Patent Application
20240208713
The present disclosure relates to a liquid-containing combination container, a container set, a method of manufacturing a liquid-containing container, and a use of a liquid-containing combination container.
A known container contains a liquid (for example, PTL 1). When a liquid-containing container is used, pressure in the container is preferably adjusted. In an example, in the case where the pressure in the container is maintained at low pressure, particularly, at negative pressure, the liquid can be effectively inhibited from unintentionally leaking when being preserved, and the liquid can be effectively inhibited from splashing when the container is opened. The problems about leakage and splashing are increasingly serious when the liquid is a toxic liquid such as a medicine (drug, chemical) that has high pharmacological activity.
From restrictions on, for example, conditions in which the liquid is manufactured, however, it is difficult to adjust pressure in a container in some cases. A liquid that has high sensitivity and that is deteriorated by post sterilization that is performed after manufacturing with, for example, heat or gamma rays such as a food product or a medicine (drug, chemical) is manufactured in a sterile environment and sealed in a container. The sterile environment is typically maintained at predetermined positive pressure in order to inhibit microbes from entering. Accordingly, the pressure in the container is the predetermined positive pressure suitable for the sterile environment.
PTL 1: JP2011-212366A
It is an object of the present disclosure to enable pressure in a container that contains a liquid to be adjusted.
A first liquid-containing combination container according to the present disclosure includes a first container that contains a liquid and that has gas permeability and a second container that contains the first container and that has a gas barrier property, and pressure in the first container is 1 atm or less.
The pressure in the first container may be negative pressure.
A second liquid-containing combination container according to the present disclosure includes a first container that contains a liquid and that has oxygen permeability, and a second container that contains the first container and that has an oxygen barrier property, an oxygen absorber that absorbs oxygen in the second container is provided, and pressure in the first container is 1 atm or less.
A third liquid-containing combination container according to the present disclosure includes a first container that contains a liquid and that has oxygen permeability, and a second container that contains the first container and that has an oxygen barrier property, an oxygen absorber that absorbs oxygen in the second container is provided, and the first container is capable of containing gas while the gas is maintained at negative pressure under atmospheric pressure.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may contain the liquid that has high sensitivity.
As for the first to third liquid-containing combination containers according to the present disclosure, pressure in the second container may be negative pressure.
As for the first to third liquid-containing combination containers according to the present disclosure, the pressure in the first container may be 0.8 atm or more.
The first liquid-containing combination container according to the present disclosure may include an oxygen absorber that absorbs oxygen in the second container.
As for the first to third liquid-containing combination containers according to the present disclosure, a dehydrating agent that absorbs moisture in the second container may be provided.
As for the first to third liquid-containing combination containers according to the present disclosure, an inside of the first container may be sterile.
As for the first to third liquid-containing combination containers according to the present disclosure, the second container may be capable of containing gas while the gas is maintained at negative pressure under atmospheric pressure.
As for the first and second liquid-containing combination containers according to the present disclosure, the first container may be capable of containing gas while the gas is maintained at negative pressure under atmospheric pressure.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, and the stopper may be capable of being punctured by a needle of a syringe.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, and the stopper may have the gas permeability.
As for the first to third liquid-containing combination containers according to the present disclosure, the container body may have a gas barrier property.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, and a gas permeability coefficient of a material of the stopper may be higher than a gas permeability coefficient of a material of the container body.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, and the stopper may contain silicone.
As for the first to third liquid-containing combination containers according to the present disclosure, the container body may be composed of glass.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a syringe that includes a cylinder and a piston includes a gasket that is disposed in the cylinder and that defines a container space for the liquid, and the gasket may have the gas permeability.
As for the first to third liquid-containing combination containers according to the present disclosure, the cylinder may have a gas barrier property.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a syringe that includes a cylinder and a piston includes a gasket that is disposed in the cylinder and that defines a container space for the liquid, and a gas permeability coefficient of a material of the gasket may be higher than a gas permeability coefficient of a material of the cylinder.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a syringe that includes a cylinder and a piston includes a gasket that is disposed in the cylinder and that defines a container space for the liquid, and the gasket may be at least partly composed of silicone.
As for the first to third liquid-containing combination containers according to the present disclosure, the cylinder may be composed of glass.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a syringe that includes a cylinder and a piston that is inserted into the cylinder, and the syringe may contain the liquid in a container space that is defined by the cylinder and the piston.
As for the first to third liquid-containing combination containers according to the present disclosure, the piston may include a gasket that is disposed in the cylinder and that defines the container space, and the gasket may have the gas permeability.
As for the first to third liquid-containing combination containers according to the present disclosure, the syringe may include a stopper that closes an opening portion that is provided in the cylinder, and the stopper may have the gas permeability.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a fixture that is mounted on the container body and that fixes the stopper to the container body, the stopper may include a plate portion that is disposed on the container body and that covers the opening portion and an insertion projection that projects from the plate portion and that is inserted into the opening portion, the fixture may cover a periphery of the plate portion, and the fixture may have an exposure hole through which a region of the plate portion that is exposed to an inside of the container body is exposed. The container body may have an oxygen barrier property. The container body may be composed of glass. The fixture may have an oxygen barrier property. The fixture may be composed of metal. The stopper may have oxygen permeability. The stopper may contain silicone.
As for the first to third liquid-containing combination containers according to the present disclosure, a step may be formed between a portion around the exposure hole of the fixture and a portion of the stopper that is exposed to an inside of the exposure hole.
As for the first to third liquid-containing combination containers according to the present disclosure, a portion around the exposure hole of the fixture may include a bent portion that bends such that the bent portion approaches the plate portion and may press the plate portion toward an inner portion of the container body.
As for the first to third liquid-containing combination containers according to the present disclosure, a portion of the stopper that is exposed to an inside of the exposure hole may include a linear projecting portion that linearly extends, and the linear projecting portion may indicate a position of a region of the plate portion that is exposed to an inside of the container body.
As for the first to third liquid-containing combination containers according to the present disclosure, a portion of the stopper that is exposed to an inside of the exposure hole may include a linear projecting portion that linearly extends, and the linear projecting portion may extend on a peripheral portion of a region of the plate portion that is exposed to an inside of the container body.
As for the first to third liquid-containing combination containers according to the present disclosure, a portion of the stopper that is exposed to an inside of the exposure hole may include a linear projecting portion that linearly extends, a part of the linear projecting portion may be covered by the fixture, and the other part of the linear projecting portion may be exposed to the inside of the exposure hole.
As for the first to third liquid-containing combination containers according to the present disclosure, a gap may be formed between a portion around the exposure hole of the fixture and a portion adjacent to the linear projecting portion of the stopper.
As for the first to third liquid-containing combination containers according to the present disclosure, the linear projecting portion may include multiple linear projecting portions that are separated from each other, and an end portion of the linear projecting portion that is exposed to an inside of the exposure hole may be located on a region of the plate portion that is exposed to an inside of the container body.
As for the first to third liquid-containing combination containers according to the present disclosure, the second container may include a to-be-opened portion (opening-intention portion) that is to be opened, and an oxygen absorber may be between the to-be-opened portion of the second container and the first container.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the container body may have an oxygen barrier property, the stopper has oxygen permeability, and an oxygen absorber may be between the second container and the stopper.
As for the first to third liquid-containing combination containers according to the present disclosure, a deoxygenated member that includes the oxygen absorber and a parcel (package, pouch) that contains the oxygen absorber may be attached to (mounted on) the second container.
The first to third liquid-containing combination containers according to the present disclosure may include an oxygen absorber that is disposed on a portion of the first container that has oxygen permeability.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the container body may have an oxygen barrier property, the stopper may have oxygen permeability, and an oxygen absorber may face the stopper.
The first to third liquid-containing combination containers according to the present disclosure may include an oxygen absorber, and the oxygen absorber may be at least partly located above a portion of the first container that has oxygen permeability.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a fixture that is mounted on the container body and that fixes the stopper to the container body, and a deoxygenated member that includes the oxygen absorber and a parcel (package, pouch) that contains the oxygen absorber may be attached to (mounted on) the fixture.
As for the first to third liquid-containing combination containers according to the present disclosure, the liquid may contain an aqueous solution, a deoxygenated member that includes the oxygen absorber does not contain a water retention agent or contains a water retention agent that is capable of retaining moisture in a volume equal to or less than 5% of an initial volume of the liquid.
As for the first to third liquid-containing combination containers according to the present disclosure, the liquid may contain alcohol or oil, and a deoxygenated member that includes the oxygen absorber may contain a water retention agent that retains moisture.
As for the first to third liquid-containing combination containers according to the present disclosure, the liquid may contain a non-aqueous solvent, and a deoxygenated member that includes the oxygen absorber may contain a water retention agent that retains moisture. The non-aqueous solvent may be a solvent in which a main component is not water. A ratio of a volume of moisture to the non-aqueous solvent may be 2% or less, may be 1% or less, or may be 0.5% or less.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the stopper may have the gas permeability, and a contact angle of an inner surface of the stopper may be 80° or more.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the stopper may have the gas permeability, and a sheet that has the gas permeability and liquid repellency may be provided between a liquid that is contained in the container body and the stopper.
As for the first to third liquid-containing combination containers according to the present disclosure, the sheet may be held between the stopper and the container body.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the stopper may have the gas permeability, and a recessed portion that is capable of holding gas may be provided on an inner surface of the stopper.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion, a stopper that closes the opening portion, and an extension wall portion that extends from an inner surface of the container body.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion, a stopper that closes the opening portion, and an extension wall portion that extends from an inner surface of the container body, the extension wall portion may have an annular shape that includes an outer periphery and an inner periphery, the extension wall portion may be connected to the inner surface of the container body over the entire length of the outer periphery, and a hole that is defined by the inner periphery may be provided.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the stopper may have the gas permeability, and an outer surface of the stopper may have unevenness or may include a projection that projects from the outer surface of the stopper.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the stopper may have the gas permeability, and an inner surface of the stopper may have unevenness or may include a projection that projects from the inner surface of the stopper.
As for the first to third liquid-containing combination containers according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, the stopper may be permeable to oxygen, an inner surface of the stopper may have unevenness or may include a projection that projects from the inner surface of the stopper.
A fourth liquid-containing combination container according to the present disclosure includes a first container that contains a liquid and a second container that contains the first container and that has an oxygen barrier property, the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, and a gap is formed between the stopper of the first container that is contained in the second container and the second container.
A fifth liquid-containing combination container according to the present disclosure includes a first container that contains a liquid, a tray that contains the first container, and a second container that has an oxygen barrier property and that contains the tray that contains the first container, the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, a portion of the tray is located between the stopper and the second container, and a gap is formed between the tray and the stopper.
As for the fifth liquid-containing combination container according to the present disclosure, the tray may include a bottom wall and a side wall that is connected to the bottom wall, the side wall may include a first side wall portion that faces the stopper of the first container that is contained in the tray and a second side wall portion that faces the first side wall portion, and the gap may be formed between the first side wall portion and the stopper.
As for the fifth liquid-containing combination container according to the present disclosure, the second container may be a film container, and the second side wall portion may be capable of being disposed so as to face a placement surface on which the liquid-containing combination container is placed with the second container interposed therebetween.
As for the fifth liquid-containing combination container according to the present disclosure, the second side wall portion may be capable of being disposed so as to face a placement surface on which the liquid-containing combination container is placed with the second container interposed therebetween such that the bottom wall inclines with respect to the placement surface.
As for the fifth liquid-containing combination container according to the present disclosure, the tray may include a recessed portion, a projecting portion, a hole, or a combination thereof.
As for the fifth liquid-containing combination container according to the present disclosure, the tray may include a bottom wall, a side wall that is connected to the bottom wall, and a flange portion that extends from the side wall, and the flange portion may include the recessed portion or the projecting portion.
A sixth liquid-containing combination container according to the present disclosure includes a first container that contains a liquid and a second container that contains the first container and that has an oxygen barrier property, the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the second container includes a tray that includes an opening portion and that contains the first container and a lid member that closes the opening portion of the tray, the tray includes a bottom wall and a side wall that is connected to the bottom wall and that faces the stopper, and a gap is formed between the side wall and the stopper.
As for the sixth liquid-containing combination container according to the present disclosure, the side wall may include a first side wall portion that faces the stopper of the first container that is contained in the tray and a second side wall portion that faces the first side wall portion, the gap may be formed between the first side wall portion and the stopper, and the second side wall portion may be capable of being disposed so as to be located on a placement surface on which the liquid-containing combination container is placed.
As for the sixth liquid-containing combination container according to the present disclosure, the second side wall portion may be capable of being disposed so as to be placed on a placement surface on which the liquid-containing combination container is placed such that the bottom wall inclines with respect to the placement surface.
The fifth and sixth liquid-containing combination containers according to the present disclosure may include an oxygen absorber that absorbs oxygen in the second container, and the oxygen absorber may be located between the tray and the first container.
As for the fifth and sixth liquid-containing combination containers according to the present disclosure, the tray may include a bottom wall and a side wall that is connected to the bottom wall, the side wall may include a first side wall portion that faces the stopper of the first container that is contained in the tray and a second side wall portion that faces the first side wall portion, and the oxygen absorber may be located between the first side wall portion and the stopper.
The fifth liquid-containing combination container according to the present disclosure may include an oxygen absorber that absorbs oxygen in the second container, and the oxygen absorber may be located between the tray and the second container.
The sixth liquid-containing combination container according to the present disclosure may include an oxygen absorber that absorbs oxygen in the second container, and the oxygen absorber may be held by the lid member.
As for the fifth and sixth liquid-containing combination containers according to the present disclosure, the tray may include a bottom wall and a side wall that is connected to the bottom wall, and the bottom wall may include a projection that is inserted into a recessed portion between the stopper and the container body.
A seventh liquid-containing combination container according to the present disclosure includes a first container that contains a liquid and a second container that contains the first container and that has an oxygen barrier property, the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the second container includes a first film and a second film that contains the first container between the second film and the first film, the first film and the second film are joined at a seal portion so as to be capable of being peeled, the seal portion includes a first seal portion that bends, and the first seal portion projects so as to be separated from the stopper in a direction in which the first seal portion and the stopper face each other.
The seventh liquid-containing combination container according to the present disclosure may include an oxygen absorber between the first seal portion and the stopper.
As for the seventh liquid-containing combination container according to the present disclosure, the stopper may face the first seal portion, the seal portion may include a first side seal portion that is connected to an end of the first seal portion and a second side seal portion that is connected to the other end of the first seal portion, a container space in which the first container is contained may be formed between the first side seal portion and the second side seal portion, and a minimum distance along the first film between the first side seal portion and the second side seal portion and a minimum distance along the second film between the first side seal portion and the second side seal portion may be shorter than a length of the first container in a direction in which the stopper is inserted into the opening portion.
An eighth liquid-containing combination container according to the present disclosure includes a first container that contains a liquid, and a second container that contains the first container and that has an oxygen barrier property, the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper is permeable to oxygen, the second container includes a first film and a second film that contains the first container between the second film and the first film, the second container is opened in a manner in which the first film and the second film are cut at a to-be-opened portion (opening intention portion), the first film and the second film are joined at a seal portion, the seal portion includes a first side seal portion and a second side seal portion that are separated in a longitudinal direction of the to-be-opened portion, and a through-portion that extends through the first film and the second film is provided at a position at which the second side seal portion intersects with the to-be-opened portion.
As for the eighth liquid-containing combination container according to the present disclosure, the first side seal portion may have a notch that corresponds to an end of the to-be-opened portion.
As for the eighth liquid-containing combination container according to the present disclosure, the second side seal portion may include a wide portion that is wider than an adjacent portion, and the through-portion may be provided at a position at which the wide portion intersects with the to-be-opened portion.
As for the eighth liquid-containing combination container according to the present disclosure, the second side seal portion may include an inner edge that projects such that the inner edge approaches the first side seal portion at the wide portion.
As for the eighth liquid-containing combination container according to the present disclosure, the first container may be contained in the second container such that the stopper faces a space in the second container between the first side seal portion and the wide portion.
The eighth liquid-containing combination container according to the present disclosure may include an oxygen absorber that absorbs oxygen in the second container, and the oxygen absorber may be held by the second container at a position away from the wide portion in a direction in which the space in the second container faces the stopper.
The eighth liquid-containing combination container according to the present disclosure may include an oxygen absorber between the to-be-opened portion (opening intention portion) and the first container.
A ninth liquid-containing combination container according to the present disclosure includes a first container that contains a liquid, a second container that contains the first container and that has an oxygen barrier property, and an outer box that contains the second container, the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the second container includes a first film and a second film that contains the first container between the second film and the first film, the first film and the second film are joined at a seal portion so as to be capable of being peeled, the outer box includes an outer box body and a lid portion that relatively moves with respect to the outer box body and that opens the outer box, the first film is attached to (mounted on) the outer box body, the second film is attached to (mounted on) the lid portion, the lid portion is relatively moved with respect to the outer box body, the second film is consequently peeled from the first film at the seal portion, and the second container is opened.
As for the ninth liquid-containing combination container according to the present disclosure, the outer box may include a transparent portion that is transparent.
A tenth liquid-containing combination container according to the present disclosure includes a first container that contains a liquid, a second container that contains the first container and that has an oxygen barrier property, the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, and the second container includes a first film, a second film that is joined to the first film and that contains the first container between the second film and the first film, and a gas bag (gas package, gas pouch) that is provided between the first film and the second film and that contains gas.
As for the tenth liquid-containing combination container according to the present disclosure, the gas bag may be joined to the first film and the second film.
