Container

Abstract

The invention relates to a container, in particular a filled and closed ampoule, consisting of at least one plastic material, having a container part (10) for receiving container contents (14) and having a head part (18) which can be separated from the container part (10) along a separation point (20) and which is integrally connected to the container part (10) before separation, characterised in that the container has a valve device (26) which, in its closed position, blocks a fluid-conducting connection (28) into the container part (10) and, in its open position, releases this connection.

Description

[0001] container

[0002] The invention relates to a container, in particular an ampoule, made of a plastic material, with a container part for receiving a container content and with a head part which can be separated from the container part along a separation point and which is integrally connected to the container part before separation.

[0003] WO 2019 / 063346 A1 discloses a container, in particular an ampoule, made of plastic material, with a container part for receiving a container content that can be dispensed via a container opening, which is closed by a head part that can be separated along a separation point and to which a neck part is connected, which has a plurality of different functional surfaces on the inner circumference, of which a contact functional surface serves to seal against a removal body that is provided for removing the container content when the container opening is released, wherein in addition to the existing functional surfaces, a front surface is provided on the inside of the neck part as a further functional surface, which differs geometrically from the contact functional surface, which merges seamlessly into the front surface and the front surface and the contact functional surface are accommodated between the other functional surfaces in the neck part.The known container, which is preferably manufactured using the blow molding, filling, and sealing (BFS) process, is characterized by the fact that the wall thickness in the front area, but especially in the area of ​​the functional contact surface, is significantly thinner than the average wall thickness in the neck section. This results in a significantly lower radial stiffness of the sealing area for sealing, and only minimal forces are required to expand it by the removal body during the removal process, thus facilitating the removal process.

[0004] EP 1 989 1 17 B1 discloses a container comprising: a hollow receiving body for receiving a dispensing medium,

[0005] - a discharge opening formed on the receiving body for discharging the discharge medium from the receiving body, and a closure part which has a hollow chamber outside the receiving body keeping the discharge opening free and forming a head part of the container, wherein the closure part is detachably connected to the receiving body via a separation point and has opposing wall parts in the region of the hollow chamber.

[0006] Because in the known solution the opposing wall parts of the closure part are displaced into the hollow chamber at a distance from the separation point in such a way that the remaining free chamber cross-section of the hollow chamber with its receiving volume is reduced to such an extent that the dispensing medium stored in the receiving body cannot penetrate into the hollow chamber, the dispensing medium of the container remains in the form of a very thin medium in the hollow receiving body and thus does not enter the hollow chamber, so that it cannot be lost during a removal process from the container, which is particularly disadvantageous when precise dosing is important during dispensing or the dispensing medium itself is very expensive or when precise mixing ratios and concentrations for later use are important when dispensing suspensions.

[0007] EP 2 826 457 B1 discloses an ampoule for a medicinal liquid, comprising an ampoule body for containing the medicinal liquid. The ampoule body is manufactured as a plastic injection-molded part, and a connecting part serves to connect a withdrawal device to the ampoule. The ampoule itself is constructed in several parts, and the connecting part is mounted on the ampoule body as a separate part for a withdrawal process. The connecting part is held in a form-fitting manner on a neck of the ampoule body. A membrane element is arranged between the ampoule body and the connecting part to seal a transition between the ampoule body and the connecting part.

[0008] Based on this state of the art, the invention is based on the object of improving the known solutions.

[0009] A container having the features of patent claim 1 in its entirety solves this problem.

[0010] Because, according to the characterizing part of patent claim 1, the container has a valve device which, in its closed position, blocks a fluid-carrying connection into the container part and, in its open position, releases it, it is ensured that, in the closed state of the container, no unintentional transfer of fluid stored in the container part, in particular for medical purposes, towards the head part occurs, which would otherwise lead to a change in the fill volume on the container part side and the entire container contents would then no longer be available for removal. Thus, due to its manufacturing process, the head part regularly has a hollow head space into which, without the valve device according to the invention, the contents of the container part could enter and, upon separation of the head part from the remaining container part, would no longer be available for removal by means of a conventional connection device.This is reliably prevented by the container according to the invention, and the entire container contents are available for withdrawal. Furthermore, the valve device is microbiologically safely housed in the closed container.

