HK1198247B - Multi-chamber mixing container - Google Patents

Description

Multi-chamber mixing container

Technical Field

The invention relates to a multi-chamber mixing container comprising a hinged-mouth container, a removal container and optionally different intermediate containers, to the use of a multi-chamber mixing container and to a method for mixing liquids or liquids and solids in a multi-chamber mixing container under sterile conditions.

Background

Multi-chamber mixing systems are used to mix two or more components, especially those components that should only come into contact with each other for a short time. Many single components are unstable in solution or as a mixture with other components, so it is advantageous to store the components separately and to mix them with one another or to put them into solution only shortly before use. This relates, for example, to solutions for medical use, but also to solutions for industrial use, such as coating, chemical mixing or for the preparation of materials.

In many medical, dental and veterinary applications, it is necessary to mix the components of a solution with each other just prior to use or application. These formulations and formulations may include both liquid components and solid components, such as powders. Many active agents are unstable in dilute solutions or in dissolved form, and it is therefore desirable to mix and apply the solutions in a short time. Various systems are known for mixing liquids and/or solids. Syringe-type containers for mixing two or more components are first known in the prior art, wherein most systems are dual-chamber mixing systems, the two chambers being fixed components of the system and not being replaceable or combinable at will. Therefore, most systems are industrially prefabricated. US2007/0185438 discloses a device in which the individual components of a multi-component mixture are stored in different chambers in a multi-chamber ampoule. For mixing the components, the container is pierced by means of a piston element belonging to the device. Thereby forming a total volume from the plurality of cavities. The ampoule may be mounted in a syringe type device and may be used directly as a syringe to administer the mixture in case a needle is used. The components are fixed in the ampoule by prefabrication and cannot be combined with one another either in the contents or in the desired amounts or concentrations. Application US2010/0122310 relates to a multi-chamber cartridge in which two or more chambers are arranged along a longitudinal axis and which further comprises two pistons by means of which the components are mixed and the mixture can also be used through a nozzle. WO2010051369a1 also relates to a syringe-type device in which the cylinder can be divided into sections which can be filled with different components and a piston within the cylinder empties the contents as in a syringe. A multi-chamber embodiment is also disclosed in WO2010051369a1, in which the individual compartments are separated from one another by partitions which can be pierced by a piston. These partitions are called membranes, but the membranes do not fall off completely but come to bear against the inner wall of the cylinder and thus block further advancement of the piston. It is therefore evident that the multi-chamber system disclosed in WO2010051369a1 does not work properly, since the piston has to slide in a positive fit within the cylinder and the pierced partition walls have a limited thickness and thus hinder further advancement of the piston. By using a significantly higher pressure, the piston can be pushed past the pierced partition or the pierced partition can be pushed forward with the piston, but the following great risks arise here: the obstruction created by the pierced partition is suddenly overcome and the contents of the syringe are then administered to the patient with significantly excessive pressure. In addition, when the piston slides in the cylinder, glass can be used which, although having good sliding properties, is technically impossible to provide partition walls therein and blocks the space between the outer surface of the piston and the inner wall of the cylinder when the partition walls are pierced so that the piston cannot advance further, or when plastic is used as the material of the cylinder and the piston, the inner surface of the cylinder must be siliconized to ensure sufficient sliding properties. However, siliconized surfaces are not useful for many chemical and biological substances because these substances denature or decompose on the siliconized surface. Thus, the embodiment according to WO2010051369A1 seems to work normally only without a partition, as has also been demonstrated by the inventors of the present invention.

GB787090A discloses a single container which can be placed into a syringe barrel and emptied by inversion, where no custom combination of multiple individual containers is specified.

The disclosed devices are all prefabricated and connected to existing syringe-type barrel systems. The compartments are separated by a membrane or a fixed wall in a prefabricated ampoule or cartridge or syringe or the like, but the individual components of the compartments cannot be changed, for example replaced or the order of arrangement changed, after preparation and filling by the manufacturer. Furthermore, the number of compartments in the prior art is prefabricated and cannot be varied. Another disadvantage of the embodiments of the prior art is that the needle-like and piston-like components are fixed components of the device, which are necessary for piercing and mixing.

Disclosure of Invention

The object of the invention is to provide a device which is suitable for mixing at least two components, the components and the amounts of the components being able to be varied, and which is also designed such that no needle or plunger is required in the device for mixing the solution. That is, a system should be provided that allows the physician to freely combine the type, concentration and amount of solvent and active agent in order to administer a particular concentration of a particular active agent in a particular solvent as desired.

This object is achieved by providing a multichamber mixing vessel according to claims 1, 7 and 8 and a method according to claim 15. Further advantageous embodiments, aspects and details of the invention are given by the dependent claims, the description, the embodiments and the figures.

It has surprisingly been found that a multichamber mixing vessel for providing and mixing components according to the invention solves the stated object. The multichamber mixing container according to the invention is used for separately storing at least one solvent and a liquid or active agent, the active agent being more stable in the lyophilized, spray-dried or freeze-dried state than in the dissolved state, for example, so that the solvent and the active agent can be stored separately in the multichamber mixing container and also sterile mixing can be carried out in the multichamber mixing container according to the invention immediately before use.

Active agents that may be stored in a multi-chamber mixing container, preferably for parenteral use, include, for example, antibiotics, analgesics, anti-inflammatory agents, steroids, antiproliferative agents, immunosuppressive agents, antifungal agents, cytostatic agents, anti-metastatic agents, anti-inflammatory agents, cytotoxic agents, anti-angiogenic agents, and/or anti-thrombotic agents. Liquids for dissolution or mixing include double distilled water, isotonic sodium chloride solution, various other isotonic saline solutions, or physiologically acceptable buffers.

The term "liquid" as used herein refers not only to a solvent for a solid, a solid mixture, a gel, a paste, another liquid substance or a liquid mixture, but also to a solution of a solid, an emulsion or a dispersion or a two-phase liquid mixture.

In its simplest embodiment, the multi-chamber mixing container according to the invention comprises a introversion container and a withdrawal container, which are connected to each other under sterile conditions. The solvent is in the flip-top container and the active agent in solid, gel-like or liquid form is in the withdrawal container. The active agent or active agent combination in the withdrawal container is preferably a solid which can be stored as a solid for a longer time than in solution, so that the active agent solution should only be prepared immediately before use. In principle, multi-chamber mixing vessels are suitable for storing active agents which are more stable in the absence of a solvent than in a solvent, which also includes a buffer. Multi-chamber mixing containers are also particularly well suited to allow a physician to combine individual containers so that the physician can select a container having a particular amount of a particular active agent and combine it with another container having a particular amount of a particular solvent to thereby prepare a custom mixture of a particular active agent at a particular concentration with a particular amount of a particular solvent.

If it is desired to store the active agents or the solvents or the liquid active agent and the solid active agent separately from the solvents, the multichamber mixing container according to the invention can also have, in addition to the introversion container and the removal container, one, two or more intermediate containers which are located between the introversion container and the removal container and preferably serve in each case for receiving a component.

The introversion container, the withdrawal container and the intermediate container are also collectively referred to as component containers.

The component container is closed and the closure of the component container is preferably effected by sealing by means of a sealing film. The purpose of the component container is to maintain the sterility and sterility of the contents. The component container according to the invention preferably also has at least one centering groove, recess, flange, thread or tongue on the side. This is advantageous because they ensure mechanical retention of the component containers when they are arranged in the device for mixing.

All component containers, i.e. two (two systems), three (three systems), four (four systems) or, in general terms, a plurality of component containers (multiple systems), are therefore connected to one another in a form-fitting, force-fitting or material-fitting manner and in a sterile manner. The design of the component containers also allows for the connection of multiple component containers into a dual system, a triple system or a quadruple system for separate storage of multiple incompatible contents over a longer period of time and mixing them with each other immediately before use.

The invention therefore relates not only to a fully assembled multi-chamber mixing container but also to a kit comprising at least one introversion container, at least one removal container and optionally at least one intermediate container, which containers can be combined with one another in a self-defined manner.

Here, the two-system comprises a hinged-mouth container and a removal container, the three-system comprises a hinged-mouth container, one intermediate container and a removal container and the four-system comprises a hinged-mouth container, a first intermediate container, a second intermediate container and a removal container. Each component container can here accommodate one component or a component mixture of a solution to be prepared at a later date and store it separately from the other components and keep it sterile and sterile. The connection of the component containers to one another is accomplished under aseptic conditions.

Optionally, the component containers each have an engagement edge or a thread which allows the component container to engage with one or two further component containers, achieves a mechanical retention of the connection and makes it easier to seal the connection to the outside.

The present invention includes various embodiments of component containers. The introversion container is preferably a liquid container. The introversion container according to the invention has a reversible side wall, a sealable front side, an internally located protrusion or protuberance, preferably for piercing a sealing membrane, which protrusion or protuberance is axially movable by the inversion of the side wall, and preferably at least one centering groove or recess in the wall (fig. 1). The reversible side wall is advantageous because the container surface can thereby be pressed in by external pressure. The material properties of the invertible portion of the side wall are preferably softer, i.e. weaker, and can thus be pressed in easily without damaging the material or without consuming too much force. The pressing-in or inversion is preferably assisted by so-called cut lines, so that the pressing-in is easier. The incision line is characterized by a transition to a stronger or weaker material property, which changes the turning property, for example a thinned or thickened portion in the material or wall, a defined folding position or a defined folding line or a targeted weakening position in the material or wall.

