JP7424054B2 - 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, in such a blister packaging container, when vibrations or shocks are applied to the blister packaging container from the outside, the vibrations or shocks are transmitted to the prefilled syringe with almost no attenuation. 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 have proposed a double pouch package consisting of an inner bag and an outer bag, in which the inner bag is a skin pack, gas is sealed between the inner bag and the outer bag, and the container is It was discovered that the vibration impact of the container can be buffered by having a structure in which the container is fixed with a space separated from the outer bag by the bag, 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 an inner bag made of a resin film including a skin pack film, and a resin film accommodating the inner bag. and an outer bag, the inner bag accommodates the container inside the bag and tightly fixes the container to the skin pack film by a skin pack, and the outer bag has an end that is the same as an end of the inner bag. The inner bag is fixed and sealed with gas stored outside the inner bag, and the container is fixed by the inner bag with a space separated from the outer bag.

In the container package of the present invention, the resin film of the inner bag (hereinafter also referred to as "resin film for inner bag") may include an easily openable film. Furthermore, the resin film of the outer bag (hereinafter also referred to as "resin film for outer bag") may have a structure including a barrier layer. Further, the container may be a pharmaceutical container.

The method for manufacturing a container package according to the present invention includes skin-packing a container using a resin film for an inner bag containing a skin pack film as at least one of two resin films, and then skin-packing the container using a resin film for an outer bag. It is characterized in that it is inserted into a sheet folded in half or between two sheets, and the outer bag is sealed while supplying gas to the inside of the outer bag resin film.

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.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic plan 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. FIG. 2 is a schematic plan view showing an example in which vials are accommodated in the container package of FIG. 1. FIG. 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 plan 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.

1 and 2, a container package 1 includes an inner bag 2 and an outer bag 3, and has a double bag structure in which the inner bag 2 is housed inside the outer bag 3. In the illustrated embodiment, the inner bag 2 is a skin pack packaging body, and has a skin pack film 21 made of thermoplastic resin as an inner bag resin film and a base material 22, and is located at a predetermined position on the base material 22. A skin pack film 21 softened by heating is closely attached along the outer shape of the packaged article, for example, a prefilled syringe S in this embodiment, which is placed on the packaged article, and the vacuum package is sealed with the base material 22. It is the body. At least one of the two resin films for the inner bag 2 is a skin pack film. In other words, the materials of the resin film used for the skin pack film 21 and the resin film used for the base material 22 may be different or may be the same. If they are the same, the resin film used for the base material 22 is This is a skin pack film, which is a resin film used for.

The outer bag 3 has a substantially rectangular planar shape by folding one resin film in half as the outer bag resin film or by stacking two resin films. The outer bag 3 can be a four-sided bag whose four sides are sealed using two outer bag resin films. The resin film for the outer bag 3 may be a laminated film having a base layer and a layer made of a polyolefin resin that can be bonded to the resin film on the outer surface of the inner bag 2 as the outermost layer. However, it is not limited to a four-sided bag; it can also be a three-sided bag in which three edges other than the half-folded edge are sealed, and an inner bag 2 and an outer bag 3 are added to the folded edges of the three-sided bag. It is also possible to form a four-sided bag in which the two sides are sealed so that they are fixed to each other. Even if the container package is a three-sided bag, the same material as that for a four-sided bag can be used, so the following description will be made using the four-sided bag container package 1 as a representative.

As shown in FIG. 2, the prefilled syringe S is housed inside the inner bag 2. This inner bag 2 is a skin pack package. A prefilled syringe S is housed in the inner bag 2 and sealed in a vacuum deaerated state. By softening the skin pack film 21 as a skin pack, bringing it into close contact with the prefilled syringe S, and sealing it in a vacuum deaerated state, the inside of the inner bag 2 is in a reduced pressure state, and the prefilled syringe S is attached to the skin pack film 21. It is tightly fixed. 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 inner bag 2 when viewed in the plan view of FIG.

The outer bag 3 is sealed with a gas such as air or an inert gas contained between the inner bag 2 and the outer bag 3 so that the outer bag 3 is inflated. As seen in the sectional view of FIG. 2, both ends of the inner bag 2 are sealed and fixed to the outer bag 3. Therefore, the inner bag 2 is fixed to the outer bag 3 across the inner space of the outer bag 3. Therefore, the prefilled syringe S located approximately at the center of the inner bag 2 in the width direction is also located across the inner space from the outer bag 3.

