WO2022203030A1 - 液体入り組合せ容器、容器セット、液体入り容器の製造方法および液体入り組合せ容器の使用方法 - Google Patents
液体入り組合せ容器、容器セット、液体入り容器の製造方法および液体入り組合せ容器の使用方法 Download PDFInfo
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- WO2022203030A1 WO2022203030A1 PCT/JP2022/014193 JP2022014193W WO2022203030A1 WO 2022203030 A1 WO2022203030 A1 WO 2022203030A1 JP 2022014193 W JP2022014193 W JP 2022014193W WO 2022203030 A1 WO2022203030 A1 WO 2022203030A1
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Definitions
- the present invention relates to a liquid-filled combination container, a container set, a method for manufacturing a liquid-filled container, and a method for using a liquid-filled combination container.
- a container for containing liquid is known (for example, Patent Document 1).
- the pressure inside the container is adjusted.
- the pressure inside the container is kept low, especially negative pressure, it is possible to effectively suppress unintended leakage of the liquid during storage and splashing of the liquid when the container is opened. Leakage and splashing problems are exacerbated with toxic liquids, such as highly pharmacologically active drugs.
- Patent Document 1 JP2011-212366A
- An object of the present disclosure is to make it possible to adjust the pressure inside a container containing a liquid.
- a first liquid-filled combination container comprises: a first container containing a liquid and having gas permeability; A second container containing the first container and having a gas barrier property, The inside of the first container is 1 atm or less. The pressure inside the first container may be negative.
- a second liquid-filled combination container comprises: a first container containing a liquid and having oxygen permeability; a second container containing the first container and having an oxygen barrier property, An oxygen scavenger is provided to absorb oxygen in the second container, The pressure inside the first container is 1 atm or less.
- a third liquid-filled combination container comprises: a first container containing a liquid and having oxygen permeability; a second container containing the first container and having an oxygen barrier property, An oxygen scavenger is provided to absorb oxygen in the second container,
- the first container is capable of accommodating gas while maintaining a negative pressure under atmospheric pressure.
- the first container may contain a highly sensitive liquid.
- the pressure inside the second container may be a negative pressure.
- the pressure in the first container may be 0.8 atm or higher.
- an oxygen scavenger that absorbs oxygen in the second container may be provided.
- a dehydrating agent that absorbs moisture in the second container may be provided in the first to third liquid-filled combination containers according to the present disclosure.
- the interior of the first container may be sterile.
- the second container may be capable of containing gas while maintaining a negative pressure under atmospheric pressure.
- the first container may be capable of containing gas while maintaining a negative pressure under atmospheric pressure.
- the first container has a container body having an opening and a stopper closing the opening,
- the stopper may be pierceable by a syringe needle.
- the first container has a container body having an opening and a plug closing the opening, wherein the plug is gas permeable. may have.
- the container body may have gas barrier properties.
- the first container has a container body having an opening and a stopper closing the opening, and
- the gas permeability coefficient may be greater than the gas permeability coefficient of the material forming the container body.
- the first container has a container body having an opening and a plug closing the opening, wherein the plug may contain silicone. good.
- the container body may be made of glass.
- the first container includes a syringe having a cylinder and a piston having a gasket arranged in the cylinder and separating the liquid storage space.
- the gasket may be gas permeable.
- the cylinder may have gas barrier properties.
- the first container includes a syringe having a cylinder and a piston having a gasket arranged in the cylinder and separating the liquid storage space.
- the gas permeability coefficient of the material forming the gasket may be greater than the gas permeability coefficient of the material forming the cylinder.
- the first container includes a syringe having a cylinder and a piston having a gasket arranged in the cylinder and separating the liquid storage space.
- said gasket may be at least partially composed of silicone.
- the cylinder may be made of glass.
- the first container includes a syringe including a cylinder and a piston inserted within the cylinder;
- the syringe may store the liquid in a storage space defined by the cylinder and the piston.
- the piston includes a gasket disposed within the cylinder and defining the housing space;
- the gasket may be gas permeable.
- the syringe includes a plug that closes an opening provided in the cylinder,
- the plug may be gas permeable.
- the first container has a fixture that is attached to the container body and fixes the stopper to the container body,
- the plug has a plate-like portion that is arranged on the container body and covers the opening, and an insertion protrusion that protrudes from the plate-like portion and is inserted into the opening,
- the fixture covers the peripheral edge of the plate-shaped portion,
- the fixture may have an exposure hole for exposing a region of the plate-like portion exposed inside the container body.
- the container body may have oxygen barrier properties.
- the container body may be made of glass.
- the fixture may have oxygen barrier properties.
- the fixture may be made of metal.
- the plug may be oxygen permeable.
- the plug may comprise silicone.
- a step is formed between a portion of the fixture surrounding the exposure hole and a portion of the stopper exposed in the exposure hole. good too.
- the portion of the fixture that surrounds the exposure hole has a portion bent to approach the plate-like portion, and the inside of the container body You may push the said plate-shaped part toward.
- a linear convex portion extending linearly is provided in a portion of the plug exposed in the exposure hole,
- the linear convex portion may indicate the position of the region of the plate-like portion exposed inside the container body.
- a linear convex portion extending linearly is provided in a portion of the plug exposed in the exposure hole,
- the linear convex portion may extend over a peripheral portion of a region of the plate-like portion exposed inside the container body.
- a linear convex portion extending linearly is provided in a portion of the plug exposed in the exposure hole, A portion of the linear protrusion may be covered with the fixture, and another portion of the linear protrusion may be exposed in the exposure hole.
- a gap is formed between a portion of the fixture surrounding the exposure hole and a portion of the stopper adjacent to the linear projection.
- the linear protrusions have a plurality of linear protrusions separated from each other, An end portion of the linear convex portion exposed in the exposure hole may be located on a region of the plate-like portion exposed in the container body.
- the second container has an opening scheduled portion scheduled to be opened, An oxygen scavenger may be provided between the portion to be opened in the second container and the first container.
- the first container has a container body having an opening and a stopper closing the opening,
- the container body has an oxygen barrier property, the plug has oxygen permeability,
- An oxygen scavenger may be provided between the second container and the stopper.
- an oxygen absorbing member having the oxygen absorbing agent and a package containing the oxygen absorbing agent may be attached to the second container.
- the first to third liquid-filled combination containers according to the present disclosure may comprise an oxygen scavenger disposed on the oxygen-permeable portion of the first container.
- the first container has a container body having an opening and a stopper closing the opening,
- the container body has an oxygen barrier property, the plug has oxygen permeability,
- An oxygen scavenger facing the plug may be provided.
- the first through third liquid-filled combination containers according to the present disclosure comprise an oxygen scavenger, said oxygen scavenger positioned at least partially above said oxygen permeable portion of said first container.
- the first container has a fixture that is attached to the container body and fixes the stopper to the container body,
- An oxygen scavenger member including the oxygen scavenger and a package housing the oxygen scavenger may be attached to the fixture.
- the liquid comprises an aqueous solution
- the deoxidizing member having the deoxidizing agent may contain no water retaining agent, or may contain a water retaining agent capable of retaining 5% or less of the initial volume of the liquid.
- the liquid comprises alcohol or oil
- the deoxidizing member having the deoxidizing agent may include a water retention agent that retains moisture.
- the liquid comprises a non-aqueous solvent
- the deoxidizing member having the deoxidizing agent may include a water retention agent that retains moisture.
- a non-aqueous solvent is a solvent whose main component is other than water.
- the water volume ratio of the non-aqueous solvent may be 2% or less, 1% or less, or 0.5% or less.
- the first container includes a container body having an opening and a plug that closes the opening, the plug is gas permeable,
- the contact angle of the inner surface of the plug may be 80° or more.
- the first container includes a container body having an opening and a plug that closes the opening, the plug is gas permeable, A gas-permeable and liquid-repellent sheet may be provided between the liquid contained in the container body and the plug.
- the sheet may be held between the plug and the container body.
- the first container includes a container body having an opening and a plug that closes the opening, the plug is gas permeable, An inner surface of the stopper may be provided with a recess capable of holding gas.
- the first container includes a container body having an opening, a plug closing the opening, and an extending wall portion extending from the inner surface of the container body. and may include
- the first container includes a container body having an opening, a plug that closes the opening, and an extension wall that extends from the inner surface of the container body,
- the extending wall portion has an annular shape including an outer peripheral edge and an inner peripheral edge, is connected to the inner surface of the container body over the entire length of the outer peripheral edge, and is provided with a hole defined by the inner peripheral edge. good.
- the first container includes a container body having an opening and a plug that closes the opening, the plug is gas permeable,
- the corrugation may be provided on the outer surface of the plug, or a protruding portion protruding from the outer surface of the plug may be included.
- the first container includes a container body having an opening and a plug that closes the opening, the plug is gas permeable,
- the inner surface of the plug may be provided with irregularities, or may include protrusions protruding from the inner surface of the plug.
- the first container includes a container body having an opening and a plug that closes the opening, oxygen is permeable through the plug;
- the inner surface of the plug may be provided with irregularities, or may include protrusions protruding from the inner surface of the plug.
- a fourth liquid-filled combination container comprises: a first container containing a liquid; a second container containing the first container and having an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability,
- a gap is formed between the stopper of the first container housed in the second container and the second container.
- a fifth liquid-filled combination container comprises: a first container containing a liquid; a tray that houses the first container; a second container containing the tray containing the first container and having an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability, A portion of the tray is positioned between the plug and the second container, forming a gap between the tray and the plug.
- the tray has a bottom wall and side walls connected to the bottom wall; the side wall has a first side wall facing the stopper of the first container housed in the tray and a second side wall facing the first side wall; The gap may be formed between the first side wall and the plug.
- the second container is a film container
- the second side wall portion may be arranged so as to face, through the second container, a mounting surface on which the liquid-filled combination container is mounted.
- the second side wall portion faces, through the second container, a mounting surface on which the liquid-filled combination container is mounted, and the mounting surface It may be arranged such that the bottom wall is inclined with respect to.
- the tray may be provided with one or more of recesses, protrusions and holes.
- the tray has a bottom wall, a side wall connected to the bottom wall, and a flange portion extending from the side wall;
- the concave portion or the convex portion may be provided on the flange portion.
- a sixth liquid-filled combination container comprises: a first container containing a liquid; a second container containing the first container and having an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container has a tray that has an opening and stores the first container, and a lid material that closes the opening of the tray, the tray has a bottom wall and a side wall connected to the bottom wall and facing the plug; The gap is formed between the sidewall and the plug.
- the side wall has a first side wall facing the stopper of the first container housed in the tray and a second side wall facing the first side wall; the gap is formed between the first side wall and the plug;
- the second side wall portion may be arranged so as to be positioned on a mounting surface on which the liquid-filled combination container is mounted.
- the second side wall portion is positioned on a mounting surface on which the liquid-filled combination container is mounted, and the bottom wall is inclined with respect to the mounting surface. In this way, it may be possible to place
- An oxygen scavenger is provided to absorb oxygen in the second container,
- the oxygen scavenger may be located between the tray and the first container.
- the tray has a bottom wall and side walls connected to the bottom wall; the side wall has a first side wall facing the stopper of the first container housed in the tray and a second side wall facing the first side wall;
- the oxygen scavenger may be located between the first sidewall and the plug.
- An oxygen scavenger is provided to absorb oxygen in the second container,
- the oxygen scavenger may be located between the tray and the second container.
- An oxygen scavenger is provided to absorb oxygen in the second container,
- the oxygen scavenger may be held by the lid member.
- the tray has a bottom wall and side walls connected to the bottom wall;
- the bottom wall may have a protrusion that fits into a recess between the stopper and the container body.
- a seventh liquid-filled combination container comprises: a first container containing a liquid; a second container containing the first container and having an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container has a first film and a second film that accommodates the first container between the first film, The first film and the second film are joined at the seal portion so as to be peelable, the seal portion includes a curved first seal portion; The first seal portion protrudes away from the plug in the direction in which the first seal portion and the plug face each other.
- An oxygen absorber may be provided between the seventh liquid-filled combination container according to the present disclosure, the first sealing portion and the stopper.
- a seventh liquid-filled combination container In a seventh liquid-filled combination container according to the present disclosure, The plug faces the first seal portion,
- the seal portion includes a first side seal portion connected to one end of the first seal portion and a second side seal portion connected to the other end of the first seal portion,
- An accommodation space for accommodating the first container is formed between the first side seal portion and the second side seal portion, a minimum spacing along the first film between the first side seal portion and the second side seal portion and a minimum spacing along the second film between the first side seal portion and the second side seal portion
- the spacing may be shorter than the length of the first container along the direction of inserting the plug into the opening.
- An eighth liquid-filled combination container comprises: a first container containing a liquid; a second container containing the first container and having an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug is permeable to oxygen;
- the second container has a first film and a second film that accommodates the first container between the first film,
- the second container is opened by cutting the first film and the second film at the part to be opened,
- the first film and the second film are joined at a seal portion
- the seal portion has a first side seal portion and a second side seal portion separated in the longitudinal direction of the portion to be opened, A penetrating portion penetrating through the first film and the second film is provided at a position of the second side seal portion that intersects with the portion to be opened.
- the first side seal portion may be provided with a notch that serves as one end of the portion to be opened.
- the second side seal portion has a widened portion wider than the adjacent portion,
- the penetrating portion may be provided at a position where the widened portion intersects with the portion to be opened.
- the second side seal portion may have an inner edge that protrudes closer to the first side seal portion at the widened portion.
- the stopper is positioned between the first side seal portion and the widened portion so as to face the space within the second container, and the first container is may be contained within the second container.
- An oxygen scavenger is provided to absorb oxygen in the second container,
- the oxygen absorber may be held in the second container at a position shifted from the widened portion in a direction in which the space in the second container faces the plug.
- An eighth liquid-filled combination container according to the present disclosure may include an oxygen absorber between the to-be-opened portion and the first container.
- a ninth liquid-filled combination container comprises: a first container containing a liquid; a second container containing the first container and having an oxygen barrier property; an outer box that houses the second container,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container has a first film and a second film that accommodates the first container between the first film, The first film and the second film are joined at the seal portion so as to be peelable
- the outer box has an outer box body and a lid that opens the outer box by moving relative to the outer box body, The first film is attached to the outer box main body, the second film is attached to the lid, By moving the lid portion relative to the outer box main body portion, the second film is peeled off from the first film at the seal portion to open the second container.
- the outer box may have a transparent transparent portion.
- a tenth liquid-filled combination container comprises: a first container containing a liquid; a second container containing the first container and having an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container comprises: a first film; a second film that is bonded to the first film and accommodates the first container between the first film; and a gas bag that is provided and contains gas.
- the gas bag may be bonded to the first film and the second film.
- the first film and the second film are joined at a seal portion
- the gas bag may be joined to the first film and the second film at the sealing portion.
- the seal portion has a first side seal portion and a second side seal portion provided apart in the width direction
- the gas bag includes a first gas bag bonded to the first film and the second film at the first side seal portion, and a gas bag bonded to the first film and the second film at the second side seal portion. a second gas bag;
- the first container may be positioned between the first gas bag and the second gas bag.
- An oxygen scavenger is provided to absorb oxygen in the second container,
- the oxygen scavenger may be held between one of the first film and the second film and the gas bag.
- a first container set according to the present disclosure comprises: a first container containing a liquid and having gas permeability; a second container that can accommodate the first container and has a gas barrier property, The first container is capable of accommodating gas while maintaining a negative pressure under atmospheric pressure.
- the second container may be capable of containing gas while maintaining a negative pressure under atmospheric pressure.
- the interior of the first container may be sterile.
- the oxygen concentration of the first container may be 1.5% or less.
- the liquid may be a drug injected into a syringe.
- the first container may contain a highly sensitive liquid.
- the first container has a container body having an opening and a stopper closing the opening,
- the stopper may be pierceable by a syringe needle.
- an oxygen scavenger that absorbs oxygen in the second container may be provided.
- a second container set according to the present disclosure comprises: a first container containing a liquid and having oxygen permeability; a second container capable of accommodating the first container and having an oxygen barrier property; and an oxygen scavenger that absorbs oxygen in the second container.
- a third container set according to the present disclosure comprises: a first container containing a liquid; a second container that can accommodate the first container and has an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability,
- a gap is formed between the stopper of the first container housed in the second container and the second container.
- a fourth container set according to the present disclosure comprises: a first container containing a liquid; a tray capable of accommodating the first container; a second container capable of accommodating the tray containing the first container and having an oxygen barrier property;
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability,
- the tray is positioned between the plug and the second container, and a gap is formed between the tray and the plug.
- a fifth container set according to the present disclosure comprises: a first container containing a liquid; a second container that can accommodate the first container and has an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container has a tray that has an opening and stores the first container, and a lid material that closes the opening of the tray, the tray has a bottom wall and a side wall connected to the bottom wall and facing the plug; The gap is formed between the sidewall and the plug.
- a sixth container set according to the present disclosure comprises: a first container containing a liquid; a second container that can accommodate the first container and has an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container has a first film and a second film that accommodates the first container between the first film,
- the first film and the second film are joined at the seal portion so as to be peelable, the seal portion includes a curved first seal portion;
- the first seal portion protrudes away from the plug in a direction in which the first seal portion and the plug face each other.
- a seventh container set comprises: a first container containing a liquid; a second container that can accommodate the first container and has an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container has a first film and a second film that accommodates the first container between the first film,
- the second container is opened by cutting the first film and the second film at the part to be opened,
- the first film and the second film are joined at a seal portion
- the seal portion has a first side seal portion and a second side seal portion separated in the longitudinal direction of the portion to be opened,
- a penetrating portion penetrating through the first film and the second film is provided at a position of the second side seal portion that intersects with the portion to be opened.
- An eighth container set comprises: a first container containing a liquid; a second container capable of accommodating the first container and having an oxygen barrier property; An outer box that can accommodate the second container,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container has a first film and a second film that accommodates the first container between the first film, The first film and the second film are joined at the seal portion so as to be peelable
- the outer box has an outer box body and a lid that opens the outer box by moving relative to the outer box body, The first film is attached to the outer box main body, the second film is attached to the lid, By moving the lid portion relative to the outer box main body portion, the second film is peeled off from the first film at the seal portion to open the second container.
- a ninth container set according to the present disclosure comprises: a first container containing a liquid; a second container that can accommodate the first container and has an oxygen barrier property,
- the first container has a container body having an opening and a stopper closing the opening, the plug has oxygen permeability
- the second container comprises: a first film; a second film that is bonded to the first film and accommodates the first container between the first film; and a gas bag that is provided and contains gas.
- a first liquid-filled container manufacturing method includes: Closing the second container containing the first container; adjusting the pressure within the first container housed within a second container; the first container contains a liquid and is gas permeable; The second container has a gas barrier property, In the step of adjusting the pressure, the gas in the first container permeates the first container and the pressure in the first container decreases.
- the pressure inside the first container may be reduced to a negative pressure.
- the pressure inside the first container may be positive before closing the second container.
- the second container may be closed such that the pressure inside the second container is negative.
- An oxygen scavenger is provided to absorb oxygen in the second container, In the step of adjusting the pressure, the pressure in the first container may decrease due to permeation of oxygen in the first container through the first container.
- the pressure in the first container may decrease due to permeation of oxygen in the first container through the first container.
- an oxygen scavenger that absorbs oxygen in the second container may be provided.
- the first container before closing the second container, contains a gas having an oxygen concentration of 1.5% or less, and the second container contains an inert gas. may be filled.
- the interior of the first container may be sterile.
- the first container may contain a highly sensitive liquid.
- the first container has a container body having an opening and a stopper closing the opening,
- the rubber stopper may be pierceable by a syringe needle.
- a method of using a first liquid-filled combination container according to the present disclosure comprises: A method of using any of the liquid-filled combination containers according to the present disclosure described above, comprising: opening the second container and removing the first container; piercing the first container with a needle of a syringe to inject the liquid into the syringe.
- a method for manufacturing a second liquid-filled container according to the present disclosure comprises: A method for manufacturing a liquid-filled container using the seventh to thirteenth liquid-filled combination containers according to the present disclosure, comprising: Closing the second container containing the first container; adjusting the oxygen concentration by absorbing oxygen in the second container with an oxygen scavenger; In the step of adjusting the oxygen concentration, oxygen in the first container permeates the plug, moves out of the first container, and is absorbed by the oxygen scavenger in the second container.
- a method for manufacturing a third liquid-filled container according to the present disclosure comprises: A method of manufacturing a liquid-filled container using the eighth liquid-filled combination container according to the present disclosure, comprising: Closing the second container containing the first container; adjusting the oxygen concentration by absorbing oxygen in the second container with an oxygen scavenger; In the step of adjusting the oxygen concentration, oxygen in the first container permeates the plug and moves out of the first container, is absorbed by the oxygen scavenger in the second container, The liquid-filled combination container is arranged on the mounting surface such that the second side wall faces the mounting surface on which the liquid-filled combination container is mounted through the second container.
- a fourth liquid-filled container manufacturing method comprises: A method of manufacturing a liquid-filled container using the ninth liquid-filled combination container according to the present disclosure, comprising: Closing the second container containing the first container; adjusting the oxygen concentration by absorbing oxygen in the second container with an oxygen scavenger; In the step of adjusting the oxygen concentration, oxygen in the first container permeates the plug and moves out of the first container, is absorbed by the oxygen scavenger in the second container, The liquid-filled combination container is arranged on the mounting surface such that the second side wall faces the mounting surface on which the liquid-filled combination container is mounted.
- the pressure inside the container containing the liquid can be adjusted.
- FIG. 1 is a diagram for explaining an embodiment according to the present disclosure, and is a perspective view showing an example of a liquid-filled combination container.
- 2A is a longitudinal cross-sectional view showing a liquid-filled first container that may be included in the liquid-filled combination container of FIG. 1;
- FIG. 2B is a longitudinal cross-sectional view showing a method of measuring oxygen permeation through the stopper of the first container shown in FIG. 2A.
- 3 is a longitudinal cross-sectional view showing a second container that may be included in the liquid-filled combination container of FIG. 1;
- FIG. FIG. 4 is a diagram showing an example of a method of manufacturing the liquid-filled combination container of FIG. 1 and the liquid-filled first container of FIG. FIG.
- FIG. 5 is a diagram showing an example of a method of manufacturing the liquid-filled combination container of FIG. 1 and the liquid-filled first container of FIG.
- FIG. 6 is a diagram showing an example of a method of manufacturing the liquid-filled combination container of FIG. 1 and the liquid-filled first container of FIG.
- FIG. 7 is a view showing an example of a method of manufacturing the liquid-filled combination container of FIG. 1 and the liquid-filled first container of FIG.
- FIG. 8A is a cross-sectional view showing an example of a deoxidizing member containing a deoxidizing agent.
- FIG. 8B is a cross-sectional view showing another example of a deoxidizing member containing a deoxidizing agent.
- FIG. 8C is a cross-sectional view showing an example of a deoxidizing film containing a deoxidizing agent.
- FIG. 9 is a perspective view showing a modified example of the second container.
- FIG. 10A is a perspective view showing another example of the second container.
- FIG. 10B is a perspective view showing still another example of the second container.
- FIG. 10C is a perspective view showing still another example of the second container.
- FIG. 10D is a perspective view showing still another example of the second container.
- 11 is a perspective view showing how to use the liquid-filled first container of FIG. 2.
- FIG. FIG. 12 is a vertical cross-sectional view showing a modified example of the plug.
- FIG. 13 is a longitudinal sectional view showing another modification of the plug.
- FIG. 14 is a longitudinal sectional view showing still another modification of the plug.
- FIG. 15 is a vertical cross-sectional view showing a first container including a liquid-repellent sheet.
- FIG. 16 is a longitudinal sectional view showing a stopper provided with a liquid-repellent sheet.
- FIG. 17 is a perspective view showing an example of a first container having extended walls. 18 is a diagram showing how to use the first container shown in FIG. 17.
- FIG. 19 is a diagram showing how to use the first container shown in FIG. 17.
- FIG. 20 is a perspective view showing another example of the first container having extended walls.
- FIG. 21 is a vertical cross-sectional view showing an example of the first container.
- FIG. 22 is a longitudinal sectional view showing another example of the first container.
- FIG. 23 is a top view of the first container shown in FIG. 21;
- FIG. FIG. 24 is a top view showing still another example of the first container.
- FIG. 25 is a longitudinal sectional view showing a modified example of the first container.
- FIG. 26 is a longitudinal sectional view showing another modification of the first container.
- FIG. 27 is a longitudinal sectional view showing a modified example of the first container shown in FIG. 26;
- 28 is a longitudinal sectional view showing another modification of the first container shown in FIG. 26.
- FIG. FIG. 29 is a view for explaining a first specific example of the second container, and is a perspective view showing a liquid-filled combination container. 30 is a perspective view of the liquid-filled combination container shown in FIG. 29;
- FIG. 29 is a perspective view of the liquid-filled combination container shown in FIG. 29;
- FIG. 29 is a perspective view of the liquid-filled combination container shown in FIG. 29;
- FIG. 29 is a perspective view of the liquid-filled combination container shown in FIG
- FIG. 31 is a longitudinal cross-sectional view of the liquid-filled combination container shown in FIG. 29;
- FIG. 32 is a cross-sectional perspective view showing an example of a tray included in the liquid-filled combination container shown in FIG. 29.
- FIG. 33A and 33B are diagrams illustrating an example of a method for manufacturing a liquid-filled container using the liquid-filled combination container shown in FIG. 29.
- FIG. 34 is a diagram illustrating an example of how to use the liquid-filled combination container shown in FIG. 29.
- FIG. FIG. 35 is a view for explaining a second specific example of the second container, and is a perspective view showing a liquid-filled combination container.
- FIG. 36 is a diagram illustrating an example of a method of manufacturing a liquid-filled container using the liquid-filled combination container shown in FIG. 37 is a longitudinal cross-sectional view of the liquid-filled combination container shown in FIG. 35;
- FIG. FIG. 38 is a diagram for explaining a third specific example of the second container, and is a perspective view showing a liquid-filled combination container. 39 is a perspective view of the liquid-filled combination container shown in FIG. 38;
- FIG. FIG. 40 is a diagram for explaining a fourth specific example of the second container, and is a perspective view showing a liquid-filled combination container. 41 is a perspective view showing the second container shown in FIG. 40 in an open state;
- FIG. 42 is a diagram for explaining a fifth specific example of the second container, and is a perspective view showing a liquid-filled combination container.
