JPWO2020090724A1 - Composite container, liquid supply method and liquid collection method - Google Patents

Abstract

The liquid container that can alleviate the cleanliness required for the environment in which the liquid is supplied is (1) the innermost container 12 having a space that can accommodate the liquid, and the opening 16 that connects the inside and the outside thereof. The innermost container having the innermost plug 18 airtightly arranged in the opening, and (2) the outermost container 14 having a space for accommodating the innermost container, the inside and the outside thereof. A liquid material storage composite container 10 having an outer container having an opening 20 for communication and an outermost plug 22 arranged airtightly in the opening, and the innermost container is the space of the outermost container. The innermost plug and the outermost plug are arranged inside, and the innermost plug and the outermost plug are inserted from the outside of the composite container into the space of the innermost container or from the space of the innermost container via a hollow needle 26 penetrating both of them. It is configured so that it can be aligned to move the liquid matter to the outside of the container.

Description

The present invention relates to a container for containing a liquid material, more specifically, a container for containing a liquid material with a high degree of cleanliness, and a method for using the same, specifically, a method for supplying the liquid material to such an empty container and a liquid material. It relates to a method of collecting a liquid material from such a container containing a material.

In recent years, research on cell therapy, regenerative medicine, etc., in which cells and tissues constituting the human body are used for medical treatment has been actively conducted. For example, cell therapy requires work steps such as cell preparation, culturing, and processing called cell processing. In order to apply cell-processed tissues and cells as "cell medicines" for treatment, these work processes are required to have the same safety and high quality control as the manufacture of medicines and drug substances.

The area within the facility for performing cell processing (Cell Processing Center: "CPC") is in a highly clean state. For example, when carrying a cell culture medium into such a CPC, it is necessary to avoid bringing in microorganisms and the like adhering to the medium container containing the cell culture medium and avoid adhering the microorganisms and the like to the medium container as much as possible. There is.

Carrying a medium container containing a medium into, for example, a CPC and using the medium in the CPC are carried out, for example, as follows: In a highly clean area, a medium container containing the medium (for example, commercially available) (Things) are sterilized with alcohol or the like; in a highly clean area, the medium container is packaged using multiple sterilization bags; then, the enclosed medium container is placed in the CPC of the initial environment having the initial cleanliness. Transfer to an area, where the outermost sterilization bag is breached to remove its contents; then the removed contents container is placed in an area within the CPC of an intermediate environment (first intermediate environment) with a higher predetermined intermediate cleanliness. Transfer, where the outermost sterile bag is breached to remove its contents; then the removed contents are removed into other areas within the CPC of another intermediate environment (second intermediate environment) with a higher predetermined intermediate cleanliness. Transfer to, tear the outermost sterilization bag, and remove the contents; then transfer the removed contents to another area within the CPC of another intermediate environment (third intermediate environment) with a higher degree of predetermined cleanliness. , Break the outermost sterilization bag and take out the contents; In this way, the cleanliness of the area to which the contents are transferred is gradually increased, and each time, the outermost sterilization bag is torn and the contents are taken out. Finally break the outermost bag (ie, the sterile bag adjacent to the medium container) in the CPC area of the collection environment with the given sampling cleanliness, remove the medium container and contain it. Collect the medium and use as prescribed.

When the medium container is packaged and prepared as described above, it is necessary to first sterilize the medium container containing the medium, and then multiple-wrap the medium container using a sterilization bag. All treatments need to be carried out in a clean environment. In addition, since the medium container already filled with the medium is sterilized, it is necessary to avoid the sterilization treatment from affecting the medium. For example, sterilization methods under high temperature and high pressure conditions using an autoclave, sterilization methods using radiation affect the composition contained in the medium, and the desired direction and level of differentiation during cell processing are required. It may not be applicable depending on the properties of the enclosed medium because there is a risk of adversely affecting the growth rate and the like.

On the other hand, when consumables such as pipette tips, dishes, centrifuge tubes, and sample tubes are brought into an area with a high degree of cleanliness, it has been proposed to multiplex the sterilized consumables using a sterilization bag. (See Patent Document 1 below). In this case, the sterilized consumables are kept at a high degree of cleanliness by breaking the outermost sterilization bag in the area of a predetermined degree of cleanliness, taking out the contents, and carrying the contents into the area with a high degree of cleanliness. It is explained that it can be carried in. In this proposal as well, it is necessary to carry out sterilization treatment and multiple packaging treatment of consumables in a highly clean environment.

Japanese Unexamined Patent Publication No. 2008-239168

As described above, in order to prepare a container or consumable packaged in multiple packages by a sterilization bag, an environment having a high degree of cleanliness required for sterilization of the container or consumable item and a high degree of cleanliness required for the packaging process are provided. The environment needs to be prepared. It is desired to prepare an environment having such a high degree of cleanliness, and it is not easy to process in such an environment, and it is desired that the required cleanliness standard can be relaxed. Further, it is preferable that the limitation of the applicable sterilization treatment method depending on the contents contained in the container can be relaxed. Furthermore, when alcohol or the like is used for the sterilization process, labor is required, the degree of sterilization varies depending on the operator, and microorganisms may remain due to human factors, but such sterilization process can be avoided. It's never been better.

As a result of repeated studies on a container for accommodating a liquid material in consideration of the above-mentioned problems, the present invention provides a composite container for a liquid material in the first gist, and the composite container is a composite container.
(1) An innermost container having a space capable of accommodating a liquid substance, which has an opening connecting the inside and the outside, and an innermost plug airtightly arranged in the opening. And (2) The outermost container having a space for accommodating the innermost container, which has an opening connecting the inside and the outside, and an outermost plug airtightly arranged in the opening. A liquid material storage composite container having a container.
The innermost container is placed in the space of the outermost container,
The innermost plug and the outermost plug are liquid from the outside of the composite container into the space of the innermost container and from the space of the innermost container to the outside of the composite container via a hollow needle penetrating both of them. It is characterized in that it is configured so that it can be aligned to move objects.

Throughout this specification, the term "liquid" broadly means what can be treated as a liquid, in addition to ordinary liquids, emulsions in which other fine liquids are emulsified in the liquid, in liquids. It is also used as a dispersion in which a particulate solid is dispersed, a solution in which another solid and / or a liquid is dissolved in a liquid, and the like. Specifically, a liquid medium, a cell exfoliating solution, a buffer solution, a pharmaceutical product, a washing solution, or the like can be exemplified as a liquid substance. Examples of the liquid medium include, but are not limited to, Dulbecco's modified Eagle's medium (DMEM), neural progenitor cell standard medium (NPBM: Clontech), αMEM medium and the like.

Throughout the present specification, the term "hollow needle" refers to a needle made of a metal or plastic material having a long penetrating space inside (for example, a metal injection needle having a thickness of 22 G to 18 G, φ2.5 to φ6.0 mm). (Although examples thereof include, but are not limited to, plastic needles having a thickness of), it is usually preferable that the cutting edge is sharply processed in order to facilitate penetration in the stopper. When a medical valve or the like having a slit as described later is used as a stopper, the tip does not need to be sharply processed, and the shape is like an extension of the inner cylinder of a male connector such as a syringe. You may be doing. Further, the hollow needle may be shaped like a Hoover needle having a shape in which the blade surface is parallel or substantially parallel to the penetrating direction. Such a hollow needle can be connected to a reservoir storing the liquid material to be supplied, for example, through an appropriate tube when supplying the liquid material to the composite container, and the liquid material is supplied from the reservoir to the composite container. Can be supplied. Further, when collecting the liquid material from the composite container, specifically the innermost container, the hollow needle is supplied to a device for collecting the liquid material from the innermost container and using it as specified, for example, via an appropriate tube. can. Collection may be performed using a syringe or the like without using a tube or the like, and the collection is not limited to these.

Throughout this specification, the term "plug" is used in a function that is airtightly arranged in an opening that connects the inside and the outside of the container and blocks the communication relationship between the inside and the outside of the container, that is, in the opening. It means a member having a function of substantially separating the inside and the outside of the container by arranging the container. Specifically, the plug may be in the form of a plug that can be inserted into the opening, such as a cylinder, cone or truncated cone. In another aspect, the stopper may be a member, such as in the form of a cap, in which case the container has a mouth that can be covered with the cap, eg, a mouth that protrudes from the body of the container. More specifically, in the present specification, the stopper may be a rubber stopper, a rubber cap, or the like used when closing the mouth of a vial, a test tube, or the like. The stopper placed in the opening of the container preferably has a self-sealing property. This property means that the plug allows the hollow needle to penetrate, but when the penetrating hollow needle is removed from the plug, the passage created in the plug by the penetration is naturally substantially closed. Regarding the shape of the "plug", the dimension in the direction through which the hollow needle penetrates (for example, height or thickness) does not necessarily have to be larger than the dimension in the direction perpendicular to it (for example, diameter), and self-sealing property is ensured. As long as the stopper is used, the stopper may have a thinner form, that is, a high aspect ratio (= radial dimension / height dimension), for example, a thick film or a plate-like form. ..

