EA044241B1 - SYSTEM OF CONTAINERS AND METHOD FOR PREPARING A MIXTURE OF SUBSTANCES - Google Patents

Description

The invention generally relates to providing fluid-transferable communication (hereinafter referred to as fluid communication). In particular, the invention relates to a system of containers and a method for preparing a mixture of substances, in accordance with the preamble of the independent claims.

In the medical field, there is a constant need to transfer substances from one container to another. For example, mixtures of drugs and substances are formed in a mixing vial by first transferring the contents of one container into the mixing vial, then the contents of another container, capping the mixing vial, and forming the mixture by shaking.

In some cases, also relevant to the present invention, substances stored in different containers must be mixed under sterile or foreign matter-free conditions. The present invention also relates, in particular, to the provision of a sterile fluid connection that prevents the entry of foreign substances, such as pathogens.

In this part, WO 2013/104550 A, for example, discloses a kit for the preparation of a combination vaccine, in which two bottles each have a membrane, and the kit includes a double needle for piercing the membranes and thereby ensuring constant fluid communication between the bottles. It has been found, however, that creating fluid coupling through a twin needle or similar method involves relatively high flow resistance, which can slow down the transfer process between vials. There is also a possibility that the transfer will be partial, as a result of which the required ratio of components in the mixture will not be achieved.

The objective of the present invention is to create a connection system, a container system, a method and an application that will simplify or speed up the preparation of the mixture, and/or provide versatility in compliance with sanitary requirements when preparing the mixture at the vaccination site.

This problem is solved by a system of containers and a method for preparing a mixture of substances according to the corresponding independent claims of the invention. Additional preferred features are the subject of dependent claims.

The present invention provides a container system having two containers that are initially fluid-isolated from each other and can be fluidly coupled through relative movement of the containers, wherein the relative movement is initially prevented by a retainer. In this case, the system contains a seat, preferably in the form of a groove, for the latch, into which the latch can be placed as a result of or during said relative movement.

In the possible embodiments described below, the latch can fit into or align with the socket in the axial direction, relative to or along the axis of symmetry and/or the central axis of the container system.

The nest is formed by a wall and/or behind a wall, or a section in the form of a wall, sleeve and/or pipe of a connecting structure or an extension of one of the containers.

In the initial position, the latch is located between the end surfaces/edges of the containers so that the edges rest on one another through the latch.

The retainer is capable of at least partial deformation, thereby allowing relative movement.

By activating the latch, the locking engagement can be opened so that the containers no longer rest against each other, allowing relative movement.

In the initial state, the latch blocks, in particular, only the linear and/or axial movement of the containers relative to each other.

The latch comprises or is formed by at least one locking element which, in an initial position, blocks relative movement by means of a locking engagement, and can be subjected to deformation and/or compression to release the lock to achieve said relative movement. The locking element has an edge or end surface that forms a locking engagement and is radially movable to release the lock. The locking element is injection molded at one end of the lock, molded integrally with it, and/or petal-shaped.

The latch has an annular or annular shape, and preferably the latch is made in the form of a locking ring, which is capable of being deformed at least partially or in its parts to release the lock.

The shape of the socket corresponds to or is complementary to the shape of the latch, or vice versa, wherein, preferably, the latch is formed by a locking ring, and the socket is annular in shape so that the locking ring can be partially, preferably predominantly, located in the socket during, as a result of or after opening blocking, preferably as a result of relative movement.

The retainer is made of plastic, preferably a thermoplastic material, preferably in the case where the retainer is a plastic ring.

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In the initial state, the latch is located between the containers in such a way that relative movement in the axial direction relative to or along the central axis or axis of symmetry of the system of containers is blocked, and the axial relative movement can be ensured by partial deformation of the latch along the radius in the direction of the central axis or axis of symmetry of the system containers.

The retainer is held permanently and/or permanently on the container system, and/or so that it cannot be removed and/or removed and/or rotated, and/or is held by a tapered portion and/or by means of a locking engagement.

The present invention also provides a method of preparing a mixture of substances, preferably a combination vaccine, in which the substances are provided separately from each other in two containers that can be fluidly coupled to each other, wherein the fluid connection of the containers can be accomplished by moving the containers relative to each other each other, preferably by axial relative movement with respect to or along the central axis and/or axis of symmetry of the container system, whereby a socket and a relative movement preventing lock are provided, which is placed between the containers, and the lock is activated, so that as a result of this and the relative movement, the lock is retracted into the nest.

Various features relating to container systems and methods of preparing a mixture of substances will be described below.

The first feature relates to a container with a connecting structure for establishing fluid communication between this container and another container, and in the initial state the connecting structure is sealed with respect to the fluid in the opening area and can be opened to form a fluid connection, and the opening area is closed with a lid (closure means) in the form of a cap and/or other connecting structure.

It is also provided that the lid or other connecting structure is held tightly on the container to form a sealed chamber, and the container includes a sealing device/means surrounding the opening area that isolates the volume directly in contact with the opening area from the volume chamber separated from the autopsy area.

Alternatively, or additionally, it is contemplated that the container comprises a sealing device that continuously seals a volume enclosing the opening area by means of a lid or other connecting structure when the lid or other connecting structure is moved relative to said connecting structure.

Another feature relates to a connection system for providing fluid communication between containers, comprising at least two connection structures configured to form a fluid connection, namely, a first connection structure and a second connection structure, each of which is initially sealed in relation to the fluid and can be opened in the area of opening to form a connection along the fluid.

Preferably, the connecting structures form a sealed chamber and contain a sealing device, whereby by means of the sealing device, the internal volume in direct contact with the opening areas is isolated from the outer volume of the chamber, which is separated from the opening areas.

Alternatively, or additionally, it is contemplated that the connection system includes a sealing device that continuously seals the volume in direct contact with the opening areas when the connection structures are displaced relative to each other.

As a result of double sealing by means of an additional chamber (a separate or first volume) and a second volume surrounding the opening area, and/or sealing provided during movement, it is possible to achieve a more reliable sterile seal or closure of the opening area.

Another feature relates to a connection system for providing (permanent) fluid communication, preferably between containers, comprising at least two connection structures configured to provide fluid communication, each of which contains an opening area sealed in relation to the fluid in its original state and, in particular, made in the form of a film, fragile, brittle and/or fragile, with each opening area closed in a sterile or sterilizable manner.

The advantage of such a double closure, namely the opening area and the covering of the corresponding connecting structure, is the ability to comply with hygienic requirements during transportation, storage and/or formation of a fluid connection, even at the site of vaccination.

Another feature relates to a container system having at least two containers, preferably vessels, and a connection system in accordance with the above-described feature, each of the containers comprising at least one connection structure of a connection

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In this way, it is possible to form a fluid connection between the containers and ensure mixing of their contents.

Another feature relates to a method of forming a fluid connection between connection structures and/or containers by means of connection structures that are fluidly connected in the initial state, wherein a first connection structure is exposed to another, a second connection structure, by embedding the connection structures into one another and/ or axial movement along a common axis.

In this way, it is also possible to achieve rapid formation of a reliable connection of containers in a fluid medium and mixing of their contents.

Another feature relates to the use of a system of containers, the first container of which contains a first substance, in particular a first vaccine against a first disease, and the second container contains a second substance, in particular a second vaccine against a second disease different from the first, for preparing a mixture of substances, in in particular, for the preparation of a combination vaccine for simultaneous immunization against different diseases, the containers being connected to each other in a fluid medium by means of connecting structures, due to which the substances are mixed with each other, in particular, to form a combination vaccine.

In this way, substances that are not compatible with each other, in particular vaccines, can be mixed hygienically immediately before sharing and administration, saving time and reducing stress.

Another feature relates to a container system with two containers that are fluidly separated from each other in the initial state, and between which a fluid connection can be formed by relative movement of the containers, wherein in the initial state the relative movement is prevented by a retainer.

Such a container system preferably has a slot in the form of a fastener into which the fastener can be inserted as a result of or during relative movement.

As a result, no separate parts need to be manufactured to ensure unlocking and use. It has been found that tear tabs are sometimes swallowed by animals and can cause injury. The present invention provides convenient and safe operation.

Another feature relates to a method for producing a mixture of substances, preferably a combination vaccine, for which the substances are supplied separately from each other in two containers, for which a fluid connection can be formed by moving the containers relative to each other, preferably axial movement about a central axis or axis of symmetry of the container system.

A receptacle is provided between the receptacles, and a retainer is placed or formed between the receptacles to block the relative movement, and the retainer is activated and pushed into the receptacle by the actuation and relative movement. Thanks to this, convenience and safety of work are ensured.

The connection system is preferably useful for creating a fluid connection between containers, in particular having advantages, but alternatively or in addition can also be used for any other fluid connections or connections, for example connecting a container to some other devices, or can be used independently of any containers.

The proposed connection system preferably contains at least or exactly two connection structures. Preferably, the connecting structures are formed in such a way that they are mating and/or coordinated with each other. The advantage of this approach is that fluid communication can only be achieved with connection structures that match each other. Preferably, mating and/or matched coupling structure configurations also have the advantage that the coupling structures correspond to each other such that fluid communication can be achieved.

The connecting structures are preferably in each case initially sealed against the fluid. This allows the mixture to be prepared on demand or at the point of application, or to use containers, each of which has coordinated connecting structures, as well as to use them separately or independently of each other.

It is assumed that the connecting structures are made with the possibility of their mutual opening, and this mutual opening ensures continuous communication through the fluid medium.

Preferably, the first connecting structure is configured to open another, second connecting structure. It is also preferable that the second connecting structure is designed to be removable from the first connecting structure. This ensures mutual opening of the connecting structures.

According to another feature, the proposed connection system contains several containers, each of which contains both one of the connection structures and an opening for removal/removal.

In another aspect, fluid communication can be achieved by deforming at least one of the coupling structures, preferably by breaking the exposed region of the coupling structures by deforming the coupling structure outside the exposed region.

In particular, it is assumed that each connecting structure serves as a means, contains means or is designed as a means for opening a corresponding other connecting structure. Such means are preferably attached or firmly attached to, or integrally formed with, a suitable connecting structure. The advantage of this solution is the ability to provide fluid communication without the use of tools (in addition to the actual connecting structures) and, in particular, ease of use. It is advantageous in particular that no separate tool is required to be moved or controlled separately from the connecting structures, making the proposed connecting system simple, inexpensive to manufacture, reliable and robust.

Preferably, once a fluid connection and/or mechanical connection of the connection structures or containers has been established, the connection and/or connection remains permanent and permanent. Advantageously, even partial mixing and/or penetration of foreign substances during or after the establishment of fluid communication can be effectively prevented. Preferably, due to the permanent and/or permanent fluid connection, the use of a membrane (septum) or the like is not required to provide this fluid connection, even when sterility is required. Therefore, relatively large holes, or holes with a large cross-section, can be obtained compared to the needle, which allows for faster transfer and mixing of substances.

In the present invention, the connection is permanent in the sense that, in particular, the connection can only be opened again by damage or destruction of the structure, not by hand, and/or only by the use of a tool. A permanent connection is, in particular, a connection created by snap-on jaws. However, other solutions are possible.

Preferably, at least one, preferably both, of the connecting structures (each of them) contains an opening area that must be opened by the other of the connecting structures. It is particularly preferred that the opening region comprises or is formed using or by means of a film region, a rupture region, a reduced strength region, a wall thinning, a film, in particular a sealing film, a membrane, a membrane portion and/or other structural part or connection structure region , providing opening under the influence of another connecting structure, in particular, destruction, breakthrough, rupture and/or separation of the opening area, without any other negative impact on the function or structure of the connecting structure. In particular, the (film) opening area is a mechanically weak or weakened part of the wall. The opening area may be frangible, weak and/or brittle, and/or may be, form or include a rupture area. The advantage of using an opening area is that an opening with a relatively large cross-section of passage can be created simply and quickly. This ensures rapid mixing and homogeneity of the mixture, even if the containers are at least substantially filled with liquid and/or solid.

The connecting structure or structures are or are designed to be opened once and/or irreversibly, in particular using or through the opening area or areas. The hole formed using either through or in the connection system is preferably not intended to be resealed.

In the present invention, the hole cannot be resealed, or permanently opened, in the sense that it can only be resealed using a special tool and/or by replacing damaged parts or adding new parts. The broken seal film, as a preferred form of the exposed opening area, is preferably not recoverable and is broken irreversibly according to the present invention, even though the broken seal film could theoretically be replaced and repaired using appropriate equipment.

The following is a more detailed discussion of the proposed connection system, with reference to two connection structures, a first connection structure and a second connection structure. This does not necessarily imply a sequence of opening, but serves primarily to distinguish between connecting structures. Thus, in particular, it is possible to produce the second connecting structure separately and independently of the first connecting structure.

The connecting structures are preferably different and/or have different shapes to expose another corresponding connecting structure. In this case, preferably, different mechanisms are used for opening different connecting structures, or connecting structures designed for this purpose.

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The first connecting structure preferably comprises a first opening area. The second connection structure preferably also includes an opening region, hereinafter referred to as a second opening region. This makes it possible to differentiate between them, and preferably does not imply either consistency or the possibility of creating a second opening area without the first.

The second connection structure is preferably configured to open the first connection structure by tearing, cutting or destroying the first opening area. Alternatively, or additionally, the first connection structure is configured to open the second connection structure by tearing, cutting or destroying the second opening area. Thus, the connecting structures can provide mutual opening by tearing, cutting and/or destroying the opening area of the other connecting structure by one connecting structure.

According to a particularly preferred feature, the second opening area of the second connection structure can be pierced by the first connection structure. It is also preferable that the first opening area of the first connection structure can be pierced by the second connection structure.

Alternatively or additionally, the first opening area of the first connection structure can be opened by deforming the first connection structure through the second connection structure, in particular, cracking, tearing, perforating and/or separating the first opening area, as a result of tensile stress caused by deformation.

Preferably, the connecting system in the first embodiment provides for first opening the opening area of the first connecting structure by the second connecting structure using a cutting element, followed by opening the second opening area of the second connecting structure by piercing the second opening area with the first connecting structure.

Preferably, the connecting system in the second embodiment provides, first, opening the second opening area of the second connecting structure by piercing the second opening area with the first connecting structure, followed by opening the opening area of the first connecting structure by deforming the first connecting structure through the second connecting structure.

These embodiments can be combined with each other, for example, by first opening the opening area of the first connecting structure by means of the second connecting structure using a cutting element, then opening the second opening area of the second connecting structure by piercing the second opening area using the first connecting structure, and then opening the area of opening the first connecting structure using the second connecting structure, by deforming the first connecting structure with the second connecting structure.

The connection structures may also mutually pierce each other and/or one of the connection structures may pierce another connection structure and the other connection structure may open the first connection structure by deformation.

The first and/or second connecting structure(s) preferably comprise (in each case) a neck. The neck can be made in the form of a constriction and/or a coupling, and/or a ring, or in the form of a pipe section, etc. The neck, in particular, is designed to transmit a fluid after opening.

The neck is preferably configured to create, form or enclose a fluid connection. For this purpose, the neck can be (in each case) closed in its original state. In particular, the (corresponding) neck is closed by means of an opening region, preferably so that it can be opened once and/or irreversibly and/or while maintaining a seal. The neck may have an open or outer edge on which an opening area is preferably sealed, mounted or formed.

The neck preferably surrounds the (corresponding) opening area. In particular, part of the connecting structure containing the opening area is attached to the neck, for example, by means of a sealing film that seals the open edge of the neck. It is possible, although not necessary, for the opening area to be located inside the neck. In the present invention, the term surrounds preferably means that the opening area or part of the (corresponding) connecting structure forming the opening area (in the original state) is attached to the neck circumferentially or otherwise on all sides in a fluid sealing manner. environment.

Preferably, the second connection structure includes a neck surrounding the opening area of this structure, while it is also preferable that the connection structure is configured to pierce this opening area. In this way the second connecting structure can be opened.

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Preferably, the opening area of the first connection structure is pierced by a neck and/or a separating, piercing or piercing element of the second connection structure. The neck or opening area of the second connecting structure can therefore be configured as a means or tool for opening the first connecting structure.

Alternatively or additionally, the second connecting structure is configured to deform the neck of the first connecting structure so that this deformation causes destruction, cracking, tearing and/or separation of the opening area of the first connecting structure, in particular by rotating the connecting structures relative to each other. Alternatively or additionally, the first connection structure is configured to deform the neck of the second connection structure so that this deformation causes the opening area of the second connection structure to collapse, in particular by rotating the connection structures relative to each other.

According to the described concept, it is in principle possible to functionally replace the first connecting structure with a second connecting structure.

Preferably, the neck of one first or second connecting structures is configured to be positioned along the same axis with the neck of the other first or second connecting structures, preferably so that the opening area of the other first or second connecting structures can be broken through, and/or the other of the first or second connecting structures can be opened. first and second connecting structures.

In particular, the connecting structures are thus structures each of which has a neck, also covered in each case by a plug containing an opening area, in particular a sealing film. In addition, the necks are formed different and complementary so that the neck of one of the connecting structures is capable of destroying the opening area of the other connecting structure. In this way, at least one of the connecting structures is exposed.

The connection system is preferably designed such that to create a permanent fluid connection only requires opening two connection structures or breaking through two discontinuous portions of the connection structures. Therefore, it is preferable that permanent fluid communication is established by immediately opening both connecting structures, and if only one of the connecting structures is opened, or neither of both connecting structures is opened, then hydraulic blocking or cutoff occurs.

In the present invention, permanent fluid communication means, in particular, that a passage is formed through which fluid can pass. Preferably, this passage is formed by mutual opening of the connecting structures.

In particular, it is preferable that both connecting structures comprise necks that have a non-circular cross-section and can be placed one inside the other, and are configured such that rotation of the necks relative to each other causes at least one of the necks to deform so as to pierce the opening area , surrounded by deformed necks or adjacent to the deformed necks, in particular, at least one inner opening area or one opening area related to the inner neck.

In particular, tapered necks can be designed such that by pressing them into each other and rotating them relative to each other, preferably around, in particular, a common central axis, the outer side of the inside neck comes into contact with the inner part of the outside neck so that that the resulting force changes the shape, or deforms, one or both necks. In particular, each neck may have an oval cross-section, and/or may be pressed inside another with the same orientation, at least initially, so as to cause (mutual) deformation, or change of shape, upon rotation. This may reduce the longitudinal dimension and/or increase the transverse dimension of the opening means, with corresponding tensile cracking, destruction, rupture and/or separation of the opening means, preferably at least the internal connecting structure, resulting in opening.

In particular, it is preferable that the opening area is designed to be bendable, indentable and/or stretchable by deformation. In particular, the opening area is formed in the form of a film or sealing film, which is designed to rupture when the neck on which the film is located or formed is subjected to deformation, and corresponding opening of the connecting structure.

In accordance with another feature of the present invention, when the first connecting structure approaches the second connecting structure, only one of the first and second opening areas is initially destroyed, in particular by piercing, and a permanent fluid connection is established only with further approaching of the connecting structures, by tearing the other from the first and second opening areas.

Preferably, there are at least two different possibilities for breaking the opening areas or breaking sections of different connecting structures, and thereby ensuring mutual opening of the connecting structures.

In the first option, first one connecting structure is pressed into another connecting structure with its neck, breaking through the opening area of the other connecting structure, after which the inserted connecting structure is deformed by rotating the connecting structures relative to each other, which leads to rupture of their opening areas and, in As a result, the creation of a constant connection through the fluid medium.

In the second variant, one connecting structure contains a cutting element, through which the opening area of the other connecting structure is first broken through and, thus, opening is carried out. Only after this, the neck of the other connecting structure, the opening area of which has already been opened by the cutting element, is pressed into the neck of the first connecting structure, thereby causing a rupture of the opening area of the first connecting structure. In this case, a permanent fluid connection is also formed as a result of mutual opening.

What these variants have in common is that the neck of one connection structure (hereinafter always referred to as the first connection structure) is used to break through the opening area or to open the opening area of another connection structure (hereinafter always referred to as the second connection structure), preferably by pressing into the neck of the other connecting structure.

According to another feature, the connecting structures can be connected to one another, preferably in a permanent connection and/or with a snap-on design. Preferably, the permanent connection of the connecting structure is performed before opening at least one of the first and second connecting structures. In particular, the connecting structures are designed such that first a permanent connection must be made between the connecting structures, and then a permanent fluid connection can be created.

Preferably, the connecting structures have different positions of connection with each other, in particular snap-locking positions or locking steps. The connecting structures are preferably designed such that it is not possible to open either one, or only one of the first and second connecting structures, when the first connection position is reached, and that constant fluid communication and/or opening of the two connecting structures is ensured when the first connection position is reached. another, second connection position.

Thus, there may be at least two connection positions, occupied one after the other, when the connection structures are pressed or inserted one inside the other. In the connection position that is reached first in time and/or distance, a permanent connection is created between the connecting structures, and a permanent fluid connection is created only in the second connection position. This prevents the connection structures from being separated from one another after one or both connection structures have been opened. As a result, leakage and/or contamination can be prevented.

The coupling system is preferably self-sealing once the fluid bond is formed.

Preferably, the formation of a fluid connection by means of the proposed connection system, in particular, provides a passage for the fluid, hermetically sealed from the environment.

To form a hermetic seal, preferably at least one opening region acts as at least a seal, as a result of or after the formation of the fluid connection. In particular, a second connection structure may be used comprising a breach region that acts as a seal, a sealing lip, or the like, at least at the edges where it has been breached by the neck of the first connection structure. Alternatively, or additionally, however, another seal can be used, in particular an O-ring or a sealing lip.

Another feature relates to a container system comprising containers, in particular vessels, each with a recess opening, in particular a baffle, which are further configured to provide fluid communication independent of the recess openings. For this purpose, the connecting structure is located, in particular, preferably on the side opposite the recess opening. It has been shown that for fluid communication of a container, in addition to the opening for the recess, or a device for the recess, for example a partition, in particular, it is preferable to use a connecting structure located elsewhere, in particular in the case of a vessel, on the side opposite to the constriction of the vessel . This allows permanent fluid communication through the proposed connection system without interfering with the functionality of the recess opening. The containers in this case remain suitable for use separately and independently of each other.

Another feature relates to a container system with the proposed connection system, in which the first container contains the first connection structure and the second container contains the second connection structure of the proposed connection system. In particular, it is preferred that at least one of the containers comprises a recess opening and, at a distal or opposite end from the recess opening, a connection structure of the inventive connection system. In this way, the containers can be fluidly coupled by means of the proposed connection system, in particular for mixing substances, while no blocking, for example, of standard recess openings or otherwise affecting them occurs.

