric acid, hydrochloric acid, and nitric acid, and organic acids such as acetic acid and tartaric acid are used. The amount of acid used is preferably 0.001 mol or more and 0.05 mol or less based on the total molar amount of the alkoxide and the alkoxide portion (for example, silicate portion) of the silane coupling agent.
The catalytic effect can be improved by setting the amount of the acid used to be 0.001 mol or more based on the total molar amount of the alkoxide and the alkoxide portion (eg, silicate portion) of the silane coupling agent. In addition, by setting the amount of the alkoxide and the alkoxide component (for example, silicate portion) of the silane coupling agent to 0.05 mol or less with respect to the total molar amount, the thickness of the formed gas barrier coating layer can be made uniform. .

Further, the gas barrier composition preferably contains water in a proportion of 0.1 mol or more and 100 mol or less, more preferably 0.8 mol or more and 2 mol or less, per 1 mol of the total molar amount of the alkoxide. It is preferable.
By setting the water content to 0.1 mol or more per 1 mol of the total molar amount of alkoxide, the oxygen barrier properties and water vapor barrier properties of the base material can be improved. Further, by controlling the water content to 100 mol or less per 1 mol of the total molar amount of alkoxide, the hydrolysis reaction can be carried out quickly.

Further, the gas barrier composition may contain an organic solvent. As the organic solvent, for example, methyl alcohol, ethyl alcohol, n-propyl alcohol, isopropyl alcohol, n-butanol, etc. can be used.

An embodiment of a method for forming a gas barrier coat layer will be described below.
First, a metal alkoxide, a water-soluble polymer, a sol-gel catalyst, water, an organic solvent, and if necessary a silane coupling agent are mixed to prepare a composition. A polycondensation reaction gradually proceeds in the composition.
Next, the composition is applied onto the polyolefin resin layer by the conventionally known method described above and dried. By this drying, the polycondensation reaction of the alkoxide and the water-soluble polymer (and the silane coupling agent if the composition includes the silane coupling agent) further proceeds, and a composite polymer layer is formed.
Finally, a gas barrier coat layer can be formed by heating the composition at a temperature of 20 to 250°C, preferably 50 to 220°C, for 1 second to 10 minutes.

Since the container package 1 is required to be able to visually confirm the prefilled syringe S contained therein, at least one of the lid material 2 and the blister 4 may have at least a partially transparent portion. desired. Therefore, a layer containing UV cut ink or UV cut film is selected as the UV cut layer for the lid material 2, and a transparent aluminum oxide vapor deposited layer, silicon oxide vapor deposited layer, transparent stretched nylon layer, or ethylene vinyl alcohol layer is selected as the gas barrier layer. By selecting and combining a copolymer (EVOH) layer, etc., it is possible to visually confirm the prefilled syringe S inside the container package 1 through the lid material 2, while adding UV protection and gas barrier properties to the lid material 2. It is possible to add gender.
The oxygen absorbing layer of the lid material 2 includes a layer containing an oxygen absorbent in a resin layer or an adhesive layer. The oxygen absorbent may be either an inorganic oxygen absorbent or an organic oxygen absorbent. As the inorganic oxygen absorber, conventionally used oxygen absorbers mainly composed of granular metals can be used, and metal powders having reducing properties, such as reducing iron, reducing zinc, reducing tin, etc. Powder: Low-level metal oxides, such as ferrous oxide, triiron tetroxide, titanium oxide, zinc oxide: Reducing metal compounds, such as iron carbide, iron silicate, iron carbonyl, ferrous hydroxide, etc. or Examples include those whose main ingredients are a combination of two or more types. Organic oxygen absorbers include ascorbic acid, catechol, glycerin, etc. as OH group oxidation types, conjugated double bond polymers, cyclohexane-containing polymers, unsaturated fatty acids, etc. as double bond oxidation types, and others. MXD nylon or the like can be used as the material. These oxygen absorbers are optionally combined with auxiliary agents such as alkali metal, alkaline earth metal hydroxides, carbonates, sulfites, thiosulfates, tertiary phosphates, activated alumina, and activated clay. can be used.

In addition, when the lid material 2 has an opaque layer such as an aluminum vapor-deposited layer, it is provided with a region partially free of the opaque layer for visual inspection, and this region is designated as a confirmation window of the lid material 2. It can be done.