[0011] After the head section is removed, the initially closed valve device ensures that the contents of the container remain microbiologically sealed from the environment. Only after the valve device is released, usually via a connection or withdrawal device, such as a syringe body, does the container contents flow from the container into the syringe body in a microbiologically safe manner and without puncturing a sealing element – ​​which always carries the risk of generating particles. Similarly, microbiologically safe multiple withdrawals are possible, since the valve device automatically closes the container securely after the withdrawal device is removed. This has no equivalent in the state of the art.

[0012] In a preferred embodiment of the container according to the invention, the valve device is arranged within the container wall between the container part and the head part, preferably in a neck portion between the container and the head part, and the valve device is exposed for actuation after the head part is separated. Due to its one-piece construction, the container is hermetically and microbiologically sealed before the head part is separated. Even after the head part is separated, the closed valve device ensures a tight seal against the environment along the separation point.

[0013] In a particularly preferred embodiment of the container according to the invention, the valve device for maintaining the fluid-carrying connection comprises an actuatable valve body which, under the action of a restoring force, blocks the fluid-carrying connection in an initial position. Preferably, in order to maintain the restoring force, the valve body is at least partially deformable and / or can be reset to its blocking initial position by means of a reset device, preferably in the form of an energy store. In this way, the valve body, due to its inherent elasticity and / or under the influence of an external force, repeatedly returns automatically to its blocking initial position and hermetically seals the container contents. This solution can be implemented in a space-saving manner, so that the valve solution can also be used for small ampoule sizes.

[0014] In a particularly preferred embodiment of the container according to the invention, it is provided that the valve device is actuated by a connection device, preferably in a conical shape, and thus moves from the blocking to an open position, in which the fluid-carrying connection is established for the purpose of withdrawing the container fluid or introducing another fluid from or into the container part. By means of the connection device, container fluid can be withdrawn in the usual way from the interior of the container part with the valve device open; however, it is also possible to first introduce external fluid, for example for producing a mixture or suspension, into the container part via the connection device with the valve device unlocked and to prepare the medicine on site in the open container with a predeterminable mixing ratio for a final withdrawal process.

[0015] Preferably, the valve device comprises an insert that has a connection point, preferably in the form of a connector for conical connections, such as tapered connections, for the detachable attachment of the connection device. Such connection points with connecting devices, such as syringe bodies, etc., are known in technical terms as Luer or Luer-Lock connections. This combines two functions—the connection and valve mechanism—in one container component.

[0016] In a further preferred embodiment of the container according to the invention, the insert extends, when the container is closed, between adjacent wall parts of the container part and the head part, and the separation point encloses the insert on the outer circumference. While it is possible for an inherently elastically deformable valve body to be inserted directly into the container and adjacent to its wall, an insert with the valve device is preferably provided. The insert, preferably designed to be inherently stable, protects the valve body of the valve device from incorrect operation. With a predeterminable inherent stability of the insert, it can be reliably inserted into the container as a third component during blow molding, filling, and closing production before closing, but after filling the container. Furthermore, the separation point can be supported on the insert, which facilitates the opening process by removing the head part.

[0017] Preferably, the connection point and access to the valve device are exposed upon removal of the head portion, with the insert being firmly anchored to the interior of the container portion. This ensures secure positioning of the valve device in the region of the neck portion as the transition point between the container portion and the head portion. After removal of the head portion, the connection point is exposed for attaching the connection device, so that, viewed from the outside, a secure, fluid-tight connection is established between the connection device and the container contents via the valve device.

[0018] In another particularly preferred embodiment of the container according to the invention, the insert is constructed in several parts. Due to the multi-part design of the insert, it has a modular construction, similar to a building kit, and differently designed valve devices with their valve bodies can be largely freely combined with the insert that accommodates them. This allows a multitude of different valve devices to be realized for a container as needed, with different types of connection points, which, however, are preferably standardized with regard to the respective connection device used, such as a syringe body.

[0019] For further increased microbiological safety, it can also be provided that, after removal of the head part, the exposed end face of the valve device is freely accessible, preferably for performing disinfection, particularly preferably for performing wipe disinfection. In this regard, it can also be provided that, after removal of the head part, the exposed end face of the valve device optionally has a removable cover, preferably in the form of a peelable film.

[0020] The invention further relates to a multi-component system, preferably for a container as presented above, consisting of a valve device with a resettable valve body, which is accommodated in an insert. Furthermore, the insert preferably has a connection point for attaching a connection device. This multi-component system can be manufactured separately in a variety of different configurations as a tradable product and only later, as part of the container manufacturing process, in particular in the form of a blow-molding, filling, and closing process, can be suitably combined with the container wall material.