The other component container is a take-out container. The extraction container profile is characterized by a front side, a side wall and a closing surface. The front side is sealed by a pierceable membrane as in a hinged-lid container. The withdrawal vessel may contain a liquid or a solid therein. The solid is preferably in powder form, also preferably lyophilized and further preferably freeze-dried. The shape of the removal container is preferably adapted to the shape of the hinged-lid container, i.e. the diameter and shape of the front side corresponds to the diameter and shape of the hinged-lid container, so that a sealed, i.e. cohesive, connection between the two component containers is ensured. The removal container preferably has a closure system in its closure face, by means of which the removal container is sealed closed and the contents can be removed by means of a cannula (fig. 2). Alternatively, the contents of the removal vessel or multichamber mixing vessel may be removed through a needleless access port.

In addition, a device is disclosed in which a multi-chamber mixing vessel can be placed and preferably secured in the device by means of corresponding recesses. The device is half-shell shaped and has an axially movable ejection plunger. The device is a system in the form of a carpule for mixing the contents of a component container (fig. 3). The device is preferably designed as a half-shell-like receptacle and has one or more centering recesses in the connecting plane of the component containers, which center and stabilize the multi-chamber mixing container in its position. The device for a multichamber mixing vessel with one, two or more intermediate vessels is basically of similar construction, but preferably the length and number of the existing centering grooves are adapted to the respective configuration. The container is pressed in and its walls are turned inside out by applying pressure from the pressing-out plunger to the bottom of the container and subsequently moving the pressing-out plunger in the direction of the sealing film, i.e. also in the direction of the removal of the container. As the pressing-out plunger moves forward in the direction of the removal container, the bottom of the hinged container pierces the sealing film of the hinged container and the sealing film of the subsequent removal container and the liquid of the hinged container can flow into the removal container and dissolve the substance (fig. 4). The freshly prepared solution can be removed from the removal vessel through a removal region, such as a stopper or septum. In order to completely empty the multi-chamber mixing container, the introversion container can be completely introduced into the removal container until the bottom of the introversion container rests against the removal region of the removal container (fig. 3).

It has surprisingly been found that a multichamber mixing container for separately storing and mixing the components contained therein solves the stated object, wherein the multichamber mixing container according to the invention is formed by or comprises a introversion container filled with a liquid or solid and a removal container, which are connected to one another in a sealing manner, which is closed on the upper side by a pierceable sealing membrane and has a removal region on the lower side.

In the simplest embodiment, therefore, a multi-chamber mixing container according to the invention comprises a introversion container and a withdrawal container, the introversion container always being filled with liquid. The withdrawal vessel preferably comprises a solid or a mixture of solids, but may also comprise another liquid or a mixture of liquids or a solution of one or more substances and a solvent. It is preferred that the component contained in the withdrawal vessel is more stable in the case of storage separately from the liquid in the flip-top vessel than in the case where the component contained in the withdrawal vessel is dissolved in the solution. The separation between the two component containers can be pierced by at least partially turning the introversion container into the removal container and the components contained in the removal container can be dissolved in the solution contained in the introversion container.

The invention therefore relates to a multi-chamber mixing container comprising or consisting of a hinged container which is filled with a liquid and is closed on the front side by a pierceable sealing membrane, the bottom of which can be pressed in the direction of the sealing membrane and the walls of which can be turned inwards, and a removal container which is filled with a liquid or a solid and is closed on the upper side by a pierceable sealing membrane and has a removal region on the underside, the hinged container and the removal container being sealingly connected to one another. As removal area, a plug, a septum, a valve, a closure, a cock or another closure for connecting a cannula or a hose can be used.

Preferably, the front side of the introversion container closed by the pierceable sealing membrane is sealingly connected to the upper side of the removal container closed by the pierceable sealing membrane.

In addition, it is preferred that the outside of the introversion container has a groove, a flange, a thread or a recess at the level of the sealing membrane and/or the extraction container has a groove, a flange, a thread or a recess at the level of the sealing membrane. The recesses, flanges, threads or recesses can be used, on the one hand, to fix the multiple chamber mixing vessel in a device for receiving the multiple chamber mixing vessel and, on the other hand, to provide a sealing connection of two component vessels to one another. Of course, in the case of a sealed connection of two component containers, the groove of one component container must cooperate with the groove of the other component container or the flange of one component container must cooperate with the flange of the other component container or the thread of one component container must cooperate positively with the thread of the other component container or the recess of one component container must cooperate positively with the bead of the other component container in order to form a sealed connection after a possible bonding, irradiation or heat treatment step.

In a further embodiment, the multi-chamber mixing container comprises a hinged-lid container and a removal container according to the invention and an intermediate container located between the hinged-lid container and the removal container, which is filled with a liquid or a solid, which is closed on the upper side and the lower side by a pierceable sealing film and which is connected in a sealing manner to the hinged-lid container and to the removal container.

In a further embodiment, the multi-chamber mixing container comprises a flap container and a removal container and two intermediate containers located between the flap container and the removal container, which are each filled with a liquid or a solid, and which are closed on the upper side and the lower side by a pierceable sealing film and are connected to one another in a sealing manner and one intermediate container is connected to the flap container in a sealing manner and the other intermediate container is connected to the removal container in a sealing manner.

The multi-chamber mixing container according to the invention therefore always comprises a flap container containing a liquid and a removal container containing a solid or liquid component and optionally one, two or more intermediate containers located between the flap container and the removal container, each intermediate container being connected in a sealing manner to an adjacent component container, i.e. preferably welded or adhesively bonded under sterile conditions and the surfaces of the component containers which are connected in a sealing manner to one another being closed by means of a sealing film. This construction principle allows the individual containers to be manufactured, filled and sealed under sterile conditions, which containers are only subsequently combined into a multi-chamber mixing container according to the invention.

The term "sealing connection" or "sealable connection" means the following features: the two component containers are connected or connectable by a welded connection, an adhesive connection, a screw thread or other means, so that no contents can leak out of the multi-chamber mixing container through the sealed connection when pressure is built up in order to empty the multi-chamber mixing container.

The invention further relates to a kit comprising at least one introversion container which is closed on the front side by a pierceable sealing membrane and whose base can be pressed in the direction of the sealing membrane and whose walls can be turned inwards, and at least one removal container which is closed on the upper side by a pierceable sealing membrane and which has a removal region on the underside, the introversion container and the removal container being sealingly connectable to one another.

Preferably the at least one introituted container is filled with a liquid, such as a solvent, buffer or active agent solution and more preferably is completely filled. The kit may also comprise at least one intermediate container which is closed on the upper side and on the lower side by a pierceable sealing membrane, the intermediate container being sealingly connectable to the introversion container and to the removal container.

All component containers in the kit are preferably prefilled and may be combined at will. The kit according to the invention may thus comprise a plurality of introversion containers which are, for example, filled with different buffers and which contain introversion containers which are, for example, filled with different amounts of physiological saline. The intermediate container of the kit may for example contain solutions or solids of vitamins, salts or nutritional supplements of different composition and amounts and the withdrawal container may contain the active agent or active agent mixture as a solid or solution. Such a kit allows a physician, for example, at the time of flu vaccination to select a flip-open container with 0.5M saline solution, an intermediate container with 0.5 grams of vitamin C, folic acid and certain vitamin B and a withdrawal container with a certain amount of a specific antibiotic and combine them self-defined and administer them after mixing the components in the multi-chamber mixing container into a homogeneous solution.

The invention also relates to a method for the sterile preparation of a solution comprising at least two components, characterized in that a multichamber mixing container according to the invention is placed in a device comprising a half-shell-shaped receptacle for receiving the multichamber mixing container, a holding means for the multichamber mixing container, and an axially displaceable expression plunger; the pressure is applied to the bottom of the hinged container by means of the pressing-out plunger, the bottom of the hinged container is pressed in the direction of the removal container, the wall of the hinged container is continuously hinged in and pierces the sealing film by means of the forward pressure, and the at least two components are mixed.

In a kit or in an assembled form as a multi-chamber mixing container, the introversion container is characterized by a bottom which can be pressed towards the inside, opposing surfaces which are closed by means of a sealing membrane, and inwardly-invertible walls. The intermediate container is characterized by a stable non-reversible wall which can be turned over to the height of the container part or can be turned over completely, an upper side which is closed by a sealing film, and a lower side which is closed by a sealing film. The removal container is characterized by a region, namely a removal region, an opposite upper side which is closed by means of a sealing membrane and a stable non-reversible wall, through which the solution prepared in the multi-chamber mixing container can be removed, preferably by means of a needle, a cannula or a needle-free device. In addition, all component containers preferably have the same geometric shape in their cross section and are preferably round or oval, so that the inversion of the sleeve container can be carried out as comfortably as possible. In addition, the component containers have preferably the same inner radius, whereby the component containers can be fittingly assembled and the connecting lines or connecting edges fit into one another. The multi-chamber mixing vessel is therefore preferably cylindrical and comprises a planar or inwardly curved bottom, i.e. the bottom of the introversion vessel and a top-side removal region in the form of a cap, a flap, a screw cap, a plug or the like, a compartment separated from one another by a sealing membrane and an elongated, preferably cylindrical body.

The component container or the introversion container and the removal container are connected to one another in such a way that the sealing films are placed on top of one another at a small distance. For form-locking, force-locking and/or material-locking, i.e. sealed and sterile connection, the component containers are preferably connected to one another by means of a plug connection, screw connection, adhesive connection, crimping, but particularly preferably by means of welding, so that no leakage occurs during mixing of the contents and the sterile contents remain sterile and sterile. Regardless of the joining method, the joining is carried out under sterile conditions, i.e. under sterile conditions, whereby no bacteria enter the space between the sealing films. The optional joint edges enable mechanical retention of the connection and also facilitate sealing of the connection. The component containers can also be closed by completely welding or melting the component container material or by means of a coating of a liquid-impermeable material, such as plastic, corrosion-resistant metal or polymer.