In the container package 1 of this embodiment, since the prefilled syringe S is fixed by the skin-packed inner bag 2, even if external shocks or vibrations are applied to the container package 1, the container package There is no unnecessary movement within the body. In addition, since the prefilled syringe S is located apart from the outer bag 3, even if shock or vibration is applied to the container package 1 from the outside, the gas inside the outer bag 3 acts as a cushioning material to prevent the shock. Absorb vibrations. 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 further have a barrier function etc. by laminating a functional film serving as a barrier layer etc. in the resin film of either or both of the outer bag 3 and the inner bag 2.

The inner bag 2 includes a resin film of a base material 22 and a skin pack film 21 as a skin pack. The skin pack film 21 may be used as the resin film of the base material 22. The skin pack film 21 is a resin film that softens when heated, stretches along the outer shape of the packaged item, and comes into close contact with the packaged item, 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, and ethylene-vinyl alcohol copolymers, and laminated films of a plurality 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 outer layer side is preferably made of polyethylene in consideration of adhesiveness with the outer bag 3.

The skin pack film 21 can include a functional film if necessary. For example, the gas barrier layer can include ethylene vinyl alcohol copolymer (EVOH). Furthermore, the oxygen absorbing layer may include a layer containing an oxygen absorbent in the resin. As the oxygen absorbent, a conventionally used oxygen absorbent containing granular metal as a main component can be used, and metal powder having reducing properties, such as reducing iron, reducing zinc, reducing tin powder: Low-level metal oxides, such as ferrous oxide, triiron tetroxide, titanium oxide, zinc oxide; Reducing metal compounds, such as one or two of iron carbide, iron silicate, iron carbonyl, ferrous hydroxide, etc. Examples include those whose main ingredients are combinations of the above. 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.

The resin film of the base material 22 may be a single layer or a multilayer of two or more layers. It is preferable that the skin pack film 21 is made of a resin that can be heat-adhered to the skin pack film 21. From this point of view, the same type of resin as the skin pack film 21 (in the case where the skin pack film is a laminated film, the resin film of the inner layer side surface layer) is used as the inner layer side surface layer. It is preferable that the film contains For example, when the surface layer on the inner layer side of the skin pack film 21 is a polyethylene film, the resin film of the base material 22 is preferably a polyethylene film. However, the resin film of the base material 22 is not limited to a polyethylene film.

If the resin film of the base material 22 is a laminated film in which multiple layers are laminated, the inner surface layer is a resin film of the same type as the inner surface layer of the skin pack film 21 so that it can be thermally bonded to the skin pack film 21. It is preferable that there be. Further, the outer surface layer of the base material 22 is preferably a resin film of the same type as the inner surface layer of the outer bag 3, such as a polyethylene film, so that it can be heat-sealed with the inner surface layer of the outer bag 3. Furthermore, the laminated film of the base material 22 may be a laminated film having the same laminated structure as the laminated film of the skin pack film 21.

The resin film of the base material 22 can be provided with a functional film if necessary. For example, as a gas barrier layer, ethylene vinyl alcohol copolymer (EVOH), a film, a metal or a metal oxide are laminated on a plastic film, etc. by vapor deposition, such as a silicon oxide vapor deposited plastic film, an aluminum oxide vapor deposited plastic film, an aluminum vapor deposited plastic film, etc. It can include a film, a plastic film coated with a known gas barrier agent, and the like. Furthermore, the oxygen absorbing layer may include a layer containing an oxygen absorber in the resin layer or the adhesive layer. As the oxygen absorbent for the base material 22, any oxygen absorbent used in the laminated film of the skin pack film 21 can be used. Since the oxygen absorbent used in the skin pack film 21 has already been explained, repeated explanation will be omitted here.

By using the skin pack film 21 in the inner bag 2, a container such as a prefilled syringe S can be reliably fixed in a vacuum deaerated state and in close contact with the film. This can prevent the container from moving or vibrating within the bag. In addition, since the container is in close contact with the skin pack film 21 in the inner bag 2 in a vacuum deaerated state, the residual air in the inner bag 2 can be reduced, especially when the inner bag 2 includes a gas barrier layer. , residual air in the inner bag 2 and oxygen in the air can be eliminated as much as possible, thereby preventing oxidation. Furthermore, the inner bag 2 can be made into a transparent bag, and the liquid (medicine, etc.) inside the container can be easily checked. Furthermore, the end of the inner bag 2 and the end of the outer bag 3 can be joined by heat sealing. For the inner bag 2, a film having easy-to-open properties or a film processed to provide easy-to-open properties can be used, if necessary.