Preferably, the first and second vessels each comprise an opening for a recess and, at an end remote or opposite from these openings, in particular at the corresponding base of the vessel, one of the proposed connecting structures. As a result, the vessels can be fluidly coupled to each other at an end remote from the recess opening by means of the proposed coupling system.

As a result of the formation of the fluid connection, a new combination container is preferably obtained with a volume equal to the total volume of both containers and/or with two recess openings. The advantage of this solution is that theoretically the containers can be used independently of each other by means of respective recess openings, but the contents of the containers can also be combined and mixed due to the formation of a permanent fluid connection between the containers through the proposed connection system.

The container system may also comprise at least one container having a first connection structure at a first end and another, second connection structure at a second, other, particularly opposite, end. Each of the two connecting structures is configured to form a fluid connection. The container may have, form and/or contain a volume in which preferably the substance is or may be contained. This makes it possible to fluidly connect more than two containers, or mix more than two different substances. To this end, the container contains two connection structures so that the other container can be fluidly coupled at both ends by means of the proposed connection system. This container preferably forms a transition device between other containers of the container system, but may also be used with just one additional container to create a fluid connection between them, and/or may also be manufactured separately and/or constitute an independent feature.

Another feature relates to the use of the proposed container system, in which the first container contains a first substance, in particular a first vaccine against a first disease, the second container contains a second substance, in particular a second vaccine against a second disease different from the first, the containers in each case having a recess opening and in each case contain, in addition to a corresponding recess opening, a connecting structure for providing fluid communication between the containers for preparing a mixture of substances, in particular, preparing a combination vaccine for simultaneous immunization against different diseases, wherein the containers are connected fluidly with each other by means of connecting structures so that the substances are mixed and, in particular, form a combination vaccine.

The proposed container system is, in particular, preferably used for the combined administration of drugs. In particular, it is possible to store vaccines in separate containers, the stability of which when combined is not high, and to fluidly connect these containers before use through the proposed coupling system, thereby allowing rapid and efficient formation of the mixture without affecting the extraction opening, such as a partition. Alternatively, the respective vaccines may also be used separately from each other through the recess openings if a fluid connection has not been formed by means of a coupling system.

The containers or vessels and/or connecting structures in the present invention are preferably at least substantially geometrically stable, rigid or partially rigid, and/or at least substantially formed from a plastic material, or a plastic material containing, in particular , polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE) or polypropylene.

In the present invention, the term container preferably refers to a sealable container for transporting and storing fluids, in particular liquids and solid fluids, such as powders. In the present invention, the vessel preferably has a diameter less than a height. The vessel of the present invention preferably has at least a substantially conically tapering end, also referred to as a vessel constriction. The constriction of the vessel preferably has at its end an opening, particularly circular in shape, which can be sealed and opened to remove the contents, also called a withdrawal opening. The vessels in the present invention are preferably narrow-necked vessels and/or vials. In narrow-necked vessels, the diameter or internal width of the recess opening is less than the average internal diameter of the storage space defined by the vessel, preferably less than 70%, in particular less than 50%. However, other solutions are possible.

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In the present invention, the connecting structure is preferably a device configured to provide fluid communication and, preferably, mechanical connection when forming a fluid connection. These are, in particular, a hydraulic connection, a flange, a connecting element, a fastening element, a detachable connection, a connection with a male/female element, in particular a plug connector, or parts thereof.

In the present invention, the connection structure may be a portion/region of a container, particularly a vessel, or the connection structure is (in each case) attached to the container, particularly attached by a material, frictional or interlocking connection. In particular, it is preferable that the connecting structure is at least partially formed by or as an integral part of the container or vessel. Alternatively, or additionally, the connection structure is adjacent to the container or vessel, or is otherwise adapted to hydraulically attach or connect the interior of the container or vessel.

In the present invention, the connecting structure is preferably fluid-tight when leakage or passage of a fluid, particularly a liquid, is prevented, or when leakage or passage of a fluid, particularly a liquid, is prevented by a fluid-impervious sealing means, particularly , liquid.

In the present invention, the connecting structures are capable of being inserted into one another, in particular when a part or section of one of the connecting structures can be placed inside another connecting structure, or part or section thereof. In particular, at least a portion of one of the connection structures may be pressed, laid, inserted or otherwise inserted into another or a corresponding connection structure. The connecting structures are inserted into one another, in particular when they overlap in the radial direction at least partially, substantially or completely with respect to a (common) axis of symmetry and/or a central axis, or the interior of one connecting structure is (completely) surrounded or enclosed ( radially) with the outer part of another connecting structure.

In the present invention, axial movement along a common axis is preferably a movement that is non-spiral, non-rotational, at least substantially or exclusively linear and/or strictly axial, and/or a movement that does not require a complete revolution or reversal. The connecting structures are preferably adapted to be built into one another, inserted into one another and/or at least substantially linearly fitted to each other to create a permanent and/or hydraulic connection.

In the present invention, opening, in particular, means providing access to the inside of a container or vessel, or the volume formed by the container or vessel, by forming an opening, opening, passage, slot, etc., in particular, so that entry and/or the release of a fluid, in particular a liquid.

In the present invention, a tamper-evident region is, in particular, a tamperable region, i.e. its design provides the formation of an opening, opening, passage, slot, etc., or access for a fluid inside or into the volume located in the container. The opening area is preferably sealed and capable of opening to allow fluid to pass through. The opening area can be a clogged slot, a clogged opening in the wall, a closed passage or plug, etc., which can be opened.

The opening area in the form of a film is preferably a part that is, in particular, a thin-walled or flat structure for forming an opening. The film opening area is preferably an opening/area sealed or plugged with a film, membrane, flat, thin, frangible and/or weak structure.

In the present invention, a pierceable is in particular a structure that can be pierced or pierced by an object, in particular a tip, so that a connection from one (flat) side to the opposite side can be provided. Breaking preferably provides opening. In particular, the breached opening area is destroyed upon breaking through and remains permanently exposed.

In the present invention, sealing indicates in particular that leakage and/or penetration of a substance is prevented by the sealing means.

In the present invention, self-sealing indicates in particular that the sealing is carried out without special means, due to its own properties and/or automatically, fully automatically, simultaneously or without the need for additional actions.

In the present invention, sterile self-closure means, in particular, a self-closure that forms a seal against the entry of pathogens, such as bacteria or viruses, such that at least substantially prevents the entry and/or leakage of bacteria. In particular, the seal, the sealing gap and/or the contact pressure are selected such that any possible leaks have a cross-section that blocks the passage of pathogens such as bacteria or viruses.

In the present invention, waterproof refers to a seal that is at least

- 9 044241 generally prevents the entry or exit of fluids, in particular liquids.

In the present invention, gas-tight refers to a seal that at least substantially prevents the entry or exit of gases.

In the present invention, physical structure means, in particular, a complex formation and/or structure and/or structure and/or an ordered combination of various structures, various materials, etc.

In the present invention, a layered structure, as well as a sandwich structure, a multilayer structure, in particular a composite structure, a composite material and/or a layered composite material means, in particular, a structure containing different layers, which are preferably connected to each other and/or adjacent to each other, can be logically separated or demarcated from each other, located with flat sides facing each other, or on top of each other, contain planar elements or parts that may differ in their physical or chemical properties.

In the present invention, edge or edge portion refers, in particular, to an area away from the center, middle or center of gravity, or to an area having an edge, edge, end or boundary adjacent or facing thereof. In particular, it is a portion of a preferably planar structure on its annular edge, in particular surrounding or having a ring-shaped shape, etc.

In the present invention, the central part refers in particular to the part remote from the end, edge and/or edge, and/or contains, covers or extends around the center, midpoint, center point or center of gravity.

In the present invention, destruction of the opening area refers in particular to an irreversible change in the opening area, affecting its former function as a seal, wall, sealing element and/or plug, or such that the former function is no longer performed, in particular in as a result of mechanical impact, change in shape, deformation, tearing, separation or any other impact. The exposed area can be opened and/or fluid communication can thereby be established.

In the present invention, cutting through the opening area means, in particular, separating the material of the opening area from one side to the other, in particular the opposite side, and/or separating them, and/or cutting them off by chopping, cutting, cutting or otherwise either way.

In the present invention, remaining intact means, in particular, preserving a pre-existing function. The intact opening area has and retains, in particular, the function or functions of shutting off, sealing and/or forming a seal against the entry or leakage of pathogens, fluids, liquids, gases, etc.

In the present invention, the fluid is preferably a substance having flowability. The fluid, in particular, may use a fluid bond to flow. In particular, in the present invention, the fluid is a liquid, a suspension, a fluid solid such as a powder or granular material, and/or a gas in liquid or gaseous form. In particular, it is preferable that at least one of the substances is a liquid, in particular both or at least two substances.

In the present invention, fluid communication preferably means a structure/structure configured to pass a fluid, in particular a liquid, gas or solid fluid. Specifically, it is a passage area, passage or channel.

In the present invention, a fluid passage particularly means a means configured to pass a fluid, in particular a liquid, a gas or a solid fluid. In particular, it is a transit area, connection or channel that is preferably (reliably) isolated from the environment, or from the side of the passage-forming wall remote from the passage.

In the present invention, preferably, the opening region is brittle if, in particular, due to its composition and/or design, it is suitable or intended to rupture near its elastic limit without plastic deformation or with little plastic deformation (brittle fracture).

In particular, the opening area has an elastic limit of less than 200 N/mm ² and/or a tensile strength of less than 100 N/mm ² , preferably less than 60 N/mm ² and/or a ratio of elastic limit and tensile strength of less than 1, preferably less than 0.7 or 0.5. This can be achieved in particular by structuring and/or combining, joining or laminating different materials. The opening area can be formed by laminating several films, of which preferably one film contains or consists of aluminum or is a metal foil. In particular, it is preferable that the opening area is at least partially metallic. Preferably, the opening area is formed by or from a composite material, which preferably has a preferably flat or film layer of aluminum.

In the present invention, the weak opening area is preferably the area

- 10 044241 having less mechanical strength than the parts surrounding it and/or which can be destroyed manually or by applying force, in particular, as a tear section.

In the present invention, the expression outside the opening area means a region or part separated from the opening area, but which is preferably directly or indirectly adjacent to the opening area, in particular such that deformation in this area causes tension in the opening area.

In the present invention, deformable means preferably capable of elastic or plastic deformation. The connecting structure(s) or necks are preferably characterized by elastic deformation, which causes plastic/irreversible deformation of the opening area. The connecting structure(s) or necks may, however, also exhibit plastic deformation/deformation.

In the present invention, parts or sections are considered to correspond to each other if, in particular, they have a similar and/or complementary structure, when they are inserted into one another, similar to each other, similarly positioned, have similarly oriented structures of similar shape and/or are made with the ability to interact with each other to perform a function or action.

In the present invention, counter-rotation means, in particular, rotary movement of a part, preferably a connecting structure or container, or a container with a connecting structure, relative to another part, preferably another connecting structure or another container, or another container.

In the present invention, counter-rotation means in particular the rotational movement of two parts, preferably a connecting structure or a container, or a container with a connecting structure, relative to another part, preferably another connecting structure or another container, or another container, preferably in different or opposite direction of rotation.

In the present invention, a neck is, in particular, a section or part containing or forming an opening, the edge of an opening, an opening or contraction, preferably with an opening at the end, or some other tubular part or passage radially surrounded by a wall terminating in an opening that is preferably open at the end and/or forms an opening at at least one end.

In the present invention, the term thin-walled means in particular a structure, flat or planar in cross section, the average wall thickness of which is less than 2, 1.5, 1 and/or less than 0.5 or 0.3 mm, in particular desirably , less than 20 µm, in particular less than 150 µm.

In the present invention, the locking device is preferably part of the opening area, or at least partly forms the opening area. The closure device in this case, in particular, has a flat or planar shape, or is a closure plate. In this case, the locking device in particular has a material thickness that is preferably at least 2, 3, 4 or 5 times greater than its longitudinal extent.

The locking device is preferably formed as a single unit, in particular as a single piece with a breakable section, in particular a thin section. The locking device together with the tearing section can form the opening area or part thereof. Preferably, the tear portion forms a film-like, brittle and/or weak portion of the opening region, or makes the opening region film-like, brittle and/or weak. For this reason, the tear portion is preferably sufficiently brittle to form an opening by tearing under mechanical force.

The connecting structure is preferably formed from plastic, in particular thermoplastic material, in particular by injection molding. The opening area is predominantly formed by the locking device, in particular over 70, 80, 90 or 95% of its area. In this case, compared to the surface area of the locking device, the rupture section occupies an area of less than 10, in particular less than 5%.

The locking device may have an S-shape in cross-section along the main overall dimension. The locking device may have ribs or other reinforcing elements to increase rigidity. The locking device preferably has sufficient strength or rigidity to prevent deformation, or allows minor deformation due to a breakable portion. As a result, the force acting on the burst portion does not deform the locking device, or deforms it only slightly, in particular by compression, thereby simplifying the destruction or rupture of the burst portion.

In the present invention, the tear portion, particularly the thin limited portion, is preferably a film-like, fragile and/or weak or frangible opening area or area, or a film-like, fragile and/or weak or frangible portion of the opening area.

The rupture portion is preferably manufactured and designed to rupture or

- 11 044241 tear under mechanical load to form a hole. In particular, the rupture section interacts with the locking device, as a result of which the rupture section can be stretched relative to the locking device so that the resulting stresses, shear forces, etc. lead to the destruction of the rupture section. Thus, the burst area is or forms, in particular, an area of weakness or a part with a mechanically weakened structure, compared to the surrounding areas.

The tear portion is preferably formed entirely or partially in a circular manner on or within the neck or holder. The rupture section may have the shape of a rim or a diaphragm. In particular, the tear portion forms a connecting strip to the closure device, in particular from the holder or neck.

In the present invention, a chamber is preferably referred to as a structure or volume that is tightly sealed or sealed on all sides. The chamber, however, can, in principle, be opened, for example, by means of a connecting structure, or by opening a sealing structure, etc.

In the present invention, a volume or formed volume preferably means an area or (partially) chamber that is at least substantially or completely surrounded. The term volume may, therefore, be replaced, if necessary, by the term chamber or part of a chamber. Moreover, internal volume and external volume are differentiated; preferably, it is contemplated that the functionality of the inner volume can be achieved by passing through the outer volume. Preferably, the outer volume surrounds the inner volume. This, however, is not absolutely necessary, since in other embodiments the outer volume may form an antechamber to the inner volume. Preferably, the outer volume forms an externally isolated antechamber, while the inner volume is adjacent to and isolated from the outer volume, so that the outer volume shields the inner volume from the environment.

In the present invention, the container blank is a tubular structure with at least two openings, one of which is or forms a recess opening, which is subsequently used for opening and/or closing, or filling and/or removal. The other opening is temporary and is sealed during the manufacturing process of the container, particularly preferably by sealing or inserting a connecting structure. The connecting structure itself may form part of the container and allow the container to be subsequently opened in that area.

In the present invention, the container blank has an opening for inserting or installing a connecting structure, preferably on a side opposite or distant from the recess opening. However, other solutions are possible. In addition, the container blank may also have only one opening for insertion or installation of the connecting structure. In this case, the container obtained after assembly has only one hole in the form of an area for opening the connecting structure. The container blank preferably comprises a constriction portion having at least a substantially conically tapering portion or bend region leading into a narrow passage. The narrow passage, in this case, preferably forms or contains a recess opening.

In the present invention, the sealing part is preferably an area configured and/or positioned to seal tightly. In particular, such a part is a sealing edge, a sealing strip, etc. The sealing portion may include a sealing surface formed by a surface region of the sealing portion and directly provides a sealing effect. In particular, the sealing effect is achieved by means of sealing surfaces pressing against each other. To achieve this, the sealing surfaces are preferably pressed against each other under tension or pressure, for example by a press fit or the like. The sealing surfaces are preferably formed from a sealing portion material, or a sealing portion surface. There are, however, other possibilities, for example the use of sealing gaskets in the area of the sealing part.

In the present invention, the support part preferably cooperates with the opening area or the burst portion so that the opening of the opening area or the destruction or tearing of the burst portion by means of a mixed mechanical support, a support from below, in particular creating a support pressure or counter pressure, is prevented. In particular, this device removes or displaces mechanical stress from fragile, weak areas in order to block or prevent accidental opening. The supporting part, in particular, is designed to relieve stress from the breaking section.

In the present invention, the retainer is preferably a means for preventing movements, in particular relative movements of connecting structures and/or containers, or other influences that would or could lead to the opening of the opening area. In particular, this may be a locking ring or similar element for blocking, preferably axially, the movement of the connecting structures relative to each other, and for ensuring

- 12 044241 the possibility of such movement during activation or removal. The latch preferably comprises a locking part which, as a working part or working section of the latch, directly locks, in particular the movements, when engaged or removed.

In the present invention, the guide device is preferably a mechanism or part of a mechanism, in particular of the bayonet type, directing the relative movement of the connecting structures relative to each other. This movement preferably produces a bayonet connection. A bayonet connection, also known as a bayonet lock, is preferably a mechanical connection of at least two generally cylindrical and/or rotationally symmetrical parts, in particular with respect to a central axis or axis of symmetry.

The connection via guide devices is carried out by pressing and turning. The parts are inserted into each other along the axis, and after they are inserted all the way, they rotate relative to each other, interlocking in the axial direction. This preferably creates a fluid connection.

The first guide device for this purpose is preferably a slot, groove or other guide device having at least the shape of a substantially right angle, the first part of which extends along an axis, or parallel to the central axis or axis of symmetry, and the adjacent part extends at least substantially at right angles to the direction of the first part. The part extending behind the axially directed part preferably extends at least substantially in a plane perpendicular to the central axis of symmetry. The other, or second, guide device, and/or guide device mating to the first one, is preferably a pin, post, plate or other part corresponding to the first guide device, in particular, associated with a slot, groove, or the like. In general, guide devices are preferably , form a sliding guide.

The containers for effecting fluid communication are preferably manufactured separately from each other. This ensures their universal applicability.

The features mentioned above and described in the following partial description can also be implemented and have a beneficial effect individually and in various combinations.

Other details, advantages and properties of the present invention will be apparent from the claims and the following description of preferred embodiments with reference to the drawings, in which:

in fig. 1 shows a longitudinal section of a system of containers with the proposed connecting system and with the implemented fluid connection;

in fig. 2 shows a longitudinal section of the proposed connecting system in the first embodiment, in the initial position;

in fig. 3 shows a longitudinal section through the proposed connection system in a first embodiment, in a first connection position;

in fig. 4 shows a longitudinal section through the proposed connection system in a first embodiment, in a second connection position;

in fig. 5 shows a longitudinal section of the proposed connecting system in the second embodiment, in the initial position;

in fig. 6 shows a longitudinal section through the proposed connection system in a second embodiment, in a first connection position;

in fig. 7 shows a longitudinal section through the proposed connection system in a second embodiment, in a second connection position, with the connection structures oriented relative to each other;

in fig. 8 shows a longitudinal section of the proposed connection system in a second embodiment, in a second connection position, with the connection structures rotated relative to each other about a common axis;

in fig. 9 is a schematic plan view of a first container with a first connection structure for the proposed connection system of the second embodiment;

in fig. 10 is a schematic plan view of a second container with a second connection structure for the proposed connection system of the second embodiment;

in fig. 11 is a schematic cross-sectional view of the proposed connection system of the second embodiment, along line XI-XI in FIG. 7;

in fig. 12 is a schematic cross-sectional view of the proposed connection system of the second embodiment, after partial rotation of the connection structures relative to each other;

in fig. 13 is a schematic cross-sectional view of the proposed connection system of the second embodiment along line XIII-XIII in FIG. 8;

in fig. 14 is a schematic view of a longitudinal section of a container with connecting structures in accordance with the first embodiment located on opposite sides;

in fig. 15 is a perspective view of a container with a second connection structure of the proposed connection system of the first embodiment;

in fig. 16 is a schematic longitudinal sectional view of the proposed container system with the proposed connection system, in accordance with the first embodiment, in a transport arrangement;

in fig. 17 is a schematic longitudinal sectional view of a first container with a first connection structure closed by a sterile or sterilizable lid;

in fig. 18 is a schematic longitudinal sectional view of the first container shown in FIG. 17, with cover removed;

in fig. 19 is a schematic longitudinal sectional view of a first container supported in the lid shown in FIG. 17;

in fig. 20 is a schematic longitudinal sectional view of the second container with the occlusion partially removed;

in fig. 21 is a schematic longitudinal sectional view of the proposed container system indicating the direction of movement to create a fluid connection through the proposed connection system;

in fig. 22 is a schematic longitudinal sectional view of a container system according to another embodiment in a connected state;

in fig. 23 is a schematic longitudinal sectional view of a container of the container system shown in FIG. 22, in original condition;

in fig. 24 is a schematic view of an enlarged portion of the container shown in FIG. 23;

in fig. 25 is a schematic longitudinal sectional view of the container shown in FIG. 23, with cover removed;

in fig. 26 is a perspective view of the container shown in FIG. 23, from the side of its connecting structure;

in fig. 27 is a schematic longitudinal sectional view of another container of the container system shown in FIG. 22, in original condition;

in fig. 28 is a schematic view of an enlarged longitudinal section of the container shown in FIG. 27;

in fig. 29 is a schematic longitudinal sectional view of the container shown in FIG. 27, with cover removed;

in fig. 30 is a perspective view of the container shown in FIG. 27, from the side of its connecting structure;

in fig. 31 is a schematic longitudinal sectional view of the container system shown in FIG. 22, in original condition;

in fig. 32 is a schematic view of a fragment of a longitudinal section of the container system shown in FIG. 22, in the first connection position;

in fig. 33 is a schematic view of a fragment of a longitudinal section of the container system shown in FIG. 22, in the second connection position;

in fig. 34 is a schematic view of a fragment of a longitudinal section of the container system shown in FIG. 22, in the third connection position;

in fig. 35 shows a schematic view of a longitudinal section of a system of containers, with the lock in its original position;

in fig. 36 is a schematic view of a fragment of a longitudinal section of the container system shown in FIG. 35, with actuated latch;

in fig. 37 is a schematic view of a fragment of a longitudinal section of the container system shown in FIG. 35, in connection position;

in fig. 38 is a perspective view of the fastener of the embodiment shown in FIG. 35, in original position;

in fig. 39 is a schematic view of a longitudinal section of a system of containers with the proposed lock, in accordance with the second embodiment, in its initial position;

in fig. 40 is a schematic view of a fragment of a longitudinal section of the container system shown in FIG. 39, with actuated latch;

in fig. 41 is a schematic view of a fragment of a longitudinal section of the container system shown in FIG. 39, in connection position; and in fig. 42 is a perspective view of the fastener of the embodiment shown in FIG. 39, in its original position.