The multi-chamber mixing container formed by connecting the component containers preferably has a cylindrical shape, which is defined by the shape of the component containers. The shape and diameter of the multi-chamber mixing container correspond to the shape and diameter of the introversion container and the withdrawal container and optionally the intermediate container.

The opposing sealing films of the hinged-mouth container and the removal container in the two-system, of the hinged-mouth container, of the three-system, of the four-system or of the multi-system, of the intermediate container and of the removal container are pierced in succession by a piercing projection at the bottom of the hinged-mouth container or at the bottom of the hinged-mouth container in order to mix the contents in the sense of the invention. The mechanical pressure acting on the bottom of the introversion container presses the bottom or the piercing projections on the inner side of the bottom in the direction of the sealing membrane, which is torn by the pressure. In this case, the sealing membrane of the introversion container is first pierced, and then the sealing membrane of the removal container or the sealing membrane of the intermediate container, if present, is pierced. The contents of the component containers are brought into contact with each other through the resulting opening, the liquids are mixed with each other or the solids in the withdrawal container are dissolved in the liquid contained in the previously overturned container. The mechanical pressure exerted on the bottom of the introversion container generates a pressure for piercing or tearing the sealing membrane and thereby causing the liquid of the introversion container to flow or overflow into the removal container (fig. 3).

The more the introversion of the introversion container, the greater the pressure in the multi-chamber mixing container. The increased pressure may be reduced by: the solution obtained is withdrawn through the withdrawal zone of the withdrawal vessel by means of a needle or needleless. When the obtained solution is withdrawn by means of a needle or cannula, the solution is preferably drawn into a syringe or a volume measuring device. When the obtained solution is withdrawn needleless, the solution is introduced, for example, into a drip funnel or a drip bag, in which another solution may already be present. Conversely, the pressure generated can also be discharged via a needle, cannula or a pressure relief valve located in the withdrawal container, if the prepared solution should not yet be withdrawn.

The introversion container according to the invention is a component container for receiving liquids, which is closed with a pierceable sealing film and whose base can be pressed in the direction of the sealing film and whose walls can be turned inwards. Preferably the introversion container is completely filled, i.e. there is no gas enclosure above the liquid.

The flip-top container is characterized in its profile by a bottom, walls and a front side. The term "invertibility" is defined by a change in shape. The invertible wall is pressed inward by means of the bottom of the introversion container, so that the inner side of the preferably inverted wall slides along the inner side of the not yet inverted wall and the height of the introversion container is reduced during the inversion process (fig. 4). If the multi-chamber mixing container consists only of the hinged-lid container and the removal container, then the inner side of the hinged-lid container wall can rest against the inner side of the removal container wall when the hinged-lid container is completely pivoted. If the hinged-lid container and the removal container have the same height, the hinged-lid container can be completely hinged into the removal container and the bottom of the hinged-lid container rests against or close to the removal region of the removal container (fig. 3).

The introversion container according to the invention is therefore characterized in that the wall is pressed inwards when a corresponding force acts on the bottom of the introversion container. In other words, the inversion may also be referred to as plastic deformation of the introversion container according to the invention by pressing in. The reversible wall is advantageous because a change in shape is thereby brought about by pressing the introversion container into the removal container or into the intermediate container and the removal container. The external pressure represents a mechanical push preferably acting on the centre of the bottom of the introversion container.

According to the invention, the wall of the introversion container can be at least turned over to pierce the sealing membrane of the removal container. In a multi-chamber mixing vessel comprising a hinged-lid vessel and a removal vessel, the hinged-lid vessel can preferably be pivoted into the connecting plane of the two component vessels if the removal vessel has the same height as the hinged-lid vessel or a higher height than the hinged-lid vessel. If an intermediate container is also provided between the introversion container and the removal container, the individual component containers can have the same or different heights. If all three component containers have the same height, the inversion is preferably carried out to the middle height of the intermediate container, whereby the introversion container can be completely inverted into the removal container and the intermediate container inverted to half of itself. In contrast, when the removal container and the intermediate container together have the same height as the introversion container, it is only necessary to construct the introversion container so that it can be introduced completely into the removal container and the intermediate container. In contrast, when the height of the removal container is equal to the combined height of the introversion container and the intermediate container, the introversion container and the intermediate container are designed to be reversible, so that the introversion container and the intermediate container can be introduced into the removal container. Of course, the component containers can also have any other height. But preferably should be capable of a greater degree of inversion or inversion where the height of the multiple chamber mixing container is reduced by about 50% after full inversion or inversion.

When the multi-chamber mixing container comprises a flanging container, a removal container and two intermediate containers, the component containers can again have different heights accordingly. If all four component containers have the same height, the hinged container and the first intermediate container adjacent to the hinged container can be inverted, so that when completely inverted or inverted, the inner side of the hinged container wall rests against the inner side of the removal container wall and the inner side of the first intermediate container wall rests against the inner side of the second intermediate container wall. In contrast, when the removal container, the first intermediate container and the second intermediate container together have the same height as the introversion container, the introversion container only has to be constructed so as to be reversible, whereby the introversion container can be introduced into the removal container and the two intermediate containers. When the introversion container and the two intermediate containers together have the same height as the removal container, the introversion container and the two intermediate containers are preferably constructed so as to be invertible, whereby the three component containers can be introduced into the removal container. It will be apparent to the skilled person that the four-component containers may also have any other height and should preferably be tiltable from the bottom to the middle of the multichamber mixing container, whereby the lower part of the multichamber mixing container may be tilted into the upper part of the multichamber mixing container.

It may therefore be necessary to construct component containers whose walls only have to be turned to a certain height instead of turning over their entire walls.

The reversibility is defined primarily by the material properties. Particularly strong materials do not have invertability, so that material properties are preferred which allow easy pressing and/or folding and do not damage the material or require excessive force to be applied. But the material must not be so soft that the shape of the flip-top container containing the liquid is not stable or the flip-top container may be mechanically damaged. The container may be made of any material suitable for storing liquids. Preferred materials here are metals, metal alloys, rubber or any liquid-impermeable polymers, with rubber and polymers being more preferred and polymers, especially plastics, being particularly preferred. The different rigidity of the plastic affects the transferability. Thus, soft plastics, i.e. particularly flexible plastics such as soft polyvinyl chloride or polyolefins such as polyethylene, are particularly preferably used for producing the invertible part, whereas hard plastics are preferably used for producing the part which should not be inverted. The pressing-in or inversion can be assisted or limited by so-called incision lines. The incision line which is intended to define the invertability is characterized by a transition to a stronger material property, i.e. a further simple inversion is to be prevented by the transition of the soft plastic to the plastic. The incision line is preferably used to assist the invertability and, for example, forms a taper in the wall, as a result of which the wall can be folded or inverted more easily along the incision line. Preferably, the turning of the section of the wall to the next cut-out line is thereby made easier, so that the cut-out line acts like a moving connection point of the crawler chain and the turning-in of one link of the chain to the next cut-out line can always be made easier. The incision line preferably surrounds the wall in an annularly closed manner. In addition, the incision lines preferably extend equidistantly from each other.

The volume of the introversion container according to the invention and the volume of the other component containers according to the invention is preferably between 0.5 and 20ml, more preferably between 1 and 20ml, more preferably between 2 and 18ml, more preferably between 3 and 16ml, more preferably between 4 and 15ml, more preferably between 4 and 14ml, more preferably between 5 and 13ml, more preferably between 5 and 12ml, more preferably between 5 and 11 ml. The shape of the introversion container is preferably cylindrical, where the walls are preferably round, the bottom is preferably concave, i.e. curved inwards, and the front side is flat. The bottom of the introversion container is adapted to the shape of the ejection plunger of the device for receiving the multi-chamber mixing container. The ejection plunger preferably has a conical flat tip which engages, for example, in a corresponding recess in the base of the introversion container or rests against a correspondingly designed base of the introversion container. The adaptation of the contour of the bottom of the introversion container or at least of the contour of the central area of the bottom to the shape of the tip of the expression plunger is advantageous, since thereby a sliding of the expression plunger is avoided and an efficient mechanical force transmission can be ensured. In a further advantageous embodiment, the bottom of the introversion container is flat on the outside. The tip of the ejection piston is pressed into the base, thereby preventing the ejection piston from sliding.

The material of the bottom of the introversion container preferably has a higher rigidity than the invertible soft material of the walls, i.e. is preferably made of hard plastic. Such a material reinforcement is advantageous, whereby the bottom is not damaged or even torn by the pressure exerted on the bottom by the expression plunger.

The surface of the base located in the inner space of the introversion container can have a shaping which makes the piercing of the sealing membrane easier. According to the invention, the bottom of the introversion container can have a piercing projection or a depression or a thickening or the bottom can be shaped like a depression in a champagne bottle, which is formed in the direction of the sealing membrane and arranged in the middle. The piercing projections, indentations, thickenings or recesses of the base can be made of a harder material and/or shaped to be correspondingly pointed in order to make easier the piercing of the sealing membrane.