In one aspect, in the composite container of the present invention, the plug, eg, the innermost plug, may be in the form of a cap attached to the mouth of the container, eg, the innermost container. For example, the container has a mouth portion provided in advance so as to protrude from the main body portion, and the stopper is configured as a cap that can be engaged or fitted to the outside of the mouth portion. In one form, the mouth has a threaded portion on its outside and another threaded portion screwed into this threaded portion has a stopper as a cap on the inside thereof, so that the stopper is screwed into the mouth portion. can. In another form, the stopper is elastically deformable, thereby engaging, for example, by snap-fit or press-fit to fit the stopper on the outside of the mouth or inside the mouth that protrudes from the body of the container. Or can be fitted. In these forms, the plug as a cap is an element independent of the mouth (ie, an element separate from the mouth), but in other forms they may be integral. For example, the cap may be connected to the mouth portion via a hinge portion. That is, the mouth portion and the cap may be in the form of a so-called hinge cap which is integrally connected via the hinge portion. In this case, the mouth of the hinge cap may be directly adhered to the container, or the mouth of the hinge cap may be attached to the mouth provided in advance in the main body of the container by, for example, engaging (specifically, screwing or snapping). It may be fitted by fit) or by snap fit. In any form, the cap has self-sealing properties as described above. As will be described later, it is convenient to use the innermost plug as such a cap because it is easy to take out the liquid substance.

The self-sealing property of the above-mentioned stopper is temporarily determined by the penetration of the hollow needle based on the force acting on the stopper (particularly the force acting to compress the stopper), the material constituting the stopper and / or the shape of the stopper. It can be achieved by closing the passage formed in. The material constituting the stopper includes, for example, a natural or synthetic elastic material, that is, a material having elasticity, and a polymer or an elastomer material. Specific examples thereof include, but are not limited to, materials selected from natural rubber, vulcanized natural rubber, butyl rubber, synthetic rubber such as isoprene rubber and silicone rubber, and thermoplastic elastomers.

Further, as a kind of stopper, a medical valve provided with a slit is known. This medical valve has a structure in which a disc-shaped elastic plug body having a slit formed in the central portion is attached to the opening member, and the tip portion of a plastic needle as a hollow needle, a male connector, etc. is elastic. By inserting it directly into the slit of the plug body, the tip portion of the plastic needle, male connector, etc. can be connected to the fluid flow path in a communicative state. Further, by pulling out the tip portion of the plastic needle or the like connected in this way from the elastic plug body, the fluid flow path is held in a blocked state by the restoring action of the elastic plug body at the same time as the pulling out.

Such stoppers should remain adhered to the material constituting the opening of the container constituting the composite container with sufficient strength under the conditions of use and transfer thereof of the composite container of the present invention. Preferably, and because of the self-sealing property, an airtight state is ensured between the inside and the outside of the container, and gas does not leak between them.

Such an adhesive state is, for example, a mode in which the material constituting the opening of the container is welded to the stopper, a mode in which the material constituting the stopper is welded to the material constituting the opening of the container, these two. A mode in which various types of welding occur, a mode in which an adhesive is interposed between the plug and the material constituting the opening, a mode in which a strong frictional force acts between the plug and the material constituting the opening, A mode in which the material constituting the opening and the portion of the stopper adjacent to the opening are fitted to each other (including a mode in which they are fitted in a concave-convex relationship), the material of the container and the material forming the stopper are elastic. It can be ensured by at least one or more combinations such as in close contact (including a mode in which the stopper is fitted into the opening by press fitting). In any aspect, it is preferable to maintain the adhesive state so that a force acts from the material constituting the opening toward the stopper. For example, the stopper can be hermetically adhered to the container using techniques applied to spouted pouches that are widely used in the food, healthcare and medical fields.

Throughout this specification, the term "alignable" means that the plugs of interest can be neatly lined up. As a result, a single hollow needle can extend through all the plugs along the alignment direction of the plugs, thereby spatially separating the space of the innermost container and the outside of the composite container through the space inside the hollow needle. It becomes a state of communication, and the liquid substance can move through the space inside the hollow needle. In the composite container of the present invention, each stopper may be originally (that is, from the beginning or originally) aligned, but may not be originally aligned. Preferably, the stoppers that are originally in the non-aligned state can be moved relative to each other to be in the aligned state. For example, the stopper can be relatively moved by appropriately selecting the material constituting the container and the shape of the container.

In a particularly preferred embodiment, the plugs are aligned and aligned so that the plugs engage with each other. For example, it is preferable that the stoppers to be aligned can be fitted to each other. In addition to the above-mentioned press fit and fitting of the concave portion and the convex portion, the engaging relationship can be secured by utilizing the mating relationship between the male part and the female part, the attractive force of the magnet, and the like. Specifically, an embodiment in which the plug is configured so that at least one part of the plug to be aligned has a shape that fits into at least a part of the other, a concave portion is formed in one of the plugs to be aligned, and a convex portion is formed in the other. Examples thereof include a mode of forming a magnet piece, a mode in which a magnet piece is embedded in a plug to be aligned, and the magnet pieces are attracted by a magnetic force. It should be noted that "airtightness" is not always necessary for the engagement between the aligned plugs. The stoppers in such an engaged state are convenient because they can be treated as if they are substantially integrated with respect to the penetration of the hollow needle.

Throughout this specification, the term "container" is used to mean a vessel that provides a space for accommodating an object, and has an opening that connects the inside and the outside thereof. The shape of the container is not particularly limited, and any suitable shape may be used, and the shape may be constant or variable. For example, the container may be in the form of a bag (or bag), a bottle, a bottle, a box, a cylinder, or the like, and is generally preferably in the form of a bag or a bottle. In one preferred form, the container is a two-dimensional (thin planar form with virtually no gussets) bag, a three-dimensional (thick three-dimensional form with bags) bag, eg standing. It is a pouch. In the composite container of the present invention, for the innermost container, the object is a liquid substance, and for other containers, the object is another container located adjacent to the inside thereof. The container may be made of any suitable material, for example, a plastic material, glass or the like. Further, the shape of the opening is not particularly limited as long as the stopper can be arranged airtightly. For example, the opening preferably has a shape corresponding to the outer shape of the stopper. If the outer diameter of the plug (ie, the outer contour) is circular, the opening has a corresponding circular cross section. In another aspect, the container has a short tube-shaped protrusion, the opening at the end of the short tube acting as an opening, into which a plug is fitted or which is capped. be able to.

Particularly preferred containers are films, such as films of plastic material, especially bags made of composite film material or molded articles of plastic material. The film container has an advantage that its shape can be freely changed. Therefore, if the relative movement of the stopper is preferred as described above, the container is preferably made of a plastic film material. The container may be made of the same material as the so-called sterile bag and have the same form. In another aspect, the container is a molded article made of a plastic or elastomeric material, especially a thin-walled article. In this embodiment, by appropriately selecting the wall thickness of the container and / or the shape of the container, the container can be substantially deformed and the stoppers can be moved relative to each other, and as a result, the stoppers can be formed. Can be aligned. In addition, the stoppers may be fixed and aligned in advance by weak welding.

When the container constituting the composite container is made of a film, particularly a film of a plastic material, in one embodiment the container is in the form of a standing pouch. This is generally a thin form with virtually no folds, but on the other hand, when the contents to be included are put in, the bottom fold opens and folds are formed, resulting in a three-dimensional form, so that it stands up. It is a devised soft container. That is, it is a container that is thin (2D state) in the empty state, but can stand on its own in the 3D state with the bottom surface exposed in the state containing the contents. In the composite container of the present invention described above and described later, a standing pouch may be used in any container as appropriate, but in a preferred embodiment, it is used as, for example, the innermost container. In this case, when the innermost container (including the liquid material) is taken out from the composite container containing the liquid material, the innermost container is in a state where it can stand on its own, so that the innermost container can be easily handled. Further, in the state of the empty composite container before supplying the contents, if all the containers constituting the composite container are made into standing pouches, the composite container can be made thin as a whole and the bulk becomes small. Is easy to store and handle.