The outer bag 3 may be a single layer, or may be a multilayer of two or more layers. In the case of a laminated film having two or more layers, a laminated film having a base layer such as PET or nylon 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 polyolefin resin is a layer that becomes the inner surface when the outer bag 3 is formed into a bag shape, and functions as a heat seal layer. By using the same type of polyolefin resin as the resin film on the surface of the outer layer of the inner bag 2, the peripheral part of the inner bag 2 and the peripheral part of the outer bag 3 can be easily joined by heat sealing. can. The same type of resin means, for example, that when the outer surface of the inner bag 2 is made of polyethylene resin, the outermost layer of the outer bag 3 is a layer made of polyethylene resin.

The laminated film of the outer bag 3 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, 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 vapor deposited layers such as an aluminum vapor deposition layer, an aluminum oxide vapor deposition layer, and a silicon oxide vapor deposition layer, a known gas barrier coating layer, a stretched nylon layer, and an ethylene vinyl alcohol copolymer (EVOH) layer.

The vapor-deposited layer of the gas barrier layer may be a transparent vapor-deposited layer or an opaque vapor-deposited layer. When the vapor deposition layer is a transparent vapor deposition layer, it is possible to provide 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 coat 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 partially hydrolyzed alkoxide, specifically a dimer to 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. Further, in the present invention, the alkoxide can be used alone or in combination of two or more different metal atom alkoxides 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.

The oxygen absorbing layer of the outer bag 3 includes a resin layer or an adhesive layer containing an oxygen absorbent. As the oxygen absorber, any of the oxygen absorbing layers used in the laminated film of the skin pack film 21 described above can be used, and since the oxygen absorbing layer used in the skin pack film 21 has already been explained, it will be repeated here. The explanation will be omitted.

Since the container package 1 is required to be able to visually confirm the contained container, the outer bag 3 may be required to allow the container to be visually confirmed from the outside, and in this case, A layer containing UV cut ink is selected as the light shielding layer, and a transparent aluminum oxide vapor deposited layer, silicon oxide vapor deposited film, transparent stretched nylon, ethylene vinyl alcohol copolymer (EVOH) layer, etc. are selected as the gas barrier layer and used in combination. be able to. In addition, in the case of having an opaque layer such as an aluminum vapor-deposited layer, a region partially free of the opaque layer can be provided for visual inspection, and this region can be used as a confirmation window for the outer bag 3. .

The laminated film of the outer bag 3 is, for example, a laminated film of PET film layer - aluminum oxide vapor deposited layer - adhesive layer - polyethylene film layer, PET film layer - aluminum oxide vapor deposited layer - adhesive layer - stretched nylon layer - adhesive layer - polyethylene. There are laminated films of film layers, and laminated films of stretched nylon layer-aluminum oxide vapor deposited layer-adhesive layer-polyethylene film layer. Furthermore, there are laminated films in which the aluminum oxide vapor-deposited layer of these laminated films is replaced with a barrier layer of an oxide such as silicon oxide, a resin barrier layer, or a barrier coat layer. The inner surface polyethylene film layer of these laminated films is used so as to be joined to the polyethylene film when the inner bag 2 is a polyethylene film.

The laminated film of the outer bag 3 can include a layer containing an oxygen absorbent in a resin layer or an adhesive layer as an oxygen absorbing layer. As the oxygen absorbent, a conventionally used oxygen absorbent containing granular metal as a main component can be used, and metal powder having reducing properties, such as reducing iron, reducing zinc, reducing tin powder: Low-level metal oxides, such as ferrous oxide, triiron tetroxide: Reducing metal compounds, such as iron carbide, iron silicate, iron carbonyl, ferrous hydroxide, etc., or a combination of two or more of them. Examples include those with main ingredients. 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.

The container package 1 includes a functional layer provided on the laminated film of the inner bag 2 and the laminated film of the outer bag 3 as described above, as well as an oxygen absorber provided between the inner bag 2 and the outer bag 3. , it is possible to add an antioxidant function.