The piercing projection or the base shaping can be moved axially by external pressure acting on the tilting side, in particular by tilting of the wall. The piercing projection or base is shaped to pierce a front sealing membrane of the flip top container. In addition, the piercing projections or the base are shaped to pierce the sealing film of an associated component container or the sealing films of a plurality of associated component containers. When the component container is completely filled with liquid, the piercing projection is preferably located in the vicinity of the sealing membrane to be pierced, so that the sealing membrane can already be pierced after a small pressure has been applied, so that the liquid can be mixed. When the piercing projection is not adjacent to the sealing membrane to be pierced, the piercing projection can also be configured flexibly such that, when pressure is applied to the center of the bottom of the introversion container, it can be pressed in such a way that the sealing membrane is pierced and the piercing projection then flexibly returns to the initial position before the entire bottom is pressed in to empty the multi-chamber mixing container. In case the component container is filled with a liquid, it is preferred that the component container is completely filled, i.e. does not contain a gas such as air or an inert gas such as nitrogen or argon. The complete filling of the component container provided with the sealing film can be made easier by welding the sealing film to the completely filled component container after the complete filling, for example by means of a laser, without gas entering in the process. Another preferred embodiment is for the component container to be filled with a solid or a paste or a gel or not completely with a liquid, in that the sealing membrane is permeable to gases but not to liquids or solids. In this case, the gas can pass through the sealing membrane when the sealing membrane is intact, i.e. has not yet been pierced or torn, and is thereby reduced by the sealing membrane on the basis of the pressure generated by the compression of the gas within the component container. In addition, when the cannula is located in the removal region of the removal vessel, gas then leaks out through the cannula and the pressure in the multi-lumen mixing vessel is therefore reduced. In the case where a cannula for reducing the pressure is not to be inserted in the removal region of the removal container, the septum closing the removal region of the removal container is permeable to gases and impermeable to liquids, solids or cells. In this case, the pressure in the multi-chamber mixing vessel can be reduced by letting gas leak out through the septum in the withdrawal region of the withdrawal vessel. In this case, the removal region of the removal container can, of course, be held upward like a syringe for liquid removal, so that the rising gas can escape. Instead of a diaphragm through which gas can pass, a valve can also be used.

Another option consists in piercing the sealing membrane by means of a cannula which passes through the removal region of the removal container, in which case after piercing the cannula is withdrawn, the solutions are mixed and the multi-chamber mixing container is subsequently emptied by pressing in the bottom and turning over the introversion container. When the intermediate or withdrawal vessel is filled with solids, then preferably the solids are under reduced pressure or vacuum in the component vessels. In this embodiment, the pressure generated in the introversion container by pressing in the bottom is in most cases sufficient to tear the sealing membrane before the bottom or piercing projection of the introversion container reaches the sealing membrane. The piercing projection is preferably made of the same material as the hinged-lid container, in particular if the hinged-lid container is provided with a cut-out line, or of a hard material that can withstand the forces. The hard material of the piercing projections or the base shapes is advantageous, since sufficient stability for piercing the sealing membrane or membranes can be ensured thereby. A particularly preferred material for the piercing projections is hard plastic here. The length of the piercing projection or the base formation is at least so long that it can pierce the sealing film of the front side and the sealing film of the adjacent removal container when the base or the wall is inverted. In addition, the length of the piercing projection or the bottom profile can be so long that it extends over the entire length of the introversion container. This embodiment is advantageous and preferred because it is particularly suitable for piercing a plurality of sealing membranes when a plurality of component containers are arranged in succession, for example in a three-system or four-system.

The piercing projections or the indentations or the thickened or concavely shaped bottom of the flip-top side of the flip-top container according to the invention have channels, grooves, corrugations, star-shaped recesses, hills, nodules, pins or other surface irregularities which allow a rapid inflow or overflow of liquid from the flip-top container into at least one further component container. In this case, the liquid preferably flows from the introversion container into the at least one further component container. This is particularly advantageous when the at least one further component container contains solids. The liquid can flow in particular by axial displacement of the inner device. However, when the removal container contains liquid, the liquid can also flow from one of the other component containers in the direction of the flap container and the liquids are mixed in this way. The rapid overflow of the liquid by means of the provided channels or the like is advantageous in order to ensure rapid mixing of the liquid or mixing of the solid solution or suspension with the liquid, in particular when the hinged container is partially or completely hinged into the component container connected to the front side.

The circular shape of the wall is particularly advantageous and particularly preferred, since the circular wall has an optimal invertability. However, the wall can also be divided into several partial areas by edges. In this case, the side wall is preferably divided into at least eight partial areas, since a smaller number of partial areas increases the difficulty of turning over. The smaller the internal angle between the two edges, the more difficult the turning process. When the component container is of angular rather than circular design, i.e. the cross-section is angular rather than circular, the internal angle between the edges should be at least 135 °. However, a circular cross-section of the component container and thus the cylindrical shape of the multi-chamber mixing container are most preferred, and an oval shape is also preferred here.

The front side of the introversion container is the side opposite to the bottom. The front side is closed by means of a sealing film. The introversion container is filled with liquid with the bottom facing downward and is subsequently closed by means of a sealing film. The sealing membrane can be pierced, that is to say can be pierced or torn by the action of a force. When the sealing films of the flip-top container and the adjacent component container are pierced, liquid can flow from the flip-top container into the adjacent component container.

Sealing the introversion container by means of a sealing film facilitates the sterile and cohesive closure of the container. The sealing film is used to seal a flip-top container or an entirely conventional component container which is filled under aseptic conditions so that the contents of each component container remain sterile and sterile. The sealing film used to close the component container can be, for example, a composite film. Preferred materials are for example metals, such as aluminium foil, other plastics, metal plastic compounds, polymers or combinations thereof. In a preferred embodiment, the seal is embodied as a "weak seal", i.e. the material of the sealing film is particularly weak at one or more locations, so that it can easily be passed through the material at these locations, or a pre-punched hole is added, so that the material is more easily torn at this location. It is important, however, that the sealing membrane closes the device completely and hermetically, in order to ensure sterile storage of the contents and that the sealing membrane does not break due to material shrinkage at low temperatures up to preferably 0 ℃, further preferably-15 ℃ and particularly preferably-25 ℃ during refrigerated storage of the multi-chamber mixing container. The skilled person is well aware of the materials and possibilities for realizing such sealing films. Preferred materials are for example metals, such as aluminium foil, other plastics, metal plastic compounds, polymers or combinations thereof.

In a preferred embodiment, the introversion container has a groove on the outside of the wall or a recess in the outside of the wall. The groove or recess is advantageous because it prevents the mounted introversion container from rotating in the device for receiving the introversion container with a mating piece, i.e. a corresponding projection or socket or tongue, and ensures a stable position. The groove or recess is preferably located at the level of the front side or along the contact surface or line of contact of the two component containers. This embodiment is advantageous because inversion of the wall is not hindered. It may be desirable for the groove or recess to define or block inversion at a certain location. It is therefore also preferred to provide the grooves or recesses at other heights of the wall. The shape of the recess or depression is elongate and preferably circular, but may also be angular. In addition, it is also possible and preferred that, instead of a groove or a recess, the introitus container has a projection or a sleeve or a tongue and the device for receiving the introitus container has a corresponding profile. The device according to the invention for receiving a multi-chamber mixing container is also described in more detail below and comprises a half-shell-shaped receiving portion for receiving a multi-chamber mixing container, a holding means for the multi-chamber mixing container and an axially displaceable ejection plunger.

The introversion container according to the invention preferably further comprises an engagement edge. This engagement edge is advantageous because it can engage with other containers in a slip-proof manner and achieves mechanical retention of the connection. The joining edge is here provided on the front side of the introversion container. It is desirable here for the joining edge to be made of the same material as the introversion container, to be precise as the non-invertible part of the introversion container, if this part is present. In order to connect the two containers more effectively, it is advantageous if the joining edge of one container has a groove and the other container has a tongue adapted thereto. The joining edges can also have a corresponding screwing possibility. In addition, the joining edge can preferably have said groove, recess, projection or tongue on the outside, which should prevent the flap container from rotating or sliding in the device for accommodating the flap container.

The extraction container according to the invention is characterized in its outer shape by a front side (upper side), a wall and a lower side. The upper side of the removal container is sealed by a pierceable membrane like the front side (upper side) of the introversion container, whereby the contents of the removal container are kept sterile. The same preferred criteria apply here for the material and design of the sealing membrane as for the sealing membrane of the introversion container. The removal container can here contain a liquid, a solution or a solid substance or a solid mixture. The solid substance is preferably in powder form, more preferably lyophilized or freeze-dried. The shape of the removal container is preferably adapted to the shape of the introversion container, i.e. the diameter and shape of the top side corresponds to the diameter and shape of the introversion container, so that a sealed, i.e. cohesive, connection can be ensured. It is important that the front side of the introversion container in a dual system (without intermediate container) is well adapted to the upper side of the withdrawal container, i.e. preferably should have the same diameter and also preferably should have the same wall thickness.

The material of the removal container preferably has rigid properties and is preferably identical to the non-invertible part of the introversion container, if present. The removal container does not need to be inverted, but rather it should not be inverted and the wall of the removal container should withstand the pressure exerted by the expression plunger without deforming. The removal container is preferably made of metal or polymer, preferably plastic and particularly preferably hard plastic.

It is also advantageous if the wall of the removal container has the same shape as the shape of the introversion container, so that both containers can be inserted into the same device for accommodating a multi-chamber mixing container. In addition, the same shape is advantageous, since the introversion container can be introduced into the removal container without gaps or mechanical hindrance (fig. 4). It is also advantageous if the removal container corresponds to the mirror-inverted shape of the introversion container. Therefore, the withdrawal container preferably has the same volume and the same length as the introversion container. However, the removal container can also have a larger or smaller volume and length than the hinged-mouth container, wherein the diameters of the two component containers are equal to each other or differ from each other by a maximum of 10%.

The removal container, like the introversion container, preferably has grooves, recesses, projections or tongues which prevent the removal container from rotating or sliding in the device for receiving the multiple chamber mixing container. It is particularly preferred here for the groove, recess, projection or tongue to be arranged along the connecting seam in the case of joined containers.