- 43 is a perspective view of an outer packet that may be included in the liquid-filled combination container shown in FIG. 42;
- FIG. 44 is a vertical cross-sectional view of the liquid-filled combination container shown in FIG. 42 with the outer box closed.
- 45 is a vertical cross-sectional view showing the liquid-filled combination container shown in FIG. 42 with the outer box opened.
- FIG. 46 is a view for explaining a sixth specific example of the second container, and is a perspective view showing a liquid-filled combination container. 47 is a cross-sectional view taken along line AA of FIG. 46.
- FIG. 48 is a diagram illustrating a method of manufacturing the liquid-filled combination container shown in FIG. 46.
- FIG. 49 is a perspective view showing a modification to the liquid-filled combination container shown in FIG. 38.
- FIG. 50 is a perspective view showing a modification to the liquid-filled combination container shown in FIG. 40.
- FIG. 49 is a perspective view showing a modification to the liquid-filled combination container shown in FIG. 46.
- the container set 20 has a first container 30 and a second container 40 .
- the liquid-filled first container 30 ⁇ /b>L has the first container 30 and the liquid L contained in the first container 30 .
- the first container 30 has gas permeability. That is, the first container 30 includes a portion that is at least partially permeable to gas.
- the second container 40 has gas barrier properties. The second container 40 can accommodate the liquid-filled first container 30L.
- the liquid-filled combination container 10L has a liquid-filled first container 30L and a liquid-filled second container 40, and the liquid-filled first container 30L is housed in the second container 40.
- the pressure in the second container 40 may be below atmospheric pressure (1 atm or below).
- a gas-permeable first container 30 is placed inside a second container 40 maintained at atmospheric pressure or less (1 atm or less).
- the gas-permeable first container 30 is an airtight container.
- An airtight container means a container in which gas leakage is not detected by the immersion method specified in JISZ2330:2012. More specifically, a container that can prevent air bubbles from leaking when a gas-containing container is immersed in water is judged to be an airtight container. An airtight container is judged to be in an airtight state when no air bubbles leak from the container when the container containing the gas is immersed in water. In the liquid immersion test, the container to be tested is immersed to a depth of 10 cm or more and 30 cm or less from the water surface. The presence or absence of air bubbles is determined by visual observation over 10 minutes.
- liquid-filled combination container 10L Each component of the liquid-filled combination container 10L will be described in further detail with reference to the illustrated specific example. First, the liquid-filled first container 30L will be described.
- the liquid-filled first container 30L has the first container 30 and the liquid L contained in the first container 30.
- the first container 30 has gas permeability. Meanwhile, the first container 30 can seal the liquid L. That is, the first container 30 is permeable to the gas but impermeable to the liquid L.
- the liquid L contained in the first container 30 is not particularly limited.
- a liquid may be a solution comprising a solvent and a solute dissolved in the solvent.
- the solvent is not particularly limited, and may be water or alcohol.
- the liquid is not limited to a liquid in the strict sense, and may be a suspension in which solid particles are dispersed.
- the liquid L as food may be tea, coffee, black tea, soup, juice, soup stock, or a concentrated liquid obtained by concentrating one or more of these.
- a liquid as a medicine may be an internal medicine, an external medicine, or an injection.
- the liquid L may be other than food and medicine.
- the liquid L may be blood or body fluid other than food and medicine.
- the inside of the first container 30 may be sterile.
- Liquid L may be any liquid that is to be kept sterile.
- Liquids L to be kept sterile include highly sensitive liquids such as food and medicines.
- the highly sensitive liquid L is susceptible to deterioration due to post-sterilization (also called final sterilization) performed after manufacturing.
- Post-sterilization is not applicable for sensitive liquids. Examples of post-sterilization include sterilization such as high pressure steam method, dry heat method, radiation method, ethylene oxide gas method, and hydrogen peroxide gas plasma method.
- the highly sensitive liquid L in this specification means that 5% or more of the weight ratio of all active ingredients contained in the liquid is decomposed by post-sterilization of the liquid L, and by post-sterilization of the liquid L It means a liquid in which one or more active ingredients contained in the liquid decompose at a weight ratio of 1% or more.
- a highly sensitive liquid L that cannot be subjected to post-sterilization can be manufactured using a production line arranged in an aseptic environment. That is, the highly sensitive liquid L can be produced by aseptic procedures. Examples of the highly sensitive liquid L include anticancer agents, antiviral agents, vaccines, antipsychotic agents, and the like.
- the sterile environment is maintained at positive pressure from the perspective of preventing the invasion of bacteria. Therefore, when a liquid-filled container is manufactured by manufacturing a liquid in an aseptic environment and filling the container with the liquid in an aseptic environment, the pressure in the liquid-filled container is a predetermined value that is necessarily determined according to the aseptic environment. positive pressure. On the other hand, as will be described in detail later, according to this embodiment, the pressure of the liquid-filled container, which has hitherto been provided at a predetermined positive pressure, can be adjusted. That is, the internal pressure of the first container 30 maintained in a sterile state can be adjusted from a predetermined positive pressure corresponding to a conventional manufacturing environment.
- the present embodiment is suitable for the highly sensitive liquid L manufactured by the aseptic operation method rather than the final sterilization method that performs post-sterilization, and the highly sensitive liquid-filled first container 30L. It can be said that the effects of the present embodiment are remarkable beyond the scope expected from the technical level.
- liquid L labeled as “sterilized” or “sterile”
- the inside of the container containing the product, and the product such as pharmaceuticals fall under "sterile conditions” as used herein.
- the product (liquid L) that satisfies the sterility assurance level (SAL) of 10 -6 specified in JIS T0806:2014 and the inside of the container containing the product also fall under the "sterile condition” used here. .
- SAL sterility assurance level
- the product and the interior of the container containing the product are also "sterile" as used herein.
- a drug that does not grow bacteria after being stored at a temperature of 28° C. or more and 32° C. or less for two weeks and the inside of a container containing the drug also correspond to the “aseptic condition” used here.
- the atmospheric pressure shall be 1 atm. Negative pressure means pressure less than 1 atm, which is atmospheric pressure. Positive pressure means pressure above 1 atm, which is atmospheric pressure. Whether or not the pressure inside the container is negative or whether or not the pressure inside the container is positive can be determined from the measured value of a pressure measuring device such as a pressure gauge provided in the container. If a pressure measuring device such as a pressure gauge is not provided, a syringe can be used to determine whether the pressure inside the container is negative. Specifically, when the target container is pierced with the needle of the syringe, whether the liquid or gas contained in the syringe flows into the container while only the atmospheric pressure is applied to the piston of the syringe.
- Whether the internal pressures of the first container 30 and the second container 40 are negative pressures and whether the internal pressures of the first container 30 and the second container 40 are positive pressures can be determined using a pressure measuring device such as a pressure gauge, or a pressure gauge. If a pressure measuring device is not installed, it can be confirmed by the above method using a syringe.
- the target can be measured by using a headspace pressure/humidity analyzer FMS-1400 manufactured by Lighthouse as a non-contact pressure measuring device.
- the internal pressure value of the container can be measured.
- the container to be measured is irradiated with light of a specific frequency from the outside of the container, and the light emitted from the container after passing through the headspace HS of the container is received. do.
- the change in light intensity before and after transmission is measured, and the pressure inside the container can be identified based on the change in light intensity. Therefore, the pressure value inside the container can be measured without opening the container. Changes in pressure inside the container can be checked without opening the container.
- the first container 30 can seal the liquid L as described above. That is, the first container 30 can hold the liquid L without leakage.
- the first container 30 has gas permeability.
- the entire first container 30 may be gas permeable. Only a portion of first container 30 may be gas permeable. Also, all gases may be permeable through the first container 30 . Only part of the gas may be permeable through the first container 30 .
- the first container 30 may have oxygen permeability as gas permeability.
- the first container 30 may have nitrogen permeability as gas permeability.
- the first container 30 may have water vapor permeability as gas permeability.
- gas can pass through the first container 30 to adjust the internal pressure inside the first container 30 .
- That the first container 30 has gas permeability means that gas can permeate the airtight first container 30 to the extent that the pressure inside the first container 30 can be adjusted as described later.
- the oxygen scavenger 21 absorbs oxygen in the second container 40 and promotes the movement of oxygen from the inside of the first container 30 to the inside of the second container 40 outside the first container 30, thereby 1 Adjust the pressure in the container 30 .
- the first container 30 is permeable to oxygen.
- the oxygen-permeable first container 30 is said to be gas-permeable.
- a container having oxygen permeability to the extent that it can exhibit gas permeability means that oxygen permeates the container at a predetermined oxygen permeation amount or more in an atmosphere with a temperature of 23 ° C. and a humidity of 40% RH. and the outside of 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, 1.2 (mL/(day ⁇ atm)) or more, or 3 (mL/(day ⁇ atm)) or more.
- the pressure inside the first container 30 can be adjusted by the oxygen permeation of the first container 30 .
- An upper limit may be set for the amount of oxygen that permeates the first container 30 .
- the amount of oxygen permeation through the first container 30 may be 100 (mL/(day ⁇ atm)) or less, 50 (mL/(day ⁇ atm)) or less, or 10 (mL/(day ⁇ atm)). It can be below.
- the range of the oxygen permeation amount may be determined by combining the above-described arbitrary lower limit of the oxygen permeation amount with the above-described arbitrary upper limit of the oxygen permeation amount.
- nitrogen permeability and water vapor permeability can also exhibit gas permeability that enables pressure regulation.
- Nitrogen that can ensure a nitrogen permeation amount (mL/(day ⁇ atm)) equivalent to the predetermined oxygen permeation amount (mL/(day ⁇ atm)) described as an oxygen permeability that can exhibit gas permeability Permeability can cause pressure fluctuations. If the water vapor permeation amount of the first container 30 in an atmosphere with a temperature of 40° C. and a humidity of 90% RH is 0.001 (g/day) or more, the water vapor permeability is exhibited and pressure fluctuations occur in the first container 30. can let The water vapor permeation amount of the first container 30 capable of exhibiting water vapor permeability may be 0.005 (g/day) or less.
- the material forming the gas permeable portion may have a high permeability to either nitrogen or oxygen, which are present in air at high concentrations. More specifically, at least one of the oxygen permeability coefficient and the nitrogen permeability coefficient of the material constituting the gas permeable portion is 1 ⁇ 10 ⁇ 12 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or more, 5 ⁇ 10 ⁇ 12 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa) or more, or 1 ⁇ 10 ⁇ 11 (cm 3 (STP) ⁇ cm/(cm 2 )).
- the material constituting at least one layer may have such a permeability coefficient, and all the layers may be composed of
- the material may have the above-mentioned permeability coefficient, and by setting a lower limit on the permeability coefficient, gas permeation of the first container 30 is promoted, and the pressure in the first container 30 can be quickly adjusted.
- Upper limits may be set for the nitrogen permeability coefficient and the oxygen permeability coefficient of the material forming the gas permeable portion.
- the upper limit of the permeability coefficient it is possible to suppress excessive leakage of water vapor or the like from the first container 30 .
- the upper limit it is possible to suppress the influence on the liquid L in the first container 30 due to the high gas permeation rate after the opening of the second container 40, which will be described later. Furthermore, it becomes possible to maintain the pressure in the first container 30 for a certain period of time after the second container 40 is opened.
- both the nitrogen permeability coefficient and the oxygen permeability coefficient may be 1 ⁇ 10 ⁇ 1 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or less, or 1 ⁇ 10 ⁇ 2 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or less, or 1 ⁇ 10 ⁇ 3 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or less.
- the material constituting at least one layer may have the above permeability coefficient, and the materials constituting all the layers have the above permeability coefficient. good too.
- the permeability coefficient of gases such as nitrogen, oxygen and water vapor is the value measured in accordance with JIS K7126-1.
- the permeability coefficient of gases such as nitrogen, oxygen and water vapor is a value measured according to JIS K6275-1.
- the oxygen permeability coefficient can be measured using an OXTRAN (2/61) permeation meter manufactured by MOCON, USA under an environment of temperature of 23° C. and humidity of 40 RH %.
- the nitrogen permeability coefficient and the water vapor permeability coefficient can be measured using a GTR-30XACK manufactured by GTR-TEC, which is a gas vapor permeability measuring device using a gas chromatographic method, under an environment of a temperature of 23° C. and a humidity of 40 RH%.
- the area of the gas-permeable portion of the first container 30 may be 1 mm 2 or more, 10 mm 2 or more, or 30 mm 2 or more.
- the thickness of the gas-permeable portion of the first container 30 may be 3 mm or less, 1 mm or less, or 0.5 mm or less. It may be several millimeters or less. As a result, the gas permeation of the first container 30 is promoted, and the pressure inside the first container 30 can be quickly adjusted.
- the illustrated first container 30 has a container body 32 having an opening 33 and a plug 34 held in the opening 33 of the container body 32 .
- the plug 34 regulates leakage of the liquid L from the opening 33 .
- plug 34 may be gas permeable. From the viewpoint of facilitating movement of gas from inside the first container 30 to outside the first container 30 , it is preferable that the gas-permeable portion of the first container 30 does not come into contact with the liquid L.
- the stopper 34 is typically separated from the liquid L contained within the container body 32 . That is, gas permeation through the plug 34 of the first container 30 can be promoted in the normal storage state of the first container 30 . In this regard, by making the plug 34 gas permeable, the pressure within the first container 30 can be rapidly adjusted.
- the gas-permeable plug 34 may be made of a material having the above-described permeability coefficient (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)).
- the nitrogen permeability coefficient and the oxygen permeability coefficient of the material forming the plug 34 may be higher than the nitrogen permeability coefficient and the oxygen permeability coefficient of the material forming the container body 32 .
- a portion of plug 34 may be gas permeable.
- a portion of plug 34 may be constructed of a gas-permeable material over its entire thickness. For example, plug 34 may be gas permeable through its entire thickness in a central portion spaced from the periphery and gas barrier in a peripheral portion surrounding the central portion.
- the area of the opening 33 that is, the opening area of the container body 32 may be 1 mm 2 or more, 10 mm 2 or more, or 30 mm 2 or more.
- the thickness of plug 34 may be 3 mm or less, may be 1 mm or less, and may be 0.5 mm or less. It may be several millimeters or less.
- the thickness of the stopper for example, the thickness of the rubber stopper may be 20 mm or less.
- the thickness of the stopper for example, the thickness of the rubber stopper may be 1 mm or less from the viewpoint of allowing the syringe needle or straw to pierce.
- the opening 33 An upper limit may be set for the area. Specifically, the area of the opening 33 may be 5000 mm 2 or less. From the viewpoint of securing strength, the thickness of the stopper, for example, the thickness of the rubber stopper may be 0.01 mm or more.
- the plug 34 having gas permeability is not particularly limited, and may have various configurations.
- the plug 34 is inserted into the opening 33 of the container body 32 to block the opening 33 .
- the plug 34 shown in FIG. 2A has a plate-like plate-like portion 34a and an insertion projection portion 34b extending from the plate-like portion 34a.
- the insertion protrusion 34b is, for example, cylindrical.
- a plurality of insertion protrusions 34b may be provided on the circumference.
- the insertion protrusion 34 b is inserted into the opening 33 .
- the plate-like portion 34a has a flange portion extending radially outward from the insertion projection portion 34b.
- a flange portion of the plate-like portion 34 a is placed on the head portion 32 d of the container body 32 .
- a plug having an outer spiral or an inner spiral and attached to the container body 32 by meshing of the spirals may be used.
- the plug 34 may contain silicone.
- the plug 34 may be made of silicone only. A portion of plug 34 may be formed from silicone.
- the silicone contained in plug 34 is solid under the environment in which first container 30 is intended to be used.
- the silicone contained in the plug 34 may not contain silicone that becomes liquid at room temperature, such as silicone oil.
- Silicone is a substance having a siloxane bond as a main chain.
- Plug 34 may be formed from a silicone elastomer.
- the plug 34 may be made of silicone rubber.
- Silicone rubber refers to a rubber-like material made of silicone.
- Silicone rubber is a synthetic resin containing silicone as a main component, and is a rubber-like substance. Silicone rubber is a rubber-like substance having a siloxane bond as a main chain.
- the silicone rubber may be a thermosetting compound containing siloxane bonds. Examples of silicone rubber include methylsilicone rubber, vinyl-methylsilicone rubber, phenyl-methylsilicone rubber, dimethylsilicone rubber, and fluorosilicone rubber.
- the oxygen permeability coefficient of silicone and the oxygen permeability coefficient of silicone rubber may be 1 ⁇ 10 ⁇ 12 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or more, and may be 1 ⁇ 10 ⁇ 11 (cm 3 (STP ) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or more.
- the oxygen permeability coefficient of silicone and the oxygen permeability coefficient of silicone rubber may be 1 ⁇ 10 ⁇ 9 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or less.
- Silicone and silicone rubber have a hydrogen permeability coefficient about 10 times higher, an oxygen permeability coefficient about 20 times higher, and a nitrogen permeability coefficient about 30 times higher than that of natural rubber. Silicone and silicone rubber have a hydrogen permeability coefficient that is 70 times or more, an oxygen permeability coefficient that is 40 times or more, and a nitrogen permeability coefficient that is 650 times or more as compared to butyl rubber.
- the plug 34 may be at least partially made of silicone. That is, the plug 34 may be wholly or partially made of silicone or silicone rubber.
- a portion of plug 34 may be constructed of silicone or silicone rubber over its entire thickness. The portion may be the central portion of plug 34 or some or all of the peripheral portion surrounding the central portion.
- the container body 32 may have a bottom portion 32a, a body portion 32b, a neck portion 32c and a head portion 32d in this order.
- the housing space for the liquid L is formed mainly by the bottom portion 32a and the body portion 32b.
- the head 32 d forms the tip of the container body 32 .
- the head portion 32d is thicker than other portions.
- the neck portion 32c is positioned between the body portion 32b and the head portion 32d.
- the neck portion 32c has a reduced width, especially a reduced diameter, with respect to the body portion 32b and the head portion 32d.
- the container body 32 may be transparent so that the contained liquid L can be observed from the outside.
- Transparent means that the visible light transmittance is 50% or more, preferably 80% or more.
- the visible light transmittance was measured using a spectrophotometer ("UV-3100PC" manufactured by Shimadzu Corporation, compliant with JIS K 0115) at an incident angle of 0° for every 1 nm within a measurement wavelength range of 380 nm to 780 nm. is specified as the average value of the total light transmittance at each wavelength.
- the illustrated first container 30 further has a fixture 36 .
- the fixture 36 restricts the stopper 34 from coming off the container body 32 .
- the fixture 36 is attached to the head portion 32 d of the container body 32 .
- the fixture 36 covers the periphery of the plate-like portion 34a of the plug 34, as shown in FIGS. 1 and 2A.
- the fixture 36 presses the flange portion of the plate-like portion 34a toward the head portion 32d.
- the fixture 36 restricts the stopper 34 from coming off the container body 32 while partially exposing the stopper 34 .
- the gap between the stopper 34 and the container body 32 can be made liquid-tight and air-tight.
- the fixture 36 keeps the first container 30 airtight.
- the fixture 36 may be a sheet of metal secured to the head 32d.
- the fixture 36 may be a cap that screws onto the head 32d.
- the metal fixture 36 has gas barrier properties.
- the permeability coefficient of the material comprising container body 32 may be less than the permeability coefficient of the material comprising stopper 34 .
- the container body 32 may have gas barrier properties.
- the container body 32 may have oxygen barrier properties. That is, the first container 30 may be gas permeable only partially.
- the material that makes up the part with gas barrier properties may have a low permeability coefficient with respect to both nitrogen and oxygen, which are present at high concentrations in air.
- the nitrogen permeability coefficient and the oxygen permeability coefficient of the material constituting the portion having the gas barrier property are respectively 1 ⁇ 10 ⁇ 13 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)).
- the material constituting at least one layer may have the above permeability coefficient, and the materials constituting all the layers may have the above permeability coefficient. good too.
- the container body 32 having gas barrier properties examples include a can made of metal, a container body having a metal layer formed by vapor deposition or transfer, and a glass bottle.
- the gas barrier property can also be imparted to the container body 32 produced using a resin sheet or resin plate.
- the resin sheet or resin plate may include a layer having gas barrier properties such as ethylene-vinyl alcohol copolymer (EVOH) or polyvinyl alcohol (PVA).
- the container body 32 may have a layered body including a metal deposition film. Transparency can be imparted to the container body 32 using a laminate or glass as well as a gas barrier property. When the first container 30 and the container body 32 are transparent, the liquid L contained therein can be confirmed from the outside of the first container 30 .
- That a part of the container has gas permeability means that gas can permeate the part of the first container 30 in an airtight state to the extent that the pressure inside the first container 30 can be adjusted as described later. .
- the oxygen-permeable portion of the first container 30 is said to be gas-permeable.
- the first container 30 may have nitrogen permeability to the extent that the pressure inside the first container 30 can be adjusted.
- the first container 30 may have water vapor permeability to the extent that the pressure inside the first container 30 can be adjusted.
- a part of the container has oxygen permeability means that in an atmosphere with a temperature of 23 ° C. and a humidity of 40% RH, oxygen permeates the part of the container at a predetermined oxygen permeation amount or more, and the inside of the container and the outside of the container. means that it is possible to move between
- 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, 1.2 (mL/(day ⁇ atm)) or more, or 3 (mL/(day ⁇ atm)) or more.
- the pressure inside the first container 30 can also be adjusted by having a portion of the first container 30 permeable to oxygen.
- the predetermined oxygen permeation amount may be 100 (mL/(day x atm)) or less, 50 (mL/(day x atm)) or less, or 10 (mL/(day x atm)) or less.
- an upper limit to the amount of oxygen permeation it is possible to suppress excessive leakage of water vapor, etc., and to suppress the influence of the high oxygen permeation rate on the liquid in the first container 30 after the second container 40 is opened.
- a range of oxygen transmission coefficients may be defined by combining any of the above lower limits of oxygen transmission with any of the above upper limits of oxygen transmission.
- Test container 70 includes a compartment wall 71 .
- the test container 70 has an internal space partitioned by partition walls 71 .
- the partition wall portion 71 includes a portion of the container and a main wall portion 72 having oxygen barrier properties.
- the permeation rate of a portion of the vessel is specified as the oxygen permeation rate of the test vessel 70 (mL/(day x atm)).
- the oxygen concentration in the test container 70 is kept at, for example, 0.05% or less.
- the test vessel 70 is connected to a first channel 76 and a second channel 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 flowing through the second channel 77 .
- an oxygen content measuring device used in OXTRAN (2/61) manufactured by MOCON, USA can be used.
- a first flow path 76 supplies gas into the test container 70 .
- the first flow path 76 may supply gas that does not contain oxygen.
- the first flow path 76 may supply an inert gas.
- the first flow path 76 may supply nitrogen.
- the second flow path 77 discharges the gas inside the test container 70 .
- the first flow path 76 and the second flow path 77 have oxygen barrier properties.
- the first channel 76 and the second channel 77 maintain the test container 70 in a substantially oxygen-free state.
- the oxygen concentration within test vessel 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 placed in a test atmosphere with a temperature of 23°C and a humidity of 40% RH.
- the oxygen concentration of the atmosphere in which the test container 70 is placed is higher than the oxygen concentration inside the test container 70 .
- the test atmosphere is an air atmosphere.
- the oxygen concentration in the air atmosphere is 20.95%.
- test container 70 is positioned within test chamber 78 .
- the atmosphere within test chamber 78 is maintained at a temperature of 23° C. and a humidity of 40% RH.
- Air is supplied into the test chamber 78 from a supply path 78A.
- the gas within the test chamber 78 is exhausted through the exhaust path 78B.
- Supply line 78A and exhaust line 78B circulate air to maintain an oxygen concentration of 20.95% in test chamber 78.
- a pump may be provided for circulating air in one of the supply channel 78A and the exhaust channel 78B.
- the supply channel 78A and exhaust channel 78B shown in FIG. 2B may be open to an atmosphere of air at atmospheric pressure, provided that the oxygen concentration in the test chamber 78 can be maintained constant.
- FIG. 2B shows a method for measuring the amount of oxygen permeation, taking the oxygen-permeable portion 30X of the first container 30 as an example.
- the partition wall portion 71 is composed of the oxygen-permeable portion 30X of the first container 30 and the oxygen-barrier main wall portion 72 .
- the partition wall portion 71 may be configured by the portion 30X cut out from the first container 30 and the main wall portion 72 connected to the peripheral portion 30Y of the portion 30X.
- the main wall portion 72 has a through hole 72A that exposes the portion 30X. A peripheral portion of the through hole 72A and a portion 30Y adjacent to the portion 30X may be airtightly joined.
- the portion 30Y adjacent to the portion 30X is airtightly joined to the through-hole peripheral portion of the main wall portion 72 via a barrier joint material 73 having an oxygen barrier property.
- the portion of the container set 20 shown in Figure 2A near the stopper 34 has been cut.
- the plug 34 is a portion 30X having oxygen permeability.
- Portions 32c and 32d forming the opening 33 of the container body 32 and the fixture 36 are airtightly connected to the main wall portion 72 via the barrier bonding material 73 as the portion 30Y adjacent to the oxygen permeable portion 30X. is doing.
- the container body 32 is cut at the neck 32c.
- the plug 34 is compressed and held within the opening 33 formed by the head 32 d of the container body 32 .
- Fixing member 36 makes the space between container body 32 and stopper 34 airtight.
- the container body 32 and fixture 36 having oxygen barrier properties are connected to the main wall portion 72 via a barrier joint material 73 .
- Plug 34 is maintained in a condition similar to that it would be in closing primary container 30 in actual use, such as compression within opening 33 and clamping with fastener 36 . Therefore, the amount of oxygen permeation through the plug 34 can be measured under the same conditions as in actual use.
- the method for measuring the amount of oxygen permeation (mL/(day ⁇ atm)) permeating through a portion of the container has been described above.
- the oxygen permeation amount (mL/(day ⁇ atm)) permeating the entire container can be specified by dividing the container into two or more parts and summing the oxygen permeation amounts measured for each part.