On the other hand, a container as a molded product of a plastic material may not be deformed as easily as a container made of a film by adjusting the type, shape, wall thickness, etc. of the material to be used according to the design. Therefore, it is possible to maintain the shape of the composite container as a whole, improve the independence, and the like. For example, having at least one independence of the innermost container and the intermediate container described later improves the independence of the composite container, which is convenient when handling the composite container.

Throughout this specification, the term "airtightly" means that a stopper is placed in an opening that connects the inside and the outside of a predetermined container, for example, the innermost container, so that the container is placed from the outside to the inside and from the outside to the inside. This means that the movement of gas from the inside to the outside of the container, and thus the movement of liquids such as liquids, is virtually impossible. Then, the movement of the liquid material between the inside and the outside is possible only through the hollow needle penetrating the stopper.

The composite container of the present invention comprises an innermost container and an outermost container located outside the innermost container, and thus the outermost container has a space inside which the innermost container can be accommodated. The innermost container has a space inside which a liquid substance can be stored. The container of the present invention is referred to as a "composite" container because at least two containers are combined in this way to form a single container. As used herein, "innermost" means located on the innermost side of the composite container of the present invention, and "outermost" means located on the outermost side of the composite container of the present invention. ..

In the composite container of the present invention, the innermost container and the outermost container each have an opening for connecting the inside and the outside of the container, and each opening has a stopper for airtightly blocking the inside and the outside of the container. That is, the innermost plug and the outermost plug are arranged. These stoppers can be aligned with each other and, through a hollow needle penetrating them, liquid matter from the outside of the composite container into the space of the innermost container, or from the space of the innermost container to the outside of the composite container. Can be moved to.

In the composite container of the present invention as described above, when the innermost container is empty, any appropriate sterilization treatment method may be selected as long as the composite container is not adversely affected, and the treatment can be carried out. .. For example, sterilization can be performed from the outside of the outermost container using radiation (for example, γ-rays, electron beams, etc.). In another aspect, it can also be sterilized under autoclaving conditions. After the sterilization treatment, the inside of the outermost container of the composite container is in a sterilized state, and when the stoppers are aligned and the hollow needle is penetrated, the tip portion of the hollow needle can reach the innermost container after the sterilization treatment. Therefore, for example, in order to obtain a composite container containing a medium, which is packaged using a sterilization bag, the present invention has a sterilization bag as an innermost container and an outermost container obtained by sterilization as described above. Using the composite container of, the stoppers are aligned and the hollow needles are passed through these stoppers, and then a predetermined liquid material is supplied from the outside of the composite container to the space inside the innermost container via the hollow needles. Well, very simple. In addition, since each container has already been sterilized, the environment in which the liquid is placed and packaged does not need to be as clean as described in the background art.

Therefore, in the second gist, the present invention provides a method of supplying a liquid substance from the outside of the composite container of the present invention to the innermost container, and this method is described.
The innermost container having a space for accommodating a liquid substance, the innermost container having an opening connecting the inside and the outside, and an innermost plug airtightly arranged in the opening, and the innermost container. It is an outermost container having a space for accommodating a vessel, and has an opening for connecting the inside and the outside, and an outermost container having an outermost plug arranged airtightly in the opening. , A method of supplying a liquid substance into the innermost container from the outside of the liquid substance accommodating composite container in which the innermost container is arranged in the space of the outermost container.
(1) Step of aligning the innermost plug and the outermost plug,
(2) A process of inserting a hollow needle from the outside of the composite container so as to penetrate the innermost plug and the outermost plug, and exposing the tip portion thereof into the internal space of the innermost container, and (3) holding a liquid substance. It is characterized by including a step of supplying a liquid substance from the reservoir to the innermost container via a hollow needle.

Further, in order to collect a liquid substance from the composite container of the present invention that already contains the liquid substance in the innermost container, the outermost container is removed and the contents thereof are taken out immediately after removing the outermost container in the initial environment in which the composite container originally exists. In a sampling environment having a predetermined degree of cleanliness, a hollow needle is passed through a stopper arranged in the innermost container, the tip portion thereof is inserted into the liquid material, and the liquid material is inserted through the hollow needle. Can be taken out.

Therefore, in the third gist, the present invention provides a method for collecting a liquid substance from the innermost container of the composite container of the present invention to the outside thereof.
An innermost container having a space for accommodating a liquid substance, an opening connecting the inside and the outside, and an innermost container having an innermost plug airtightly arranged in the opening, and an innermost container. The outermost container having a space for accommodating the innermost container, the outermost container having an opening connecting the inside and the outside, and the outermost plug arranged airtightly in the opening, and the outermost container. The innermost container is a method of collecting a liquid substance from a composite container for containing the liquid substance, which is arranged in the outermost container.
(1) A step of removing the outermost container and taking out its contents in an initial environment in which a composite container containing a liquid substance exists.
(2) It is characterized by including a step of transferring the taken-out contents to a collection environment and collecting the liquid material from the inside of the innermost container to the outside through a hollow needle penetrated through the innermost plug in that environment. And.

The meanings of various terms in these methods of the present invention are the same as the meanings of the terms described above or described below in relation to the composite container of the present invention.

In the composite container of the present invention, the innermost container is arranged inside the outermost container, and each of them is configured to have a stopper that can be aligned with each other. After that, the liquid material as the content can be supplied through the stopper. Therefore, it is possible to select an appropriate sterilization treatment for the composite container without considering that the sterilization treatment affects the liquid material. Then, if necessary, a liquid material can be supplied to the composite container to obtain a composite container containing the liquid material. That is, the liquid material to be contained in the composite container can be supplied to the composite container using a composite container that has been appropriately sterilized in advance. Therefore, since the sterilization treatment may be performed before the step of supplying the liquid material, a composite container containing the liquid material can be easily obtained. Further, in the method for collecting a liquid substance from a composite container of the present invention, since the liquid substance can be collected from the composite container containing the liquid substance as described above, the liquid substance contained in the composite container in an appropriately sterilized state is used. Therefore, more sufficient reliability can be ensured when using such a liquid material. In addition, since it is collected through the plug, contamination of liquid matter can be prevented.

It is a drawing which shows typically the state which the stopper of the composite container of this invention is aligned and the hollow needle is passed through the stopper, and the composite container is seen from the side before supplying the liquid material. It is a drawing which shows typically the state which the composite container of this invention shown in FIG. 1 is seen from the side after the liquid material is supplied, and in the illustrated state, the alignment state of a stopper is released. There is. It is a drawing which shows typically the composite container of this invention of another aspect which further has an outer container, like FIG. 1. FIG. 3 is a drawing schematically showing a process of collecting a liquid material from the composite container of the present invention shown in FIG. 3, as in FIG. 1. FIGS. 5 (a) and 5 (b) schematically show the state of the innermost container and the intermediate container located on the outside thereof when viewed from the side and from above, respectively.

Next, various embodiments of the present invention will be described with reference to the drawings. In such an embodiment as well, the matters described above in relation to the present invention, particularly the meanings of the terms, apply similarly. In each of the drawings, even elements that cannot be seen from the outside regarding the positional relationship of the elements constituting the composite container are represented by solid lines so that they can be easily understood. That is, the components are treated as if they are transparent, the outlines thereof are shown by solid lines, and the positional relationship and structure of the components can be easily understood. In one preferred embodiment, the various containers constituting the composite container are transparent, and it may be convenient to know the inside thereof.

FIG. 1 schematically shows how one aspect of the composite container of the present invention is viewed from the side. In the embodiment shown in FIG. 1, the composite container 10 of the present invention comprises an innermost container 12 and an outermost container 14. The innermost container 12 has an opening 16 of the innermost container that connects the inside and the outside, and the innermost plug 18 is airtightly arranged therein. The outermost container 14 has an opening 20 of the outermost container that connects the inside and the outside, and the outermost plug 22 is airtightly arranged therein. In the illustrated state, the outermost plug 22 is already aligned with the innermost plug 18. In this state, the hollow needle can be passed through the stoppers 22 and 18 as shown.

