Container

Abstract

The invention relates to a container, in particular a filled and closed ampoule, made of at least one plastic material, having a container part (10) for receiving a container content (14) and a head part (18), the invention relates to a container (10) having a head part (20) which can be separated from the container part (10) along a separation point (20) and which is connected in one piece to the container part (10) prior to the separation, characterized in that the container has a valve device (26) which, in the closed position thereof, closes off and, in the open position thereof, releases a flow-conducting connection (28) into the container part (10).

Description

Technical Field

[0001] The invention relates to a container, in particular an ampoule, which is made of a plastic material and has a container part for accommodating container contents and a head part, which can be separated from the container part along a separation point and is connected in one piece to the container part before separation. Background Art

[0002] WO 2019 / 063346 A1 discloses a container, in particular an ampoule, made of a plastic material, having a container part for accommodating container contents that can be released via a container opening, the container opening being closed by a head part that can be separated along a separation point, a neck part being connected to the head part, the neck part having a plurality of different functional surfaces on the inner circumference, one of which is abutting functional surfaces for sealing relative to a removal body, the removal body being provided for removing the container contents when the container opening is released, and a front surface on the inner side of the neck part being provided as a further functional surface in addition to the existing functional surfaces, the front surface being geometrically different from the abutting functional surface, the abutting functional surface seamlessly transitioning into the front surface and the front surface and the abutting functional surface being accommodated in the neck part between the other functional surfaces. The known container, which can preferably be manufactured according to the blow molding, filling and sealing method (BFS), is characterized in that the wall thickness in the region of the front surface, but in particular in the region of the abutting functional surface, is much smaller than the average wall thickness of the neck part. This results in a decisively low radial rigidity of the sealing region for sealing, and only low forces are required to expand the sealing region by the removal body during the removal process, which facilitates the removal process.

[0003] A container is known from EP 1 989 117 B1, which has:

[0004] A hollow container for accommodating the discharged medium,

[0005] a discharge opening formed on the receiving body for discharging the discharge medium from the receiving body, and

[0006] A closure part, which has a cavity outside the receiving body that opens the discharge opening and forms the head part of the container, wherein

[0007] The closure element is detachably connected to the receiving body via a separation point and has mutually opposing wall parts in the region of the cavity.

[0008] In the known solution, the wall parts of the closure element which are located opposite one another are pressed into the cavity at a distance from the separation point in such a way that the remaining free cavity cross section of the cavity with its storage volume is reduced in such a way that the discharge medium stored in the receiving body cannot penetrate into the cavity, and the discharge medium of the container also remains in the form of a very thin liquid medium in the hollow receiving body and does not reach the cavity, so that the discharge medium is not lost during the removal process from the container, which has disadvantages in particular when exact metering is required during the discharge or the discharge medium itself is very expensive or when exact mixing ratios and concentrations are required for subsequent use when discharging suspended matter.

[0009] An ampoule for medical liquids is known from EP2826457B1, which has an ampoule body for containing the medical liquid, which is manufactured as a plastic injection-molded part by means of plastic injection molding, and a connecting part for connecting a removal device to the ampoule. The ampoule itself is constructed in multiple parts, and the connecting part is mounted on the ampoule body as a separate part for the removal process, the connecting part is held on the neck of the ampoule body in a form-fitting manner, and a membrane element for sealing the transition between the ampoule body and the connecting part is arranged between the ampoule body and the connecting part. Summary of the invention

[0010] Starting from this prior art, the object of the present invention is to improve the known solutions.

[0011] A container having the features of claim 1 achieves the associated object in its entirety.

[0012] By virtue of the fact that, according to the characterizing part of claim 1, the container has a valve device which, in its closed position, blocks and, in its open position, releases the fluid-conducting connection into the container part, it is at least ensured that in the closed state of the container, there is no unintentional transfer of fluid stored in the container part, in particular for medical purposes, in the direction of the head part, which would otherwise lead to a change in the filling amount on the part of the container and then no longer all the container contents are available for removal. The head part therefore usually has a hollow head space due to its manufacture, into which the contents of the container part could enter without the valve device according to the invention and would no longer be available for removal by means of conventional connecting devices when the other container parts are separated from the head part. This is reliably prevented with the container according to the invention and, in this respect, all the container contents are available for removal. Furthermore, the valve device is microbiologically reliably accommodated in the closed container.