Next, a method for manufacturing the container package 1 will be described using FIG. 4. FIG. 4 shows an example in which the outer bag 3 is a square bag.
The container package 1 can be manufactured using a packaging machine. First, a container such as a prefilled syringe S is wrapped in a skin pack using an inner bag 2. For this skin pack packaging, for example, a skin pack packaging machine 30 shown in FIG. 5 is used. In addition, in FIG. 4, only the vacuum chamber 31 and the suction table 34 are shown as main parts of the skin pack packaging machine 30. In the skin pack packaging machine 30, a prefilled syringe S, which is an object to be packaged, is placed at a predetermined position on the base material 22, and is housed in the vacuum chamber 31 of the skin pack packaging machine 30, and placed on the suction table 34. At the same time, the skin pack film 21 is fed to the vacuum chamber, and vacuum is drawn from above the vacuum chamber 31 and from below the suction table 34 to transfer the skin pack film 21 to the hot plate on the top surface of the vacuum chamber 31. After heating and softening the skin pack film 21 while adsorbed to it, air is introduced between the skin pack film 21 and the hot plate on the top surface of the vacuum chamber 31 to cover the container with the skin pack film 21, and the prefilled syringe is then heated. It is deformed and stretched to follow the outer shape of S, and is closely attached to the prefilled syringe S and heat-tightly sealed with the base material 22 to obtain the inner bag 2.

FIG. 5 shows a schematic diagram of the skin pack packaging machine 30. The skin pack packaging machine 30 in FIG. 5 includes a vacuum chamber 31 that can be sucked and evacuated, a holding section 32 that is provided in the vacuum chamber 31 and holds the skin pack film 21, and a heating device 33 that heats the skin pack film 21. , and a suction table 34 on which the table material 22 is placed. A plurality of suction holes 35 are formed on the upper surface of the suction table 34, and an exhaust port 36 is formed on the lower part thereof, which is connected to a suction device (not shown) to exhaust the air in the vacuum chamber 31 and reduce the pressure. The heating device 33 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 21.

In FIG. 4, the inner bag 2 taken out from the vacuum chamber 31 of the skin pack packaging machine 30 is rolled with two resin films for the outer bag 3 on the upper and lower sides of the inner bag 2 on the packaging machine line. It is unrolled and fed continuously.

The ends of the inner bag 2 are sandwiched between the upper and lower resin films for the outer bag 3, and the ends of the inner bag 2 and the outer bag 3 are joined by heat-sealing by heating and pressing. The line has a double bag shape with only the rear end in the flow direction open, and a gas supply tube 11 inserted between the inner bag 2 and the outer bag 3 allows air or inert gas to be supplied, for example. The outer bag 3 is sealed by heat-sealing the opening at the rear end while blowing nitrogen gas.

After the opening at the rear end is heat-sealed, the front and rear ends in the moving direction of the resin film are cut to obtain individual container packages 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 resin film for the inner bag 2 is a laminated film (thickness 100 μm) of (ionomer/ethylene-vinyl acetate copolymer) for the skin pack film 21, and the base material 22 is a polyethylene film (thickness 50 μm), and for the outer bag 3. An example in which the resin film is a laminated film (thickness 45 μm) of (PET film 12 μm/adhesive layer/low density polyethylene film 30 μm) and a prefilled syringe S is housed in the form described using FIGS. 1 and 2. A container package of No. 1 was obtained. 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 40 mm on the short side x 130 mm on the long side.
The method for creating the test package is to place the prefilled syringe S in the center of the base material 22, wrap it in a skin pack with the skin pack film 21 of the inner bag 2, and then sandwich it vertically with the outer bag film, one of the short sides. The four-sided bag of Example 1 was obtained by heat-sealing the three sides excluding the outer bag 3 and the inner bag 2, and heat-sealing the remaining open short sides while filling air between the outer bag 3 and the inner bag 2.

When the container package of Example 1 was dropped from a height of 30 cm to the floor and the movement of the container within the bag was visually observed, it was found that the container package of Example 1 did not move as far as the inner bag 2. The impact was alleviated by the air between the container and the outer bag 3, and the inner bag 2, which was fixed to the outer bag 3, was in close contact with the skin pack package, and no movement of the container within the bag was observed.