In the illustrated embodiment, the outermost plug 22 has a recess 24 on the lower side thereof, and when the outermost plug 22 is moved in the direction indicated by the broken line arrow with respect to the innermost plug 18, the upper part of the innermost plug 18 becomes the recess 24. It is preferable that it fits in, that is, fits in. By fitting in this way, the innermost plug 18 and the outermost plug 22 can be ensured to be aligned, and therefore, they can be handled integrally, so that the hollow needle can be penetrated as described above. It will be easier. In the illustrated embodiment, the central portion of one plug (for example, the outermost plug) is provided with a recess, and the upper part of the other plug (innermost plug) is not provided with a special convex portion, which fits into the concave portion. It functions as a convex portion provided on the upper side of the innermost plug to be inserted. By providing a concave portion on one side of the object to be aligned and providing a convex portion corresponding to the concave portion on the other side and fitting them together, the aligned state can be easily ensured. As shown in the figure, the arrangement of the concave portion and the convex portion does not necessarily have to be provided at the central portion of the stopper, and the concave portion and / or the convex portion may be provided at the peripheral portion of the stopper. For example, a convex portion may be provided in a circumferential shape or a part thereof on the lower peripheral portion of the outermost plug 22, and a concave portion corresponding to the upper peripheral portion of the innermost plug 18 may be provided in a circumferential shape or a part thereof.

Providing the concave portion and the convex portion in this way to secure the alignment not only applies to the outermost plug and the innermost plug, but also to secure the alignment state with other plugs such as the outer plug described later. Also applies. In order to facilitate the alignment of the plugs, in another aspect, in place of or in addition to the fitting described above, the plugs to be aligned are configured to be aligned by being attracted by a magnetic force, yet to ensure an aligned state. good. For example, magnet pieces may be embedded in each plug and attracted to each other to be aligned, or such an aligned state may be ensured.

The innermost plug 18 and the outermost plug 22 are preferably made of an elastic material such as rubber, and the above-mentioned fitting state can be achieved and maintained by, for example, press fitting. After the stoppers are aligned in this way to ensure the state, as shown in FIG. 1, the hollow needle 26 can be passed through the aligned stoppers to position the tip portion 29 inside the innermost container 12. can. After that, a predetermined liquid material is supplied into the innermost container 12 via the hollow needle 26 to obtain a composite container containing the liquid material of the present invention.

As shown in FIG. 1, in the composite container 10 of the present invention, the inside of the outermost container 14 is completely isolated from the outside of the composite container 10 before the hollow needle 26 is penetrated. Therefore, in this state, any appropriate sterilization method may be applied to sterilize the composite container as long as it does not adversely affect the elements constituting the composite container, and the effect of the sterilization treatment inside the outermost container may be applied. Can be maintained. Therefore, regardless of the nature of the liquid material supplied to the innermost container 12 of the composite container 10, an appropriate sterilization method can be selected and the composite container can be sterilized using that method. After sterilization, the inside of the outermost container is substantially shielded from the outside, so that the outermost plug of the composite container is moved with respect to the innermost plug and fitted to each other in a predetermined environment. After the hollow needle is passed through the stopper, the liquid material can be supplied from the reservoir holding the liquid material to the innermost container via the hollow needle, for example.

In one aspect of the invention, as shown in FIG. 1, the composite container 10 further comprises an intermediate container 13 between the innermost container 12 and the outermost container 14. This intermediate container is located between the outermost container and the innermost container (or between the outer container and the innermost container if the outer container is further provided as described later), and the inside and the outside thereof are separated from each other. It has an opening 17 to communicate with. The innermost plug 18 arranged at the opening of the innermost container is also airtightly arranged at the opening 17 of the intermediate container. That is, the opening 16 and the opening 17 share the innermost plug 18. Such an intermediate container can function to protect the innermost container.

In one embodiment, such an intermediate container is such that the shape does not substantially change when the composite container 13 contains at least a liquid material in the innermost container. For example, the intermediate container is a bottle formed of a plastic material, and in this case, the shape of the intermediate container does not substantially change regardless of the presence or absence of a liquid substance. As a result, even if the container located outside the intermediate container is made of, for example, a film-like plastic material and therefore does not have self-supporting property, the intermediate container located inside the intermediate container is self-supporting, so that the composite container becomes self-supporting. The shape has a stable independence as a whole, and has an advantage that a composite container can be placed as needed. For example, they can be stacked. Further, since the innermost container is, for example, bag-shaped and the intermediate container is self-supporting even if it is not self-supporting, when the outer container of the intermediate container is removed in the composite container, the innermost container located inside the intermediate container is removed. Can be held stably inside a self-supporting intermediate container. For example, when the liquid material is taken out from the composite container, when the container located outside the intermediate container is removed to expose the intermediate container, the intermediate container shares the innermost plug with the innermost container. With the innermost container stably held inside, it can stand on its own without using any special support means. Such an intermediate container has an advantage that it can be stably placed on a table, for example, as it is.

In this way, the intermediate container that imparts independence does not necessarily have to surround substantially all of the innermost container as long as it is self-supporting, for example, a frustum that surrounds only the side of the innermost container. It may be the side part of (ie, a frustum or a frustum) (ie, there is no top and bottom of the frustum, and the perimeter defining the top surrounds, eg, surrounds) the innermost plug. In the form, it may be a part of a surface constituting such a side surface portion. Such an intermediate container 13 together with the innermost container 12 located inside the intermediate container 13 is schematically shown in FIGS. 5 (a) and 5 (b) when viewed from the side and when viewed from above, respectively.

In the illustrated embodiment, the intermediate container 13 has an opening 17 corresponding to the top of the truncated cone, and the innermost plug 18 is shared with the innermost container 12 to surround the innermost container 12. In the illustrated embodiment, the bottom surface portion 15 of the truncated cone shown by the broken line does not necessarily have to exist, and may be in an open state (that is, a skirt-like form) without being present. The side surface portion 11 may have a form that surrounds the entire circumference of the innermost container 12 as shown in the drawing, but for easy understanding, a sheet-like element (for example, the innermost plug) as a part of the side surface portion including the generatrix. An arcuately curved sheet-like element (for example, an element 19 in the area sandwiched by the dotted line in FIG. 5B) extending diagonally downward from 18 exists so as to face each other across the innermost container 12. The independence of the intermediate container can be ensured by itself.

In such an embodiment, the sheet-like element 19 does not necessarily have to be curved and may be a flat sheet-like element, in which case the intermediate container 13 has substantially no function of receiving the object. Often no longer in the form of a container. Therefore, it is appropriate to call such an element an intermediate element rather than an intermediate container. Considering the independence, the sheet-like element 19 preferably exists at an equal angle around the innermost plug 18, and for example, as shown in FIG. 5B, 2 around the innermost plug 18 at 180 ° intervals. Provide one sheet. In another aspect, 6 sheet-like elements 19 at 60 ° intervals and 4 sheet-like elements 19 at 90 ° intervals may be provided, and when 3 sheets are provided at 120 ° intervals, the length of the sheet-like elements is stable even if there is a difference. It is advantageous in that it can be self-reliant.

In another aspect, the intermediate container is made of a film material, in which case the intermediate container is generally non-self-supporting, but the overall composite container is compact. In this case, the intermediate container functions as an outer container, for example, when it can perform a function of protecting the innermost container and can maintain the airtightness of the space between the intermediate container and the innermost container. obtain. In one form, before supplying the liquid to the composite container, the innermost container inside it in addition to the intermediate container is not self-supporting, for example, bag-shaped, and in the preferred form, at least the intermediate container is standing. It may be in the form of a pouch. In this form, when the innermost container corresponding to the contents of the intermediate container swells with a liquid substance, the standing pouch as the intermediate container swells and can stand on its own. An intermediate container that is swollen and self-supporting in this way can be regarded as equivalent to an intermediate container in which the above-mentioned shape does not change substantially. When the outermost container and the outer container (if any) are removed, there is an advantage that the innermost container can be self-supporting while being held inside. If a standing pouch is used as the innermost container, the innermost container containing liquid matter can stand on its own without using the independence of the intermediate container. Since it is possible to stand on its own even in the state of only the container, the function of imparting the independence of the intermediate container becomes unnecessary, and as a result, the intermediate container can be omitted in the composite container of the present invention.

In one embodiment, the intermediate container preferably has at least one through hole 30 in the wall constituting it, as shown. In this hole, for example, when the space between the intermediate container and the innermost container is a substantially closed space, the volume of the innermost container 12 increases when the liquid material is supplied to the innermost container 12. It is possible to prevent the pressure in the intermediate container from increasing excessively.

In one preferred embodiment of the invention, the innermost container is in the form of a standing pouch. In this aspect, when the innermost container contains a liquid substance and the bottom is widened and swollen, it can stand on its own. Therefore, in this aspect, there is no need for an intermediate container that imparts independence to the innermost container as described above. Therefore, in the composite container of the present invention, the intermediate container does not necessarily have to exist between the innermost container and the outermost container or the outer container (if any).