[0013] After the head section is separated, the valve device that is closed first also ensures that the contents of the container section remain microbiologically reliably sealed from the environment and that the container contents of the container only reach the syringe body microbiologically reliably and without piercing the sealing element (which always involves the risk of particle generation) after the valve device is released, usually via a connection or removal device, such as a syringe body. In a similar manner, microbiologically reliable multiple partial removals are possible, because the valve device automatically and reliably closes the container after the removal device is removed. Therefore, there is no corresponding solution in the prior art.

[0014] In a preferred embodiment of the container according to the invention, it is provided that the valve device is arranged in the container wall between the container part and the head part, preferably in the neck part between the container part and the head part, and after the head part is separated, the valve device is exposed for actuation. Due to the one-piece design of the container, the container is tightly and microbiologically sealed before the head part is separated. After the head part is separated along the separation point, a sealed closure relative to the environment is also provided by the closed valve device.

[0015] In a particularly preferred embodiment of the container according to the invention, it is provided that the valve device has an actuable valve body for obtaining the flow-conducting connection, which valve body blocks the flow-conducting connection in a starting position under the action of a restoring force. Preferably, in order to obtain the restoring force, the valve body can be at least partially deformed and / or can be reset to its closed initial position by means of a restoring device, preferably in the form of an accumulator. In this way, the valve body always automatically returns to the closed initial position due to its inherent elasticity and / or under the influence of external force manipulation and seals the container content. The relevant solution can be realized in a space-saving manner, so that the valve solution can also be used for small ampoule sizes.

[0016] In a particularly preferred embodiment of the container according to the invention, it is provided that the valve device can be actuated by means of a connection device, which is preferably conical in shape, and thus can be brought from a blocking position into an open position, in which the fluid-conducting connection is established for removing a container fluid from the container part or for introducing another fluid into the container part. By means of the connection device, the container fluid can usually be removed from the interior of the container part when the valve device is opened; however, there is also the possibility that, for example, in order to produce a mixture or suspension, an external fluid can first be introduced into the container part via the connection device when the valve device is unlocked and immediately the drug is prepared in a predeterminable mixing ratio in the opened container for the final removal process.

[0017] Preferably, the valve device has an insert having a connection point preferably in the form of a connector for a conical connection, such as a cone connection, for the purpose of releasably mounting the connection device. The corresponding connector connection with the connection device, such as a syringe body, etc., is known in technical terms by the name Luer or Luer lock connector. Thus, the two functions "connection and valve mechanism" are combined in one container component.

[0018] In another preferred embodiment of the container according to the invention, it is provided that the insert, in the closed state of the container, extends between the adjacent wall parts of the container part and the head part, and that the separation point surrounds the insert on the outer circumference. It is possible to attach the inherently elastically deformable valve body to the container wall of the container by directly inserting it into the container, whereas an insert with a valve device is preferably provided, which is preferably designed to be self-stabilizing, protects the valve body of the valve device against erroneous operation, and can be introduced into the container as a third component in a process-reliable manner within the scope of blow molding, filling and closing production, but after filling the container, using its predeterminable self-stability. In addition, the separation point can be supported on the insert, which facilitates the opening process by removing the head part.

[0019] It is preferably provided that, with the removal of the head part, the connection point and the access opening to the valve device are exposed, and the insert is connected to the interior of the container part in a fixedly anchored manner. This enables a reliable positioning of the valve device in the region of the neck part as a transition between the container part and the head part. After the removal of the head part, the connection point is exposed for mounting the connection device, so that, when viewed from the outside, a reliable fluid-tight connection is established between the connection device and the container contents via the valve device.

