JP7400466B2 - 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 a container is housed inside the inner bag and sealed for degassing, and there is no gas between the inner bag and the outer bag. The inventors have discovered that it is possible to buffer the vibration impact of the container by enclosing the container into a structure in which the container is fixed by an inner bag with a space separated from the outer bag, leading to the present invention.

The container package of the present invention based on the above knowledge is a package for accommodating a container filled with liquid, and includes an inner bag made of a resin film, and an outer bag containing the inner bag and made of a resin film. The inner bag accommodates the container inside the bag and is sealed in a deaerated state, and the outer bag has an end fixed to an end of the inner bag so as to be placed outside the inner bag. It is characterized in that the container is sealed while containing gas, 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 inner bag and the outer bag may be a three-sided bag or a four-sided bag. Further, the resin film of the inner bag (hereinafter also referred to as "resin film for inner bag") may include at least a polyolefin resin 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. Still further, the container can be a pharmaceutical container.

The method for manufacturing a container package according to the present invention includes stacking a resin film for an inner bag and a resin film for an outer bag, and then folding the container in half so that the resin film for the inner bag is on the inside. The inner bag is inserted between the resin films, the inner bag is sealed while degassing between the resin films for the inner bag, and the outer bag is sealed while supplying gas between the resin film for the inner bag and the resin film for the outer bag. It is characterized by sealing.

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. FIG. 3 is a schematic plan view of another embodiment of the container package of the present invention. FIG. 5 is a sectional view of the container packaging shown in FIG. 4; It is a schematic diagram explaining that the resin film for inner bags and the resin film for outer bags are partially joined by a point seal. FIG. 7(a) is a schematic diagram illustrating an embodiment of the method for manufacturing a container package of the present invention, in which FIG. 7(a) is a view of the manufacturing line viewed diagonally from above, and FIG. This is a diagram. FIG. 2 is a schematic cross-sectional view showing the arrangement of an air suction tube and a gas supply tube of the packaging machine during manufacturing of the container package of the present invention.

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.

In FIGS. 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, both the inner bag 2 and the outer bag 3 have a substantially rectangular planar shape with resin films folded in half, and three edges other than the folded edge are sealed. It is formed into a three-sided bag. However, the bag is not limited to a three-sided bag, but may be a four-sided bag in which the inner bag 2 and the outer bag 3 are sealed to each other at the bent edges. FIG. 4 shows a schematic plan view of a container package of the four-sided bag embodiment, and FIG. 5 shows a cross-sectional view taken along line AA of the container package of FIG. 4. The container package 1 shown in FIGS. 4 and 5 includes an inner bag 5 and an outer bag 6, and has a double bag structure in which the inner bag 5 is housed inside the outer bag 6. The container packaging body 1 shown in FIGS. 1 and 2 and the container packaging body 4 shown in FIGS. 4 and 5 are the same except for the structure of the three-sided bag or the four-sided bag, and they are made of the same material. Therefore, in the following explanation, the three-sided bag container package 1 will be used as a representative example.
The resin film for the inner bag 2 can be a single layer or a laminate of polyolefin resin films. The resin film for the outer bag 3 may be a laminated film having a base layer and a polyolefin resin layer on the inner surface layer.

As shown in FIG. 2, the prefilled syringe S is housed inside the inner bag 2. This inner bag 2 accommodates a prefilled syringe S and is sealed in a deaerated state. By being deaerated, the inner bag 2 is brought into a reduced pressure state, and the prefilled syringe S is fixed in close contact with the resin film forming the inner bag 2. 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 cross-sectional view of FIG. 2, the inner bag 2 is sealed and fixed to the outer bag 3 at one end thereof. In the case of the square bag shown in FIG. 5, both ends are sealed and fixed to the outer bag 3. In the case of the three-sided bag shown in FIG. 2, the other end of the inner bag 2 is not sealed with the outer bag 3, but gas is sealed inside the outer bag 3 and it swells. As a result, both ends of the inner bag 2 are pressed and fixed. 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 deaerated 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 and the inner bag.