As for the tenth liquid-containing combination container according to the present disclosure, the first film and the second film may be joined at a seal portion, and the gas bag may be joined to the first film and the second film at the seal portion.
As for the tenth liquid-containing combination container according to the present disclosure, the seal portion may include a first side seal portion and a second side seal portion that are separated in a width direction, the gas bag may include a first gas bag that is joined to the first film and the second film at the first side seal portion and a second gas bag that is joined to the first film and the second film at the second side seal portion, and the first container may be located between the first gas bag and the second gas bag.
The tenth liquid-containing combination container according to the present disclosure may include an oxygen absorber that absorbs oxygen in the second container, and the oxygen absorber may be held between the gas bag and one of the first film and the second film.
A first container set according to the present disclosure includes a first container that contains a liquid and that has gas permeability and a second container that is capable of containing the first container and that has a gas barrier property, wherein the first container is capable of containing gas while the gas is maintained at negative pressure under atmospheric pressure.
As for the first container set according to the present disclosure, the second container may be capable of containing gas while the gas is maintained at negative pressure under the atmospheric pressure.
As for the first container set according to the present disclosure, an inside of the first container may be sterile.
As for the first container set according to the present disclosure, an oxygen concentration in the first container may be 1.5% or less.
As for the first container set according to the present disclosure, the liquid may be a medicine (drug, chemical) that is injected into a syringe.
As for the first container set according to the present disclosure, the first container may contain the liquid that has high sensitivity.
As for the first container set according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, and the stopper may be capable of being punctured by a needle of a syringe.
The first container set according to the present disclosure may include an oxygen absorber that absorbs oxygen in the second container.
A second container set according to the present disclosure includes a first container that contains a liquid and that has oxygen permeability, a second container that is capable of containing the first container and that has an oxygen barrier property, and an oxygen absorber that absorbs oxygen in the second container.
A third container set according to the present disclosure includes a first container that contains a liquid and a second container that is capable of containing the first container and that has an oxygen barrier property, wherein the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, and a gap is formed between the stopper of the first container that is contained in the second container and the second container.
A fourth container set according to the present disclosure includes a first container that contains a liquid, a tray that is capable of containing the first container, and a second container that has an oxygen barrier property and that is capable of containing the tray that contains the first container, wherein the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the tray is located between the stopper and the second container, and a gap is formed between the tray and the stopper.
A fifth container set according to the present disclosure includes a first container that contains a liquid and a second container that is capable of containing the first container and that has an oxygen barrier property, wherein the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the second container includes a tray that includes an opening portion and that contains the first container and a lid member that closes the opening portion of the tray, the tray includes a bottom wall and a side wall that is connected to the bottom wall and that faces the stopper, and a gap is formed between the side wall and the stopper.
A sixth container set according to the present disclosure includes a first container that contains a liquid and a second container that is capable of containing the first container and that has an oxygen barrier property, wherein the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the second container includes a first film and a second film that contains the first container between the second film and the first film, the first film and the second film are joined at a seal portion so as to be capable of being peeled, the seal portion includes a first seal portion that bends, and the first seal portion projects so as to be separated from the stopper in a direction in which the first seal portion and the stopper face each other.
A seventh container set according to the present disclosure includes a first container that contains a liquid and a second container that is capable of containing the first container and that has an oxygen barrier property, wherein the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the second container includes a first film and a second film that contains the first container between the second film and the first film, the second container is opened in a manner in which the first film and the second film are cut at a to-be-opened portion (opening intention portion), the first film and the second film are joined at a seal portion, the seal portion includes a first side seal portion and a second side seal portion that are separated in a longitudinal direction of the to-be-opened portion, and a through-portion that extends through the first film and the second film is provided at a position at which the second side seal portion intersects with the to-be-opened portion.
An eighth container set according to the present disclosure includes a first container that contains a liquid, a second container that is capable of containing the first container and that has an oxygen barrier property, and an outer box that is capable of containing the second container, wherein the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, the second container includes a first film and a second film that contains the first container between the second film and the first film, the first film and the second film are joined at a seal portion so as to be capable of being peeled, the outer box includes an outer box body and a lid portion that relatively moves with respect to the outer box body and that opens the outer box, the first film is attached to (mounted on) the outer box body, the second film is attached to (mounted on) the lid portion, the lid portion is relatively moved with respect to the outer box body, the second film is consequently peeled from the first film at the seal portion, and the second container is opened.
A ninth container set according to the present disclosure includes a first container that contains a liquid and a second container that is capable of containing the first container and that has an oxygen barrier property, wherein the first container includes a container body that includes an opening portion and a stopper that closes the opening portion, the stopper has oxygen permeability, and the second container includes a first film, a second film that is joined to the first film and that contains the first container between the second film and the first film, and a gas bag that is provided between the first film and the second film and that contains gas.
A first method of manufacturing a liquid-containing container according to the present disclosure includes closing a second container that contains a first container, and adjusting pressure in the first container that is contained in the second container, the first container contains a liquid and has gas permeability, the second container has a gas barrier property, and in the adjusting the pressure, gas in the first container permeates the first container, and the pressure in the first container reduces.
In the adjusting the pressure in the first method of manufacturing the liquid-containing container according to the present disclosure, the pressure in the first container may reduce to negative pressure.
In the first method of manufacturing the liquid-containing container according to the present disclosure, the pressure in the first container may be positive pressure before the second container is closed.
In the closing the second container in the first method of manufacturing the liquid-containing container according to the present disclosure, the second container may be closed such that pressure in the second container is negative pressure.
In the first method of manufacturing the liquid-containing container according to the present disclosure, an oxygen absorber that absorbs oxygen in the second container is provided, and in the adjusting the pressure, oxygen in the first container permeates the first container, and consequently, the pressure in the first container may reduce.
In the first method of manufacturing the liquid-containing container according to the present disclosure, the second container may be filled with inert gas before the second container is closed, and in the adjusting the pressure, oxygen in the first container permeates the first container, and consequently, the pressure in the first container may reduce.
In the first method of manufacturing the liquid-containing container according to the present disclosure, an oxygen absorber that absorbs oxygen in the second container may be provided.
In the first method of manufacturing the liquid-containing container according to the present disclosure, the first container may contain gas that has an oxygen concentration of 1.5% or less before the second container is closed, and the second container may be filled with inert gas.
In the first method of manufacturing the liquid-containing container according to the present disclosure, an inside of the first container may be sterile.
In the first method of manufacturing the liquid-containing container according to the present disclosure, the first container may contain the liquid that has high sensitivity.
In the first method of manufacturing the liquid-containing container according to the present disclosure, the first container may include a container body that includes an opening portion and a stopper that closes the opening portion, and the rubber stopper may be capable of being punctured by a needle of a syringe.
A first method of using a liquid-containing combination container (first use of a liquid-containing combination container) according to the present disclosure is a method of using any one of liquid-containing combination containers described above according to the present disclosure and includes opening the second container and taking out the first container, and a causing a needle of a syringe to puncture the first container and injecting the liquid into the syringe.
A second method of manufacturing a liquid-containing container (second use of a liquid-containing combination container) according to the present disclosure is a method of manufacturing a liquid-containing container by using any one of the seventh to thirteenth liquid-containing combination containers according to the present disclosure and includes closing a second container that contains a first container and adjusting an oxygen concentration in a manner in which an oxygen absorber absorbs oxygen in the second container. In the adjusting the oxygen concentration, oxygen in the first container permeates the stopper, moves to a position outside the first container, and is absorbed by the oxygen absorber in the second container.
A third method of manufacturing a liquid-containing container (third use of a liquid-containing combination container) according to the present disclosure is a method of manufacturing a liquid-containing container by using the eighth liquid-containing combination container according to the present disclosure and includes closing a second container that contains a first container and adjusting an oxygen concentration in a manner in which an oxygen absorber absorbs oxygen in the second container, in the adjusting the oxygen concentration, oxygen in the first container permeates the stopper, moves to a position outside the first container, and is absorbed by the oxygen absorber in the second container, and the liquid-containing combination container is disposed on a placement surface such that the second side wall portion faces the placement surface on which the liquid-containing combination container is placed with the second container interposed therebetween.
A fourth method of manufacturing a liquid-containing container (fourth use of a liquid-containing combination container) according to the present disclosure is a method of manufacturing a liquid-containing container by using the ninth liquid-containing combination container according to the present disclosure and includes a closing a second container that contains a first container and adjusting an oxygen concentration in a manner in which an oxygen absorber absorbs oxygen in the second container, in the adjusting the oxygen concentration, oxygen in the first container permeates the stopper, moves to a position outside the first container, and is absorbed by the oxygen absorber in the second container, and the liquid-containing combination container is disposed on a placement surface such that the second side wall portion faces the placement surface on which the liquid-containing combination container is placed.
According to the present disclosure, pressure in a container that contains a liquid can be adjusted.
An embodiment of the present disclosure will hereinafter be described with reference to the drawings. In the drawings attached to the present specification, a scale and an aspect ratio, for example, are appropriately changed from actual ones and exaggerated for convenience of ease of illustration and understanding.
A liquid-containing combination container 10L includes the liquid-containing first container 30L and the second container 40. The liquid-containing first container 30L is contained in the second container 40. Pressure in the second container 40 may be atmospheric pressure or less (1 atm or less). The first container 30 that has the gas permeability is disposed in the second container 40 that is maintained at the atmospheric pressure or less (1 atm or less). The liquid-containing first container 30L is preserved in the second container 40, and consequently, the inner pressure of the liquid-containing first container 30L can be adjusted from the pressure before the liquid-containing first container 30L is sealed in the second container 40.
The first container 30 that has the gas permeability is an airtight container.
An airtight container means a container an air leak of which is not detected in a liquid immersion method that is defined as JISZ2330:2012. More specifically, when a container that contains gas is immersed in water and can inhibit bubbles from leaking, the container is determined to be the airtight container. In a state in which no bubbles that leak from the container are detected when the container that contains gas is immersed in water, the state of the airtight container is determined to be an airtight state. In a liquid immersion test, the container to be tested is immersed at a depth of 10 cm or more and 30 cm or less from a water surface. Whether bubbles are present is determined by visual observation for 10 minutes.
Components of the liquid-containing combination container 10L will be described in detail with reference to an illustrated specific example. The liquid-containing first container 30L will now be described.
The liquid-containing first container 30L includes the first container 30 and the liquid L that is contained in the first container 30 as described above. The first container 30 has the gas permeability. However, the first container 30 can seal the liquid L. That is, the first container 30 is permeable to gas but is not permeable to the liquid L.
The liquid L that is contained in the first container 30 is not particularly limited. The liquid may be a solution that contains a solvent and solute that is dissolved in the solvent. The solvent is not particularly limited but may be water or alcohol. The liquid is not limited to a liquid in strict meaning but may be a suspension in which solid particles are dispersed. The liquid L may be a food product such as green tea, coffee, black tea, soup, juice, broth, or a concentrate obtained by concentrating one or more of these. The liquid may be a medicine (drug, chemical) such as an internal medicine, an external medicine, or an injectable solution. The liquid L may not be a food product or a medicine. The liquid L may be blood or a body fluid other than a food product or a medicine.
The inside of the first container 30 may be sterile. The liquid L may be a liquid to be kept sterile. Examples of the liquid L to be kept sterile include a liquid that has high sensitivity such as a food product or a medicine. The liquid L that has the high sensitivity is likely to deteriorate due to post sterilization (also referred to as final sterilization) that is performed after manufacturing. The post sterilization cannot be used for the liquid that has the high sensitivity. Examples of the post sterilization include sterilization methods such as a high pressure steam method, a dry heat method, a radiation method, an ethylene oxide gas method, and a hydrogen peroxide gas plasma method. In the present specification, the liquid L that has the high sensitivity means that 5% or more of all active ingredients that are contained in the liquid in weight is dissolved (decomposed) when the post sterilization is performed on the liquid L, and 1% or more of one or more kinds of the active ingredients that are contained in the liquid is dissolved (decomposed) in weight when the post sterilization is performed on the liquid L. The liquid L that has the high sensitivity on which the post sterilization cannot be performed can be manufactured by using a manufacturing line that is disposed in a sterile environment. That is, the liquid L that has the high sensitivity can be manufactured by using a sterile operation method. Examples of the liquid L that has the high sensitivity include an anticancer drug, an antiviral agent, a vaccine, and an antipsychotic drug.
From the perspective that microbes are prevented from entering, the sterile environment is maintained at positive pressure. Accordingly, in the case where a liquid-containing container is manufactured in a manner in which a liquid is manufactured in the sterile environment, and the container is filled with the liquid in the sterile environment, pressure in the liquid-containing container has a predetermined positive pressure value that is inevitably determined depending on the sterile environment. According to the present embodiment, the pressure in the liquid-containing container, which is provided as the predetermined positive pressure value so far, can be adjusted as described in detail later. That is, the inner pressure of the first container 30 that is kept sterile can be adjusted from predetermined positive pressure suitable for an existing manufacturing environment. Accordingly, the present embodiment is preferable for the liquid L that has the high sensitivity and that is manufactured by using the sterile operation method instead of a final sterilization method in which the post sterilization is performed and the liquid-containing first container 30L that contains the liquid that has the high sensitivity. It can be said that actions and effects according to the present embodiment are remarkable beyond the range that is predicted based on the technical level.
A product (the liquid L) that exhibits, for example, “sterilized” or “sterile”, the inside of a container that contains the product, a product (the liquid L) such as a medicine that needs to be “sterile” for marketing, and the inside of a container that contains the product are “sterile”, which is described herein. A product (the liquid L) that satisfies 10−6 of a sterility assurance level (SAL) that is defined as JIS T0806:2014 and the inside of a container that contains the product are also “sterile”, which is described herein. A product in which no microbes multiply at the room temperature (for example 20° C.) or more after the product is preserved for four weeks, the inside of a container that contains the product, a product in which no microbes multiply in a refrigeration state (for example, 8° C. or less) after the product is preserved for eight weeks or more, and the inside of a container that contains the product are also “sterile”, which is described herein. A medicine (drug, chemical) in which no microbes multiply at a temperature of 28° C. or more and 32° C. or less after the product is preserved for two weeks, and the inside of a container that contains the medicine are also “sterile”, which is described herein.
The atmospheric pressure is 1 atm. Negative pressure means a pressure of less than 1 atm that is the atmospheric pressure. Positive pressure means a pressure of more than 1 atm that is the atmospheric pressure. Whether pressure in a container is negative pressure or whether the pressure in the container is positive pressure can be determined by using a value that is measured by a pressure measuring device such as a pressure gauge that is provided in the container. In the case where a pressure measuring device such as a pressure gauge is not provided, whether the pressure in the container is negative pressure can be determined by using a syringe. Specifically, when the needle of the syringe punctures the container, the determination can be made depending on whether a liquid or gas that is contained in the syringe enters the container with only the atmospheric pressure applied to the piston of the syringe. In the case where the liquid or gas that is contained in the syringe enters the container, it is determined that the pressure in the container is negative pressure. Similarly, whether the pressure in the container is positive pressure can be determined depending on whether the liquid or gas that is contained in the container enters the syringe with only the atmospheric pressure applied to the piston of the syringe when the needle of the syringe punctures the container. In the case where the liquid or gas that is contained in the container enters the syringe, it is determined that the pressure in the container is positive pressure. Whether the inner pressure of the first container 30 and the second container 40 is negative pressure or whether the inner pressure of the first container 30 and the second container 40 is positive pressure can be checked by using the above method in which the syringe is used in the case where the pressure measuring device such as a pressure gauge is not provided.
In the case where the pressure measuring device such as a pressure gauge that measures pressure is not provided in the container, the value of the inner pressure of the container can be measured by a headspace pressure/humidity analyzer FMS-1400 made by lighthouse as a non-contact pressure measuring device. As for measurement by using the non-contact pressure measuring device, light at a specific frequency is emitted from a position outside the container toward the container that is the target for measurement, and light that passes through a headspace HS of the container and that exits from the container is received. A change in light intensity is measured before and after permeation, and the pressure in the container can be specified based on the change in the light intensity. Accordingly, the value of the pressure in the container can be measured without opening the container. A change in the pressure in the container can be checked without opening the container.
The first container 30 that contains the liquid L will now be described. The first container 30 can seal the liquid L as described above. That is, the first container 30 can hold the liquid L without leaking.
The first container 30 has the gas permeability. The whole of the first container 30 may have the gas permeability. Only a portion of the first container 30 may have the gas permeability. The first container 30 may be permeable to all gases. The first container 30 may be permeable to only some of gases. For example, the first container 30 may have oxygen permeability as the gas permeability. The first container 30 may have nitrogen permeability as the gas permeability. The first container 30 may have water vapor permeability as the gas permeability.
According to the present embodiment, gas permeates the first container 30, and the inner pressure of the first container 30 can be adjusted as described later. The first container 30 having the gas permeability means that gas can permeate the first container 30 that is airtight to an extent that the pressure in the first container 30 can be adjusted as described later.
In an example described later, an oxygen absorber (oxygen scavenger) 21 absorbs oxygen in the second container 40, movement of oxygen in the first container 30 into the second container 40 outside the first container 30 is facilitated, and consequently, the pressure in the first container 30 is adjusted. In this example, the first container 30 has the oxygen permeability. In this example, it can be said that the first container 30 that has the oxygen permeability has the gas permeability.