[0020] In another particularly preferred embodiment of the container according to the invention, it is provided that the insert is of multi-part design. Due to the multi-part design of the insert, the insert is modularly designed in the sense of a component and valve devices of different designs with their valve bodies can be combined largely freely with the inserts that respectively accommodate the valve devices, so that, depending on the requirements, a large number of very different valve devices can be realized for containers, which valve devices have different types of connection points, which are however preferably standardized with respect to the respectively used connection devices, such as syringe bodies.

[0021] For further increased microbiological safety, it can also be provided that after removal of the head part, the exposed end side of the valve device is freely accessible, preferably for disinfection, particularly preferably for wipe disinfection. Relatedly, it can also be provided that after removal of the head part, the free end side of the valve device optionally has a removable cover, preferably in the form of a pull-out film.

[0022] The invention also relates to a multi-component system, preferably for a container as provided above, comprising a valve device with a repositionable valve body, which is accommodated in an insert. In addition, the insert preferably has a connection point for mounting a connection device. The corresponding multi-component system can be produced separately as a tradable article in many different designs and then only connected to the wall material of the container in a suitable manner within the scope of a production method for the container, in particular in the form of a blow molding, filling and closing method.

[0023] In this regard, the invention also relates to an associated production method, wherein the multicomponent system is preferably inserted into the container in a form-fitting manner after filling the container part and is preferably covered by a head part in a welded manner, which can be separated from the container part via a separation point.

[0024] The container is preferably filled with a fluid, in particular for medical purposes, which may optionally contain a preservative. In addition, the container preferably has a layer of cycloolefin polymer and / or cycloolefin copolymer at least on the inner side of the container part. The insert and / or the valve device are mainly made of polyolefin plastics, such as polyethylene (PE) and / or polypropylene (PP) and / or cycloolefin polymer (COP) and / or cycloolefin copolymer (COC). BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The container according to the present invention is explained in detail below with the aid of an embodiment according to the accompanying drawings. Here, it is shown in principle and not to scale:

[0026] Figure 1 shows an end view of a filled container in the form of an ampoule;

[0027] Figure 2 The diagram shows in longitudinal section the direction of the relevant container with the valve device in the unactuated state. Figure 1 viewing the area above from a direction above; and

[0028] Figure 3 Shown in the open state, after removal of the head part, in the removal position according to Figure 2 A container, in which the valve device is placed in an open position by a connecting device that is installed from the outside. DETAILED DESCRIPTION

[0029] Figure 1As a whole, a one-piece filled container is shown before it is opened, in particular in the form of an ampoule, which is made of plastic material and has a container part 10 for accommodating container contents 14 for medical purposes or for a similar purpose that can be discharged by means of the container. Figure 1 1 and 10. The fill level of the container content 14 is shown in its vertical position and is indicated by a dashed fill level line 16 in the container part 10. The container content 14 usually consists of a fluid, for example in the form of a liquid for medical purposes; however, the possibility of providing a pasty medium as the container content 14 is also open.

[0030] The container is along Figure 1 The head part 18, viewed from the top, has a head part 18 which can be separated from the container part 10 along a separation point 20. Below the head part 18, the neck part 22 forms a transition between the container part 10 and the head part 18. The head part 18 has a handle 24 on its top side, which is also called a twist-off knob in professional terms, with which the head part 18 can be removed from the neck part 22 or from the container part 10 along the separation point 20 with a small actuation torque or actuation force. The relevant design is common in such containers, such as ampoules produced according to the BFS method, so that it will not be explained in detail here.

[0031] As especially Figure 2 and Figure 3 As shown, the container has a valve device, generally indicated at 26, which is Figure 2 The closed position is blocked and Figure 3 In the illustration of FIG. 2 , in its open position, the flow-conducting connection 28 into the container part 10 is released. Figure 2 and Figure 3 As further shown, the valve device 26 is accommodated in the container wall 30 between the container part 10 and the head part 18, preferably at least partially in the area of ​​the neck part 22. After the head part 18 has been separated from the container part 10 along the separation point 20 above the neck part 22, the valve device 26 is then exposed at the end for actuation.