In the description of preferred embodiments set forth below with reference to the drawings, the same or corresponding reference numerals (with or without an apostrophe) are used for the same or similar components or parts, with similar or identical advantages and

- 14 044241 properties can be obtained even when the description relating to them has not been repeated.

In fig. 1 is a schematic cross-section of the proposed system B of containers with a first container B1 and a second container B2.

The container system B preferably contains the proposed connection system 1. The connection system 1 is preferably configured to form a fluid connection 2, preferably between the first container B1 and the second container B2 of the container system B.

The connection system 1 preferably includes a number of connection structures 3A, 3B, in particular, a first connection structure 3A associated with the first container B1 of the container system B, and a second connection structure 3B associated with the second container B2 of the container system B. Preferably, the first container B1 contains a first connection structure 3A, and the second container B2 contains a second connection structure 3B, and vice versa.

Containers B1, B2 are preferably used for storing substances S1, S2, in particular for storing a first fluid and a second fluid and/or different vaccines. In particular, the containers B1, B2 are completely or partially filled with one or more substances S1, S2 or vaccines. Alternatively or additionally, the container or containers B1, B2 may also contain and/or store other substances S1, S2, preferably in solid form. It is possible that only one substance S1, S2 will be a fluid, in particular a liquid. The solid substance S1, S2 can be presented in the form of a solution or suspension with other substances S1, S2.

The proposed container system B is preferably used for the preparation of medicinal products, in particular combination medicinal products, combination vaccines or the like. There are, however, other possible and preferred applications of the proposed container system B.

Preferably, the first container B1 contains a recess opening E1 or the second container B2 contains a recess opening E2. In particular, it is preferable that both or at least two containers B1, B2 of the proposed container system B each contain a recess opening E1, E2.

In the present invention, the withdrawal openings E1, E2 are preferably configured to dispense or withdraw the contents of the corresponding container B1, B2.

At least one and preferably several or all of the openings E1, E2 can preferably be reused or reused several times, re-sealed, reused and/or contain a closure element V1, V2, which preferably allows opening and closing them for extracting discrete doses. This can be achieved by using a membrane.

Preferably, the withdrawal openings E1, E2 are closed or can be closed and/or are the main means for removing the substances S1, S2 from the containers B1, B2.

In the embodiment shown, preferably at least one of the recess openings E1, E2 and in particular both recess openings E1, E2 are closed with membranes. The membrane is a device with a rubber-like closure element V1, V2, in particular a rubber stopper or injection stopper, which is suitable for piercing with an injection needle to extract the contents, the membrane automatically closing the (corresponding) hole E1, E2 for removal due to its recovery ability shape and size after deformation, after removing the injection needle. The membrane, also called a pierceable membrane, preferably has a thin region, particularly in the center, suitable for piercing when collecting liquid for injection using an injection needle. The injection stopper or membrane is preferably secured to the vessel constriction or recess opening E1, E2 by means of a flanged cap, preferably made of aluminum.

Preferably, one, both or all of the containers B1, B2 are injection ampoules or vials, for example so-called multi-dose containers, in particular for vaccinating several animals with one dose each.

The substances S1, S2 in containers B1, B2 in the form of powdered medicinal preparations, solutions or suspensions, or vaccines can be transported in this form.

Containers B1, B2 may each have a capacity of more than 10 ml, preferably more than 50, 100 or 200 ml, and/or less than 2 l, preferably less than 1.5 or 1 l, in particular less than 750 ml ( each or after their connection).

As shown in FIG. 1, the sealing element V1, V2 is preferably sealed with the corresponding recess opening E1, E2, preferably pressed, in particular by means of a pressure ring or compression ring, or a cover with a flange. However, other technical solutions are also possible, for example joining by adhesive, welding, injection molding or other methods.

Of course, it is preferable that each container B1, B2 of the proposed container system B has a recess opening E1, E2, but not all containers B1, B2 of the container system B must necessarily have a recess opening E1, E2.

Preferably, the use of recess openings E1, E2 on several containers B1, B2 allows the use of the corresponding substance S1, S2 from the corresponding container B1, B2, regardless of the use of the connection system 1. Preferably, the container system B allows both the use of containers B1 , B2 separately, and used in conjunction with the fluid connection 2 provided by the connection system 1.

The containers B1, B2 are preferably fluidly connected to each other so that the fluid connection 2 between the volumes formed or contained by the containers B1, B2 provides a common internal space formed by the containers B1, B2 connected by the connection system 1 The combined internal space is particularly characterized in that the permanent fluid connection 2 is provided by a hydraulic cross-section exceeding 2 square meters. millimeters, preferably more than 5 or 10 square meters. millimeters, in particular more than 1, 2 or 3 square meters. centimeters, or there are no restrictions at all between the containers B1, B2 after the formation of the fluid connection 2, having a size less than this hydraulic cross-section, or where the fluid connection 2 has at least this hydraulic cross-section.

The container or containers B1, B2 are or are preferably shaped like vessels. In particular, preferably, the containers B1, B2 (each) have a narrowing F1, F2 defining or adjacent to the recess openings E1, E2. The narrowing F1, F2 can, starting from the end edge or opening E1, E2 for the recess, include an expansion of the (hydraulic) cross-section by more than 1.5 times, in particular by more than 2 or 2.5 times. However, the holes E1, E2 can also have a different design.

The containers B1, B2 preferably contain recess openings E1, E2 and connecting structures 3A, 3B at different, opposite, diametrically opposed sides, ends, at the ends of the axis and/or in the narrowing area on one side, and in the base area, with the other side. Specifically, the recess hole E1, E2 is formed in the constriction F1, F2, and the connecting structure 3A, 3B is located in the base region or at the opposite end from the constriction F1, F2. A clear advantage of this solution is that when using the connecting structures 3A, 3B, the hole(s) E1, E2 remains accessible and its function is not impaired.

The connecting structures 3A, 3B are preferably not intended to be retracted, but only to establish a reliable fluid connection 2 once or permanently, or not intended to be closed repeatedly.

The effect of the present invention is illustrated in particular by the preferred use of containers B1, B2, in particular vessels, for connecting. It is, however, possible and preferable to use the proposed connection system 1 also in other areas, for example for creating a fluid connection of the container B1, B2 with other systems, for example for the rapid extraction of substance S1, S2.

In fig. 2 shows a longitudinal section through the proposed connection system 1, in accordance with the first embodiment, in an initial position or in a non-connected state.

In fig. 3 shows a longitudinal section through the proposed connection system 1, according to a first embodiment, in a first connection position, in which preferably the fluid connection has not yet been established, but one of the regions 4A, 4B has already been opened.

In fig. 4 shows a longitudinal section through the proposed connection system 1, according to the first embodiment, in a second connection position in which a fluid connection 2 is established. This position is also shown in Fig. 1.

The proposed connection system 1 preferably contains several connection structures 3A, 3B, in particular, preferably at least a first connection structure 3A and a second connection structure 3B, preferably configured to at least partially complement each other or correspond to each other to a friend.

The first connecting structure 3A preferably includes an opening area 4A. The second connection structure 3B preferably includes an opening region 4B.

Preferably, the containers B1, B2 comprise opening regions 4A, 4B, or the areas 4A, 4B form or form part of a corresponding connecting structure 3A, 3B associated with the corresponding container B1, B2.

Preferably, one or both opening areas 4A, 4B are areas or parts of the corresponding connecting structure 3A, 3B, configured to create a (long-lasting and irreversible) fluid connection 2, in particular by (irreversibly) destroying this structure. For this purpose, the opening area or areas 4A, 4B may have a (mechanically) weakened area or tear portion, or may be configured as a weakened area or break portion. The opening areas 4A, 4B may have the same, similar or different design, in particular with respect to the thin material and/or shape of the opening areas 4A, 4B.

In particular, the opening areas 4A, 4B are configured to be (mechanically) broken or pierced to form a fluid bond 2. For this purpose, the region 4A, 4B in accordance with the present invention can be configured to be broken, pierced and/or torn by mechanical action to ensure the formation of a fluid bond 2.

- 16 044241

In the illustrated embodiment, the opening areas 4A, 4B are formed by film-like or membrane-like wall portions of the corresponding connecting structure 3A, 3B. In particular, one or more of the opening areas 4A, 4B are or are sealing films. As such, the opening regions 4A, 4B may also be formed by loosening the material forming the respective connection structures 3A, 3B and/or may be formed integrally with the corresponding connection structure 3A, 3B.

The areas 4A, 4B are preferably formed as part of the wall (corresponding) of the connecting structure 3A, 3B. Regions 4A, 4B are preferably regions of low wall thickness that have been weakened to some extent compared to adjacent regions. Preferably, the thickness of the material in the opening areas 4A, 4B is less than the thickness of the material in the adjacent areas, in particular the walls, of the (corresponding) connecting structure 3A, 3B. The (corresponding) opening areas 4A, 4B are therefore preferably thinner, more film and/or membrane-like compared to the adjacent areas.

The opening area or areas 4A, 4B preferably contain or contain one or more discontinuous areas, in particular, notches, thin areas, fragile areas or parts. Specifically, the second connection structure 3B or its opening region 4B includes a tear portion corresponding to the neck 5A of the first connection structure 3A. This promotes or promotes the destruction or puncture of the opening region 4B of the second connecting structure 3B, even if, when the neck 5A is used for this purpose, the separating force applied to the opening region 4B acts or is distributed over a larger area.

In the embodiment shown in FIG. 2-5, the opening areas 4A, 4B are each formed by sealing films that are welded, adhesively attached, or otherwise firmly attached, in particular watertightly, to a respective connection structure 3A, 3B, preferably to its neck 5A, 5B .

In particular, it is preferable that the opening regions 4A, 4B are formed by a laminate or plate material, in particular a plastic/metal composite film or laminate. The opening areas 4A, 4B can, however, also be designed differently, for example by using multiple layers and/or brittle or porous material so as to have limited elasticity, so that even under slight mechanical stress, the opening areas 4A, 4B are torn or destroyed in other ways.

The opening area or areas 4A, 4B are preferably configured to erode under mechanical stress and form a fluid bond 2. Preferably, the opening areas 4A, 4B contain a material whose modulus of elasticity is greater than 2000, preferably greater than 4000, in particular greater than 6000 N/mm ² . Alternatively or additionally, the opening regions 4A, 4B may have a tensile strength of less than 100, preferably less than 80, more preferably less than 60 N/mm ² . The elastic modulus and tensile strength can be determined in accordance with EN ISO 6892-1, ISO 6892, ASTM E 8, ASTM E 21, DIN 50154, DIN 50125 and/or ISO 527, ASTM D 63.

It is also preferable that the area or areas of exposure have a material thickness of less than 100 µm, preferably less than 70, in particular less than 50 and/or more than 5, in particular more than 10 µm.

The first connection structure 3A, 3A' preferably comprises first, particularly film-like opening regions 4A, 4A', and/or the second connection structure 3B, 3B' preferably comprises a second, particularly film-like opening region 4B , 4B' autopsy. Preferably, this simultaneously ensures effective sealing of the 14 corresponding connecting structures 3A, 3A', 3B, 3B' and reliable and simple opening of the corresponding areas 4A, 4A', 4B, 4B'.

The first connection structure 3A, 3A' is preferably configured to open the second connection structure 3B, 3B' by piercing or destroying the second opening area 4B, 4B'. Alternatively or additionally, the second connection structure 3B, 3B' is preferably configured to open the first connection structure 3A, 3A' by piercing or destroying the first opening area 4A, 4A'. This allows the fluid connection 2 to be formed manually, or without the use of a tool. The internal volumes of the containers B1, B2, B3 are preferably able to be connected by means of connecting structures 3A, 3A', 3B, 3B' without any additional devices or tools.

Preferably, to create the fluid connection 2, the opening area 4B, 4B' of the second connection structure 3B, 3B' may be cut by the first connection structure 3A, 3A', and preferably the first opening area 4A, 4A' of the first connection structure 3A, 3A' can be cut by the second connecting structure 3B, 3B', in particular by its cutting element 7. Thus, the fluid connection can be formed by mutual punching or piercing.

The connection structures 3A, 3A', 3B, 3B' preferably have necks 5A, 5A', 5B, 5B' formed such that the neck 5A, 5A', 5B, 5B' of one of the first or second connection structures 3A, 3A', 3B, 3B' may be pine with a neck 5A, 5A', 5B, 5B' of another first or second connecting structure 3A, 3A', 3B, 3B', whereby the area 4A can preferably be cut through, 4A', 4B, 4B' opening another first or second connecting structures 3A, 3A', 3B,

3B', and/or the other first or second connecting structures 3A, 3A', 3B, 3B' can be opened.

The opening area 4A preferably includes a neck 5A, and/or the opening area 4B includes a neck 5B. The necks 5A, 5B preferably define the boundaries of the opening regions 4A, 4B. The necks 5A, 5B may be formed integrally with the corresponding connecting structures 3A, 3B, or form part of a wall thereof. Preferably, the necks 5A, 5B have open edges or are formed as sleeves or constrictions, the corresponding opening areas 4A, 4B being preferably surrounded or limited by the corresponding necks 5A, 5B. The necks 5A, 5B, or their open edges, preferably adjoin or limit the opening areas 4A, 4B, or vice versa. In particular, preferably, the open edge of the respective necks 5A, 5B forms a (circular) fastening part for the opening area 4A, 4B, which is particularly preferably film-like or formed by a film.

The container system B, in accordance with another feature, comprises a lid (closing means) 6 configured to hold one of the containers B1, B2, in particular serving as a support for it. Preferably, the lid 6 can alternatively or additionally serve in particular as a sterile protective cover for one of the containers B1, B2, and/or one of the connecting structures 3A, 3B. The following is a more detailed discussion of this feature.

The connecting structure 3A, 3B and the method of forming by fluid communication thereof are discussed in more detail below in the first embodiment shown in FIG. 2-5.

In the first embodiment, the first connection structure 3A is configured to open the area 4B to open the second connection structure 3B. Particularly, it is preferable that the neck 5A of the first connecting structure 3A is adapted to be inserted or pressed into the neck 5B of the connecting structure 3B so that, in the process of insertion or pressing, the opening area 4B of the second connecting structure 3B is exposed.

In the embodiment shown, the first connection structure 3A, 3A', or the first neck 5A, 5A', is preferably a male joint member, and/or the second connection structure 3B, 3B', or the second neck 5B, 5B', is preferably constituted a female connecting element, in particular forming a fluid connection.

In particular, it is provided that one end or open edge of the neck 5A has an outer circular edge that can be placed inside the inner circular edge of the neck 5B.

Preferably, the outer circumferential edge of the neck 5A of the first connection structure 3A matches or is similar to the inner circumferential edge of the neck 5B of the second connection structure 3B, or vice versa. Specifically, the neck 5A of the first connection structure 3A has an outer diameter, at least in diameter or at the transition to the opening region 4A, smaller than the inner diameter of the neck 5B of the second connection structure 3B, preferably at least at the end edge or at the transition to the region 4B autopsy. In the embodiment shown in FIG. 2-5, the neck 5A, 5B preferably has a tapered shape and/or is at least substantially circular in cross section.

In the present invention, unless otherwise specified, a cross-section refers to a section or cross-sectional image at right angles to the longitudinal axis or symmetry axis 9 of the corresponding container B1, B2 and/or the corresponding connecting structure 3A, 3B.

The second connection structure 3B of the first embodiment preferably includes a cutting element 7, which is preferably configured to pierce, cut, cut or generally destroy the opening area 4A of the first connection structure 3A. In particular, the cutting element 7 contains a piercing device, a point, a blade, a wedge or generally a cutting and/or cutting device.

The cutting element 7 is preferably located and/or secured to the opening area 4B of the second connecting structure, in particular directly. The cutting element 7 is preferably located on the outer side of the second connecting structure 3B or on the side or outer side away from the interior of the container 3B. The cutting element 7 is preferably arranged such that when the connecting structure 3B or the cutting element 7 approaches the opening area 4A of the first connecting structure, the cutting element 7 exerts a force on the opening area 4A, which leads to destruction and opening of the opening area 4A, preferably without opening or destroying the area 4B of opening the second connecting structure 3B.

Specifically, the cutting member 7 is a device that concentrates a force acting on the opening area 4A or distributes a counter force acting on the second connecting structure 3B or the opening area 4A so that the opening area 4B of the second connecting structure 3B remains intact when the area 4A opening is opened - 18 044241 is opened when destroyed by the cutting element 7.

In an embodiment (not shown), the cutting element 7 is located on the inner side of the connecting structure, on the inside or inside the internal space of the container B1 or (when viewed from the outside) is located behind the opening area 4B of the second connecting structure 3B. Preferably, the opening region 4A, 4A' of the first connecting structure 3A is destroyed by the cutting member 7 when the neck 5A is pushed into the throat 5B of the second connecting structure 3B. For this purpose, a cutting element 7 is used, which is located, in particular, directly (inside or on the side away from the first connecting structure 3A) behind the opening area 4B of the second connecting structure 3B.

Preferably, the cutting element 7 is fixedly located or fixed on the second connecting structure 3B, in particular (directly) on, in front of or behind the opening area 4A.

In fig. 2 shows the proposed connection system 1 in the initial position, where the opening areas 4A, 4B of the containers B1, B2 are closed or sealed. In particular, they are (in each case) bottle-shaped vessels or containers B1, B2, whose lower opening regions 4A, 4B are initially closed.

As shown by the movement arrow 8, the first connecting structure 3A and the second connecting structure 3B can be moved towards each other or pressed into each other. For this purpose, the connecting structures 3A, 3B are preferably moved along an axis towards each other relative to the central axis or axis of symmetry 9. The central axis or axis of symmetry 9 is preferably the central axis or axis 9 of symmetry of the neck or parts 5A, 5B, and/or the opening area or areas 4A, 4B, and/or the container or containers B1, B2.

The containers B1, B2, connecting structures 3A, 3B, opening areas 4A, 4B and/or necks 5A, 5B can then be formed to be substantially symmetrical about the central axis or symmetry axis 9. The axisymmetric and rotationally symmetric design of the necks 5A, 5B is preferred because it allows the connection structures 3A, 3B to be used regardless of their angular position. Theoretically, however, other solutions are possible, in particular those in which the necks 5A, 5B are rotationally asymmetrical or non-circular, and preferably a guide is provided that is capable of determining the angular position of the connecting structures 3A, 3B relative to the central axis or axis 9 symmetries. This will be discussed in more detail in connection with the second embodiment.

As can be seen in FIG. 3, as the connecting structures 3A, 3B are moved closer to each other, the cutting element 7 is applied to the opening area 4A, preferably with the tip 7A, and as the connecting structures 3A, 3B are further moved towards each other, is forced through the area 4A, 4B autopsy. In this way, the opening area 4A is destroyed or the connecting structure 3A and/or the container B1 is opened.

The connecting structures 3A, 3A', 3B, 3B' are preferably designed to be separate and/or independent from each other in the initial position (see also FIGS. 16 and 17). This also makes it possible to use, either together or separately, cavities or containers B1, B2, B3 that are connected or capable of being connected to the connecting structures 3A, 3A', 3B, 3B'.

In the initial position, the connecting structures 3A, 3A', 3B, 3B' are preferably not connected and are fluidly separated from each other. As a result of the formation of the fluid connection 2, the connecting structures 3A, 3A', 3B, 3B' are shifted to the connection position in which the fluid connection is formed.

The fluid connection 2 between the containers B1, B2, B3 is preferably formed at least when it becomes possible to move between the containers B1, B2, B3 the masses or substances S1, S2, S3 contained in these containers under the influence of gravity and /or mixing with each other.

The fluid connection 2 is in particular provided by a channel or passage through which fluids S1, S2, S3, in particular liquids, can flow.

The connecting structures 3A, 3A', 3B, 3B' can preferably only be used once and/or can be opened irreversibly; the fluid connection 2 is preferably permanent and/or irreversible.

The connection system 1 is preferably configured to form a connection without the possibility of separation and separation, in particular to form a non-separable connection even before at least one of the connection structures 3A, 3A', 3B, 3B' has been opened. This prevents loss of substances and, importantly, prevents the process of partial mixing.

The connection structures 3A, 3A', 3B, 3B' preferably include permanent connection latches 10A, 10B, which form a permanent connection between the connection structures 3A, 3A', 3B, 3B' by inserting one into the other and/or passing one through the other with axial movement along their common axis. In particular, the fasteners 10A, 10B include snap hooks or snap interlocking connections. In this way, it is possible to guarantee that the connection cannot be released manually and/or without damage or destruction.

The connecting structures 3A, 3A', 3B, 3B' can preferably be connected to each other without the possibility of separation or separation by interlocking and/or frictional engagement, in particular by snap-locking. In particular, by mounting one into the other and/or inserting one into the other while moving axially along a common axis, various connection positions, in particular locking positions, can be realized.

In particular, one of the connecting structures 3A, 3A', 3B, 3B' includes snap means, in particular one or more snap projections, located on parts located one behind the other along the axis. Preferably, the snap means of one of the connecting structures are arranged such that one or more mating snap means of the other connecting structure 3A, 3A', 3B, 3B', in particular one or more grooves or notches, snap onto each other to form a circumferential engagement one another and/or insertion of one into the other during axial movement along a common axis. This ensures that a permanent or inseparable connection, or connection position, is achieved.

The connection structures 3A, 3A', 3B, 3B' are preferably configured to form a permanent and permanent connection upon reaching a first connection position in which none or only one of the first or second connection structures 3A, 3A', 3B, 3B' is open or was open. In this case, the fluid connection 2 in this first blocking position is preferably not yet formed or not completely formed.

When, after the first connection position, preferably in location or time, another second connection position is reached, a permanent fluid connection 2 is formed and/or the two connection structures 3A, 3A', 3B, 3B' are opened.

By sliding the first connecting structure 3A, 3A' and the second connecting structure 3B, 3B' together with each other, preferably, first only one of the first or second opening areas 4A, 4A', 4B, 4B' is destroyed, in particular by piercing, and only after the connecting structures 3A, 3A', 3B, 3B' are moved closer or rotated relative to each other, or pressed into one another, a permanent fluid connection 2 is formed due to the destruction of the other first or second regions 4A, 4A', 4B , 4B' autopsy.