- the oxygen transmission rate of the first container 30 shown in FIG. 2A is obtained by measuring the oxygen transmission rate of the container body 32, and the oxygen transmission rate of the container body 32 and the portion measured by the method shown in FIG. 2B. It can be specified by adding 30X oxygen permeation amount.
- the oxygen permeation amount (mL/(day ⁇ atm)) of the container body 32 can be measured by using the test container 70 manufactured by combining the container body 32 with the main wall portion 72 .
- the permeation amount of gases other than oxygen can also be measured.
- the concentration of the gas to be measured in the test container 70 is set to 0.05% or less.
- a gas containing no object to be measured is supplied from the first channel 76 , and the gas in the test container 70 is discharged from the second channel 77 .
- Test container 70 is positioned within test chamber 78 .
- the atmosphere within test chamber 78 is maintained at a temperature of 23° C. and a humidity of 40% RH.
- the concentration of the gas to be measured in the test chamber 78 is kept constant by the gas supply from the supply channel 78A and the gas discharge from the exhaust channel 78B.
- the permeation amount of the gas to be measured (mL/(day ⁇ atm)) can be specified.
- the permeation amount of nitrogen and the permeation amount of water vapor are measured using a gas measurement device incorporated in GTR-30XACK manufactured by GTR-TEC as the gas measurement device 79 .
- the volume of the first container 30 may be, for example, 1 mL or more and 1100 mL or less, 3 mL or more and 700 mL or less, or 5 mL or more and 200 mL or less.
- the container body 32 is a colorless or colored glass bottle.
- the container body 32 is made of borosilicate glass, for example.
- This first container 30 may be a vial.
- a vial is a container containing a container body, a stopper inserted into an opening of the container body, and a seal as a fixture 36 for fixing the stopper. It is crimped together with the plug on the head of the main body.
- the volume of the first container 30, which is a vial bottle may be 1 mL or more, or 3 mL or more.
- the volume of the first container 30, which is a vial bottle may be 500 mL or less, or may be 200 mL or less.
- the oxygen permeability coefficient of the material forming the stopper 34 may be greater than the oxygen permeability coefficient of the glass forming the container body 32 .
- the nitrogen permeability coefficient of the material forming the stopper 34 may be greater than the nitrogen permeability coefficient of the glass forming the container body 32 .
- the internal pressure of the liquid-filled first container 30L is adjusted.
- the first container 30 can maintain a negative internal pressure under atmospheric pressure.
- the first container 30 can accommodate the gas under atmospheric pressure while maintaining the gas at a negative pressure.
- the first container 30 may be capable of containing the gas under atmospheric pressure while maintaining the gas at a positive pressure.
- the first container 30 may have sufficient rigidity to maintain its shape.
- the first container 30 may deform somewhat under atmospheric pressure when maintaining the internal pressure at negative pressure or positive pressure.
- the first container 30 can suppress pressure change based on volume change by having sufficient rigidity.
- the first container 30 capable of maintaining the internal pressure at negative pressure or positive pressure
- the specific examples illustrated above and cans made of metal are exemplified.
- the first container 30 is an airtight container, it has gas permeability. Therefore, the internal pressure of the first container 30 placed under atmospheric pressure can return to the atmospheric pressure in the equilibrium state.
- the phrase “under atmospheric pressure, the gas can be accommodated while maintaining the gas at a negative pressure or a positive pressure” used for the first container 30 means that the internal pressure of the first container 30 returns to the atmospheric pressure due to gas permeation. It means that the gas can be accommodated while maintaining the gas at a negative pressure or a positive pressure as described above.
- the first container 30, which "can contain gas while maintaining the gas at negative pressure or positive pressure under atmospheric pressure", can suppress pressure changes based on volume changes by having sufficient rigidity. Therefore, changes in the internal pressure of the first container 30 are primarily caused by changes in the amount of gas within the first container 30 . As will be described later, the internal pressure of the first container 30 can be adjusted by promoting the movement of the gas that has permeated the first container 30 between the inside and the outside of the first container 30 .
- Capable of accommodating gas under atmospheric pressure while maintaining a negative pressure means that the gas can be accommodated without damage while the internal pressure is kept at a negative pressure of 0.80 atm or more.
- a container capable of holding a gas under atmospheric pressure while maintaining a negative pressure may be airtight when the internal pressure is 0.80 atm.
- the volume when the internal pressure is 0.80 atm may be maintained at 95% or more of the volume when the internal pressure is 1.0 atm.
- the phrase "capable of accommodating a gas while maintaining a positive pressure in the atmosphere” means that the gas can be accommodated without damage while the internal pressure is maintained at a positive pressure of 1.2 atm or less.
- a container capable of holding a gas under atmospheric pressure while maintaining a positive pressure may be airtight when the internal pressure is 1.20 atm.
- the volume when the internal pressure is 1.2 atm may be maintained at 105% or less of the volume when the internal pressure is 1.0 atm. .
- the first container 30 is intended to be accommodated within a second container 40 having gas barrier properties.
- the first container 30 contained in the second container 40 contains gas without being damaged when the difference between the internal pressure of the first container 30 and the internal pressure of the second container 40 is 0.2 atm or less. You can.
- the first container 30 housed within the second container 40 may be airtight when the difference between the internal pressure of the first container 30 and the internal pressure of the second container 40 is 0.2 atm or less.
- the internal pressure of the first container 30 is may have a volume of 95% or more and 105% or less of the volume of the first container 30 when is the same as the internal pressure of the second container 40 .
- the internal pressure of the first container 30 may be lower than the internal pressure of the second container 40, or the internal pressure of the first container 30 may be lower than that of the second container. 40 internal pressure.
- the second container 40 has a volume that can accommodate the first container 30 .
- the second container 40 can be brought into a closed and airtight state by, for example, welding such as heat sealing or ultrasonic bonding, or bonding using an adhesive material or adhesive material.
- the second container 40 may be an airtight container.
- the volume of the second container 40 may be, for example, 5 mL or more and 1200 mL or less.
- the first container 30 is a small container such as a vial bottle, for example, a container with a volume of 1 mL or more and 20 mL or less
- the volume of the second container may be 1.5 mL or more and 500 mL or less.
- the second container 40 has gas barrier properties.
- the internal pressure in the first container 30 can be adjusted by moving gas from the first container 30 into the second container 40, as will be described later. That the second container 40 has a gas barrier property means that gas cannot permeate the airtight second container 40 to the extent that the pressure in the first container 30 can be adjusted as described later. do.
- the oxygen scavenger 21 absorbs oxygen in the second container 40 and promotes the movement of oxygen from the inside of the first container 30 to the inside of the second container 40 outside the first container 30, thereby 1 Adjust the pressure in the container 30 .
- the second container 40 has oxygen barrier properties.
- the first container 30 having oxygen barrier properties has sufficient gas barrier properties.
- That the container has oxygen barrier properties means that the oxygen permeability (mL/(m 2 ⁇ day ⁇ atm)) of the material constituting the container is 1 or less.
- the oxygen permeability (mL/(m 2 ⁇ day ⁇ atm)) of the container having oxygen barrier properties may be 0.5 or less or 0.1 or less in an atmosphere of 23° C. temperature and 40% RH humidity.
- Oxygen permeability is measured according to JIS K7126-1.
- Oxygen permeability is measured using OXTRAN, 2/61, which is a permeability meter manufactured by MOCON, USA, under an environment of temperature 23° C. and humidity 40% RH.
- the oxygen permeability may be specified by measuring the oxygen permeability described above and dividing the obtained oxygen permeability by the surface area.
- the second container 40 can also exhibit gas barrier properties that enable pressure adjustment in the first container 30 by having nitrogen barrier properties and water vapor barrier properties. Nitrogen permeability (mL/(m 2 ⁇ day ⁇ atm)) equivalent to the predetermined oxygen permeability (mL/(m 2 ⁇ day ⁇ atm)) described as an oxygen barrier property that can exhibit gas barrier properties ), the nitrogen barrier property can be exhibited, and the pressure fluctuation in the first container 30 can be caused. If the water vapor permeability of the material constituting the second container 40 in an atmosphere of 40° C. and 90% RH is 1 (g/(m 2 ⁇ day)) or less, the water vapor barrier property is exhibited and the first container pressure fluctuations within 30 can occur. The water vapor transmission rate of the material constituting the second container 40 capable of exhibiting water vapor barrier properties may be 0.5 (g/(m 2 ⁇ day)) or less.
- the oxygen permeability coefficient of the material constituting the second container 40 having oxygen barrier properties may be 1 ⁇ 10 ⁇ 13 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or less, and may be 1 ⁇ 10 ⁇ It may be 17 (cm 3 (STP) ⁇ cm/(cm 2 ⁇ sec ⁇ Pa)) or less.
- the second container 40 may be able to maintain a negative internal pressure under atmospheric pressure. That is, the second container 40 may be able to contain the gas under atmospheric pressure while maintaining the gas at a negative pressure. Also, the second container 40 may be capable of maintaining a positive internal pressure under atmospheric pressure. That is, the second container 40 may be able to contain the gas under atmospheric pressure while maintaining the gas at a positive pressure. The second container 40 may have sufficient rigidity to maintain its shape. However, the second container 40 may deform somewhat under atmospheric pressure when maintaining the internal pressure at negative or positive pressure. The second container 40 can suppress pressure changes based on volume changes by having sufficient rigidity. Moreover, as will be described later, the second container 40 may not be able to maintain the internal pressure at a negative pressure or a positive pressure.
- the second container 40 which "can contain the gas while maintaining the gas at a negative pressure or a positive pressure under atmospheric pressure", can suppress pressure changes based on volume changes by having sufficient rigidity. Therefore, changes in the internal pressure of the second container 40 are mainly caused by changes in the amount of gas. For example, as will be described later, the internal pressure of the second container 40 can be adjusted by the degassing agent absorbing the gas inside the second container 40 . By setting the internal pressure of the second container 40 to negative pressure or positive pressure, the internal pressure of the first container 30 can be easily adjusted.
- Examples of the second container 40 having gas barrier properties include a can made of metal, a container having a metal layer formed by vapor deposition or transfer, and a glass bottle.
- the second container 40 may also include a laminate including a layer having gas barrier properties.
- the laminate may include a gas-barrier resin layer such as ethylene-vinyl alcohol copolymer (EVOH) or polyvinyl alcohol (PVA), or a metal deposition film.
- Second container 40 may include a transparent portion. The entire second container 40 may be transparent.
- the second container 40 using a laminate and the second container 40 using glass or resin can be imparted with gas barrier properties and transparency. By imparting transparency to the second container 40 , the liquid-filled first container 30 ⁇ /b>L accommodated inside can be confirmed from the outside of the second container 40 .
- the second container 40 has a container body 42 and a lid 44.
- the container body 42 has a housing portion 42a and a flange portion 42b.
- the accommodation portion 42a forms a rectangular parallelepiped accommodation space.
- the first container 30 is housed in this housing space.
- the accommodating portion 42a has a rectangular parallelepiped outer shape with one open surface.
- the flange portion 42b is provided on the periphery of the opening of the housing portion 42a.
- the lid 44 is flat. A peripheral portion of the lid 44 can be airtightly joined to the flange portion 42 b of the container body 42 .
- the container main body 42 and the lid 44 may be made of a resin plate having gas barrier properties.
- the thickness of the gas barrier resin plate may be 0.05 mm or more and 2 mm or less, or may be 0.1 mm or more and 1.5 mm or less.
- Lid 44 and container body 42 may be transparent. With the lid 44 joined to the container body 42, a negative pressure or a positive pressure can be maintained inside the illustrated second container 40 under atmospheric pressure. At this time, the container main body 42 and the lid 44 may be slightly deformed, for example, by bending the resin plate.
- a gap G is formed between the stopper 34 of the first container 30 housed in the second container 40 and the second container 40 .
- the container set 20 and combination container 10 are configured by the first container 30 and the second container 40 described above. Using a container set 20 having a liquid-filled first container 30L and a liquid-filled second container 40, a liquid-filled combination container 10L is obtained.
- the liquid-filled combination container 10L By manufacturing the liquid-filled combination container 10L, the liquid-filled first container 30L whose internal pressure is adjusted is obtained.
- the liquid-filled first container 30L and the second container 40 before closing are prepared.
- the liquid-filled first container 30L is manufactured by filling the liquid L into the first container 30 .
- a highly sensitive liquid L such as food or medicine is manufactured using a manufacturing line installed in an aseptic environment maintained at positive pressure.
- the aseptic environment is maintained at a positive pressure from the viewpoint of suppressing the invasion of foreign substances such as bacteria.
- the obtained internal pressure of the liquid-filled first container 30L becomes a positive pressure, similar to the manufacturing environment.
- the first liquid-filled container 30L is accommodated in the container main body 42. Then, as shown in FIG. After that, the container body 42 containing the liquid-filled first container 30L is housed in the pressure chamber 59 .
- the pressure chamber 59 is separated from the atmosphere of air under atmospheric pressure. The internal pressure of the pressure chamber 59 is adjustable. Pressure chamber 59 is maintained at a negative pressure.
- the internal atmosphere of the pressure chamber 59 is an inert gas atmosphere. That is, the inside of the pressure chamber 59 is filled with an inert gas, and the air inside the pressure chamber 59 is replaced with the inert gas.
- pressure chamber 59 is filled with nitrogen. Therefore, when the container body 42 is accommodated in the pressure chamber 59, the atmosphere inside the container body 42 is also replaced with an inert gas such as nitrogen. As a result, the liquid-filled first container 30L is positioned in an inert gas atmosphere.
- the inert gas is a stable gas with low reactivity. Examples of inert gases other than nitrogen include rare gases such as helium, neon, and argon.
- the second container 40 containing the liquid-filled first container 30L is closed.
- the second container 40 is closed by joining the peripheral portion of the lid 44 to the flange portion 42 b of the container body 42 .
- the lid 44 may be joined to the container body 42 using a joining material such as an adhesive or adhesive.
- the lid 44 may be bonded to the container body 42 by welding such as heat sealing or ultrasonic bonding.
- the second container 40 becomes airtight.
- the inside of the second container 40 is made to have a negative pressure, and the second container 40 is closed.
- container body 42 is positioned within pressure chamber 59 which is maintained at a negative pressure.
- the lid 44 is joined to the container body 42 in a pressure chamber 59 maintained at a negative pressure. Therefore, the pressure inside the container body 42 is less than the atmospheric pressure.
- the inside of the pressure chamber 59 may be maintained in a sterile state.
- an aseptically manufactured liquid-filled first container 30L and a sterilized or aseptically manufactured second container 40 are brought into the pressure chamber 59 .
- the second container 40 containing the liquid-filled first container 30L is closed in the pressure chamber 59 which is kept sterile. Therefore, the inside of the second container 40 containing the liquid-filled first container 30L is also kept sterile. That is, the liquid-filled first container 30L can be stored in the second container 40 in an aseptic state.
- the liquid-filled combination container 10L is taken out from the pressure chamber 59. Then, the liquid-filled first container 30L is stored in the second container 40 .
- the second container 40 has gas barrier properties. Therefore, it is possible to effectively prevent the gas from permeating the second container 40 and entering the second container 40 .
- the first container 30 has gas permeability.
- the pressure inside the second container 40 is maintained at a negative pressure. For these reasons, the gas in the first container 30 permeates the first container 30 and moves into the second container 40 . Then, the pressure inside the second container 40 increases and the pressure inside the first container 30 decreases. At a final equilibrium state in which gas permeation through first vessel 30 is in equilibrium, the pressure within first vessel 30 may match the pressure within second vessel 40 .
- the pressure of the first container 30 containing the liquid L can be adjusted after the first container 30 is closed. Therefore, the pressure-regulated liquid-filled first container 30L can be manufactured without depending on the method of manufacturing the liquid L, the method of sealing the liquid L in the first container 30, or the like.
- This embodiment which can adjust the internal pressure of the first container 30 after enclosing the liquid L, is suitable for highly sensitive liquids that can be deteriorated by post-sterilization performed after manufacturing, that is, liquids to which the final sterilization method cannot be applied, such as food and Suitable for chemicals.
- Sensitive liquids that are not suitable for post-sterilization are manufactured using production lines that are sterilized and maintained aseptically. That is, it is manufactured by aseptic techniques.
- the inside of the container containing the liquid also becomes a predetermined positive pressure.
- the pressure of the liquid-filled container which has hitherto been provided at a predetermined positive pressure, can be adjusted after the liquid is sealed.
- the pressure in the first container 30 can be greatly changed.
- the pressure inside the first container 30 which was initially positive, can be adjusted to a negative pressure by storing the first container 30 inside the second container 40 .
- highly sensitive liquid L such as food and medicine
- solutes in aqueous solutions as chemicals can be decomposed by oxygen.
- Solutes and solvents in chemical liquids and chemical aqueous solutions can be decomposed by oxygen.
- Oxygen can decompose particles dispersed in liquid suspensions for pharmaceuticals and foods.
- by filling the second container 40 with an inert gas and closing the second container 40 decomposition of the liquid L by oxygen can be suppressed. That is, as the gas permeates the first container 30, the atmosphere in the first container 30 and the atmosphere in the second container 40 are balanced not only in terms of pressure but also oxygen concentration.
- the oxygen concentration in the first container 30 can be the same as the oxygen concentration in the second container 40 in an equilibrium state in which gas permeation through the first container 30 is balanced. Thereby, deterioration of the liquid L due to oxygen can be suppressed.
- the dissolved oxygen amount (mg/L) in the liquid L decreases.
- the dissolved oxygen amount (mg/L) of the liquid L is also called the dissolved oxygen amount (mg/L) of the liquid L.
- the liquid L in the first container 30 can be easily decomposed by oxygen dissolved in the liquid L. Therefore, by reducing the amount of oxygen dissolved in the liquid L, deterioration of the liquid L by oxygen can be suppressed more effectively.
- the oxygen in the second container 40 is An absorbing oxygen scavenger 21 may be provided.
- the oxygen concentration in the second container 40 and the oxygen concentration in the first container 30 can be reduced more effectively.
- the oxygen concentration in the second container 40 and the oxygen concentration in the first container 30 can be reduced by using the oxygen scavenger 21 that absorbs a sufficient amount of oxygen in the second container 40. , can be kept low, for example below 0.3%, below 0.1%, below 0.05%, below 0.03%, or even 0%.
- the amount of oxygen dissolved in the liquid L contained in the first container 30 can be , can be maintained low, eg, below 0.15 mg/L, below 0.04 mg/L, below 0.03 mg/L, below 0.015 mg/L, or even 0 mg/L.
- the amount of the oxygen scavenger 21 is set to an amount that can absorb the total amount of oxygen present in the first container 30 and the second container 40 .
- the oxygen scavenger 21 is not particularly limited as long as it is a composition capable of absorbing oxygen.
- an iron-based oxygen scavenger or a non-ferrous oxygen scavenger can be used as the oxygen scavenger 21, an iron-based oxygen scavenger or a non-ferrous oxygen scavenger can be used.
- metal powder such as iron powder, reducing inorganic substances such as iron compounds, polyhydric phenols, polyhydric alcohols, reducing organic substances such as ascorbic acid or salts thereof, or metal complexes are used as the main agent for the oxygen absorption reaction.
- You may use the oxygen scavenger composition which carries out as a scavenger.
- the combination container 10 may have the oxygen scavenging member 22 housed within the second container 40 along with the liquid-filled first container 30L.
- the deoxidizing member 22 includes an oxygen-permeable package 22a and an oxygen absorber 21 housed in the package 22a.
- an iron-based moisture-dependent type FX type an iron-based self-reacting type S type, SPE type, ZP type, and ZI-PT available from Mitsubishi Gas Chemical Co., Inc. type, ZJ-PK type, E type, organic self-reacting GLS type, GL-M type, GE type, etc.
- ZH type, Z-PK Ya, Z-PR, Z-PKR, ZM type, etc. for pharmaceuticals available from Mitsubishi Gas Chemical Co., Ltd. may be used.
- the deoxidizing member 22 may contain a water retention agent 22b that retains moisture, as shown in FIG. 8B.
- a water retention agent 22b one or more selected from the group consisting of diatomaceous earth, silica and activated carbon are exemplified.
- the water retention agent 22b may be used as a support for supporting the oxygen scavenger 21 .
- the water retention agent 22b that retains moisture is effective in ensuring the oxygen absorption function of the oxygen absorber 21.
- a non-aqueous solvent refers to a solvent whose main component with the largest volume ratio is other than water.
- a non-aqueous solvent may be substantially free of water.
- the water volume ratio of the non-aqueous solvent may be 2% or less, 1% or less, or 0.5% or less. Non-aqueous solvents do not have to contain water.
- the deoxidizing member 22 may not contain the water retention agent 22b.
- the oxygen permeable first container 30 is often water vapor permeable.
- moisture can be supplied to the oxygen absorber 21 without using the water retention agent 22b. Rather, the moisture absorption by the water retention agent 22b may be suppressed.
- the moisture absorption capacity of the water retention agent 22b used in the deoxidizing member 22 may be 5% or less of the volume (mL) of the liquid L contained in the first container 30.
- FIG. As storage conditions for liquids such as pharmaceuticals, the amount of volume reduction can be set to 5% or less.
- the amount of decrease of the liquid L in the first container 30 can be regulated. By setting the amount of water that can be absorbed by the water retention agent 22b to 5% or less of the initial volume (mL) of the liquid L, this storage condition can be satisfied.
- the deoxidizing agent 21 when the deoxidizing agent 21 is activated by the water vapor that has passed through the first container 30 and moved into the second container 40, the deoxidizing agent 21 is vertically above the oxygen-permeable portion of the first container 30.
- a part or all of the oxygen agent 21 and a part or all of the deoxidizing member 22 may be arranged.
- the container body 32 has oxygen barrier properties and the plug 34 has oxygen permeability
- part or all of the oxygen scavenger 21 may be arranged above the plug 34 .
- the container body 32 has oxygen barrier properties and the plug 34 has oxygen permeability
- part or all of the deoxidizing member 22 may be arranged above the plug 34 .
- Water vapor is light compared to nitrogen, oxygen and many inert gases. Therefore, the water vapor that has passed through the first container 30 can be efficiently used for activating the oxygen scavenger 21 .
- FIG. 8C shows an example of laminate 46 including deoxidizing film 23 .
- Laminate 46 including oxygen scavenging film 23 may constitute container body 42 and lid 44 of second container 40 shown in FIGS.
- the laminate 46 including the deoxidizing film 23 may constitute the films 41a-41d of the second container 40 shown in FIG. 9, which will be described later.
- the laminate 46 shown in FIG. 8C includes a first layer 46a, a second layer 46b and a third layer 46c.
- the first layer 46a may be the outermost layer made of polyethylene terephthalate, nylon, or the like.
- the second layer 46b may be an oxygen barrier layer made of aluminum foil, inorganic deposition film, metal deposition film, or the like.
- the third layer 46c may be the innermost layer forming a heat seal layer.
- the illustrated third layer 46c has a base material made of a thermoplastic resin and the deoxidizing agent 21 dispersed in the base material.
- the second container 40 may include the oxygen scavenger film 23 containing the oxygen scavenger 21 as part of the laminate 46 .
- the oxygen absorber 21 is not limited to the example shown in FIG. 8C, and is not limited to the heat seal layer or the innermost layer 46c, and may be contained in the adhesive layer or the intermediate layer of the laminate.
- first container 30 may include deoxidizing film 23 containing deoxidizing agent 21 .
- the oxygen scavenger 21 may be provided separately from the first container 30 and the second container 40 as in the examples shown in FIGS. 40 may be provided.
- the oxygen concentration (%) in the first container 30 and the oxygen concentration (%) in the second container 40 are specified by one measuring device suitable for measuring these oxygen concentrations.
- a measuring device for measuring oxygen concentration a headspace oxygen content measuring device, a fluorescent contact type oxygen content measuring device, and a fluorescent non-contact type oxygen content measuring device are known.
- the dissolved oxygen content (mg/L) of the liquid contained in the first container 30 is specified by a measuring device suitable for measuring the dissolved oxygen content of the liquid.
- a measuring device for measuring the amount of dissolved oxygen a fluorescent contact oxygen content measuring device, a fluorescent non-contact oxygen content measuring device, and the like are known.
- a measuring device for measuring oxygen concentration and oxygen dissolution amount one appropriate measuring device is selected considering the measurement limit, the stability of measurement in the oxygen concentration band to be measured, the measurement environment, the measurement conditions, etc. be done.
- a headspace analyzer FMS760 manufactured by Lighthouse is used as the oxygen content measurement device for the headspace method.
- a container containing oxygen to be measured is irradiated with light of a frequency that can be absorbed by oxygen from the outside of the container, and the light emitted from the container through the headspace HS of the container. receive light.
- the change in light intensity before and after transmission is measured, and the oxygen concentration (%) in the container can be specified based on the change in light intensity. Therefore, if the first container 30 can transmit the light from the measuring device, the oxygen concentration in the first container 30 can be identified without opening the first container 30 .
- the second container 40 can transmit the light from the measuring device, the light from the outside of the second container 40 can also be transmitted to the first container 30 accommodated in the second container 40 without opening the second container 40 . can be irradiated to measure the oxygen concentration in the first container 30 .
- the oxygen concentration (%) in the second container 40 can also be measured using a headspace analyzer FMS760 manufactured by Lighthouse. From the measured headspace HS oxygen concentration (%) and temperature, the saturation solubility of oxygen in the liquid L can be determined. Based on the specified saturated solubility, the oxygen dissolution amount (mg/L) of the liquid L can be specified.
- the headspace analyzer FMS760 can measure the oxygen concentration in the container from outside the container. However, the lower limit of oxygen concentration measurable by the headspace analyzer FMS760 is higher than the lower limit of oxygen concentration measurable by other measuring devices.
- the oxygen content measurement device Microx4 As a fluorescence contact type oxygen measurement device, the oxygen content measurement device Microx4 from PreSens of Germany is used.
- the oxygen content measuring device Microx4 is a needle type device.
- the oxygen content measuring device Microx4 can measure the oxygen concentration and the amount of oxygen dissolved in the container by piercing the container with a needle. Excellent in nature.
- the oxygen concentration and dissolved oxygen amount in the first container 30 and the second container 40 can be measured using a fluorescent non-contact oxygen amount measuring device.