The laminated film of the lid material 2 is, for example, a laminated film of PET layer-adhesive layer-stretched nylon layer-adhesive layer-polyethylene layer, a laminated film of PET layer-adhesive layer-polyethylene layer, a laminate film of stretched nylon layer-adhesive layer-polyethylene layer, etc. Laminated film, PET layer-barrier layer-adhesive layer-stretched nylon layer-adhesive layer-polyethylene layer laminate film, PET layer-barrier layer-adhesive layer-polyethylene layer laminate film, stretched nylon layer-barrier layer-adhesive layer- There are laminated films with polyethylene layers, etc. The outermost polyethylene layer of these laminated films is used so as to be joined to the polyethylene film when the outermost layer of the skin pack film 3 or the blister 4 is a polyethylene film.
As the lid material 2, a film having easy-to-open properties or a film processed to provide easy-to-open properties can be used, if necessary.

The skin pack film 3 is a resin film that softens when heated, stretches along the outer shape of the packaged object, and comes into close contact with the packaged object, and may be a single layer or a multilayer of two or more layers. Good too. Examples include resin films made of soft vinyl chloride, ionomers, polyethylene, ethylene-vinyl acetate copolymers, ethylene-vinyl alcohol copolymers, etc., and laminated films made by laminating multiple of these resins may also be used. . In the case of a laminated film in which multiple layers are laminated, the surface layer on the inner layer side is preferably made of polyethylene in consideration of adhesiveness with the lid material 2 and the blister 4.

The skin pack film 3 can be provided with a functional film if necessary. For example, the gas barrier layer can include ethylene vinyl alcohol copolymer (EVOH). Moreover, an oxygen absorber can be included in the resin layer as an oxygen absorbing layer. Any oxygen absorbent used in the laminated film of the lid material 2 can be used as the oxygen absorbent. Since the oxygen absorbent used in the lid material 2 has already been explained, a redundant explanation will be omitted here.

The skin pack film 3 can reliably fix a container such as a prefilled syringe S to the lid material 2 in a vacuum deaerated state and in close contact with the film. This can prevent the container from moving or vibrating within the container package 1. In addition, since the container is in close contact with the skin pack film 3 in a vacuum deaerated state and is fixed to the lid material 2, residual air between the lid material 2 and the skin pack film 3 can be eliminated as much as possible. When the skin pack film 2 and the skin pack film 3 include a gas barrier layer or an oxygen absorption layer, the amount of oxygen can be reduced and the influence of oxygen can be suppressed. Furthermore, a transparent film can be used as the skin pack film 3, so that the liquid inside the container can be easily confirmed. Furthermore, the skin pack film 3 can be joined to the lid material 2 and the blister 4 by heat sealing.
As the skin pack film 3, a film having easy-to-open properties or a film processed to provide easy-to-open properties can be used, if necessary.

The laminated film of the skin pack film 3 includes, for example, a laminated film of a polyethylene layer - an adhesive layer - an ionomer layer - an ethylene/vinyl acetate copolymer layer, or a laminated film of a polyethylene layer - an ethylene/vinyl acetate copolymer layer - a polyethylene layer. .

As a laminated film of the skin pack film 3 having a gas barrier layer, for example, a polyethylene layer - ethylene/vinyl acetate copolymer layer - adhesive layer - ethylene/vinyl alcohol copolymer layer - adhesive layer - ethylene/vinyl acetate copolymer layer - Laminated film of polyethylene layer, polyethylene layer - adhesive layer - ionomer layer - adhesive layer - ethylene/vinyl alcohol copolymer layer - adhesive layer - polyethylene layer, polyethylene layer - adhesive layer - ionomer layer - adhesive layer - ethylene layer There is a laminated film consisting of a vinyl alcohol copolymer layer, an adhesive layer, and an ethylene/vinyl acetate copolymer layer.

The blister 4 is a transparent plastic molded product, and is made by vacuum forming a resin sheet such as PET (polyethylene terephthalate), PE (polyethylene), or PP (polypropylene). It may be a single layer or a multilayer of two or more layers. In particular, the blister 4 is preferably made of polyethylene in order to be heat-sealed to the surface polyethylene layer on the inner layer side of the skin pack film 3.