The resin film for the inner bag 2 may be a single layer or a multilayer of two or more layers. In either case, at least a film made of polyolefin resin such as polyethylene or polypropylene is included. Since the resin film for the inner bag 2 includes a film made of polyolefin resin, a container such as the prefilled syringe S can be reliably fixed in a deaerated state. Moreover, the inner bag 2 can be made into a transparent bag. In addition, polyolefin resin can be used to heat the inner bag resin films together when folding the inner bag resin film in half to create a three-sided bag, or when creating a four-sided bag using two inner bag resin films. The inner bag can be easily manufactured by sealing. Further, the peripheral portion of the inner bag 2 and the peripheral portion of the outer bag 3 can be easily fixed by thermal bonding. More specifically, the polyolefin resin is one type selected from low-density polyethylene, linear low-density polyethylene, medium-density polyethylene, random polypropylene, homopolypropylene, blocked polypropylene, and heat-sealable stretched polypropylene (HS-OPP). Or it can be two or more types.

In the case of a laminated film in which multiple layers of resin films for the inner bag 2 are laminated, for example, a laminated film of an unstretched polypropylene film and a polyethylene film can be used. Moreover, the laminated film of the inner bag 2 can be provided with a functional layer if necessary. Examples of the functional layer include a gas barrier layer and an oxygen absorption layer. As a gas barrier layer, stretched nylon, ethylene vinyl alcohol copolymer (EVOH), metal or metal oxide vapor deposited layer, for example, silicon oxide vapor deposited layer, aluminum oxide vapor deposited layer, aluminum vapor deposited layer, IB film, and other known gas barriers. A barrier coat layer may be included.

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 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. 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 (for example, 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 gas barrier coat layer formed 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 includes a resin layer or an adhesive layer containing an oxygen absorber. 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.

Furthermore, 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.

Next, the outer bag 3 will be explained. The outer bag 3 may be a laminated film having a base layer made of PET, nylon, or the like, and a layer made of polyolefin resin on the inner surface layer. 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 polyolefin resin film on the surface of the outer layer of the inner bag 2, the peripheral part of the inner bag and the peripheral part of the outer bag can be easily thermally bonded by heat sealing. I can do it. The same type of resin means, for example, that when the outer surface of the inner bag 2 is made of polyethylene resin, the inner surface layer of the outer bag 3 is a layer made of polyethylene resin, and the outer surface of the inner bag 2 is made of polyethylene resin. This means that when the outer bag 3 is made of polypropylene resin, the inner layer side surface layer of the outer bag 3 is a layer made of polypropylene 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) and a gas barrier layer. Examples of the light-shielding layer include aluminum foil, an aluminum vapor-deposited film, and a layer containing an ultraviolet absorber. The gas barrier layer includes a vapor deposition layer such as an aluminum vapor deposition layer, an aluminum oxide vapor deposition layer, a silicon oxide vapor deposition layer, an IB film, other known gas barrier coating layers, a stretched nylon layer, an ethylene vinyl alcohol copolymer (EVOH) layer, etc. I can give an example. As the gas barrier layer of the outer bag 3, any of the gas barrier layers used in the laminated film of the inner bag 2 can be used. Since the gas barrier layer used in the inner bag 2 has already been explained, repeated explanation will be omitted here. Further, the laminated film of the outer bag 3 can include a layer containing an oxygen absorbent in the resin layer or the adhesive layer as the oxygen absorbing layer. As the oxygen absorbent, any of the oxygen absorbing layers used in the laminated film of the inner bag 2 can be used, and since the oxygen absorbing layer used in the inner bag 2 has already been explained, a redundant explanation will be omitted here.

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, For example, a layer containing UV cut ink or a UV cut film is selected as a layer containing an ultraviolet absorbing material as a light shielding layer among the functional layers mentioned above, and a transparent aluminum oxide vapor deposited layer, a transparent silicon oxide vapor deposited film, or a transparent silicon oxide vapor deposited film is selected as a gas barrier layer. Stretched nylon, ethylene vinyl alcohol copolymer (EVOH) layer, etc. can be selected and used in combination. 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. 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.