[0021] In this respect, the invention also relates to a corresponding manufacturing method, wherein the said multi-component system is preferably inserted into the container in a form-fitting manner after filling the container part and is preferably welded, and covered by a head part which can be separated from the container part via a separation point. The container is preferably filled with a fluid, in particular for medical purposes, which may optionally contain a preservative. Furthermore, the container preferably has a cycloolefin polymer and / or cycloolefin copolymer-containing layer, at least on the inside of the container part. The insert and / or the valve device consists predominantly of polyolefinic plastics, such as polyethylene (PE) and / or polypropylene (PP) and / or cycloolefin polymers (COP) and / or cycloolefin copolymers (COC).

[0022] In the following, the container according to the invention is explained in more detail using an exemplary embodiment according to the drawing. In this diagram, not to scale, the

[0023] Figure 1 is a front view of a filled container in the form of an ampoule;

[0024] Figure 2 shows, in the form of a longitudinal section, the upper region of the container in question, as viewed in the direction of Figure 1, with a valve device in the unactuated state; and

[0025] Figure 3 shows the container according to Figure 2 in the open state, after removal of a head part, in a removal position in which the valve device is brought into the open position by a connection device attached from the outside.

[0026] Figure 1 shows, as a whole, a one-piece, filled container, particularly in the form of an ampoule, made of plastic material, prior to its opening, with a container part 10 for receiving a container content 14 that can be dispensed via the container for medical purposes or the like. The container is shown in its vertical position in Figure 1, and the fill level of the container content 14 in the container part 10 is indicated by a dashed fill level line 16. The container content 14 is usually formed from a fluid, for example in the form of a liquid for medical purposes; however, it is also possible to provide pasty media as the container content 14.

[0027] As viewed in the direction of Figure 1, the container has a head part 18 towards the top, which can be separated from the container part 10 along a separation point 20. Below the head part 18, a neck part 22 represents a transition between the container part 10 and the head part 18. The head part 18 has a handle 24 on its upper side, which is also technically called a twist-off toggle, 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 low actuating torques or actuating forces. This design is common for containers such as ampoules produced using the BFS process, so it will not be discussed in more detail here.

[0028] As Figures 2 and 3 in particular show, the container has a valve device, designated as a whole by 26, which in its closed position, as shown in Figure 2, blocks a fluid-carrying connection 28 in the container part 10 and, as shown in Figure 3, releases it in its open position. As Figures 2 and 3 further show, the valve device 26 is accommodated within the container wall 30 between the container part 10 and the head part 18, preferably at least partially in the region of the neck part 22. After the head part 18 has been separated along the separation point 20 from the container part 10 above the neck part 22, the valve device 26 is then exposed at the front for actuation.

[0029] To maintain the fluid-carrying connection 28 already mentioned, the valve device 26 has an actuatable valve body 32 which is designed to be more or less elastic and is returned to its blocking starting position as shown in Figure 2 under the action of a restoring force which is permanently applied by means of a restoring device 34. The valve body 32 can be moved downwards along an actuating axis 36 against the force of the restoring device 34 and thus moves from its blocking position shown in Figure 2 into the open position shown in Figure 3. The valve body 32 is designed to be essentially rotationally symmetrical with respect to the actuating axis 36 and has a conically circumferential contact surface 38 in the direction of the handle 24 which, in a fictitious extension with the actuating axis 36, encloses an angle of inclination of approximately 45°.On the free end face of the valve body 32, and approximately in the center, a radial overflow channel 40 is provided, which projects into the image plane in a fictitious extension and, accordingly, merges at its free ends into the conical contact surface 38. To this extent, the actuating axis 36 extends from above through the center of the radial overflow channel 40, which extends horizontally in this respect, provided the container assumes its vertical position shown in the figures. Otherwise, the valve body 32 is designed to be flat on its free end face except for the recessed radial overflow channel 40.

[0030] Below the conical contact surface 38, the valve body 32 is cylindrical, with individual axial overflow channels 44 recessed into the cylindrical outer surface 42, which enable a fluid connection from the underside 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 outer surface 42 merges seamlessly into the conical contact surface 38.Furthermore, the valve body 32 has on its underside, as a return device 34, an elastically resilient element 46, which is preferably an integral part of the valve body 32 and consists, for example, of a hollow plastic molded part, which is shown in its extended position in Figure 2 and in the compressed position in Figure 3. In the extended state of the element 46, the valve body 32 is in its closed position and, in the compressed, actuated position, assumes its open position releasing the fluid-carrying connection 28. Instead of the solution shown, the elastically resilient element 46 can also be formed entirely from elastomer material, which is used as an insert below the valve body 32. Further return devices 34 in the form of an energy storage device, such as a spiral spring, are possible if required.