Preferably, the connection system 1 has a first connection position in which the connection structures 3A, 3B are permanently connected to each other, preferably by a snap connection. To this end, the connecting structures 3A, 3B may have locking latches 10A, 10B corresponding to each other, which form a permanent connection between the connecting structures 3A, 3B when they come close together.

In the illustrated embodiment, the fasteners 10A, 10B are formed by corresponding or mating cutouts, snap protrusions, etc. In particular, individual snap protrusions are formed on one of the connecting structures 3A, 3B and, in particular, annular beads and/or cutouts are formed on the other of connecting structures 3A, 3B, thanks to the interaction of which a locked connection is ensured between the connecting structures 3A, 3B.

Particularly preferably, the clamps 10A, 10B are configured to permanently connect the connecting structures 3A, 3B to each other in the first connection position, but allow further movement of the connecting structures towards each other.

Moreover, the latches 10A, 10B are preferably configured to maintain a further second connection position in which the connection structures 3A, 3B are moved more tightly or pressed deeper into each other than in the first connection position. In particular, it is preferable that several snap-connection positions are provided in which, in the first snap-connection position, the connection structures 3A, 3B are already permanently connected to each other. The proposed connection system 1 is shown in this first connection position in FIG. 3.

In the first connection position, one of the connection structures 3A, 3B may already be opened. Alternatively or additionally, the first connection position may also be characterized in that a permanent connection has actually been made between the connecting structures, but none of the areas 4A, 4B have yet been opened or are in the process of opening.

In the embodiment shown in FIG. 3, in the first connection position, the first connection structure 3A is connected to the second connection structure 3B by a permanent snap-lock connection, and the first opening area 4A has already been opened or destroyed by the cutting member 7.

In fig. 4 shows the proposed connection system 1 in a second connection position, in particular a subsequent snap position, in which the connection structures 3A, 3B are moved further apart from each other and/or pushed further into each other, in particular at least substantially completely, compared to the first connection position. In the second connection position, the first opening area 4A of the first connecting structure 3A was opened by the second connecting structure 3B and, in addition, the opening area 4B of the second connecting structure 3B was opened by the first opening means 3A.

In order to open the second connection structure 3B using or by means of the first connection structure 3A, preferably, the neck 5A of the first connection structure 3A is forced through the opening area 4B of the second connection structure 3B, thereby destroying the opening area 4B. Preferably, this is done when the connection structures 3A, 3B are moved from the first connection position to the second connection position.

The locks 10A, 10B are preferably configured to prevent the connecting structures 3A, 3B in the first connecting position and the second connecting position from moving away from each other (axially). It is therefore provided in particular that the connecting structures 3A, 3B are able to move into the second connection position from the first connection position, but not in the opposite direction. It is also preferable that the connection structures 3A, 3B in the second connection position (see FIG. 4) cannot be moved back to the first connection position.

Preferably, in the first connection position, the connection structures 3A, 3B abut one another, partially creating a sealed connection. This prevents the leakage of substances S1, S2.

According to one feature, during or as a result of opening the opening area 4B of the second connection structure 3B by the neck 5A of the first connection structure 3A, a seal to the environment is formed. Specifically, the opening region 4B of the second connection structure 3B forms a sealing system using the neck 5B of the second connection structure 3B. Alternatively, or additionally, the necks 5A, 5B may provide a seal by pressing against each other, while the opening region 4B creates a sealing effect or provides a seal, particularly along the edges and/or in the transition area to the neck 5B. However, other solutions are also possible, for example the use of an additional or separate rubber seal, sealing lip or similar element.

The connection structures 3A, 3B or the connection system 1 are preferably formed or formed without the use of threads. It has been found that prior art systems that use threads to move a cutting tool to open containers are more susceptible to defects and are more expensive to create a hole or fluid connection. Preferably, the connection structures 3A, 3B of the present connection system can be connected to each other by simple linear or axial movement and/or by displacement directly towards each other (without the need for any additional rotation of several revolutions relative to each other). This provides the advantage of speed and convenience of forming the connection 2 in a fluid medium.

Another advantage of the proposed connection system 1 is that it contains one or more connection positions, in particular, preferably, locking positions. This has, in particular, the advantage over locking threads that a permanent connection can be created between the connecting structures 3A, 3B. On the other hand, when using a threaded connection, disassembly and contamination are possible.

Theoretically, however, it is possible to combine the features of the present invention with connection structures 3A, 3B that are connected or connectable by locking threads, or in which the fluid connection 2 can be formed by locking threads and a rotational movement relative to each other.

In fig. 5-13 are illustrations of the proposed connection system 1, in accordance with the second embodiment. Only special features and differences from the embodiments described above will be considered, so the above remarks will also apply in addition to the second embodiment, unless the contrary is specifically indicated or obvious to a person skilled in the art.

In fig. 5 shows the initial position of the first connecting structure 3A' and the second connecting structure 3B', in accordance with the second embodiment. In the second embodiment, preferably, none of the connecting structures 3A', 3B' has a cutting element. In particular, the connection system 1, according to the second embodiment, does not have a cutting tool, cutting mechanisms and/or protrusions with sharp edges or parts thereof to be opened.

In the second embodiment, the necks 5A' and 5B' of the connecting structure 3A', 3B' are preferably made rotationally asymmetrical or non-circular, or oval, relative to the central axis or axis of symmetry 9. Preferably, the necks 5A, 5B are configured to correspond to each other and/or similar to each other with respect to the circular line, so that they can be located one inside the other and/or one can be pressed into the other. Moreover, as additional information, you can use the description of the necks 5A, 5B in the first embodiment.

In fig. 6 shows the connecting structures 3A', 3B' in a first connection position where they are preferably permanently connected to each other. Fasteners can be used for this

10A, 10B, as described above.

The connecting structure 3A', 3B' preferably includes regions 4A', 4B' corresponding to or resembling the opening regions 4A, 4B of the first embodiment. In the first connection position shown in FIG. 6, the regions 4A', 4B' abut each other or are directly adjacent to each other. On the contrary, in the first connection position, the opening area 4B' of the second connecting structure 3B' can, however, also already be opened, as shown above with reference to FIG. 7.

To open or penetrate the second opening area 4B', the neck 5A' of the first connection structure 3A' is pressed through the opening area 4B' of the second connection structure 3B', as shown above when considering the opening of the area 4B in the first embodiment. Preferably, the opening area 4B', in particular the sealing film or the film-shaped part of the second connecting structure 3B' is destroyed or opened, in particular by pressing a part of the first connecting structure 3A' through the opening area 4B' so that the opening area 4B' is opened, or the film or film-like part forming the opening region 4B' is pierced or destroyed. The result is shown in Fig. 7, which shows how, as a result of reaching the second connection position, the second connection structure 3B' is opened in the manner described.

Unlike the first embodiment, the method of forming the fluid connection 2 in the second embodiment begins with the step of opening the second connection structure 3B' using the neck 5A', or destroying the area 4B' of opening the second connection structure 3B' using the neck 5A'.

In the second embodiment, it is also provided that the connecting structures 3A', 3B' are rotatable relative to each other, or around a (common) central axis or axis of symmetry 9 in their connected state, in particular in the second connection position. As a result, preferably, in particular, another of the connecting structures 3A', 3B' is opened, i.e. the first connecting structure 3A', as described in detail below with reference to FIG. 8-13.

According to one aspect, it is preferable that the first region 4A, 4A' of the first connection structure 3A, 3A' can be opened by deformation by the second connection structure 3B, 3B'. Regions 4A, 4A', 4B, 4B' can also be mutually opened by mutual deformation. Opening by deformation preferably does not require any shearing edges or cutting elements, which is advantageous from the point of view of simplifying the manufacturing process and saving materials.

The second connection structure 3B, 3B' is preferably configured to open the first connection structure 3A, 3A', in particular, the second connection structure 3B, 3B' is preferably configured to open the region 4A, 4A' of the first connection structure 3A, 3A ' by deforming the first connecting structure 3A, 3A'.

In particular, it is preferable according to this feature that the deformation is initiated by rotation of the connecting structures relative to each other, in particular with respect to the common axis 9, and/or opening of the areas 4A, 4A' by opening the first connecting structure 3A, 3A'.

The connecting structures 3A, 3A', 3B, 3B' preferably have non-circular, in particular oval or at least substantially elliptical parts corresponding to one another, which can be inserted into one another and/or cause deformation and/ or opening when they are rotated relative to each other.

The deformation preferably creates tensile stresses in the opening region 4A, 4A', at least substantially radial or transverse with respect to the central axis or axis of symmetry 9, or along the opening region of the opening region 4A, 4A', causing the opening region to rupture, is destroyed or separated and/or the area 4A, 4A' is opened.

At the same time, the second connecting structure 3B, 3B' may have, in particular, a film-shaped, fragile and/or weak region 4B, 4B', preferably, the first connecting structure 3A, 3A' being designed to open the second connecting structure 3B, 3B'. In particular, the first connecting structure 3A, 3A' is configured to open the second connecting structure 3B, 3B' by tearing the opening area 4B, 4B' of the second connecting structure 3B, 3B'.

The first connection structure 3A, 3A' preferably includes a neck 5A, 5A' adjacent to or surrounding the opening area 4A, 4A', the neck 5A, 5A' being deformable such that the opening area 4A, 4A' is deformable such that the opening area 4A, 4A' is deformable. The opening 4A' can be opened by deformation.

The neck 5A, 5A' preferably has the shape of a diaphragm, a constriction, a wall, a thin wall, or it is elastic and/or flexible, and/or the neck 5A, 5A' is more elastic, more

- 22 044241 resilient and/or stronger than the opening region 4A, 4A', which is preferably opened when the neck 5A, 5A' and the opening region 4A, 4A' are deformed, in particular by tearing, breaking or separating.

The second connection structure 3B, 3B' is preferably configured to deform the neck of the first connection structure 3A, 3A' so that this deformation causes the opening of the region 4A, 4A' of the first connection structure 3A, 3A'.

The neck 5A, 5A', 5B, 5B' preferably has a cross-section that is non-circular, in particular oval, at least substantially elliptical and/or polygonal in shape, while the second connecting structure 3B, 3B ' has a corresponding cross-section such that rotation of the connecting structures 3A, 3A', 3B, 3B' relative to each other causes deformation and/or opening of the first connecting structure 3A, 3A' in their opening areas 4A, 4A'.

Both connecting structures 3A, 3A', 3B, 3B' preferably have necks 5A, 5A', 5B, 5B', which can be oriented inside each other, or can be pushed into each other while rotating the connecting structures 3A, 3A', 3B, 3B' or necks 5A, 5A', 5B, 5B' relative to each other causes deformation of the first and preferably second neck 5A, 5A', 5B, 5B'.

The connection structures 3A, 3A', 3B, 3B' may be bayonet-type connected to each other, or they may have connectors or guides 18A, 18B configured to form a bayonet-type connection. For this purpose, the necks 5A, 5A', 5B, 5B' can first be pushed in, or can be pushed into each other (only) in the axial direction, and only then can they be rotated, or can be rotated relative to each other, in this case, the fluid connection 2 is not formed until they are rotated relative to each other. The guides 18A, 18B may be designed to provide a bayonet connection. For this purpose, a guide extending (only) along an axis adjacent to (only) a radial guide is used.

Preferably, by rotating the connecting structures 3A', 3B' relative to each other, while the neck 5A' of the first connecting structure 3A' is placed in the neck 5B' of the second connecting structure 3B', the opening area 4A' of the first connecting structure 3A' is subjected to mechanical stress , in particular, due to the deformation of the neck 5A' of the first connecting structure 3A', to such an extent that it breaks.

To make the opening mechanism of the first opening area 4A' of the first connecting structure 3A' of the second embodiment more clear, FIG. 9 and 10 are plan views of the connecting structure 3A', 3B'. The second connection structure 3B' shown in FIG. 9 preferably has a neck 5B' similar in shape and/or outline to the neck 5A' of the first connection structure 3A' shown in FIG. 10, but having large dimensions, diameters, longitudinal extent and/or transverse extent (at right angles to the central axis or axis of symmetry 9).

Specifically, the second connecting structure 3B' includes an inner circular edge 15, shown as a dotted line in the plan view of FIG. 9 similar in shape to, corresponding to, and/or configured as the outer circumferential edge 16 of the neck 5A' so that the outer circumferential edge 16 can be accommodated within the inner circumferential edge 15. Preferably, the maximum diameter of the inner circumferential edge 15 is greater than the maximum diameter of the outer circumferential edge 16, and/or the minimum diameter of the inner circular edge 15 is greater than the minimum diameter of the outer circular edge 16, preferably by more than 2 or 3 and/or by less than 40, preferably by less than 30, more preferably by less than 20, 15 or 10%. This ensures the ease of insertion of the necks 5A', 5B' into one another and, at the same time, the reliability of opening the area 4A' of the first connecting structure 3A.

The necks 5A', 5B' may preferably be located inside each other, or pressed into each other with some clearance. With this arrangement of the necks 5A', 5B', a gap 17 or gap is formed (at least partially) between the inner circular edge 15 and the outer circular edge 16.

In the illustrated embodiment, which is particularly a preferred embodiment, the necks 5A', 5B' each have an oval cross-section, in particular at least substantially elliptical. Theoretically, however, other shapes are also possible, for example at least substantially square or polygonal. In theory, it is preferable that the cross-sectional extent in the major axis direction, or the maximum extension in the secondary axial direction (central or transverse or perpendicular to the major axial direction) be greater than 1.2 times the minimum cross-sectional extent, preferably 1.3 times, in particular 1.5 times and/or at least or at least substantially 2 times. This ensures that the deformation during rotation of the connecting structures relative to each other is sufficiently strong so that the opening region 4A' of the first connecting structure 3A' can be reliably opened.

- 23 044241

In fig. 11-13, the connection structures 3A', 3B' are shown in different angular positions relative to each other, preferably in the second connection position.

Preferably, the connecting structures 3A', 3B' can be rotated around the (common) central axis or axis of symmetry 9 by an angle of more than 45 and/or less than 200, in particular less than 135 and/or at least substantially 90°, in its (inseparably) connected state or with the necks 5A', 5B' inserted into each other. This ensures that one or both necks 5A', 5B' are deformed and the opening region 4A', 4B', in particular the region 4A' of the first connecting structure 3A', is opened.

In the embodiment shown in FIG. 8, the necks 5A', 5B' are similar, in particular with respect to a circular line radially spaced from the central axis or axis of symmetry 9, in particular so that after the first neck 5A' has been inserted or pressed into the second neck 5B', they fit into each other freely or with a gap, or at least partially abut directly against each other, in particular at at least two points located opposite each other relative to the central axis or axis of symmetry 9, and/or at least , by 20, preferably by at least 50% of the corresponding circular line.

Due to the rotationally asymmetrical or non-circular shape of the necks 5A, 5B, as a result of the rotation indicated by the rotation arrows 11, a force is generated that exerts a deforming effect on the first connecting structure 3A', in particular its neck 5A'. In the embodiment shown, the necks 5A', 5B' have an oval cross-section. This is particularly advantageous in that it allows the necks 5A', 5B' to rotate relative to each other in a sliding, jam-free manner, with at least continuous deformation of the neck 5B' of the second connection structure 3B' during the rotation of the connection structures 3A', 3B' each other regarding a friend. However, other rotationally asymmetrical or non-circular cross-sections are also possible, for example rectangular, polygonal, triangular, etc.

In fig. 12 schematically shows a cross-section of the connection system 1, in particular in the second connection position, where the necks 5A', 5B' are shown in a position rotated by 45° relative to each other. The respective necks 5A', 5B' exert forces on each other so as to cause deformation of the neck 5B' of the second connection structure 3B' and, preferably, at the same time, in particular, a corresponding deformation of the neck 5A' of the first connection structure 3A'. As shown by the broken lines 12, deformation of the neck 5B' results in tensile stresses and/or compressive stresses on the opening region 4B' and preferably results in tearing or opening.

In fig. 13 is a schematic cross-sectional view of the proposed connection system 1, where the first connection structure 3A' has been rotated by at least substantially 90° relative to the second connection structure 3B'. Compared to the 45° rotation shown in FIG. 12, the increased angle of rotation of the connecting structures 3A', 3B' relative to each other increases the stress or pressure and/or tensile stress on the opening area 4B' so that the opening area 4B' is torn, destroyed, separated (at the edges) or opened in some way in a different way.

The connection system 1, according to the second embodiment, preferably includes a guide 18A, 18B (cf. FIGS. 9 and 10) for connecting the connection structures 3A', 3B' in an angular orientation position, or for determining the angular position during their connection . In particular, a sliding guide or similar device is used by which the connecting structures 3A', 3B', or necks 5A', 5B' can be inserted, positioned or pressed into each other only in certain angular positions (relative to the central axis or axis of symmetry 9 ), preferably so that the necks 5A', 5B' have the same orientation.

The necks 5A', 5B' have the same orientation, in particular when the main axes, longitudinal axes, transverse axes, ends, angles and/or similar features coincide with each other at least substantially, in particular such that the first neck 5A ' can be pushed into the second neck 5B' at least substantially without any deformation of the neck 5A', 5B'.

The guides 18A', 18B' are preferably designed such that in the (second) connection position or after the connecting structures 3A', 3B' have been attached, or after the necks 5A', 5B' have been inserted or pressed into each other, there is the possibility of their rotation relative to each other, in particular, around the central axis, or axis 9 of symmetry. In particular, the guide 18A, 18B includes a groove or portion extending along an axis or parallel to the central axis or symmetry axis 9 and further has a radially extending portion, thereby realizing the rotational movement described above. However, other solutions are possible.

Features of the first and second embodiments can also be combined with each other. Thus, additionally, the second connection system 3B, 3B' may include a cutting element 7 that at least partially opens the opening area 4A, 4A' of the first connection structure 3A, 3A' when the connection structures 3A, 3A', 3B, 3B' are placed one inside the other. Further, the necks 5A, 5A' can be used to open, in particular to pierce, the opening area 4B' of the second connecting structure 3A, 3B'. Rotation of connecting structures 3A,

- 24 044241

3A', 3B, 3B' relative to each other around the central axis, or axis of symmetry 9 further leads to deformation of one or both necks 5A, 5A', 5B, 5B'. This results in tension in the opening region or regions 4A, 4A', 4B, 4B'. In this way, it may be advantageous to destroy and/or rupture the opening region or regions 4A, 4A', 4B, 4B', as a result of which the fluid connection 2 can be improved, or the hydraulic cross-section of the fluid connection 2 can be increased .

The connecting structures 3A, 3A', 3B, 3B' are preferably designed to be mutually openable and/or mutually complementary and/or consistent with each other, whereby a permanent fluid connection 2 can be formed.

The connecting structures 3A, 3A', 3B, 3B' are preferably designed so as to form a hydraulic cross-section of more than 0.5, preferably more than 1 cm ² when creating a fluid connection 2. This ensures fast and complete mixing.

The connecting structures 3A, 3A', 3B, 3B' are preferably adapted to be axially inserted into each other, integrated into each other and/or formed without the use of threads. This ensures fast and simple formation of the fluid connection 2.

When forming a fluid connection 2, a passage is thereby preferably formed between containers B1, B2, B3, which are hermetically sealed from the environment. This prevents the penetration of foreign substances and microbes.

The second connection structure 3B, 3B' is preferably configured to open the first connection structure 3A, 3A' by breaking through the first opening area 4A, 4A', and/or the first connection structure 3A, 3A' is configured to open the second connection structure 3B , 3B' by breaking through the second opening region 4B, 4B'. Due to the mutual destruction of the regions 4A, 4A', 4B, 4B', it is possible to form an irreversible fluid bond 2, characterized by a diameter large enough to ensure rapid mixing.

The connecting system 1 is preferably self-sealing as a result of the formation of a fluid bond 2, in which, in particular, at least one of the opening regions 4A, 4A', 4B, 4B' has a sealing property due to the formation of a fluid bond 2 , or thereafter, so that the permanent fluid connection 2 forms a passage isolated from the environment. Preferably, the formation of the fluid connection 2 forms a fluid passage sealed from the environment, in particular waterproof, impervious to microbes and/or gases.

For this purpose, one of the opening areas 4A, 4A', 4B, 4B' or a device forming the corresponding opening area, after it has been pierced or otherwise disrupted, for example, a sealing edge can extend between the connecting structures 3A, 3A', 3B , 3B' and thereby seal the connecting structures 3A, 3A', 3B, 3B' from or to each other.

The connection system 1 is preferably self-sealing in the sense of being sterile or sterilizable as a result of the fluid connection 2 being formed. In particular, the formation of bond 2 across the fluid forms a seal that prevents the penetration of microbes.

Preferably, a sealing gasket, in particular an O-ring or a sealing lip, is used to seal the connecting structures 3A, 3A', 3B, 3B' to each other.

In particular, preferably, for sealing the fluid connection 2, preferably to the environment, or for sealing the fluid passage, at least one opening region 4A, 4A', 4B, 4B', preferably a second region 4B, 4B ', acts as a sealant as a result of the formation of the bond 2 in the fluid, or thereafter.

In particular, it is assumed that at least one opening area 4A, 4A', 4B, 4B', preferably the second opening area 4B, 4B', has a sealing property or acts as a seal at least on the edges, or forms a sealing ring or a sealing lip when the fluid bond 2 has been formed. Alternatively, or additionally, it may be contemplated that at least one opening area 4A, 4A', 4B, 4B', preferably a second opening area 4B, 4B', is sealed into the connection structure 3A, 3A', 3B, 3B ', preferably into the first or corresponding connecting structure, in particular its neck 5A, 5A', 5B, 5B', when it has been pierced by the neck 5A, 5A', 5B, 5B' to form a fluid connection 2.

Preferably, the design of at least one opening area 4A, 4A', 4B, 4B', preferably at least one opening area 4A, 4A', 4B, 4B', suppresses edge cracking and/or forms a seal, and /or it uses a construction material, or a layered structure in the edge region, as opposed to the central region, so that the edge area has greater strength and/or functions as a seal after the edge area is opened.

- 25 044241

The containers B1, B2, B3 of the proposed system B of containers in the initial state were preferably manufactured separately from each other, and can be used separately and/or separated by fluid from one another. In the initial state, the connecting structures 3A, 3A', 3B, 3B' are each preferably sealed against fluid, independently of each other. After the fluid connection 2 has been formed between the containers B1, B2, B3, these containers are preferably connected without the possibility of separation and release.

In fig. 14 shows another container B3, which may also constitute or form part of a system B of containers. The container system B preferably contains a container B3. This container has two different, corresponding and/or complementary connection structures 4A, 4A', 4B, 4B'. As a result, this container B3 can serve as a transition device between other containers B1, B2 and/or can be connected to different containers B1, B2 and/or can provide mixing of more than two substances S1, S2, S3.