[0032] In order to achieve the above-mentioned flow-conducting connection 28, the valve device 26 has an actuatable valve body 32 which is designed to be more or less elastic and which is reset under the action of a restoring force into its position according to the invention. Figure 2 In the closed starting position shown in the figure, the restoring force is permanently applied by means of the restoring device 34. The valve body 32 can move downward along the actuation axis 36 against the force of the restoring device 34 and thus move from its position in the Figure 2 The cut-off position shown in the figure is reached according to Figure 3The valve body 32 is designed essentially rotationally symmetrically with respect to the actuation axis 36 and has a conically circumferential abutment surface 38 in the direction of the handle 24, which, in the assumed extension dimension, forms an inclination angle of approximately 45° with the actuation axis 36. A radial overflow channel 40 is arranged approximately centrally on the free end side of the valve body 32, which, in the assumed extension dimension, extends into the plane of the drawing and therefore transitions into the conical abutment surface 38 at its free end. In this regard, as long as the container occupies its vertical position shown in the drawing, the actuation axis 36 passes through the center of the radial overflow channel 40, which extends horizontally in this regard, from above. Otherwise, the valve body 32 is designed to extend flatly on its free end side, except for the radial overflow channel 40 introduced concavely.

[0033] Below the conically extending contact surface 38, the valve body 32 is cylindrically designed, and a single axial overflow channel 44 is introduced concavely into the corresponding cylindrical circumferential surface 42, which enables a fluid connection from the bottom side of the valve body 32 in the direction of the conical contact surface 38 and in the direction of the radial overflow channel 40. Otherwise, the cylindrical circumferential surface 42 transitions into the conical contact surface 38 without transition. In addition, the valve body 32 has an elastic element 46 on its bottom side as a reset device 34 and is made, for example, of a hollow plastic molded part, which is preferably a one-piece component of the valve body 32, which is in the Figure 2 is shown in its extended position and in Figure 3 4 shows in the compressed position, in which the valve body 32 is in its closed position in the extended state of the element 46 and assumes its open position in the actuated compressed position, which releases the flow-conducting connection 28. As an alternative to the solution shown, the elastic element 46 can also be formed completely from an elastomeric material, which is used as an insert under the valve body 32. Other restoring devices 34 in the form of energy storage devices, such as helical springs, are possible if necessary.

[0034] According to the present embodiment, the valve device 26 has an insert 48, which has a connection 50 with a connection point 52 on the free end side of the connection 50. The corresponding connection 50 together with the connection point 52 is used to releasably mount a connecting device 54, as shown in the example and in part in Figure 3 The insert 48 is substantially constructed from a wall section 56 which forms a hollow cylinder, the relevant wall section 56 being penetrated in one piece on the foot side or the bottom side by a transverse wall 58 which has a plurality of fluid passages 60 as part of the flow-conducting connection 28, which are preferably arranged diametrically opposite one another in succession in the transverse wall 58 with respect to the actuation axis 36. Figure 2 and Figure 3The vertically extending wall portion 56, viewed from the upper side, has a projection below the transverse wall 58 and is fixedly connected to the container wall 30 on the free end side of the relevant projection by means of an annular weld seam 62, wherein the container wall here rests flush against the insert 48 in the direction of the tapered portion 64 of the neck portion 22. On the peripheral side, in the closed state of the container, the separation location 20 includes a cylindrical wall portion 56, which is formed by a welded portion along the insert 46, which can also be called an "insert". In this regard, the container wall 30 rests on the outer circumference of the insert 48 on the peripheral side in the closed state of the container, and in accordance with Figure 3 After removal of the head section 18 , the upper region of the insert 48 together with the wall section 56 is exposed.