The blister 4 can be a laminated film in which multiple layers are laminated for the purpose of adding a barrier layer and other functions. The functional layer can include, for example, ethylene vinyl alcohol copolymer (EVOH) as a gas barrier layer. Further, a resin layer containing an ultraviolet absorber can be included as a UV cut layer. Furthermore, the oxygen absorbing layer may include a layer containing an oxygen absorbent in the resin. Any oxygen absorbent used in the laminated film of the lid material 2 can be used as the oxygen absorbent. Since the oxygen absorbent used in the lid material 2 has already been explained, a redundant explanation will be omitted here.

As a laminated film containing the above gas barrier layer, there is a laminated film of a polyethylene layer, an adhesive layer, an ethylene/vinyl alcohol copolymer, an adhesive layer, and a polyethylene layer. In the illustrated laminated film, the inner surface layer is a polyethylene layer in order to be heat-sealed with the inner surface polyethylene layer of the skin pack film 3.

Preferably, the blister 4 is a soft blister. Soft blister refers to a blister made of a soft material, meaning that it does not contain a single layer or a thick layer of a hard material such as PET. By being a soft blister, the blister 4 has a buffering effect, and the buffering effect of the container package 1 can be improved. The blister 4, which is a laminate including a polyolefin resin or polyethylene layer, is a soft blister, which is preferable in terms of its cushioning effect.

The container package 1 includes either a structure that includes a gas barrier layer or a structure that does not include a gas barrier layer. When a gas barrier layer is provided, a structure in which the lid material 2 and the skin pack film 3 are each provided with a gas barrier layer, or a structure in which the lid material 2 and the blister 4 are each provided with a gas barrier layer is preferable. However, this does not exclude a structure in which each of the lid material 2, the skin pack film 3, and the blister 4 includes a gas barrier layer.

In addition, in the case of a structure in which the lid material 2 and the blister 4 are each provided with a gas barrier layer, in order to suppress the influence of oxygen in the air in the space between the skin pack film 3 and the blister 4, the skin pack film 3 and the blister 4 An oxygen absorber may be provided in the space between the lid material 2 or the skin pack film 3, a layer with oxygen absorption ability may be provided on the lid material 2 or the skin pack film 3, or an oxygen absorber may be provided in the gap between the lid material 2 and the skin pack film 3. can do.

Next, a method for manufacturing the container package 1 will be described using FIG. 4.
The container package 1 can be manufactured using a packaging machine including the skin pack packaging machine 20. First, a container such as a prefilled syringe S is wrapped in a skin pack using a lid material 2 and a skin pack film 3 using a skin pack packaging machine 20 shown in FIG. The skin pack packaging machine 20 includes, for example, a vacuum chamber 21 and a suction stand 24. In addition, in FIG. 4, only essential parts of the skin pack packaging machine 20 are shown. Using the skin pack packaging machine 20, the prefilled syringe S, which is an object to be packaged, is placed at a predetermined position on the lid material 2 and is housed in the vacuum chamber 21 of the skin pack packaging machine 20. The skin pack film 3 is placed on the suction table 24 , and the skin pack film 3 is fed to the vacuum chamber, and vacuum is drawn from above the vacuum chamber 21 and from below the suction table 24 to remove the skin pack film 3 from the vacuum chamber 21 . After heating and softening the skin pack film 3 while it is adsorbed to the hot plate on the upper surface of the vacuum chamber 21, the skin pack film 3 is The prefilled syringe S is coated, deformed and stretched to follow the outer shape of the prefilled syringe S, and tightly attached to the prefilled syringe S and tightly fixed to the lid material 2 for sealing to obtain a skin pack package.
FIG. 5 shows a schematic diagram of the skin pack packaging machine 20. The skin pack packaging machine 20 in FIG. 5 includes a vacuum chamber 21 capable of suction and exhaust, a holding section 22 provided in the vacuum chamber 21 for holding the skin pack film 3, and a heating device 23 for heating the skin pack film 3. , and a suction table 24 on which the lid material 2 is placed. A plurality of suction holes 25 are formed on the upper surface of the suction table 24, and an exhaust port 26 is formed on the lower part thereof, which is connected to a suction device (not shown) to exhaust the air in the vacuum chamber 21 and reduce the pressure. The heating device 23 may be an infrared irradiation device, a hot air generation device, or the like, in addition to a hot plate that adsorbs and heats the skin pack film 3.