A container having the oxygen permeability to an extent that the gas permeability can be achieved means that oxygen in a predetermined oxygen permeation amount or more permeates the container in an atmosphere at a temperature of 23° C. and a humidity of 40% RH and is movable between a position inside the container and a position outside the container. The predetermined oxygen permeation amount is 1×10−1 (mL/(day×atm)) or more. The predetermined oxygen permeation amount may be 1 (mL/(day×atm)) or more, may be 1.2 (mL/(day×atm)) or more, or may be 3 (mL/(day×atm)) or more. The first container 30 that has the oxygen permeability enables the pressure in the first container 30 to be adjusted due to the permeation of oxygen through the first container 30.
An upper limit may be set for the oxygen permeation amount of oxygen that permeates the first container 30. Setting the upper limit enables water vapor, for example, to be inhibited from excessively leaking from the first container 30. Setting the upper limit enables the liquid L in the first container 30 to be inhibited from being affected by a high speed at which gas permeates after the second container 40 is opened, which will be described later. The oxygen permeation amount of oxygen that permeates the first container 30 may be 100 (mL/(day×atm)) or less, may be 50 (mL/(day×atm)) or less, or may be 10 (mL/(day×atm)) or less.
The range of the oxygen permeation amount may be determined by using a combination of a freely selected value of the lower limit of the oxygen permeation amount described above and a freely selected value of the upper limit of the oxygen permeation amount described above.
Also, the nitrogen permeability and the water vapor permeability can serve as the gas permeability that enables the pressure to be adjusted as described above. The nitrogen permeability enables the pressure to vary when the nitrogen permeability enables a nitrogen permeation amount (mL/(day×atm)) roughly equal to the predetermined oxygen permeation amount (mL/(day×atm)) that is described as the oxygen permeability that can serve as the gas permeability to be ensured. When the water vapor permeation amount of the first container 30 is 0.001 (g/day) or more in an atmosphere at a temperature of 40° C. and a humidity of 90% RH, the water vapor permeability is achieved, and the pressure in the first container 30 can vary. The water vapor permeation amount of the first container 30 that can have the water vapor permeability may be 0.005 (g/day) or less.
The material of a portion that has the gas permeability may have high permeability to nitrogen or oxygen that is present at a high concentration in air. More specifically, at least the oxygen permeability coefficient or the nitrogen permeability coefficient of the material of the portion that has the gas permeability may be 1×10−12 (cm3 (STP)·cm/(cm2·sec·Pa)) or more, may be 5×10−12 (cm3 (STP)·cm/(cm2 sec·Pa) or more, or may be 1×10−11 (cm3 (STP)·cm/(cm2 sec·Pa) or more. In the case where the portion that has the gas permeability includes multiple layers, the material of at least one of the layers may have the permeability coefficient or the material of all of the layers may have the permeability coefficient described above. Setting the lower limit for the permeability coefficient enables the permeation of gas in the first container 30 to be facilitated and enables the pressure in the first container 30 to be rapidly adjusted.
An upper limit may be set for each of the nitrogen permeability coefficient and the oxygen permeability coefficient of the material of the portion that has the gas permeability. Setting the upper limit for each permeability coefficient enables water vapor, for example, to be inhibited from excessively leaking from the first container 30. Setting the upper limit enables the liquid L in the first container 30 to be inhibited from being affected by a high speed at which gas permeates after the second container 40 is opened as described later. In addition, the pressure in the first container 30 can be maintained for a certain period after the second container 40 is opened. Specifically, both of the nitrogen permeability coefficient and the oxygen permeability coefficient may be 1×10−1 (cm3 (STP)·cm/(cm2·sec·Pa)) or less, may be 1×10−2 (cm3 (STP)·cm/(cm2·sec·Pa)) or less, or may be 1×10−3 (cm3 (STP)·cm/(cm2·sec·Pa)) or less.
In the case where the portion that has the gas permeability includes multiple layers, the material of at least one of the layers may have the permeability coefficient described above or the material of all of the layers may have the permeability coefficient described above.
In the case where the object to be measured is a resin film or a resin sheet, the permeability coefficients of gases such as nitrogen, oxygen, and water vapor have values that are measured in accordance with JIS K7126-1. In the case where the object to be measured is rubber, the permeability coefficients of gases such as nitrogen, oxygen, and water vapor have values that are measured in accordance with JIS K6275-1. The oxygen permeability coefficient can be measured by using OXTRAN (OXTRAN, 2/61) that is a permeation measuring device made by AMETEK MOCON, the United States of America, in environments of a temperature of 23° C. and a humidity of 40% RH. The nitrogen permeability coefficient and the water vapor permeability coefficient can be measured by using GTR-30XACK made by GTR TEC Corporation that is a gas and water vapor permeation measuring device that uses a gas chromatography method in environments of a temperature 23° C. and a humidity of 40% RH.
The area of a portion of the first container 30 that has the gas permeability may be 1 mm2 or more, may be 10 mm2 or more, or may be 30 mm2 or more. The thickness of the portion of the first container 30 that has the gas permeability may be 3 mm or less, may be 1 mm or less, or may be several tenths mm or less. This enables the permeation of gas in the first container 30 to be facilitated and enables the pressure in the first container 30 to be rapidly adjusted.
The first container 30 illustrated includes a container body 32 that includes an opening portion 33 and a stopper (plug) 34 that is held by the opening portion 33 of the container body 32. The stopper 34 restricts leakage of the liquid L from the opening portion 33. In this example, the stopper 34 may have the gas permeability. From the perspective that movement of gas in the first container 30 to a position outside the first container 30 is facilitated, the portion of the first container 30 that has the gas permeability is preferably not in contact with the liquid L. As for the container that includes the container body 32 and the stopper 34, the stopper 34 is typically separated from the liquid L that is contained in the container body 32. That is, in a typical state in which the first container 30 is preserved, the permeation of gas through the stopper 34 of the first container 30 can be facilitated. In this point of view, the stopper 34 that has the gas permeability enables the pressure in the first container 30 to be rapidly adjusted.
The stopper 34 that has the gas permeability may be composed of the material that has the permeability coefficient (cm3 (STP)·cm/(cm2·sec·Pa)) described above. The nitrogen permeability coefficient and the oxygen permeability coefficient of the material of the stopper 34 may be higher than the nitrogen permeability coefficient and the oxygen permeability coefficient of the material of the container body 32. A portion of the stopper 34 may have the gas permeability. A portion of the stopper 34 may be composed of the material that has the gas permeability over the entire thickness. For example, the stopper 34 may have the gas permeability over the entire thickness at a central portion away from the periphery and may have the gas barrier property at a peripheral portion that surrounds the central portion.
In an illustrated example, the area of the opening portion 33, that is, the opening area of the container body 32 may be 1 mm2 or more, may be 10 mm2 or more, or may be 30 mm2 or more. The thickness of the stopper 34 may be 3 mm or less, may be 1 mm or less, or may be several tenths mm or less. This facilitates the permeation of gas in the first container 30 and enables the pressure in the first container 30 to be rapidly adjusted. From the perspective that flexibility and sealability are ensured, the thickness of the stopper, for example, the thickness of the stopper that is composed of rubber may be 20 mm or less. From the perspective of being punctured by the needle of the syringe or a straw, the thickness of the stopper, for example, the thickness of the stopper that is composed of rubber may be 1 mm or less.
From the perspective that excessive leakage of, for example, water vapor is reduced, or from the perspective that the liquid in the first container 30 is inhibited from being affected by a high speed at which gas permeates after the second container 40 is opened, an upper limit may be set for the area of the opening portion 33. Specifically, the area of the opening portion 33 may be 5000 mm2 or less. From the perspective that strength is ensured, the thickness of the stopper, for example, the thickness of the stopper composed of rubber may be 0.01 mm or more.
The stopper 34 that has the gas permeability is not particularly limited but may have various structures. In an illustrated example, the stopper 34 is inserted into the opening portion 33 of the container body 32 and covers the opening portion 33. The stopper 34 illustrated in
The stopper 34 may contain silicone. The stopper 34 may consist of silicone. A portion of the stopper 34 may be composed of silicone. The silicone that is contained in the stopper 34 is solid in environments in which the first container 30 is to be used. The silicone that is contained in the stopper 34 may not contain silicone that becomes a liquid in the room temperature such as silicone oil. Silicone is a substance a main chain of which is a siloxane bond. The stopper 34 may be composed of a silicone elastomer. The stopper 34 may be composed of silicone rubber.
Silicone rubber means rubber composed of silicone. Silicone rubber is synthetic resin a main component of which is silicone and is a rubber material. Silicone rubber is a rubber material a main chain of which is a siloxane bond. Silicone rubber may be a thermosetting compound that contains a siloxane bond. Examples of silicone rubber include methyl silicone rubber, vinyl-methyl silicone rubber, phenyl-methyl silicone rubber, dimethyl silicone rubber, and fluoro-silicone rubber.
The oxygen permeability coefficient of silicone and the oxygen permeability coefficient of silicone rubber may be 1×10−12 (cm3 (STP)·cm/(cm2·sec·Pa)) or more or may be 1×10−11 (cm3 (STP)·cm/(cm2·sec·Pa)) or more. The oxygen permeability coefficient of silicone and the oxygen permeability coefficient of silicone rubber may be 1×10−9 (cm3 (STP)·cm/(cm2·sec·Pa)) or less. Silicone and silicone rubber have a hydrogen permeability coefficient of about 10 times that of natural rubber, an oxygen permeability coefficient of about 20 times thereof, and a nitrogen permeability coefficient of about 30 times thereof. Silicone and silicone rubber have a hydrogen permeability coefficient of 70 times or more of that of butyl rubber, an oxygen permeability coefficient of 40 times or more thereof, and a nitrogen permeability coefficient of 650 times or more thereof.
At least a portion of the stopper 34 may be composed of silicone. That is, the whole or a portion of the stopper 34 may be composed of silicone or silicone rubber. For example, a portion of the stopper 34 may be composed of silicone or silicone rubber over the entire thickness. The portion may be a central portion of the stopper 34 or may be a part or the whole of a peripheral portion that surrounds the central portion.
As illustrated in
The container body 32 may be transparent such that the liquid L that is contained is observable from the outside. Being transparent means that visible light transmittance is 50% or more and is preferably 80% or more. The visible light transmittance is measured at a measurement wavelength ranging from 380 nm to 780 nm by using a spectrophotometer (“UV-3100PC” conforming JIS K 0115 made by SHIMADZU CORPORATION) at an incident angle of 0° per 1 nm and is specified as the average value of total light transmittance at wavelengths.
The first container 30 illustrated also includes a fixture 36. The fixture 36 restricts the stopper 34 such that the stopper 34 does not come off from the container body 32. The fixture 36 is mounted on the head portion 32d of the container body 32. As illustrated in
In an illustrated example, the permeability coefficient of the material of the container body 32 may be lower than the permeability coefficient of the material of the stopper 34. The container body 32 may have the gas barrier property. The container body 32 may have an oxygen barrier property. That is, only a portion of the first container 30 may have the gas permeability. The material of a portion that has the gas barrier property may have a low permeability coefficient to both of nitrogen and oxygen that are present at a high concentration in air. Specifically, the nitrogen permeability coefficient and the oxygen permeability coefficient of the material of the portion that has the gas barrier property may be 1×103 (cm3 (STP)·cm/(cm2·sec·Pa)) or less or may be 1×10−17 (cm3 (STP)·cm/(cm2·sec·Pa)) or less. In the case where the portion that has the gas barrier property includes multiple layers, the material of at least one of the layers may have the permeability coefficient described above or the material of all of the layers may have the permeability coefficient described above.
Examples of the container body 32 that has the gas barrier property include a can composed of metal, a container body that includes a metal layer that is formed by vapor deposition or transfer, and a glass bottle. The container body 32 composed of a resin sheet or a resin plate can have the gas barrier property. In this example, the resin sheet and the resin plate may include a layer that has the gas barrier property such as an ethylene-vinyl alcohol copolymer (EVOH) or a polyvinyl alcohol (PVA) layer. The container body 32 may include a multilayer body that includes a metal deposition film. The container body 32 that uses the multilayer body or glass can have the gas barrier property and can be transparent. In the case where the first container 30 and the container body 32 are transparent, the liquid L that is contained therein can be checked from a position outside the first container 30.
The portion of the container having the gas permeability means that gas can permeate the portion of the first container 30 that is airtight to an extent that the pressure in the first container 30 can be adjusted as described later. In an example described later in which the oxygen absorber 21 is used, it can be said that a portion of the first container 30 that has the oxygen permeability has the gas permeability. The first container 30 may have, as the gas permeability, the nitrogen permeability to an extent that the pressure in the first container 30 can be adjusted. The first container 30 may have, as the gas permeability, the water vapor permeability to an extent that the pressure in the first container 30 can be adjusted.
A portion of a container having the oxygen permeability means that oxygen in a predetermined oxygen permeation amount or more permeates the portion of the container and is movable between a position inside the container and a position outside the container in an atmosphere at a temperature of 23° C. and a humidity of 40% RH. The predetermined oxygen permeation amount is 1×10−1 (mL/(day×atm)) or more. The predetermined oxygen permeation amount may be 1 (mL/(day×atm)) or more, may be 1.2 (mL/(day×atm)) or more, or may be 3 (mL/(day×atm)) or more. Also in the case where the portion of the first container 30 has the oxygen permeability, the pressure in the first container 30 can be adjusted.
The predetermined oxygen permeation amount may be 100 (mL/(day×atm)) or less, may be 50 (mL/(day×atm)) or less, or may be 10 (mL/(day×atm)) or less. Setting the upper limit for the oxygen permeation amount enables the excessive leakage of, for example, water vapor to be reduced and enables the liquid in the first container 30 to be inhibited from being affected by a high speed at which oxygen permeates after the second container 40 is opened. The range of the oxygen permeation amount may be determined by using a combination of a freely selected value of the lower limit of the oxygen permeation amount described above and a freely selected value of the upper limit of the oxygen permeation amount described above.
As illustrated in
The oxygen concentration in the test container 70 is maintained, for example, at 0.05% or less. The test container 70 is connected to a first flow path 76 and a second flow path 77. The second flow path 77 is connected to a gas measuring device 79 that measures the amount of oxygen. The gas measuring device 79 can measure the amount (mL) of oxygen that flows in the second flow path 77. The gas measuring device 79 can be an oxygen measuring device that is used in OXTRAN (OXTRAN, 2/61) made by AMETEK MOCON, the United States of America. The first flow path 76 supplies gas into the test container 70. The first flow path 76 may supply gas that contains no oxygen. The first flow path 76 may supply inert gas. The first flow path 76 may supply nitrogen. The second flow path 77 discharges gas in the test container 70. The first flow path 76 and the second flow path 77 have the oxygen barrier property. The test container 70 is maintained by using the first flow path 76 and the second flow path 77 such that no oxygen is substantially present therein. The oxygen concentration in the test container 70 may be maintained at 0.05% or less, may be maintained at less than 0.03%, or may be maintained at 0%.
The test container 70 is disposed in a test atmosphere at a temperature of 23° C. and a humidity of 40% RH. The oxygen concentration of the atmosphere in which the test container 70 is disposed is higher than the oxygen concentration in the test container 70. The test atmosphere is an air atmosphere. The oxygen concentration of the air atmosphere is 20.95%. The test container 70 is disposed in the test atmosphere, and consequently, oxygen permeates a portion 30X of the container and moves from the test atmosphere into the test container 70. Gas in the test container 70 is discharged from the second flow path 77. The amount of oxygen that flows in the second flow path 77 is measured by the gas measuring device 79, and the oxygen permeation amount (mL/(day×atm)) of oxygen that permeates the portion 30X in the atmosphere at a temperature of 23° C. and a humidity of 40% RH in a day can be measured.
In an example illustrated, the test container 70 is disposed in a test chamber 78. An atmosphere in the test chamber 78 is maintained at a temperature of 23° C. and a humidity of 40% RH. Air is supplied from a supply path 78A into the test chamber 78. Gas in the test chamber 78 is discharged via a discharge path 78B. Air circulates through the supply path 78A and the discharge path 78B, and the oxygen concentration in the test chamber 78 is maintained at 20.95%.
In an example illustrated in
In the example illustrated in
The method of measuring the oxygen permeation amount (mL/(day×atm)) of oxygen that permeates the portion of the container is described above. The oxygen permeation amount (mL/(day×atm)) of oxygen that permeates the whole of the container can be specified in a manner in which the oxygen permeation amounts that are measured concerning two or more separated portions of the container are added. For example, the oxygen permeation amount of the first container 30 illustrated in
A gas permeation amount other than the oxygen permeation amount can be measured by using a method of measuring the gas permeation amount (mL/(day×atm)) in which the test container 70 illustrated in
The volume of the first container 30 may be, for example, 1 mL or more and 1100 mL or less, may be 3 ml or more and 700 ml or less, or may be 5 mL or more and 200 mL or less.
In an illustrated example, the container body 32 is a glass bottle that is colorless or colored. The container body 32 is composed of, for example, borosilicate glass. The first container 30 may be a vial bottle. A vial bottle is a container that includes a container body, a stopper (plug) that is inserted into an opening portion of the container body, and a seal that fixes the stopper and that corresponds to the fixture 36, and the seal is clamped (tightened, pressed, press-fitted, capped) to a head portion of the container body together with the stopper by using, for example, a hand gripper. The volume of the first container 30 that is a vial bottle may be 1 mL or more or may be 3 mL or more. The volume of the first container 30 that is a vial bottle may be 500 mL or less or may be 200 mL or less.