In addition to the above, the laminated film of the outer bag 3 includes a laminated film of a PET film layer, an aluminum oxide vapor deposited layer, an adhesive layer, and an unstretched polypropylene layer. The inner surface polypropylene layer of this laminated film is used to be bonded to the polypropylene layer when the inner bag 2 is a laminated film of polypropylene layer-adhesive layer-polyethylene layer.

Next, a method for manufacturing the container package 1 will be explained using FIGS. 6 to 8.
The container package 1 can be manufactured using a packaging machine. First, a resin film for the inner bag 2 and a resin film for the outer bag 3 are prepared. The roll of resin film for inner bag 2 and the roll of resin film for outer bag 3 may be set in the packaging machine, respectively, or the resin film for inner bag 2 and the resin film for outer bag 3 may be stacked in advance. The roll may be placed in a packaging machine. When overlapping the resin film for inner bag 2 and the resin film for outer bag 3 in advance, place point stickers as shown in Figure 6 to prevent positional deviation between the resin film for inner bag 2 and the resin film for outer bag 3. It is preferable that the resin film for the inner bag 2 and the resin film for the outer bag 3 be partially joined by P. As shown in the schematic diagram seen from diagonally above in FIG. 7(a) and the schematic front view in FIG. and the resin film for the outer bag 3 are continuously fed so that they overlap.

For example, prefilled syringes S as containers are sequentially supplied at regular intervals to the stacked resin films so as to be positioned on the inner surface side of the resin film for the inner bag 2.

The resin film in which the resin film for inner bag 2 and the resin film for outer bag 3 are stacked is folded in half so that one surface of the resin film for inner bag 2 faces each other, and the ends of the resin film are heat-sealed. Make it into a cylindrical shape. The bent ends of the folded resin films may be heat-sealed so that the resin film for the inner bag 2 and the resin film for the outer bag 3 are firmly attached.

The leading end of the cylindrical resin film in the moving direction is heat-sealed to form a double bag with only the rear end open, and air is inserted inside the inner bag 2 of the double bag. The prefilled syringe S is degassed using the suction tube 11 so as to be located approximately at the center.

At the same time as degassing, the opening at the rear end is heat-sealed while blowing air or an inert gas such as nitrogen gas through the gas supply tube 12 inserted between the inner bag 2 and the outer bag 3. The inner bag 2 and outer bag 3 are sealed at the same time. FIG. 8 is a schematic cross-sectional view showing the arrangement of an air suction tube 11 for deaerating the inner bag 2 and a gas supply tube 12 for supplying gas to the outer bag 3 in the packaging machine.

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 inner bag 2 was a polyethylene film with a thickness of 50 μm, and the resin film for outer bag 3 was a laminated film (45 μm thick) of PET film 12 μm/adhesive layer/low-density polyethylene film 30 μm, and using FIGS. 1 and 2. A container package of Example 1 was obtained, which housed a prefilled syringe S in the form described above. For Prefilled Syringe S, a plastic (COP) 1 mL prefilled syringe 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 package for the test was to match the resin film for the outer bag with the resin film for the inner bag, fold it in half, heat seal one of the long and short sides, house the prefilled syringe S, and then fold it in half from the open part. The inner bag was vacuum degassed and hermetically sealed. At the same time, the three-sided bag of Example 1 was obtained by filling air between the outer bag and the inner bag and heat-sealing the open remaining short sides.

In the drop impact test, strain gauges were attached to a prefilled syringe S housed in a container package with adhesive in two directions, the circumferential direction and the vertical direction, and the test was performed by dropping the strain gauge onto the floor from a height of 30 cm. The micro-strain caused in the prefilled syringe S was measured by dropping the prefilled syringe S in two ways: dropping the prefilled syringe S in a direction in which the axial direction is almost vertical, and dropping the prefilled syringe S in a direction in which the axial direction of the prefilled syringe S is almost horizontal. was detected by an attached strain gauge, measured by a strain measuring device, and analyzed to determine the presence or absence of a buffering effect of the package. 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 value and the minimum value of minute strain was 56 με for vertical strain and 48 με for circumferential strain in the vertical direction test, 86 με for vertical strain and 33 με for circumferential strain in the horizontal direction test. Container packaging No. 1 had a sufficient buffering effect.