In FIG. 4, a skin pack package taken out from the vacuum chamber 21 of the skin pack packaging machine 20 is covered with a blister 4 on the line of the packaging machine, and the ends of the blister 4 and the lid material 2 or the skin pack film 3 are are heat-sealed to obtain a container package 1. Note that the manufacturing process is not limited to the above process, and many modifications are possible.

EXAMPLES Hereinafter, the present invention will be explained in more detail using Examples, but the present invention is not limited to these Examples in any way.

Container packages of Examples were produced and evaluated by a drop impact test.
(Example 1)
The lid material 2 is a laminated film (thickness 70 μm) of (PET film 12 μm/adhesive layer/stretched nylon film 15 μm/adhesive layer/low density polyethylene film 40 μm), and the skin pack film 3 is (ionomer/ethylene-vinyl acetate copolymer). The resin film of the blister 4 is a polyethylene laminated film (thickness 200 μm), and the resin film of the blister 4 is a polyethylene laminated film (thickness 200 μm). After arranging the prefilled syringe S and skin-packaging it with the skin-packing film 3, a blister 4 was placed on it and heat-sealed to obtain the container package of Example 1 containing the prefilled syringe S.
For Prefilled Syringe S, a 1 mL prefilled syringe made of plastic (COP) was used, filled with 1 mL of water, the tip of the syringe body was sealed with a butyl rubber cap, and a butyl rubber gasket was inserted from the rear end of the syringe body. .
The size of the package was 30 mm on the short side, 130 mm on the long side, and 20 mm in height.

In the drop impact test, strain gauges were attached to the prefilled syringe S housed in a container package with adhesive in two directions: the circumferential direction and the vertical direction, and the sample was dropped from a height of 30 cm onto the floor. Two types of tests were conducted: one in which the axial direction of the prefilled syringe S was dropped in a direction that was almost vertical, and the other in which the axial direction of the prefilled syringe S was dropped in a direction in which the axial direction was almost horizontal. The minute strain that occurs was detected by an attached strain gauge, measured by a strain measuring device, and analyzed to determine whether or not the package had a buffering effect. The strain gauge at this time was a KFEM type (foil extra large strain gauge) manufactured by Kyowa Dengyo, and the measuring device was an EDX-10 series, EDX-14A strain measurement unit manufactured by Kyowa Dengyo.

As a result, the difference between the maximum and minimum microstrains was the same in the vertical test (vertical strain was 36με, circumferential strain was 21με), and in the horizontal test when the cover material 2 was dropped with the cover 2 facing down (vertical strain was 36με, circumferential strain was 21με). The strain was 68 με, the circumferential strain was 28 με), and when the blister 4 was dropped with the blister 4 facing down (the vertical strain was 31 με, the circumferential strain was 26 με), the container package of Example 1 had sufficient A buffering effect was obtained.
(Example 2)
As Example 2, the lid material 2 is a laminated film (thickness 70 μm) of (transparent alumina vapor-deposited PET film 12 μm/adhesive layer/stretched nylon film 15 μm/adhesive layer/low density polyethylene film 40 μm), and the skin pack film 3 is ( Example except that a laminated film (thickness: 100 μm) of (ionomer/ethylene-vinyl acetate copolymer) was used, and blister 4 was a laminated sheet (thickness: 200 μm) of (polyethylene/ethylene-vinyl alcohol copolymer/polyethylene). A container package of Example 2 was obtained in the same manner as in Example 1.
When the obtained container package of Example 3 was subjected to the same impact drop test as in Example 1, the difference between the maximum value and the minimum value of microstrain was as follows: vertical strain was 37με in the vertical direction test, circular When the circumferential strain was 23με and the lid material 2 was dropped in the horizontal direction test (vertical strain was 66με and the circumferential strain was 28με), and when the blister 4 was dropped with the blister 4 facing down (the vertical strain was 33με and the circular The circumferential strain was 27με), and the container packaging of Example 2 had a sufficient buffering effect.
(Example 3)
As Example 3, the lid material 2 is a laminated film (thickness approximately 60 μm) of transparent alumina vapor-deposited PET film 12 μm/UV cut ink layer/adhesive layer/stretched nylon film 15 μm/adhesive layer/low density polyethylene film 30 μm), and a skin The pack film 3 is a laminated film (thickness 100 μm) of (ionomer/ethylene-vinyl acetate copolymer), and the blister 4 is a laminated sheet (thickness 200 μm) of (polyethylene/ethylene-vinyl alcohol copolymer/polyethylene). A container package of Example 2 was obtained in the same manner as in Example 1 except for the following steps.
When the obtained container package of Example 3 was subjected to an impact drop test similar to that of Example 1, the difference between the maximum value and the minimum value of microstrain was as follows: vertical strain was 34με in the vertical direction test, circular When the circumferential strain was 21με and the lid material 2 was dropped in the horizontal direction test (vertical strain was 68με and the circumferential strain was 27με), when the blister 4 was dropped with the blister 4 facing down (the vertical strain was 36με and the circular The circumferential strain was 30 με), and the container package of Example 3 had a sufficient buffering effect.