- a fluorescent non-contact oxygen content measuring device an oxygen content measuring device Fibox3 manufactured by PreSens of Germany is used.
- the oxygen sensor emits self-luminescence when it receives light in a specific wavelength range.
- the amount of self-luminescence of the oxygen sensor increases as the amount of oxygen around the sensor increases.
- the fluorescence non-contact type oxygen measurement device can emit light of a specific wavelength that the oxygen sensor emits by itself. L) can be measured.
- the container set 20 and combination container 10 may include an oxygen detector 25 that detects the oxygen state within the second container 40 .
- the oxygen detector 25 may display the detected oxygen state.
- the oxygen detector 25 may detect oxygen concentration.
- the oxygen detector 25 may display the detected oxygen concentration value.
- the oxygen detection material 25 may display the detected oxygen concentration value by color.
- the oxygen sensing material 25 may contain a variable organic dye that reversibly changes color due to oxidation and reduction.
- the oxygen reducing agent includes an organic dye such as a thiazine dye, an azine dye, or an oxazine dye, and a reducing agent, and may be solid.
- the oxygen reducing agent may comprise an oxygen indicator ink composition.
- the oxygen indicator ink composition may contain a resin solution, a thiazine dye or the like, a reducing sugar, and an alkaline substance. Reducing sugars, such as thiazine dyes, and alkaline substances may be dissolved or dispersed in the resin solution. Substances contained in the oxygen sensing material 25 may reversibly change due to oxidation and reduction.
- the oxygen detecting material 25 accommodated in the container before the deoxidation is completed changes its display color as the container is deoxygenated.
- the amount of oxygen in the container can be observed from outside the transparent container to determine the oxygen-related conditions within the container.
- the oxygen detecting material 25 housed in the container indicates the increase in oxygen concentration after deoxidation is completed, for example, the state in which oxygen flows into the container due to the formation of pinholes or the like in the container during the distribution process. It can be notified by changing the color.
- an oxygen detecting material available from Mitsubishi Gas Chemical Co., Ltd. under the trade name of "AGELESS EYE” may be used.
- an oxygen detector coated with an ink composition having an oxygen detection function for example, an oxygen detector 25 available from Mitsubishi Gas Chemical Co., Ltd. under the trade name of "Paper Eye” may be used.
- "Ageless Eye” and “Paper Eye” are functional products that can easily indicate by color change that the oxygen concentration in a transparent container is less than 0.1% by volume, indicating an oxygen-free state.
- an oxygen absorber for example, an oxygen absorber available from Mitsubishi Gas Chemical Co., Ltd. under the trade name of "Ageless", those that can be used to maintain the freshness of foods and the quality of medical and pharmaceutical products. may be used.
- the oxygen detection material 25 may be provided so that the display section 26 can be observed from the outside of the transparent second container 40 .
- the oxygen detecting material 25 is accommodated in the second container 40 as well as the oxygen scavenger 21 and the oxygen scavenger member 22 .
- the oxygen detecting material 25 may be joined to the inner surface of the second container 40 or the outer surface of the first container 30 via welding or a bonding material.
- the oxygen detecting material 25 may be arranged so that the display portion 26 thereof is not observable by the deoxidizing member 22 or the dehydrating agent 24 .
- the deoxidizing member 22, the dehydrating agent 24 and the oxygen detecting member 25 are preferably arranged so as not to cover the label.
- the oxygen detection material 25 may detect the oxygen state within the first container 30 . That is, container set 20 and combination container 10 may include oxygen sensing material 25 that senses the oxygen state within first container 30 . This oxygen sensing material 25 may be accommodated in the first container 30 . The oxygen detector 25 may indicate the detected oxygen state in the first container 30 . The oxygen detection material 25 may detect the oxygen concentration inside the first container 30 . The oxygen detector 25 may display the detected oxygen concentration value in the first container 30 . The oxygen detection material 25 may display the detected oxygen concentration value in the first container 30 by color.
- the gas is caused to move from the first container 30 to the second container 40, and the inside of the first container 30 pressure.
- the method of putting the second container 40 in the negative pressure state is not limited to closing the inside of the second container 40 in the negative pressure state.
- the pressure inside the second container 40 may be made negative by providing an oxygen absorber 21 that absorbs oxygen inside the second container 40 that can maintain the internal pressure at a negative pressure. That is, when the first container 30L containing liquid is housed in the second container 40 whose internal pressure is the atmospheric pressure and the second container 40 is closed, oxygen absorption by the oxygen absorber 21 causes the second container 40 to The internal pressure can be made negative.
- Making the internal pressure of the second container 40 negative by using the oxygen scavenger 21 can also cause gas to move from the first container 30 to the second container 40 and reduce the pressure in the first container 30.
- any kind of degassing agent that can permeate the first container 30, such as nitrogen or water vapor, can be used to remove the oxygen from the first container 30 to the second container 40. can cause gas to move to and adjust the internal pressure of the first container 30 .
- the liquid L contained in the first container 30 contains a non-aqueous solvent such as alcohol or oil. It's okay. In this example, it is possible to prevent the solvent of the liquid L from being absorbed by the dehydrating agent or the like.
- the non-aqueous solvent refers to a solvent other than water as the main component with the largest volume ratio, as described above.
- a non-aqueous solvent may be substantially free of water.
- the water volume ratio of the non-aqueous solvent may be 2% or less, 1% or less, or 0.5% or less. Non-aqueous solvents do not have to contain water.
- gas transfer from the first vessel 30 to the second vessel 40 can be induced by utilizing concentration equilibrium rather than pressure differentials.
- concentration equilibrium rather than pressure differentials.
- the first container 30 contains a type of gas not contained in the second container 40, or contains a type of gas contained in the second container 40 at a higher concentration than the second container 40, Gases of that type permeate the first container 30 and move from the first container 30 to the second container 40 .
- a degassing agent such as the deoxidizing agent 21, after closing the second container 40, a specific type of gas
- the concentration of the second container 40 may be lower than the concentration of the first container 30 .
- the permeation of the gas through the first container 30 can be promoted more when using concentration equilibrium than when using a pressure difference. Therefore, when utilizing the concentration equilibrium, the internal pressure of the second container 40 may be set equal to or higher than the internal pressure of the first container 30 . Furthermore, the second container 40 may be a container that cannot maintain a negative internal pressure under atmospheric pressure. In the example shown in FIG. 9, the second container 40 is made of resin film and has flexibility. The deformation of the second container 40 maintains the gas in the second container 40 at atmospheric pressure.
- the second Oxygen is caused to move from the first container 30 to the second container 40 and the internal pressure of the first container 30 decreases.
- the second container 40 shown in FIG. 9 is composed of a gas barrier resin film, resin sheet, resin plate, or the like.
- the second container 40 is a so-called pouch.
- the second container 40 is a so-called gusset bag.
- the second container 40 has a first main film 41a, a second main film 41b, a first gusset film 41c and a second gusset film 41d.
- the first main film 41a and the second main film 41b face each other.
- the first gusset film 41c is creased and located between the first main film 41a and the second main film 41b.
- the first gusset film 41c connects one side edge of the first main film 41a and one side edge of the second main film 41b.
- the second gusset film 41d is creased and positioned between the first main film 41a and the second main film 41b.
- the second gusset film 41d connects the other side edge of the first main film 41a and the other side edge of the second main film 41b.
- the first and second main films 41a, 41b and the first and second gusset films 41c, 41d are also joined together at their upper and lower edges.
- the films 41a to 41d are airtightly joined by, for example, welding such as heat sealing or ultrasonic joining, or joining using a joining material such as an adhesive or an adhesive.
- one folded film may constitute two or more of the films 41a to 41d that are adjacently arranged.
- the gusset bag can form a rectangular bottom surface on the second container 40 .
- the first container 30 can be stored stably within the second container 40 .
- the second container 40 may have a bottom film 41e together with the first main film 41a and the second main film 41b instead of the gusset bag, as shown in FIG. 10A.
- This pouch is also called a standing pouch.
- This pouch also forms a bottom surface, and the first container 30 can be stably stored in the second container 40 .
- a second container 40 that can be developed in a plane may be used. Any of the second containers 40 shown in FIGS. 10B to 10D can be manufactured by joining resin films with a seal portion 49.
- FIG. The second container 40 shown in FIG. 10B can be produced by joining the first main film 41a and the second main film 41b at the sealing portion 49 provided around their circumference.
- the second container 40 shown in FIG. 10C has the film 41 folded back at the folded portion 41x.
- the second container 40 can be produced by joining the facing portions of the folded film 41 at the seal portion 49 .
- a storage space is formed in a portion surrounded by the folded portion 41x and the three-way seal portion 49. As shown in FIG.
- the second container 40 shown in FIG. 10D is also called a pillow type.
- the film 41 is formed into a tubular shape by bonding both ends of one sheet of film 41 as seal portions 49 , and the second container 40 is obtained by further bonding both ends of the tubular shape as seal portions 49 .
- the film forming the second container 40 may be transparent.
- the container set 20 and combination container 10 may be provided with a dehydrating agent 24 that absorbs moisture and water vapor in the second container 40 .
- the dehydrating agent 24 is a substance having a property of absorbing moisture such as water vapor or water, or a composition containing such substance. Examples of the dehydrating agent 24 include calcium chloride, soda lime, silica gel, and the like.
- the dehydrating agent 24 may be contained in the second container 40 together with the first container 30 and the second container 40 may be closed. Moisture can be removed by the dehydrating agent 24 . Further, as described above, the dehydrating agent 24 can adjust the internal pressure of the first container 30 .
- the dehydrating agent 24 is arranged in the second container 40 as a dehydrating member housed in a package. Similar to the deoxidizing agent described above, a film-like dehydrating film containing the dehydrating agent may be included as part of the first container 30 or the second container 40 . In this example, the gas barrier layer forming the second container 40 and the dewatering film containing the dehydrating agent 24 may be laminated and integrated.
- a non-aqueous solvent such as glycerin or alcohol is stored in the first container 30
- moisture such as water vapor or water in the first container 30 can be removed by the dehydrating agent 24 stored in the second container.
- the amount of moisture in the first container 30 can be reduced to 100 ⁇ g or less, 50 ⁇ g or less, or 10 ⁇ g or less by storing the dehydrating agent in the second container 40 .
- the water content in the first container 30 when using the dehydrating agent 24 can be measured using the Karl Fischer method. Specifically, the moisture content in the first container 30 can be specified by coulometric titration using a Karl Fischer moisture meter MKC-610 manufactured by Kyoto Electronics Industry Co., Ltd.
- the first container 30 has a container body 32 and a stopper 34 .
- This first container 30 may be a vial.
- vials containing liquids particularly vials containing liquids in an aseptic state, are manufactured using butyl rubber or fluororubber, which has low gas permeability and gas barrier properties.
- the plug 34 is gas permeable. That is, gas can permeate the plug 34 .
- the gas permeability coefficient such as the nitrogen permeability coefficient and the oxygen permeability coefficient of the material forming the plug 34 is set large.
- the plug 34 may be made of silicone or silicone rubber.
- the gas permeability coefficient of the material forming the plug 34 may be higher than the gas permeability coefficient of the material forming the container body 32 .
- the nitrogen permeability coefficient of the material forming the plug 34 may be greater than the nitrogen permeability coefficient of the material forming the container body 32 .
- the oxygen permeability coefficient of the material forming the plug 34 may be greater than the oxygen permeability coefficient of the material forming the container body 32 .
- the gas permeates the plug 34 and moves out of the first container 30 .
- Gas permeability can be easily imparted to an existing container such as a conventionally used vial bottle by replacing the stopper 34 .
- gas permeability can be imparted to a region of the first container 30 separated from the liquid L, in other words, a region exposed from the liquid in the first container 30 such as the so-called headspace HS.
- the container body 32 has gas barrier properties. Therefore, the gas permeation of the first container 30 is performed only in the area separated from the liquid L such as the headspace HS in the first container 30 . Therefore, dissolution of the gas that has passed through the first container 30 into the liquid L can be suppressed. Thereby, the time until the dissolution of the gas into the liquid L reaches equilibrium can be shortened.
- the time to reach equilibrium depends on the gas permeability of the plug 34 . Therefore, by adjusting the area of the opening 33 of the container body 32 and the thickness of the plug 34 as described above, the second container 40 containing the first container 30L containing the liquid is closed, and then the first container 30 is closed. It is possible to reduce the time required for the permeation of gas to equilibrate.
- the partial volume of the first container 30 (the volume of the headspace HS) obtained by subtracting the volume of the liquid L from the volume of the first container 30 may be 50 mL or less, 30 mL, 10 mL, or 5 mL or less. According to such a liquid-filled combination container 10L, it is possible to shorten the time from closing the second container 40 containing the first container 30 until gas permeation through the first container 30 is balanced.
- the volume of the liquid L contained in the first container 30 may be 20 mL or less, or may be 10 mL or less. According to such a liquid-filled combination container 10L, it is possible to shorten the time from closing the second container 40 containing the first container 30 until gas permeation through the first container 30 is balanced.
- the ratio of the volume of the liquid L to the volume of the first container 30 is large. When this ratio is large, the time for gas permeation through the first container 30 to equilibrate can be shortened.
- the ratio of the volume of the liquid L to the volume of the first container 30 is preferably 50% or more, more preferably 75% or more, and even more preferably 90% or more.
- the volume occupied by the first container 30 from the volume of the second container 40 which is the partial volume (volume of the headspace HS) (mL) of the first container 30 obtained by subtracting the volume of the liquid L from the volume of the first container 30, is An upper limit and a lower limit may be set for the ratio (%) to the subtracted partial volume (mL) of the second container 40 .
- This ratio may be 50% or less, or may be 20% or less.
- a space for accommodating the first container 30 can be secured within the second container 40 , and the first container 30 can be easily accommodated within the second container 40 .
- the time from the closing of the second container 40 containing the first container 30 to the equilibrium of gas permeation through the first container 30 can be shortened.
- this ratio may be 5% or more, or may be 10% or more.
- Whether the gas permeation through the first container 30 is in equilibrium is determined based on the pressure value of the internal pressure of the second container 40 .
- This judgment uses the first pressure value (atm) in the second container 40 at a certain time and the second pressure value (atm) in the second container 40 24 hours before the certain time. Specifically, when the ratio of the difference between the second pressure value and the first pressure value to the first pressure value is ⁇ 5% or less, it is determined that an equilibrium state has been reached at a certain point.
- the internal pressure adjustment of the first container 30 within the second container 40 may be performed until the permeation of the gas through the first container 30 is balanced.
- the adjustment of the internal pressure of the first container 30 within the second container 40 may be performed until the pressure within the first container 30 drops to a predetermined pressure.
- the internal pressure adjustment of the first container 30 within the second container 40 may be performed until the pressure within the second container 40 rises to a predetermined pressure.
- the internal pressure adjustment of the first container 30 within the second container 40 may be performed until the liquid L in the combination container 10 is used. Further, while the first container 30 is housed in the second container 40 to adjust the internal pressure, the liquid-filled combination container 10L may be circulated.
- the second container 40 is opened.
- the liquid-filled first container 30L is taken out from the opened second container 40 .
- the liquid L can be taken out from the liquid-filled first container 30L and used.
- the first container 30 can be opened by removing the fastener 36 from the container body 32 and removing the stopper 34 from the container body 32 . Thereby, the liquid L in the first container 30 can be used.
- the pressure inside the first container 30 is adjusted while it is housed inside the second container 40 . Specifically, the pressure inside the first container 30 decreases. Therefore, it is possible to prevent the liquid L from unintentionally leaking out of the first container 30 before the first container 30 is opened. Moreover, it is possible to prevent the liquid L from scattering from the first container 30 when the first container 30 is opened. In particular, by lowering the pressure inside the first container 30 to a negative pressure, it is possible to extremely effectively suppress scattering when the first container 30 is opened.
- the liquid L that is a chemical especially the liquid L that is a highly pharmacologically active chemical, may have toxicity, it is possible to reduce the risk of inhalation and exposure of the operator when the first container 30 is opened.
- the liquid L may be a chemical that is injected into the syringe 60. That is, the liquid L may be a liquid contained in the first container 30, which is a vial bottle.
- the liquid L may be an injection of drugs. Examples of injections include anticancer agents, antiviral agents, vaccines, antipsychotic agents, and the like.
- the syringe 60 has a cylinder 62 and a piston 66 .
- the cylinder 62 has a cylinder body 63 and a needle 64 projecting from the cylinder body 63 .
- a tubular needle 64 allows access to the space for containing the liquid L in the cylinder body 63 .
- the piston 66 has a piston body 67 and a gasket 68 retained on the piston body 67 .
- Gasket 68 may be made of rubber or the like.
- the gasket 68 is inserted into the cylinder body 63 to partition the housing space for the liquid L within the cylinder body 63 .
- the liquid L injected into the syringe 60 may be transferred from the syringe 60 to another syringe, container, or the like before being administered to a patient or the like. In this instance, it may be administered to the patient from a separate syringe, container, or the like.
- the illustrated first container 30 has a container body 32 having an opening 33 and a rubber stopper 34 closing the opening 33 . Punctureable.
- the needle 64 of the syringe 60 is pierced through the plug 34 .
- the needle 64 penetrates the stopper 34 and the tip of the needle 64 is immersed in the liquid L in the first container 30 .
- the piston 66 By retracting the piston 66 in this state, the liquid L is drawn through the needle 64 into the space defined by the cylinder 62 and the gasket 68 .
- the liquid L can be injected into the syringe 60 in a sterile state from the first container 30 maintained in a sterile state.
- the syringe 60 When the syringe 60 is used, if the pressure inside the first container 30 is positive, the liquid L inside the first container 30 pushes the piston 66 and automatically flows into the syringe 60 . Therefore, when the pressure inside the first container 30 is positive, it is not easy to collect the desired amount of the liquid L into the syringe 60 . On the other hand, by adjusting the pressure in the first container 30 as described above, when the needle 64 of the syringe 60 is punctured into the first container 30, the liquid L automatically flows into the syringe 60. can control the influx of Thereby, an appropriate amount of liquid can be taken out into the syringe 60 .
- 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 higher, or 0.9 atm or higher. According to the pressure adjustment using the oxygen scavenger 21 described above, the pressure in the first container 30 can be easily reduced to 0.8 atm in a short time. Any lower limit for the pressure within the first container 30 may be combined with any upper limit for the pressure within the first container 30 to define an adjustment range for the pressure within the first container 30 .
- the pressure in the first container 30 is 1 atm or less, it is possible to effectively suppress leakage and scattering of the liquid L from the first container 30 when the needle 64 of the syringe 60 is punctured into the plug 34 of the first container 30. . If the pressure in the first container 30 is a negative pressure, for example, 0.98 atm or less, leakage and scattering of the liquid L from the first container 30 when the needle 64 is punctured into the plug 34 can be suppressed more stably. .
- the pressure in the first container 30 is 0.8 atm or more, when the needle 64 of the syringe 60 is pierced through the plug 34 of the first container 30, the piston is suppressed from being strongly drawn, and the syringe is released from the first container 30. An appropriate amount of liquid can be taken out in 60 with high accuracy. If the pressure in the first container 30 is 0.9 atm or more, there is almost no feeling that the piston is drawn in when the needle 64 is punctured into the stopper 34, and the appropriate amount of liquid is injected from the first container 30 into the syringe 60 with even higher accuracy. can be taken out.
- the container set 20 includes the first container 30 that contains the liquid L and has gas permeability, and the second container 30 that can contain the first container 30 and has gas barrier properties. 2 container 40 .
- the first container 30 can contain the gas while maintaining the negative pressure in the second container 40 .
- the first container 30 can maintain a negative internal pressure inside the second container 40 .
- Combination container 10 is obtained by housing first container 30 in second container 40 . That is, the liquid-filled combination container 10L has a first container 30 that contains the liquid L and has gas permeability, and a second container 40 that contains the first container 30 and has gas barrier properties.
- the method for manufacturing the liquid-filled first container 30L includes a step of closing the second container 40 containing the first container 30, and a step of adjusting the pressure inside the first container 30 accommodated in the second container 40. and including.
- the step of adjusting the pressure one or more gaseous species in the first container 30 permeate the first container 30 and move from within the first container 30 to outside the first container 30, thereby pressure drops.
- the gas in the first container 30 permeates the first container 30 and moves into the second container 40 .
- the pressure in the first container 30 can be lowered. That is, the pressure inside the first container 30 containing the liquid L can be adjusted after the first container 30 is closed. Moreover, the pressure inside the first container 30 can be adjusted while the first container 30 is accommodated in the second container 40 . Therefore, according to this embodiment, the pressure-regulated liquid-filled first container 30L can be easily manufactured without depending on the method of manufacturing the liquid L, the method of sealing the liquid L in the first liquid container 30, or the like. can be manufactured.
- Making the internal pressure of the second container 40 less than the internal pressure of the first container 30 is exemplified as an example of a method for causing the movement of the gas that permeates the first container 30 from the first container 30 to the second container 40 .
- a second container 40 is used that can contain the gas while maintaining it at a negative pressure. More specifically, the internal pressure of the second container 40 may be made lower than the internal pressure of the first container 30, and the second container 40 containing the first container 30 may be closed.
- a degassing agent that absorbs the gas in the second container 40 for example, a deoxidizing agent 21 may be provided.
- Concentration equilibrium may be used as another example of a method for causing gas movement from the first container 30 to the second container 40 that permeates the first container 30 . More specifically, the internal atmosphere of the second container 40 is replaced so that the second container 40 contains the gas at a concentration lower than that of the one or more gases contained in the first container 30 . The second container 40 may be closed. Further, the internal atmosphere of the second container 40 may be replaced and the second container 40 may be closed so that the second container 40 does not contain the one or more gases contained in the first container 30 . Furthermore, using a degassing agent (for example, the deoxidizing agent 21) that absorbs one or more gases contained in the first container 30, the concentration of the gas in the second container 40 is reduced after the second container 40 is closed. You may let
- the first container 30 may be able to contain the gas under atmospheric pressure while maintaining the gas at a negative pressure or a positive pressure.
- the first container 30 since the first container 30 has sufficient rigidity, changes in the internal pressure of the first container 30 due to changes in the volume of the first container 30 can be suppressed. Therefore, changes in the internal pressure of the first container 30 are primarily caused by changes in the amount of gas within the first container 30 .
- the internal pressure of the first container 30 can be adjusted by promoting the movement of the gas that has permeated the first container 30 between the inside and the outside of the first container 30 .
- the second container 40 may be able to contain the gas under atmospheric pressure while maintaining the gas at a negative pressure or a positive pressure.
- the second container 40 since the second container 40 has sufficient rigidity, the pressure change of the second container 40 due to the volume change of the second container 40 can be suppressed. Therefore, changes in the internal pressure of the second container 40 are mainly caused by changes in the amount of gas.
- the internal pressure of the second container 40 can be adjusted by the degassing agent absorbing the gas inside the second container 40 . By setting the internal pressure of the second container 40 to negative pressure or positive pressure, the internal pressure of the first container 30 can be easily adjusted.
- the pressure inside the first container 30 may be lowered to a negative pressure.
- the pressure in the first container 30 may be reduced from positive pressure to 1 atm (atmospheric pressure) or less.
- the pressure in the first container 30 may be 0.8 atm or more and less than 1 atm, 0.9 atm or more and less than 1 atm or less, or 0.9 atm or more and 0.98 atm or less.
- this embodiment is suitable for highly sensitive liquids, such as chemicals, that are degraded by post-sterilization processing performed after manufacturing.
- Sensitive liquids L that are not suitable for post-sterilization are manufactured using aseptic production lines. Since the aseptic production line is normally maintained at a positive pressure, the inside of the first container 30 containing the liquid L is also at a predetermined positive pressure. According to the present embodiment, the pressure of the container containing the liquid, which has hitherto been provided at a predetermined positive pressure, can be adjusted in a state in which the container is closed and the liquid L is enclosed, and can be reduced to 1 atm or less. pressure can be reduced.
- the second container 40 is responsible for pressure regulation and gas barrier properties.
- the liquid-filled first container 30L may be responsible for the sterility of the liquid L contained therein. In this way, the storage environment required for the liquid L is efficiently realized by the combination of the first container 30 and the second container 40 . According to the combination container 10 and the container set 20, the storage environment required for the liquid L can be easily realized with a high degree of freedom at low cost.
- the first container 30 may have a container body 32 having an opening 33 and a plug 34 that closes the opening 33 .
- Stopper 34 may be pierceable by needle 64 of syringe 60 .
- liquid L may be a drug that is injected into syringe 60 .
- the aseptic liquid L can be collected into the syringe 60 in an aseptic state. Further, since the pressure inside the first container 30 is adjusted, a desired amount of the liquid L can be collected in the syringe 60 with high accuracy.
- a gap G may be formed between the gas-permeable plug 34 of the first container 30 housed in the second container 40 and the second container 40 .
- the inside of the second container 40 may be in an inert gas atmosphere.
- oxygen permeates the first container 30
- the oxygen concentration in the first container 30 can be reduced, and the dissolved oxygen content of the liquid L can also be reduced.
- the oxygen concentration contained in the first container 30 before the second container 40 is closed may be 1.5% or less.
- Such an oxygen concentration can be achieved, for example, in the pressure chamber 59 described above.
- the oxygen concentration in the first container 30 in the final liquid-filled combination container 10L can be reduced to less than 1%.
- the oxygen deterioration of the liquid L can be extremely effectively suppressed. can be suppressed to Therefore, this example is suitable for application to emergency foods, medicines, and the like.
- an oxygen absorber 21 that absorbs oxygen in the second container 40 may be provided.
- the oxygen concentration in the second container 40 and the oxygen concentration in the first container 30 can be reduced more effectively.
- the amount of oxygen dissolved in the liquid L accommodated in the first container 30 can be reduced to 0.04 mg/L or less and 0.03 mg/L. /L or less, 0.02 mg/L or less, less than 0.0.015 mg/L, or even 0 mg/L.
- a dehydrating agent 24 that absorbs moisture such as water vapor and water in the second container 40 may be provided.
- a non-aqueous liquid such as glycerin or alcohol
- the dehydrating agent contained in the second container can remove the moisture in the first container 30.