The removal container also has a removal region and preferably a region that can be pierced by a needle on the underside of the removal container. The removal area sealingly closes the removal container, whereby the contents remain sterile and sterile, and a freshly prepared solution can nevertheless be removed through the removal area. The area pierceable by a needle is preferably a stopper or septum whereby the solution can be withdrawn by means of a needle or cannula and drawn into a syringe or introduced into a container or bag. The plug can advantageously be crimped with the container in a form-fitting manner by means of a metal crimp cap, i.e. an external closure preferably made of aluminum foil. A closure system of this type can be a so-called Tip closure (Tip-Cap-Verschl ü sse). For optimum positive locking of the crimping, it is desirable for the region beyond the plug to be provided with a funnel-shaped undercut, i.e. an edge around which the jaw cover can be crimped. In principle, the plug can also be inserted from the inside of the container and welded, so that the jaw cover can be dispensed with. In order to minimize the contact surface of the contents with the plug or septum, the solution provided with a jaw cover is more advantageous and therefore preferred.

Furthermore, needleless access to the withdrawal receptacle is possible and preferred. In the case of needleless access, a polymer hose with a membrane valve is passed through the stopper into the removal container. Needleless access known from infusion therapy, such as so-called intravenous drip sets, is conceivable here. Needleless access allows for reliable and comfortable removal of the mixed contents of the connected container from the removal container. Where the contents are introduced into a collection container such as a drip bag. The removal container together with the needleless access opening and the collection container form a closed sterile system. In addition, the dispensing container preferably has a pressure-controlled venting or pressure-reducing valve for leakage of excess air.

In a further preferred embodiment, the multi-chamber mixing container according to the invention comprises a hinged-lid container and a removal container and an intermediate container (fig. 5) located between the hinged-lid container and the removal container, which is filled with a liquid or a solid, which is closed on the upper side and the lower side by a pierceable sealing membrane, which is connected in a sealing manner to the hinged-lid container and to the removal container. In this embodiment the multi-chamber mixing vessel is a three-system (fig. 6).

The intermediate container is another component container that provides a third component for mixing. The intermediate container features walls, an upper side and a lower side. Both the upper side and the lower side are each closed by a pierceable sealing film. The preferred criteria mentioned in connection with the hinged-lid container and the removal container apply here to the material of the sealing film. In multi-chamber mixing containers a total of four sealing films (front side of the introversion container, upper and lower sides of the intermediate container and upper side of the removal container) must be pierced in order to ensure contact and mixing of all the components.

The shape of the intermediate container is preferably adapted to the shape of the further component container, i.e. to the diameter and shape of the further component container, so that a sealed, i.e. cohesive, connection to the further component container can be ensured.

The volume of the intermediate container can have any size here, but preferably corresponds to the volume of the other component containers. More preferably, the volume of the intermediate container is less than the volume of the introversion container or the withdrawal container. There is in principle no restriction on the volume of the component containers. Since all component containers should have approximately the same diameter, the volume of the respective component container is determined by its height. In addition, since preferably only the introversion container is configured to be invertible and the removal container and the intermediate container are not invertible, i.e. substantially dimensionally stable, the height of the introversion container should correspond substantially to the total height of the removal container and all intermediate containers, so that the introversion container can be completely introduced into the intermediate container and the removal container.

The material of the intermediate container wall preferably has rigid properties and is preferably identical here to the properties of the removal container. The walls of the intermediate container are therefore preferably made of metal or polymer, more preferably plastic, and particularly preferably hard plastic.

In a further preferred embodiment, however, the walls of the intermediate container can also be made of a soft plastic, i.e. of a particularly flexible plastic such as soft polyvinyl chloride or a polyolefin, for example polyethylene. The material realizes turnover. The turnability is advantageous because it allows for turning over beyond the introversion of the flip-top container. This is necessary, for example, if the intermediate container is too large to be pierced by the ejection plunger of the introversion container by the lower sealing membrane of the intermediate container and the sealing membrane of the associated removal container. Thus, when the height of the removal container plus the height of the intermediate container is greater than the height of the introversion container, the intermediate container should always be at least partially or completely introversion. If the height of the removal container is equal to the height of the intermediate container plus the height of the hinged-mouth container, the intermediate container should be pivotable over its entire height, so that the intermediate container and the hinged-mouth container can be completely pivoted into the removal container.

A preferred embodiment of the invention therefore relates to a multi-chamber mixing container comprising a hinged-lid container and a removal container and an intermediate container located between the hinged-lid container and the removal container, which is filled with a liquid or a solid, which is closed on the upper side and the lower side by a pierceable sealing film, which is connected in a sealing manner to the hinged-lid container and to the removal container.

Preferably, in the multi-chamber mixing container, the introversion container, the intermediate container and the removal container have a recess, a collar, a thread or a depression at the level of the sealing film for the purpose of a sealed connection between the introversion container and the intermediate container and between the intermediate container and the removal container.

According to the invention, the component container is cylindrical in shape and has a uniform or approximately uniform outer radius. In this multi-chamber mixing vessel, which comprises three component vessels, the introversion vessel contains a liquid, the intermediate vessel contains a liquid or a solid and the withdrawal vessel also contains a liquid or a solid. Such a multichamber mixing container may also be assembled by the physician or hospital staff himself from the individual component containers of the kit disclosed herein, thereby allowing great flexibility in the choice and amount of solvents and choice, amount and concentration of active agents.

In a further preferred embodiment, the multi-chamber mixing container according to the invention comprises a introversion container, a removal container and two intermediate containers located between the introversion container and the removal container, which are each filled with a liquid or a solid, the two intermediate containers being closed on the upper side and the lower side by a pierceable sealing film and the two intermediate containers being connected to one another in a sealing manner and the one intermediate container being connected to the introversion container in a sealing manner and the other intermediate container being connected to the removal container in a sealing manner. In this embodiment the multiple chamber mixing vessel constitutes a four system.

The invention therefore also relates to a multi-chamber mixing container comprising a hinged-lid container and a removal container and two intermediate containers located between the hinged-lid container and the removal container, which are each filled with a liquid or a solid, the two intermediate containers being closed on the upper side and the lower side by pierceable sealing films, the two intermediate containers being connected to one another in a sealing manner and the one intermediate container being connected to the hinged-lid container in a sealing manner and the other intermediate container being connected to the removal container in a sealing manner.

Preference is given here to a multichamber mixing vessel in which the introversion vessel, the one intermediate vessel, the other intermediate vessel and the removal vessel have a recess, a collar, a thread or a depression at the level of the sealing membrane for the sealed connection between the introversion vessel and the one intermediate vessel and between the one intermediate vessel and the other intermediate vessel and between the other intermediate vessel and the removal vessel.

Preference is furthermore given to a multi-chamber mixing vessel in which the multi-chamber mixing vessel comprising the introversion vessel and the removal vessel has a recess on the outside along the connecting line between the introversion vessel and the removal vessel or the multi-chamber mixing vessel comprising the introversion vessel, the intermediate vessel and the removal vessel has a recess on the outside along the connecting line between the introversion vessel and the intermediate vessel and/or between the intermediate vessel and the removal vessel or the multi-chamber mixing vessel comprising the introversion vessel, the two intermediate vessels and the removal vessel has a recess on the outside along the connecting line between the introversion vessel and one intermediate vessel and/or between the two intermediate vessels and/or between the other intermediate vessel and the removal vessel. This recess serves on the one hand for the sealing connection of the two component containers to one another and on the other hand also for fixing the multiple chamber mixing container in the device for receiving the multiple chamber mixing container. In a further preferred embodiment, the component containers are connected to one another in a sealing manner by means of a screw thread, resulting in a smooth, groove-free outer circumferential surface, i.e. a smooth cylinder, which can be inserted into a corresponding tubular device, so that the multichamber mixing container can be emptied in this tubular device as usual by means of pressure acting on the base of the introversion container.

In addition to the (first) intermediate container described above, the second intermediate container is another component container that provides a fourth component for mixing. The second intermediate container features a wall and two faces sealed by a sealing membrane. The preferred criteria mentioned in the context of the hinged-lid container, the removal container and the first intermediate container apply here to the material of the sealing film. In a multi-chamber mixing container, a total of six sealing films (front side of the hinged-lid container, top and bottom side of the first intermediate container, top and bottom side of the second intermediate container, top side of the removal container) must be pierced in order to ensure contact and mixing of all the components.

However, it is also possible and preferred for the four component containers to be connected to one another in such a way that only one sealing film is present between the respective components. In this way, only three sealing films have to be pierced in the multi-chamber mixing container to ensure contact and mixing of the components.

The shape of the second intermediate container is preferably adapted to the shape of the further component container, i.e. to the diameter and shape of the further component container, so that a sealed, i.e. cohesive, connection can be ensured.

The same criteria apply here for the volume and size of the second intermediate container as for the first intermediate container. The intermediate containers may have the same size, but may also be different sizes. The same applies to the material of the second intermediate container wall. The second intermediate container may also be reversible, but is preferably not reversible. However, it is particularly preferred that only one of the two intermediate containers is reversible. If an intermediate container is reversible, this is the intermediate container connected to the introversion container.

In other possible preferred embodiments, the multichamber mixing vessel may also contain more than two intermediate vessels. In this case referred to as multisystems. Preferably, at least one of the intermediate containers is reversible.

The intermediate container, like the removal container and the introversion container, preferably has a recess, indentation, protrusion or tongue, which prevents the intermediate container from rotating or sliding in the device for receiving the multiple chamber mixing container. It is particularly preferred here for the groove, recess, projection or tongue to follow the contact surface of the component container in the case of an engaged component container.