[0035] The connector 50 is received as a whole in the insert 48 and is fixed in one piece with its outer periphery partially on the inner periphery of the insert 48 in a defined manner. The connector 50 has a connection point 52 on its free upper end side, which is Figure 2 and Figure 3 In the simplified diagram, only a part of the thread line 66 in the form of an external thread is shown, onto which the connecting device 54 can be screwed with a correspondingly designed internal thread 67. The relevant threaded connection thus forms part of a standardized Luer lock connector. Since the relevant connection technology is common in this field, it will not be explained in detail here and reference is made to the relevant prior art in this regard.

[0036] Furthermore, the connection 50 has a conically extending recess 68 on the inner circumference, the recess 68 in question tapers conically in the direction of the valve body 32. Figure 3 As shown, the conically extending recess 68 in the connector 50 is used to introduce a precisely matched removal cone 70 of the connecting device 54, in this case in the form of a so-called Luer lock syringe. However, other connecting devices of almost any design can also be connected to the open container via the connector 50, which is preferably used to accommodate a conical connection or other conically extending connecting element.

[0037] The connection 50 is cylindrically designed on the outer circumference, in addition to the protruding outer thread with the corresponding thread line 66, and is embedded in the inner circumference of the insert 48 with an exact fit, in which the lower end of the connection 50 is placed on the upper side of the transverse wall 58, and more precisely in such a way that the fluid outlet 60 is guaranteed to be open in each case. In this regard, the connection 50 forms a valve space 72 on its inner circumference, in which the valve body 32 is guided in a longitudinally displaceable manner, with the criterion that the valve space 72 opened by the valve body 32 in each displacement position of the valve body is part of the fluid-conducting connection 28 and is permanently connected to the fluid outlet 60 in the transverse wall 58 in a fluid-conducting manner.

[0038] In addition, the joint 50 is configured to form a valve sealing seat 74 opposite the contact surface 38 of the valve body 32. In order to form the valve sealing seat 74, the contact surface 38 can preferably be in flat contact with the inner wall surface of the joint 50 which is also conically inclined; however, it is preferred that the contact surface 38 be in flat contact with the inner wall surface of the joint 50 which is also conically inclined; Figure 2 The illustration of provides that the contact cone 76 on the inner side of the connector 50 is more inclined than the cone for the contact surface 38, so that a linear valve seat pressure is generated with an increased sealing effect along the valve sealing seat 74. Due to the linear valve sealing seat design, an unimpeded opening process for the valve body 32 is also achieved. At least in its widest upper region with the thread line 66, the radial extension for the connector 50 is selected so that the head part 18 is adapted to the radial spacing via the edge geometry of the insert 48 and the connector 50.

[0039] If the head part 18 is removed and the connecting device 54 is engaged with the conical removal part 70 in the connector 50, the valve body 32 is pushed open by the free syringe end of the connecting device 54 against the action of the restoring device 34, so that the fluid or the container content 14 passes through the fluid-conducting connection 28 into the removal channel 78 of the connecting device 54, which extends concentrically with the actuation axis 36 within the connecting device 54. The fluid thus passes through the interior of the container part 10 and through the interior of the neck part 22 through the fluid outlet 60 into the lower region of the valve space 72 and from there can flow laterally in the direction of the radial overflow channel 40 via the axial overflow channel 44 in the direction of the abutment surface 38, from which the liquid enters the removal channel 78, which is spaced apart from the valve sealing seat 74. In this way, the free end of the removal cone 70 presses the valve body 32 against the action of the restoring device 34 when the end is in contact, and the restoring force of the restoring device 34 is increased accordingly. Once the removal process is completed or initiated within the desired scope, the connection device 54 is unscrewed from the container again and the valve device 26 is closed, so that the interior of the container is again tightly sealed from the environment. In principle, it is also possible to introduce a fluid stored therein into the container via the connection device 54 in order to thus carry out a mixing with the fluid of the container content 14. Thus, a medicament mixture or suspension can be produced in this way and then discharged again via the connection device 54, which is meaningful when components that otherwise cannot be stored continuously for a long time in a combination with each other due to their chemical properties are to be mixed with each other. The insert 48 used is designed in multiple parts, preferably in the present embodiment in two parts, wherein one insert part has a connection point 52 as a joint 50 and the other insert part supports the separation point 20 in the form of a cylindrical wall part 56.