- FIG. As a result of confirmation by the present inventors, it was possible to reduce the water content in the first container 30 to 100 ⁇ g or less, 50 ⁇ g or less, or 10 ⁇ g or less by storing the dehydrating agent in the second container 40 .
- the second container 40 described below can be used in combination with the first container 30 having the container body 32 and the stopper 34 described above, the stopper 34 being permeable to oxygen. That is, in the following description, the first container 30 has oxygen permeability and the second container 40 has oxygen barrier properties. The internal pressure of the first container 30 and the internal pressure of the second container 40 are adjusted by using the oxygen scavenger 21 that absorbs oxygen in the second container 40 .
- the first container 30 may be gas permeable to one or more gases and the second container 40 may be gas barrier to the gas.
- FIG. 29-34 show a first embodiment of the second container 40.
- the liquid-filled combination container 10L has a tray 90 that accommodates the first containers 30 .
- the tray 90 is a flat container with an opening 90A.
- the second container 40 accommodates a tray 90 containing the first containers 30 .
- the first container 30 can be configured as described above.
- the illustrated first container 30 has a container body 32 with an opening 33 and a stopper 34 closing the opening 33 .
- the plug 34 has oxygen permeability. That is, oxygen is permeable through plug 34 .
- the second container 40 has oxygen barrier properties as described above.
- the second container 40 is not particularly limited, and can be configured in the same manner as the example of the second container described above.
- the second container 40 may be a film container.
- the second container 40 may be a gusset-type container using a resin film, or any of the containers shown in FIGS. 10A to 10D.
- the liquid-filled combination container 10L may be provided with the oxygen scavenger 21 that absorbs oxygen in the second container 40, as described above.
- the liquid-filled combination container 10L may further have an outer box 100.
- Outer box 100 may be formed of various materials.
- the outer box 100 is made of paper.
- the outer case 100 may have a light shielding property in order to suppress deterioration of the liquid L due to light.
- the light-shielding property imparted to the outer casing 100 may be a light-shielding property against light caused by deterioration of the liquid L, and may have a visible light-shielding property, for example. Having a light-shielding property means that the total light transmittance of light in the target wavelength range is 30% or less, preferably 10% or less, and more preferably 5% or less.
- FIG. 31 is a longitudinal sectional view of the liquid-filled combination container 10L shown in FIG. A gap G is formed between the tray 90 and the plug 34 .
- the oxygen concentration (%) in the head space HS of the first container 30 can be stably reduced and the The oxygen dissolution amount (mg/L) of the liquid L can be stably reduced. Thereby, the internal pressure of the first container 30 can be stably reduced.
- the tray 90 has a bottom wall 91 and side walls 92 connected to the bottom wall 91.
- FIG. 32 is a cross-sectional perspective view showing an example of the tray 90.
- a side wall 92 rises from the bottom wall 91 .
- Side wall 92 is cylindrical.
- One opening of the cylindrical side wall 92 forms an opening 90A of the tray 90 .
- the other opening of the cylindrical side wall 92 is closed by the bottom wall 91 .
- the side wall 92 has a pair of opposed first side wall portions 92a and second side wall portions 92b.
- the first side wall portion 92 a faces the plug 34 of the first container 30 accommodated in the tray 90 .
- the second side wall portion 92 b faces the bottom portion 32 a of the container body 32 of the first container 30 accommodated in the tray 90 . As shown in FIG. 31, a gap G is formed between the first side wall portion 92a and the plug 34. As shown in FIG. A first side wall portion 92 a is located between the stopper 34 and the second container 40 . The first side wall portion 92 a prevents the second container 40 from contacting the plug 34 .
- the illustrated tray 90 has a third side wall portion 92c and a fourth side wall portion 92d.
- the third side wall portion 92c connects one end of the first side wall portion 92a and one end of the second side wall portion 92b.
- the fourth side wall portion 92d connects the other end of the first side wall portion 92a and the other end of the second side wall portion 92b.
- a cylindrical side wall 92 is formed by the first side wall portion 92a to the fourth side wall portion 92d.
- Tray 90 further includes a flange portion 93 extending from side wall 92 .
- Bottom wall 91 connects to one end of side wall 92 .
- the flange portion 93 is connected to the other end of the side wall 92 .
- the flange portion 93 is circumferential like the side wall 92 .
- the flange portion 93 extends outward from the side wall 92 , that is, to the side opposite to the accommodation space of the tray 90 .
- a circumferential flange portion 93 defines the opening portion 90A.
- the tray 90 may have positioning portions 91X and 91Y for restricting movement of the first container 30 accommodated therein.
- the tray 90 shown in FIG. 32 has a first positioning portion 91X and a second positioning portion 91Y.
- the first positioning portion 91X has a first positioning protrusion 91a provided on the bottom wall 91 .
- the first positioning projection 91a is recessed into the recess of the first container 30.
- the first positioning protrusion 91 a protrudes toward the neck 32 c of the first container 30 .
- a recess is formed in the neck portion 32c between the stopper 34 and the body portion 32b of the container body 32. As shown in FIG.
- the first positioning protrusion 91a restricts relative movement of the first container 30 with respect to the tray 90 in the direction in which the plug 34 and the first side wall 92a face each other by coming into contact with the plug 34 and the body 32b. Therefore, the gap G between the first side wall portion 92a and the plug 34 can be stably maintained. As a result, oxygen can stably move from the inside of the first container 30 to the outside of the first container 30 by permeating the plug 34 .
- the second positioning portion 91Y has a second positioning protrusion 91b provided on the bottom wall 91.
- the second positioning protrusions 91b are a pair of protrusions.
- the second positioning protrusion 91b contacts the body 32b of the first container 30 from a direction orthogonal to the direction in which the plug 34 and the first side wall 92a face each other, and moves the first container 30 relative to the tray 90. can be regulated. As a result, the position of the first container 30 on the tray 90 is stabilized, and the liquid L in the first container 30 can be stably stored.
- the tray 90 may or may not have oxygen barrier properties.
- the tray 90 may be oxygen permeable or impermeable to oxygen.
- the tray 90 is made of resin, for example.
- the tray 90 may be produced by injection molding, or may be produced by drawing a resin plate. Tray 90 may be colorless or colored. Tray 90 may be transparent. If the second container 40 and the tray 90 are transparent, the state of the first container 30 can be confirmed from the outside of the second container 40 .
- the oxygen content measuring device Fibox3 the oxygen content in the first container 30 can be measured by irradiating light from the outside of the second container 40 toward the first container 30 .
- the oxygen scavenger 21 can be provided in the liquid-filled combination container 10L as described above.
- the second container 40 and the first container 30 may contain the deoxidizing film 23 .
- An oxygen scavenger 21 may be contained in tray 90 .
- a deoxidizing member 22 may be housed within the second container 40 . As shown in FIG. 8A, the deoxidizing member 22 has an oxygen-permeable package 22a and an oxygen absorber 21 housed in the package 22a.
- the deoxidizing member 22 is positioned between the tray 90 and the second container 40.
- the deoxidizing member 22 is positioned between the bottom wall 91 of the tray 90 and the second container 40 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned between the side wall 92 of the tray 90 and the second container 40 .
- the deoxidizing agent 21 and the deoxidizing member 22 may be positioned between the first side wall portion 92 a and the second container 40 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned between the tray 90 and the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned between the bottom wall 91 and the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned between the side wall 92 and the first container 30 .
- the deoxidizing agent 21 and the deoxidizing member 22 may be positioned between the first side wall portion 92 a and the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger 22 may be positioned between the third side wall portion 92c or the fourth side wall portion 92d and the first container 30, as indicated by a two-dot chain line.
- the deoxidizing agent 21 and the deoxidizing member 22 may be positioned between the second container 40 and the first container 30 .
- the deoxidizing member 22 may be attached to one or more of the first container 30, the second container 40, and the tray 90 via a bonding material such as an adhesive.
- the tray 90 may be provided with one or more of the concave portion 95A, the convex portion 95B and the hole 95C.
- the recesses, protrusions and holes can form oxygen flow channels.
- the flange portion 93 and the second container 40 may be in surface contact.
- the area where the first container 30 is located and the area where the oxygen scavenger 21 is located can be separated by the contact between the flange portion 93 and the second container 40 .
- the flange portion 93 is provided with a groove-shaped concave portion 95A.
- a convex portion 95B is provided on the flange portion 93 .
- the concave portion 95A and the convex portion 95B can prevent the second container 40 from coming into close contact with the entire flange portion 93 .
- sidewall 92 is provided with holes 95C. Note that the hole 95C can be used to measure the oxygen concentration by irradiating it with visible light.
- the second side wall portion 92b may face the mounting surface PL through the second container 40 so that the liquid-filled combination container 10L can be arranged on the mounting surface PL.
- the liquid L in the first container 30 leaves the oxygen-permeable plug 34 .
- Plug 34 is exposed to headspace HS.
- oxygen permeation through the plug 34 can be promoted, and the oxygen concentration can be reduced in a short period of time. Therefore, after performing the step of closing the second container 40 containing the first container 30, for example, by absorbing the oxygen in the second container 40 using the oxygen scavenger 21, in the step of adjusting the oxygen concentration , the liquid-filled combination container 10L may be placed on the placement surface PL in the state shown in FIG.
- the second side wall portion 92b is inclined with respect to the bottom wall 91 at an angle greater than 90°. That is, the second side wall portion 92 b is inclined with respect to the normal line direction to the bottom wall 91 so that the opening 90 A is wider than the bottom wall 91 . Therefore, when the liquid-filled combination container 10L is arranged on the mounting surface PL so that the second side wall portion 92b faces the mounting surface PL through the second container 40, as shown in FIG.
- the bottom wall 91 is inclined with respect to .
- the first container 30 lying on the bottom wall 91 can be maintained in an inclined state with respect to the vertical direction. As a result, the area of the liquid surface of the liquid L exposed to the headspace HS is increased. As a result, the movement of oxygen dissolved in the liquid L to the headspace HS is promoted, and the amount of oxygen in the first container 30 can be reduced in a short period of time.
- the first side wall portion 92a is also inclined with respect to the bottom wall 91 at an angle greater than 90°. That is, the first side wall portion 92 a is inclined with respect to the normal line direction to the bottom wall 91 so that the opening 90 A is wider than the bottom wall 91 . Thereby, the gap G between the first side wall portion 92a and the plug 34 can be stably secured. In addition, the oxygen that permeates the plug 34 can easily flow within the tray 90 . Therefore, the amount of oxygen in the first container 30 can be stably reduced in a short period of time.
- the tray 90 may be used even after the second container 40 is opened.
- the first container 30 can stand up within the tray 90 .
- the first container 30 can be placed in the tray 90 such that the bottom portion 32a of the container body 32 faces the bottom wall 91 of the tray 90 .
- the stopper 34 and the opening 33 of the container body 32 face the side away from the bottom wall 91 in the normal direction to the bottom wall 91 .
- the operation of removing the liquid L from the first container 30 shown in FIG. 11 can be performed on the first container 30 arranged in the tray 90 . As a result, it is possible to prevent the liquid L from adhering to the mounting surface PL, which is preferable in terms of hygiene.
- FIG. 35-37 show a second embodiment of the second container 40.
- FIG. FIG. 35 is a perspective view showing a liquid-filled combination container 10L according to the second specific example.
- FIG. 37 is a longitudinal sectional view of the liquid-filled combination container 10L shown in FIG.
- a liquid-filled combination container 10L has a first container 30 and a second container 40 .
- the illustrated first container 30 has a container body 32 with an opening 33 and a plug 34 closing the opening 33 .
- Plug 34 is permeable to oxygen.
- Plug 34 is permeable to oxygen.
- the second container 40 has oxygen barrier properties.
- the second container 40 has a tray 90 that has an opening 90A and accommodates the first container 30, and a lid member 95 that closes the opening 90A of the tray 90.
- the tray 90 included in the second container 40 of the second specific example can be configured similarly to the tray 90 of the first specific example as long as it has oxygen barrier properties.
- the lid member 95 has an oxygen barrier property.
- a lid member 95 is joined to the tray 90 .
- the lid material 95 may be joined by welding such as heat sealing or ultrasonic joining, or joining using an adhesive material or an adhesive material.
- the lid member 95 is joined to the flange portion 93 .
- the lid member 95 can be formed using various materials having oxygen barrier properties as described above.
- Lid 95 may be transparent for the same reason as tray 90 .
- the liquid-filled combination container 10L may include a deoxidizing member 22 that absorbs oxygen within the second container 40 .
- the liquid-filled combination container 10L according to the second embodiment may have an outer box similar to that of the first embodiment.
- the tray 90 has a bottom wall 91 and side walls 92.
- a gap G is formed between the side wall 92 and the plug 34 .
- the plug 34 having oxygen permeability from being covered by the second container 40 having oxygen barrier properties. Therefore, it is possible to promote the movement of oxygen from inside the first container 30 to outside the first container 30 by allowing the oxygen to permeate the plug 34 .
- the oxygen concentration (%) in the head space HS of the first container 30 can be stably reduced and the The oxygen dissolution amount (mg/L) of the liquid L can be stably reduced. Thereby, the internal pressure of the first container 30 can be stably reduced.
- the tray 90 according to the second specific example may have a first positioning portion 91X for the same purpose as the first specific example shown in FIG.
- the tray 90 may have a first positioning protrusion 91a.
- the tray 90 according to the second specific example may have a second positioning portion 91Y for the same purpose as the first specific example shown in FIG.
- the tray 90 may have a second positioning protrusion 91b.
- the oxygen scavenger 21 can be provided in the liquid-filled combination container 10L.
- the second container 40 and the first container 30 may contain the deoxidizing film 23 .
- the oxygen scavenger 21 may be contained in the tray 90 and lid member 95 .
- a deoxidizing member 22 may be housed within the second container 40 .
- the deoxidizing member 22 is positioned between the lid member 95 and the first container 30.
- the deoxidizing member 22 may be joined to the lid member 95 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned between the tray 90 and the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned between the bottom wall 91 and the first container 30, as indicated by a two-dot chain line in FIG.
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned between the side wall 92 and the first container 30 .
- the deoxidizing agent 21 and the deoxidizing member 22 may be positioned between the first side wall portion 92 a and the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger 22 may be positioned between the third side wall portion 92c or the fourth side wall portion 92d and the first container 30, as indicated by a two-dot chain line.
- the liquid-filled combination container 10L may be arranged on the mounting surface PL so that the second side wall portion 92b faces the mounting surface PL.
- the liquid L in the first container 30 leaves the oxygen-permeable plug 34 .
- Plug 34 is exposed to headspace HS.
- oxygen permeation through the plug 34 can be promoted, and the oxygen concentration can be reduced in a short period of time. Therefore, after performing the step of closing the second container 40 containing the first container 30, for example, by absorbing the oxygen in the second container 40 using the oxygen scavenger 21, in the step of adjusting the oxygen concentration , the liquid-filled combination container 10L may be arranged on the mounting surface PL in the state shown in FIG.
- the second side wall portion 92b is inclined with respect to the bottom wall 91 at an angle greater than 90°. That is, the second side wall portion 92 b is inclined with respect to the normal line direction to the bottom wall 91 so that the opening 90 A is wider than the bottom wall 91 . Therefore, when the liquid-filled combination container 10L is arranged on the mounting surface PL so that the second side wall portion 92b faces the mounting surface PL through the second container 40, the mounting surface PL The bottom wall 91 is inclined with respect to .
- the first container 30 lying on the bottom wall 91 can be maintained in an inclined state with respect to the vertical direction. As a result, the area of the liquid surface of the liquid L exposed to the headspace HS is increased. As a result, the movement of oxygen dissolved in the liquid L to the headspace HS is promoted, and the amount of oxygen in the first container 30 can be reduced in a short period of time.
- the first side wall portion 92a is also inclined with respect to the bottom wall 91 at an angle greater than 90°. That is, the first side wall portion 92 a is inclined with respect to the normal line direction to the bottom wall 91 so that the opening 90 A is wider than the bottom wall 91 . Thereby, the gap G between the first side wall portion 92a and the plug 34 can be stably secured. In addition, the oxygen that permeates the plug 34 can easily flow within the tray 90 . Therefore, the amount of oxygen in the first container 30 can be stably reduced in a short period of time.
- the tray 90 may be used after the second container 40 is opened, as in the first specific example described with reference to FIG.
- the operation of removing the liquid L from the first container 30 shown in FIG. 11 may be performed on the first container 30 arranged in the tray 90.
- FIG. FIG. 38 is a perspective view showing a liquid-filled combination container 10L according to the third specific example.
- a liquid-filled combination container 10L has a first container 30 and a second container 40 .
- the illustrated first container 30 has a container body 32 with an opening 33 and a plug 34 closing the opening 33 .
- Plug 34 is permeable to oxygen. That is, oxygen is permeable through plug 34 .
- the second container 40 has oxygen barrier properties.
- the second container 40 is a film container.
- the film used for the second container 40 is as described above.
- the second container has a first main film (first film) 41a and a second main film (second film) 41b.
- the first main film 41a and the second main film 41b are arranged facing each other.
- the first main film 41a and the second main film 41b may be different films, or may be a single folded film.
- the first main film 41a and the second main film 41b are joined to each other at the seal portion 49 .
- the bonding at the seal portion 49 may be, for example, welding such as heat sealing or ultrasonic bonding, or bonding using an adhesive material or an adhesive material.
- a housing space for housing the first container 30 is formed between the first main film 41a and the second main film 41b.
- the first main film 41 a and the second main film 41 b can be peeled off at the seal portion 49 .
- the first main film 41a and the second main film 41b are separated from each other at the seal portion 49 by the user applying a force to peel the first main film 41a and the second main film 41b apart.
- the sealing portion 49 can be peeled off by adjusting the processing conditions at the time of bonding, the material and thickness of the bonding material, and the like.
- the seal portion 49 includes a curved first seal portion 49a.
- the stopper 34 of the first container 30 housed in the second container 40 faces the first seal portion 49a.
- the first seal portion 49a is bent.
- the first seal portion 49a may be curved.
- the first seal portion 49 a protrudes outside the second container 40 . That is, the first seal portion 49a protrudes away from the accommodation space of the second container 40 .
- the first seal portion 49a protrudes away from the plug 34 in the direction in which the first seal portion 49a and the plug 34 face each other.
- a gap G is formed between the second container 40 and the plug 34 by the first sealing portion 49a bent to expand the accommodation space of the second container 40 and facing the plug 34 of the first container 30 .
- the plug 34 having oxygen permeability As a result, it is possible to prevent the plug 34 having oxygen permeability from being covered by the second container 40 having oxygen barrier properties. Therefore, it is possible to promote the movement of oxygen from inside the first container 30 to outside the first container 30 by allowing the oxygen to permeate the plug 34 .
- the oxygen concentration (%) in the head space HS of the first container 30 can be stably reduced and the The oxygen dissolution amount (mg/L) of the liquid L can be stably reduced. Thereby, the internal pressure of the first container 30 can be stably reduced.
- the seal portion 49 includes a first side seal portion 49b connected to one end of the first seal portion 49a and a second side seal portion 49c connected to the other end of the first seal portion 49a. I'm in.
- a housing space for housing the first container 30 is formed between the first side seal portion 49b and the second side seal portion 49c.
- the minimum spacing DXa along the first main film 41a between the first side seal portion 49b and the second side seal portion 49c is the length of the first container 30 along the direction DA in which the plug 34 is inserted into the opening 33. It may be shorter than L30.
- the minimum spacing DXb along the second main film 41b between the first side seal portion 49b and the second side seal portion 49c is the length of the first container 30 along the direction DA in which the plug 34 is inserted into the opening 33. It may be shorter than L30.
- the minimum distance DXa along the first main film 41a between the first side seal portion 49b and the second side seal portion 49c is the first main film distance between the first side seal portion 49b and the second side seal portion 49c. 41a minimum length.
- the minimum distance DXb along the second main film 41b between the first side seal portion 49b and the second side seal portion 49c is the second main film distance between the first side seal portion 49b and the second side seal portion 49c. 41b minimum length.
- the length L30 of the first container 30 is the length in the axial direction of the first container 30 and is generally the length in the longitudinal direction of the first container 30 .
- the direction of the first container 30 is adjusted to the inside of the second container 40. It is possible to suppress a large change in As a result, the plug 34 of the first container 30 stably faces the first seal portion 49a. Therefore, the gap G between the second container 40 and the stopper 34 can be stably secured. As a result, the amount of oxygen in the first container 30 can be stably reduced.
- the first main film 41a may include extended film portions 50 that are not joined to the second main film 41b.
- the second main film 41b may include extended film portions 50 that are not joined to the first main film 41a.
- the extending film portion 50 may be adjacent to the seal portion 49 .
- the user can easily apply a peeling force to the first main film 41a and the second main film 41b by gripping the extended film portion 50.
- the extended film portion 50 is adjacent to the curved first seal portion 49a.
- the extending film portion 50 is composed of the same first and second main films 41 a and 41 b as the portion forming the accommodation space of the second container 40 .
- the extending film portion 50 and the portion forming the accommodation space of the second container 40 are the portions where the first and second main films 41 a and 41 b are partitioned by the sealing portion 49 .
- the peeling force concentrates on the bent position of the first seal portion 49a, so that the first main film 41a and the second main film 41b can be smoothly peeled off.
- the first seal portion 49 a serves as the portion to be opened 51 .
- the opening scheduled portion 51 is a portion intended to be opened when the second container 40 is opened.
- the seal portion 49 further has a second seal portion 49d connecting the first side seal portion 49b and the second side seal portion 49c.
- a circumferential seal portion 49 is formed by the first seal portion 49a, the first side seal portion 49b, the second side seal portion 49c, and the second seal portion 49d. forming a space.
- a folded portion 41x formed by folding one sheet of film may be provided.
- the bottom film 41e shown in FIG. 10D may be used. By using the bottom film 41e, the second container 40 may be used as a standing pouch that can stand on its own.
- the seal strength of the seal portion 49 may be increased on the second seal portion 49d side of the first side seal portion 49b and the second side seal portion 49c.
- the bonding strength between the first main film 41a and the second main film 41b may be increased on the second seal portion 49d side of the first side seal portion 49b and the second side seal portion 49c.
- the width of the side seal portions 49b and 49c may be widened on the side of the second seal portion 49d, as indicated by the dashed line in FIG.
- the processing temperature for forming the seal portion 49 may be set to a high temperature on the second seal portion 49d side of the side seal portions 49b and 49c.
- the number of times of processing for forming the seal portion 49 may be increased on the second seal portion 49d side of the side seal portions 49b and 49c. According to such an example, the peeling of the first main film 41a and the second main film 41b starting from the first seal portion 49a can be easily stopped in the middle of the side seal portions 49b and 49c. Accordingly, when the second container 40 is opened, it is possible to prevent the first container 30 from being greatly shaken inside the second container 40 and prevent the first container 30 from unintentionally falling out of the second container 40 .
- a deoxidizing agent 21 may be provided in the liquid-filled combination container 10L.
- the second container 40 and the first container 30 may contain the deoxidizing film 23 .
- a deoxidizing member 22 may be housed within the second container 40 .
- a deoxidizing member 22 may be joined to the second container 40 .
- the liquid-filled combination container 10L may have an outer box 100 as in other specific examples.
- the first main film 41a and the second main film 41b extend along the diagonal lines in the housing space of the outer box 100.
- the second container 40 containing the first container 30 may be housed inside the outer box 100 .
- the first side seal portion 49b and the second side seal portion 49c are arranged along a pair of diagonal corners in the outer box 100, respectively, so that the first container 30 is accommodated in the second container. 40 may be housed within the outer box 100 .
- the movement of the second container 40 containing the first container 30 within the outer case 100 can be suppressed.
- the liquid L in the first container 30 can be stably stored.
- the gap G between the second container 40 and the plug 34 is stably maintained while being housed in the outer case 100, and the flow path of oxygen from the plug 34 to the oxygen scavenger 21 is maintained. Secured.
- This flow path accommodates the second container 40 containing the first container 30 in the outer case 100 so that the side seal portions 49b and 49c are along a pair of corners in the outer case 100, By ensuring the gap G by making the container 40 sufficiently longer than the first container 30, the stability can be ensured.
- FIG. 40 and 41 show a fourth specific example of the second container 40.
- FIG. FIG. 40 is a perspective view showing a liquid-filled combination container 10L according to the fourth specific example.
- FIG. 41 shows the second container 40 of FIG. 40 in an open state.
- a liquid-filled combination container 10L has a first container 30 and a second container 40 .
- the illustrated first container 30 has a container body 32 with an opening 33 and a plug 34 closing the opening 33 .
- Plug 34 is permeable to oxygen. That is, oxygen is permeable through plug 34 .
- the second container 40 has oxygen barrier properties.
- the second container 40 is a film container.
- the film used for the second container 40 is as described above.
- the second container 40 has a first main film 41a and a second main film 41b.
- the first main film 41a and the second main film 41b are arranged facing each other.
- the first main film 41a and the second main film 41b may be different films, or may be a single folded film.
- the first main film 41a and the second main film 41b are joined to each other at the seal portion 49 .
- the bonding at the seal portion 49 may be, for example, welding such as heat sealing or ultrasonic bonding, or bonding using an adhesive material or an adhesive material.
- a housing space for housing the first container 30 is formed between the first main film 41a and the second main film 41b.
- the second container 40 is opened by cutting the first main film 41a and the second main film 41b at the part 51 to be opened.
- the scheduled opening portion 51 is a portion intended to be cut when the second container 40 is opened.
- the planned opening portion 51 is a linear portion.
- the intended opening portion 51 can be formed by the material 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 intended opening portion 51 can be formed by imparting anisotropy to the materials of the first main film 41a and the second main film 41b by stretching or the like.
- the portion to be opened 51 can be formed by half-cutting or laser processing the first main film 41a and the second main film 41b, straight-cutting the intermediate layer film, or the like.
- the seal portion 49 has a first side seal portion 49b and a second side seal portion 49c separated in the longitudinal direction of the portion to be opened 51 .
- the first side seal portion 49b and the second side seal portion 49c face each other in the width direction.
- a penetrating portion 52 penetrating through the first main film 41a and the second main film 41b is provided at a position where the second side seal portion 49c intersects with the intended opening portion 51.