The multichamber mixing vessel according to the invention thus has a plurality of grooves, recesses, projections or tongues which can be in line and which fit into corresponding tongues, projections, recesses or grooves of the device for accommodating the multichamber mixing vessel, whereby the multichamber mixing vessel can be supported in the device in a slip-proof or non-rotatable manner.

All intermediate containers preferably have an engagement edge. In addition, all the intermediate containers preferably have grooves, recesses, projections or tongues on the upper side and/or the lower side, i.e. in the connecting surface of the component containers.

The present invention also includes a device for receiving a multi-chamber mixing container to effect inversion and thereby freshly prepare a desired solution. The device comprises a half-shell-shaped receptacle for receiving a multi-chamber mixing container, a holding means for the multi-chamber mixing container, and an axially displaceable ejection plunger. The device is preferably a carpule system for mixing the contents of component containers (fig. 4). The device is designed as a half-shell receptacle and has one or more centering grooves, recesses, tongues or projections in the connecting plane of the container as retaining means which center and hold the multi-chamber mixing container in its position. The device is characterized in that the device can accommodate a multi-chamber mixing container, stabilize the multi-chamber mixing container in its position by means of a holding means and further comprises an axially displaceable expression plunger for applying an external pressure to the bottom of the introversion container.

The axially displaceable ejection plunger preferably has a centering tip which engages in a recess provided in the bottom of the introversion container. The centering tip is advantageous because it ensures effective force transmission from the expression plunger to the bottom of the introversion container and prevents sliding of the expression plunger. The ejection plunger preferably also has a stop ring to limit the ejection plunger from being pressed further into the device to an undesirable extent.

In principle, the devices for three, four or more systems are similar in construction, only the length of the devices and the number of centering grooves being adapted to the respective configuration of the multi-chamber mixing vessel.

The invention also relates to a method for the sterile production of solutions comprising at least two components, characterized in that a multi-chamber mixing container is placed in a device for receiving the multi-chamber mixing container, the bottom of the introversion container is pressed in the direction of the removal container by applying pressure to the bottom of the introversion container by means of a pressure-exerting plunger, the walls of the introversion container are continuously introduced inward and the sealing membrane is pierced by means of the forward pressure and the at least two components are mixed.

After the solution has been prepared under sterile conditions, the prepared solution is withdrawn through the withdrawal area of the withdrawal vessel by means of a needle or needleless as described above.

Miscible components, preferably for parenteral use, which are preferably stored as solids in a multi-chamber mixing container and can be mixed immediately before use with solvents separately stored in the multi-chamber mixing container, include, for example, antibiotics, analgesics, anti-inflammatory agents, steroids, antiproliferative agents, immunosuppressive agents, antifungal agents, cytostatic agents, antimetastatic agents, anti-inflammatory agents, cytotoxic agents, antiangiogenic and/or antithrombotic agents, vitamins, carotenoids, analgesics, or amino acids or other active agents. The liquid used for dissolving or mixing preferably comprises double distilled water, isotonic sodium chloride solution, or various other isotonic saline solutions.

The invention is illustrated below by means of two examples, which disclose specific embodiments without limiting the scope of protection of the invention. Thus, variations and modifications obvious to the skilled person are intended to fall within the scope of protection of the claims.

List of reference numerals

1 sealing film

2 wall of a container with a turnover opening

3 liquid

4 piercing projections or recesses or thickenings

5-opening container

6 profiled section for receiving an extrusion plunger

7 grooves or flanges

8 bottom of the container

9 front or upper side of a container with a turned-over mouth

10 line of incision

11 sealing film

12 wall of a withdrawal container

13 solid or liquid

14 concave part

15 closure (plug, diaphragm, valve)

16 take-out container

17 grooves or flanges

18 extraction area

19 front or upper side

20 Multi-chamber mixing Container

21 sealing film

22 wall of the intermediate container

23 solid or liquid

24 sealing film

25 upper side

26 underside

27 grooves or flanges

28 grooves or flanges

29 intermediate container

30 device for receiving a multi-chamber mixing container

31 grip panel

32 extrusion plunger

33 thickened portion or ring

34 centering the tip

35 holding device

36 cannula or needle

Detailed Description

FIG. 1 shows a schematic view of a

Fig. 1 shows a flap container (5) as a component container, which is filled to approximately half with a liquid (3). The front or upper side (9) of the hinged-lid container (5) is closed by means of a sealing film (1), whereby the contents of the hinged-lid container (5) are kept sterile, sterile and preserved. A flange or recess (7) extends along the edge of the upper side (9) of the introversion container (5), said flange or recess being advantageously used for the sealing and/or cohesive connection of the component containers and also as a means for fastening into a device (30) for receiving a multi-chamber mixing container (20). The sealing membrane (1) is designed in such a way that it can be pierced by the piercing projections (4) or the indentations (4) or the thickened regions (4). A piercing projection (4) or a concave arch (4) or a thickening (4) is arranged in the middle of the bottom (8) of the flanging container (5). In addition, the bottom (8) of the introversion container (5) is cylindrically recessed inward, so that a recess (6) or a molding (6) for receiving the ejection plunger (32) is formed. The introversion container (5) also has a surrounding wall (2) made of an elastic polymer. The wall (2) is further provided with circumferential incision lines (10) (not shown), which makes it easier to turn the wall (2) from one incision line to the next incision line (10). The wall (2) of the introversion container (5) is designed in such a way that by applying a pressure on the base (8) of the introversion container (5) in the direction of the sealing film (1) or in the direction of the upper side (9), the wall (2) is turned over on the base (8) of the introversion container (5) and pressed into the interior, i.e. into the recess or the molding (6), whereby the base (8) of the introversion container (5) is continuously displaced in the direction of the sealing film (1). When the bottom (8) of the introversion container (5) reaches the sealing film (1), the introversion container (5) is only half as high as initially, since half of the outer wall is now located inside.

FIG. 2

Fig. 2 shows the removal container (16) as a component container, which is filled approximately one third with the solid (13) or the liquid (13). The upper side (19) of the removal container (16) is closed by means of a sealing film (11), whereby the contents of the removal container (16) remain sterile, sterile and preserved. The sealing membrane (11) is designed such that it can be pierced by pressure exerted on the base (8) of the introversion container (5). A flange or recess (17) extends along the edge of the upper side (19) of the removal container (16), said flange or recess (17) facilitating a sealed and/or cohesive connection of the component containers and also serving as a means for fastening into a device (30) for receiving a multi-chamber mixing container (20). The sealing membrane (11) is designed in such a way that it can be pierced by a piercing projection (4) or a depression (4) or a thickening (4) of the introversion container (5). The removal container (16) has a removal region (18) on the underside, through which a freshly prepared solution of the components of the hinged container (5) and the components of the removal container (16) can be removed by means of a needle or cannula or needleless. The removal region (18) is located in the closure (15) or forms part of the closure (15). The closure (15) may be a plug or a membrane which is secured around the neck on the underside of the removal container (16), for example by means of a crimp cap. The plug or membrane may be bonded or welded to the material of the removal container (16). In this case the jaw cover can be dispensed with. The stopper or septum may be pierced by a needle or cannula so that a freshly prepared solution may be removed from the multi-chamber mixing container (20). An extraction region (18), i.e. at the end of the needle tip or cannula tip, is provided in the extraction container (16) below the stopper or below the septum. A recess (14) or notch (14) may also be provided in the bottom of the removal container (16). The recess (14) or recess (14) is intended to receive a piercing projection (4) or a recess arch (4) or a thickening (4) of the introversion container (5). When the closure (15) is configured as a valve, the solution can also be withdrawn from the multi-chamber mixing container (20) without a needle. The removal container (16) also has a surrounding wall (12) made of a strong or rigid polymer. The removal container (16) is configured to be non-reversible. The removal container (16) is therefore made of a solid material which can withstand without deformation the pressure acting on the bottom (8) of the introversion container (5).

FIG. 3

Fig. 3 shows a multi-chamber mixing vessel (20) comprising a introversion vessel (5) and a removal vessel (16) which are sealingly connected to each other and are placed in a device (30) for receiving the multi-chamber mixing vessel (20). The device (30) comprises a half-shell-shaped receptacle for a multi-chamber mixing vessel (20); a holding means (35) for the multiple chamber mixing vessel (20) for securing the multiple chamber mixing vessel (20) in its position; and an axially movable ejection plunger (32). The ejection piston (32) has a grip plate (31) and a thickening (33) or a ring (33) on its rear side in order to limit the axial movement of the ejection piston (32). A centering tip (34) is provided at the head of the ejection plunger (32) and rests on the bottom (8) of the hinged-lid container (5) in order to move the bottom in the direction of the removal container (16) or in the direction of the removal region (18) of the removal container (16) and thereby to continuously invert the hinged-lid container (5). Fig. 3 now shows the state in which the introversion container (5) is completely introduced into the removal container (16) and the ejection plunger (32) is pressed in as far as the thickening (33) or the ring (33). The centering tip (34) of the ejection plunger (32) is pushed forward as far as the ejection region (18) of the ejection container (16) and the wall (2) of the introversion container (5) rests against the wall (12) of the ejection container (16). The liquid (3) located in the hinged container (5) can flow into the removal container (16) after piercing the sealing films (7 and 17) and dissolve the components (13) of the removal container (16). The freshly prepared solution can flow out of the removal region (18) and through the closure (15) of the removal container (16) via the cannula (36) during the pressing-down process. Figure 3 shows the multi-chamber mixing vessel (20) fully empty. The plunger (32) can now be pulled out of the inverted multi-chamber mixing container (20), and the multi-chamber mixing container (20) can be removed from the device (30).