[0040] Due to this modular construction, there is also the possibility of using other valve devices 26. For example, it is conceivable that: in an embodiment not shown, an elastically flexible valve body is directly arranged on the inner wall side of the container wall 30, which valve body is again elastically and flexibly operated from the outside via a connecting device 54 to release the fluid path in the direction of the interior of the container part 10 and otherwise cuts off the relevant fluid path due to its inherent elastic reset.

[0041] If according to Figure 3 If the container is opened, i.e. the head portion 18 is removed, the free end side of the valve device 26 can be sterilized from the outside, for example, by wiping. In addition, for improved microbiologically reliable sealing, the valve device 26 can optionally have a removable cover (not shown), which is preferably in the form of a pullable film.

[0042] The solution described above can be produced within the scope of a conventional blow-molding, filling and closing method, and the use of inserts is in principle known within the scope of such a production method and is shown by way of example in DE 10 2014 008 611 A1.

[0043] For sterile products, such as parenteral drugs, preferably sterilized valve devices 26 are introduced into the filled BFS container in a clean room environment, preferably in an isolator. The valve device 26 is preferably sterilized with high-energy radiation (e.g. in the form of gamma radiation, electron radiation, X-ray radiation, light), by autoclaving or by sterilizing gases, such as ethylene oxide, chlorine dioxide, hydrogen peroxide.

[0044] Furthermore, the function of the valve device 26 is advantageous (particularly for sterile products and products which are heat-treated for sterilization) in the case where an overpressure is to be built up in the container part 10 (e.g. due to temperature changes during transport, changes in air pressure or mechanical forces acting on the container).

[0045] Particularly preferably, materials containing cycloolefin polymers (COP, manufactured by Zeonex) and / or cycloolefin copolymers (COC, manufactured by Topas) are used as container materials and also as outer materials for the valve device 26. It is surprising to a person skilled in the art that these material combinations can be welded well to one another during the BFS production process. In addition, BFS containers made of multilayer plastics are possible, as described, for example, in DE 103 47 908 A1.

[0046] Halogenated butyl rubber, silicone or particularly preferably elastomer-modified cycloolefin copolymers are preferably used as elastomeric materials for the valve body 32 , the latter being producible in a simple manner by injection molding.

[0047] It is also particularly advantageous in the case of the container or ampoule according to the invention that the space above and below the valve device 26 with the movable valve body 32 is surrounded by the same material and thus provides uniform permeation properties.

[0048] Overall, therefore, a container solution is provided, preferably in the form of an ampoule, which is suitable for injectable medications and which advantageously combines the following features:

[0049] - Integrated original closure via detachable head part,

[0050] - an optional additional primary closure by a pull-out membrane on the valve device,

[0051] - no ampoule contents are ejected when the head is removed,

[0052] - simple access port without risk of particle formation, since no small tubes, punches or the like need to be used,

[0053] - a reliable seal before and after each use (including disposal),

[0054] - simple optional wipe disinfection before each removal and minimal losses by water penetration during storage of the filled and closed container,

[0055] - Reliable sealing even in the event of overpressure in the container part.

[0056] Therefore, there is no corresponding solution in the prior art.

Claims

1. A container, in particular a filled and closed ampoule, made of at least one plastic material, comprising a container part (10) for accommodating a container content (14) and a head part (18), the head part being separable from the container part (10) along a separation point (20) and being integrally connected to the container part (10) before separation, characterized in that The container has a valve device (26) which blocks the flow in its closed position and releases a fluid-conducting connection (28) into the container part (10) in its open position.

2. The container according to claim 1, characterized in that The valve device (26) is arranged within the container wall (30) between the container part (10) and the head part (18), preferably at least partially in the neck part (22) between the container part (10) and the head part (18), and after the head part (18) is separated, the valve device (26) is preferably exposed at the end side for actuation.