In the case where the first container 30 is a vial bottle, the oxygen permeability coefficient of the material of the stopper 34 may be higher than the oxygen permeability coefficient of glass of which the container body 32 is composed. In the case where the first container 30 is a vial bottle, the nitrogen permeability coefficient of the material of the stopper 34 may be higher than the nitrogen permeability coefficient of glass of which the container body 32 is composed. The portion of the first container 30 that has the gas permeability is separated from the liquid L, and consequently, movement of gas in the first container 30 to a position outside the first container 30 can be facilitated. The first container 30 that is a vial bottle can be stably disposed on a placement surface in a manner in which the bottom portion 32a of the container body 32 is brought into contact with the placement surface. At this time, the stopper 34 is separated from the liquid L. The stopper 34 does not come into contact with the liquid 1. Accordingly, the permeation of gas through the stopper 34 of the first container 30 can be facilitated with the first container 30 normally preserved.
The inner pressure of the liquid-containing first container 30L is adjusted as described in detail later. The first container 30 can maintain the inner pressure at negative pressure under the atmospheric pressure. The first container 30 is capable of containing gas while the gas is maintained at negative pressure under the atmospheric pressure. The first container 30 may be capable of containing gas while the gas is maintained at positive pressure under the atmospheric pressure. In these examples, the first container 30 may have rigidity so as to sufficiently maintain the shape thereof. However, the first container 30 may somewhat deform under the atmospheric pressure when the inner pressure is maintained at negative pressure or positive pressure. The first container 30 has sufficient rigidity and consequently enables a change in pressure based on a change in volume to be reduced.
Examples of the first container 30 that can maintain the inner pressure at negative pressure or positive pressure include the illustrated specific example described above and a can composed of metal. The first container 30 is airtight and has the gas permeability. Accordingly, the inner pressure of the first container 30 that is disposed under the atmospheric pressure can return to the atmospheric pressure in an equilibrium state. The phrase “be capable of containing gas while the gas is maintained at negative pressure or positive pressure under the atmospheric pressure” that is used for the first container 30 means that the gas can be contained while the gas is maintained at negative pressure or positive pressure as described above while the inner pressure of the first container 30 returns to the atmospheric pressure due to the permeation of the gas.
The first container 30 “that is capable of containing gas while the gas is maintained at negative pressure or positive pressure under the atmospheric pressure” has sufficient rigidity and consequently enables the change in pressure based on the change in volume to be reduced. Accordingly, the inner pressure of the first container 30 is changed mainly due to a change in the gas amount in the first container 30. Movement of gas that permeates the first container 30 between a position inside the first container 30 and a position outside the first container 30 is facilitated as described later, and consequently, the inner pressure of the first container 30 can be adjusted.
The phrase “be capable of containing gas while the gas is maintained at negative pressure under the atmospheric pressure” means that the inner pressure is a negative pressure of 0.80 atm or more, and the container can contain gas without damage. The container that is capable of containing gas while the gas is maintained at negative pressure under the atmospheric pressure may be airtight in the case where the inner pressure is 0.80 atm. The container that is capable of containing gas while the gas is maintained at negative pressure under the atmospheric pressure may be capable of maintaining the volume in the case where the inner pressure is 0.80 atm at 95% or more of the volume in the case where the inner pressure is 1.0 atm. The phrase “be capable of containing gas while the gas is maintained at positive pressure under the atmospheric pressure” means that the inner pressure is a positive pressure of 1.2 atm or less, and the container can contain gas without damage. The container that is capable of containing gas while the gas is maintained at positive pressure under the atmospheric pressure may be airtight in the case where the inner pressure is 1.20 atm. The container that is capable of containing gas while the gas is maintained at positive pressure under the atmospheric pressure may be capable of maintaining the volume in the case where the inner pressure is 1.2 atm at 105% or less of the volume in the case where the inner pressure is 1.0 atm.
The first container 30 is contained in the second container 40 that has the gas barrier property. The first container 30 that is contained in the second container 40 may be capable of containing gas without damage in the case where a difference between the inner pressure of the first container 30 and the inner pressure of the second container 40 is 0.2 atm or less. The first container 30 that is contained in the second container 40 may be airtight in the case where a difference between the inner pressure of the first container 30 and the inner pressure of the second container 40 is 0.2 atm or less. The first container 30 that is contained in the second container 40 may have a volume of 95% or more and 105% or less of the volume of the first container 30 when the inner pressure of the first container 30 is equal to the inner pressure of the second container 40 in the case where the difference between the inner pressure of the first container 30 and the inner pressure of the second container 40 is 0.2 atm or less. The inner pressure of the first container 30 may be less than the inner pressure of the second container 40 or the inner pressure of the first container 30 may be higher than the inner pressure of the second container 40 with the first container 30 contained in the second container 40.
The second container 40 will now be described mainly with reference to
The second container 40 has the gas barrier property. According to the present embodiment, gas moves from the first container 30 into the second container 40, and consequently, the inner pressure of the first container 30 can be adjusted as described above. The second container 40 having the gas barrier property means that gas does not permeate the second container 40 that is airtight to an extent that the pressure in the first container 30 can be adjusted as described above.
In an example described later, the oxygen absorber 21 absorbs oxygen in the second container 40, movement of oxygen in the first container 30 into the second container 40 outside the first container 30 is facilitated, and consequently, the pressure in the first container 30 is adjusted. In this example, the second container 40 has the oxygen barrier property. In this example, it can be said that the first container 30 that has the oxygen barrier property has a sufficient gas barrier property.
A container having the oxygen barrier property means that the degree of the oxygen permeability, in other words, oxygen transmission rate (mL/(m2×day×atm)) of the material of the container is 1 or less. The degree of the oxygen permeability (mL/(m2×day×atm)) of the container that has the oxygen barrier property may be 0.5 or less or may be 0.1 or less in an atmosphere at a temperature of 23° C. and a humidity of 40% RH. The degree of the oxygen permeability (oxygen transmission rate) is measured in accordance with JIS K7126-1. The degree of the oxygen permeability is measured by using OXTRAN (OXTRAN, 2/61) that is a permeation measuring device made by AMETEK MOCON, the United States of America, in environments of a temperature of 23° C. and a humidity of 40% RH. As for a container to which JIS K7126-1 is not used, the degree of the oxygen permeability may be specified in a manner in which the oxygen permeation amount described above is measured, and the obtained oxygen permeation amount is divided by a surface area.
The second container 40 that has the nitrogen barrier property or the water vapor barrier property also has the gas barrier property that enables the pressure in the first container 30 to be adjusted. The degree of the nitrogen permeability (mL/(m2×day×atm)) roughly equal to the predetermined degree of the oxygen permeability (mL/(m2×day×atm)) that is described as the oxygen barrier property that can serve as the gas barrier property enables the nitrogen barrier property to be achieved and enables the pressure in the first container 30 to vary. When the degree of the water vapor permeability of the material of the second container 40 in an atmosphere at a temperature of 40° C. and a humidity of 90% RH is 1 (g/(m2×day)) or less, the water vapor barrier property is achieved, and the pressure in the first container 30 can vary. The degree of the water vapor permeability of the material of the second container 40 that can have the water vapor barrier property may be 0.5 (g/(m2×day)) or less.
The oxygen permeability coefficient of the material of the second container 40 that has the oxygen barrier property may be 1×10−13 (cm3 (STP)·cm/(cm2·sec·Pa)) or less or may be 1×10−17 (cm3 (STP)·cm/(cm2·sec·Pa)) or less.
The second container 40 may be capable of maintaining the inner pressure at negative pressure under the atmospheric pressure. That is, the second container 40 may be capable of containing gas while the gas is maintained at negative pressure under the atmospheric pressure. The second container 40 may be capable of maintaining the inner pressure at positive pressure under the atmospheric pressure. That is, the second container 40 may be capable of containing gas while the gas is maintained at positive pressure under the atmospheric pressure. The second container 40 may have rigidity so as to sufficiently maintain the shape thereof. However, the second container 40 may somewhat deform under the atmospheric pressure when the inner pressure is maintained at negative pressure or positive pressure. The second container 40 that has sufficient rigidity can reduce a change in pressure based on a change in volume. The second container 40 may not be capable of maintaining the inner pressure at negative pressure or positive pressure as described later.
The second container 40 “that is capable of containing gas while the gas is maintained at negative pressure or positive pressure under the atmospheric pressure” has sufficient rigidity and consequently enables the change in pressure based on the change in volume to be reduced. Accordingly, the inner pressure of the second container 40 is changed mainly due to a change in the gas amount. For example, a gas absorber absorbs gas in the second container 40, and consequently, the inner pressure of the second container 40 can be adjusted as described above. The inner pressure of the second container 40 is negative pressure or positive pressure, and consequently, the inner pressure of the first container 30 can be easily adjusted.
Examples of the second container 40 that has the gas barrier property include a can composed of metal, a container that includes a metal layer that is formed by vapor deposition or transfer, and a glass bottle. The second container 40 may include a multilayer body that includes a layer that has the gas barrier property. The multilayer body may include a resin layer or a metal deposition film that has the gas barrier property such as an ethylene-vinyl alcohol copolymer (EVOH) or a polyvinyl alcohol (PVA) layer. The second container 40 may include a transparent portion. The whole of the second container 40 may be transparent. The second container 40 that uses the multilayer body and the second container 40 that uses glass or resin can have the gas barrier property and can be transparent. The second container 40 that is transparent enables the liquid-containing first container 30L that is contained therein to be checked from a position outside the second container 40.
In an example illustrated in
The portion of the first container 30 that has the gas permeability is at least partly separated from the second container 40 that has the gas barrier property, and consequently, movement of gas in the first container 30 into the second container 40 can be facilitated. In the example illustrated in
The first container 30 and the second container 40 described above are included in the container set 20 and a combination container 10. The liquid-containing combination container 10L is obtained by using the container set 20 that includes the liquid-containing first container 30L and the second container 40.
A method of manufacturing the liquid-containing combination container 10L will now be described. The liquid-containing combination container 10L is manufactured, and consequently, the liquid-containing first container 30L that has an adjusted inner pressure is obtained.
The liquid-containing first container 30L and the second container 40 that is not closed are first prepared. The liquid-containing first container 30L is manufactured in a manner in which the first container 30 is filled with the liquid L. The liquid L that has the high sensitivity such as a food product or a medicine (drug, chemical) is manufactured by using a manufacturing line that is disposed in a sterile environment at positive pressure. Pressure in the sterile environment is maintained at positive pressure from the perspective that foreign substances such as microbes are inhibited from entering. As a result, the inner pressure of the liquid-containing first container 30L that is obtained is positive pressure as in manufacturing environments.
Subsequently, as illustrated in
In an illustrated example, an atmosphere in the pressure chamber 59 is an inert gas atmosphere. That is, the pressure chamber 59 is filled with inert gas, and air in the pressure chamber 59 is replaced with the inert gas. In the illustrated example, the pressure chamber 59 is filled with nitrogen. Accordingly, when the container body 42 is contained in the pressure chamber 59, an atmosphere in the container body 42 is replaced with inert gas such as nitrogen. Consequently, the liquid-containing first container 30L is located in an inert gas atmosphere. The inert gas is gas that is stable and less reactive. Examples of the inert gas other than nitrogen include noble gas such as helium, neon, and argon.
Subsequently, as illustrated in
According to the present embodiment, the second container 40 is closed such that the pressure in the second container 40 is negative pressure. In the illustrated example, the container body 42 is disposed in the pressure chamber 59 that is maintained at negative pressure. The lid 44 is joined to the container body 42 in the pressure chamber 59 that is maintained at negative pressure. Accordingly, pressure in the container body 42 is less than the atmospheric pressure.
The inside of the pressure chamber 59 may be kept sterile. In this example, the liquid-containing first container 30L that is manufactured in a sterile state and the second container 40 that is sterilized or manufactured in a sterile state are brought in the pressure chamber 59. The second container 40 that contains the liquid-containing first container 30L is closed in the pressure chamber 59 that is kept sterile. Accordingly, the inside of the second container 40 that contains the liquid-containing first container 30L is also sterile. That is, the liquid-containing first container 30L can be preserved in the second container 40 in a sterile state.
Subsequently, as illustrated in
The second container 40 has the gas barrier property as described above. Accordingly, gas can be effectively inhibited from permeating the second container 40 and entering the second container 40. The first container 30 has the gas permeability. The pressure in the second container 40 is maintained at negative pressure. Consequently, gas in the first container 30 permeates the first container 30 and moves into the second container 40. The pressure in the second container 40 increases, and the pressure in the first container 30 reduces. In a final equilibrium state in which the permeation of gas through the first container 30 is equilibrated, the pressure in the first container 30 can match the pressure in the second container 40.
That is, the pressure in the first container 30 that contains the liquid L can be adjusted after the first container 30 is closed. Accordingly, the liquid-containing first container 30L the pressure of which is adjusted can be manufactured, which does not depend on a method of manufacturing the liquid L or a method of sealing the liquid L in the first container 30. The present embodiment that enables the inner pressure of the first container 30 to be adjusted after the liquid L is sealed is preferable for, for example, a liquid that has the high sensitivity and that is deteriorated by a post sterilization process that is performed after manufacturing, that is, a liquid to which the final sterilization method cannot be used such as a food product or a medicine (drug, chemical). The liquid L that has the high sensitivity and that is not suitable for the post sterilization process is manufactured by using a manufacturing line that is sterilized and that is kept sterile. That is, the liquid is manufactured by using the sterile operation method. The sterilized manufacturing line is typically maintained at positive pressure, and accordingly, pressure in a container in which the liquid is sealed is predetermined positive pressure. According to the present embodiment, the pressure in the liquid-containing container that is provided at predetermined positive pressure so far can be adjusted after the liquid is sealed. In particular, the volume of the second container 40 is increased, or the initial pressure of the second container 40 is greatly reduced, and consequently, the pressure in the first container 30 can be greatly adjusted. This enables the pressure in the first container 30 that is originally positive pressure to be adjusted to negative pressure in a manner in which the first container 30 is preserved in the second container 40.
The liquid L that has the high sensitivity such as a food product or a medicine (drug, chemical) can be dissolved (decomposed) by oxygen. For example, a solute in an aqueous solution that is a medicine can be dissolved (decomposed) by oxygen. A liquid that is a medicine and a solute and a solvent in an aqueous solution that is a medicine can be dissolved (decomposed) by oxygen. Particles that are dispersed in a liquid in a suspension that is a medicine or a food product can be dissolved (decomposed) by oxygen. In the case where the second container 40 is filled with inert gas, and the second container 40 is closed, liquid L can be inhibited from being dissolved (decomposed) by oxygen. That is, gas permeates the first container 30, and consequently, an atmosphere in the first container 30 and an atmosphere in the second container 40 are equilibrated concerning not only the pressure but also the oxygen concentration. That is, oxygen that remains in the first container 30 moves into the second container 40, and the inert gas in the second container 40 moves into the first container 30. Accordingly, the oxygen concentration in the first container 30 reduces. The oxygen concentration in the first container 30 can be equal to the oxygen concentration in the second container 40 in an equilibrium state in which equilibrium of the permeation of gas through the first container 30 is reached. This enables the liquid L to be inhibited from deteriorating due to oxygen.
As the oxygen concentration in the first container 30 reduces, and the partial pressure of oxygen in the first container 30 reduces, the saturation solubility of the liquid L reduces. Accordingly, in the case where the liquid-containing first container 30L is preserved in the second container 40, the amount (mg/L) of dissolved oxygen in the liquid L also reduces. The amount (mg/L) of dissolved oxygen in the liquid L is also referred to as the dissolved oxygen amount (mg/L) of the liquid L. The liquid L in the first container 30 can be easily dissolved (decomposed) by oxygen dissolved in the liquid L. Accordingly, a reduction in the amount of dissolved oxygen in the liquid L enables the liquid L to be effectively inhibited from deteriorating due to oxygen.
The oxygen absorber 21 that absorbs oxygen in the second container 40 may be provided instead of filling the second container 40 with the inert gas or in addition to filling the second container 40 with the inert gas when the second container 40 is closed. The use of the oxygen absorber 21 enables the oxygen concentration in the second container 40 and the oxygen concentration in the first container 30 to be more effectively reduced. The present inventors confirm that the use of the oxygen absorber 21 in a sufficient amount for absorbing oxygen in the second container 40 enables the oxygen concentration in the second container 40 and the oxygen concentration in the first container 30 to be maintained at low concentrations, for example, less than 0.3%, 0.1% or less, 0.05% or less, less than 0.03%, or 0%. The present inventors also confirm that the use of the oxygen absorber 21 in a sufficient amount for absorbing oxygen in the second container 40 enables the amount of dissolved oxygen in the liquid L that is contained in the first container 30 to be maintained at a small amount, for example, less than 0.15 mg/L, 0.04 mg/L or less, 0.03 mg/L or less, less than 0.015 mg/L, or 0 mg/L.
The amount of the oxygen absorber 21 is set such that the total amount of oxygen in the first container 30 and the second container 40 can be absorbed.
The oxygen absorber 21 is not particularly limited provided that the oxygen absorber 21 is a composition that can absorb oxygen. Examples of the oxygen absorber 21 can include an iron oxygen absorber and a non-iron oxygen absorber. The oxygen absorber may be an oxygen absorber composition that contains, as a main component for an oxygen absorbing reaction, metal powder such as iron powder, a reducible inorganic substance such as an iron compound, polyhydric phenol, polyhydric alcohol, ascorbic acid, a reducible organic substance such as the salt thereof, or a metal complex. As illustrated in
As illustrated in
In an example in which the liquid L contains a non-aqueous solvent such as alcohol or oil, the water retention agent 22b that retains moisture is effective for ensuring a function of the oxygen absorber 21 to absorb oxygen. A non-aqueous solvent means a solvent in which a main component that has the maximum volume ratio is not water. The non-aqueous solvent may substantially not contain water. The ratio of the volume of moisture to the non-aqueous solvent may be 2% or less, may be 1% or less, or may be 0.5% or less. The non-aqueous solvent may not contain water.