[0031] 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 face of the connection 50. The connection 50 and the connection point 52 serve for the detachable attachment of a connection device 54, as is shown by way of example and in part in Figure 3. The insert 48 essentially consists of a wall part 56 which forms a hollow cylinder, wherein the wall part 56 is integrally penetrated on the foot or bottom side by a transverse wall 58 which has a plurality of fluid passage points 60 as part of the fluid-carrying connection 28, which are preferably arranged continuously in the transverse wall 58, opposite one another, diametrically to the actuating axis 36.The vertically extending wall portion 56, as viewed in the direction of Figures 2 and 3, has a projection below the transverse wall 58 and is firmly connected to the container wall 30 at the free end of this projection by means of an annular weld seam 62, which at this point lies flush with the insert 48 in the direction of a taper 64 of the neck portion 22. On the outer circumference side, the cylindrical wall portion 56 is encompassed by the separation point 20 in the closed state of the container, which is formed from a weld along the insert 46, which can also be referred to as an "insert." Thus, on the outer circumference side, the container wall 30, in the closed state of the container, rests completely against the outer circumference of the insert 48, wherein after removal of the head portion 18, as shown in Figure 3, the upper region of the insert 48 with the wall portion 56 is exposed.

[0032] The connector 50 is accommodated as a whole in the insert 48, the outer circumference of which is partially fixed in a defined manner to the inner circumference of the insert 48. On its free upper end face, the connector 50 has the connection point 52, which in Figures 2 and 3, in a simplified representation, shows only part of a screw thread 66 in the manner of an external thread, onto which the connection device 54 with a correspondingly designed internal thread 67 can be screwed. The corresponding screw connection thus represents part of a standardized Luer-Lock connection. Since this connection technology is common in this field, it will not be discussed in more detail here and reference is made to the relevant state of the art.

[0033] Furthermore, the connection 50 has a conical recess 68 on its inner circumference, with the recess 68 tapering conically toward the valve body 32. As Figure 3 shows, the conical recess 68 in the connection 50 serves to insert a precisely matched withdrawal cone 70 of the connection device 54, here in the form of a so-called Luer-Lock syringe. However, other, almost arbitrarily designed connection devices can also be connected to the opened container via the connection 50, with the connection 50 preferably serving to accommodate conical connections or other conical connection components.The connection 50 is cylindrical on the outer circumference except for the projecting external thread with the respective screw thread 66 and is inserted into the inner circumference of the insert 48 with a precise fit, whereby the lower end of the connection 50 rests on the upper side of the transverse wall 58 in such a way that it is ensured in all cases that the fluid passages 60 are kept clear. In this respect, the connection 50 forms a type of valve chamber 72 on its inner circumference, in which the valve body 32 is guided so as to be longitudinally movable, with the proviso that the valve chamber 72 kept clear by the valve body 32 in every travel position thereof is part of the fluid-carrying connection 28 and is permanently in fluid-carrying communication with the fluid passages 60 in the transverse wall 58.

[0034] Furthermore, the connection 50 forms a valve sealing seat 74 opposite the contact surface 38 of the valve body 32. To form the valve sealing seat 74, the contact surface 38 can preferably come into flat contact with the equally conically inclined inner wall surface of the connection 50 at this point; however, it is preferably provided, as shown in Figure 2, that the contact cone 76 on the inside of the connection 50 is more steeply inclined than the cone for the contact surface 38, so that a linear valve seat pressure is obtained with an increased sealing effect along the aforementioned valve sealing seat 74. Due to the linear valve sealing seat formation, an unobstructed opening process for the valve body 32 is also achieved.At its widest upper point with the screw thread 66, the radial extension for the connection 50 is selected in such a way that the head part 18 fits over the edge geometry of the insert 48 and the connection 50 with a radial distance.