3. The container according to claim 1 or 2, characterized in that The valve device (26) has an actuatable valve body (32) for establishing the fluid-conducting connection (28), which valve body blocks the fluid-conducting connection (28) in a starting position under the action of a restoring force.

4. A container according to any one of the preceding claims, characterized in that The container, preferably in the form of an ampoule, allows for a simple access port and without the use of cannulas, punches or the like.

5. A container according to any one of the preceding claims, characterized in that The valve body (32) is designed essentially rotationally symmetrically with respect to an actuation axis (36) and has a conically circumferential contact surface (38) in the direction of the handle (24) for separating the head part (18).

6. A container according to any one of the preceding claims, characterized in that A radially extending overflow channel (40) is provided on the free end side of the valve body (32) and transitions at its free end into a conical contact surface (38).

7. A container according to any one of the preceding claims, characterized in that The valve body (32) is cylindrically constructed below the conically extending abutment surface (38), and a single overflow channel (44) is recessed into the cylindrical circumferential surface (42), which enables a fluid connection from the bottom side of the valve body (32) in the direction of the conical abutment surface (38) and in the direction of the radial overflow channel (40).

8. A container according to any one of the preceding claims, characterized in that The valve body (32) is at least partially deformable in order to obtain a restoring force and / or can be reset into its blocked starting position by means of a restoring device (34), which is preferably designed in the form of an energy storage device, particularly preferably as a spring element (46).

9. A container according to any one of the preceding claims, characterized in that The valve device (26) can be actuated via a connection device (54), preferably in the form of a cone, and can be moved from a blocking position into an open position, in which the fluid-conducting connection (28) is established for removing fluid from the container part (10) and / or for introducing fluid into the container part.

10. A container according to any one of the preceding claims, characterised in that The valve device (26) has an insert (48) having a connection point (52), preferably in the form of a coupling for a conical cone connection, for releasably mounting the connecting device (54).

11. A container according to any one of the preceding claims, characterized in that The insert (48) has a hollow cylindrical wall section (56) which is penetrated in one piece on the foot side or bottom side by a transverse wall (58) which has a plurality of fluid passages (60) as part of the fluid-conducting connection (28).

12. A container according to any one of the preceding claims, characterised in that The insert (48) extends between the container part (10) and an adjacent wall part (30) of the head part (18) in the closed state of the container, and the separation point (20) surrounds the insert (48) on the outer circumference.

13. A container according to any one of the preceding claims, characterised in that With the head part (18) removed, the connection point (52) and the access opening to the valve device (26) are exposed.

14. A container according to any one of the preceding claims, characterised in that The insert (48) is fixedly connected to the interior of the container part (10), preferably by welding.

15. A container according to any one of the preceding claims, characterised in that The insert (48) is constructed in multiple parts, preferably in two parts, and one of the insert parts has the connecting point (52) and the other insert part at least partially surrounds the one insert part in a manner that supports the separation point (20) and has at least one through-hole (60) as part of the flow-conducting connection (28), which produces a permanent connection between the container part (10) and a valve space (72) having the valve body (32).

16. A container according to any one of the preceding claims, characterised in that After the head part (18) has been removed, the free end side of the valve device (26) is freely accessible, preferably for sterilization, particularly preferably for wipe sterilization.

17. A container according to any one of the preceding claims, characterised in that After the head part (18) has been removed, the free end side of the valve device (26) optionally has a removable cover, preferably in the form of a removable film.

18. A multicomponent system, preferably for a container according to any one of the preceding claims, comprising a valve device (26) having a valve body (32), which is accommodated in an insert (48).

19. The multi-component system according to claim 18, characterized in that The insert (48) has a connection location (52) for mounting a connecting device (54).

20. A blow-molding, filling and closing method for producing a container according to any one of claims 1 to 17, wherein the container has a multi-component system according to claim 18 or 19, which is inserted in a form-fitting manner after the container part (10) is filled and is preferably covered by a head part (18) by welding, and the head part can be separated from the container part (10) via a separation point (20).

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