- a plan view shape of the penetrating portion 52 is not particularly limited.
- the planar view shape of the penetrating portion 52 may be an ellipse as in the illustrated example, a circle, a polygon such as a triangle or a square, or an elongated slit shape.
- cutting of the first main film 41a and the second main film 41b can be stopped at the penetration portion 52 when the second container 40 is opened. That is, when the second container 40 is opened, it is possible to suppress the generation of pieces of the second container 40 . Therefore, the handleability of the combination container 10 discarded after use is improved.
- This specific example is suitable for places where highly sensitive liquids L such as foods and medicines are handled, since hygiene considerations are required.
- the first side seal portion 49b may be provided with a notch 51a serving as one end of the portion to be opened 51.
- the notch 51a may be a slit or a notch.
- the second side seal portion 49c may have a widened portion 49X.
- the widened portion 49X is wider than the portion adjacent to the widened portion 49X of the second side seal portion 49c.
- the widened portion 49X may be wider than other portions of the second side seal portion 49c.
- the penetrating portion 52 may be provided at a position that intersects the opening-scheduled portion 51 of the widened portion 49X. According to this example, the size of the through portion 52 can be increased. Therefore, when the second container 40 is opened, the cutting of the first main film 41a and the second main film 41b can be stopped more stably at the penetrating portion 52 .
- the width of the second side seal portion 49c may be constant.
- the second side seal portion 49c has an inner edge 49c1 that protrudes closer to the first side seal portion 49b at the widened portion 49X.
- the widened portion 49X is formed by locally widening the second side seal portion 49c along the longitudinal direction of the portion to be opened 51 toward the first side seal portion 49b. Therefore, the widened portion 49X can be provided while suppressing the enlargement of the second container 40 .
- the oxygen-permeable stopper 34 of the first container 30 is positioned between the first side seal portion 49b and the widened portion 49X of the second side seal portion 49c. You may face the space S in the container 40 . Further, the oxygen-permeable stopper 34 of the first container 30 is partially located in the space S inside the second container 40 located between the first side seal portion 49b and the widened portion 49X of the second side seal portion 49c. can be positioned According to this example, space S may form gap G between second container 40 and stopper 34 . As a result, it is possible to prevent the plug 34 having oxygen permeability from being covered by the second container 40 having oxygen barrier properties.
- the oxygen concentration (%) in the headspace HS of the first container 30 can be stably reduced and the The oxygen dissolution amount (mg/L) of the liquid L can be stably reduced. Thereby, the internal pressure of the first container 30 can be stably reduced.
- a deoxidizing agent 21 may be provided in the liquid-filled combination container 10L.
- the second container 40 and the first container 30 may contain the deoxidizing film 23 .
- a deoxidizing member 22 may be housed within the second container 40 .
- a deoxidizing member 22 may be joined to the second container 40 .
- the deoxidizing agent 21 and the deoxidizing member 22 deviate from the widened portion 49X in the direction in which the space S in the second container 40 and the stopper face each other. may be held at In the illustrated example, the oxygen scavenging member 22 may be joined to the second container 40 .
- the deoxidizing member 22 can suppress the movement of the portion 51 to be opened of the first container 30 in the second container 40 in the longitudinal direction (width direction). That is, the deoxidizing member 22 maintains the state in which the plug 34 faces the space S, thereby promoting the reduction of the amount of oxygen in the first container 30 .
- the seal portion 49 connects the first side seal portion 49b and the second side seal portion 49c with a first seal portion 49a that connects the first side seal portion 49b and the second side seal portion 49c. and a second seal portion 49d.
- a circumferential seal portion 49 is formed by the first seal portion 49a, the first side seal portion 49b, the second side seal portion 49c, and the second seal portion 49d. forming a space.
- a folded portion 41x formed by folding one sheet of film may be provided.
- the bottom film 41e shown in FIG. 10D may be used. By using the bottom film 41e, the second container 40 may be used as a standing pouch that can stand on its own.
- the minimum distances DXa and DXb along the main films 41a and 41b between the side seal portions 49b and 49c are made shorter than the length L30 of the first container 30. good too. According to this configuration, it is possible to prevent the orientation of the first container 30 from significantly changing within the second container 40 . As a result, the plug 34 of the first container 30 stably faces the first seal portion 49a. Therefore, the gap G between the second container 40 and the stopper 34 can be stably secured. As a result, the amount of oxygen in the first container 30 can be stably reduced.
- the liquid-filled combination container 10L may have an outer box 100 as in other specific examples.
- the method of housing the second container 40 housing the first container 30 in the outer box 100 may be the same as in the third specific example described with reference to FIG.
- FIG. FIG. 42 is a perspective view showing the outer case 100 of the liquid-filled combination container 10L according to the fifth specific example.
- FIG. 43 shows the second container 40 containing the first container 30 housed in the outer box 100 of FIG.
- a liquid-filled combination container 10L has a first container 30, a second container 40 and an outer box 100.
- the illustrated first container 30 has a container body 32 with an opening 33 and a plug 34 closing the opening 33 .
- Plug 34 is permeable to oxygen. That is, oxygen is permeable through plug 34 .
- the second container 40 has oxygen barrier properties.
- the second container 40 is a film container.
- the film used for the second container 40 is as described above.
- the second container may have a first main film 41a and a second main film 41b.
- the first main film 41a and the second main film 41b are arranged facing each other.
- the first main film 41a and the second main film 41b may be different films, or may be a single folded film.
- the first main film 41a and the second main film 41b are joined to each other at the seal portion 49 .
- the bonding at the seal portion 49 may be, for example, welding such as heat sealing or ultrasonic bonding, or bonding using an adhesive material or an adhesive material.
- a housing space for housing the first container 30 is formed between the first main film 41a and the second main film 41b.
- the first main film 41 a and the second main film 41 b can be peeled off at the seal portion 49 .
- the first main film 41a and the second main film 41b are separated from each other at the seal portion 49 by the user applying a force to peel the first main film 41a and the second main film 41b apart.
- the sealing portion 49 can be peeled off by adjusting the processing conditions at the time of bonding, the material and thickness of the bonding material, and the like.
- the outer box 100 has an outer box body 101 and a lid 102 that can move relative to the outer box body 101 .
- the outer case 100 can be opened by relative movement of the lid portion 102 and the outer case body portion 101 .
- the outer box 100 can be made of paper.
- the lid portion 102 is swingable with respect to the outer box main body portion 101 .
- the lid portion 102 may be formed integrally with the outer box body portion 101 .
- an outer case 100 is provided with a portion to be cut 100a constituted by holes, half-cuts, or the like arranged in a dotted line.
- the lid 102 can swing with respect to the outer box main body 101 .
- the outer case 100 is opened by swinging the lid portion 102 with respect to the outer case main body portion 101 .
- the first main film 41a is attached to the outer box body 101
- the second main film 41b is attached to the lid 102.
- the lid portion 102 When the lid portion 102 is moved relative to the outer box main body portion 101, the second main film 41b is separated from the first main film 41a.
- the second main film 41b is peeled off from the first main film 41a at the sealing portion 49, thereby 2 container 40 is opened.
- This configuration facilitates taking out the first container 30 from the liquid-filled combination container 10L having the outer case 100 .
- the first main film 41a and the second main film 41b are attached to the outer case 100, it is possible to prevent the oxygen-permeable plug 34 from being covered by the oxygen-barrier second container 40. That is, a gap G can be formed between the second container 40 and the stopper 34 . Therefore, it is possible to promote the movement of oxygen from inside the first container 30 to outside the first container 30 by allowing the oxygen to permeate the plug 34 .
- the oxygen concentration (%) in the headspace HS of the first container 30 can be stably reduced and the The oxygen dissolution amount (mg/L) of the liquid L can be stably reduced. Thereby, the internal pressure of the first container 30 can be stably reduced.
- the seal portion 49 includes a curved first seal portion 49a.
- the first seal portion 49a is bent.
- the first seal portion 49a may be curved.
- the first seal portion 49 a protrudes away from the first container 30 . That is, the first seal portion 49a protrudes toward the side where the accommodation space of the second container 40 is widened.
- the illustrated seal portion 49 further includes a first side seal portion 49b, a second side seal portion 49c, and a second seal portion 49d.
- the first side seal portion 49b is connected to one end of the first seal portion 49a and one end of the second seal portion 49d.
- the second side seal portion 49c is connected to the other end of the first seal portion 49a and the other end of the second seal portion 49d.
- the second seal portion 49d is positioned to face the first seal portion 49a.
- a circumferential seal portion 49 is formed by the first seal portion 49a, the first side seal portion 49b, the second side seal portion 49c, and the second seal portion 49d. forming a space.
- a folded portion 41x formed by folding one sheet of film may be provided.
- the bottom film 41e shown in FIG. 10D may be used instead of joining the first main film 41a and the second main film 41b at the second seal portion 49d.
- the first main film 41a may include extended film portions 50 that are not joined to the second main film 41b.
- the second main film 41b may include extended film portions 50 that are not joined to the first main film 41a.
- the extending film portion 50 may be adjacent to the seal portion 49 .
- the seal portion 49 of the first main film 41a is bonded to the lid portion 102 via a bonding material 28 such as an adhesive or adhesive.
- a bonding material 28 such as an adhesive or adhesive.
- the extended film portion 50 is adjacent to the curved first seal portion 49a.
- the peeling force concentrates on the bent position of the first seal portion 49a, so that the first main film 41a and the second main film 41b can be smoothly peeled off.
- the portion forming the accommodation space of the first main film 41a that is, the portion of the first main film 41a facing the first container 30 is also connected to the outer box 100 with the bonding material 28 interposed therebetween.
- the portion of the second main film 41b that forms the accommodation space that is, the portion of the second main film 41b that faces the first container 30 is also joined to the outer case 100 via the joining material .
- the first main film 41a and the second main film 41b can be peeled off smoothly.
- the gap G can be stably secured between the plug 34 of the first container 30 and the second container 40, thereby quickly reducing the amount of oxygen.
- the outer box 100 may have a transparent transparent portion 100b.
- the state of the first container 30 and the second container 40 accommodated in the outer case 100 can be confirmed through the transparent portion 100b.
- visible light is irradiated from the outside of the outer box 100 toward the first container 30 by using, for example, the oxygen content measuring device Fibox3, and the inside of the first container 30 Oxygen content can be measured.
- a deoxidizing agent 21 may be provided in the liquid-filled combination container 10L.
- the second container 40 and the first container 30 may contain the deoxidizing film 23 .
- a deoxidizing member 22 may be housed within the second container 40 .
- a deoxidizing member 22 may be joined to the second container 40 .
- FIG. 46-48 show a sixth embodiment of the second container 40.
- FIG. FIG. 46 is a perspective view showing a liquid-filled combination container 10L according to the sixth specific example.
- FIG. 47 shows the liquid-filled combination container 10L in cross section along line AA in FIG. 48A and 48B are diagrams illustrating a method of manufacturing the liquid-filled combination container 10L shown in FIG.
- the illustrated first container 30 has a container body 32 with an opening 33 and a plug 34 closing the opening 33 .
- Plug 34 is permeable to oxygen. That is, oxygen is permeable through plug 34 .
- the second container 40 has oxygen barrier properties.
- the second container 40 is a film container.
- the film used for the second container 40 is as described above.
- the second container 40 has a first main film 41a and a second main film 41b.
- the first main film 41a and the second main film 41b are arranged facing each other.
- the first main film 41a and the second main film 41b may be different films, or may be a single folded film.
- the first main film 41a and the second main film 41b are joined to each other at the seal portion 49 .
- the bonding at the seal portion 49 may be, for example, welding such as heat sealing or ultrasonic bonding, or bonding using an adhesive material or an adhesive material.
- a housing space for housing the first container 30 is formed between the first main film 41a and the second main film 41b.
- the second container 40 has a gas bag 53 provided between the first main film 41a and the second main film 41b.
- the gas bag 53 is a bag containing gas.
- the gas bag 53 is made using, for example, a resin film.
- the gas bag 53 may not have oxygen barrier properties as long as it does not form the outer surface of the second container 40 .
- the gas bag 53 may have oxygen barrier properties.
- the gas sealed in the gas bag 53 is not particularly limited.
- the gas sealed in the gas bag 53 may be an inert gas.
- the gas bag 53 By providing the gas bag 53 in the accommodation space of the second container 40 formed between the first main film 41a and the second main film 41b, the gas bag 53 functions as a cushioning material to protect the first container 30. It can be stably housed in the second container 40 . As a result, in addition to being able to suppress breakage of the first container 30, vibration and impact of the first container 30 can be suppressed. Therefore, the liquid L in the first container 30 can be stably stored.
- the arrangement of the first container 30 within the second container 40 can be stabilized. Furthermore, the distance between the pair of main films 41a and 41b can be widened. As a result, it is possible to prevent the plug 34 having oxygen permeability from being covered by the second container 40 having oxygen barrier properties. That is, a gap G can be formed between the second container 40 and the stopper 34 . Therefore, it is possible to promote the movement of oxygen from inside the first container 30 to outside the first container 30 by allowing the oxygen to permeate the plug 34 .
- the oxygen concentration (%) in the headspace HS of the first container 30 can be stably reduced and the The oxygen dissolution amount (mg/L) of the liquid L can be stably reduced.
- the gas bag 53 may be joined to the first main film 41a and the second main film 41b.
- the bonding may be, for example, welding such as heat sealing or ultrasonic bonding, or bonding using an adhesive material or an adhesive material.
- the position of gas bag 53 is stabilized by joining gas bag 53 to first main film 41a and second main film 41b. Thereby, the arrangement of the first container 30 in the second container 40 can be stabilized. Thereby, the liquid L in the first container 30 can be stably stored.
- the gas bag 53 may be joined to the main films 41a and 41b at the sealing portion 49 that joins the first main film 41a and the second main film 41b. According to this example, the bonding of the gas bag 53 to the main films 41a, 41b can be performed when the second container 40 is manufactured.
- the seal portion 49 may have a first side seal portion 49b and a second side seal portion 49c.
- the first side seal portion 49b and the second side seal portion 49c are arranged to face each other.
- the first side seal portion 49b and the second side seal portion 49c are spaced apart in the width direction.
- FIG. 47 is a cross section of the liquid-filled combination container 10L along the width direction.
- the second container 40 includes a first gas bag 53A joined to the main films 41a and 41b at the first side seal portion 49b and a second gas bag 53B joined to the main films 41a and 41b at the second side seal portion 49c. and have In the accommodation space of the second container 40, the first container 30 is positioned between the first gas bag 53A and the second gas bag 53B. According to this configuration, the first container 30 can be stored more stably. Also, the gap G can be secured more stably.
- the seal portion 49 connects the first side seal portion 49b and the second side seal portion 49c with a first seal portion 49a that connects the first side seal portion 49b and the second side seal portion 49c. and a second seal portion 49d.
- a circumferential seal portion 49 is formed by the first seal portion 49a, the first side seal portion 49b, the second side seal portion 49c, and the second seal portion 49d. forming a space.
- the second container 40 can be composed of a first main film 41a and a second main film 41b, and a first bag film 41f and a second bag film 41g.
- the first bag film 41f is a single folded film placed between the pair of main films 41a and 41b. Both side edges of the folded first bag film 41f are joined to one side edge of the pair of main films 41a and 41b to form a first side seal portion 49b. The upper edge of the folded first bag film 41f is joined to part of the upper edges of the pair of main films 41a and 41b to form part of the first seal portion 49a.
- the lower edge of the folded back first bag film 41f is joined to part of the lower edges of the pair of main films 41a and 41b to form part of the second seal portion 49d. In this way, the folded first bag film 41f is sealed on three sides.
- gas is supplied to the folded region of the first bag film 41f to obtain the first gas bag 53A.
- the second bag film 41g is arranged symmetrically with the first bag film 41f to form the second gas bag 53B with a structure symmetrical with the first bag film 41f.
- the first bag film 41f and the second bag film 41g may be films that can be used for the second container 40 described above, such as films used for the main films 41a and 41b.
- a deoxidizing agent 21 may be provided in the liquid-filled combination container 10L.
- the second container 40 and the first container 30 may contain the deoxidizing film 23 .
- a deoxidizing member 22 may be housed within the second container 40 .
- a deoxidizing member 22 may be joined to the second container 40 .
- the oxygen absorber 21 and the oxygen absorber 22 may be held between one of the first main film 41a and the second main film 41b and the gas bag 53.
- the deoxidizing member 22 is sandwiched between the first gas bag 53A and the second main film 41b. Since the deoxidizing member 22 is held in the second container 40 without using a bonding material such as an adhesive, the waste can be easily separated when the liquid-filled combination container 10L is discarded.
- the liquid-filled combination container 10L may have an outer box 100 as in other specific examples.
- a notch (not shown) may be provided in the sealing portion 49 of the second container 40 . The notch facilitates opening of the second container.
- a barrier layer 81 may be provided on the surface of the plug 34 to restrict elution of the contents of the plug 34 .
- plug 34 includes plug body 35 and barrier layer 81 .
- the plug body 35 may contain silicone.
- a barrier layer 81 may be provided on the inner surface of the plug 34 . As indicated by reference numeral 81 in FIG.
- the barrier layer 81 may be provided on a portion of the plug 34 that is inserted into the container body 32 .
- Barrier layers 81 and 81A may be provided at positions of the plug 34 that can contact the container body 32, as indicated by reference numeral 81A in FIG.
- Barrier layers 81, 81A, and 81B may be provided on the entire surface of plug 34, as indicated by reference numeral 81B in FIG.
- the barrier layer 81 may contain a paraxylylene layer.
- the para-xylylene layer may contain para-xylylene N, para-xylylene C, or para-xylylene HT.
- the para-xylylene layer may be fabricated on the plug body 35 by vacuum deposition.
- the thickness of the paraxylylene layer may be 0.1 ⁇ m or more and 2 ⁇ m or less, 0.1 ⁇ m or more and 1 ⁇ m or less, or 0.1 ⁇ m or more and 0.5 ⁇ m or less.
- Sufficient gas permeability can be imparted to the plug 34 by setting an upper limit for the thickness of the paraxylylene layer. By setting a lower limit for the thickness of the paraxylylene layer, the plug 34 can be provided with a sufficient elution inhibiting function.
- the barrier layer 81 may include a fluororesin layer.
- the fluororesin layer may contain perfluoroalkoxyalkane (PFA).
- the fluororesin layer may contain perfluoroethylene propene copolymer (FEP).
- the fluororesin layer may contain ethylenetetrafluoroethylene copolymer (ETFE).
- the fluororesin layer may be formed on the plug main body 35 by coating.
- the thickness of the fluororesin layer may be 0.1 ⁇ m or more and 60 ⁇ m or less, 0.1 ⁇ m or more and 40 ⁇ m or less, or 0.1 ⁇ m or more and 25 ⁇ m or less.
- the plug 34 By setting an upper limit for the thickness of the fluororesin layer, it is possible to impart sufficient gas permeability to the plug 34 . By setting a lower limit for the thickness of the fluororesin layer, the plug 34 can be provided with a sufficient elution inhibiting function.
- the barrier layer 81 may include an amorphous fluorine layer.
- the amorphous fluorine layer may be produced on the plug body 35 by coating.
- the thickness of the amorphous fluorine layer may be 0.1 ⁇ m or more and 4 mm or less.
- the plug 34 is preferably not in contact with the liquid L in the step of adjusting the pressure.
- plug 34 is kept away from liquid L during the pressure adjustment step.
- plug 34 is in contact with gas during the pressure adjustment step. Therefore, the stopper 34 may be subjected to a liquid-repellent treatment.
- the plug 34 may have a liquid-repellent structure.
- the contact angle of the inner surface of the plug 34 that has been subjected to liquid-repellent treatment or has a liquid-repellent structure may be 80° or more, or 90° or more in the static drop method of the surface wettability test method conforming to JIS R3257. It may be 95° or more, or less than 180°.
- liquid-repellent treatment examples include surface modification treatment such as ion beam irradiation and plasma treatment.
- the surface of the plug 34 facing the inside of the container body 32 may include an uneven surface 82 .
- the uneven surface 82 forming the inner surface of the plug 34 includes a fine uneven structure.
- the recesses 82X of the uneven surface 82 can retain gas. According to this example, the uneven surface 82 can be maintained in a state in which air bubbles are attached.
- the surface area of the plug 34 is increased.
- the increased surface area of the plug 34 can facilitate gas permeation through the plug 34 .
- a protrusion 83 may be provided that protrudes from the inner surface of plug 34 to increase the surface area of plug 34 . For example, as shown by a two-dot chain line in FIG. By separating from the container body 32, the surface area of the projecting portion 83 can be effectively increased.
- the surface area of the plug 34 may be increased by making the outer surface of the plug 34 an uneven surface 84 .
- the increased surface area of the plug 34 can facilitate gas permeation through the plug 34 .
- protrusions 85 may be provided that protrude from the outer surface of plug 34 to increase the surface area of plug 34 .
- the concave-convex surface 84 may be formed such that a gap through which gas can pass is formed between the portion of the plug 34 covered by the fixture 36 and the fixture 36 . According to this example, gas permeation through the plug 34 can be stably promoted.
- a gas-permeable and liquid-repellent sheet 86 may be provided between the container body 32 and the stopper 34 .
- the sheet 86 is exemplified by a sheet having pores capable of retaining gas, such as a non-woven fabric.
- the sheet 86 is exemplified by a sheet material including a sheet main body provided with holes and a liquid-repellent coating layer laminated on the sheet main body.
- the coating layer of the sheet material may be a fluorine-based vapor deposition film or coating film.
- the gas permeability of the sheet is evaluated similarly to the gas permeability of the first container 30 .
- the liquid repellency of the sheet 86 means having a contact angle of 80° or more in the static drop method of the wettability test method based on JIS R3257.
- the sheet 86 shown in FIG. 15 may be attached to and form part of the plug 34 as shown in FIG.
- the sheet 86 shown in FIG. 15 may be held by being sandwiched between the container body 32 and the stopper 34 as a member separate from the container body 32 and the stopper 34 .
- the first container 30 may include an extension wall portion 87 extending from the inner surface of the container body 32. As shown in FIGS. The extension wall portion 87 can prevent the liquid L from adhering to the inner surface of the plug 34 .
- the extension wall portion 87 divides the internal space of the container body 32 into two spaces.
- the liquid L can move between two spaces within the container body 32 .
- the first container 30 in the step of adjusting the pressure in the first container 30, the first container 30 may be stored in a state where the stopper 34 and the bottom portion 32a of the container body 32 face sideways. .
- the first container 30 is arranged such that the body portion 32b is positioned on the mounting surface 5.
- the liquid L is held in a space defined by the container body 32 and the extension wall portion 87 and is not in contact with the stopper 34 . This can promote gas permeation through the plug 34 .
- the first container 30 when the syringe 60 is used to take out the liquid L from the first container 30, the first container 30 may be held with the plug 34 facing downward. In the state shown in FIG. 19, the liquid L passes through the gap between the container body 32 and the extension wall portion 87 and is Move to a demarcated space. In the state shown in FIG. 19, the liquid L is in contact with the plug 34 and the syringe 60 can be used to remove the liquid L from the first container 30 .
- FIG. 20 shows another example of the extending wall portion 87.
- the extending wall portion 87 is annular.
- the annular extending wall portion 87 includes an outer peripheral edge 87a and an inner peripheral edge 87b.
- the extending wall portion 87 is connected to the inner surface of the cylindrical body portion 32b of the container body 32 over the entire length of the outer peripheral edge 87a.
- the extending wall portion 87 is formed with a hole 87c defined by an inner peripheral edge 87b.
- the extending wall portion 87 divides the internal space of the container body 32 into two. Liquid L can pass through hole 87c and move between the two spaces.
- the extending wall portion 87 slopes from the outer peripheral edge 87a toward the inner peripheral edge 87b away from the opening 33 and closer to the bottom portion 32a. According to this example, the liquid L can be collected in the space on the side of the bottom portion 32a away from the plug 34. FIG. This makes it possible to more stably prevent the liquid L from adhering to the inner surface of the plug 34 .
- the first container 30 includes a container body 32 having an opening 33, a plug 34 closing the opening 33, and a fixture 36 attached to the container body 32 and securing the plug 34 to the container body 32. and have
- the plug 34 has a plate-like portion 34 a that is arranged on the container body 32 and covers the opening 33 , and an insertion protrusion 34 b that protrudes from the plate-like portion 34 a and is inserted into the opening 33 .
- the insertion protrusion 34b may be cylindrical.
- the insertion protrusion 34b may have a plurality of insertion protrusions 34b positioned on the circumference.
- the plug 34 has gas permeability such as oxygen permeability
- gas such as oxygen mainly passes through the container body 32 of the plug 34. It penetrates the exposed region (exposed portion) 34c exposed inside.
- the exposed region 34c is a region of the portion facing the opening 33 of the plate-like portion 34a where the insertion protrusion 34b is not provided.
- the fixture 36 may have an exposure hole (through hole) 36a for exposing the exposed area 34c of the plate-like portion 34a inside the container body 32.
- an exposure hole 36a in the fixture 36 having gas barrier properties, it is possible to promote movement of gas such as oxygen from the inside of the first container 30 to the outside.
- a direction DA for inserting the plug 34 into the opening 33 is provided between a peripheral portion 36b of the fixture 36 surrounding the exposure hole 36a and a portion of the plug 34 exposed in the exposure hole 36a.
- a step 31 may be formed to the . The formation of the step 31 prevents the second container 40 having flexibility and gas barrier properties such as oxygen barrier properties from coming into contact with the plug 34 of the first container 30 having gas permeability such as oxygen permeability. can be suppressed. As a result, the movement of gas such as oxygen from the inside of the first container 30 to the outside can be promoted stably.
- the plate-shaped portion 34a has a recess 34d that is recessed toward the inside (body portion 32b) of the container body 32 in the direction DA in which the stopper 34 is inserted into the opening 33, and exposes the plate-shaped portion 34a. It may also have portions exposed within hole 36a, particularly at exposed region 34c.
- the plate-like portion 34a is closer to the inside of the container body 32 (body portion 32b) in the direction DA in which the plug 34 is inserted into the opening 33 than the portion of the plate-like portion 34a covered by the fixture 36. ing.
- the step 31 can be enlarged by the recess 34d.