[0035] If the head part 18 is removed and the connection device 54 engages with the conical withdrawal part 70 in the connection 50, the free tip end of the connection device 54 pushes the valve body 32 open against the action of the return device 34, so that fluid or the container contents 14 passes via the fluid-carrying connection 28 into the withdrawal channel 78 of the connection device 54, which runs concentrically to the actuating axis 36 within the connection device 54. Accordingly, the fluid passes via the interior of the container part 10 and via the interior of the neck part 22 through the fluid passages 60 into the lower region of the valve chamber 72 and from there via the axial overflow channels 44 in the direction of the contact surface 38, which, kept at a distance from the valve sealing seat 74, enables a lateral flow past in the direction of the radial overflow channel 40, from where the liquid enters the withdrawal channel 78.In this way, the free end of the extraction cone 70 presses the valve body 32 open, counter to the action of the return device 34, while restoring the end face, thereby increasing the return force of the return device 34. Once the extraction process is complete or initiated to the desired extent, the connection device 54 is unscrewed from the container and the valve device 26 closes, thereby hermetically sealing the interior of the container from the environment. In this way, it is also fundamentally possible to introduce stored fluid into the container via the connection device 54 in order to mix it with the fluid in the container contents 14.In this way, pharmaceutical mixtures or suspensions can be prepared and then discharged via the connection device 54, which is useful when components are to be mixed together that otherwise cannot be stored for long periods due to their chemical properties in combination. The insert 48 used is made of several parts, preferably two parts in the present embodiment, with one insert part having the connection point 52 as the connection 50, and the other insert part in the form of the cylindrical wall part 56 supporting the separation point 20.Due to this modular construction, it is also possible to use other valve devices 26. For example, in an embodiment not shown, it would be conceivable to place an elastically flexible valve body directly on the inner wall side of the container wall 30, which in turn is actuated from the outside via a connection device 54 and elastically releases a fluid path in the direction of the interior of the container part 10 and otherwise blocks the corresponding fluid path due to its inherent elasticity.

[0036] If the container is opened as shown in Figure 3, i.e., the head part 18 is removed, the free end face of the valve device 26 can be disinfected from the outside, for example, by wiping. Furthermore, for improved microbiologically safe sealing, the valve device 26 can optionally have a removable cover (not shown), preferably in the form of a peelable film.

[0037] The solution described above can be produced within the framework of a conventional blow-molding, filling and closing process and the insertion of insert bodies is generally known within the framework of such manufacturing processes and is shown by way of example in DE 10 2014 008 61 1 A1.

[0038] For sterile products, such as parenterals, sterilized valve devices 26 are preferably introduced into the filled BFS container in a cleanroom environment, preferably an isolator. Sterilization of the valve device 26 is preferably carried out with high-energy radiation (for example, in the form of gamma radiation, electron beams, X-rays, etc.), by autoclaving, or by sterilizing gases such as ethylene oxide, chlorine dioxide, or hydrogen peroxide.

[0039] Furthermore - particularly for sterile products and products that are heat-treated for sterilization - the function of the valve device 26 is advantageous in the event that an overpressure should arise in the container part 10 - for example caused by temperature changes, air pressure changes during transport or mechanical forces on the container.

[0040] Particularly preferred materials are cycloolefin polymer-containing materials (COP, manufactured by Zeonex) and / or cycloolefin copolymer-containing materials (COC, manufactured by Topas) as container materials, as well as as outer material for the valve device 26. It will be surprising to a person of ordinary skill in the art that these material combinations can be easily welded together in the BFS manufacturing process. Furthermore, BFS containers made of multilayer plastics are possible, as described, for example, in DE 10 347 908 A1.

[0041] Halogenobutyl rubbers, silicones or, particularly preferably, elastomer-modified cycloolefin copolymers are preferably used as elastomer material for the valve body 32; the latter can be easily produced by injection molding.

[0042] What is particularly advantageous in the containers or ampoules according to the invention is that the space above and below the valve device 26 with the movable valve body 32 is surrounded by the same material and thus a uniform permeation behavior is provided.

[0043] Overall, a container solution is therefore created, preferably in the form of an ampoule, which is suitable for parenterals and advantageously combines the following features: integrated tamper-evident closure by means of a detachable head part,

[0044] - optional additional tamper-evident closure by means of a removable foil on the valve device, no leakage of the ampoule contents when removing the head part, easy access without the risk of particle formation as no cannula, spike or similar is necessary, secure sealing before and after each use (including disposal), simple optional wipe disinfection before each withdrawal and minimal

[0045] Losses due to water permeation during storage of the filled and sealed container, secure sealing even in the event of overpressure in the container part.

[0046] This has no equivalent in the state of the art.