(Example 2)
Example 2 uses a laminated film (thickness 100 μm) of two identical skin pack films (polyethylene/adhesive layer/ionomer/ethylene-vinyl acetate copolymer) as the skin pack film 21 and base material 22 of the inner bag 2. ), and the four-sided bag of Example 2 was prepared in the same manner as in Example 1, except that the resin film for outer bag 3 was a laminated film (thickness: approximately 45 μm) of (PET film 12 μm/adhesive layer/low density polyethylene film 30 μm). I got it.
When the obtained four-sided bag of Example 2 was subjected to the same impact drop test as in Example 1, it was found that the container package of Example 2 was damaged by the air between the inner bag 2 and the outer bag 3. The impact was alleviated, and the inner bag 2 was in close contact with the skin pack packaging body fixed to the outer bag, and no movement of the container within the bag was observed.

(Example 3)
In Example 3, the skin pack film 21 of the inner bag 2 is a laminated film (thickness: 100 μm) of (polyethylene/adhesive layer/ionomer/ethylene-vinyl acetate copolymer), and the base material 22 is a polyethylene film (thickness: Except that the resin film for the outer bag 3 was a laminated film (thickness about 60 μm) of (transparent alumina vapor-deposited PET film 12 μm/adhesive layer/stretched nylon film 15 μm/adhesive layer/low-density polyethylene film 30 μm). A four-sided bag of Example 3 was obtained in the same manner as Example 1.
When the obtained four-sided bag of Example 3 was subjected to the same impact drop test as in Example 1, it was found that the container package of Example 3 was damaged by the air between the inner bag 2 and outer bag 3. The impact was alleviated, the inner bag 2 was in close contact with the skin pack packaging body fixed to the outer bag 3, and no movement of the container within the bag was observed.

(Comparative example)
As a comparative example, a container without the inner bag skin pack was placed in a bag equivalent to the outer bag of Example 1, and the bag was sealed by heat sealing to obtain a container package of a comparative example. When the container package of this comparative example was dropped on the floor, the container moved violently within the bag.

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 Inner bag 3 Outer bag 11 Gas supply tube

Claims (8)

A package containing a container filled with a liquid and having a predetermined external shape ,
An inner bag consisting of two resin films, at least one of which includes a skin pack film that softens upon heating and stretches along the outer shape of the container to come into close contact with the container. , an outer bag containing the inner bag and made of a resin film,
The inner bag accommodates the container inside the bag and is tightly fixed to the skin pack film by a skin pack, and the outer bag has an end fixed to an end of the inner bag so that the outer bag is attached to the outside of the inner bag. 1. A package for a container, characterized in that the container is sealed in a state in which a gas is contained therein, and the container is fixed by the inner bag with a space separated from the outer bag. A package comprising a container filled with a liquid and having a predetermined external shape, and a package housing the container,
The packaging body is composed of two resin films, and at least one of the two resin films includes a skin pack film that is softened by heating, stretches along the outer shape of the container, and comes into close contact with the container. and an outer bag that accommodates the inner bag and is made of a resin film,
The inner bag accommodates the container inside the bag and is tightly fixed to the skin pack film by a skin pack, and the outer bag has an end fixed to an end of the inner bag so that the outer bag is attached to the outside of the inner bag. 1. A packaged article, characterized in that the container is sealed with a gas contained therein, and the container is fixed by the inner bag with a space separated from the outer bag. The container package according to claim 1 or the package according to claim 2, wherein the resin film of the inner bag includes an easily openable film. The container package according to claim 1 or 3, or the package according to claim 2, wherein the resin film of the outer bag includes a barrier layer. The container package according to claim 1 , 3 or 4, or the package according to claim 2, wherein the container is a pharmaceutical container. 6. The packaging container according to claim 1, 3, 4, or 5, or the package according to claim 2, wherein the container includes any one of a prefilled syringe, an ampoule, and a vial, and the liquid in the container is a drug. At least one of the two resin films is filled with liquid using an inner bag resin film that softens upon heating and includes a skin pack film that stretches along the outer shape of the container and comes into close contact with the container. After skin-packing a container with a predetermined external shape , one sheet of resin film for the outer bag is folded in half or inserted between two sheets, and the outer bag is packed while supplying gas to the inside of the resin film for the outer bag. 1. A method for producing a container package, the method comprising: sealing a container package. A container filled with a liquid and having a predetermined shape is prepared, and at least one of the two resin films is coated with a skin pack film that is softened by heating and stretches along the outer shape of the container to come into close contact with the container. After skin-packing the container using the resin film for the inner bag, one sheet of the resin film for the outer bag is folded in half or inserted between two sheets, and a gas is applied to the inside of the resin film for the outer bag. A method for manufacturing a packaged article comprising the container and a package housing the container, the method comprising: sealing the outer bag while supplying the container.

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