(Example 2)
In Example 2, the resin film for the inner bag 2 was a multilayer film (thickness 50 μm) made of (polyethylene-ethylene vinyl alcohol copolymer-polyethylene), and the resin film for the outer bag 3 was (aluminum oxide vapor-deposited PET film 12 μm/ A three-sided bag of Example 2 was obtained in the same manner as in Example 1, except that a laminated film (thickness: about 45 μm) of adhesive layer/low density polyethylene film (30 μm) was used.
When the obtained three-sided bag of Example 2 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 55 με in the vertical direction test, and circumferential strain was 55με in the vertical direction test. was 40 με, vertical strain was 90 με, and circumferential strain was 31 με) in the horizontal direction test, and the container method package of Example 2 had a sufficient buffering effect.

In Example 3, the resin film for the inner bag 2 is a multilayer film (thickness 50 μm) made of (polyethylene-ethylene vinyl alcohol copolymer-polyethylene), and the resin film for the outer bag 3 is (aluminum oxide vapor deposited PET film 12 μm/ A three-sided bag of Example 3 was obtained in the same manner as in Example 1, except that a laminated film (about 60 μm thick) of UV cut ink layer/adhesive layer/stretched nylon film 15 μm/adhesive layer/low density polyethylene film 30 μm was used. Ta.
When the obtained three-sided bag of Example 2 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 58 με in the vertical direction test, and circumferential strain was 58με in the vertical direction test. was 45 με, vertical strain was 95 με, and circumferential strain was 33 με in the horizontal direction test), and the container method 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. The prefilled syringe S was filled with water and sealed with a cap and gasket in the same manner as in Example 1. When a drop impact test was conducted in the same manner as in Example 1, the maximum and minimum values of microstrain were determined. The difference in vertical strain was 67 με and circumferential strain was 35 με in the vertical direction test, and 150 με in vertical strain and 52 με in circumferential strain in the horizontal direction test.

As Comparative Example 2, the resin film for the outer bag 3 of Example 1 was used, but a single-layer pouch was created without the inner bag 2, and a prefilled syringe S filled with water was enclosed and sealed in the same manner as in Example 1. When a drop impact test was conducted in the same manner as in Example 1 and Comparative Example 1, the difference between the maximum and minimum microstrain was 61 με for vertical strain, 34 με for circumferential strain, and 34 με for horizontal strain in the vertical direction test. In the test (vertical strain was 116 με and circumferential strain was 30 με).

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 Air suction tube 12 Gas supply tube

Claims (6)

A package for accommodating a container filled with a liquid,
comprising an inner bag made of a resin film, and an outer bag made of a resin film for accommodating the inner bag,
The inner bag accommodates the container inside the bag and is sealed in a deaerated state, and the outer bag has an end fixed to an end of the inner bag to store gas outside the inner bag. 1. A package for a container, characterized in that the container is sealed in a closed state, and the container is fixed by the inner bag with a space separated from the outer bag. The container package according to claim 1, wherein the inner bag and the outer bag are three-sided bags or four-sided bags. The container package according to claim 1 or 2, wherein the resin film of the inner bag includes at least a polyolefin resin film. The container package according to any one of claims 1 to 3, wherein the resin film of the outer bag includes a barrier layer. The container package according to any one of claims 1 to 4, wherein the container is a pharmaceutical container. After overlapping the resin film for the inner bag and the resin film for the outer bag, fold in half so that the resin film for the inner bag is on the inside, insert the container between the resin films for the inner bag, and stack the resin film for the inner bag. A container packaging characterized in that the inner bag is sealed while degassing between the films, and the outer bag is sealed while supplying gas between the resin film for the inner bag and the resin film for the outer bag. How the body is manufactured.

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