In the case where the liquid L is an aqueous solution, the deoxygenated member 22 may not contain the water retention agent 22b. The first container 30 that has the oxygen permeability has the water vapor permeability in many cases. In this example, moisture can be supplied to the oxygen absorber 21 without using the water retention agent 22b. Moisture may be inhibited from being absorbed by the water retention agent 22b. For example, the amount of moisture that can be absorbed by the water retention agent 22b that is used for the deoxygenated member 22 may be 5% or less of the volume (mL) of the liquid L that is contained in the first container 30. As for a condition in which the liquid such as a medicine is preserved, a reduction in the volume can be set at 5% or less. A reduction in the liquid L in the first container 30 can be restricted. This condition can be satisfied when the amount of moisture that can be absorbed by the water retention agent 22b is set at 5% or less of the initial volume (mL) of the liquid L.
In the case where water vapor that permeates the first container 30 and that moves into the second container 40 activates the oxygen absorber 21, a portion or the whole of the oxygen absorber 21 or a portion or the whole of the deoxygenated member 22 may be disposed above the portion of the first container 30 that has the oxygen permeability in the vertical direction. For example, in the case where the container body 32 has the oxygen barrier property, and the stopper 34 has the oxygen permeability, a portion or the whole of the oxygen absorber 21 may be disposed above the stopper 34. In the case where the container body 32 has the oxygen barrier property, and the stopper 34 has the oxygen permeability, a portion or the whole of the deoxygenated member 22 may be disposed above the stopper 34. Water vapor is lighter than nitrogen, oxygen, and many kinds of inert gas. Accordingly, the water vapor that permeates the first container 30 can be effectively used to activate the oxygen absorber 21.
The oxygen absorber 21 may be contained in a deoxygenated film 23.
The oxygen concentration (%) in the first container 30 and the oxygen concentration (%) in the second container 40 are specified by a measurement device that is suitable for measurement of these oxygen concentrations. An oxygen amount measuring device in a headspace method, an oxygen amount measuring device in a fluorescent contact method, and an oxygen amount measuring device in a fluorescent non-contact method are known as measurement devices that measure an oxygen concentration. The amount (mg/L) of dissolved oxygen in the liquid that is contained in the first container 30 is specified by a measurement device that is suitable for measurement of the amount of dissolved oxygen in the liquid. The oxygen amount measuring device in the fluorescent contact method and the oxygen amount measuring device in the fluorescent non-contact method, for example, are known as measurement devices that measure the amount of dissolved oxygen. An appropriate measurement device is selected as the measurement device that measures the oxygen concentration and the amount of dissolved oxygen in consideration for, for example, a measurement limit, stability of measurement in an oxygen concentration band to be measured, a measurement environment, and a measurement condition.
A headspace analyzer FMS760 made by lighthouse is used as the oxygen amount measuring device in the headspace method. As for measurement by using the measurement device, light at a frequency that can be absorbed by oxygen is emitted from a position outside a container toward the container that contains oxygen to be measured, and light that passes through a headspace HS of the container and that exits from the container is received. A change in light intensity is measured before and after permeation, and the oxygen concentration (%) in the container can be specified based on the change in the light intensity. Accordingly, if light from the measurement device can pass through the first container 30, the oxygen concentration in the first container 30 can be specified without opening the first container 30. If light from the measurement device can pass through the second container 40, light is emitted from a position outside the second container 40, and the oxygen concentration in the first container 30 can be measured without opening the second container 40 also as for the first container 30 that is contained in the second container 40. The oxygen concentration (%) in the second container 40 can be measured by using the headspace analyzer FMS760 made by lighthouse. The saturation solubility of oxygen into the liquid L can be specified by using the oxygen concentration (%) and temperature of the headspace HS that is measured. The amount (mg/L) of dissolved oxygen in the liquid L can be specified based on the specified saturation solubility. The oxygen concentration in a container can be measured by using the headspace analyzer FMS760 from a position outside the container. The lower limit of the oxygen concentration that can be measured by the headspace analyzer FMS760 is higher than the lower limit of the oxygen concentration that can be measured by other measurement devices.
An oxygen amount measuring device Microx4 made by PreSens Precision Sensing GmbH in Germany is used as the oxygen amount measuring device in the fluorescent contact method. The oxygen amount measuring device Microx4 is a needle device. The oxygen amount measuring device Microx4 punctures a needle into a container, can consequently measure the oxygen concentration and the amount of dissolved oxygen in the container, and is excellent for stability of measurement depending on the structure of a portion of the container into which the needle is punctured. Multiple combination containers or containers that are manufactured in the same condition are prepared, the amounts of oxygen in the containers are measured by using a needle oxygen amount measuring device with different timings, and consequently, variations in the amounts of oxygen over time can be evaluated.
An oxygen sensor is contained in advance in a container, and consequently, the oxygen concentrations and the amounts of dissolved oxygen in the first container 30 and in the second container 40 can be measured by the oxygen amount measuring device in the fluorescent non-contact method. An oxygen amount measuring device Fibox3 made by PreSens Precision Sensing GmbH in Germany is used as the oxygen amount measuring device in the fluorescent non-contact method. The oxygen sensor receives light in a specific wavelength range and consequently generates autofluorescence. The amount of the autofluorescence of the oxygen sensor increases as the amount of oxygen around the sensor increases. The oxygen amount measuring device in the fluorescent non-contact method can radiate light at a specific wavelength at which the oxygen sensor generates the autofluorescence, measures the amount of the autofluorescence of the oxygen sensor, and can measure the oxygen concentrations (%) and the amounts (mg/L) of dissolved oxygen. In the case where the first container 30 is contained in the second container 40, light is emitted from a position outside the second container 40 without opening the second container 40, and the amount of dissolved oxygen in the liquid L can be measured.
The container set 20 and the combination container 10 may include an oxygen detection member 25 that detects the state of oxygen in the second container 40. The oxygen detection member 25 may display the detected state of oxygen. The oxygen detection member 25 may detect the oxygen concentration. The oxygen detection member 25 may display the value of the detected oxygen concentration. The oxygen detection member 25 may display the value of the detected oxygen concentration by using a color.
The oxygen detection member 25 may contain variable organic dye that reversibly changes the color thereof due to oxidation-reduction. For example, an oxygen reducing agent contains organic dye such as thiazine dye, azine dye, or oxazine dye and a reducing agent and may be solid. The oxygen reducing agent may contain an oxygen indicator ink composition. The oxygen indicator ink composition may contain a resin solution, thiazine dye, reducing sugar, and an alkali substance. The thiazine dye, the reducing sugar, and the alkali substance may be dissolved or dispersed in the resin solution. A substance that is contained in the oxygen detection member 25 may reversibly change due to oxidation and reduction. The oxygen detection member 25 that is contained in a container changes the displayed color due to deoxidation in the container before the deoxidation ends by using the oxygen detection member 25 that contains a reversible substance, the amount of oxygen in the container is consequently observed from a position outside the container that is transparent, and a state related to oxygen in the container can be grasped. The oxygen detection member 25 that is contained in the container can change the displayed color and can report an increase in the oxygen concentration after the deoxidation ends, such as a state in which a pinhole, for example, is formed in the container, and oxygen enters the container during, for example, distribution.
More specifically, an oxygen detection member named “AGELESS EYE” available from MITSUBISHI GAS CHEMICAL COMPANY, INC., may be used as the oxygen detection member 25 that is a tablet. The oxygen detection member named “PAPER EYE” available from MITSUBISHI GAS CHEMICAL COMPANY, INC., for example, may be used as an oxygen detector to which an ink composition that has a function of detecting oxygen is applied. The “AGELESS EYE” and “PAPER EYE” are functional products that can simply display a non-oxygen state in which the oxygen concentration in a transparent container is less than 0.1 volume % by using a color variation. For example, the oxygen detection member 25 may be a product that can be used, for example, to maintain the freshness of a food product and the quality of a medicine in addition to the oxygen absorber such as an oxygen absorber named “AGELESS” available from MITSUBISHI GAS CHEMICAL COMPANY, INC.
As illustrated in
The oxygen detection member 25 may detect the state of oxygen in the first container 30. That is, the container set 20 and the combination container 10 may include the oxygen detection member 25 that detects the state of oxygen in the first container 30. The oxygen detection member 25 may be contained in the first container 30. The oxygen detection member 25 may display the detected state of oxygen in the first container 30. The oxygen detection member 25 may detect the oxygen concentration in the first container 30. The oxygen detection member 25 may display the value of the detected oxygen concentration in the first container 30. The oxygen detection member 25 may display the value of the detected oxygen concentration in the first container 30 by using a color.
In the examples described above, the second container 40 that has the gas barrier property is closed at negative pressure, gas consequently moves from the first container 30 into the second container 40, and the pressure in the first container 30 reduces. However, a method of making the pressure in the second container 40 into negative pressure is not limited to a method of closing the second container 40 at negative pressure. The negative pressure in the second container 40 may be obtained in a manner in which the oxygen absorber 21 that absorbs oxygen in the second container 40 that can maintain the inner pressure at negative pressure is provided. That is, in the case where the liquid-containing first container 30L is contained in the second container 40 the inner pressure of which is the atmospheric pressure, and the second container 40 is closed, the oxygen absorber 21 absorbs oxygen, and consequently, the inner pressure of the second container 40 can be made into negative pressure. Also, making the inner pressure of the second container 40 into negative pressure by using the oxygen absorber 21 enables gas to move from the first container 30 into the second container 40 and enables the pressure in the first container 30 to reduce. The oxygen absorber 21 is not a limitation. The use of a gas absorber that absorbs any kind of gas that can permeate the first container 30 such as nitrogen or water vapor causes gas to move from the first container 30 into the second container 40 and enables the inner pressure of the first container 30 to be adjusted.
In an example in which water vapor moves from the first container 30 into the second container 40, and the inner pressure of the first container 30 is adjusted, the liquid L that is contained in the first container 30 may contain a non-aqueous solvent such as alcohol or oil. In this example, a dehydrating agent, for example, can be inhibited from absorbing a solvent in the liquid L. A non-aqueous solvent means a solvent in which a main component that has the maximum volume ratio is not water as described above. The non-aqueous solvent may substantially not contain water. The ratio of the volume of moisture to the non-aqueous solvent may be 2% or less, may be 1% or less, or may be 0.5% or less. The non-aqueous solvent may not contain water.
The inner pressure of the second container 40 is lower than the inner pressure of the first container 30, gas consequently moves from the first container 30 into the second container 40, and the pressure in the first container 30 can reduce as described above. The use of concentration equilibrium instead of a difference in pressure enables gas to move from the first container 30 into the second container 40. For example, in the case where the atmosphere in the second container 40 is replaced with nitrogen as described above, the oxygen concentration in the first container 30 is higher than the oxygen concentration in the second container 40 right after the second container 40 is closed, and consequently, oxygen permeates the first container 30 and moves from the first container 30 into the second container 40. That is, in the case where the first container 30 contains a kind of gas that is not contained in the second container 40 or contains a kind of gas that is contained in the second container 40 at a concentration higher than that of the second container 40, the kind of gas permeates the first container 30 and moves from the first container 30 into the second container 40. The atmosphere in the second container 40 may not be replaced with gas before the second container 40 is closed, and the concentration of a specific kind of gas in the second container 40 may be reduced to a concentration lower than the concentration of the first container 30 by using a gas absorber such as the oxygen absorber 21 after the second container 40 is closed.
In the case of using the concentration equilibrium, the permeation of gas through the first container 30 can be facilitated more than in the case of using the difference in pressure. Accordingly, in the case of using the concentration equilibrium, the inner pressure of the second container 40 may be equal to or higher than the inner pressure of the first container 30. The second container 40 may be a container that cannot maintain the inner pressure at negative pressure under the atmospheric pressure. In the example illustrated in
The second container 40 illustrated in
As for the second container 40 illustrated in
As illustrated in
The second container 40 illustrated in
The second container 40 illustrated in
In the various examples described above, each film that forms the second container 40 may be transparent.
As in the examples illustrated in
In the example illustrated in
In the case of using the dehydrating agent 24, moisture in the first container 30 can be measured by using the Karl Fischer Method. Specifically, the amount of moisture in the first container 30 can be specified in a coulometric titration method by using a Karl Fischer moisture titrator MKC-610 made by Kyoto Electronics Manufacturing Co., Ltd.
In the specific example described above, the first container 30 includes the container body 32 and the stopper 34. The first container 30 may be a vial bottle. A vial bottle that contains a liquid, particularly, a vial bottle that contains a liquid in a sterile state is manufactured by using butyl rubber or fluorine rubber that has low gas permeability and the gas barrier property. In the specific example described above, however, the stopper 34 has the gas permeability. That is, the stopper 34 is permeable to gas. For example, the gas permeability coefficient such as the nitrogen permeability coefficient or the oxygen permeability coefficient of the material of the stopper 34 is set to a large value. The stopper 34 may be composed of silicone or silicone rubber. The gas permeability coefficient of the material of the stopper 34 may be higher than the gas permeability coefficient of the material of the container body 32. The nitrogen permeability coefficient of the material of the stopper 34 may be higher than the nitrogen permeability coefficient of the material of the container body 32. The oxygen permeability coefficient of the material of the stopper 34 may be higher than the oxygen permeability coefficient of the material of the container body 32.
In the specific example, gas permeates the stopper 34 and moves to a position outside the first container 30. Replacing the stopper 34 easily enables an existing container such as a vial bottle that has been used to have the gas permeability.
A region away from the liquid L in the first container 30, in other words, a region that is exposed to the liquid in the first container 30 such as the so-called headspace HS can have the gas permeability. Consequently, the permeation of gas through the first container 30 is smooth, and the time until the equilibrium of the permeation of gas through the first container 30 is reached after the second container 40 that contains the liquid-containing first container 30L is closed can be reduced. In particular, in the illustrated specific example, the container body 32 has the gas barrier property. Accordingly, gas permeates the first container 30 only in a region away from the liquid L such as the headspace HS in the first container 30. Accordingly, the gas that permeates the first container 30 can be inhibited from being dissolved in the liquid L. This enables the time until the equilibrium of gas dissolved in the liquid L is reached to be reduced.
In the specific example, the time until the equilibrium is reached depends on the amount of gas to which the stopper 34 is permeable. Accordingly, the area of the opening portion 33 of the container body 32 or the thickness of the stopper 34 is adjusted as described above, and consequently, the time until the equilibrium of the permeation of gas through the first container 30 is reached after the second container 40 that contains the liquid-containing first container 30L is closed can be reduced.
A partial volume (the volume of the headspace HS) of the first container 30 that is obtained by subtracting the volume of the liquid L from the volume of the first container 30 may be 50 mL or less, may be 30 mL, may be 10 mL, or may be 5 mL or less. The liquid-containing combination container 10L can reduce the time until the equilibrium of the permeation of gas through the first container 30 is reached after the second container 40 that contains the first container 30 is closed.
Similarly, the volume of the liquid L that is contained in the first container 30 may be 20 mL or less or may be 10 mL or less. The liquid-containing combination container 10L can reduce the time until the equilibrium of the permeation of gas through the first container 30 is reached after the second container 40 that contains the first container 30 is closed.
The ratio of the volume of the liquid L to the volume of the first container 30 is preferably high. When the ratio is high, the time until the equilibrium of the permeation of gas through the first container 30 is reached can be reduced. The ratio of the volume of the liquid L to the volume of the first container 30 may be preferably 50% or more, may be more preferably 75% or more, or may be further preferably 90% or more.
An upper limit and a lower limit may be set for a ratio (%) of the partial volume (mL) (the volume of the headspace HS) of the first container 30 that is obtained by subtracting the volume of the liquid L from the volume of the first container 30 to a partial volume (mL) of the second container 40 that is obtained by subtracting the volume of the first container 30 from the volume of the second container 40. The ratio may be 50% or less or may be 20% or less. Setting the upper limit enables a space for containing the first container 30 in the second container 40 to be ensured and enables the first container 30 to be easily contained in the second container 40. In addition, the time until the equilibrium of the permeation of gas through the first container 30 is reached after the second container 40 that contains the first container 30 is closed can be reduced. The ratio may be 5% or more or may be 10% or more. Setting the lower limit enables the second container 40 to be prevented from being too large in comparison with the first container 30 and enables the ease of handling the combination container 10 to be inhibited from reducing.
Whether the equilibrium of the permeation of gas through the first container 30 is reached is determined based on the value of the inner pressure of the second container 40. The value (atm) of first pressure in the second container 40 at a point of time and the value (atm) of second pressure in the second container 40 before the point of time by 24 hours are used for the determination. Specifically, it is determined that the equilibrium is reached at the point of time in the case where the ratio of a difference between the value of the second pressure and the value of the first pressure to the value of the first pressure is ±5% or less.
The liquid-containing first container 30L and the liquid-containing combination container 10L that have an adjusted pressure can be obtained in the above manner. The inner pressure of the first container 30 in the second container 40 may be adjusted until the equilibrium of the permeation of gas through the first container 30 is reached. The inner pressure of the first container 30 in the second container 40 may be adjusted until the pressure in the first container 30 reduces to predetermined pressure. The inner pressure of the first container 30 in the second container 40 may be adjusted until the pressure in the second container 40 increases to predetermined pressure. The inner pressure of the first container 30 in the second container 40 may be adjusted until the liquid L of the combination container 10 starts to be used. The liquid-containing combination container 10L may be delivered while the first container 30 is contained in the second container 40, and the inner pressure is adjusted.