- the second container 40 having gas barrier properties such as oxygen barrier properties from coming into contact with the plug 34 having gas permeability such as oxygen permeability of the first container 30 .
- the movement of gas such as oxygen from the inside of the first container 30 to the outside can be promoted stably.
- a peripheral portion 36b surrounding the exposure hole 36a of the fixture 36 has a portion 36ba bent toward the plate-like portion 34a in the direction DA in which the plug 34 is inserted into the opening 33.
- the bent portion 36ba can push the plate-like portion 34a toward the inside of the container body 32 .
- the step 31 can be enlarged. Therefore, it is possible to prevent the second container 40 having gas permeability such as oxygen barrier property from coming into contact with the plug 34 having gas permeability such as oxygen permeability of the first container 30 . As a result, the movement of gas such as oxygen from the inside of the first container 30 to the outside can be promoted stably.
- a portion of the plug 34 exposed in the exposure hole 36a is provided with a linear protrusion 34e extending linearly.
- a portion of the plug 34 exposed in the exposure hole 36a is provided with a linear protrusion 34e extending linearly.
- the linear convex portion 34e may indicate the position of the exposed area 34c of the plate-like portion 34a exposed inside the container body 32 . Since the exposed region 34c can be grasped from the outside of the first container 30, the second container 40 having flexibility and gas barrier properties such as oxygen barrier properties can be prevented from coming into contact with the exposed region 34c. In addition, when the syringe 60 is used to take out the liquid L from the first container 30, the region into which the needle 64 of the syringe 60 should be inserted can be easily grasped.
- FIGS. 21 and 22 are sectional views of the first container 30 corresponding to FIG. 2 and the like. 21 and 22 show cross sections along the direction DA in which the plug 34 is inserted into the opening 33.
- FIG. 23 and 24 are plan views of the first container 30 from the direction DA in which the plug 34 is inserted into the opening 33.
- FIG. 21 and 22 show cross sections along the direction DA in which the plug 34 is inserted into the opening 33.
- FIG. 23 and 24 are plan views of the first container 30 from the direction DA in which the plug 34 is inserted into the opening 33.
- the linear protrusion 34e is an exposed region 34c of the plate-like portion 34a exposed inside the container body 32 when projected in the direction DA in which the plug 34 is inserted into the opening 33. extends over the periphery of the According to this example, the user can handle the combination container 10 such that the entire exposed region 34c does not come into contact with the second container 40 having flexibility and gas barrier properties such as oxygen barrier properties. As a result, the movement of gas such as oxygen from the inside of the first container 30 to the outside can be promoted stably.
- a portion of the linear projection 34e is covered with the fixture 36 attached to the container body 32.
- the rest of the linear protrusion 34e is exposed in the exposure hole 36a.
- a gap GA can be formed between the peripheral portion 36b of the fixture 36 surrounding the exposure hole 36a and the portion of the plug 34 adjacent to the linear protrusion 34e. That is, plug 34 can be separated from fixture 36 in a portion of the region facing fixture 36 . That is, a gap can be formed between plug 34 and fixture 36 .
- the linear protrusions 34e have a plurality of linear protrusions 34e separated from each other.
- An end portion 34ea of the linear convex portion 34e exposed in the exposure hole 36a is above the exposed region 34c of the plate-like portion 34a exposed in the container body 32 when projected in the direction DA in which the plug 34 is inserted into the opening 33. may be located in
- the end portion 34ea exposed in the exposure hole 36a of the linear convex portion 34e is located inside the container body 32 of the plate-like portion 34a when projected in the direction DA in which the plug 34 is inserted into the opening 33.
- the exposed region 34c can be shown as the region surrounded by the ends 34ea of the plurality of linear projections 34e.
- the stopper 34 of the first container 30 may be film-like or sheet-like to cover the opening 33 .
- the stopper 34 shown in FIG. 25 is joined to the tip surface of the container body 32 by using a joining material or by welding, for example.
- the plug 34 may have gas permeability or gas barrier properties.
- FIG. 26 shows another modification of the first container 30.
- the first container 30 shown in FIG. 26 is a syringe 60 . Similar to the example already described with reference to FIG. 11, the syringe 60 shown in FIG. 26 has a cylinder 62 and a piston 66. As shown in FIG.
- the cylinder 62 has a cylinder body 63 made of glass or resin and a needle 64 made of metal.
- the cylinder 62 is the container body 32 of the first container 30 and forms a space for containing the liquid L.
- the piston 66 has a glass or resin piston body 67 and a gasket 68 arranged in the opening 33 of the cylinder 62 .
- a gasket 68 is the plug 34 of the first container 30 and closes the opening 33 .
- a storage space for the liquid L is defined between the cylinder 62 and the gasket 68 .
- the illustrated syringe 60 also has a cap 69 .
- Cap 69 is removably attached to needle 64 .
- Cap 69 regulates leakage of liquid L from needle 64 and seals liquid L to syringe 60 .
- the syringe 60 taken out from the second container 40 can be used for the patient or the like as it is.
- the gasket 68 may be made gas permeable.
- a plug made of silicone or silicone rubber may be used as the gas-permeable gasket 68 .
- the cylinder 62 may be provided with gas barrier properties.
- the oxygen and nitrogen permeability coefficients of the gasket 68 may be set similarly to the oxygen and nitrogen permeability coefficients of the plug 34 described above.
- the oxygen permeability coefficient and nitrogen permeability coefficient of the cylinder 62 may be set similarly to the oxygen permeability coefficient and nitrogen permeability coefficient of the container body 32 described above.
- the syringe 60 has a fixed part 61 that restricts relative movement of the piston 66 with respect to the cylinder 62 .
- Fixed component 61 is removably attached to one or more of cylinder 62 and piston 66 .
- This fixing part 61 makes it possible to maintain the housing space defined by the cylinder 62 and the piston 66 at a negative pressure or a positive pressure.
- a rubber or a clip is exemplified as the fixing part 61 .
- the pressure inside the syringe 60 can be adjusted by gas permeation through the gasket 68 .
- the accommodation space of the first container 30 partitioned by the cylinder body 63 and the gasket 68 can be depressurized, particularly to a negative pressure.
- a double-chamber syringe is exemplified.
- the housing space inside the syringe is divided into a front chamber positioned on the needle side and a rear chamber spaced apart from the needle.
- the substance such as the freeze-dried agent contained in the antechamber is dissolved in the solvent, and a solution is obtained in the antechamber. Further, pushing the piston 66 expels the solution from the needle. In such a double-chamber syringe, adjusting the internal pressure of the cylinder can prevent the solvent from unintentionally flowing into the front chamber and dissolving the substance.
- the syringe 60 as the first container 30 may further include a plug 34 that closes the opening 33 provided in the cylinder 62 .
- needle 64 may form opening 33 and plug 34 may block the tip of needle 64 .
- This plug 34 may be gas permeable.
- the gas-permeable plug 34 may be made of silicone rubber. Plug 34 closes opening 33 formed by needle 64 .
- the syringe 60 forming the first container 30 may be accommodated in the second container 40 with the needle 64 removed.
- the cylinder body 63 has a tip protrusion 63a.
- the needle 64 can be attached to the tip protrusion 63a.
- the syringe 60 may also include a plug 34 that closes the opening of the distal projection 63a.
- This plug 34 may be gas permeable.
- the gas-permeable plug 34 may be made of silicone rubber. The plug 34 closes the opening 33 formed by the tip protrusion 63a.
- the gasket 68 may or may not be gas permeable. In the example shown in FIGS. 27 and 28, the gasket 68 may or may not have gas barrier properties.
- the pressure inside the syringe 60 can be adjusted by permeating the plug 34 with gas.
- the accommodation space of the first container 30 partitioned by the cylinder body 63 and the gasket 68 can be depressurized, particularly to 1 atm (atmospheric pressure) or less, and further to negative pressure.
- the first container 30 may have a label.
- the label may express information about the liquid.
- the label may be attached to the container body 32 .
- the label does not extend around the entire circumference to allow observation of the inside of the container body 32 .
- the label may face the second container 40 to allow observation of the label inscription.
- the label preferably faces away from the bottom wall 91 of the tray 90 .
- the first container 30 is a vial, it is preferable that the container body 32 is exposed by 10 mm or more, preferably 20 mm or more, between the label and the stopper 34 and fixture 36 . The liquid in the first container 30 can be observed through the transparent container body 32 .
- the amount of oxygen in the first container 30 can be measured by irradiating light through the transparent container body 32 .
- the body portion 32b is preferably exposed between the label and the stopper 34 and fixture 36.
- the fixture 36 shown in FIGS. 1 and 2 is provided with an opening (exposure hole 36a) through which the plug 34 is exposed.
- the fixture 36 is not limited to this example, and may have a removable plate portion that forms an opening when removed.
- the stopper 34 may be a flip cap.
- the flip cap is an integrated aluminum seal and plastic. As a specific configuration of the flip cap, configurations disclosed in JP7-165252A and JP2008-222270A may be employed.
- the first container 30 has a container body 32 and a stopper 34, and the stopper 34 has gas permeability.
- the container body 32 may be gas permeable and the plug 34 may be gas barrier.
- the specific configuration of the second container 40 described above is merely an example, and various modifications are possible.
- the combination container 10 had a degassing agent such as an oxygen absorber.
- a degassing agent such as an oxygen absorber.
- the placement of the degassing agent can be adjusted as follows. In the following description, a specific configuration will be described in relation to the deoxidizing agent 21 and the deoxidizing member 22 including the deoxidizing agent 21 .
- the configuration described below is not limited to application to the oxygen scavenger 21 and the oxygen scavenger member 22, and can also be applied to degassing agents other than the oxygen scavenger 21 and the oxygen scavenger member 22, as in the description so far. is.
- the oxygen scavenger 21 absorbs oxygen in the second container 40 and oxygen that has passed through the oxygen-permeable portion of the first container 30 and moved from the first container 30 to the second container 40. .
- the oxygen scavenger 21 and the oxygen scavenger 22 may be arranged between the oxygen-permeable portion of the first container 30 and the second container.
- the oxygen scavenger 21 and the oxygen scavenger 22 may be arranged facing the oxygen-permeable portion of the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be placed on the oxygen-permeable portion of the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger 22 may be in contact with a gas-permeable portion such as an oxygen-permeable portion of the first container 30 .
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be in contact with each other so as not to cover (expose) at least a portion of the gas-permeable portion of the first container 30 such as the oxygen-permeable portion.
- These arrangements facilitate the movement of oxygen from the interior of the first container 30 to the exterior.
- the second container 40 having gas barrier properties such as flexibility and oxygen barrier properties can be prevented from coming into contact with the plug 34 of the first container 30 having gas permeability such as oxygen permeability. Also by this, the movement of gas such as oxygen from the inside of the first container 30 to the outside can be promoted stably.
- the oxygen scavenger 21 or the oxygen scavenger member 22 is heat-sealed or bonded using a bonding material. It may be fixed to the first container 30 .
- the oxygen scavenger 21 or the oxygen scavenger 22 may be fixed to a portion of the first container 30 other than the portion having gas permeability such as oxygen permeability.
- an appropriate relative positional relationship between the oxygen scavenger 21 or the oxygen scavenger member 22 and the portion having gas permeability such as oxygen permeability of the first container 30 is maintained, and the inside of the first container 30 is maintained. It can stably promote the movement of oxygen from the to the outside.
- the container body 32 and fixture 36 have gas barrier properties such as oxygen barrier properties, and the stopper 34 has gas permeability such as oxygen permeability.
- the deoxidizing member 22 having the deoxidizing agent 21 is placed facing the plug 34 having gas permeability such as oxygen permeability.
- the oxygen scavenger member 22 having the oxygen scavenger 21 may contact a plug 34 having gas permeability such as oxygen permeability.
- the oxygen scavenger member 22 with the oxygen scavenger 21 may contact only a portion of the plug 34 that is gas permeable, such as oxygen permeable.
- the deoxidizing member 22 having the deoxidizing agent 21 may be arranged with a gap provided between it and the plug 34 having gas permeability such as oxygen permeability. According to the deoxidizing agent 21 and the deoxidizing member 22 indicated by the two-dot chain lines in FIGS. 1 and 9, the movement of gases such as oxygen from the inside of the first container 30 to the outside can be promoted. In addition, the second container 40 having gas barrier properties such as flexibility and oxygen barrier properties can be prevented from coming into contact with the plug 34 of the first container 30 having gas permeability such as oxygen permeability.
- the deoxidizing member 22 may be fixed to the first container 30 in order to maintain the relative positions of the deoxidizing member 22 and the plug 34 .
- the deoxidizing member 22 having the deoxidizing agent 21 may be fixed to the plug 34 or fixture 36 or the first container 30 using heat sealing or bonding material.
- the oxygen scavenging member 22 When the oxygen scavenging member 22 is secured to the plug 34 , it may be secured to a portion of the plug 34 .
- the oxygen scavenging member 22 may be secured to a fixture 36 to ensure a gap between the oxygen scavenging member 22 and the plug 34 .
- the second container 40 has an opening planned portion 51.
- the scheduled opening portion 51 is a portion of the second container 40 scheduled to be opened.
- a structure for guiding and promoting the opening of the second container 40 is provided in the opening planned portion 51 .
- the portion to be opened 51 of the second container 40 is configured by the first sealing portion 49a.
- the part to be opened 51 of the second container 40 was formed by material or processing.
- one second container 40 may include two or more structures for forming the intended opening portion 51 .
- the second container 40 shown in FIG. 49 has a portion 51 to be opened of the third specific example by the first sealing portion 49a and a portion to be opened 51 of the fourth specific example by the material and processing.
- a part or all of the deoxidizing agent 21 and the deoxidizing member 22 may be arranged between the planned opening portion 51 and the first container 30 in the second container 40 .
- the oxygen scavenger 21 when the second container 40 is opened, the oxygen scavenger 21 is positioned between the first container 30 and the opening for opening the second container 40 . Therefore, the oxygen concentration (%) in the first container 30 and the oxygen dissolution amount (mg/L) in the liquid L can be prevented from sharply increasing. Further, in this arrangement, the oxygen scavenger 21 and the oxygen scavenger 22 may be separated from the gas-permeable portion of the first container 30 such as oxygen-permeable.
- an oxygen permeation path (gas permeation path) from the inside to the outside of the first container 30 is secured, and the movement of oxygen from the inside to the outside of the first container 30 can be stably promoted.
- the oxygen scavenger 21 and the oxygen scavenger member 22 may be positioned above the first container 30 . This arrangement also allows the deoxidizing agent 21 and the deoxidizing member 22 to be separated from the gas-permeable portion of the first container 30 such as the oxygen-permeable portion. Further, according to this arrangement, it is also possible to activate the deoxidizing agent 21 by the water vapor described above.
- the deoxidizing member 22 having the deoxidizing agent 21 may be fixed to the second container 40 using heat sealing or a bonding material.
- the deoxidizing member 22 may be fixed at a position between the opening scheduled portion 51 of the second container 40 and the first container 30 .
- the deoxidizing member 22 may be fixed to the second container 40 so as to be separated from the first container 30 .
- the deoxidizing member 22 may be fixed to the second container 40 such that a gap is formed between the first container 30 and the deoxidizing member 22 .
- the container set 20 may be fixed to the second container 40 so that part or all of the deoxidizing member 22 is positioned above the first container 30 .
- the deoxidizing member 22 By fixing the deoxidizing member 22 to the second container 40 as described above, the movement of oxygen from the inside to the outside of the first container 30 can be stably promoted. Furthermore, by fixing the deoxidizing member 22 to the second container 40, the flexibility of the second container 40 can be limited. As a result, the second container 40, which has gas barrier properties such as flexibility and oxygen barrier properties, covers the portion of the first container 30 which has gas permeability such as oxygen permeability. is suppressed.
- the deoxidizing member 22 may be fixed to the second container 40 so as to be separated from the planned opening portion 51 .
- the deoxidizing member 22 may be fixed to the second container 40 so that a gap is formed between the portion to be opened 51 and the deoxidizing member 22 .
- the package 22a of the deoxidizing member 22 can be prevented from being damaged.
- the first container 30 may be arranged inside the second container 40 so that the plug 34 faces the part 51 to be opened. Such an arrangement facilitates removal of the first container 30 from the opened second container 40 and stabilizes the liquid L in the first container 30 .
- the oxygen concentration (%) in the first container 30 and the dissolved oxygen amount (mg /L) can be effectively suppressed. As a result, it is possible to effectively suppress a rapid increase in the internal pressure of the first container 30 when the second container 40 is opened.
- the oxygen detecting material 25 may be placed at the same position as the deoxidizing agent 21 and deoxidizing member 22 described above. As a result, changes in the oxygen concentration (%) in the second container 40 can be quickly grasped.
- a vial with a capacity of about 8.2 mL was prepared as the first container.
- the first container had the configuration shown in FIG. 2A.
- a vial serving as the first container had a container body made of glass. The first container was able to contain the gas while maintaining it at a negative pressure.
- the container body of this vial had an opening with a diameter of about 12 mm ⁇ .
- Water for injection with a volume of about 4 mL was placed in the first container as the liquid L.
- the opening of the container body containing the water for injection was closed with a rubber plug.
- the rubber plug was made of silicone rubber and had oxygen permeability.
- a hand clipper was used to fix the aluminum seal to the head of the container body to prepare the liquid-filled first container 30L.
- An aluminum seal served as the fixture shown in FIG. 2A. That is, the aluminum seal restricted the rubber plug from coming off the container body. After sealing with the aluminum seal, the space between the container body and the rubber stopper was airtight. A volume of approximately 4.2 mL of headspace remained in the first container that was not filled with water for injection. Closure of the first container was performed in air. Therefore, the headspace of the first container 30 contained air. The oxygen concentration in the headspace of the first container 30 was 21.0%. The amount of dissolved oxygen in the water for injection contained in the first container was 8.84 mg/L. The oxygen permeation amount of the stopper of the first container was measured by the method shown in FIG. Was.
- the second container made up of a transparent gas barrier packaging material was prepared.
- the second container had the configuration shown in FIG.
- the second container was a so-called pouch, which had flexibility and could not contain gas while maintaining a negative pressure.
- the liquid-filled first container and the oxygen scavenger were placed in the second container, and the second container was heat-sealed to make it airtight.
- the oxygen scavenger was in the form of the oxygen scavenger member shown in FIG. 8A.
- the second container which was closed, contained approximately 100 mL of air. An oxygen absorber capable of absorbing 200 mL of oxygen was used.
- Example 1 All the materials and members used in Example 1 were sterilized. Filling the first container with water for injection, closing the first container, filling the second container with the liquid-filled first container and the oxygen scavenger, and closing the second container were performed in an isolator under aseptic conditions. .
- the use of sterilized materials and work in an aseptic isolator were the same for other examples and comparative examples described below.
- Example 2 In Example 2, the second container 40 was filled with nitrogen before the second container 40 was closed. In Example 2, no oxygen scavenger was used. Example 2 was different from Example 1 in these two points, and was otherwise the same as Example 1.
- Example 3 the second container 40 is the cup-shaped container shown in FIG. 1, and is a container capable of containing gas while maintaining a negative pressure.
- the second container containing the liquid-filled first container was sealed by heat sealing under an atmospheric pressure of 0.5 atm.
- no oxygen scavenger was used.
- Example 3 was different from Example 1 in these three points, and the others were the same as Example 1. As a result, in Example 3, the internal pressure of the second container was negative immediately after the second container was closed.
- Comparative Example 1 the rubber plug for closing the opening of the container body of the first container was made of butyl rubber. Comparative Example 1 is different from Example 1 in this one point, and is otherwise the same as Example 1.
- the butyl rubber forming the rubber plug of Comparative Example 1 had an oxygen permeability of about 80 (cm 3 /(m 2 ⁇ 24h ⁇ atm)), which was almost no gas permeability.
- the oxygen permeation amount of the first container of Comparative Example 1 was measured by the method shown in FIG. 2B, it was 0.005 (mL/(day ⁇ atm)).
- Comparative Example 2 the rubber stopper for closing the opening of the container body of the first container was made of the same butyl rubber as the rubber stopper of Comparative Example 1. Comparative Example 2 is different from Example 2 in this one point, and is otherwise the same as Example 2.
- Comparative Example 3 the rubber stopper for closing the opening of the container body of the first container was made of the same butyl rubber as the rubber stopper of Comparative Example 1. Comparative Example 3 is different from Example 3 in this one point, and is otherwise the same as Example 3.
- Comparative Example 4 A liquid-filled first container was produced in the same manner as in Examples 1-3. This liquid-filled first container was designated as Comparative Example 4. That is, in Comparative Example 4, the second container was omitted.
- the rubber stopper of the first container was made of silicone rubber as in Examples 1-3.
- the confirmation method was as follows. First, a syringe with an injection needle containing physiological saline was prepared. Next, the rubber stoppers of the first containers of Examples 1-3 and Comparative Examples 1-4 were pierced with the needle of a syringe. It was confirmed whether or not the water for injection in the syringe was sucked into the first container when the rubber plug was punctured with the needle. The results are shown in the "Pressure” column of Table 1. For samples in which the water for injection in the syringe was sucked into the first container, "A" was entered in the "Pressure” column of Table 1.
- Examples 1 to 3 The evaluation of Examples 1 to 3 was "A". That is, in all of Examples 1 to 3 using the silicone rubber stopper, the inside of the first container could be adjusted to a negative pressure. That is, by imparting gas permeability and oxygen permeability to the first container, the pressure inside the first container sealed under atmospheric pressure could be easily adjusted to a negative pressure.
- the dissolved amount of oxygen in the water for injection in the first container of Examples 1 to 3 was significantly lower than the saturated solubility under atmospheric pressure. Therefore, it is extremely suitable for application to liquids that are easily decomposed by oxygen.
- the aspiration of water for injection in Examples 1 and 3 was greater than the aspiration of water for injection in example 2. That is, the internal pressures of the first containers of Examples 1 and 3 were lower than the internal pressure of the first container of Example 2.
- Examples 1 to 3 the water for injection was cultured by a culture method to confirm the increase or decrease of bacteria in the water for injection. As a result, growth of bacteria in the water for injection was not observed for Examples 1-3. As described above, in Examples 1 to 3, negative-pressure primary containers could be easily manufactured at low cost without contamination such as bacteria.