FIG. 4

Fig. 4 shows a multi-chamber mixing vessel (20) comprising a introversion vessel (5) and a withdrawal vessel (16) which are sealingly connected to each other and are placed in a device (30) for receiving the multi-chamber mixing vessel (20). The device (30) comprises a half-shell-like receptacle for the multi-chamber mixing container (20), a holding means (35) for the multi-chamber mixing container (20) for fixing the multi-chamber mixing container (20) in its position, and an axially displaceable ejection plunger (32). The ejection plunger (32) has a grip plate (31) and a thickening (33) or a ring (33) on its rear side in order to limit the axial movement of the ejection plunger (32). A centering tip (34) is provided at the head of the ejection plunger (32) and rests against the base (8) of the hinged-lid container (5) in order to move the base in the direction of the removal container (16) or in the direction of the removal region (18) of the removal container (16) and thereby to continuously invert the hinged-lid container (5). Fig. 4 shows a state in which the introversion container (5) is slightly more than half of its height, in the following manner: a pressure is applied to the gripping plate (31) of the ejection plunger (32), said pressure being transmitted via the centering tip (34) of the ejection plunger (32) to the bottom (8) of the introversion container (5) and thereby causing the bottom to move axially forward uniformly and thereby causing the introversion container (5) to be introduced. In order to ensure that the multi-chamber mixing vessel (20) does not slip out of the device (30) during the application of pressure, the recesses (7 and 17) which are connected to one another (glued or welded) are located in a retaining means (35) which is designed as a recess. It can also be seen that the base (8) of the hinged-lid container (5) has a piercing projection (4) or a depression (4) or a thickening (4) in the middle, which piercing projection (4) or depression (4) or thickening (4) has pierced the sealing membrane (1) of the hinged-lid container (5) and the sealing membrane (11) of the removal container (16), so that the liquid (3) can flow out of the hinged-lid container (5) into the removal container (16) in order to dissolve the components (13) of the removal container (16). The solution thus prepared can be removed by means of a needle or cannula or also needleless through or from the removal region (18) of the removal container (16).

FIG. 5

Fig. 5 shows an intermediate container (29) as a component container, which is filled to approximately half with a solid (23) or a liquid (23). The upper side (25) of the intermediate container (29) is sealed by means of a sealing film (21), so that the contents of the intermediate container (29) remain sterile, sterile and preserved. The sealing membrane (21) is designed such that it can be pierced by pressure exerted on the base (8) of the introversion container (5). A flange or recess (27) extends along the edge of the upper side (25) of the intermediate container (29), said flange or recess being advantageously used for the sealing and/or cohesive connection of the component containers and also as a means for fastening into a device (30) for receiving a multi-chamber mixing container (20). The underside (26) of the intermediate container (29) is sealed by means of a sealing film (24), so that the contents of the intermediate container (29) remain sterile, sterile and preserved. The sealing membrane (24) is designed such that it can be pierced by pressure exerted on the base (8) of the introversion container (5). A flange or recess (28) extends along the edge of the underside (26) of the intermediate container (29), said flange or recess being advantageously used for the sealing and/or cohesive connection of the component containers and also as a means for fastening into a device (30) for receiving the multi-chamber mixing container (20). The sealing membranes (21 and 24) are designed in such a way that they can be pierced by the pressure exerted on the base (8) of the introversion container (5). The walls (22) of the intermediate container (29) may be rigid or reversible or may be constructed to be partially rigid and partially reversible. If the intermediate container (29) is not to be tilted into the removal container (16), the wall (22) is made of a solid material which can withstand without deformation the pressure acting on the bottom (8) of the tilting container (5). If, on the other hand, the intermediate container (29) is to be turned into the removal container (16), the wall (22) of the intermediate container (29) is flexible and reversible and can have a cut-out line. When the intermediate container (29) is constructed to be reversible, the intermediate container is preferably made of the same material as the introversion container (5) and also preferably has the same form and design of the incision line. If, on the other hand, the intermediate container (29) is to be turned only partially, the height of its wall (22) up to the point at which the intermediate container (29) is to be turned is designed to be reversible and, in addition, the wall (22) is made of a firm, non-reversible material.

FIG. 6

Fig. 6 shows a multi-chamber mixing vessel (20) comprising a introversion vessel (5), an intermediate vessel (29) and a withdrawal vessel (16), which are sealed and aseptically connected to each other. The recess (6) or the profile (6) for the ejection plunger (32) of the receiving device (30) is seen from above. The bottom (8) of the introversion container (5) has a piercing projection (4) or a depression (4) or a thickening (4) which points in the direction of the removal container (16). The turn-up container (5) is partially filled with liquid (3). The wall (2) of the introversion container (5) has a circumferential collar or groove (7) on the top side (9), which collar or groove is connected in a material-locking manner to a collar or groove on the top side (25) of the intermediate container (29). The sealing film (1) arranged on the upper side of the flanging container (5) is positioned above the sealing film (21) of the middle container (29). The intermediate container (29) is surrounded by a wall (22) which has a further flange or groove (28) on the edge of the underside (26). A further sealing film (24) is also provided on the underside (26), whereby the contents of the intermediate container (29) are sterilized and closed in a sterile manner. The flange or the groove (28) is connected in a sealing and material-locking manner to the flange or the groove (17) of the removal container (16). A sealing film (11) of the removal container (16) is arranged below the sealing film (24) of the intermediate container (29). The withdrawal vessel (16) is partially filled with a liquid (13) or a solid (13) and is surrounded by a wall (12). On the underside, the removal container (16) has a closure (15) and a removal region (18) through which a freshly prepared solution, which is composed of the components of the introversion container (5) and of the intermediate container (29) and of the removal container (16), can be removed either by means of a needle or cannula or needleless. The multi-chamber mixing container (20) is designed in such a way that the height of the flap container (5) is equal to the sum of the heights of the intermediate container (29) and the removal container (16), and even the flap container (5) can be slightly higher, so that the flap container (5) can be completely folded into the intermediate container (29) and the removal container (16).

FIG. 7

Fig. 7 shows a removal container (16) of a multi-chamber mixing container (20) according to the invention, which is provided with a thread for the sealed connection to a flanging container (5). The matching flip-top container (5) is shown in fig. 8 in filled and non-inverted form and in fig. 9 in inverted form.

FIG. 8

Fig. 8 shows the introversion container (5) in filled and non-inverted form, provided with an internal thread for a form-locking and sealing connection of a removal container (16) as in fig. 7.

FIG. 9

Fig. 9 shows the introversion container (5) in a substantially empty and inverted form, provided with an internal thread for a form-locking and sealing connection of a removal container (16) as in fig. 7.

FIG. 10 shows a schematic view of a

Fig. 10 shows a multi-chamber mixing container (20) comprising a introversion container (5) as in fig. 8 and a withdrawal container (16) as in fig. 7, which are sealingly connected by means of a screw thread as in a ball-point pen, so that a smooth outer peripheral surface with a constant outer diameter is formed. In this embodiment, no recess or flange is present and the multi-chamber mixing container (20) can be inserted into the tubular device on the basis of its cylindrical outer circumferential surface, whereby the removal region of the removal container (16) can be extended out of the tubular device and the multi-chamber mixing container (20) can be emptied by means of the ejector plunger (32).

FIG. 11

In a device corresponding to the arrangement in fig. 21 or 22 of WO2010051369a1, a core of 9.9mm diameter is inserted into a cylinder of 10.0mm internal diameter in order to pierce and subsequently overcome the membrane corresponding to membrane 250 in fig. 21 or 22 of WO2010051369a 1. The commercially available elements of the port system of braun Melsungen AG (bern medical limited, germany) were used. The membrane sheet corresponding to membrane sheet 250 in fig. 21 or 22 of WO2010051369a1 has a thickness of 0.2 mm. A second membrane sheet corresponding to membrane sheet 250' in fig. 21 or 22 of WO2010051369a1 is not present. Fig. 11 shows the pressure curve (in newton (N)) for the stroke (in mm) traversed by the core at a continuous speed of 200mm/min, in which the membrane is pierced after a stroke of about 4mm and at a pressure of about 40N, but it then takes about 240N of pressure to overcome the membrane pierced and pressed onto the inner wall of the cylinder by means of the core. It can clearly be seen that a first pressure drop occurs after a stroke of about 8mm after overcoming the diaphragm and another distinct and rapid pressure drop occurs after a stroke of 11mm, which can lead to uncontrolled axial movements of the piston and cause serious injuries to the patient. Furthermore, in a manually operated device for emptying containers which, for example, are used for determining the pressure curve shown in fig. 12 and which correspond to the containers according to fig. 21 or 22 of WO2010051369a1, the pressure drop cannot be controlled, so that at least one mechanical device has to be used for emptying, which is inconvenient and leads to additional costs and constitutes another source of interference. The second line in fig. 11 shows the pressure curve in a repeated experiment with the same experimental setup (double decision), thereby increasing the effectiveness of the experiment.