Claims

Patent claims for a container, in particular a filled and sealed ampoule, consisting of at least one plastic material, with a container part (10) for receiving a container contents (14) and with a head part (18) which can be separated from the container part (10) along a separation point (20) and which is integrally connected to the container part (10) before separation, characterized in that the container has a valve device (26) which, in its closed position, blocks a fluid-carrying connection (28) into the container part (10) and, in its open position, releases it.Container according to claim 1, characterized in that the valve assembly (26) is arranged within the container wall (30) between the container part (10) and the head part (18), preferably at least partially in a neck part (22) between the container (10) and the head part (18), and that after the head part (18) is detached, the valve assembly (26) is exposed for actuation, preferably at its end face. Container according to claim 1 or 2, characterized in that the valve assembly (26) has an actuable valve body (32) for maintaining the fluid-carrying connection (28), which, under the influence of a restoring force, blocks the fluid-carrying connection (28) in an initial position. Container according to any one of the preceding claims, preferably in the configuration of an ampoule, which allows easy access and is free from the use of a cannula, spike, or similar device. Container according to one of the preceding claims, characterized in that the valve body (32) is substantially rotationally symmetrical with respect to an actuating axis (36) and has a conically circumferential contact surface (38) in the direction of a handle (24) for separating the head part (18). Container according to one of the preceding claims, characterized in that a radially extending overflow channel (40) is provided on the free end face of the valve body (32), which transitions into the conical contact surface (38) at its free ends.Container according to one of the preceding claims, characterized in that the valve body (32) is cylindrical below the conically extending contact surface (38) and that individual overflow channels (44) are recessed into the cylindrical outer surface (42) in this respect, which allow fluid to flow from the underside of the valve body (32) towards the conical contact surface (38) and towards the radial overflow channel (40). Container according to one of the preceding claims, characterized in that, to maintain the restoring force, the valve body (32) is at least partially deformable and / or can be restored to its blocking initial position by means of a restoring device (34), preferably in the form of an energy storage element, particularly preferably designed as an elastically resilient element (46).Container according to one of the preceding claims, characterized in that the valve device (26) can be actuated by a connection device (54), preferably in a conical form, and thus moves from the closed to an open position, in which a fluid can be withdrawn and / or introduced from the container. or the fluid-carrying connection (28) is established in the container part (10).

10. Container according to one of the preceding claims, characterized in that the valve device (26) has an insert (48) which has a connection point (52), preferably in the form of a connection for conical cone connections, for the releasable attachment of the connection device (54). 1 1. Container according to one of the preceding claims, characterized in that the insert (48) has a hollow cylindrical wall part (56) which is integrally penetrated at the foot or bottom side by a transverse wall (58) which has several fluid passage points (60) as part of the fluid-carrying connection (28).

12. Container according to one of the preceding claims, characterized in that the insert (48) extends between adjacent wall parts (30) of container part (10) and head part (18) in the closed state of the container and that the separation point (20) encompasses the insert (48) on its outer circumference.

13. Container according to one of the preceding claims, characterized in that the connection point (52) and access to the valve assembly (26) are exposed upon removal of the head part (18).

14. Container according to one of the preceding claims, characterized in that the insert (48) is firmly connected to the interior of the container part (10), preferably by welding.

15. Container according to one of the preceding claims, characterized in that the insert (48) is designed in multiple parts, preferably in two parts, and that one insert part has the connection point (52) and the other insert part supports the separation point (20). at least partially comprises one insert part and, as part of the fluid-carrying connection (28), has at least one through-opening (60) that establishes a permanent connection between the container part (10) and a valve chamber (72) with the valve body (32).

6. Container according to one of the preceding claims, characterized in that, after removal of the head part (18), the free end face of the valve assembly (26) is freely accessible, preferably for carrying out disinfection, particularly preferably for carrying out wipe disinfection.

7. Container according to one of the preceding claims, characterized in that, after removal of the head part (18), the free end face of the valve assembly (26) optionally has a removable cover, preferably in the form of a peelable film. 8.Multi-component system, preferably for a container according to one of the preceding claims, comprising a valve assembly (26) with a valve body (32) which is received in an insert (48).

9. Multi-component system according to claim 18, characterized in that the insert (48) has a connection point (52) for attaching a connection device (54).

0. Blow molding, filling, and closing manufacturing method for producing a container according to one of claims 1 to 17 with a multi-component system according to claim 18 or 19, which, after filling a container part (10), is positively inserted and, preferably welded, covered by a head part (18) which can be separated from the container part (10) via a separation point (20).

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