In a particularly preferred embodiment of the composite container in the absence of an intermediate container, the outer container (if any) located outside the innermost container in the form of a standing pouch and the outermost container are in a closed, thin state where the innermost container is empty. Also, the innermost container is configured so that it can be located outside such an innermost container even when the innermost container contains a liquid substance and the bottom is widened and swollen. For example, all of the containers located outside the innermost container are in the form of standing pouches. In this embodiment, each outer container is in a closed thin state while containing it when the container adjacent to the inside is in a closed thin state, and includes it when the adjacent container is inflated. It becomes a swollen state. Therefore, when the composite container is empty and does not contain liquid, the innermost container and the outermost container (that is, the outermost container and the outer container if present) of the composite container are closed. In a thin state and containing a liquid substance, both the innermost container and the outer container thereof (that is, the outermost container and the outer container when present) are in a swollen and thick state.

State of the composite container when the supply of the liquid substance to the innermost container 12 is completed as described above, the hollow needle 26 is removed, and then the alignment state of the innermost plug 18 and the outermost plug 22 is released. Is schematically shown in FIG. 2 in the same manner as in FIG. In FIG. 2, for example, as shown by the arrows on both ends of the broken line, the alignment state is released by relatively pulling the stoppers apart, and the innermost container 12 is expanded in volume due to the inclusion of the liquid substance 32. The state is schematically shown. It is not always necessary to release the alignment state of the innermost plug 18 and the outermost plug 22. The liquid material 32 can be collected from the composite container 10 as follows, for example.

The composite container 10 containing the liquid material is moved to the vicinity of the area where the liquid material 32 is intended to be used (having an initial environment) as shown in FIG. An intermediate environment in the vicinity of such an initial environment, preferably adjacent to an area where the liquid material 32 is intended to be used after sterilizing the composite container 10, specifically the outermost container 14, by, for example, alcohol spraying. The outermost container 14 is broken at its weakened portion 34 (indicated by the dashed line). Immediately, the broken portion is expanded by using the broken portion as a trigger, and the contents including the intermediate container 13 are taken out. Immediately after that, the taken-out contents are moved to a predetermined area having a sampling environment where the liquid material 32 is planned to be used. For example, a hollow needle is passed through the innermost plug 18 and the tip portion 29 thereof is inside the liquid material 32. After pushing into, the liquid material can be collected from the innermost container via a hollow needle and used as specified.

In one aspect of the invention, the composite container 10 of the present invention provides a space between the outermost container 14 and the innermost container 12 or the intermediate container 13 (if any) that can accommodate the innermost container or the intermediate container. It further comprises an outer container 40 having. This aspect is schematically shown in FIG. 3 as in FIG. The composite container 10 shown does not include the intermediate container 13 included in the composite container 10 shown in FIG. 1 or 2. Like the innermost container 12 or the outermost container 14, the outer container 40 has an opening 42 that connects the inside and the outside thereof, and the outer plug 44 is airtightly arranged therein. The outer plug 44 is configured to align with the innermost plug 18 and the outermost plug 22, and thus the innermost plug 18, the outer plug 44 and the outermost plug 22 are arranged side by side in this order. In the illustrated embodiment, the outermost container 14 has a weakened portion 34, and the outer container 40 also has a weakened portion 35.

In the embodiment shown in FIG. 1, the innermost container 12 has a shape like a round balloon, but in the embodiment shown in FIG. 3, the innermost container 12 has a thin rectangular shape as a whole, for example, a culture bag. It is a form like. The innermost container 12 may have any suitable form, but a container having a shape like a culture bag is used as the innermost container, and the outermost container and the outer container (if any) thereof are also used. The entire composite container can be made compact by adopting a rectangular shape that surrounds the container, preferably a similar rectangular shape.

Specifically, the outer plug 44 has an outer plug recess 46 on the lower side thereof, and when the outer plug 44 is moved in the direction indicated by the broken line arrow A with respect to the innermost plug 18, the upper part of the innermost plug 18 is moved. It is designed to fit into the outer plug recess 46. In the illustrated state, these plugs are already aligned, but by fitting in this way, the state where the innermost plug 18 and the outer plug 44 are aligned is ensured. Further, as described above, the outermost plug 22 has a recess 24 on the lower side thereof, and when the outermost plug 22 is moved in the direction indicated by the broken line arrow B with respect to the outer plug 44, the outer plug 44 becomes The upper part fits into the recess 24.

As a result, a state in which the innermost plug 18, the outer plug 44, and the outermost plug 22 are aligned in this order is ensured. In the illustrated embodiment, these plugs are relatively moved and fitted as shown by the arrows so that they are aligned and substantially integrated. This makes it easier for the hollow needle 26 to penetrate these plugs, as shown in FIG. Through the hollow needle 26 penetrating the stopper in this way, it is possible to communicate from the outside of the composite container to the space of the innermost container or from the space of the innermost container to the outside of the composite container. The liquid material can be moved. It should be noted that the movement of the liquid material from the inside to the outside of the composite container may be made possible after removing the outermost container 14 and the outer container 40, as will be clear from the explanation described later.

In the embodiment shown in FIG. 3, the outer container 40 is composed of a single outer container element 41, but instead of the single outer container element 41, the outer container may be composed of a plurality of outer container elements. .. In one preferred embodiment, such an outer container is formed by stacking a plurality of outer container elements in a multi-layered structure. Each outer container element has an opening that connects the inside and the outside, and the stopper is airtightly arranged in the opening. In this case, the composite container of the present invention is configured so that the outermost plug, a plurality of plugs arranged on these outer container elements, and the innermost plug can be arranged in this order. Here, the "multi-structured outer container" means a form in which at least two outer container elements are overlapped so as to be adjacent to each other, and one of the adjacent ones accommodates the other inside. Between the innermost container (provided that the intermediate container does not exist) or the intermediate container (provided that it exists) and the outermost container, there is an outer container having a multi-layer structure in which a plurality of outer container elements are overlapped with each other. ..

Specifically, the "outer container formed by stacking in a multi-layer structure" means, for example, in the case of a quadruple structure outer container, the inner outer container element (referred to as the first container element) is adjacent to the outer container. Of the outer container element (referred to as the third container element) that is located within the space of the outer container element (referred to as the second container element) and adjacent to the outer container element (ie, the second container element). It means a structure that is arranged in the space and the outer container element (that is, the third container element) is arranged in the space of the outer container element (referred to as the fourth container element) adjacent to the outer container element (that is, the third container element). .. In this example, a multi-layer structure in which the third container element exists inside the fourth container element, the second container element exists inside the third container element, and the first container element exists inside the second container element. Has. The outermost container is located on the outside of this multi-layer structure, and the innermost container or intermediate container is located on the inside. Each outer container element has an opening that connects the inside and the outside, and the opening has an airtightly arranged stopper.

When moving the liquid material from the innermost container of the composite container in which the innermost container contains the liquid material in advance to the outside of the composite container, that is, when collecting the liquid material, the liquid material is placed in the composite container or its outside. The contents obtained by removing the located container are one or more in which the cleanliness is gradually increased from the cleanliness of the initial environment in which the composite container exists to the cleanliness of the sampling environment in which the liquid material is intended to be collected. Move through the intermediate environment of. The work of removing the outermost container element located in each intermediate environment and moving the exposed contents to the next intermediate environment is performed by collecting the contents exposed by the innermost container 12 or the intermediate container 13. Carry out until moved to the environment. In other words, it is convenient to multiplex the number of outer container elements corresponding to the number of intermediate environments existing between the initial environment and the sampling environment to form the outer container of the composite container.

More specifically, the outermost container 14 is removed in the initial environment, the obtained contents are transferred to the next intermediate environment, and the outermost container element located in the outermost environment in that environment is removed, and the obtained contents are obtained. Is further transferred to the next intermediate environment, the outermost container element located in that environment is removed, the innermost container or intermediate container which is the obtained content is transferred to the collection environment, and the innermost plug 18 in that environment. A hollow needle is pierced through the container, and the liquid material is collected to the outside through the hollow needle.

In the embodiment in which the outer container 40 is composed of the plurality of outer container elements 41, the stoppers arranged in the openings of two or more adjacent outer container elements may be integrated in one embodiment. In this case, adjacent outer container elements share a single stopper. That is, in this embodiment, a single stopper common to the openings of at least two adjacent outer container elements is arranged, and the embodiment in which the single stopper is shared in this way is the above-mentioned most. This is the same as the mode in which the inner container and the intermediate container share the innermost plug. By sharing the stoppers in this way, it is possible to save the trouble of aligning the stoppers arranged on the adjacent outer container elements.