A method of using the liquid-containing combination container 10L will now be described.
Before the liquid L that is contained in the combination container 10 is used, the second container 40 is first opened. Subsequently, the liquid-containing first container 30L is taken out from the second container 40 that is opened. Subsequently, the liquid L is taken out from the liquid-containing first container 30L and can be used. As for the first container 30 illustrated, the fixture 36 is removed from the container body 32, the stopper 34 is removed from the container body 32, and consequently, the first container 30 can be opened. This enables the liquid L in the first container 30 to be used.
The pressure in the first container 30 is adjusted while being contained in the second container 40 as described above. Specifically, the pressure in the first container 30 reduces. Accordingly, the liquid L can be inhibited from unintentionally leaking from the first container 30 before the first container 30 is opened. In addition, the liquid L can be inhibited from splashing from the first container 30 when the first container 30 is opened. In particular, the pressure in the first container 30 is reduced to negative pressure, and consequently, splashing when the first container 30 is opened can be quite effectively reduced. In some cases, the liquid L that is a medicine (drug, chemical), particularly, the liquid L that is a medicine (drug, chemical) that has high pharmacological activity has toxicity. However, a suction risk and an exposure risk to an operator when the first container 30 is opened can be reduced.
As illustrated in
The first container 30 illustrated includes the container body 32 that includes the opening portion 33 and the stopper 34 that closes the opening portion 33 and that is composed of rubber, and the stopper 34 composed of rubber can be punctured by the needle 64 of the syringe 60. In the case where the liquid L is injected into the syringe 60, the needle 64 of the syringe 60 punctures the stopper 34. As illustrated in
In the case of using the syringe 60, when the pressure in the first container 30 is positive pressure, the liquid L in the first container 30 presses the piston 66 and automatically flows into the syringe 60. Accordingly, when the pressure in the first container 30 is positive pressure, it is not easy to take the liquid L in a desired amount in the syringe 60. However, the pressure in the first container 30 is adjusted in advance as described above, and consequently, the liquid L is inhibited from being automatically flowing into the syringe 60 when the needle 64 of the syringe 60 punctures the first container 30. This enables the liquid in an appropriate amount to be taken in the syringe 60. Specifically, the adjusted pressure in the first container 30 may be 1 atm or less, may be less than 1 atm, or may be 0.98 atm or less. The adjusted pressure in the first container 30 may be 0.8 atm or more or may be 0.9 atm or more. The use of the oxygen absorber 21 as above to adjust the pressure enables the pressure in the first container 30 to be easily reduced to 0.8 atm in a short time. The range of the adjusted pressure in the first container 30 may be determined by using a combination of a freely selected value of the lower limit of the pressure in the first container 30 and a freely selected value of the upper limit of the pressure in the first container 30.
In the case where the pressure in the first container 30 is 1 atm or less, the liquid L can be effectively inhibited from leaking or splashing from the first container 30 when the needle 64 of the syringe 60 punctures the stopper 34 of the first container 30. In the case where the pressure in the first container 30 is negative pressure, for example, 0.98 atm or less, the liquid L can be more stably inhibited from leaking or splashing from the first container 30 when the needle 64 punctures the stopper 34. In the case where the pressure in the first container 30 is 0.8 atm or more, the piston can be inhibited from being strongly pulled when the needle 64 of the syringe 60 punctures the stopper 34 of the first container 30, and the liquid in the appropriate amount can be taken in the syringe 60 from the first container 30 with precision In the case where the pressure in the first container 30 is 0.9 atm or more when the needle 64 punctures the stopper 34, the piston is scarcely pulled, and the liquid in the appropriate amount can be taken in the syringe 60 from the first container 30 with more precision.
According to the embodiment described above, the container set 20 includes the first container 30 that contains the liquid L and that has the gas permeability and the second container 40 that is capable of containing the first container 30 and that has the gas barrier property. The first container 30 is capable of containing gas while the gas is maintained at negative pressure in the second container 40. The first container 30 can maintain the inner pressure at negative pressure in the second container 40. The first container 30 is contained in the second container 40, and consequently, the combination container 10 is obtained. That is, the liquid-containing combination container 10L includes the first container 30 that contains the liquid L and that has the gas permeability and the second container 40 that contains the first container 30 and that has the gas barrier property. A method of manufacturing the liquid-containing first container 30L includes a process of closing the second container 40 that contains the first container 30 and a process of adjusting the pressure in the first container 30 that is contained in the second container 40. In the process of adjusting the pressure, one or more kinds of gases in the first container 30 permeate the first container 30 and move from a position inside the first container 30 to a position outside the first container 30, and consequently, the pressure in the first container 30 reduces.
According to the embodiment, gas in the first container 30 permeates the first container 30 and moves into the second container 40. This enables the pressure in the first container 30 to be reduced. That is, the pressure in the first container 30 that contains the liquid L can be adjusted after the first container 30 is closed. In addition, the pressure in the first container 30 can be adjusted while the first container 30 is contained in the second container 40. According to the embodiment, the liquid-containing first container 30L the pressure of which is adjusted can accordingly be easily manufactured, which does not depend on a method of manufacturing the liquid L or a method of sealing the liquid L in the first container 30 for the liquid.
An example of a method of causing gas that permeates the first container 30 to move from the first container 30 into the second container 40 is that the inner pressure of the second container 40 is less than the inner pressure of the first container 30. In this example, the second container 40 is capable of containing gas while the gas is maintained at negative pressure. More specifically, the second container 40 that contains the first container 30 may be closed such that the inner pressure of the second container 40 is less than the inner pressure of the first container 30. A gas absorber that absorbs gas in the second container 40 such as the oxygen absorber 21 may be provided.
Another example of the method of causing gas that permeates the first container 30 to move from the first container 30 into the second container 40 is that the concentration equilibrium is used. More specifically, the atmosphere in the second container 40 may be replaced, and the second container 40 may be closed such that the second container 40 contains one or more gases at a concentration lower than the concentration of the one or more gases contained in the first container 30. The atmosphere in the second container 40 may be replaced, and the second container 40 may be closed such that the second container 40 does not contain the one or more gases contained in the first container 30. A gas absorber (for example, the oxygen absorber 21) that absorbs the one or more gases contained in the first container 30 may be used, and the concentration of the one or more gases in the second container 40 may be reduced after the second container 40 is closed.
In a specific example according to the embodiment described above, the first container 30 may be capable of containing gas under the atmospheric pressure, while the gas is maintained at negative pressure or positive pressure. In this example, the first container 30 has sufficient rigidity, and consequently, a change in the inner pressure of the first container 30 based on a change in the volume of the first container 30 can be reduced. Accordingly, the change in the inner pressure of the first container 30 is caused mainly by a change in the amount of gas in the first container 30. Movement of gas that permeates the first container 30 between positions inside and outside the first container 30 is facilitated, and consequently, the inner pressure of the first container 30 can be adjusted.
In a specific example according to the embodiment described above, the second container 40 may be capable of containing gas under the atmospheric pressure, while the gas is maintained at negative pressure or positive pressure. In this example, the second container 40 has sufficient rigidity, and consequently, a change in the pressure in the second container 40 based on a change in the volume of the second container 40 can be reduced. Accordingly, the change in the inner pressure of the second container 40 is caused mainly by a change in the amount of gas. For example, a gas absorber absorbs gas in the second container 40, and consequently, the inner pressure of the second container 40 can be adjusted as described later. The inner pressure of the second container 40 is made into negative pressure or positive pressure, and consequently, the inner pressure of the first container 30 can be easily adjusted.
In a specific example according to the embodiment described above, the pressure in the first container 30 may be reduced to negative pressure. The pressure in the first container 30 may be reduced from positive pressure to 1 atm (the atmospheric pressure) or less. In this specific example, the liquid L can be effectively inhibited from leaking from the first container 30, and the liquid L can be effectively inhibited from splashing when the first container 30 is opened. For example, the pressure in the first container 30 may be 0.8 atm or more and less than 1 atm, may be 0.9 atm or more and less than 1 atm, or may be 0.9 atm or more and 0.98 atm or less. Setting the pressure in the first container 30 in this way enables the liquid L in the desired amount to be taken in the syringe 60 from the first container 30 with precision.
For example, the present embodiment is preferable for a liquid that has the high sensitivity and that is deteriorated by the post sterilization process that is performed after manufacturing such as a medicine (drug, chemical). A liquid L that has the high sensitivity and that is not suitable for the post sterilization process is manufactured by using a sterile manufacturing line. The sterile manufacturing line is typically maintained at positive pressure, and accordingly, the pressure in the first container 30 in which the liquid L is sealed is predetermined positive pressure. According to the present embodiment, the pressure in the liquid-containing container that is provided at predetermined positive pressure so far can be adjusted with the container closed and with the liquid L sealed, can be reduced to 1 atm or less, and can be further reduced to negative pressure.
As for the combination container 10, the second container 40 contributes to adjusting the pressure and has the gas barrier property. The liquid-containing first container 30L may contribute to sterilization of the inside and the liquid L that is contained. A container environment required for the liquid L is effectively achieved by using a combination of the first container 30 and the second container 40. The combination container 10 and the container set 20 easily enable a preservation environment required for the liquid L to be achieved at a high degree of freedom and low costs.
In a specific example according to the embodiment described above, the first container 30 may include the container body 32 that includes the opening portion 33 and the stopper 34 that closes the opening portion 33. The stopper 34 can be punctured by the needle 64 of the syringe 60. In this example, the liquid L may be a medicine (drug, chemical) that is injected into the syringe 60. In this example, the liquid L that is sterile can be taken in the syringe 60 such that the liquid L is kept sterile. Since the pressure in the first container 30 is adjusted, the liquid L in the desired amount can be taken in the syringe 60 with high precision.
As illustrated in
In a specific example according to the embodiment described above, the atmosphere in the second container 40 may be an inert gas atmosphere when the second container 40 that contains the first container 30 is closed. In this example, oxygen permeates the first container 30, the oxygen concentration in the first container 30 can consequently reduce, and the dissolved oxygen amount of the liquid L can reduce. This enables the liquid L that has the high sensitivity such as a food product or a medicine can be effectively inhibited from deteriorating due to oxygen.
In this example, the concentration of oxygen that is contained in the first container 30 before the second container 40 is closed, that is, the oxygen concentration in the first container 30 of the container set 20 may be 1.5% or less. The pressure chamber 59 described above, for example, enables the oxygen concentration to be obtained. The oxygen concentration in the first container 30 of the liquid-containing combination container 10L can be finally reduced to less than 1%. In this example, the liquid L can be quite effectively inhibited from deteriorating due to oxygen. For example, the deterioration of the liquid L after the liquid-containing first container 30L is preserved in the second container 40 for three years can be reduced to 5% or less. Accordingly, this example is preferable for, for example, an emergency food product or a medicine.
The oxygen absorber 21 that absorbs oxygen in the second container 40 may be provided. In this example, the oxygen concentration in the second container 40 and the oxygen concentration in the first container 30 can be effectively reduced. The present inventors confirm that the amount of dissolved oxygen in the liquid L that is contained in the first container 30 can be reduced to 0.04 mg/L or less, 0.03 mg/L or less, 0.02 mg/L or less, less than 0.015 mg/L, or 0 mg/L in a manner in which the oxygen absorber is contained in the second container 40.
In a specific example according to the embodiment described above, the dehydrating agent 24 that absorbs moisture such as water vapor or water in the second container 40 may be provided. In the case where a water-insoluble liquid such as glycerin or alcohol is contained in the first container 30, the dehydrating agent that is contained in the second container can remove moisture in the first container 30. The present inventors confirm that moisture in the first container 30 can be 100 μg or less, 50 μg or less, or 10 μg or less in a manner in which the dehydrating agent is contained in the second container 40.
Specific examples of the second container 40 will now be described. The second container 40 that will be described below can be used so as to be combined with the first container 30 that includes the container body 32 and the stopper 34 described above, and the stopper 34 has the oxygen permeability. That is, in the following description, the first container 30 has the oxygen permeability, and the second container 40 has the oxygen barrier property. The oxygen absorber 21 that absorbs oxygen in the second container 40 is used, and consequently, the inner pressure of the first container 30 and the inner pressure of the second container 40 are adjusted. However, in first to sixth specific examples described later, the first container 30 may have the gas permeability to one or more kinds of gases, and the second container 40 may have the gas barrier property to the one or more kinds of gases.
In the description below and the figures used for the description below, a portion that can have the same structure as in the examples described above and a portion that can have the same structure as in some specific examples described later are designated by using like reference signs, and a duplicated description is omitted.
The first container 30 can have the structure described above. The first container 30 illustrated includes the container body 32 that includes the opening portion 33 and the stopper 34 that closes the opening portion 33. The stopper 34 has the oxygen permeability. That is, the stopper 34 is permeable to oxygen. The second container 40 has the oxygen barrier property as described above. The second container 40 is not particularly limited but can have the same structure as in the second container described above. The second container 40 may be a film container. For example, the second container 40 may be a gusset container that uses a resin film or any one of the containers illustrated in
As illustrated in
As illustrated in
As illustrated in
The tray 90 illustrated includes a third side wall portion 92c and a fourth side wall portion 92d. The third side wall portion 92c connects an edge of the first side wall portion 92a and an edge of the second side wall portion 92b to each other. The fourth side wall portion 92d connects another edge of the first side wall portion 92a and another edge of the second side wall portion 92b to each other. The first side wall portion 92a to the fourth side wall portion 92d are included in the side wall 92 that is tubular. The tray 90 also includes a flange portion 93 that extends from the side wall 92. The bottom wall 91 is connected to an edge of the side wall 92. The flange portion 93 is connected to another edge of the side wall 92. The flange portion 93 has a surrounding shape as in the side wall 92. The flange portion 93 extends outward from the side wall 92, that is, in a direction opposite the container space of the tray 90. The flange portion 93 that has a surrounding shape defines the opening portion 90A.
The tray 90 may include positioning portions 91X and 91Y that restrict movement of the first container 30 that is contained. The tray 90 illustrated in
As illustrated in
The tray 90 may have or may not have the oxygen barrier property. Oxygen may or may not permeate the tray 90. The tray 90 is composed of, for example, resin. The tray 90 may be manufactured by injection molding or may be manufactured by drawing a resin plate. The tray 90 may be colorless or colored. The tray 90 may be transparent. When the second container 40 and the tray 90 are transparent, the state of the first container 30 can be checked from a position outside the second container 40. For example, light is emitted from a position outside the second container 40 toward the first container 30, and the amount of oxygen in the first container 30 can be measured by using the oxygen amount measuring device Fibox3. A method of measuring oxygen or pressure by using, for example, a laser can be used.
The oxygen absorber 21 can be provided in the liquid-containing combination container 10L as described above. For example, the second container 40 or the first container 30 may include the deoxygenated film 23. The oxygen absorber 21 may be contained in the tray 90. The deoxygenated member 22 may be contained in the second container 40. As illustrated in
In an example illustrated by using solid lines in
Unlike this example, the oxygen absorber 21 and the deoxygenated member 22 may be located between the side wall 92 of the tray 90 and the second container 40. As illustrated by using two-dot chain lines in
The tray 90 may include a recessed portion 95A, a projecting portion 95B, or holes 95C or a combination thereof. The recessed portion, the projecting portion, and the holes can form a flow pass for oxygen. For example, in the example illustrated by using the solid lines in
As illustrated in
In the illustrated example, the second side wall portion 92b inclines with respect to the bottom wall 91 at an angle of larger than 90°. That is, the second side wall portion 92b inclines with respect to the direction of a normal to the bottom wall 91 such that the opening portion 90A is wider than the bottom wall 91. Accordingly, in the case where the liquid-containing combination container 10L is disposed on the placement surface PL such that the second side wall portion 92b faces the placement surface PL with the second container 40 interposed therebetween, as illustrated in
In the illustrated example, the first side wall portion 92a inclines with respect to the bottom wall 91 at an angle of larger than 90°. That is, the first side wall portion 92a inclines with respect to the direction of the normal to the bottom wall 91 such that the opening portion 90A is wider than the bottom wall 91. This enables the gap G between the first side wall portion 92a and the stopper 34 to be stably ensured. In addition, oxygen that permeates the stopper 34 is likely to move in the tray 90. Accordingly, the amount of oxygen in the first container 30 can be stably reduced in a short time.
As illustrated in
The second container 40 has the oxygen barrier property. The second container 40 includes the tray 90 that includes the opening portion 90A and that contains the first container 30 and a lid member 95 that closes the opening portion 90A of the tray 90. The tray 90 that is included in the second container 40 in the second specific example can have the same structure as the tray 90 in the first specific example, provided that the tray 90 has the oxygen barrier property. The lid member 95 has the oxygen barrier property. The lid member 95 is joined to the tray 90. The lid member 95 may be joined, for example, by being welded by using heat sealing or ultrasonic joining or by being joined by using adhesive or glue. In the illustrated example, the lid member 95 is joined to the flange portion 93. The lid member 95 can be composed of one or more of various kinds of materials that have the oxygen barrier property described above. The lid member 95 may be transparent for the same reason as the tray 90. The liquid-containing combination container 10L may include the deoxygenated member 22 that absorbs oxygen in the second container 40. The liquid-containing combination container 10L in the second specific example may include the same outer box as in the first specific example.