FIG. 12

In a device corresponding to the arrangement in fig. 21 or 22 of WO2010051369a1, a core of minimum diameter less than 6.0mm is inserted into a cylinder of internal diameter 6.0mm in order to pierce and subsequently overcome the membrane corresponding to membrane 250 in fig. 21 or 22 of WO2010051369a 1. The commercially available elements of the port system of braun Melsungen AG (bern medical limited, germany) were used. The membrane sheet corresponding to membrane sheet 250 in fig. 21 or 22 of WO2010051369a1 has a thickness of 0.2 mm. A second membrane sheet corresponding to membrane sheet 250' in fig. 21 or 22 of WO2010051369a1 is not present. Fig. 12 shows the pressure curve (in newtons (N)) in relation to the stroke (in mm) which the core has traversed at a continuous speed of 200mm/min, wherein a maximum force of slightly more than 40N is reached after a stroke of about 6 mm. It can clearly be seen that a significant and rapid pressure drop occurs after a stroke of approximately 6-7 mm after overcoming the diaphragm, but this pressure drop is much less intense than in the previous example of fig. 11, since the core is not clamped by the part of the diaphragm that bears against the wall. The second line in fig. 12 shows the pressure curve in a repeated experiment with the same experimental setup (double decision), thereby increasing the effectiveness of the experiment.

Fig. 13 shows the core pieces used in examples 3 and 4 (left: 6mm, right: 9.9 mm). A core piece with a diameter of 9.9mm was used in example 11. The pressure curve measured in connection with this is shown in fig. 11. A core of 6mm diameter was used in example 12. The pressure curve measured in connection with this is shown in fig. 12.

Figure 14 shows the 9.9mm core in the inserted position.

Fig. 15 shows the instrument set with the port elements before piercing.

Fig. 16 shows the port element before piercing.

Fig. 17 shows the port element after piercing.

Example 1

In an ultraclean bench, under aseptic conditions, a 10 ml-volume, overturned container containing 6ml of isotonic sodium chloride solution and a 10 ml-volume removal container containing 6mg of the bleomycin lyophilized preparation are plugged together at the existing joint edge with a groove or tongue and welded by thermal effect so that the sealing films of the two component containers are opposite. The multi-chamber mixing container thus produced is placed in a kaplan-type device, the device is closed and mechanical pressure is applied to the bottom of the introversion container by means of the pressing-out plunger of the device. The introversion of the introversion container is continued and the internal expression plunger pierces the two sealing membranes between the introversion container and the removal container. The pressure created based on the reduction in the volume of the introverted container causes the sodium chloride solution to flow rapidly into the withdrawal container and dissolve the bleomycin lyophilized formulation. The turning over of the introversion container is facilitated by the circumferential incision line in the wall of the introversion container. The groove between the introversion container and the removal container blocks the introversion process. Excess air leaks out through the pressure controlled vent valve that withdraws the container. The turning process is terminated when the introversion container is completely turned into the removal container. The bleomycin solution is withdrawn through a cannula on the underside of the withdrawal container through a stopper in the withdrawal area and into a drip bag.

Example 2

A total volume of 8ml of a flip-top container containing 5ml of isotonic sodium chloride solution was joined in a cohesive manner to a total volume of 4ml of an intermediate container containing 40mg of powdered ibuprofen by gluing under sterile conditions. The other side of the intermediate container is joined in a cohesive manner under sterile conditions to a withdrawal container having a total volume of 8ml and containing 500mg of powdered vitamin C. The introversion container is turned inwards and the internal expression plunger pierces the two sealing films between the introversion container and the intermediate container and subsequently between the intermediate container and the removal container. The introversion container has no cut line and is completely introverted into the volume of the intermediate container and the removal container. The pressure generated on the basis of the reduction in volume of the introversion container causes the sodium chloride solution to flow rapidly into the withdrawal container and dissolve the powdery substance. Excess air leaks out through the pressure controlled vent valve that withdraws the container. The ibuprofen solution is removed by means of a needle which penetrates a removal region in the form of a septum and is drawn into the syringe.

Example 3

Fig. 13-17 schematically illustrate the experimental setup. The apparatus used for both experiments was identical except for the core used.

Fig. 13 shows the core pieces used (left: 6mm, right: 9.9 mm). Figure 14 shows the 9.9mm core in the inserted position. Fig. 15 shows the instrument set with the port elements before piercing. Fig. 16 shows the port element before piercing. Fig. 17 shows the port element after piercing.

The respective core (fig. a) is inserted into a receptacle of a commercially available tensile testing machine and secured by means of a pin in a slip-proof manner (fig. 15). The port element is embedded in the receiver (fig. 15) and is oriented concentrically with the core on the table. This position is fixed by a stop. The experimental conditions were set on a tensile tester. The travel is determined by means of a vernier caliper from the manually inserted core (fig. 17). The following were chosen:

moving speed: 200mm/min

Termination conditions were as follows: reach a defined travel limit (penetration depth)

Starting conditions were as follows: to a pre-stress of 2N

After the port system is embedded in the holding device, the procedure is initiated. The core moves at a defined speed up to a preset stroke. The machine automatically returns to the initial position again after the stroke is completed.

Example 4

The same as example 3, except that a core of 6mm in diameter was used.

Claims (15)

1. A multi-chamber mixing container comprising or consisting of a hinged container and a removal container, the hinged container being filled with a liquid and being closed on the front side by a pierceable sealing film and the bottom of the hinged container being able to be pressed in the direction of the sealing film and the walls being able to be turned inwards, and the removal container being filled with a liquid or a solid and being closed on the upper side by a pierceable sealing film and having a removal region on the underside, and the hinged container and the removal container being sealingly connected to one another.

2. A multiple chamber mixing container according to claim 1, wherein the front side of the introversion container closed with the pierceable sealing membrane is sealingly connected to the upper side of the removal container closed with the pierceable sealing membrane.

3. A multiple chamber mixing vessel according to claim 1 wherein the outside of the introversion vessel has a groove, flange, thread or recess at the level of the sealing membrane and/or the extraction vessel has a groove, flange, thread or recess at the level of the sealing membrane.

4. A multiple chamber mixing vessel according to claim 1, wherein the bottom of the introversion vessel has a piercing projection or a concave arch or a thickening which is formed in the direction of the sealing membrane and is arranged in the middle, or the bottom is concavely shaped.

5. A multiple chamber mixing vessel according to claim 4 wherein the piercing projections or indentations or thickened portions or concave shaped bottoms have channels, grooves, corrugations, star-shaped recesses, hills, nodules, pins or other surface irregularities.

6. A multiple chamber mixing vessel according to claim 1 wherein the evertable wall of the introversion vessel is provided with a circumferential cut-out line.

7. A multiple chamber mixing vessel according to one of claims 1 to 6, consisting of a hinged-lid vessel and a removal vessel and an intermediate vessel located between the hinged-lid vessel and the removal vessel, which intermediate vessel is filled with a liquid or a solid, which intermediate vessel is closed on the upper side and the lower side by a pierceable sealing membrane and which intermediate vessel is connected in a sealing manner to the hinged-lid vessel and to the removal vessel.

8. A multiple chamber mixing vessel according to one of claims 1 to 6, consisting of a introversion vessel and a withdrawal vessel and two intermediate vessels between the introversion vessel and the withdrawal vessel, which are filled with a liquid or a solid, respectively, which are closed on the upper side and the lower side by a pierceable sealing membrane and which are connected to one another in a sealing manner, and one intermediate vessel is connected to the introversion vessel in a sealing manner and the other intermediate vessel is connected to the withdrawal vessel in a sealing manner.

9. A multiple chamber mixing vessel according to one of claims 1 to 6, wherein the multiple chamber mixing vessel composed of the introversion vessel and the removal vessel has a recess on the outside along the connecting line between the introversion vessel and the removal vessel, or the multiple chamber mixing vessel composed of the introversion vessel, one intermediate vessel and the removal vessel has a recess on the outside along the connecting line between the introversion vessel and the intermediate vessel and/or between the intermediate vessel and the removal vessel, or the multiple chamber mixing vessel composed of the introversion vessel, two intermediate vessels and the removal vessel has a recess on the outside along the connecting line between the introversion vessel and one intermediate vessel and/or between two intermediate vessels and/or between the other intermediate vessel and the removal vessel.

10. A multiple chamber mixing vessel according to claim 7 wherein, for the sealed connection between the introversion vessel and the intermediate vessel and between the intermediate vessel and the removal vessel, the introversion vessel, the intermediate vessel and the removal vessel have a groove, flange, thread or indentation at the level of the sealing membrane.

11. A multiple chamber mixing vessel according to claim 8 wherein, for the sealed connection between the introversion vessel and the one intermediate vessel and between the one intermediate vessel and the another intermediate vessel and between the another intermediate vessel and the removal vessel, the introversion vessel, the one intermediate vessel, the another intermediate vessel and the removal vessel have a groove, flange, thread or indentation at the level of the sealing membrane.

12. A multiple chamber mixing vessel according to any of claims 1-6 wherein the flip top container is completely filled with liquid.

13. A kit comprising at least one introversion container which is closed on the front side by a pierceable sealing film and whose base can be pressed in the direction of the sealing film and whose walls can be turned inwards, and at least one removal container which is closed on the upper side by a pierceable sealing film and which has a removal region on the underside, the introversion container and the removal container being sealingly connectable to one another.

14. The plant according to claim 13, further comprising at least one intermediate container which is closed on the upper side and on the lower side by a pierceable sealing membrane, the intermediate container being sealingly connectable with the introversion container and sealingly connectable with the removal container.

15. Method for the sterile preparation of a solution comprising at least two components, characterized in that a multi-chamber mixing container according to one of claims 1 to 12 is placed in an apparatus comprising a half-shell-shaped receptacle for receiving the multi-chamber mixing container, a holding means for the multi-chamber mixing container and an axially movable expression plunger; applying pressure to the bottom of the flanging container by pressing out the plunger; the bottom of the hinged container is pressed in the direction of the removal container, wherein the wall of the hinged container is continuously hinged inwards and pierces the sealing film by means of the forward pressure, and the at least two components are mixed.