The container B3 contains both first and second connecting structures 3A and 3B on different, preferably opposite sides. The container B3 then contains a first connecting structure 3A, 3A' on the first side, and a second connecting structure 3B, 3B' on the second side, remote from the first side. This container is preferably free of recess openings E1, E2.

Moreover, another container B3 is configured to form a fluid connection 2 on both sides by means of the proposed connection system 1. Another container B3 may contain or enclose an additional, different substance S3, different from the previous substances S1, S2, in particular dry or sublimated substance (lyophilisate).

Several containers B3 can be connected to each other and to the first and/or second container B2, B2. In this way, more than three substances S1, S2, S3 can be mixed and/or a combination of more than three containers B1, B2, B3 can be formed, and/or more than three containers B1, B2, B3 can be fluidly connected to each other .

As has already been shown with reference to FIG. 1, the proposed connection system 1 is preferably used for fluid connection of bottle-shaped vessels or containers B1, B2, in particular for pharmaceutical applications. In particular, it is preferable that the opening areas 4A, 4A', 4B, 4B' be configured to be sealed as a sterile container for transport.

In fig. 15 is a schematic perspective view of the first connecting structure 3A with the cutting member 7 located on the opening area 4A. In the embodiment shown in FIG. 15, the cutting element 7 has 4 or (dotted) three rods, but may also have more rods 19. The rods 19 are preferably wedge-shaped, at least partially, either at the edges, or have cutting edges remote from the area 4A autopsy. The cutting element 7 preferably has a tip 20 directed away from the opening area 4A. The tip 20 preferably abuts the rods 19, or vice versa. By means of the tip 20 and/or the rods 19, shear forces can be increased and the opening area 4B can be destroyed or perforated. However, other alternative embodiments of the cutting element 7 are theoretically possible.

In the embodiment shown, the cutting element 7 preferably has tab-shaped connecting parts 21 connecting to the opening area 4B. They can be configured to apply or distribute the force generated by the cutting element 7, in particular the tip 20 or the rods 19, to the opening area 4A. Alternatively, or additionally, the connecting parts 21 may be used and arranged such that when the connecting structures 3A, 3B are pressed into one another, the neck 5B presses on or near the connecting parts 21, as a result of which shear forces can be generated or increased, acting on area 4B of opening. This facilitates the opening of the opening area 4A.

The cutting element 7 is preferably located and/or configured to pierce, cut, cut or destroy the opening area 4A, 4A' of the first connecting structure 3A, 3A'.

The cutting element 7 is preferably located and/or secured to the opening area 4A, 4A' of the second connecting structure 3B, 3B', in particular directly. Alternatively or additionally, the cutting element 7 is configured to concentrate a force acting on the opening area 4A, 4A' and/or distribute a force or counter force acting on the area 4B, 4B' so that the opening area 4B of the second connecting structure 3B, 3B' remained intact when the opening area 4A, 4A' was opened by destroying it by the cutting member 7.

According to another feature, it is assumed that the cutting element 7 includes one or more connecting parts 21 to which, or with which, the cutting element 7 is connected, preferably by bonding material to the opening region 4A, 4A', 4B, 4B'.

The connecting parts 21 preferably form tear portions for the opening regions 4B, 4B' of the second connecting structure 3B, 3B'. Preferably, the connecting parts 21 are arranged to correspond to the first connecting structure 3A, 3A', in particular its neck 5A, 5A'. Moreover, the connecting parts 21 are preferably configured such that the forces acting on the opening area 4B, 4B' of the second connecting structure 3B, 3B' are concentrated by the first connecting structure 3A, 3A'. This makes it easier to destroy and/or open the area

4B, 4B' of the second connection structure 3B, 3B' by means of the first connection structure

3A. 3A', in particular its necks 5A, 5A'.

In fig. 16 shows the proposed container system in its transport position, or orientation. The containers B1, B2, B3 are preferably able to be detachably connected to each other for transport, due to the fact that the part or narrowing F1, F2 of the vessel of the container B1, B2, B3, forming an opening for the recess, is adapted to be held by the holding device of the lid 6 in in the form of a cap.

The first container B1 preferably has a lid 6, or the first connecting structure 3A, 3A' is closed by the lid 6. The second container B2 is inserted into and/or held by the lid 6, preferably in or through the area of its recess opening E2 or its constriction F2 vessel. In this way, or by some other means, the containers B1, B2 of the container system can form a set or combination combining the containers B1, B2 with each other. This preferably makes it possible to avoid unintended combinations of containers B1, B2, or substances S1, S2.

The lid 6 may preferably be supported on the first container B1, and is configured to support both the opening region E1, E2, or the constriction F1, F2 of the vessel of the first container B1, and the second container B2. Thus, the cover 6 has a triple function, namely, providing a (sterile) shelter, forming a transport combination, and as a support. The last function will be discussed further below.

In fig. 17 shows the first container B1 in a longitudinal section, the first connection structure 3A being closed, preferably in a sterile manner, by a lid 6. The lid 6 can be held removably on the container B1 by means of or using one of the latches 10A, 10B, or some other or by other means on container B1.

One or both opening areas 4A, 4A', 4B, 4B' are preferably sterilely isolated from the environment by a cap-like cover 6. The (other) opening area 4A, 4A', 4B, 4B' is preferably sterile or sterilizable, isolated from the environment by means of a removable, detachable, tear-off and/or film closure 14.

The double closure may be formed by corresponding opening areas 4A, 4A', 4B, 4B' and a corresponding sterile or sterilizable cover. In this way, a sterile or sterilizable or sterile occluded area or space or cavity can be formed between the sterile or sterilizable cover and the corresponding connecting structure 3A, 3A', 3B, 3B'.

The sterile or sterilizable cover is preferably removable. This makes it possible to create a (sufficiently) sterile fluid connection 2 through the connection system 1 by removing the covers and using the opening areas 4A, 4A', 4B, 4B' located in the sterile area to form the fluid connection 2.

In the embodiment shown, the cap 6 forms a sterile enclosure for the first opening areas 4A, 4A', and/or the closure 14 forms a sterile enclosure for the second opening area 4B, 4B' by sealing or welding or otherwise tightly applied film. In theory, however, sterile protection can also be provided by other means, for example by replacing the film with a cap or (screw) closure, optionally with a sealing gasket or similar method, and/or by making the cap 6 without retaining means, or with other holding device.

In the present invention, sterility means in particular, at least mainly, germ protection or antiseptic protection. A sterile or sterilizable cover is preferably a device designed to prevent the entry of microbes, in particular by forming a germ-impermeable barrier.

From a manufacturing standpoint, the sterile or sterilizable cover is preferably tightly attached or connected to a corresponding connecting structure 3A, 3A', 3B, 3B' so as to provide a germ-tight barrier.

A cover is sterilizable when it uses materials, or a sterile or sterilizable cover contains or is made of materials that are suitable for use at least one sterilization method for killing microbes known in the art. For example, such materials can be sterilized by one of the known sterilization methods without damaging them or losing their microbial barrier function. Known sterilization methods include irradiation, in particular with gamma rays or electron beams, gas disinfection, hot air treatment or autoclave sterilization. Preferably, the connection structures 3A, 3A', 3B, 3B' are also sterile or sterilizable.

The opening areas 4A, 4A', 4B, 4B' are preferably manufactured independently of each other, or separately from one another in the initial state, and/or closed sterilely or with the possibility of sterilization separately from each other. This ensures the possibility of separate use of containers B1, B2, B3.

Between the opening areas 4A, 4A', 4B, 4B' and the sterile or sterilizable cover, or means for sterile covering, in particular the lid 6 and/or closure 14, it is preferably formed that is sterilized, sterilizable, and/or sterilely sealed in the original state space, or with a seal that provides airtightness or protection from germs.

According to another feature, a substance, in particular an active substance, a vaccine and/or an activating drug, is located, attached and/or retained in said space. In particular, the substance is located in this space in a lattice structure and/or is held by the cutting element 7.

According to a preferred feature, the cutting element 7, or another part of one of the connecting structures, within the space can be dissolved, made soluble and/or suspended. In this way, after the formation of the fluid bond 2, the substance from said space can become part of the mixture of substances S1, S2, S3.

The substance located in the space can be dissolved and/or can be made soluble and/or form a suspension on the connecting structure 3A, 3A', 3B, 3B', or the area 4A, 4A', 4B, 4B' by opening by one of substances S1, S2, S3.

In a preferred feature, a lyophilisate (freeze-dried preparation) is dried or otherwise applied to the area of the opening. The lyophilisate, as well as one or more substances S1, S2, S3, may contain a vaccine, an active substance, and/or an activating preparation for the preparation of a vaccine or a combination vaccine. Thus, after forming the fluid bond 2, the substance located in said space can form a component of a mixture of substances, in particular a combination vaccine.

The sterile covering means, in particular the lid 6 and/or the closure 14, can preferably be removed or separated, in particular manually or without the use of a tool, so that the opening areas 4A, 4A', 4B, 4B' become available for formation fluid connections 2.

One of the containers B1, B2, B3 preferably contains, on the side remote from the opening E1, E2 for the recess, a removable lid 6 in the form of a cap, which in the initial position covers the connecting structures 3A, 3A', 3B, 3B', preferably ensuring sterility.

The cap 6 preferably includes a holding device for the opening E1, E2 for the recess or constriction F1, F2 of the vessel. The holding device, in particular the seat 13, is preferably configured to hold a part of the container B1, B2, B3, in particular the narrowing F1, F2 of the container forming the opening E1, E2, E3 for the recess.

The lid 6 preferably includes a support part, the shape of which resembles a flange and/or corresponds to or is associated with the inflection area of the container B1, B2 adjacent to the recess opening E1, E2.

In the embodiment shown, the lid 6 preferably includes a receptacle 13 configured to receive and/or hold, preferably by means of a locking or snap-locking mechanism, a constriction F1, F2 of a container or containers B1, B2.

The lid 6 is preferably designed as a holder or stand for the container or containers B1, B2. For this purpose, a recess opening E1, E2 or a constriction F1, F2 can preferably be inserted into the cover 6. In particular, the seat 13 is designed to grip and/or snap and/or releasably hold the container or containers B1, B2, preferably in the area of the openings E1, E2 for the recess and/or narrowing F1, F2. This ensures reliable operation as a support or stand and/or for holding or forming a set or combination of containers B1, B2, in particular vessels of the container system B.

The lid 6 preferably serves as a base or support surface for one of the containers B1, B2, in particular the first container B1, if its opening area 4A is closed by the lid 6. The seat 13 can be located at the bottom in an initial position and/or accessible from the outside. This provides the additional advantage that the containers B1, B2 can be stacked on top of each other by placing a first container B1 containing a lid 6 with a seat 13 on a second container B2 in such a way that its recess opening E2 or constriction F2 is pressed into the socket 13 and is preferably held, in particular by snapping and/or gripping. In this way, a set can be obtained in which containers B1, B2 are connected to each other in a separable manner, thereby preventing incorrect packaging and erroneous mixing of substances when using the connecting system 1.

When using the proposed connection system 1, it can be assumed that first the lid 6 is separated or removed from the first container B1 (see Fig. 18).

As shown as an example in FIG. 19, thereafter the first container B1 (or, alternatively, the second container B2) is preferably inserted with the recess opening E1, E2 or the constriction F1, F2, or part thereof, into the seat 13 of the cover 6. For this purpose, the cover 6 can be installed with hole

- 28 044241 of the socket 13 oriented upwards in the working position, wherein the opening E1, E2 for the recess or the narrowing F1, F2 in the working position is pressed from above into the socket 13 at least partially. Theoretically, however, it is also possible to insert the container B1, B2 into slot 13 in other positions. Preferably, the cover 6 is then used as a holder or support or stand in the operating position. In this case, the first connecting structure 3A or its opening area 4A in the operating position has access from above.

The lid 6 can be used as a stand for containers B1, B2, B3 if the containers B1, B2, B3 are held by the holding device or seat 13 by the part forming the opening E1, E2 for the recess or the narrowing F1, F2.

The lid 6 thus preferably forms a holder or stand for the container B1, B2 held by the lid. The dual function of the cover saves space and material and, in addition, allows the cover 6 to be used as a holder or stand, preventing contamination of the connecting structures 3A, 3A', 3B, 3B'.

The cap 6 is preferably in the form of a cap, and in the initial position or during transport forms an airtight seal with the connecting structure 3A, 3A', 3B, 3B' so as to create a sterile or sterilizable closure.

The cover 6 preferably includes a seat 13 and a support portion for holding on the connecting structure 3A, 3A', 3B, 3B' on different sides, in particular opposite sides. The support portion may have an area attached or removably attached to the connection structure 3A, 3A', 3B, 3B' by means of a gripping and/or latching element. For this purpose, the cover 6 in the support part and the connecting structure 3A, 3A', 3B, 3B' may have complementary or corresponding structures.

The cover 6 is preferably made of plastic and contains plastic. The cover 6 is preferably a thermoformed or injection molded part and/or a molded part made of sheet material. The cover 6 preferably has a wall thickness of more than 1 mm and/or less than 2 mm. However, other technical solutions are also possible.

In the embodiment shown, the cap 6 has a generally W or U shape in longitudinal section, with a recess at the curvature of the U, which forms a seat 13. Essentially, however, the cap 6 can also be shaped differently to realize the dual function of sterile blockage, on the one hand, and the supporting device, on the other.

In fig. 20 shows a second container B2 in which the opening area 4B is closed, in particular sterilely, by a closure 14, in particular a removable plug, a film, a sealing film, etc. Preferably, the closure 14 is removable, in particular by tearing, for use of the proposed connection system 1. The closure 14 may, for this purpose, have a tab.

At least one of the connection structures 3A, 3A', 3B, 3B', in particular the second connection structure 3B, 3B' in the illustrated embodiment, preferably has a socket for another one of the connection structures 3A, 3A', 3B, 3B' which may preferably be formed by a coupling 22, or alternatively or additionally by some other means. The coupling 22 can help secure the connecting structures 3A, 3A', 3B, 3B' to each other, guide their movement as needed, and/or protect the connecting structures 3A, 3A', 3B, 3B' laterally. Preferably, the coupling includes device latches 10A, 10B or parts thereof.

Preferably, one of the connection structures 3A, 3A', 3B, 3B', in particular the second connection structure 3B, 3B', is surrounded by a sleeve 22 in the (first and/or second) connection position.

The coupling 22 preferably serves to guide into it (respectively) another connecting structure 3A, 3A', 3B, 3B' or to form a socket and/or guide, in this case preferably a linear guide in the direction of the central axis or axis of symmetry 9 .

In the embodiment shown, the coupling 22 is located on the second connecting structure 3B, 3B' or on the second container B2. Alternatively or additionally, the sleeve 22 may also be located around the first connection structure 3A, 3A' of the first container B1.

The coupling 22 is preferably fixedly, rigidly and/or non-rotatably connected to the associated connecting structures 3A, 3A', 3B, 3B', preferably by means of a locking engagement, in particular a snap and/or frictional engagement, in particular a gripping and/or by bonding with a material, in particular by adhesive bonding or injection molding, but alternatively also by being integral with one of the connecting structures 3A, 3A', 3B, 3B' or containers B1, B2.

The sleeve 22 preferably extends beyond the necks 5A, 5A', 5B, 5B' and/or extends at least partially parallel thereto or in the same direction and preferably thereby forming a socket or linear guide for another one of the connection structures 3A, 3A', 3B, 3B'.

The sleeve 22, or a socket that may be formed therefrom, is preferably at least

- 29 044241 partially, contains guides 18A, 18B, in particular, a groove, a guide pin, etc.

The open edge of the coupling 22 preferably forms a stop for those of the connection structures 3A, 3A', 3B, 3B' which it does not surround in the separated state of the connection structures

3A, 3A', 3B, 3B', and/or for container B1 connected to it. Preferably, in the second connection position, the connection structures 3A, 3A', 3B, 3B' abut each other in the stop region.

The sleeve 22 is preferably closed, in particular sterilely, at one end, or on the open side, by a closure 14, in particular a sealed film.

In fig. 21 shows, as a particular example, how containers B1, B2 can be fluidly connected to each other by means of the proposed connection system 1. For this purpose, the plug 14 is preferably removed from the second container B2, after which the second container B2 together with the second the connecting structure 3B, 3B' is placed on top of the first connecting structure 3A, 3A'. In the embodiment shown, the first coupling structure 3A, 3A' projects into the receptacle formed by the coupling 22.

Next, the opening areas 4A, 4A', 4B, 4B' are opened. By means of a combination of connecting structures 3A, 3B, which form in particular the base regions of bottle-shaped vessels or containers B1, B2, a fluid connection 2 can be formed, as previously shown with reference to FIGS. 2-8. In fig. 21 shows the first embodiment, but the same applies to the second embodiment and combinations of embodiments.

According to another feature, the connection system 1, or connection structures 3A, 3A', 3B, 3B' are sized to specific containers.

In particular, the proposed system B of containers contains containers B1, B2, B3 of different sizes, volumes and/or specific quantities of substance S1, S2, S3 to obtain the required mixture proportions. For this purpose, it is preferable that the connecting structures 3A, 3A', 3B, 3B' have such mechanical characteristics that containers B1, B2, B3 with compatible contents can be connected, and containers B1, B2, B3 with incompatible contents, or containers B1 , B2, B3, the use of which would result in a mixture with an unacceptable ratio when forming a fluid bond, had connecting structures 3A, 3A', 3B, 3B', mechanically incompatible with each other.

In particular, it is preferable that the connecting structures 3A, 3A', 3B, 3B' can be manufactured to mate with each other, in particular according to the lock and key principle. This may be accomplished using guides 18A, 18B, guide channels, diameters, etc., which may or may not be compatible with each other.

The features described with reference to FIGS. 16-21 may be advantageous either alone or in various combinations, in particular in whole or in part, or with respect to certain details in the course of explanation. In particular, the cover 6 is preferably removed and used as a holder or stand before the second connection structure 3B is opened or unsealed, in particular by removing the plug 14.

Moreover, in FIG. 16 to 21 show the connecting structures 3A, 3B of the first embodiment. Instead, however, it is possible to use the connecting structures 3A', 3B' of the second embodiment, or a combination of the first connecting structure 3A, 3A', and the second connecting structure 3B, 3B'. The previously given descriptions of features are applicable in this case.

The fluid connection 2 may alternatively, or additionally, be obtained by deformation. In this case, the cutting element 7 is optional and the coupling 22 preferably has a non-circular cross-section, so that when the connecting structures 3A, 3B, 3A', 3B' are rotated relative to each other, the fluid connection 2 is formed by shaping or deformation . For clarity of presentation, the description of the relevant operations will not be repeated here.

Other features that may be implemented alone or in combination with each other, and/or may be implemented in conjunction with the features and characteristics described previously and are preferred, will be described in more detail below.

One feature that may be implemented independently, or in combination with one or more previously described features, relates to a connection system 1 for forming a fluid connection 2, preferably between containers B1, B2, B3, wherein the connection system 1 comprises at least at least two connecting structures 3A, 3A', 3B, 3B', configured to form a fluid connection 2, namely, a first connecting structure 3A, 3A' and a second connecting structure 3B, 3B', which, in the initial state, each fluid-sealed and each sealed independently of one another, wherein the connecting structures 3A, 3A', 3B, 3B' can be inserted into one another and/or adapted to be inserted into one another, preferably at least linearly and/or axial movement along a common axis, by means of which at least one of the connecting structures 3A, 3A', 3B, 3B' can be opened.

In particular, the fluid connection 2 is formed during said introduction. The advantage of this method is that the fluid connection 2 is formed quickly and reliably, in particular, without the need to repeatedly rotate the connecting structures 3A, 3A', 3B, 3B' along several turns of the spiral or thread.

The insertion of the connecting structures 3A, 3A', 3B, 3B' into one another also allows the connecting structures 3A, 3A', 3B, 3B', oriented with each other relative to the position of rotation about the (common) axis of symmetry, or central axis 9, to be moved together. that it is particularly advantageous if the necks 5A, 5A', 5B, 5B' of the connecting structures 3A, 3A', 3B, 3B' are not circular in cross-section, or opening at least one of the connecting structures 3A, 3A', 3B, 3B' is performed by deformation and resulting stretching of the opening area 4A, 4A', 4B, 4B'.

Another feature, which can also be implemented independently or in combination with one or more of the features discussed above, relates to a connection system 1 for forming a fluid connection 2, preferably between containers B1, B2, B3, wherein the connection system 1 comprises at least two connecting structures 3A, 3A', 3B, 3B', configured to form a fluid connection 2, namely, a first connecting structure 3A, 3A' and a second connecting structure 3B, 3B', which are sealed to fluid in initial state, the first connecting structure 3A, 3A' having, in particular, a film-like, fragile and/or weak area 4A, 4A', 4B, 4B', can be subjected to deformation outside the area 4A, 4A', 4B , 4B' opening, and is configured such that the deformation causes opening of the first connecting structure 3A, 3A', 3B, 3B' in the opening areas 4A, 4A', 4B, 4B'.

Another feature, which may also be implemented independently or in combination with one or more of the features discussed above, relates to one or more containers B1, B2, B3 or vessels, which, in each case, contain connecting structures 3A, 3A', 3B , 3B'.

Another feature, which can also be implemented independently or in combination with one or more of the features discussed above, relates to a connecting system 1 for forming a fluid connection 2, preferably between containers B1, B2, B3, wherein the connecting system 1 has at least two connecting structures 3A, 3A', 3B, 3B', configured to form a connection 2 through the fluid, each of which contains an opening area 4A, 4A', 4B, 4B', closed to the passage of the fluid in the initial state, in particular, by means of a film, or characterized by fragility, brittleness and/or fragility, wherein the opening areas 4A, 4A', 4B, 4B' each have a sterile or sterilizable plug.

In particular, the opening or formation of the fluid connection 2 is achieved due to the fact that the region 4A, 4A' of the first connecting structure 3A, 3A' is a breaking area or forms it, so that the deformation of the first connecting structure 3A, 3A', in particular , through tension, causes the opening region 4A, 4A' to tear or collapse. This has the advantage, in particular, that no tip or other cutting element is required to effect the opening. The cutting elements 7 generally must have sharp edges and be rigid to allow opening of the opening area 4A, 4A', 4B, 4B'. As a result, due to the absence of such a cutting element, softer materials can be used in production and/or production will be simpler. As already shown above, a combination of the features described above using the cutting element 7 is also possible, while the advantage of the present feature is to enlarge and widen the hole or fluid connection 2.