As illustrated in
The tray 90 in the second specific example may include the first positioning portion 91X for the same purpose as in the first specific example illustrated in
The liquid-containing combination container 10L can include the oxygen absorber 21. For example, the second container 40 or the first container 30 may include the deoxygenated film 23. The oxygen absorber 21 may be included in the tray 90 or the lid member 95. The deoxygenated member 22 may be contained in the second container 40.
In the example illustrated in
As illustrated in
In the illustrated example, the second side wall portion 92b inclines with respect to the bottom wall 91 at an angle of larger than 90°. That is, the second side wall portion 92b inclines with respect to the direction of the normal to the bottom wall 91 such that the opening portion 90A is wider than the bottom wall 91. Accordingly, in the case where the liquid-containing combination container 10L is disposed on the placement surface PL such that the second side wall portion 92b faces the placement surface PL with the second container 40 interposed therebetween, as illustrated in
In the illustrated example, the first side wall portion 92a inclines with respect to the bottom wall 91 at an angle of larger than 90°. That is, the first side wall portion 92a inclines with respect to the direction of the normal to the bottom wall 91 such that the opening portion 90A is wider than the bottom wall 91. This enables the gap G between the first side wall portion 92a and the stopper 34 to be stably ensured. In addition, oxygen that permeates the stopper 34 is likely to move in the tray 90. Accordingly, the amount of oxygen in the first container 30 can be stably reduced in a short time.
The tray 90 may be used after the second container 40 is opened as in the first specific example described with reference to
The second container 40 has the oxygen barrier property. The second container 40 is a film container. A film that is used for the second container 40 is as described above.
The second container includes the first main film (a first film) 41a and the second main film (a second film) 41b. The first main film 41a and the second main film 41b face each other. The first main film 41a and the second main film 41b may be different films or may be a single film that is folded. The first main film 41a and the second main film 41b are joined to each other at the seal portion 49. Joining at the seal portion 49 may be, for example, welding by using heat sealing or ultrasonic joining or joining by using adhesive or glue. The container space in which the first container 30 is contained is formed between the first main film 41a and the second main film 41b.
The first main film 41a and the second main film 41b can be peeled at the seal portion 49. A user applies force for peeling the first main film 41a and the second main film 41b, and consequently, the first main film 41a and the second main film 41b are separated from each other at the seal portion 49. Process conditions during joining and the quality and thickness of a joining material, for example, are adjusted, and consequently, the seal portion 49 can be peeled.
The seal portion 49 includes a first seal portion 49a that bends. The stopper 34 of the first container 30 that is contained in the second container 40 faces the first seal portion 49a. In the illustrated example, the first seal portion 49a bends. The first seal portion 49a may curve. The first seal portion 49a projects toward outside the second container 40. That is, the first seal portion 49a projects so as to be separated from the container space of the second container 40. The first seal portion 49a projects so as to be separated from the stopper 34 in a direction in which the first seal portion 49a and the stopper 34 face each other. The first seal portion 49a that bends such that the container space of the second container 40 is widened faces the stopper 34 of the first container 30, and consequently, the gap G is formed between the second container 40 and the stopper 34. This enables the second container 40 that has the oxygen barrier property to be inhibited from covering the stopper 34 that has the oxygen permeability. Accordingly, movement of oxygen in the first container 30 to a position outside the first container 30 due to the permeation of oxygen through the stopper 34 can be facilitated. For example, oxygen in the second container 40 is absorbed by using the oxygen absorber 21, the oxygen concentration (%) in the headspace HS in the first container 30 can be consequently stably reduced, and the amount (mg/L) of dissolved oxygen in the liquid L that is contained in the first container 30 can be stably reduced. This enables the inner pressure of the first container 30 to be stably reduced.
In the illustrated example, the seal portion 49 includes a first side seal portion 49b that is connected to an end of the first seal portion 49a and a second side seal portion 49c that is connected to the other end of the first seal portion 49a. The container space in which the first container 30 is contained is formed between the first side seal portion 49b and the second side seal portion 49c. A minimum distance DXa between the first side seal portion 49b and the second side seal portion 49c along the first main film 41a may be shorter than a length L30 of the first container 30 in a direction DA in which the stopper 34 is inserted into the opening portion 33. A minimum distance DXb between the first side seal portion 49b and the second side seal portion 49c along the second main film 41b may be shorter than the length L30 of the first container 30 in the direction DA in which the stopper 34 is inserted into the opening portion 33.
The minimum distance DXa between the first side seal portion 49b and the second side seal portion 49c along the first main film 41a is equal to the minimum length of the first main film 41a between the first side seal portion 49b and the second side seal portion 49c. The minimum distance DXb between the first side seal portion 49b and the second side seal portion 49c along the second main film 41b is equal to the minimum length of the second main film 41b between the first side seal portion 49b and the second side seal portion 49c. The length L30 of the first container 30 is the length of the first container 30 in the axial direction and is typically the length of the first container 30 in the longitudinal direction.
The minimum distances DXa and DXb between the side seal portions 49b and 49c along the main films 41a and 41b are shorter than the length L30 of the first container 30, and consequently, the direction of the first container 30 can be inhibited from greatly changing in the second container 40. Consequently, the stopper 34 of the first container 30 stably faces the first seal portion 49a. Accordingly, the gap G between the second container 40 and the stopper 34 can be stably ensured. As a result, the amount of oxygen in the first container 30 can be stably reduced.
As illustrated in
In the illustrated example, the seal portion 49 also includes a second seal portion 49d that connects the first side seal portion 49b and the second side seal portion 49c. The first seal portion 49a, the first side seal portion 49b, the second side seal portion 49c, and the second seal portion 49d are included in the seal portion 49 that has a surrounding shape and form the container space of the second container 40 that contains the first container 30. The fold portion 41x that is formed by folding a single film may be provided instead of the second seal portion 49d. As for the second seal portion 49d, the bottom surface film 41e illustrated in
At positions on the first side seal portion 49b and the second side seal portion 49c near the second seal portion 49d, the seal strength of the seal portion 49 may be increased. In other words, at the positions on the first side seal portion 49b and the second side seal portion 49c near the second seal portion 49d, the joining strength of the first main film 41a and the second main film 41b may be increased. In an example, as illustrated by using one-dot chain lines in
The liquid-containing combination container 10L may include the oxygen absorber 21. For example, the second container 40 or the first container 30 may include the deoxygenated film 23. The deoxygenated member 22 may be contained in the second container 40. The deoxygenated member 22 may be joined to the second container 40.
As illustrated in
The second container 40 has the oxygen barrier property. The second container 40 is a film container. A film that is used for the second container 40 is as described above.
The second container 40 includes the first main film 41a and the second main film 41b. The first main film 41a and the second main film 41b face each other. The first main film 41a and the second main film 41b may be different films or may be a single film that is folded. The first main film 41a and the second main film 41b are joined to each other at the seal portion 49. Joining at the seal portion 49 may be, for example, welding by using heat sealing or ultrasonic joining or joining by using adhesive or glue. The container space in which the first container 30 is contained is formed between the first main film 41a and the second main film 41b.
The second container 40 is opened in a manner in which the first main film 41a and the second main film 41b are cut at the to-be-opened portion (opening intention portion) 51. In other words, the to-be-opened portion 51 is to be cut when the second container 40 is opened. The to-be-opened portion 51 is a linear portion. The to-be-opened portion 51 can be formed due to the materials of the first main film 41a and the second main film 41b or by processing the first main film 41a and the second main film 41b. Specifically, the to-be-opened portion 51 can be formed when the materials of the first main film 41a and the second main film 41b have aeolotropy that is given by a stretching process. The to-be-opened portion 51 can be formed in manner in which the first main film 41a and the second main film 41b are half cut or processed by using a laser or a film of the intermediate layer is processed by, for example, straight cutting.
The seal portion 49 includes the first side seal portion 49b and the second side seal portion 49c that are separated in the longitudinal direction of the to-be-opened portion (opening intention portion) 51. The first side seal portion 49b and the second side seal portion 49c face in the width direction. A through-portion 52 that extends through the first main film 41a and the second main film 41b is provided at a position at which the second side seal portion 49c intersects with the to-be-opened portion 51. The shape of the through-portion 52 in a plan view is not particularly limited. The shape of the through-portion 52 in a plan view may be ellipse as in the illustrated example, circular, polygonal such as triangular or rectangular, or a thin slit shape.
In this example, as illustrated in
As illustrated, the first side seal portion 49b may include a notch 51a that corresponds to an end of the to-be-opened portion (opening intention portion) 51. The notch 51a may be a slit or a cut portion. The notch 51a enables the to-be-opened portion 51 to be indicated to the user. The notch 51a makes the second container 40 easy to open.
As illustrated, the second side seal portion 49c may include a wide portion 49X that has an increased width. The wide portion 49X is wider than a portion of the second side seal portion 49c adjacent to the wide portion 49X. The wide portion 49X may be wider than the other portion of the second side seal portion 49c. The through-portion 52 may be provided at a position at which the wide portion 49X intersects with the to-be-opened portion (opening intention portion) 51. In this example, the size of the through-portion 52 can be increased. Accordingly, cutting the first main film 41a and the second main film 41b can be more stably stopped at the through-portion 52 when the second container 40 is opened. Unlike the illustrated example, the width of the second side seal portion 49c may be constant.
In the example illustrated in
As illustrated in
The liquid-containing combination container 10L may include the oxygen absorber 21. For example, the second container 40 or the first container 30 may include the deoxygenated film 23. The deoxygenated member 22 may be contained in the second container 40. The deoxygenated member 22 may be joined to the second container 40.
As illustrated in
In the illustrated example, the seal portion 49 includes the first seal portion 49a that connects the first side seal portion 49b and the second side seal portion 49c and the second seal portion 49d that connects the first side seal portion 49b and the second side seal portion 49c. The first seal portion 49a, the first side seal portion 49b, the second side seal portion 49c, and the second seal portion 49d form the seal portion 49 that has a surrounding shape and form the container space of the second container 40 that contains the first container 30. The fold portion 41x that is formed by folding a single film may be provided instead of the first seal portion 49a or the second seal portion 49d. As for the second seal portion 49d, the bottom surface film 41e illustrated in
Also in the fourth specific example, the minimum distances DXa and DXb between the side seal portions 49b and 49c along the main films 41a and 41b may be shorter than the length L30 of the first container 30 as in the third specific example. With this structure, the direction of the first container 30 can be inhibited from greatly changing in the second container 40. Consequently, the stopper 34 of the first container 30 stably faces the first seal portion 49a. Accordingly, the gap G between the second container 40 and the stopper 34 can be stably ensured. As a result, the amount of oxygen in the first container 30 can be stably reduced.
The liquid-containing combination container 10L may include the outer box 100 as in another specific example. A method of containing the second container 40 that contains the first container 30 in the outer box 100 may be the same as in the third specific example described with reference to
The second container 40 has the oxygen barrier property. The second container 40 is a film container. A film that is used for the second container 40 is as described above.
As illustrated in
The first main film 41a and the second main film 41b can be peeled at the seal portion 49. The user applies the force for peeling the first main film 41a and the second main film 41b, and consequently, the first main film 41a and the second main film 41b are separated from each other at the seal portion 49. Process conditions during joining and the quality and thickness of a joining material, for example, are adjusted, and consequently, the seal portion 49 can be peeled.
As illustrated in
As illustrated in
Since the first main film 41a and the second main film 41b are attached to (mounted on) the outer box 100, the second container 40 that has the oxygen barrier property can be inhibited from covering the stopper 34 that has the oxygen permeability. That is, the gap G can be formed between the second container 40 and the stopper 34. Accordingly, movement of oxygen in the first container 30 to a position outside the first container 30 due to the permeation of oxygen through the stopper 34 can be facilitated. For example, oxygen in the second container 40 is absorbed by using the oxygen absorber, the oxygen concentration (%) in the headspace HS in the first container 30 can be consequently stably reduced and the amount (mg/L) of dissolved oxygen in the liquid L that is contained in the first container 30 can be stably reduced. This enables the inner pressure of the first container 30 to be stably reduced.
As illustrated in
As illustrated in
As illustrated in
The liquid-containing combination container 10L may include the oxygen absorber 21. For example, the second container 40 or the first container 30 may include the deoxygenated film 23. The deoxygenated member 22 may be contained in the second container 40. The deoxygenated member 22 may be joined to the second container 40.
The second container 40 has the oxygen barrier property. The second container 40 is a film container. A film that is used for the second container 40 is as described above.
The second container 40 includes the first main film 41a and the second main film 41b. The first main film 41a and the second main film 41b face each other. The first main film 41a and the second main film 41b may be different films or may be a single film that is folded. The first main film 41a and the second main film 41b are joined to each other at the seal portion 49. Joining at the seal portion 49 may be, for example, welding by using heat sealing or ultrasonic joining or joining by using adhesive or glue. The container space in which the first container 30 is contained is formed between the first main film 41a and the second main film 41b.
As illustrated in
The gas bag 53 is provided in the container space of the second container 40 that is formed between the first main film 41a and the second main film 41b, the gas bag 53 consequently functions as a buffer material, and the first container 30 can be stably contained in the second container 40. This enables the first container 30 to be inhibited from being damaged and enables the first container 30 to be inhibited from vibrating and from being impacted. Accordingly, the liquid L in the first container 30 can be stably preserved.
In addition, the use of the gas bag 53 enables the first container 30 that is disposed in the second container 40 to be stable. In addition, a distance between the main films 41a and 41b that are paired can be increased. This enables the second container 40 that has the oxygen barrier property to be inhibited from covering the stopper 34 that has the oxygen permeability. That is, the gap G between the second container 40 and the stopper 34 can be formed. Accordingly, movement of oxygen in the first container 30 to a position outside the first container 30 due to the permeation of oxygen through the stopper 34 can be facilitated. For example, oxygen in the second container 40 is absorbed by using the oxygen absorber, the oxygen concentration (%) in the headspace HS in the first container 30 can be consequently stably reduced, and the amount (mg/L) of dissolved oxygen in the liquid L that is contained in the first container 30 can be stably reduced.
The gas bag 53 may be joined to the first main film 41a and the second main film 41b. For example, joining may be welding by using heat sealing or ultrasonic joining or joining by using adhesive or glue. The gas bag 53 is joined to the first main film 41a and the second main film 41b, and consequently, the position of the gas bag 53 is stabilized. This enables the first container 30 that is disposed in the second container 40 to be stable. This enables the liquid L in the first container 30 to be stably preserved.
The gas bag 53 may be joined to the main films 41a and 41b at the seal portion 49 at which the first main film 41a and the second main film 41b are joined. In this example, the gas bag 53 can be joined to the main films 41a and 41b when the second container 40 is manufactured.
As illustrated in
In the illustrated example, the seal portion 49 includes the first seal portion 49a that connects the first side seal portion 49b and the second side seal portion 49c and the second seal portion 49d that connects the first side seal portion 49b and the second side seal portion 49c. The first seal portion 49a, the first side seal portion 49b, the second side seal portion 49c, and the second seal portion 49d form the seal portion 49 of a surrounding shape and form the container space of the second container 40 that contains the first container 30.
As illustrated in
The liquid-containing combination container 10L may include the oxygen absorber 21. For example, the second container 40 or the first container 30 may include the deoxygenated film 23. The deoxygenated member 22 may be contained in the second container 40. The deoxygenated member 22 may be joined to the second container 40.
As illustrated in
The liquid-containing combination container 10L may include the outer box 100 as in another specific example. The seal portion 49 of the second container 40 may has a notch (not illustrated). The notch enables the second container to be easily opened.
The embodiment is described above with reference to the specific examples. The specific examples described above do not limit the embodiment. According to the embodiment described above, various specific examples can be provided, various omissions, replacements, modifications, and additions, for example, can be made without departing from the spirit thereof.
Examples of the modifications will now be described with reference to the drawings. In the description below and the figures used for the description below, a portion that can have the same structure as in the specific examples described above is designated by using a reference sign like to that used for a portion that corresponds to one in the specific examples described above, and a duplicated description is omitted.
In the specific examples described above, a specific structure of the stopper 34 that has the gas permeability is described but is not limited to that in the examples described above. For example, as illustrated in
The barrier layer 81 may include a para-xylylene layer. The para-xylylene layer may contain para-xylylene N, may contain para-xylylene C, or may contain para-xylylene HT. The para-xylylene layer may be manufactured on the stopper body 35 by using vacuum deposition. The thickness of the para-xylylene layer may be 0.1 μm or more and 2 μm or less, may be 0.1 μm or more and 1 μm or less, or may be 0.1 μm or more and 0.5 μm or less. The upper limit that is set for the thickness of the para-xylylene layer enables the stopper 34 to have sufficient gas permeability. The lower limit that is set for the thickness of the para-xylylene layer enables the stopper 34 to have a function of sufficiently reducing elution.
The barrier layer 81 may include a fluorine resin layer. The fluorine resin layer may contain perfluoroalkoxy alkane (PFA). The fluorine resin layer may contain perfluoroethylene propylene copolymer (FEP). The fluorine resin layer may contain ethylene tetrafluoroethylene copolymer (ETFE)). The fluorine resin layer may be manufactured on the stopper body 35 by using coating. The thickness of the fluorine resin layer may be 0.1 μm or more and 60 μm or less, may be 0.1 μm or more and 40 μm or less, or may be 0.1 μm or more and 25 μm or less. The upper limit that is set for the thickness of the fluorine resin layer enables the stopper 34 to have sufficient gas permeability. The lower limit that is set for the thickness of the fluorine resin layer enables the stopper 34 to have the function of sufficiently reducing elution.