When multiple outer container elements share a single stopper as described above, if the outer container element is broken and removed at the adhesive portion between the stopper and the portion defining the opening of the outer container element, the outer container element can be removed. It is preferably configured so that the contents can be exposed. In this case, even if one outer container element is removed, the stopper shared by the opening of the remaining other outer container elements remains. By doing so, it is not necessary to penetrate the hollow needle through a plurality of stoppers, so that the penetration resistance when the hollow needle is penetrated through the stopper can be relaxed, and the hollow needle can be smoothly penetrated. Become.

When collecting the liquid material supplied to the innermost container of the composite container of the present invention, as described above, various containers located around the innermost container are removed, the innermost container is taken out and exposed, and then the innermost container is exposed. A liquid material is collected from the innermost container to the outside. At the time of this collection, usually, a hollow needle is passed through the innermost plug and the liquid material is taken out through the hollow needle. Taking out such a liquid substance requires preparation of a hollow needle, and in some cases, it can be a complicated process.

In consideration of this, in one preferred embodiment, in the composite container of the present invention, the innermost plug is in the form of a cap that can be attached to the mouth portion provided in the innermost container. For example, the innermost container has a mouth portion provided in advance so as to protrude from the main body portion, and the innermost plug is configured as a cap that can be engaged or fitted to the outside of the mouth portion. In one embodiment, such a cap is piercable by a hollow needle. In one form, the mouth has a threaded portion on its outside and the innermost plug as a cap has another threaded portion screwed into this threaded portion on the inside, so that the innermost plug is the mouth. Can be screwed into the part. In another form, the innermost plug is elastically deformable, thereby snap-fitting, for example, to fit the innermost plug on the outside of the mouth or inside the mouth that protrudes from the body of the innermost container. Alternatively, it can be engaged or fitted by press-fitting. In these forms, the innermost plug as a cap is an element independent of the mouth (ie, an element separate from the mouth), but in other forms they may be integral. For example, the cap may be connected to the mouth portion via a hinge portion. That is, the mouth portion and the cap may be in the form of a so-called hinge cap which is integrally connected via the hinge portion. In this case, the mouth of the hinge cap may be directly adhered to the innermost container, or the mouth of the hinge cap may be attached to the mouth provided in advance in the main body of the innermost container by, for example, engaging (specifically, by engaging). It may be fitted by screwing or snap-fitting) or by snap-fitting. The cap is self-sealing in any form. When the innermost plug has a cap structure in this way, the liquid material can be supplied to the composite container with a hollow needle, but the liquid material can be taken out, for example, by removing the cap from the mouth (for example, screwing). If it is in a state, loosen the screw and remove the cap, and if it is a hinge cap, open the hinge part and remove the cap), and it is convenient because the liquid substance can be poured out from the opening of the opening part that appears.

Therefore, when the innermost plug in the form of a cap as described above is used, the mouth portion of the innermost container is exposed by removing the cap, so that the liquid material can be taken out from the innermost container without using a hollow needle. The liquid can be collected by a predetermined method, for example, by tilting the innermost container or by pipette. Therefore, in the method of collecting a liquid substance from the innermost container of the composite container to the outside in the third gist, a cap that can be attached to the mouth of the innermost container as the innermost plug, for example, a screwable cap or a hinge cap. In the case of using, instead of penetrating the hollow needle through the innermost plug in the step (3), the cap is removed from the mouth of the innermost container, and the liquid material is discharged from the opening of the mouth of the innermost container by a predetermined method. Can be collected outside the innermost container.

Unless there are special inconveniences, the explanations of the meanings of the terms, the containers, the outermost plugs, the innermost plugs, and the like described in relation to the composite container of the present invention include the intermediate container, the outer container, and the outer container. Those skilled in the art will easily understand that the same applies to the plugs and the like placed on it.

In the composite container of the present invention, the outermost container and the outer container or the outer container element all expose the inner container (that is, the outer container element, the intermediate container or the innermost container) adjacent thereto in order. It is configured to be removable. This exposure can be performed by any suitable method as long as the outermost container in the environment where the composite container is present can be destroyed to expose the contents existing inside the compound container. May be good.

For example, the strength of a part of the container to be removed (for example, a part near the stopper, a part around the stopper, etc.) is made relatively smaller than the other parts to form a weakened part, and as a result, a force (for example, a human) is applied to the weakened part. When the force applied by the hand) was applied, the weakened part was torn, and then the weakened part was torn larger, and if necessary, the container was surrounded by removing the container together with the stopper. The contents can be exposed. The weakened portion may be formed in the container by any suitable method.

Specifically, the weakened portion can be formed by reducing the wall thickness of a part of the container, forming a notch portion in a part of the container to form a weak portion, or providing a thin portion. For example, when the outermost container or the outer container (or the outer container element) is bag-shaped, an edge portion (for example, a heat seal portion) in which a film is overlapped and adhered is provided on the edge portion of the container, and the outermost portion of the edge portion is provided. A notch or notch is formed. The bag can be torn from the notch by applying force in opposite directions on both sides of the notch so that the notch becomes larger. It is well known to form cuts for such fractures and is widely used, for example, so that bags of various plastic materials for food can be easily torn and their contents taken out.

As described above, the composite container 10 of the present invention is in the state before the liquid material is put in the innermost container, that is, the innermost container 12, the outermost container 14, and the intermediate container 13 (if present) and / or. Outer containers 40 (if present, single or multiple outer container elements) are stacked in a multi-layered structure, with stoppers 18, 22 and 44 (if present) airtightly placed in the openings of each container. It can be subjected to an appropriate sterilization treatment in the state where the hollow needle 26 is not present in FIG. 1 or the liquid substance 32 is not present in FIG. 2 or 3). Since the composite container 10 does not contain a liquid substance as the content, there is an advantage that the sterilization treatment method can be selected independently of the liquid substance. Of course, if the liquid material is not adversely affected by the sterilization treatment method adopted, it is not excluded that the innermost container 12 of the composite container 10 is sterilized while containing the liquid material.

Further, in the supply of the liquid material to the composite container 10, after aligning the stoppers, a hollow needle is passed through the stopper, and the hollow space portion directly connects the inside of the innermost container 12 and the outside of the composite container 10. It becomes possible by doing. This communication state can minimize the influence of the environment around the composite container on the inside of the outermost container, particularly the inside of the innermost container, preferably substantially no influence on the composite container 10. When supplying the liquid material 32, there is an advantage that the cleanliness of the environment in which the composite container is present does not necessarily have to be as high as commonly used.

Therefore, the present invention also provides a method of supplying a liquid material to the composite container 10 of the present invention described in the present specification, in other words, a method of manufacturing a composite container containing the liquid material. These methods will be described in more detail with reference to the drawings.

First, the composite container 10 of the present invention that has already been subjected to a predetermined sterilization treatment is prepared. For example, the composite container 10 of FIG. 1 (provided that the intermediate container 13 may be provided as needed and the hollow needle 26 is not present) or the composite container 10 of FIG. 3 (provided that the outer container 40 (that is, a single container) is present). Alternatively, a plurality of outer container elements) may be included as needed, and a state in which the hollow needle 26 and the liquid material 32 are absent) is prepared. In this state, a stopper is arranged at the opening of each container constituting the composite container 10, whereby the inside and the outside of the container are airtightly isolated from each other.

Next, the innermost plug 18, 1 or more outer plugs 44 (if any) and the outermost plugs 22 of the composite container are aligned and later along the extending direction of the hollow needle 26 to be penetrated. Make sure to line up in a row. In a preferred embodiment, the alignment is ensured at the same time as or thereafter, for example by fitting, as described above. After that, the hollow needle is inserted into the aligned stopper and penetrated so that the tip portion 29 of the hollow needle is exposed inside the innermost container 12. Then, after connecting the reservoir (not shown) holding the predetermined liquid material and the other end of the hollow needle with an appropriate pipe (for example, a tube), the liquid material is transferred from the reservoir to the innermost container via the hollow needle. Supply inside.

In the case of aligning as described above, it is preferable that the plugs are substantially integrally connected to each other in a fitting relationship, and the hollow needle can be easily penetrated. For example, it is preferable that the plugs are fitted by press-fitting, and once they are fitted, the fitted state cannot be released unless a certain amount of force is applied. For example, such favorable fitting can be achieved by utilizing the elastic expansion and contraction of the plug material, the friction on the contact surface of the plug, and / or the uneven shape applied to the plug.