The advantage of sterile or sterilizable plugs of the opening areas 4A, 4A', 4B, 4B' is that they provide the formation of a fluid bond 2 while preventing the penetration of microbes or other foreign substances, particularly in the pharmaceutical/medical field. Alternatively, or additionally, sterile or sterilizable plugs of the areas 4A, 4A', 4B, 4B' allow the containers B1, B2, B3 with the connection structure 3A, 3A', 3B, 3B' to be used separately from each other in the environment and , optionally, in combination with each other.

One feature, which can also be implemented independently or in combination with one or more of the features discussed above, relates to a container system B with at least two containers B1, B2, B3, preferably vessels, and a connecting system 1, wherein containers B1 , B2, B3 for forming a fluid connection 2 between the containers B1, B2, B3, in each case contain at least one connecting structure 3A, 3A', 3B, 3B' of the connecting system 1.

At the same time, the use of the proposed connecting system 1 for connecting containers B1, B2, B3 turned out to be preferable, in particular because it is possible to form a permanent and/or irreversible fluid connection 2 between containers B1, B2, B3, thereby guaranteeing complete mixing the contents of containers B1, B2, B3.

Another feature, which can also be implemented independently or in combination with one or more of the features discussed above, relates to a container system B with at least two containers B1, B2, B3, preferably containers, each containing openings E1, E2 for removal, each is preferably sealed with a membrane, preferably containers B1,

- 31 044241

B2, B3 comprise, on the side opposite the respective recess opening E1, E2, in particular at the base of the respective container, a connecting structure 3A, 3A', 3B, 3B' for forming a fluid connection 2 between the containers B1, B2, B3 , and/or are configured to form a fluid connection 2 between containers B1, B2, B3.

The use of two containers B1, B2, B3, each of which contains a recess opening E1, E2 and a connecting structure 3A, 3A', 3B, 3B', is particularly preferable since the containers B1, B2, B3 can also be used separately from each other from each other, but, at the same time, in the case of joint use through the connecting structures 3A, 3A', 3B, 3B', a fluid connection with a relatively large cross-section can be formed for rapid or accelerated mixing of the contents of containers B1, B2 , AT 3.

Another feature, which may also be implemented independently or in combination with one or more of the features discussed above, relates to a method of forming a fluid connection 2 between the connecting structures 3A, 3A', 3B, 3B' and/or the capacitors B1, B2, B3 by means of connecting structures 3A, 3A', 3B, 3B', in which in the initial state the connecting structures 3A, 3A', 3B, 3B' are in each case sealed against the fluid, and the first connecting structure 3A, 3A' is opened by the other , the second connecting structure 3B, 3B', and the second connecting structure 3B, 3B' is exposed by the first connecting structure 3A, 3A', thereby forming a permanent fluid connection 2 between the connecting structures 3A, 3A', 3B, 3B'.

This provides corresponding advantages, i.e. in particular, the rapid and reliable formation of bond 2 in a fluid medium or mixing of substances S1, S2, S3.

Another feature, which can also be implemented independently or in combination with one or more of the features discussed above, relates to the use of a container system B, in which the first container B1 contains a first substance S1, in particular a first vaccine against a first disease, and a second container B2 contains a second substance S2, in particular a second vaccine against a second disease, different from the first, for the preparation of a mixture of substances, in particular for the preparation of a combined vaccine for simultaneous immunization against different diseases, wherein containers B1, B2, B3 are connected to each other by fluid through connecting structures 3A, 3A', 3B, 3B' so that the substances are mixed with each other, in particular to form a combination vaccine.

The advantage of using the proposed connection system 1, or container system B, for the preparation of a combination vaccine is, for example, that the vaccines can be used individually or in combination, as required. The proposed connection system 1, or container system B, provides on-site decision flexibility regarding the separate administration of substances S1, S2, or vaccines, or in combination. This avoids the stress of animals due to an unnecessarily large number of individual injections, or avoids the need to always vaccinate with a combination vaccine, even if vaccination with one of the administered vaccines is not required, if appropriate immunity is present. Thanks to this, it is possible to reduce the consumption of materials and the cost of vaccination.

Another feature, which may also be implemented independently or in combination with one or more of the features discussed above, relates to a method of forming a fluid connection 2 between the connecting structures 3A, 3A', 3B, 3B' and/or the capacitors B1, B2, B3 by means of the connecting structures 3A, 3A', 3B, 3B' of the connecting system 1, whereby the sterile covering means, in particular the lid and/or plug 14, are preferably removed from the areas 4A, 4A', 4B, 4B' opening in each case, and the still closed exposed areas 4A, 4A', 4B, 4B' opening are opened to form a fluid connection 2.

Another feature, which may also be implemented independently or in combination with one or more of the features discussed above, relates to a method of forming a fluid connection 2 between the connecting structures 3A, 3A', 3B, 3B' and/or the capacitors B1, B2, B3 by means of the connecting structures 3A, 3A', 3B, 3B', in the implementation of which in the initial state the connecting structures 3A, 3A', 3B, 3B' are in each case sealed to the fluid, and the first connecting structure 3A, 3A' is opened by another, the second connecting structure 3B, 3B', and the second connecting structure 3B, 3B' is opened by the first connecting structure 3A, 3A', thereby forming a permanent fluid connection 2 between the connecting structures 3A, 3A', 3B, 3B'.

Another feature that can be implemented independently, the present invention relates to a set with two proposed containers B1, B2, B3, or with containers B1, B2, B3, which can be fluidly connected to each other by means of a connecting system 1 so that a mixture of substances S1, S2, S3 contained in containers B1, B2, B3 can be formed. This prevents the mixing of other, incompatible substances S1, S2, S3.

In the present invention, a kit is, in particular, a combination and/or system comprising a first container B1 and a second container B2, which form the components of the kit. The set can also

- 32 044241 contain a third container B3 and/or other containers and components.

The components of the kit are preferably supplied as a kit, in particular in a common package or similar. However, the components can also form any combination for use together. It may be possible to provide common or connecting components, for example, a general set of operating instructions, recommendations for working with components, text information on one or more of the components of the set, etc.

Preferably, the containers B1, B2, B3 form a set connected to each other, in particular by means of a lid 6 or a socket 13.

Containers B1, B2, B3 are preferably intended for the preparation of a combined vaccine for simultaneous immunization against different diseases, preferably due to the possibility of forming a fluid connection of containers B1, B2, B3 with each other through connecting structures 3A, 3A', 3B, 3B' so that the substances S1, S2, S3 located in the containers B1, B2, B3 are mixed with each other to form a combination vaccine, while in particular the substances S1, S2, S3 can be withdrawn through the openings E1, E2 for the recess independently of each other and are subsequently used, in particular before or without forming the fluid connection 2.

Preferably, at least one of the containers B1, B2, B3 contains openings E1, E2 for recess, preferably sealed with a membrane, while the container B1, B2, B3 is preferably configured to form, on the side away from the opening E1, E2 for a recess, in particular at the bottom of the vessel, a fluid connection 2 between the containers B1, B2. B3 and/or contains a connecting structure 3A, 3A', 3B, 3B'.

The containers B1, B2, B3 are preferably fluidly connected to each other by means of connecting structures 3A, 3A', 3B, 3B' so that the substances are mixed, preferably forming a combination vaccine.

Another feature, which can be implemented independently, the present invention relates to the use of the connection system 1, set or system B of the containers proposed in the invention for the preparation of medicinal products or supply of medicinal products for live animals, preferably mammals, and/or for medical use .

Another feature, which can be implemented independently, the present invention relates to the use of the connection system 1, kit or container system B according to the invention for the preparation of a vaccine and/or supply of a vaccine, in particular for immunization against the disease(s) of porcine circovirus disease (PVD) and/or enzootic pneumonia (EP) or infection with porcine circovirus disease and/or infection with a bacterium strain of mycoplasma, in particular Mycoplasma hyopneumonia, preferably for immunization against diseases of porcine circovirus disease (PVD) and/or enzootic pneumonia (EP) ) or infection with porcine circovirus and/or infection with a bacterium of a mycoplasma strain, in particular mycoplasma hyopneumonia.

For this purpose, the first proposed container B1 contains a first reagent as a first substance S1, and the second proposed container B2 contains a second reagent as a second substance S2. The reagents may be vaccines against different diseases, or the isolated substances may contain vaccines against different diseases.

In particular, it is preferred that the first reagent contains only the first of the components of a mycoplasma vaccine or mycoplasma antigen or a circovirus vaccine or circovirus antigen (and optionally other substances). The first reagent may thus comprise either a mycoplasma vaccine or one or more mycoplasma antigens, or, alternatively, a circovirus vaccine or one or more circovirus antigens. The first reagent is preferably stored separately from the second reagent, particularly if the reagents are unstable when stored together for long periods of time. The second reagent preferably contains only another of the components of a mycoplasma vaccine, or one or more mycoplasma antigens, or a circovirus vaccine, or one or more circovirus antigens (and, optionally, other substances). If the first reagent contains a mycoplasma vaccine or one or more mycoplasma antigens, then the second reagent contains a circovirus vaccine or one or more circovirus antigens, or vice versa.

The mycoplasma vaccine may contain weakened and/or inactivated bacteria, bacterial fragments or recombinant parts of mycoplasma hyopneumonia, but at least one or more antigens of mycoplasma hyopneumonia. Preferably, the Mycoplasma hyopneumonia antigen is derived from a Mycoplasma hyopneumonia J strain, or the inactivated Mycoplasma hyopneumonia bacteria is a J strain. Moreover, the mycoplasma vaccine may be one of the following vaccines, or the mycoplasma hyopneumonia antigen may be the antigen or antigens contained in one of the following vaccines: Ingelvac®MycoFlex (Boehringer Ingelheim Vetmedica Inc., St. Joseph, MO, USA), Porcillis M hyo, Myco Silencer® BPM, Myco Silencer® BPME, Myco Silencer® ME, Myco Silencer® M, Myco Silencer® Once, Myco Silencer® MEN (all produced by Intervet Inc., Millsbrough, USA), Stellamune Mycoplasma (Pfizer Inc. , New York, NY, USA), Suvaxyn Mycoplasma, Suvaxyn M. Hyo, Suvaxyn MH-One (all formerly Fort Dodge Animal Health, Overland Park, NY, USA).

- 33 044241

Kansas, USA (now Pfizer Animal Health).

The porcine circovirus vaccine may comprise an attenuated and/or inactivated porcine circovirus, preferably type 2, in particular type 2 ORF2 protein. In particular, it is preferable to use porcine circovirus type 2 ORF2 protein expressed by recombination, preferably expressed in cell culture and derived from of this culture in laboratory conditions. Examples of ORF2 proteins of porcine circovirus type 2 are described, among others, in international patent application WO 2006-072065. The examples given have shown, in particular, their advantages for effective vaccination. In addition, the circovirus vaccine may be one of the following vaccines, or the circovirus antigen may be an antigen or antigens contained in one of the following vaccines: Ingelvac® CircoFLEX (Boehringer Ingelheim Vetmedica Inc., St. Joseph, MO, USA), CircoVac® ( Merial SAS, Lyon, France), CircoVent (Intervet Inc., Millsbrough, DE, USA), or Suvaxyn PCV-2 One Dose® (Fort Dodge Animal Health, Kansas City, KS, USA.

The circovirus vaccine, if it contains ORF2 protein, preferably contains from 2 to 150, preferably from 2 to 60, more preferably from 2 to 50, more preferably from 2 to 40, more preferably from 2 to 30, more preferably from 2 to 25, more preferably from 2 to 20, more preferably from 4 to 20, more preferably from 4 to 16 μg of ORF2 protein per administered dose. The circovirus vaccine is preferably prepared or formulated such that 1 ml of vaccine corresponds to a single dose. In particular, the circovirus vaccine may contain ORF2 protein in an amount of more than 2, preferably more than 4 and/or less than 150, preferably less than 60, 50, 40, 30, 25 μg/ml, in particular less than 20 μg/ml. This contributes to the reliability of vaccine administration.

The mycoplasma vaccine, if it contains inactivated mycoplasma bacteria, preferably inactivated mycoplasma hyopneumonia bacteria, preferably contains from 103 to ¹⁰⁹ colony forming units (CFU), preferably from ¹⁰⁴ to ¹⁰⁸ CFU, more preferably from 105 to 106 CFU per dose administered, with the corresponding CFU value adjusted before inactivating the bacteria. The mycoplasma vaccine is preferably prepared or formulated such that 1 ml of vaccine corresponds to a single dose. In particular, the mycoplasma vaccine may contain more than 103 CFU/ml, preferably more than 104 CFU/ml, in particular more than 105 CFU/ml, and/or less than 10 ⁹ CFU/ml, preferably less than 10 ⁸ CFU/ml, in in particular, less than 10 ⁷ CFU/ml, or less than 10 6 CFU/ml of inactivated Mycoplasma bacterium, preferably inactivated Mycoplasma hyopneumonia bacterium, in particular before inactivation of the bacteria.

At least one of the reagents and/or the vaccine or combination vaccine may contain an adjuvant, preferably a polymeric adjuvant, in particular a carbomer. Preferably, at least or exactly one of the two reagents, preferably both reagents, contain an amount of adjuvant from 500 μg to 5 mg, preferably from 750 μg to 2.5 mg, more preferably about 1 mg of adjuvant per dose administered. The reagents are preferably prepared or formulated such that 1 ml of the respective reagent corresponds to a unit dose. The use of an adjuvant, preferably a polymeric adjuvant such as carbomer, for example, has advantages regarding the effectiveness of the immunization or the duration of its action. However, the use of alternative and/or additional adjuvants cannot be excluded.

According to another feature, the first and/or second and/or combination of the first and second containers B1, B2, B3 with an established fluid connection 2 can be configured for use in or with an injection device and/or used with him. In particular, the injection device can be used repeatedly, for example a syringe gun, a needleless syringe and/or a self-filling syringe, similar to those used for vaccination of large herds of animals, for example.

The set or system B of containers may contain or be associated with such an injection device. In particular, the recess opening E1, E2 or another opening, flange or other connecting or sealing element of at least one of the containers B1, B2 and/or both containers B1, B2 can be configured for direct use in the injection device, or with him. Moreover, the recess device, opening, flange, or other connecting or closure element may be configured to connect specifically to a particular injection device. This can reduce the likelihood of misuse, in particular the administration of incorrect quantities of the active substance or incorrect routes of administration.

Another feature, which can be implemented independently, relates to an injection device with a plug-in combination of at least two of the proposed containers B1, B2, B3, fluidly connected to each other through the connecting structures 3A, 3A', 3B, 3B', proposed in the present invention. Specifically, through the fluid connection 2, a mixture of substances S1, S2, S3 is formed from containers B1, B2, B3, and the injection device is prepared to inject the mixture of substances S1, S2, S3.

The following is a description of other features, with reference to other embodiments, with

- 34 044241 with a detailed consideration of only the differences and special features, in comparison with the previously considered embodiments. These features may therefore be combined with previously discussed features, and vice versa, unless specifically excluded. In addition, reference will be made to previously provided explanations and definitions.

The embodiment discussed below with reference to FIG. 22 ff preferably refers to the above-described embodiment in which the first connecting structure 3A' is deformable outside the opening region 4A' and is configured such that the deformation causes opening of the opening region 4A' by the first connecting structure 3A'. Details will be apparent from consideration of FIG. 5-13 and explanations thereto.

According to a feature that can be implemented independently, the first connection structure 3A' preferably comprises a rigid, inflexible and/or dimensionally stable closure device 23, in particular a closure plate. The locking device 23 is preferably sealed to the holder 25 by means of a weak rupture portion 24, in particular a portion of reduced thickness. Thereby, an opening area 4 A' of the first connecting structure 3A' with or through the locking device 23 and/or the breaking section 24 can be formed.

The features discussed above in connection with the fragility of the opening region 4A', particularly with respect to material thickness and other factors, may preferably be applied to, or transferred to, the rupture portion 24. The difference lies in particular in that the opening area 4A' of the first connecting structure 3A' further comprises a locking device 23, which stabilizes or strengthens the opening area 4A' in the central part or the part surrounded by a film-like, fragile, weak and/or brittle area in the form of a tear section 24.

The holder 25 preferably corresponds to the neck 5A' of the first connection structure 3A' and/or the neck 5A' includes a holder 25. The corresponding explanations regarding the neck 5A' can therefore also be applied to the holder 25, alternatively or in addition . If necessary, the holder 25 can therefore be completely defined by or completely or partially formed by the neck 5A' or vice versa.

In particular, it is preferable that the holder 25 is movable when deformed relative to the locking device 23 so that the first connection structure 3A' can be opened by tearing the tear portion 24. It has been found that by using the locking device 23 and the corresponding concentration applied due to the deformation force to the frangible area (tear section 24) surrounding the locking device 23, it is possible to achieve, in particular, reliable and easier opening by deformation.

Fig. 22 gives an overview of the tank system B, in which the tanks B1, B2 are fluidly coupled to each other by means of connecting structures 3A', 3B'. For this purpose, the first connecting structure 3A' or its opening area 4A' and the second connecting structure 3B' or its opening area 4B' are shown exposed in each case.

Further explanations further refer to FIGS. 23-25, where in FIG. 23 shows a longitudinal section through the first container B1 with the first connection structure 3A' in the initial state with the opening region 4A' closed. In fig. 24 shows an enlarged fragment of a part of the locking device 23 and the holder 25 with a breaking section 24 between them. In the illustrated embodiment, according to FIG. 23, the opening area 4A' is preferably closed by a lid (closure means) 26 in the form of a cap. Cover 26 has been removed in the embodiment shown in FIG. 25. In FIG. 26 is a perspective view of the first connection structure 3A' as part of the first container B1 without the lid 26.

The locking device 23 is preferably shaped and/or supported by the rupture portion 24 such that the locking device 23 tilts when the holder 25 is deformed.

Preferably, the discontinuous portion 24 or the surface or plane 27 formed or formed by the discontinuous portion 24 is inclined relative to the central axes or axes of symmetry 9. This either facilitates pressing, rotation and/or further tilting of the locking device 23 during the opening process, or prevents the locking device 23 from locking relative to the holder 25.

During opening, the locking device 23 may slide on the holder 25 as a result of deformation of the holder 25, in particular during tilting or tilting.

The holder 25 preferably includes a frame 28 or is constructed in the form of a frame. The locking device 23 is preferably inclined relative to the frame 28 in its initial state. As a result, the frame 28 and the locking device 23 are each partially offset with respect to each other, whereby the offset immediately adjacent to the tear portion 24 can form this region, or offset region. The displacement is preferably in the opposite direction on opposite sides. The advantage of having an offset is that when the holder 25 is deformed, the locking device 23 can slide along the frame 28 or be tucked behind it. This simplifies the opening process since the deformation of the holder 25 is prevented from being blocked by the locking device 23 and, as a result, the opening of the opening area 4A' is simplified.

Preferably, in particular, as a result of a stepwise displacement of the frame 28 relative to the edge of the locking device 23 near the rupture section 24, and/or as a result of the inclination of the locking device 23 and/or the rupture section 24 relative to the central axis 9, during the deformation process it becomes possible, or is achieved, shearing action of the locking device 23 relative to the frame 28. This shearing action allows a strong mechanical load to be applied to the tearing section 24, in accordance with the degree of deformation of the holder 25, in particular by creating tensile or shear stresses, thereby making it easier to cut or tear the breaking section 24. In general, this ensures convenient and reliable opening of the opening area 4A' of the first connecting structure 3A'.

According to another feature, the locking device 23 is formed as an inclined platform starting from the breaking portion 24 located at its edge. This can be achieved by increasing the thickness of the material, preferably relative to the surface or plane 27 formed by or passing through the tear portion 24. Alternatively or additionally, the locking device 23 is formed as a ramp starting from the offset area. In this way, it is possible to tilt the locking device 23 more and more as the deformation of the holder 25 increases. The inclined part of the locking device 23 can slide along the holder 25 and thereby increase its inclination.

The closure device 23 itself preferably contains reinforcing elements 29, which in the illustrated embodiment are shown in the form of ribs or other elements of added material or thickenings of material that increase mechanical strength. These reinforcing elements 29 can be formed along the edge of the locking device 23, or can be made in the form of an inclined platform starting from the tear section 24 at the edge, in particular, so that the inclination of the locking device 23 increases as the deformation increases.

As can be seen in particular from the perspective view of FIG. 26, the holder 25 preferably has a non-circular shape in a plane not perpendicular to the central axis or axis of symmetry 9, in particular an oval shape, as mentioned above in relation to FIG. 5-13. This also applies, alternatively or additionally, to the rupture portion 24 and/or the edge surrounding the locking device 23 or a similar edge adjacent to the rupture portion 24 and/or the frame 28.

The tear portion 24, particularly the thin point portion, is preferably so weak that deformation of the holder 25 may cause the break portion 24 to collapse and, as a result, expose the connecting structure 3A'.

In the embodiment shown, the tear portion 24 is only ten microns thick, preferably less than 300 microns, more preferably less than 200 microns, or less than 150 microns. The distance between the holder 25 and the locking device 23, sealed by means of the rupture portion 24, is preferably less than 3 mm, in particular preferably less than 2 or 1 mm, in the embodiment shown less than 0.5 mm. It is also preferable that the distance between the locking device 23 and the holder 25, or the length of the rupture section 24, does not exceed, or exceeds slightly, the corresponding values throughout the area surrounding the closure device 23. The rupture section 24 is preferably at least substantially a constant length and/or thickness of material along that length around the closure device 23. The rupture portion 24 thus preferably surrounds the closure device 23 at least substantially completely.

The holder 25 is preferably capable of deformation upon insertion of the deforming device 30 of at least a substantially conjugate shape, and subsequent rotation of the holder 25 relative to the deforming device 30 about a central axis and/or axis of symmetry 9. In particular, the holder 25 is capable of deformation in the radial direction relative to the central axis and/or the axis of symmetry 9, and/or in its direction.

In fig. 27 shows a cross-section of the second container B2 with the second connecting structure 3B', and FIG. Figure 28 shows an enlarged sectional fragment. In fig. 29 shows the second container B2 with the lid 6 removed, and FIG. 30 is a perspective view of the second connection structure 3B'.

The deforming device 30 is particularly preferably formed by the second connecting structure 3B', in particular by its neck 5B'. Appropriate explanations regarding FIGS. may be used here. 5 to 13 and the following explanations regarding the second connection structure 3B' of the embodiment shown in FIG. 22 ff.