The barrier layer 81 may include an amorphous fluorine layer. The amorphous fluorine layer may be manufactured on the stopper body 35 by using coating. The thickness of the amorphous fluorine layer may be 0.1 μm or more and 4 mm or less. The upper limit that is set for the thickness of the amorphous fluorine layer enables the stopper 34 to have sufficient gas permeability. The lower limit that is set for the thickness of the amorphous fluorine layer enables the stopper 34 to have the function of sufficiently reducing elution.
In the specific examples described above, the specific structure of the stopper 34 that has the gas permeability is described. From the perspective that the permeation of gas through the stopper 34 that has the gas permeability is facilitated, the stopper 34 is preferably not in contact with the liquid L in a process of adjusting the pressure. The stopper 34 is preferably separated from the liquid L in the process of adjusting the pressure. The stopper 34 is preferably in contact with gas in the process of adjusting the pressure. In view of this, the stopper 34 may be subject to a liquid repellent process. The stopper 34 may has a liquid repellent structure. The contact angle of the inner surface of the stopper 34 that is subject to the liquid repellent process or that has the liquid repellent structure in a sessile drop method in a wettability test in accordance with JIS R3257 may be 80° or more, may be 90° or more, may be 95° or more, or may be less than 180°.
An example of the liquid repellent process is a surface modification process by using ion beam radiation or plasma processing. As illustrated in
The use of the inner surface of the stopper 34 that includes the unevenness surface 82 increases the surface area of the stopper 34. The increase in the surface area of the stopper 34 enables the permeation of gas through the stopper 34 to be facilitated. Projections 83 that project from the inner surface of the stopper 34 may be provided, and the surface area of the stopper 34 may be increased. For example, as illustrated by using two-dot chain lines in
As illustrated in
As illustrated in
As illustrated in
In examples illustrated in
In the specific examples described above, the first container 30 includes the container body 32 that includes the opening portion 33, the stopper 34 that closes the opening portion 33, and the fixture 36 that is mounted on the container body 32 and that fixes the stopper 34 to the container body 32. The stopper 34 includes the plate portion 34a that is disposed on the container body 32 and that covers the opening portion 33 and the insertion projection 34b that projects from the plate portion 34a and that is inserted into the opening portion 33. The insertion projection 34b may have a cylindrical shape. The insertion projection 34b may include the multiple insertion projections 34b that are located on a circle.
In an example in which the container body 32 and the fixture 36 have the gas barrier property such as the oxygen barrier property, and the stopper 34 has the gas permeability such as the oxygen permeability, gas such as oxygen mainly permeates an exposed region (an exposed portion) 34c of the stopper 34 that is exposed to the inside of the container body 32. The exposed region 34c is a region of a portion of the plate portion 34a that faces the opening portion 33 where the insertion projection 34b is not provided.
In this example, the fixture 36 may has an exposure hole (the through-hole) 36a through which the exposed region 34c of the plate portion 34a that is exposed to the inside of the container body 32 is exposed. The fixture 36 that has the gas barrier property has the exposure hole 36a, and consequently, movement of gas such as oxygen in the first container 30 to the outside can be facilitated.
As illustrated in
As illustrated in
As illustrated in
In examples illustrated in
In the examples illustrated in
In the example illustrated in
In the example illustrated in
In the specific examples described above, a specific structure of the first container 30 is described, but this is not a limitation, and various containers may be used. For example, as illustrated in
In the example illustrated in
In the example illustrated in
In the example illustrated in
As for the syringe 60 where a lyophilizer and a solvent that dissolves the lyophilizer are separated from each other and are contained in the container space, the inner pressure reduces, and consequently, the lyophilizer can be inhibited from unintentionally coming into contact with the solvent and being dissolved. An example of the syringe 60 is a double chamber syringe. As for the double chamber syringe, a container space in the syringe is divided into a front room that is located near a needle and a rear room that is separated from the needle. When the piston 66 is pushed, the solvent that is located in the rear room is supplied to the front room via a bypass. Consequently, a substance such as the lyophilizer that is contained in the front room is dissolved in the solvent, and a solution is obtained in the front room. When the piston 66 is further pushed, the solution is discharged from the needle. As for the double chamber syringe, the inner pressure of a cylinder is adjusted, and consequently, the solvent can be inhibited from unintentionally flowing into the front room, and the substance can be inhibited from being dissolved.
As illustrated in
The stopper 34 may has the gas permeability. The stopper 34 that has the gas permeability may be composed of silicone rubber. The stopper 34 covers the opening portion 33 that is formed by the needle 64.
In another example, as illustrated in
In examples illustrated in
Also in the examples illustrated in
The first container 30 may have a label. As for the label, information about the liquid may be displayed. The label may be stuck to the container body 32. The label preferably does not extend over the entire circumference such that the inside of the container body 32 can be observed. As for a combination with the second container 40 in the first specific example described with reference to
The fixture 36 illustrated in
In the specific examples described above, the first container 30 includes the container body 32 and the stopper 34, and the stopper 34 has the gas permeability. However, at least a portion of the container body 32 may have the gas permeability, and the stopper 34 may have the gas barrier property. The specific structure of the second container 40 described above is just an example, and various modifications can be made.
In the specific examples described above, the combination container 10 includes the gas absorber such as the oxygen absorber. The arrangement of the gas absorber can be adjusted in a manner described later. Specific structures related to the deoxygenated member 22 that includes the oxygen absorber 21 and the oxygen absorber 21 will be described later. The structures described later are not limited to application to the oxygen absorber 21 and the deoxygenated member 22 but can be used for another gas absorber other than the oxygen absorber 21 and the deoxygenated member 22 as in the above description.
The oxygen absorber 21 absorbs oxygen in the second container 40 and oxygen that permeates the portion of the first container 30 that has the oxygen permeability and that moves from a position inside the first container 30 into the second container 40. The oxygen absorber 21 and the deoxygenated member 22 may be disposed between the portion of the first container 30 that has the oxygen permeability and the second container. The oxygen absorber 21 and the deoxygenated member 22 may face the portion of the first container 30 that has the oxygen permeability. The oxygen absorber 21 and the deoxygenated member 22 may be disposed on the portion of the first container 30 that has the oxygen permeability. The oxygen absorber 21 and the deoxygenated member 22 may be in contact with the portion of the first container 30 that has the gas permeability such as the oxygen permeability. The oxygen absorber 21 and the deoxygenated member 22 may be in contact with the portion so as not to cover (so as to expose) at least a part of the portion of the first container 30 that has the gas permeability such as the oxygen permeability. This arrangement enables movement of oxygen in the first container 30 to the outside to be facilitated. The second container 40 that is flexible and that has the gas barrier property such as the oxygen barrier property can be inhibited from coming into contact with the stopper 34 that has the gas permeability such as the oxygen permeability and that is included in the first container 30. This enables movement of gas such as oxygen in the first container 30 to the outside to be stably facilitated.
The oxygen absorber 21 or the deoxygenated member 22 may be fixed to the first container 30 by using heat sealing or a joining material in order to maintain relative positions of the oxygen absorber 21 or the deoxygenated member 22 and the portion of the first container 30 that has the oxygen permeability. The oxygen absorber 21 or the deoxygenated member 22 may be fixed to a portion other than the portion of the first container 30 that has the gas permeability such as the oxygen permeability. With this structure, an appropriate relationship between the relative positions of the oxygen absorber 21 or the deoxygenated member 22 and the portion of the first container 30 that has the gas permeability such as the oxygen permeability is maintained, and movement of oxygen in the first container 30 to the outside can be stably facilitated.
In the examples illustrated in
The deoxygenated member 22 may be fixed to the first container 30 in order to maintain the relative positions of the deoxygenated member 22 and the stopper 34. The deoxygenated member 22 that includes the oxygen absorber 21 may be fixed to the stopper 34, the fixture 36 or the first container 30 by using heat sealing or a joining material. In the case where the deoxygenated member 22 is fixed to the stopper 34, the deoxygenated member 22 may be fixed to a portion of the stopper 34. The deoxygenated member 22 may be fixed to the fixture 36 such that the gap is ensured between the deoxygenated member 22 and the stopper 34.
In the examples illustrated in
The oxygen absorber 21 and the deoxygenated member 22 are partly or entirely disposed between the to-be-opened portion 51 and the first container 30 in the second container 40. In this example, when the second container 40 is opened, the oxygen absorber 21 is located between a portion at which the second container 40 is opened and the first container 30. Accordingly, the oxygen concentration (%) in the first container 30 and the amount (mg/L) of dissolved oxygen in the liquid L can be inhibited from rapidly increasing. As for this arrangement, the oxygen absorber 21 and the deoxygenated member 22 may be separated from the portion of the first container 30 that has the gas permeability such as the oxygen permeability. Consequently, a path for permeation of oxygen (a path for permeation of gas) in the first container 30 to the outside is ensured, and movement of oxygen in the first container 30 to the outside can be stably facilitated. In this example, the oxygen absorber 21 and the deoxygenated member 22 may be located above the first container 30. Similarly, this arrangement enables the oxygen absorber 21 and the deoxygenated member 22 to be separated from the portion of the first container 30 that has the gas permeability such as the oxygen permeability. This arrangement also enables the oxygen absorber 21 to be activated due to the water vapor as described above.
The deoxygenated member 22 that includes the oxygen absorber 21 may be fixed to the second container 40 by using heat sealing or a joining material in order to maintain this arrangement. For example, the deoxygenated member 22 may be fixed between the to-be-opened portion (opening intention portion) 51 of the second container 40 and the first container 30. The deoxygenated member 22 may be fixed to the second container 40 so as to be separated from the first container 30. In other words, the deoxygenated member 22 may be fixed to the second container 40 such that a gap is formed between the first container 30 and the deoxygenated member 22. The deoxygenated member 22 may be fixed to the second container 40 such that the deoxygenated member 22 is partly or entirely located above the first container 30. The deoxygenated member 22 is thus fixed to the second container 40, and consequently, movement of oxygen in the first container 30 to the outside can be stably facilitated. The deoxygenated member 22 is fixed to the second container 40, and consequently, the flexibility of the second container 40 can be limited. This enables the permeation of gas such as oxygen to be inhibited from being restricted due to the second container 40 that is flexible and that has the gas barrier property such as the oxygen barrier property covering the portion of the first container 30 that has the gas permeability such as the oxygen permeability.
The deoxygenated member 22 may be fixed to the second container 40 so as to be separated from the to-be-opened portion (opening intention portion) 51. In other words, the deoxygenated member 22 may be fixed to the second container 40 such that a gap is formed between the to-be-opened portion 51 and the deoxygenated member 22. When the second container 40 is opened at the to-be-opened portion 51, the parcel 22a of the deoxygenated member 22 can be inhibited from being damaged.
In consideration for use, the first container 30 may be disposed in the second container 40 such that the stopper 34 faces the to-be-opened portion 51. This arrangement enables the first container 30 to be easily taken out from the second container 40 that is opened and makes the liquid L in the first container 30 stable. In this example, the oxygen absorber 21 or the deoxygenated member 22 is disposed between the stopper 34 and the to-be-opened portion 51, and consequently, the oxygen concentration (%) in the first container 30 and the amount (mg/L) of dissolved oxygen in the liquid L can be effectively inhibited from rapidly increasing. This enables the inner pressure of the first container 30 to be inhibited from rapidly increasing when the second container 40 is opened.
The oxygen detection member 25 may be disposed at the same position as the oxygen absorber 21 and the deoxygenated member 22 described above. This enables a change in the oxygen concentration (%) in the second container 40 to be rapidly grasped.
The embodiment described above will now be described in more detail by using examples, but the examples do not limit the embodiment described above.
A vial bottle that had a volume of about 8.2 ml was prepared as the first container. The first container had the structure illustrated in
Subsequently, the second container composed of a transparent packing material that had the gas barrier property was prepared. The second container had the structure illustrated in
Materials and members that were used in EXAMPLE 1, for example, were sterilized. The injection water was contained in the first container, the first container was closed, the liquid-containing first container and the oxygen absorber were contained in the second container, and the second container was closed in a sterile isolator. The use of the sterilized materials and operations in the sterile isolator were the same as those in other EXAMPLES and COMPARATIVE EXAMPLES described below.
In EXAMPLE 2, the second container 40 was filled with nitrogen before the second container 40 was closed. In EXAMPLE 2, no oxygen absorber was used. EXAMPLE 2 differed from EXAMPLE 1 in these two points, and the other was the same as in EXAMPLE 1.
In EXAMPLE 3, the second container 40 was a cup container illustrated in
In COMPARATIVE EXAMPLE 1, a rubber stopper that closed an opening portion of a container body of a first container was composed of butyl rubber. COMPARATIVE EXAMPLE 1 differed from EXAMPLE 1 in this point, and the other was the same as in EXAMPLE 1. The degree of the oxygen permeability (oxygen transmission rate) of the butyl rubber of which the rubber stopper in COMPARATIVE EXAMPLE 1 was about 80 (cm3/(m2×24 h×atm)) and did not substantially have the gas permeability. The oxygen permeation amount of the first container in COMPARATIVE EXAMPLE 1 was measured by using the method illustrated in
In COMPARATIVE EXAMPLE 2, a rubber stopper that closed an opening portion of a container body of a first container was composed of the same butyl rubber as that of the rubber stopper in COMPARATIVE EXAMPLE 1. COMPARATIVE EXAMPLE 2 differed from EXAMPLE 2 in this point, and the other was the same as in EXAMPLE 2.
In COMPARATIVE EXAMPLE 3, a rubber stopper that closed an opening portion of a container body of a first container was composed of same butyl rubber as that of the rubber stopper in COMPARATIVE EXAMPLE 1. COMPARATIVE EXAMPLE 3 differed from EXAMPLE 3 in this point, and the other was the same as in EXAMPLE 3.
A liquid-containing first container was manufactured in the same manner as in EXAMPLE 1 to EXAMPLE 3. The liquid-containing first container corresponded to COMPARATIVE EXAMPLE 4. That is, in COMPARATIVE EXAMPLE 4, a second container was omitted. A rubber stopper of the first container was composed of silicone rubber as in EXAMPLE 1 to EXAMPLE 3.
In EXAMPLE 1 to EXAMPLE 3 and COMPARATIVE EXAMPLE 1 to COMPARATIVE EXAMPLE 3, each second container was closed, and each liquid-containing combination container was subsequently preserved for two weeks. Subsequently, each second container 40 was opened, and each liquid-containing first container was taken out from the second container. In COMPARATIVE EXAMPLE 4, the first container was closed, and the liquid-containing first container was subsequently preserved for two weeks. In EXAMPLE 1 to EXAMPLE 3 and COMPARATIVE EXAMPLE 1 to COMPARATIVE EXAMPLE 4, a preservation environment was an air atmosphere at 22° C. under the atmospheric pressure.
Whether the inner pressure of each first container that was preserved for two weeks was negative pressure was checked. A checking method was as described below. A syringe that contained physiological saline and that included an injection needle was prepared. Subsequently, the rubber stopper of each first container in EXAMPLE 1 to EXAMPLE 3 and COMPARATIVE EXAMPLE 1 to COMPARATIVE EXAMPLE 4 was punctured by the needle of the syringe. When the rubber stopper was punctured by the needle, whether injection water in the syringe was sucked into the first container was checked. The result is illustrated in a column “Pressure” in Table 1. In the column “Pressure” in Table 1, “A” is illustrated for each of samples in which the injection water in the syringe was sucked into the first container. As for the samples for which “A” is illustrated, it was thought that the inner pressure of the first container was negative pressure. In the column “Pressure” in Table 1, “B” is illustrated for each of samples in which the injection water in the syringe was not sucked into the first container. As for the samples for which “B” is illustrated, it was thought that the inner pressure of the first container was not negative pressure. The amount (mg/L) of dissolved oxygen in the injection water was measured by a needle measuring device (the oxygen amount measuring device Microx4 made by PreSens Precision Sensing GmbH in Germany). The limit of detection of the measuring device was 0.015 mg/L Measured values are illustrated in a column “Amount of Dissolved Oxygen” in Table 1.
EXAMPLE 1 to EXAMPLE 3 were evaluated as “A”. That is, in all of EXAMPLE 1 to EXAMPLE 3 in which the silicone rubber stoppers were used, the pressure in the first container was able to be adjusted to negative pressure. That is, the first container had the gas permeability or the oxygen permeability, and consequently, the pressure in the first container that was sealed under the atmospheric pressure was easily adjusted to negative pressure. In EXAMPLE 1 to EXAMPLE 3, the amount of dissolved oxygen in the injection water in the first container was greatly reduced from that for the saturation solubility under the atmospheric pressure. Accordingly, application to a liquid that is likely to be dissolved (decomposed) due to oxygen is greatly preferable. The amount of the sucked injection water in EXAMPLE 1 and EXAMPLE 3 was larger than the amount of the sucked injection water in EXAMPLE 2. That is, the inner pressure of the first container in EXAMPLE 1 and EXAMPLE 3 was lower than the inner pressure of the first container in EXAMPLE 2. In EXAMPLE 1 to EXAMPLE 3, the injection water was cultured by using a culture method, and whether microbes increased or reduced in the injection water was checked. As a result, in EXAMPLE 1 to EXAMPLE 3, development of microbes in the injection water was not observed. In EXAMPLE 1 to EXAMPLE 3, a primary container that was maintained at negative pressure and that was not contaminated by microbes was able to be easily manufactured at low costs in the above manner.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2021-050742 | Mar 2021 | JP | national |
| 2021-154831 | Sep 2021 | JP | national |
| 2021-215304 | Dec 2021 | JP | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/JP2022/014193 | 3/24/2022 | WO |