Further, the container, particularly the outer container 40 (or outer container element 41) and / or the outermost container 14, has a gas barrier property so as to facilitate the relative movement of the stoppers when aligning the stoppers. Packaging bags made of thin plastic film materials (eg, ethylene vinyl alcohol copolymer (EVOH), polyethylene terephthalate (PET), polyvinylidene chloride (PVDC), nylon, etc .; these materials A packaging bag constructed by vapor-depositing a gas barrier substance such as silica or alumina; or a packaging bag composed of a multilayer film combining these materials), preferably having a small or substantially small gusset. Those not found in (that is, 2D-shaped pouches) are preferable. For example, when the composite container 10 is preferably self-supporting, for example, the intermediate container 13 is preferably formed so as to have a stable shape. For example, the intermediate container 13 may be formed by blow molding of a plastic material by heat-sealing a thick plastic material film to form a three-dimensional bag (3D-shaped pouch).

When the hollow needle 26 is passed through the aligned stopper to supply the liquid material to the composite container 10 as described above, the tip portion 29 of the hollow needle is located inside the composite container. It is preferred that at least such a tip is pre-sealed prior to penetration and isolated from the environment in which the hollow needle is present. Such isolation can be achieved by surrounding the tip with an elastic material. More specifically, it is preferable to cover a sleeve or cap of an elastic material such as rubber over at least the tip portion 29 of the hollow needle, particularly preferably over substantially the entire length of the hollow needle.

When the hollow needle is inserted into the outermost plug, such a sealing portion is pressed by bringing the sealing material covering the tip of the hollow needle into contact with the outermost plug, and then when further insertion is attempted, a sharp cutting edge portion 28 Can break the sealing material and enter the outermost plug. That is, the tip portion of the hollow needle can enter the composite container while being isolated from the environment in which the hollow needle was present. This has the advantage that when the hollow needle penetrates, contamination of the composite container due to the environment in which the hollow needle was present can be minimized. When inserting as described above, if the insertion angle of the hollow needle deviates greatly from the alignment direction of the plugs and the hollow needle is inserted at an excessive angle, the wall surface of the innermost container may be damaged. In order to prevent such diagonal insertion, it is preferable to provide a guide 48 under the innermost plug 18 as shown in FIG. The guide 48 may be a cylindrical member (for example, a cylindrical member) provided so as to surround the center of the lower surface of the innermost plug 18 and project downward. Such members are preferably formed using a plastic or metal material that does not penetrate even the sharp edge of the hollow needle. As a result, the cutting edge 28 of the hollow needle 26 inserted excessively diagonally comes into contact with the guide 48, and further diagonal insertion becomes impossible, so that damage to the innermost container due to the hollow needle can be prevented. In this case, the penetration may be performed again. In a more preferred embodiment, even after the hollow needle 26 has come into contact with the guide 48, if the penetration is continued, for example, the tip portion 29 of the hollow needle is curved to some extent and the tip portion thereof damages the innermost container. It can be located inside it as prescribed. That is, the guide 48 has a function of correcting the insertion of the hollow needle.

In addition to the method for supplying a liquid substance to the composite container as described above, the present invention also provides a method for taking out, that is, collecting the liquid substance from the composite container 10 containing the liquid substance 32 obtained as described above. do. In particular, with reference to FIG. 4, a method in which the composite container 10 existing in the initial environment 50 is moved to the next intermediate environment 52, and then the liquid material 32 is collected in a predetermined collection environment 54 and used as predetermined. Will be described as an example of the case where the liquid material is collected from the composite container 10 shown in FIG. 3, which already contains the liquid material 32. It is assumed that these environments are close to each other. The cleanliness of these environments is gradually improved from the initial environment to the sampling environment in the order of initial cleanliness → intermediate cleanliness (one or more stages) → sampling cleanliness, and the sampling environment is improved. Therefore, it has an appropriate degree of cleanliness for collecting and using liquids.

In the illustrated embodiment, the composite container 10 comprises an innermost container 12, an outer container 40 (consisting of a single outer container element 41 in the illustrated embodiment), and an outermost container 14, respectively. The container is arranged with stoppers (18, 44 and 22). The innermost container 12 contains a liquid substance 32.

First, in the composite container 10 existing in the initial environment 50 close to the intermediate environment 52, the outermost container 14 is broken and removed with the weakened portion 34 (not shown in FIG. 4) as a trigger, and the contents thereof are taken out. This state is schematically shown in FIG. 4 (1). The outermost container 14 that has been torn and removed is shown by a broken line, and the outer container and the like corresponding to the contents are shown by a solid line. Immediately after that, the contents are moved into the intermediate environment 52.

Next, the container located on the outermost side of the contents, that is, the outer container 40 is torn and removed by using the weakened portion 35 (not shown in FIG. 4) as a trigger, and the contents, that is, the outermost container, is removed. Take out the container. This state is schematically shown in FIG. 4 (2). The outer container 40 that has been torn and removed is shown by a broken line, and the innermost container 12 that corresponds to the contents is shown by a solid line.

Immediately after that, the innermost container 12 is moved into the collection environment 54, the hollow needle 56 is inserted into the innermost plug 18, and the tip portion 62 is immersed in the liquid substance 32 in the innermost container 12, and the liquid substance 32. Can be taken out as shown by the dashed arrow. This state is schematically shown in FIG. 4 (3). In the illustrated embodiment, the entire length of the hollow needle 56 is covered by the rubber sleeve 58, but when penetrating the innermost plug 18, the rubber sleeve 58 is broken by the cutting edge portion 60, and the hollow needle 56 The tip portion 62 enters the innermost container 12 in a state where the sterilized state is maintained.

The mode in which the hollow needle 56 has the rubber sleeve 58 as described above can be similarly applied when supplying a liquid material to the composite container. That is, in FIG. 1, a liquid material as shown in FIG. 1 or 3 is formed by using a hollow needle in a state in which at least the tip portion 62 of the pre-sterilized hollow needle 26 is covered with a rubber sleeve and shielded from the surrounding environment. When applied when inserting into a composite container, the tip portion 62 of the hollow needle can enter the composite container while maintaining its sterilized state.

In the embodiment shown in FIG. 4, there is only one intermediate environment, but a plurality of intermediate environments configured so that the degree of cleanliness gradually improves toward the sampling environment (for example, the above-mentioned first intermediate environment to third intermediate environment). Environment) may exist. Each time it goes through the intermediate environment, it breaks the outer container elements located on the outside one by one, takes out the contents, and moves the contents to the next intermediate environment. Therefore, the required number of outer container elements constituting the outer container corresponds to the number of intermediate environments located between the initial environment and the sampling environment. This required number is the minimum number, and more outer container elements may be used to construct a multi-layered outer container.

As described above, the composite container of the present invention can contain a liquid substance such as a liquid medium. In addition, the range of choices of the sterilization treatment method for the composite container is widened, and the cleanliness that the environment for supplying the liquid material to the composite container should have can be relaxed. As a result, the supply of the liquid material using the composite container of the present invention becomes simple, and the liquid material can be collected from such a composite container.

Cross-reference of related applications

This application is based on Japanese Patent Application No. 2018-206712 (Filing date: November 1, 2018, Title of invention: Composite container), No. 2018-206715 (Filing date: November 1, 2018, Invention). Name: Liquid Supply Method) and 2018-206719 (Filing Date: November 1, 2018, Invention Name: Liquid Collection Method), which are disclosed in these applications. The matters constitute a part of the specification and drawings of the present application.

10 ... composite container, 11 ... side surface, 12 ... innermost container, 13 ... intermediate container, 14 ... outermost container,
15 ... bottom surface, 16 ... innermost container opening, 17 ... intermediate container opening, 18 ... innermost plug,
19 ... Sheet-like element, 20 ... Opening of outermost container, 22 ... Outermost plug, 24 ... Outermost plug recess,
26 ... Hollow needle, 28 ... Cutting edge of hollow needle, 29 ... Tip of hollow needle, 30 ... Hole,
32 ... Liquid, 34 ... Weakened part, 40 ... Outer container, 41 ... Outer container element,
42 ... outer container opening, 44 ... outer plug, 46 ... outer plug recess, 48 ... guide,
50 ... initial environment, 52 ... intermediate environment, 54 ... sampling environment, 56 ... hollow needle,
60 ... The tip of the hollow needle, 62 ... The tip of the hollow needle.