The holder 25 of the first connecting structure 3A' preferably has the shape of a constriction, a sleeve and/or a tube with a flexible deformable wall 31, and in particular is formed by such a wall. In the embodiment shown in FIG. 22 et seq., the wall 31 preferably forms at least a substantially conical surface converging towards the frame 28, which in the present case may form a neck 5A'. Theoretically, however, other solutions are possible.

It is also preferable that the holder 25, in particular the frame 28, has a piercing and/or cutting edge 32 or other cutting element 7. The piercing and/or cutting edge 32 is preferably attached to the frame 28, formed by the frame 28, in particular in as a single piece

- 36 044241 and/or casting. The piercing and/or cutting edge 32 is preferably formed by at least a generally axially extending strip, preferably having a point.

The piercing and/or cutting edge 32 is preferably configured to open the second connection structure 3B', in particular by piercing or piercing the area 4B' of the second connection structure 3B' by means of the piercing and/or cutting edge 32. Preferably, during axial movement of the connecting structures 3A', 3B' towards each other, the opening area 4B' of the second connecting structure 3B' is first pierced by a piercing and/or cutting edge 32 projecting axially outwardly relative to the opening area 4A', in particularly with respect to the locking device 23, and only then can the opening area 4A' of the first connecting structure 3A' be opened by rotating the connecting structures 3A', 3B' relative to each other, as described above. Compared with the embodiment described with reference to FIG. 5 to 13, in the present case, the holder 25 or the neck 5A' is configured to pierce the opening area 4B' of the second connecting structure 3B'. The previous discussion can be used for more information on this issue.

In the present embodiment, compared with the previous embodiment, the piercing and/or cutting edge 32 is located on the neck 5A', which is also possible in the previous embodiment and is preferable to simplify the opening of the opening area 4B' of the second connecting structure 3B'.

In the present embodiment, the opening area 4B' of the second connecting structure 3B' is covered, in particular, at least substantially by a rigid, geometrically stable and/or plate-shaped closure device 33, in particular a closure plate or disk, which , is preferably sealed to the neck 5B, in particular by means of a rupture portion 34. Other designs are also theoretically possible, for example those described with reference to FIGS. 7. However, the use of the locking device 33, similar to the sealing of the first connection structure 3A' by the locking device 23, makes it easier to open the second connection structure 3B' in the opening area 4B'.

The piercing and/or cutting edge 32 preferably corresponds in orientation and location to the rupture portion 34 of the second connection structure 3B' such that the approach of the connection structures 3A', 3B' to each other results in the piercing and/or cutting edge 32 being exposed to tear portion 34, whereby the tear portion 34 can be cut starting from the starting point of application of the piercing/cutting edge 32. Preferably, the connecting structures 3A', 3B' are respectively oriented in a direction towards each other.

The frame 28 and/or the piercing and/or cutting edge 32 preferably has a rounded and/or beveled portion so that when the piercing and/or cutting edge 32 acts on the tearing portion 34, the tearing portion 34 is partially retained, thereby preferably the intact part of the tear portion 34 continues to hold the closure device 33 pressed against the neck 5B' after opening, in particular in a similar manner to a film hinge. This ensures that the locking device 33 does not come off and prevents one of the recess openings E1, E2 from being blocked.

In the illustrated embodiment, in the initial state, the closure device 33 has an orientation that matches the orientation of the neck 5B', at least substantially perpendicular to the central axis or axis of symmetry 9. Of course, an inclined alignment is also possible, as is the case with the locking device 23 in the first connection structure 3A', but this is not strictly necessary since the second connection structure 3B' is preferably opened primarily by the piercing and/or cutting edge 32 rather than deformation of the neck 5B'.

The neck 5B' preferably has sufficient structural strength and positional stability such that when the connecting structures 3A', 3B' are rotated after being inserted into each other, deformation occurs at least substantially, or in any case predominantly, in the area of the necks 5A' or in the holder 25. However, some deformation of the neck 5B' and/or the deforming device 30 of the second connecting structure 3B' is also possible.

According to another feature, (each) container(s) B1, B2 is formed or formed from a container blank BR1, BR2 and corresponding connecting structures 3A', 3B'. The same can also be applied to the previous embodiment.

In the illustrated embodiment, the container blanks BR1, BR2 are parts of an upper container or vessel configured to be connected to corresponding connecting structures 3A', 3B' at a side or end remote from or opposite to the recess opening E1, E2. In particular, they are container blanks BR1, BR2 without bases, the resulting open areas being closed during manufacture by means of corresponding connecting structures 3A', 3B' to form the corresponding container B1, B2.

The container blanks BR1, BR2 are in particular structures with a recess opening E1, E2 and another open part which can be closed by a corresponding connecting structure 3A', 3B'.

Preferably, the corresponding connecting structure 3A', 3B' is firmly attached to the wall of the container blank BR1, BR2 by bonding with a material, particularly preferably by welding, adhesive bonding, injection molding or some other method. The connecting structures 3A', 3B' can therefore be used in containers B1, B2 of any type, or can also be used independently of containers B1, B2, for example for connecting a container B1, B2 by fluid to another structure, for example a pipe , connector, etc. However, it is particularly preferred to connect the containers B1, B2, B3 to each other.

Preferably, the (corresponding) connecting structure 3A', 3B' is configured to connect a container to the blank BR1, BR2 to form a container B1, B2. It is also preferable that the container blank BR1, BR2 has a wall 35A', 35B' with an open edge 36A', 36B' forming a receptacle for the connecting structure 3A', 3B' into which a corresponding connecting structure 3A', 3B' and hermetically connected to the blank BR1, BR2 of the container.

Another feature relates to the connection system 1 having a first connection structure 3A' containing a holder 25 and a tear portion 24, and a second connection structure 3B' containing a deformation device 30 corresponding to the holder 25, wherein the connection structures 3A', 3B' can be sealed are inserted into each other and, upon rotation of the connecting structures 3A', 3B' relative to each other, as a result of deformation of the holder 25 by the deforming device 30, the first connecting structure 3A' can be opened to form a fluid connection 2.

Another feature, which can be implemented independently, relates to one or more containers B1, B2, B3, in particular containers (each) having connecting structures 3A', 3B' in accordance with the present invention, preferably at a side or end remote from the opening of the container or the opening E1, E2 for the recess, other connecting structure 3A', 3B' or the base.

Another feature, which can be independently implemented, relates to a container system B with at least two containers B1, B2, B3, in which the first container B1 contains a first connection structure 3A', and the second container B2, B3 contains a second connection structure 3B' , corresponding to the first connecting structure 3A'.

The connecting structures 3A', 3B' are preferably constructed as described above. In particular, it is preferable for the first connection structure 3A' to have a piercing and/or cutting edge 32, by means of which the second connection structure 3B' can be opened.

Alternatively or additionally, the second connection structure 3B' includes a neck 5B' or a deformation device 30 for opening the first container B1 through the first connection structure 3A' by deforming the holder 25 or the neck 5A'.

It is also preferable that the connection structures 3A', 3B' provide the formation of a fluid connection 2 by mutual opening, when the first connection structure 3A' opens the second connection structure 3B', and the second connection structure 3B' opens the first connection structure 3A', forming thereby, fluid connection 2.

According to another feature, which can be implemented independently, the connecting structures 3A', 3B' are used in the preparation of a mixture of substances, preferably drugs, in particular a vaccine or combination vaccine, to form a fluid bond 2 and/or to mix starting materials or substances S1, S2, which were stored separately.

Another feature relates to a method, which can be carried out independently, of producing one of the connecting structures 3A', 3B' or the connecting system 1 and/or the container B1, B2, B3, in which the closure device 23, 33, the breaking section 24, 34 and the holder 25 or the neck 5A', 5B' are injection molded in one operation. This is preferable from the point of view of the reliability of manufacturing the breaking section 24, 34.

In carrying out the method, if there is a blank BR1, BR2 with an open end, in particular a vessel blank with a recess opening E1, E2, in addition to the open end, it is also preferable that the open end is sealed with a separately manufactured connecting structure 3A', 3B '.

The connection structure 3A', 3B' preferably comprises a sleeve or tube portion 37A', 37B' radially externally enclosing the connection structure 3A', 3B', respectively, and corresponding to the wall 35A', 35B' of the respective container B1, B2 or the blank BR1, BR2 of the container, for insertion into it and connection to the blank BR1, BR2 of the container.

Another feature, which can also be implemented independently, relates to the sealing principle based on the connection with each other of the connecting structures 3A', 3B', or one of the connecting structures 3A', 3B' with, preferably, a lid 6, 26 in the form of a cap .

Capacity B1, B2 available. B3, having a connecting structure 3A', 3B' for forming a fluid connection 2 of the container B1, B2, B3 with another container B1, B2, B3. In its original state,

- 38 044241 the connecting structure 3A', 3B' can be sealed by a fluid in the opening area 4A', 4B', and can be opened to form a fluid connection 2. The opening area 4A', 4B' is closed by a cap-like cover 6, 26 and/or another connecting structure 3A', 3B'. This feature thus applies in particular to the individual container B1, B2, B3 belonging to the container system B, or its connecting structure, combined with the cap-shaped lid 6, 26 and/or the (corresponding) connecting structure 3A', 3B' .

According to another feature, which can also be independently implemented, it appears that the lid 6, 26 or other connecting structure 3A', 3B' is sealed against the proposed container B1, B2, B3, thereby forming a sealed chamber 38A, 38B, 38C . Moreover, the proposed container B1, B2, B3 contains a sealing device 39 surrounding its opening area 4A', 4B', which seals the volume 40A, 40B, 40C of the chamber 38A, 38B, 38C in direct contact with the opening area 4A', 4B' . In particular, it is preferable that the sealing device 39 seals the internal volume 40A, 40B, 40C from the external volume 41A, 41B, 41C of the chamber 38A, 38B, 38C. This makes it possible to close the opening area 4A', 4B', in particular by double sealing. As a result, the effectiveness of protection against the penetration of substances, in particular microbes, increases.

As a result, in particular, foreign substances can enter the inner volume 40A, 40B, 40C only by passing through the outer volume 41A, 41B, 41C. The sealing device 39 is, preferably mechanically, separated from the environment by an external seal in the form of a cover 6, 26, such that any force acting on the cover 6, 26 may affect the sealing of the outer volume 41A, 41B, 41C, but the inner volume 40A, 40B, 40C remain sealed even in this case, preferably to provide airtightness, in particular to provide protection against the penetration of germs and bacteria. In this way, a sterile environment can be guaranteed in the opening area 4A', 4B'.

Alternatively, or in addition, the sealing device 39 seals the internal volume 40A, 40B, 40C surrounding the opening area 4A', 4B' by means of a cover 6, 26, or other connecting structure 3A', 3B' when continuous movement occurs covers 6, 26 or other connecting structure 3A', 3B' relative to the connecting structure 3A', 3B' of the proposed container B1, B2, B3. In this way, during the process of inserting the connecting structures 3A', 3B' into one another, and/or during the process of assembling or removing the cover(s) 6, 26, the area 4A', 4B' can be protected from the penetration of foreign substances, in particular microbes .

In particular, it is preferable to combine two features, i.e. form a chamber 38A, 38B, 38C, which is divided by a sealing device 39 into an internal volume 40A, 40B, 40C and an external volume 41A, 41B, 41C, and the sealing device 39 is designed to prevent the penetration of foreign substances, in particular microbes, into the internal volume 40A, 40B, 40C during, in particular, axial movement of the cover 6, 26 or other connecting structure 3A', 3B'.

The sealing device 39 preferably includes sealing portions 42A, 42B, 43A, 43B corresponding to each other, the first sealing portion 42A, 42B being associated with the connecting structure 3A', 3B', and the second sealing portion 43A, 43B being disposed on the cover 6. 26 and/or on another connecting structure 3A', 3B', in particular formed with it in one piece.

The sealing portions 42A, 42B, 43A, 43B preferably include sealing surfaces 44A, 44B, 45A, 45B, corresponding to each other, which closely abut each other when the cover 6, 26 is placed on the connecting structure 3A', 3B', or the connecting structures 3A', 3B' are inserted into each other.

The sealing surfaces 44A, 44B, 45A, 45B preferably have a similar cross-sectional shape (perpendicular to the central axis or axis of symmetry 9) and/or have circular and/or rotational symmetry with respect to the common axis of symmetry and/or the central axis 9.

Preferably, the sealing surfaces 44A, 44B, 45A, 45B are designed and/or matched so that the lid 6, 26 and/or other connecting structure 3A', 3B' can be rotated relative to the container B1, B2, B3.

Preferably, one of the connection structures 3A', 3B' includes a sealing surface 44A, 44B that matches both the sealing surface 44A, 44B of the other connection structure 3A', 3B' and the sealing surface 45A, 45B of the cover 6, 26 corresponding to the connection surface 3A', 3B'. The sealing device 39 can thus be formed based on the connecting structure 3A', 3B' with either a corresponding cover 6, 26 or another connecting structure 3A', 3B'. In this way, it is possible to form a seal on the cover 6, 26 during transportation, and on the other connecting structure 3A', 3B' during use, using the same means or repeatedly using the same means.

Another feature, which can be implemented independently, relates to the connecting system 1 for forming a fluid connection 2 between the containers B1, B2, B3 and/or the container B3, the connecting system 1 or the container B3 having at least two connecting connections. 044241 arms 3A', 3B', configured to form a fluid connection 2, namely, a first connection structure 3A' and a second connection structure 3B', each of which is sealed to the fluid in the initial state, or isolated to the fluid from containers B1,

B2, B3, and can be opened in the opening region 4A', 4B' to form a fluid bond 2.

According to another feature, the connecting structures 3A', 3B' form the chamber 38C and contain a sealing device 39, while the volume 40C directly in contact with the opening areas 4A', 4B' is isolated from the volume 41C of the chamber 38C separated from the areas 4A' , 4B' opening by means of a sealing device 39.

Alternatively, or additionally, the connection system 1 includes a sealing device 39 that without interruption seals the volume 40C directly in contact with the opening areas 4A', 4B' when the connection structures 3A', 3B' are moved relative to each other.

It is also preferable if the connecting structure 3A', 3B' has at least two positions for connection with each other, which it sequentially occupies in time and space when the connecting structures are pressed or inserted into each other. In the first connection position, a permanent connection is formed between the connection structures 3A', 3B', and the fluid connection 2 is or can be formed only in the second connection position. Other details can be found in the description relating to the embodiments discussed above.

In particular, it is preferable that the sealing device 39 isolates or seals the internal volume 40C without interruption at the first connection position, at the second connection position and between the first and second connection positions, and/or without interruption isolates or separates the internal volume 40C from the outer volume 41C.

Other elements of the connecting system 1 associated with the sealing device 39 are discussed above, in particular with respect to a sterile or sterilizable cover, with reference to, for example, FIG. 16, 17 and 20 and/or in connection with the proposed container B1, B2, B3 with a sealing device 39.

Other features that can also be independently implemented relate to the connection structure 3A', 3B' and/or the container B1, B2, B3 having this connection structure 3A', 3B', the opening area 4A', 4B' of the connection structure 3A ', 3B' is sealed to the fluid in the initial state and can be opened to form a fluid connection 2. According to this feature, the connection structure 3A', 3B' includes a lid 6, 26, which may preferably be snap-attached to the container B1, B2, B3 or the connection structure 3A', 3B', and/or be in the form of a cap and/or be removable and which covers the opening area 4A', 4B'.

According to this feature, the cover 6, 26 preferably includes a support portion 46 corresponding to the opening area 4A', 4B' and directly or so tightly pressed against the opening area 4A', 4B' that the force FS acting on the area 4A', 4B ' tampering in the direction of the support portion 46 is absorbed by contacting at least a portion of the tampering region 4A', 4B' with the supporting portion 46 so that tampering of the tampering region 4A', 4B' is prevented.

In the embodiment shown in FIG. 23, the cover 26 suitably covers the connecting structure 3A'. The support portion 46A in this case is directly adjacent to the closure device 23. When the force FS acts on the closure device 23 from inside the container B1, for example, when the container B1 is opened in the area of the lid 26, in case of its inversion or the like, and, as a result, the substance S1, located in the container, suddenly exerts a force FS on the opening area 4A', in particular on the closure device 23, the closure device 23 can be supported by the support part 46A, while the force FS is in any case partially absorbed by being intercepted and/or by the deflected support portion 46A. In this case, the opening area 4A' is protected from accidental opening, in particular as a result of impact or overturning.

This operating mechanism is preferred, as illustrated in FIG. 27, wherein the support portion 46B of the cover 6 is combined with the tamper-evident area 4B' or the locking device 33. In addition, the described tamper-evident protection provided by the support portion 46A, 46B can also be applied to the previous embodiments and features by correspondingly replacing the cover 6 or blocking 14 with a lid 6, 26 having a supporting part 46A, 46B.

The support portion 46 is preferably at least substantially supported, or may be supported, on the wall of the container B1, B2, B3 and/or on the connecting structure 3A', 3B'. In this case, it is possible to deflect the force FS acting on the support part 46A, 46B. In particular, it is preferable that the support portion 46A is at least substantially rigidly connected to the neck 5A', 5B' or holder 25 by means of the connecting structure 3A', 3B' and/or the container B1, B2, B3 by its design or by mechanical means.

In this case, the opening area 4A', 4B' is preferably held on the container B1, B2, B3 or on the wall of the container B1, B2, B3 by means of a neck 5A', or a holder 25 and a support part 46A, 46B

- 40 044241 is held at least substantially rigidly on the same container B1, B2, B3 or on the same wall of the container B1, B2, B3. Thus, the force FS acting on the opening area 4A', 4B', or the closure device 23, 33, towards the support part 46A, 46B or outward from the interior of the container can be absorbed and deflected through or by means of the rupture portion 24, 34 , or not only through or by means of the breaking section 24, 34. By removing the load from the breaking section 24, 34 in the event of any forces FS, accidental opening of the connecting structure 3A', 3B' is prevented.

The support part 46A, 46B preferably corresponds to and/or is adjacent to the locking device of the corresponding opening area 4A', 4B', in particular the corresponding locking device 23, 33. The support portion 46A, 46B may form a flat portion configured and/or mounted at least substantially parallel and/or corresponding to the side surface of the locking device 23, 33 facing the support portion 46A, 46B. It is also preferred that movement of the locking device 23, 33 toward the support portion 46A, 46B results in flat contact and/or contact that resists tilting of the locking device, particularly due to forces acting on the locking device during impact or inversion.

The support portion 46A, 46B is preferably formed by the base of the recess 47 or the seat 13 of the cover 6, 26, which is accessible from the outside when mounted or attached to the container B1, B2, B3 or the connecting structure 3A', 3B'. Additional information regarding slot 13 is also provided in the description of the previous embodiments. In particular, it can be provided that the seat 13, recess 47 or cavity corresponds to the opening E1, E2 for the recess or narrowing F1, F2 of the vessel of the container B1, B2, B3, so that it can be placed in the seat 13, recess 47 or cavity, in particular for transportation and/or as a support.

The cover 6 preferably includes reinforcement elements 48 in the form of ribs, preferably helping to support or increase the strength of the support portion 46B. Alternatively, or additionally, the reinforcing elements 48 are associated with a constriction F1, F2 of the vessel to accommodate, support and/or strengthen it. As such, the cover 26 may also include corresponding or similar reinforcing elements 48, even though they are not represented in this embodiment.

The support portion 46A, 46B is preferably supported by an inclined or at least substantially conical strip 49 preventing movement or deformation in axial directions or directions along or parallel to the central axis and/or the symmetry axis 9.

It is also preferable that the lid 6, 26 be sealed onto the container and/or connection structure 3A', 3B' using a sealing device 39. The sealing device 39 preferably seals the side of the support portion 46A, 46B facing the area 4A'. 4B' autopsy. Alternatively, or additionally, a sealing device 39 is located on the wall of the container B1, B2, B3 if used in addition to sealing and/or snap-fitting the lid 6, 26. Thus, chamber 38A, 38B, internal volume 40A, 40B and/or volumes 40A, 40B, 41A, 41B, separated from one another, may be formed within the cap(s) 6, 26, which are, or may be, attached to the container B1, B2, B3 or connecting structure 3A' , 3B'.

Another feature, which can be implemented independently, relates to the cap-like lid 6, 26, and/or its combination with the connecting structure 3A', 3B', to form a fluid connection 2, in particular between containers B1, B2, B3, wherein the cover 6, 26 has a side wall 50A, 50B and a base 51A, 51B adjacent to the side wall 50A, 50B.

A retaining device is provided on the side wall 50A, 50B for detachably holding the cover 6, 26 by locking and/or frictional engagement. In particular, it is one or more areas configured to be sealed and/or otherwise attached by locking and/or frictional connection of one or more, preferably one female connection to the container B1, B2, B3, in particular without interruption, in the form folded edge or other means.

Preferably, the base 50 includes a seat 13, a recess 47 or a cavity into which a bottleneck-shaped opening E1, E2 can be inserted for a container recess B1, B2, B3.

Alternatively, or additionally, the area of the base of the seat 13, recess 47 or cavity facing the opening of the lid 6, 26 includes a flat support portion 46A, 46B for supporting the opening area 4A', 4B' of the connecting structure 3A', 3B', container B1, B2, B3 or parts thereof.

Alternatively, or additionally, the base 51A, 51B of the lid 6, 26 includes a female tape seal portion 43A, 43B configured to form multiple sealed volumes 40A, 40B, 40C, 41A, 41B, 41C and/or compartmentalize the chamber 38A , 38B and/or create a support for the base 51A, 51B.

The support portion 46A, 46B is preferably supported or strengthened, in particular by rib-like reinforcements 48, preferably so that the lid 6, 26 is stiffened to deflect the force FS acting on the support portion 46A, 46B into the wall of the container B1 , B2, B3.

- 41 044241

Another feature, which can also be implemented independently, relates to the use of a cap-like lid 6, 26 comprising a support portion 46A, 46B which is located directly adjacent or at such a small distance from the opening area 4A', 4B' of the container B1, B2, B3, that the force FS acting on the area 4A', 4B' in the direction of the support part 46A, 46B is absorbed by the flat contact of at least a part of the opening area 4A', 4B' with the support part 46A, 46B, to protect against accidental opening under the force external forces, preferably accelerations, in particular as a result of impact or overturning of the container B1, B2, B3, which is connected, or can be connected to the lid 6, 26, and/or the connecting structure 3A', 3B' provided for the container B1 , B2, B3, or its forming part.

With reference to FIG. 31 to 34, in relation to the present embodiment, it is once again explained how the containers B1, B2, B3 are connected to each other by means of the first and second connecting structures 3A', 3B' shown as an example in FIG. 26 and 30, to form 2 by fluid. This procedure corresponds, at least in essence, to the procedure already described with reference to FIG. 5-13, or vice versa.