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Abstract
Description
液体を収容し、気体透過性を有する第1容器と、
前記第1容器を収容し、気体バリア性を有した第2容器と、を備え、
前記第1容器内は1atm以下である。
前記第1容器内は陰圧でもよい。
液体を収容し、酸素透過性を有する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、を備え、
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記第1容器内の圧力は1atm以下である。
液体を収容し、酸素透過性を有する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、を備え、
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記第1容器は、大気圧下で気体を陰圧に維持して収容可能である。
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は、シリンジの針によって穿刺可能でもよい。
前記第1容器は、シリンダと、前記シリンダ内に挿入されたピストンと、を含むシリンジを含み、
前記シリンジは、前記シリンダおよび前記ピストンによって区画される収容空間に前記液体を収容してもよい。
前記ピストンは、前記シリンダ内に配置され前記収容空間を区間するガスケットを含み、
前記ガスケットは、気体透過性を有してもよい。
前記シリンジは、前記シリンダに設けられた開口部を塞ぐ栓を含み、
前記栓は、気体透過性を有してもよい。
前記第1容器は、前記容器本体に取り付けられ前記栓を前記容器本体に固定する固定具を有し、
前記栓は、前記容器本体上に配置され前記開口部を覆う板状部と、前記板状部から突出して前記開口部内に挿入される挿入突出部と、を有し、
前記固定具は、前記板状部の周縁を覆い、
前記固定具は、前記板状部の前記容器本体内に露出した領域を露出させる露出孔を有してもよい。
前記容器本体は、酸素バリア性を有してもよい。前記容器本体は、ガラス製でもよい。前記固定具は、酸素バリア性を有してもよい。前記固定具は、金属製でもよい。
前記栓は、酸素透過性を有してもよい。前記栓は、シリコーンを含んでもよい。
前記栓の前記露出孔内に露出した部分に、線状に延びる線状凸部が設けられ、
前記線状凸部は、前記板状部の前記容器本体内に露出した領域の位置を示してもよい。
前記栓の前記露出孔内に露出した部分に、線状に延びる線状凸部が設けられ、
前記線状凸部は、前記板状部の前記容器本体内に露出した領域の周縁部上を延びてもよい。
前記栓の前記露出孔内に露出した部分に、線状に延びる線状凸部が設けられ、
前記線状凸部の一部分は前記固定具に覆われ、前記線状凸部の他の一部分は前記露出孔内に露出してもよい。
前記線状凸部は、互いから離れた複数の線状凸部を有し、
前記線状凸部の前記露出孔内に露出した端部は、前記板状部の前記容器本体内に露出した領域上に位置してもよい。
前記第2容器は、開放を予定された開放予定部を有し、
前記第2容器内における前記開放予定部と前記第1容器との間に脱酸素剤を備えてもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を閉鎖する栓と、を有し、
前記容器本体は酸素バリア性を有し、
前記栓は酸素透過性を有し、
前記第2容器と前記栓との間に脱酸素剤を備えてもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を閉鎖する栓と、を有し、
前記容器本体は酸素バリア性を有し、
前記栓は酸素透過性を有し、
前記栓に対面した脱酸素剤を備えてもよい。
前記第1容器は、前記容器本体に取り付けられ前記栓を前記容器本体に固定する固定具を有し、
前記脱酸素剤と、前記脱酸素剤を収容した包装体と、を含む脱酸素部材が、前記固定具に取り付けられてもよい。
前記液体が水溶液を含み、
前記脱酸素剤を有する脱酸素部材は、保水剤を含んでいない、又は、前記液体の初期体積の5%以下の水分を保持可能な保水剤を含んでもよい。
前記液体がアルコール又は油を含み、
前記脱酸素剤を有する脱酸素部材は、水分を保持した保水剤を含んでもよい。
前記液体が非水系溶媒を含み、
前記脱酸素剤を有する脱酸素部材は、水分を保持した保水剤を含んでもよい。
非水系溶媒は、主成分が水以外である溶媒である。非水系溶媒の水分体積割合は、2%以下でもよく、1%以下でもよく、0.5%以下でもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を塞ぐ栓と、を含み、
前記栓は気体透過性を有し、
前記栓の内面の接触角は80°以上でもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を塞ぐ栓と、を含み、
前記栓は気体透過性を有し、
前記容器本体に収容された液体と前記栓との間に、気体透過性および撥液性を有したシートが設けられてもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を塞ぐ栓と、を含み、
前記栓は気体透過性を有し、
前記栓の内面に、気体を保持可能な凹部が設けられてもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を塞ぐ栓と、前記容器本体の内面から延び出した延出壁部と、を含み、
前記延出壁部は、外周縁および内周縁を含む環状であって、前記外周縁の全長に亘って前記容器本体の前記内面に接続し、前記内周縁によって区画された穴が設けられてもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を塞ぐ栓と、を含み、
前記栓は気体透過性を有し、
前記栓の外面に凹凸が設けられてもよく、又は、前記栓の外面から突出した突出部を含んでもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を塞ぐ栓と、を含み、
前記栓は気体透過性を有し、
前記栓の内面に凹凸が設けられてもよく、又は、前記栓の内面から突出した突出部を含んでもよい。
前記第1容器は、開口部を有する容器本体と、前記開口部を塞ぐ栓と、を含み、
酸素は前記栓を透過可能であり、
前記栓の内面に凹凸が設けられてもよく、又は、前記栓の内面から突出した突出部を含んでもよい。
液体を収容する第1容器と、
前記第1容器を収容し、酸素バリア性を有する第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器内に収容された前記第1容器の栓と、前記第2容器との間に隙間が形成される。
液体を収容する第1容器と、
前記第1容器を収容するトレイと、
前記第1容器を収容した前記トレイを収容し、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記トレイの一部は前記栓と前記第2容器との間に位置し、前記トレイと前記栓との間に隙間が形成される。
前記トレイは、底壁と、前記底壁に接続した側壁と、を有し、
前記側壁は、前記トレイ内に収容された前記第1容器の前記栓に対面する第1側壁部と、前記第1側壁部に対向する第2側壁部と、を有し、
前記第1側壁部と前記栓との間に前記隙間が形成されてもよい。
前記第2容器は、フィルム製容器であり、
前記第2側壁部が、前記第2容器を介して、前記液体入り組合せ容器が載置される載置面に対面するようにして、配置可能でもよい。
前記トレイは、底壁と、前記底壁に接続した側壁と、前記側壁から延び出したフランジ部と、を有し、
前記凹部または前記凸部は、前記フランジ部に設けられてもよい。
液体を収容する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、開口部を有し前記第1容器を収容するトレイと、前記トレイの開口部を閉鎖する蓋材と、を有し、
前記トレイは、底壁と、前記底壁に接続し前記栓に対面する側壁と、を有し、
前記側壁と前記栓との間に前記隙間が形成される。
前記側壁は、前記トレイ内に収容された前記第1容器の前記栓に対面する第1側壁部と、前記第1側壁部に対向する第2側壁部と、を有し、
前記第1側壁部と前記栓との間に前記隙間が形成され、
前記第2側壁部が、前記液体入り組合せ容器が載置される載置面上に位置するようにして、配置可能でもよい。
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記脱酸素剤は、前記トレイと前記第1容器との間に位置してもよい。
前記トレイは、底壁と、前記底壁に接続した側壁と、を有し、
前記側壁は、前記トレイ内に収容された前記第1容器の前記栓に対面する第1側壁部と、前記第1側壁部に対向する第2側壁部と、を有し、
前記脱酸素剤は、前記第1側壁部と前記栓との間に位置してもよい。
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記脱酸素剤は、前記トレイと前記第2容器との間に位置してもよい。
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記脱酸素剤は、前記蓋材によって保持されてもよい。
前記トレイは、底壁と、前記底壁に接続した側壁と、を有し、
前記底壁は、前記栓と前記容器本体との間の凹部内に入り込む突出部を有してもよい。
液体を収容する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第1フィルムおよび前記第2フィルムは、シール部において、引き剥がし可能に接合し、
前記シール部は、曲がった第1シール部を含み、
前記第1シール部は、前記第1シール部と前記栓とが対面する方向において前記栓から離れる側に突出している。
前記栓は、前記第1シール部に対面し、
前記シール部は、前記第1シール部の一端に接続した第1側シール部と、前記第1シール部の他端に接続した第2側シール部と、を含み、
前記第1側シール部および前記第2側シール部の間に、前記第1容器を収容する収容空間が形成され、
前記第1側シール部および前記第2側シール部の間の前記第1フィルムに沿った最小間隔および前記第1側シール部および前記第2側シール部の間の前記第2フィルムに沿った最小間隔は、前記栓を前記開口部に挿入する方向に沿った前記第1容器の長さよりも短くてもよい。
液体を収容する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素を透過可能であり、
前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第2容器は、開放予定部にて前記第1フィルムおよび前記第2フィルムを切断することによって開放され、
前記第1フィルムおよび前記第2フィルムは、シール部において接合し、
前記シール部は、前記開放予定部の長手方向に離れた第1側シール部および第2側シール部を有し、
前記第2側シール部の前記開放予定部と交わる位置に、前記第1フィルムおよび前記第2フィルムを貫通した貫通部が設けられている。
前記第2側シール部は、隣接する部分より幅が広くなった拡幅部を有し、
前記貫通部は、前記拡幅部の前記開放予定部と交わる位置に設けられてもよい。
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記脱酸素剤は、前記第2容器内の前記空間と前記栓とが対面する方向に前記拡幅部からずれた位置において、前記第2容器に保持されてもよい。
液体を収容する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、
前記第2容器を収容する外箱と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第1フィルムおよび前記第2フィルムは、シール部において、引き剥がし可能に接合し、
前記外箱は、外箱本体部と、前記外箱本体部に対して相対動作して前記外箱を開放する蓋部と、を有し、
前記第1フィルムは前記外箱本体部に取り付けられ、前記第2フィルムは前記蓋部に取り付けられ、
前記外箱本体部に対して前記蓋部を相対動作させることによって、前記第2フィルムが前記第1フィルムからシール部において引き剥がされて、前記第2容器が開放される。
液体を収容する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムと接合し前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、前記第1フィルムおよび前記第2フィルムの間に設けられ気体を収容した気体袋と、を有する。
前記第1フィルムおよび前記第2フィルムは、シール部において接合し、
前記気体袋は、前記シール部において、前記第1フィルムおよび前記第2フィルムに接合してもよい。
前記シール部は、幅方向に離れて設けられた第1側シール部および第2側シール部を有し、
前記気体袋は、前記第1側シール部において前記第1フィルムおよび前記第2フィルムに接合した第1気体袋と、前記第2側シール部において、前記第1フィルムおよび前記第2フィルムに接合した第2気体袋と、を含み、
前記第1気体袋および前記第2気体袋の間に、前記第1容器が位置してもよい。
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記脱酸素剤は、前記第1フィルムおよび前記第2フィルムの一方と前記気体袋との間に保持されてもよい。
液体を収容し、気体透過性を有した第1容器と、
前記第1容器を収容可能であり、気体バリア性を有した第2容器と、を備え、
前記第1容器は、大気圧下で気体を陰圧に維持して収容可能である。
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は、シリンジの針によって穿刺可能でもよい。
液体を収容し、酸素透過性を有した第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、
前記第2容器内の酸素を吸収する脱酸素剤と、を備える。
液体を収容する第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器内に収容された前記第1容器の栓と、前記第2容器との間に隙間が形成される。
液体を収容する第1容器と、
前記第1容器を収容可能なトレイと、
前記第1容器を収容した前記トレイを収容可能であり、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記トレイは前記栓と前記第2容器との間に位置し、前記トレイと前記栓との間に隙間が形成される。
液体を収容する第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、開口部を有し前記第1容器を収容するトレイと、前記トレイの開口部を閉鎖する蓋材と、を有し、
前記トレイは、底壁と、前記底壁に接続し前記栓に対面する側壁と、を有し、
前記側壁と前記栓との間に前記隙間が形成される。
液体を収容する第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第1フィルムおよび前記第2フィルムは、シール部において、引き剥がし可能に接合し、
前記シール部は、曲がった第1シール部を含み、
前記第1シール部は、前記第1シール部と前記栓とが対面する方向において前記栓から離れる側に突出する。
液体を収容する第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第2容器は、開放予定部にて前記第1フィルムおよび前記第2フィルムを切断することによって開放され、
前記第1フィルムおよび前記第2フィルムは、シール部において接合し、
前記シール部は、前記開放予定部の長手方向に離れた第1側シール部および第2側シール部を有し、
前記第2側シール部の前記開放予定部と交わる位置に、前記第1フィルムおよび前記第2フィルムを貫通した貫通部が設けられている。
液体を収容する第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、
前記第2容器を収容可能な外箱と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第1フィルムおよび前記第2フィルムは、シール部において、引き剥がし可能に接合し、
前記外箱は、外箱本体部と、前記外箱本体部に対して相対動作して前記外箱を開放する蓋部と、を有し、
前記第1フィルムは前記外箱本体部に取り付けられ、前記第2フィルムは前記蓋部に取り付けられ、
前記外箱本体部に対して前記蓋部を相対動作させることによって、前記第2フィルムが前記第1フィルムからシール部において引き剥がされて、前記第2容器が開放される。
液体を収容する第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、を備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムと接合し前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、前記第1フィルムおよび前記第2フィルムの間に設けられ気体を収容した気体袋と、を有する。
第1容器を収容した第2容器を、閉鎖する工程と、
第2容器内に収容された前記第1容器内の圧力を調整する工程と、を含み、
前記第1容器は液体を収容し且つ気体透過性を有し、
前記第2容器は気体バリア性を有し、
前記圧力を調整する工程において、前記第1容器内の気体が前記第1容器を透過し、前記第1容器内の圧力が低下する。
前記第2容器内の酸素を吸収する脱酸素剤が設けられ、
前記圧力を調整する工程において、前記第1容器内の酸素が前記第1容器を透過することによって、前記第1容器内の圧力が低下してもよい。
前記第2容器を閉鎖する前に、前記第2容器内に不活性ガスが充填され、
前記圧力を調整する工程において、前記第1容器内の酸素が前記第1容器を透過することによって、前記第1容器内の圧力が低下してもよい。
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記ゴム栓は、シリンジの針によって穿刺可能でもよい。
上述した本開示による液体入り組合せ容器のいずれかの使用方法であって、
前記第2容器を開放して前記第1容器を取り出す工程と、
前記第1容器にシリンジの針を穿刺して、前記液体をシリンジに注入する工程と、を備える。
本開示による第7~第13の液体入り組合せ容器を用いて液体入り容器を製造する方法であって、
第1容器を収容した第2容器を閉鎖する工程と、
脱酸素剤によって前記第2容器内の酸素を吸収することによって、酸素濃度を調整する工程と、を備え、
前記酸素濃度を調整する工程において、前記第1容器内の酸素が前記栓を透過して前記第1容器外へ移動し、前記第2容器内で前記脱酸素剤によって吸収される。
本開示による第8の液体入り組合せ容器を用いて液体入り容器を製造する方法であって、
第1容器を収容した第2容器を閉鎖する工程と、
脱酸素剤によって前記第2容器内の酸素を吸収することによって、酸素濃度を調整する工程と、を備え、
前記酸素濃度を調整する工程において、前記第1容器内の酸素が前記栓を透過して前記第1容器外へ移動し、前記第2容器内で前記脱酸素剤によって吸収され、
前記第2側壁部が、前記第2容器を介して、前記液体入り組合せ容器が載置される載置面に対面するようにして、液体入り組合せ容器が前記載置面に配置される。
本開示による第9の液体入り組合せ容器を用いて液体入り容器を製造する方法であって、
第1容器を収容した第2容器を閉鎖する工程と、
脱酸素剤によって前記第2容器内の酸素を吸収することによって、酸素濃度を調整する工程と、を備え、
前記酸素濃度を調整する工程において、前記第1容器内の酸素が前記栓を透過して前記第1容器外へ移動し、前記第2容器内で前記脱酸素剤によって吸収され、
前記第2側壁部が、前記液体入り組合せ容器が載置される載置面に対面するようにして、液体入り組合せ容器が前記載置面に配置される。
図29~図34は、第2容器40の第1具体例を示している。第1具体例において、液体入り組合せ容器10Lは、第1容器30を収容するトレイ90を有している。トレイ90は、開口部90Aを有した平たい容器である。第2容器40は、第1容器30を収容したトレイ90を収容する。
図35~図37は、第2容器40の第2具体例を示している。図35は、第2具体例に係る液体入り組合せ容器10Lを示す斜視図である。図37は、図35に示された液体入り組合せ容器10Lの縦断面図である。第2具体例において、液体入り組合せ容器10Lは、第1容器30および第2容器40を有している。図示された第1容器30は、開口部33を有した容器本体32と、開口部33を閉鎖する栓34と、を有する。栓34は、酸素を透過可能である。栓34は、酸素を透過可能である。
図38および図39は、第2容器40の第3具体例を示している。図38は、第3具体例に係る液体入り組合せ容器10Lを示す斜視図である。第3具体例において、液体入り組合せ容器10Lは、第1容器30および第2容器40を有している。図示された第1容器30は、開口部33を有した容器本体32と、開口部33を閉鎖する栓34と、を有する。栓34は酸素透過性を有する。すなわち、酸素は栓34を透過可能である。
図40および図41は、第2容器40の第4具体例を示している。図40は、第4具体例に係る液体入り組合せ容器10Lを示す斜視図である。図41は、図40の第2容器40を開放した状態にて示している。第4具体例において、液体入り組合せ容器10Lは、第1容器30および第2容器40を有している。図示された第1容器30は、開口部33を有した容器本体32と、開口部33を閉鎖する栓34と、を有する。栓34は酸素透過性を有する。すなわち、酸素は栓34を透過可能である。
図44~図45は、第2容器40の第5具体例を示している。図42は、第5具体例に係る液体入り組合せ容器10Lの外箱100を示す斜視図である。図43は、図42の外箱100に収容される第1容器30を収容した第2容器40を示す図である。第5具体例において、液体入り組合せ容器10Lは、第1容器30、第2容器40および外箱100を有している。図示された第1容器30は、開口部33を有した容器本体32と、開口部33を閉鎖する栓34と、を有する。栓34は酸素透過性を有する。すなわち、酸素は栓34を透過可能である。
図46~図48は、第2容器40の第6具体例を示している。図46は、第6具体例に係る液体入り組合せ容器10Lを示す斜視図である。図47は、図46のA-A線に沿った断面にて、液体入り組合せ容器10Lを示している。図48は、図46に示された液体入り組合せ容器10Lの製造方法を説明する図である。図示された第1容器30は、開口部33を有した容器本体32と、開口部33を閉鎖する栓34と、を有する。栓34は酸素透過性を有する。すなわち、酸素は栓34を透過可能である。
容量約8.2mLのバイアル瓶を第1容器として用意した。第1容器は、図2Aに示す構成を有していた。第1容器をなすバイアル瓶は、ガラス製の容器本体を有していた。第1容器は、気体を陰圧に維持して収容可能であった。このバイアル瓶の容器本体は、口径が約12mmφの開口部を形成していた。容量約4mLの注射用水を液体Lとして、第1容器に収容した。注射用水を収容した容器本体の開口部をゴム栓で閉鎖した。ゴム栓は、シリコーンゴムによって構成され、酸素透過性を有していた。ハンドクリッパーを用いてアルミシールを容器本体の頭部に固定し、液体入り第1容器30Lを作製した。アルミシールは、図2Aに示された固定具として機能した。すなわちアルミシールは、ゴム栓が容器本体から外れることを規制した。アルミシールを用いた密閉後の状態において、容器本体及びゴム栓の間は気密となった。第1容器内には、注射用水が充填されていないヘッドスペースが約4.2mLの容積で残った。第1容器の閉鎖は空気中で行った。したがって、第1容器30のヘッドスペースには、空気が含まれていた。第1容器30のヘッドスペースにおける酸素濃度は、21.0%であった。第1容器に収容された注射用水の酸素溶解量は、8.84mg/Lであった。図2Bに示された方法にて、第1容器の栓の酸素透過量を測定したところ、3(mL/(day×atm))であり、実施例1の第1容器は酸素透過性を有していた。
実施例2において、第2容器40を閉鎖する前に、第2容器40内に窒素を充填した。実施例2では、脱酸素剤を用いなかった。実施例2は、これらの二点において実施例1と異なり、他は実施例1と同様とした。
実施例3において、第2容器40は、図1に示されたカップ状容器であって、気体を陰圧に維持して収容可能な容器とした。実施例3では、0.5atmの気圧下で、液体入り第1容器を収容した第2容器をヒートシールにより密閉した。実施例3では脱酸素剤を用いなかった。実施例3は、これらの三点において実施例1と異なり、他は実施例1と同様とした。結果として、実施例3では、第2容器の閉鎖直後、第2容器の内圧は陰圧であった。
比較例1では、第1容器の容器本体の開口部を閉鎖するゴム栓がブチルゴムによって構成されていた。比較例1は、この一点において実施例1と異なり、他は実施例1と同様とした。比較例1のゴム栓をなすブチルゴムの酸素透過度は80(cm3/(m2×24h×atm))程度であり、気体透過性を有しない程度であった。図2Bに示された方法にて、比較例1の第1容器の酸素透過量を測定したところ、0.005(mL/(day×atm))であった。
比較例2では、第1容器の容器本体の開口部を閉鎖するゴム栓が、比較例1のゴム栓と同一のブチルゴムによって構成されていた。比較例2は、この一点において実施例2と異なり、他は実施例2と同様とした。
比較例3では、第1容器の容器本体の開口部を閉鎖するゴム栓が、比較例1のゴム栓と同一のブチルゴムによって構成されていた。比較例3は、この一点において実施例3と異なり、他は実施例3と同様とした。
実施例1~3と同様にして、液体入り第1容器を作製した。この液体入り第1容器を比較例4とした。すなわち、比較例4では第2容器が省略された。第1容器のゴム栓は、実施例1~3と同様にシリコーンゴムによって構成されていた。
実施例1~3および比較例1~3について、第2容器を閉鎖した後、液体入り組合せ容器を二週間保存した。その後、第2容器40を開放して、第2容器から液体入り第1容器を取り出した。比較例4については、第1容器を閉鎖した後、液体入り第1容器を二週間保存した。実施例1~3および比較例1~4を保存した環境は、22℃の空気雰囲気で大気圧下とした。
Claims (29)
- 液体を収容し、酸素透過性を有する第1容器と、
前記第1容器を収容し、酸素バリア性を有した第2容器と、
前記第2容器内の酸素を吸収する脱酸素剤と、を備え、
前記第1容器内は1atm以下である、液体入り組合せ容器。 - 前記第1容器内の圧力は陰圧である、請求項1に記載の液体入り組合せ容器。
- 前記第1容器内は無菌状態であり、
前記第1容器は、高感受性の液体を収容する、請求項1又は2に記載の液体入り組合せ容器。 - 前記第1容器は、開口部を有するガラス製の容器本体と、前記開口部を閉鎖する栓と、を有する、請求項1~3のいずれか一項に記載の液体入り組合せ容器。
- 前記第2容器は、大気圧下で気体を陰圧に維持して収容可能である、請求項1~4のいずれか一項に記載の液体入り組合せ容器。
- 前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、前記容器本体に取り付けられ前記栓を前記容器本体に固定する固定具と、を有し、
前記栓は、前記容器本体上に配置され前記開口部を覆う板状部と、前記板状部から突出して前記開口部内に挿入される挿入突出部と、を有し、
前記栓は酸素透過性を有し、
前記固定具は、前記板状部の周縁を覆い、
前記固定具は、前記板状部の前記容器本体内に露出した領域を露出させる露出孔を有する、請求項1~5のいずれか一項に記載の液体入り組合せ容器。 - 前記固定具の前記露出孔の周囲となる部分は、前記板状部に接近するように曲がった部分を有し、前記容器本体の内部に向けて前記板状部を押している、請求項6に記載の液体入り組合せ容器。
- 前記栓の前記露出孔内に露出した部分に、線状に延びる線状凸部が設けられ、
前記線状凸部は、前記板状部の前記容器本体内に露出した領域の位置を示す、請求項6又は7に記載の液体入り組合せ容器。 - 前記栓の前記露出孔内に露出した部分に、線状に延びる線状凸部が設けられ、
前記線状凸部は、前記板状部の前記容器本体内に露出した領域の周縁部上を延びる、請求項6~8のいずれか一項に記載の液体入り組合せ容器。 - 前記第2容器は、開放を予定された開放予定部を有し、
前記脱酸素剤は、少なくとも部分的に、前記第2容器内における前記開放予定部と前記第1容器との間に位置する、請求項1~9のいずれか一項に記載の液体入り組合せ容器。 - 前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記脱酸素剤は、少なくとも部分的に、前記第2容器と前記栓との間に位置する、請求項1~10のいずれか一項に記載の液体入り組合せ容器。 - 前記脱酸素剤と、前記脱酸素剤を収容した包装体と、を含む脱酸素部材が、前記第2容器に取り付けられている、請求項10又は11に記載の液体入り組合せ容器。
- 前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記脱酸素剤は前記栓に対面している、請求項1~12のいずれか一項に記載の液体入り組合せ容器。 - 前記脱酸素剤は、少なくとも部分的に、前記第1容器の前記酸素透過性を有する部分よりも上方に位置する、請求項1~13のいずれか一項に記載の液体入り組合せ容器。
- 前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、前記容器本体に取り付けられ前記栓を前記容器本体に固定する固定具と、を有し、
前記栓は酸素透過性を有し、
前記脱酸素剤と、前記脱酸素剤を収容した包装体と、を含む脱酸素部材が、前記固定具に固定されている、請求項13又は14に記載の液体入り組合せ容器。 - 前記液体が水溶液を含み、
前記脱酸素剤を有する脱酸素部材は、保水剤を含んでいない、又は、前記液体の初期体積の5%以下の水分を保持可能な保水剤を含む、請求項1~15のいずれか一項に記載の液体入り組合せ容器。 - 前記液体がアルコール又は油を含み、
前記脱酸素剤を有する脱酸素部材は、水分を保持した保水剤を含む、請求項1~15のいずれか一項に記載の液体入り組合せ容器。 - 前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器内に収容された前記第1容器の前記栓と、前記第2容器との間に隙間が形成される、請求項1~17のいずれか一項に記載の液体入り組合せ容器。 - 前記第1容器を収容するトレイを備え、
前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、前記第1容器を収容した前記トレイを収容し、
前記トレイの一部は前記栓と前記第2容器との間に位置し、前記トレイと前記栓との間に隙間が形成される、請求項1~18のいずれか一項に記載の液体入り組合せ容器。 - 前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、開口部を有し前記第1容器を収容するトレイと、前記トレイの開口部を閉鎖する蓋材と、を有し、
前記トレイは、底壁と、前記底壁に接続し前記栓に対面する側壁と、を有し、
前記側壁と前記栓との間に隙間が形成される、請求項1~18のいずれか一項に記載の液体入り組合せ容器。 - 前記第1容器は、開口部を有した容器本体と、前記開口部を閉鎖する栓と、を有し、
前記栓は酸素透過性を有し、
前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第1フィルムおよび前記第2フィルムは、シール部において、引き剥がし可能に接合し、
前記シール部は、曲がった第1シール部を含み、
前記第1シール部は、前記第1シール部と前記栓とが対面する方向において前記栓から離れる側に突出している、請求項1~18のいずれか一項に記載の液体入り組合せ容器。 - 前記第2容器は、第1フィルムと、前記第1フィルムとの間に前記第1容器を収容する第2フィルムと、を有し、
前記第2容器は、開放予定部にて前記第1フィルムおよび前記第2フィルムを切断することによって開放され、
前記第1フィルムおよび前記第2フィルムは、シール部において接合し、
前記シール部は、前記開放予定部の長手方向に離れた第1側シール部および第2側シール部を有し、
前記第2側シール部の前記開放予定部と交わる位置に、前記第1フィルムおよび前記第2フィルムを貫通した貫通部が設けられている、請求項1~18のいずれか一項に記載の液体入り組合せ容器。 - 液体を収容し、酸素透過性を有する第1容器と、
前記第1容器を収容可能であり、酸素バリア性を有した第2容器と、
前記第2容器内の酸素を吸収する脱酸素剤と、を備え、
前記第1容器は、前記第2容器内に収容された状態において、大気圧下で気体を陰圧に維持して収容可能である、容器セット。 - 第1容器を収容した第2容器を閉鎖する工程と、
第2容器内に収容された前記第1容器内の圧力を調整する工程と、を備え、
前記第1容器は液体を収容し且つ気体透過性を有し、
前記第2容器は気体バリア性を有し、
前記圧力を調整する工程において、前記第1容器内の気体が前記第1容器を透過し、前記第1容器内の圧力が低下する、液体入り容器の製造方法。 - 前記第2容器を閉鎖する前、前記第1容器内は陽圧であり、
前記圧力を調整する工程において、前記第1容器内の圧力は低下して1atm以下となる、請求項24に記載の液体入り容器の製造方法。 - 前記第2容器内の酸素を吸収する脱酸素剤が設けられている、請求項24又は25に記載の液体入り容器の製造方法。
- 前記第1容器内は無菌状態である、請求項24~26のいずれか一項に記載の液体入り容器の製造方法。
- 前記第1容器は、高感受性の液体を収容している、請求項24~27のいずれか一項に記載の液体入り容器の製造方法。
- 請求項1~22のいずれか一項に記載の液体入り組合せ容器の使用方法であって、
前記第2容器を開放して前記第1容器を取り出す工程と、
前記第1容器にシリンジの針を穿刺して、前記液体をシリンジに注入する工程と、を備える、液体入り組合せ容器の使用方法。
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EP22775811.7A EP4317017A1 (en) | 2021-03-24 | 2022-03-24 | Liquid-containing combined container, container set, manufacturing method for liquid-containing container, and method of use for liquid-containing combined container |
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- 2022-03-24 EP EP22775811.7A patent/EP4317017A1/en active Pending
- 2022-03-24 WO PCT/JP2022/014193 patent/WO2022203030A1/ja active Application Filing
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JPWO2022203030A1 (ja) | 2022-09-29 |
EP4317017A1 (en) | 2024-02-07 |
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