Claims (34)

(1) An innermost container having a space capable of accommodating a liquid substance, which has an opening connecting the inside and the outside, and an innermost plug airtightly arranged in the opening. And (2) The outermost container having a space for accommodating the innermost container, which has an opening connecting the inside and the outside, and an outermost plug airtightly arranged in the opening. A liquid material storage composite container having a container.
The innermost container is placed in the space of the outermost container,
The innermost plug and the outermost plug are liquid substances from the outside of the composite container to the inside of the innermost container, or from the space of the innermost container to the outside of the composite container via a hollow needle penetrating both of them. A composite container for liquids, characterized in that it is configured to be aligned for movement. Adjacent to the innermost container, it also has an intermediate container surrounding the innermost container.
The intermediate container is characterized by having an opening connecting the inside and the outside thereof, and the innermost plug is airtightly arranged in the opening of the intermediate container in addition to the opening of the innermost container. The composite container according to claim 1. Further an outer container having a space for accommodating the innermost container or the intermediate container between the outermost container and the innermost container (provided that the intermediate container does not exist) or between the outermost container and the intermediate container. Have
The outer container has an outer plug that is airtightly arranged in an opening that connects the inside and the outside.
The outer plug is configured to align with the innermost and outermost plugs, thereby allowing the outermost of the composite container to the space of the innermost container or the innermost part via a hollow needle penetrating these plugs. The composite container according to claim 1 or 2, wherein a liquid substance can be moved from the space of the container to the outside of the composite container. The composite container according to claim 3, wherein the outer container is composed of a single outer container element that defines the outer container. The outer container has a multi-layer structure in which a plurality of outer container elements are stacked.
Each outer container element consists of an opening that connects the inside and the outside, and a stopper that is airtightly arranged in the opening.
These plugs and the innermost and outermost plugs are placed from the outside of the composite container into the space of the innermost container or from the space of the innermost container to the outside of the composite container via a hollow needle penetrating them. The composite container according to claim 3, wherein the composite container is configured so that the liquid material can be aligned to move the liquid material. The multi-layered outer container consists of a single plug that is airtightly arranged in common with the openings of each outer container element that composes it, and this plug and the innermost and outermost plugs are these. It is configured to be aligned to move the liquid from the outside of the composite container into the space of the innermost container or from the space of the innermost container to the outside of the composite container via a hollow needle penetrating the container. The composite container according to claim 5, wherein the container is provided. 7. Composite container. The outermost plug, the innermost plug, and the outer plug (if any) are configured such that at least two plugs adjacent to each other fit together, so that these plugs are hollow needles that penetrate. The composite container according to any one of claims 1 to 7, wherein the composite container can be aligned with respect to the above. The outermost plug, the innermost plug, and the outer plug (if any) are characterized in that at least two plugs adjacent to each other are substantially one single element. The composite container according to any. The composite container according to any one of claims 1 to 9, wherein the stopper is self-sealing. 6. Composite container. The composite container according to any one of claims 1 to 10, wherein the innermost container and / or the intermediate container (provided that it exists) is self-supporting. The composite container according to claim 12, wherein the innermost container and / or the intermediate container (provided that it exists) is made of a glass or plastic material. The composite container according to any one of claims 2 to 13, wherein the intermediate container has a hole penetrating a wall defining the intermediate container. The composite container according to any one of claims 1 to 14, wherein the liquid material is a liquid medium. The innermost container having a space for accommodating a liquid substance, the innermost container having an opening connecting the inside and the outside, and an innermost plug airtightly arranged in the opening, and the innermost container. It is an outermost container having a space for accommodating a vessel, and has an opening for connecting the inside and the outside, and an outermost container having an outermost plug arranged airtightly in the opening. , A method of supplying a liquid substance into the innermost container from the outside of the liquid substance accommodating composite container in which the innermost container is arranged in the space of the outermost container.
(1) Step of aligning the innermost plug and the outermost plug,
(2) A step of inserting a hollow needle from the outside of the composite container so as to penetrate the innermost plug and the outermost plug to expose the tip portion into the internal space of the innermost container, and (3) holding a liquid substance. A method for supplying a liquid substance from a reservoir to a composite container, which comprises a step of supplying the liquid substance into the innermost container via a hollow needle. The composite container consists of an intermediate container that is adjacent to the innermost container and surrounds the innermost container.
The intermediate container is characterized by having an opening connecting the inside and the outside thereof, and the innermost plug is airtightly arranged in the opening of the intermediate container in addition to the opening of the innermost container. The supply method according to claim 16. The composite container further comprises an outer container having a space between the outermost container and the innermost container (if no intermediate container exists) or the intermediate container to accommodate the innermost container or the intermediate container.
The outer container consists of an airtightly placed outer plug in the opening connecting the inside and the outside.
The supply method according to claim 16 or 17, wherein in step (1), the outer plug is aligned in addition to the innermost plug and the outermost plug. The supply method according to any one of claims 16 to 18, wherein the composite container is pre-sterilized. The hollow needle has a portion that penetrates the stopper during supply and a tip portion that protrudes from the innermost plug toward the inside of the innermost container from the innermost plug.
At least such a part of the hollow needle is pre-covered with a rubber sleeve
A claim characterized in that when the hollow needle penetrates the aligned stopper, the leading edge of the hollow needle breaks the sleeve so that at least the tip of the hollow needle is exposed in the innermost container. Item 6. The supply method according to any one of Items 16 to 19. The supply method according to any one of claims 16 to 20, wherein the outermost container and the outer container are configured so that the container existing adjacent to the outermost container and the outer container can be removed so as to be exposed. The outermost plug, the innermost plug, and the outer plug (if any) are configured such that at least two plugs adjacent to each other fit together, so that these plugs are hollow needles that penetrate. The supply method according to any one of claims 16 to 21, wherein the supply method can be aligned with respect to the above. 13. Supply method. The supply method according to any one of claims 16 to 23, wherein the innermost container and / or the intermediate container (provided that it exists) is self-supporting. The supply method according to claim 24, wherein the innermost container and / or the intermediate container (provided that it exists) is made of glass or plastic. The supply method according to any one of claims 17 to 25, wherein the intermediate container has a hole penetrating a wall defining the intermediate container. The supply method according to any one of claims 16 to 26, wherein the liquid material is a liquid medium. An innermost container having a space for accommodating a liquid substance, which has an opening connecting the inside and the outside, and an innermost plug airtightly arranged in the opening.
The outermost container having a space for accommodating the innermost container, the outermost container having an opening connecting the inside and the outside, and the outermost plug airtightly arranged in the opening, and the outermost container. An outer container located between the inner container and the outermost container, the outer container having an opening connecting the inside and the outside and an outer stopper arranged airtightly in the opening. It's made up
The innermost container is arranged in the outer container, and the outer container is arranged in the outermost container, which is a method of collecting a liquid substance from a composite container containing the liquid substance.
(1) A step of removing the outermost container and taking out its contents in an initial environment in which a composite container containing a liquid substance exists.
(2) The steps of moving the taken-out contents to an intermediate environment, removing the outer container in that environment, and taking out the contents, and (3) moving the contents taken out in the step (2) to a collecting environment, and the step of taking out the contents. A method for collecting a liquid material, which comprises a step of collecting a liquid material from the inside of the innermost container to the outside through a hollow needle penetrated through the innermost plug in the environment. The composite container is composed of an intermediate container that surrounds the innermost container between the innermost container and the outer container.
The intermediate container is characterized by having an opening connecting the inside and the outside thereof, and the innermost plug is airtightly arranged in the opening of the intermediate container in addition to the opening of the innermost container. 28. The collection method according to claim 28. The initial environment has a cleanliness in which the composite container containing the liquid is stored, the sampling environment has an appropriate cleanliness for removing the liquid from the composite container, and the intermediate environment has the initial cleanliness. The sampling method according to claim 28 or 29, wherein the sampling method has a cleanliness between the sampling cleanliness and the sampling cleanliness. The outer container has a structure in which a plurality of outer container elements are stacked.
Each outer container element consists of an opening that connects the inside and the outside, and a stopper that is airtightly arranged in the opening.
From the initial environment to the sampling environment, there are different intermediate environments corresponding to the number of outer container elements, and in each intermediate environment, the outer container is removed from the contents taken out in the previous environment. The collection method according to any one of claims 28 to 30, wherein the liquid substance is finally collected in the collection environment by sequentially carrying out the transfer to the next environment. The sampling method according to claim 31, wherein the cleanliness of each intermediate environment is characterized in that the cleanliness gradually improves in each environment toward the sampling environment. The hollow needle has a portion that penetrates the innermost plug during collection and a tip portion that protrudes from the innermost plug toward the inside of the innermost container from the innermost plug.
At least such a part of the hollow needle is pre-covered with a rubber sleeve
28 to 28, wherein when the hollow needle penetrates the stopper, at least the tip portion of the hollow needle is exposed in the innermost container by breaking the sleeve at the tip end portion of the hollow needle. The collection method according to any one of 32. The collection method according to any one of claims 28 to 33, wherein the liquid material is a liquid medium.

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