Preferably, the covers 6, 26 are first removed, exposing the connecting structures 3A', 3B'. Cover 6 can be used as a stand.

The connecting structures 3A', 3B' are then moved closer to each other along the axis and inserted into one another, as exemplified in FIG. 31-33.

In fig. 32 illustrates a preliminary, optional snap connection stage in a first connection position in which the connection structures 3A', 3B', or opening areas 4A', 4B' thereof, still remain occluded, however, the connection structures 3A', 3B' or containers B1 , B2, B3 are already fastened to each other, in particular by a locking engagement, in particular by a permanent one. Details of this step are given in the corresponding explanations for the previously described embodiments.

In fig. 33 shows how the first connection structure 3A opens the opening area 4B' of the second connection structure 3B', in this case preferably by means of a piercing and/or cutting edge 32 or some other cutting element 7. To this end, a piercing or cutting edge 32 acts along the axis on the breaking section 34, which holds the locking device 33. As the movement continues, the breaking section 34 is cut, in particular cut by the piercing and/or cutting edge 32 or torn. As a result, the opening area 4B' of the second connecting structure 3B' is initially opened.

In the next step, the connecting structures 3A', 3B', or containers B1, B2, B3, are rotated relative to each other around a common central axis, or axis of symmetry 9, as a result of which the holder 25 or the neck 5A' of the first connecting structure 3A' is deformed and , as a result, the opening area 4A' of the first connecting structure 3A' is also opened, as shown in FIG. 22 and 34 in the final opening position.

The connection structures 3A', 3B' are preferably capable of being connected to each other by a bayonet-type connector in which at least mainly, or exclusively, axial movement along a central axis or axis of symmetry 9 after the connection structures 3A' , 3B' were pushed one inside the other, complemented by the rotational movement of the connecting structures 3A', 3B' relative to each other around the central axis or axis of symmetry 9.

Said bayonet movement is preferably guided by the connecting structures 3A', 3B'. In particular, as shown, for example, in perspective views of the first connection structure 3A' in FIGS. 26 and the second connecting structure 3B' in FIG. 30, there are corresponding guide devices or guides 18A, 18B which preferably guide the bayonet movement described above. In particular, the first connecting structure includes a guide device or strip guide 18A which preferably extends at least in a plane or along a plane perpendicular to the central axis or symmetry axis 9. The guide device or guide 18B of the second connection structure 3B' preferably has a conjugate, preferably complementary, structure. It may include a guide groove into which a guide device, or guide, 18A can be inserted to guide movement.

The guide devices, or guides, 18A, 18B may also be configured to perform pre-alignment with respect to the central axis, or axis of symmetry 9, when the connecting structures 3A', 3B' are moved towards each other. This alignment is preferably carried out such that the opening areas 4A', 4B', having an oval shape, for example in the embodiments shown, correspond to each other or are positioned in the same orientation relative to each other.

The guide means or guides 18A, 18B are preferably configured to prevent rotation of the connecting structures 3A', 3B' about the central axis or axis of symmetry 9 by means of a locking engagement while the connecting structures 3A', 3B' are moving towards each other. Once the connecting structures 3A', 3B' have been inserted

- 42 044241 one into the other, in particular, while opening the area 4B' of the second connecting structure 3B', the guide devices 57A, 57B provide rotational movement of the connecting structures 3A', 3B' relative to each other around a common central axis, or axis of symmetry 9 . This rotation causes the above-mentioned deformation of the neck 5A' or the holder 25 of the first connection structure 3A' and, consequently, to the opening of the opening area 4A' of the first connection structure 3A', thereby forming a fluid connection 2.

The guide devices or guides 18A, 18B preferably also allow the relative position of the connecting structures 3A', 3B' to be locked in the axial direction, i.e. in the direction of the central axis or axis of symmetry 9, in particular by means of a locking engagement through or after rotation of the connecting structures 3A', 3B' relative to each other.

Alternatively, or in addition, locking means may be used to prevent reverse rotation. This ensures that once the fluid connection 2 has been established, the connecting structure 3A', 3B' cannot be separated again, which in particular ensures the sterility of the fluid connection 2.

Another feature, which can also be implemented independently, relates to a container system B with two containers B1, B2, B3, B4, which are fluidly separated from each other in the initial state, and are fluidly connected to each other by movement containers B1, B2, B3, B4 relative to each other, while in the initial state the lock 52 blocks, in particular, partial and/or initially axial movement of containers B1, B2, B3, B4 or their connecting structures 3A', 3B' each other relative to each other.

In the embodiment shown in FIG. 35, the first container B1 is shown as an example with an additional container B4 and a lock 52. The additional container B4 in the shown embodiment has only one possible access hole, which is formed by the second opening device 4B'. However, other solutions are possible, for example, using containers B2, B3, described earlier.

In fig. 35 shows the latch 52 in the initial state, in which the containers B1, B2 are not connected to each other. In this initial state, the lock 52 prevents the containers B1, B4 from moving relative to each other, which is necessary to open or create a connection between the containers B1, B4. In this case, the clamp 52 acts as a spacer between the containers B1, B4, preventing the axial movement of the containers relative to each other.

In fig. 36 is an enlarged view of a fragment of the embodiment shown in FIG. 35, in which the latch 52 is activated, or activated. In this state, the containers B1, B4 can move relative to each other so that a fluid connection 2 can be formed. For this purpose, it is particularly preferable that the opening areas 4A, 4B, 4A', 4B' are opened by means of the connecting container 3A, 3A', 3B, 3B' described above, by first axially or intermediately moving and then rotating the containers B1, B4 relative to each other.

In fig. 37 is an enlarged view of a fragment of the embodiment shown in FIG. 35, in the state after relative movement has occurred.

In fig. 38, a perspective view of the lock 52 is shown.

For the present feature, it is preferable that the containers B1, B4 can be connected to each other through the proposed connecting structures 3A', 3B'. In principle, however, other connection methods can be considered.

The container system B preferably includes a receptacle 53, in particular a pocket for a latch 52, into which the latch 52 can be inserted, in particular by pressing, as a result of or during relative movement.

In the illustrated embodiment, in order to open the second connecting structure 3B', in particular, the connecting structures 3A', 3B' are moved axially relative to each other. This relative axial movement is initially prevented by the lock 52, and may be permitted by the lock 52.

The socket 53 is preferably located behind the wall 35A', 36A' of one of the containers B1, B4 and/or behind the annular and/or tubular portion 37A', 37B' of one of the connecting structures 3A', 3B', as viewed from the outside. In the embodiment shown, this wall is the wall of the container B1, which preferably forms a tubular or annular extension of the wall of the container B1, delimiting the inner chamber, in particular, located along the same axis.

In the illustrated embodiment, a socket 53 is formed between the wall 35A', 36A' or the sleeve 37A, 37B, and the neck 5A', 5B', or the opening area 4A', 4B' of the container B1. Alternatively, or additionally, however, the same may apply to the other containers B2, B3, B4.

The container system B is preferably designed such that, during or as a result of, or after activation, the latch 52 can protrude into the seat 53 in the axial direction or may have a common central axis and/or symmetry axis 9 of the container system B with it.

It is also preferable that the latch 52 be located in the initial position between the edges 36A', 36B' of the containers B1, B2, B3, B4 or connecting structures 3A', 3B', which, in particular, are located opposite each other or correspond one another so that the edges 36A', 36B' rest against each other through the latch 52.

The retainer 52 is preferably at least partially subject to deformation such that relative movement is possible. In particular, as a result of activation of the latch 52, the locking engagement can be broken so that the containers B1, B2, B3, B4 cease to rest on each other, which ensures their mutual movement.

In the illustrated embodiment, the latch 52 has an annular or annular shape, in particular is made in the form of a ring, in particular a retaining ring, or contains such a ring, capable of at least partial deformation, or deformation in certain places, for release . This, however, is not essential and can also be achieved in some other way, although the use of a ring has advantages from a manufacturing and assembly point of view.

The latch 52 preferably includes at least one locking element 54, preferably in the form of a valve or petal, or formed in this way. In the initial position, the locking element 54 prevents the connecting structures 3A', 3B' from moving relative to each other due to the locking engagement. Moreover, the locking element 54 is preferably deformable and/or indentable to release the lock and allow for mutual movement.

In the embodiment shown, the locking element 54, or locking elements 54, includes an edge 55 that forms a locking engagement and is movable and deformable in at least a substantially radial direction (relative to or in the direction of the central axis or axis 9 of symmetry) to remove the blockage. Specifically, the locking member 54 at one end is injection molded integrally with the lock 52 and/or has a petal shape.

The receptacle 53 preferably conforms in shape to the retainer 52, or vice versa, and may further comprise a cavity or pocket, or be formed by a cavity or pocket which, in particular, also has an annular or annular shape associated with the shape of the retainer 52. The cavity or the pocket preferably includes an opening facing the latch 52 or the connecting structure 3A', 3B' located opposite the socket 53.

The retainer 52 is preferably formed from a plastic material, in particular a thermoplastic material. The retainer 52 may be a plastic ring. The locking elements 54 preferably have elastic deformation properties. Alternatively, unlocking can also be accomplished by plastically deforming the locking elements 54.

In the initial state, the latch 52 is preferably located between the containers B1, B2, B3, B4 in such a way that movement in the axial direction relative to the central axis and/or axis 9 of symmetry of the system B of the tanks is blocked, and due to partial deformation of the latch 52 radially in the direction the central axis and/or axis 9 of symmetry of the system B of the containers, the relative movement can be unlocked.

The latch 52 preferably cannot be removed and/or removed. Instead, the latch 52 is placed in the slot 53 during or after activation and therefore does not form a separate part that must be separately disposed of, thereby simplifying the use of the system and its operational reliability.

In the embodiment shown, the latch 52 is rotatable, in particular mounted to rotate around a central axis and/or an axis of symmetry 9. The retainer 52 is held on the tapered portion and/or by a locking engagement on the container system B.

Another feature, which can be implemented independently, relates to a method for preparing a mixture of substances, in particular a vaccine, in which the starting substances in the form of a first substance S1 and a second substance S2 are supplied separately from each other in two containers B1, B2, B3, B4, which have the possibility of fluid connection, carried out by moving the containers B1, B2, B3, B4 relative to each other, preferably by axial movement relative to the central axis and/or axis of symmetry of the system B of containers.

Preferably, the process uses a socket 53 and a lock 52 located or formed between the containers B1, B2, B3, B4, blocking the movement of the containers B1, B2, B3, B4 relative to each other in the initial state. The process involves activating the latch 52 and sliding it into the slot 53 as a result of this activation and/or relative movement.

In the embodiment shown, the latch 52 is located, for example, between the first container B1 and the fourth container B4. However, in theory, these containers could also be replaced by other types of containers, particularly as previously described. Thus, during the formation of the socket 53, the latch 52 could theoretically also be in the first connection position, according to FIG. 32 in the same manner as in the embodiment shown in FIG. 22-33.

In fig. 37 is an enlarged view of the area containing the latch 52 and the seat 53 in which relative movement has already occurred. As a result, the latch 52 or the locking elements 54 have each been pushed partially or at least substantially into the seat 53. In particular, the edge 55 has been pushed into the seat 53. Preferably, this prevents the latch from engaging another locking engagement. In the embodiment shown, the latch 52 is located in the receptacle 53 between the tubular projection or wall apron 35A' of the first container B1 and the first connecting structure 3A'.

In fig. 38 is a separate schematic perspective view of the proposed latch 52. Clearly shown here are petal locking members 54 formed in a film hinge manner or hinged to the latch 52 through a film hinge connection. In the embodiment shown in FIG. 39, the axis of rotation of the locking element 54 is located at least substantially in the plane formed by the lock 52.

In fig. 39 schematically shows a cross-section of a system B of containers with a clamp, in accordance with the second embodiment. The second embodiment is functionally similar to the first embodiment and, therefore, other details can be learned from the description relating to the previous embodiment with reference to FIG. 35-38. Therefore, only differences from the previously described embodiments will be considered below.

In fig. 39 shows the container system B or the lock 52 in the initial or locked position. In this position, the locking element 54 acts between the containers B1, B4 so that they rest against each other and thus prevent relative movement.

In fig. 40 shows the container system B with the detent 52 activated when relative movement is possible. To do this, the locking element or elements 54 are deformed or displaced so that they or the lock 52 can be placed in the seat 53, in particular by pressing them there.

In fig. 41 shows the system B of containers in the process of or after relative movement or part thereof, during which or as a result thereof, the latch 52 was pushed into the seat 53.

In fig. 42 shows a separate perspective view of the lock 52 of the second embodiment. One or more blocking elements 54 are petal-shaped. The locking elements 54 initially protrude at least generally tangentially along the circumferential line of the latch 52 or container B1, B4. In other words, the locking element 54 can be bent about one or more axes extending at least substantially parallel to the central axis or axis of symmetry 9, and/or can be deformed by twisting it into a shape that matches the shape of the socket 53 or provides relative displacement.

The goal in both embodiments is to unlock by shaping and/or placing the locking element in a position in which the latch 52 is engaged with the socket 53 and in which relative movement is possible so that the latch can be pressed into the socket 53 as a result of either during relative movement.

In the embodiments according to FIGS. 35-42, the latch 52 is made in the form of a separate part, not connected to the connecting structures 3A, 3A', 3B, 3B' and/or containers B1, B2. In this case, if necessary, during the assembly process, the retainer 52 can be placed between the connecting structure 3A, 3A', 3B, 3B', or the containers B1, B2.

Alternatively, or additionally, it is possible that the latch 52 is formed by, or has a fixed and/or permanent connection with, the container B1, B4 and/or the connecting structure 3A, 3A', 3B, 3B'.

In this case, the socket 53 and the latch 52, in particular one or more locking elements 54, are located on different containers B1, B4, or connecting structures 3A, 3A', 3B, 3B', preferably opposite each other. Due to this, the latch 52 and/or one or more locking elements 54 can be slid into the slot 53 during or after the latch 52 is activated.

The latch 52, in particular one or more locking elements 54, may be connected to the container B1, B4, or the connecting structure 3A, 3A', 3B, 3B', through positive locking, frictional connection and/or adhesion, or may be formed as a single whole with them. In particular, it is preferable that the locking element 52 and/or the locking elements 54 be fitted together, inserted and/or formed in one operation with the container B1, B4, or the connecting structure 3A, 3A', 3B, 3B', in particularly by injection molding. It is possible, however, that the latch 52 is held on the container B1, B2, or the connecting structure 3A, 3A', 3B, 3B', by a snap fastening or other means.

The locking elements 54 are preferably supported on the container B1, B2 and/or the connecting structure 3A, 3A', 3B, 3B' in a manner similar to a film hinge. Alternatively, or additionally, the locking elements 54 may be formed and/or secured in a deformable manner. This ensures that the locking elements 54 operate without separately releasing the latch 52. In this case, the locking elements 54 can be designed as shown in FIG. 38 and/or 42, or in another way.

Another feature that can be implemented independently relates to the use of connecting structures and/or containers for mixing viscous liquids, in particular vaccines,

- 45 044241 preferably having a dynamic viscosity at 23°C and a shear rate gradient of 1s ^-1 (in particular measured in a Brookfield RVT type viscometer with a No. 4 spindle), greater than 1.5 or 2, preferably greater than 4, in particular more than 6 or 10, and/or less than 100, in particular less than 70, preferably less than 50, and/or in the range from 1 to 100, in particular from 2 to 70, preferably from 5 to 50 Pa-s . The above viscosities can be determined, in particular, by the method in accordance with the EN ISO 2884-1:2006 standard. When working with viscous liquids, in particular, the use of large hydraulic minimum cross-sections of connections provides benefits compared to known designs.

The described features can be used in combination with each other. In particular, features of the embodiments described with reference to FIGS. 1-20 may also be used, respectively, in the embodiments described with reference to FIGS. 21-37, and vice versa.

For example, features related to the sealing device 39 and/or the support portion 46A, 46B may also be present in the cover 6 of the embodiments of FIGS. 1-20. The caps 6, 26 can provide, in particular, a repeatable or multi-stage sterile and/or sterilizable closure, while the features discussed with reference to FIGS. 17 may be combined with features regarding the sealing device 39 described with reference to FIG. 22-34. Alternatively, or additionally, features related to strain opening discussed with reference to FIG. 6-15 can be combined with features related to the locking device 33 and vice versa. These examples clearly show that there are numerous preferred combinations of features that may form the subject matter of the present invention, even if these combinations are not explicitly described.

Reference number designations:

- connecting system;

- fluid communication;

A, 3A' - the first connecting structure;

3B, 3B' - second connecting structure;

4A, 4A' - opening area of the first connecting structure;

4B, 4B' - opening area of the second connecting structure;

5A, 5A' - neck of the first connecting structure;

5B, 5B' - neck of the second connecting structure;

- closing means (lid);

- cutting element;

- arrow indicating movement;

- central axis, or axis of symmetry;

A, 10B - clamp;

- rotation direction arrow;

- break line;

- nest;

- blockage;

- inner annular edge;

- outer annular edge;

- gap;

A - guide of the first connecting structure;

18B - guide of the second connecting structure;

- rod;

- tip;

- connecting part;

- coupling;

- locking device (first connecting structure);

- breaking section (of the first connecting structure);

- holder;

- closing means (lid);

- plane;

- frame;

- reinforcing element;

- deforming device;

- wall;

- piercing and/or cutting edge;

- locking device (second connecting structure);

- breaking section (of the second connecting structure);

35A', 35B' - wall (container/container blank);

36A', 36B' - edge (of containers/container blanks);

-

Claims (16)

37A', 37B' - coupling and/or tubular part; 38A-38S - camera; 39 - sealing device; 40A-40C - internal volume; 41A-41C - external volume; 42A-42C - sealing part; 43A-43C - sealing part; 44A, 44B - sealing surface; 45A, 45B - sealing surface; 46A, 46B - support part; 47 - recess; 48 - reinforcing element; 49A, 49B - strip; 50A, 50B - side wall; 51A, 51B - base; 52 - latch; 53 - socket; 54 - blocking element; 55 - edge; B - system of containers; B1 - first container; B2 - second container; B3 - third container; B4 - additional capacity; BR 1 - container blank; BR 2 - container blank; E1 - hole for removing the first container; E2 - hole for removing the second container; F1 - narrowing of the vessel of the first container; F2 - narrowing of the vessel of the second container; FS - strength; S1 - substance in the first container; S2 - substance in the second container; S3 - substance in the third container; V1 - sealing element of the first container; V2 is the sealing element of the second container. CLAIM 1. System (B) of containers having two containers (B1, B2, B3, B4), in the initial state isolated from each other in relation to the fluid medium and having the ability to be connected via a fluid medium by means of relative movement of the containers (B1, B2, B3, B4), which is initially prevented by the latch (52), and the container system (B) contains a seat (53) for the latch (52), into which the latch (52) can be placed as a result of or during said relative movement, wherein the latch (52) contains or is formed by at least one locking element (54) which, in an initial position, blocks relative movement by means of a locking engagement, and can be subjected to deformation and/or compression to release the lock so that said relative movement is achieved , characterized in that the shape of the socket (53) corresponds to the shape of the latch (52), or vice versa, wherein the latch (52) is formed by a locking ring, and the socket has an annular shape so that the locking ring can be partially placed in the socket (53) during , as a result of or after the release of the lock due to relative movement. 2. The system of containers according to claim 1, characterized in that the latch (52) can fit into the socket (53) or be aligned with it in the axial direction, relative to or along the axis of symmetry and/or the central axis (9) of the system (B) of containers . 3. A container system according to claim 1 or 2, characterized in that the seat (53) is formed by a wall and/or behind a wall (35A', 35B'), or a section (37A', 37B') in the form of a wall, a sleeve and/ or pipes of a connecting structure (3A', 3B') or an extension of one of the containers (B1, B2, B3, B4). 4. System of containers according to one of claims 1-3, characterized in that in the initial position the latch (52) is located between the end surfaces/edges (54A', 54B') of the containers (B1, B2, B3, B4) so that the edges (54A', 54B') rest on one another through the lock (52). - 47 044241 5. A container system according to one of claims 1 to 4, characterized in that the lock (52) is capable of at least partial deformation, thereby ensuring relative movement. 6. Container system according to one of claims 1 to 5, characterized in that by activating the lock (52) the locking engagement can be opened so that the containers (B1, B2, B3, B4) no longer rest against each other, which makes possible relative movement. 7. A system of containers according to one of claims 1 to 6, characterized in that in the initial state the lock (52) blocks, in particular, only the linear and/or axial movement of the containers (B1, B2, B3, B4) relative to each other. 8. A container system according to one of claims 1 to 7, characterized in that the locking element (54) has an edge (55) or end surface which forms a locking engagement and is radially movable to release the lock. 9. A container system according to one of claims 1 to 8, characterized in that the locking element (54) is injection molded at one end of the lock (52), formed integrally with it and/or has a petal shape. 10. A container system according to one of claims 1 to 9, characterized in that the retainer (52) has an annular or annular shape, and preferably the retainer (52) is made in the form of a retaining ring, which is capable of being deformed at least partially or in their parts to unlock the lock. 11. Container system according to one of claims 1 to 10, characterized in that the retainer (52) is made of plastic, preferably thermoplastic material, preferably in the case where the retainer (52) is a plastic ring. 12. System of containers according to one of claims 1 to 11, characterized in that in the initial state the latch (52) is located between the containers in such a way that relative movement in the axial direction relative to or along the central axis or axis (9) of symmetry of the system is blocked ( B) containers, and the axial relative movement can be ensured due to partial deformation of the latch (52) along the radius in the direction of the central axis or axis (9) of symmetry of the system (B) of containers. 13. System of containers according to one of claims 1 to 12, characterized in that the latch (52) is held on the system (B) of containers permanently and/or without the possibility of removal, and/or so that it cannot be removed and/or removed and/or rotated and/or held on the tapered portion and/or by means of a locking engagement. 14. A method for preparing a mixture of substances, in which the substances (S1, S2) are provided separately from each other in two containers (B1, B2, B3, B4) in the system (B) of containers according to claim 1, and in which the fixative (52) is activated ), so that as a result of this and the relative movement, the latch (52) is pushed into the seat (53). 15. The method according to claim 14, characterized in that a combined vaccine is prepared. 16. The method according to claim 14 or 15, characterized in that the connection of the containers (B1, B2, B3, B4) through the fluid is carried out by axial relative movement of the containers (B1, B2, B3, B4) relative to or along the central axis and/ or axis (9) of symmetry of the system (B) of containers. -