As Comparative Example 1, a prefilled syringe S that was not housed in a package was created. Prefilled syringe S was filled with water and sealed with a cap and gasket in the same manner as in the example, and a drop impact test was conducted in the same manner as in the example. The difference was in the vertical test (vertical strain 67 με, circumferential strain 35 με) and in the horizontal test (vertical strain 150 με, circumferential strain 52 με).

As Comparative Example 2, a single pouch was created using the lid material 2 of Example 1 and the resin film of the blister 4 without the skin pack film 3, and a prefilled syringe S filled with water was similarly sealed and sealed. A drop impact test was conducted in the same manner as in 1 and Comparative Example 1, and the difference between the maximum and minimum microstrain values was as follows in the vertical test (vertical strain: 61με, circumferential strain: 34με), and in the horizontal test. (Vertical strain was 116με, circumferential strain was 30με).

Although the container packaging of the present invention has been specifically described above using the embodiments and examples, the container packaging of the present invention is not limited to the description of these embodiments and examples. Many modifications can be made without departing from the spirit of the invention.

1 Container packaging 2 Lid material 3 Skin pack film 4 Blister

Claims (7)

A package for accommodating a container filled with a liquid,
a lid material, a skin pack film that accommodates the container between the lid material and is deformed according to the outer shape of the container and is closely fixed to the lid material; and a blister that accommodates the deformed portion of the skin pack film and is tightly fixed to the lid material or the skin pack film that is tightly fixed to the lid material,
The bulging portion of the blister is formed with a space separated from the deformed portion of the skin pack film,
A packaging body for a container , wherein at least one of the skin pack film and the blister and the lid material are made of a laminated film including a barrier layer . The container packaging according to claim 1, wherein the blister is a soft blister. At least the blister and the lid material are made of a laminated film including the barrier layer,
The container package according to claim 1 or 2, further comprising an oxygen absorber in a space between the skin pack film and the blister. At least the blister and the lid material are made of a laminated film including the barrier layer,
The container package according to claim 1 or 2, wherein the lid material or the skin pack film includes a layer having oxygen absorption ability. At least the blister and the lid material are made of a laminated film including the barrier layer,
The container package according to claim 1 or 2, wherein an oxygen absorber is provided in a gap between the lid material and the skin pack film. The container package according to any one of claims 1 to 5 , further comprising means for easily opening the lid and the skin pack film. a lid material, a skin pack film that accommodates the container between the lid material, is deformed according to the outer shape of the container, and is closely fixed to the lid material, and a bulge is formed in which the container and a blister that accommodates a deformed portion of the skin pack film and is tightly fixed to the lid material or the skin pack film that is tightly fixed to the lid material, and at least one of the skin pack film and the blister. , a method for manufacturing a container packaging body in which the lid material is a laminated film including a barrier layer,
After the container is skin-packed and fixed to the lid material, the blister formed so as to separate a space from the deformed part of the skin pack to which the container is fixed is tightly fixed to the lid material or the lid material. A method for producing a packaging body for a container, characterized in that the packaging body is closely fixed to the skin pack film.

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