CAP FOR A MEDICAL CONTAINER AND METHOD FOR ITS FITTING

Description

Field of invention

[0001] The invention relates to a cap for a container filled with a medical liquid, which is in particular designed as a bottle. The invention further relates to a method for assembling the cap of a medical container. Background of the invention

[0002] Containers, especially bottles, are known for storing medical fluids, such as infusion solutions, which have a pierceable sealing element to allow the fluid to be removed by means of a transfer device, for example by means of a spike of an administration system, or to inject fluid, such as a pharmaceutical active ingredient, into the medical container, for example by means of a needle syringe.

[0003] The sealing element is particularly resealable and is inserted with a spike or needle. A spike is a hollow needle, typically made of plastic or metal, with a larger diameter than metal needles.

[0004] The basic principle is the same, however: a hollow needle is inserted into an elastic sealing element, which closes automatically after the hollow needle is withdrawn.

[0005] Bottles filled with a medical fluid, manufactured using the so-called blow-fill-seal process, are particularly well-known. In this process, a base body made of plastic is blown, then filled with the medical fluid, hermetically sealed, and finally connected with a cap that is equipped with a sealing element.

[0006] Such a container is known in particular from document WO 2016 / 156 242 A1 (Fresenius Kabi Deutschland GmbH). The cap shown in this document includes a sealing element with a convex upper surface. The sealing element is easily wipeable, which is required by regulations in some countries.

[0007] To fix the sealing element in the cap, the sealing element has an annular, axially extending ridge on the top and bottom edges, which sits in a complementarily designed groove in the cap.

[0008] To install the sealing element, it can be inserted into the cap from the inside. Then, a collar on the cap that extends around the sealing element is crimped over, thus securing and clamping the sealing element in such a way that sufficient sealing is ensured and the sealing element is held securely.

[0009] The crimping of the collar requires a suitable system, which may be complex and system-specific, especially if it is located, for example, in an aseptic part of the production plant.

[0010] Such a container, in which the sealing elements are also fixed by means of crimping, is also known from document US 2009 / 054865 A1 (Fresenius Kabi Deutschland GmbH). There, a further embodiment is described in which a retaining plate is arranged on the inside of the lid part of the cap, with which the sealing elements are clamped. For this purpose, the retaining plate preferably has projections that engage under the sealing elements. Object of the invention

[0011] In contrast, the invention aims to simplify the assembly of the sealing element(s) of a closure cap for a container filled with a medical fluid. At the same time, the closure cap should be particularly secure, both during assembly and in its subsequent use on the medical container. Summary of the invention

[0012] The object of the invention is already achieved by a closure cap for a container filled with a medical liquid and by a method for assembling a closure cap for a container filled with a medical liquid according to one of the independent claims.

[0013] Preferred embodiments and further developments of the invention can be found in the subject matter of the dependent claims, the description and the drawings.

[0014] The invention relates to a cap for a container filled with a medical fluid, wherein the cap has at least one connection with a sealing element which can be pierced with a spike or needle for the purpose of dispensing the medical fluid, wherein a flap is arranged on the inside of the cap which is connected to the base body by means of a hinge, and wherein the sealing element is fixed to or in the cap by the flap which is folded against the base body. The medical fluid is preferably a medical fluid for infusion, transfusion, enteral nutrition, parenteral nutrition and / or a rinsing solution.

[0015] According to claim 1, the invention is described by a closure cap for a container filled with a medical liquid, wherein the closure cap has a base body and at least one connection with a sealing element which can be pierced with a spike or a needle for the purpose of removing the medical liquid, characterized in that a flap is arranged on the inside of an underside of the base body of the closure cap, which is connected to the base body by means of a hinge, wherein the sealing element is fixed to the closure cap by the flap folded against the base body.

[0016] The closure cap is designed in particular as a plastic injection molded part, especially made of polypropylene and / or polyethylene.

[0017] The main body of the cap consists of a base and a side wall. The flap is located on the inside of the base of the main body.

[0018] The cap preferably has a connection flange for the base body of a medical container. This allows the cap to be welded or glued to the base body, for example.

[0019] The connection with at least one sealing element can, for example, be designed as a nozzle containing an elastic sealing element that can be pierced with a spike or needle, at least for the purpose of extracting the medical fluid. Generally, the sealing element is pierced with a spike to extract the medical fluid.

[0020] The sealing element is preferably self-sealing. When providing a sealing element for a hollow needle, particularly one made of metal, the sealing element can be designed as a closed membrane. A channel pierced by the needle closes automatically due to the elasticity of the sealing element when the needle is withdrawn. For example, a pharmaceutical active ingredient can be added to the medical fluid using a needle syringe.

[0021] Particularly when using spikes to extract the medical fluid, the sealing element may also include at least one slot or punched hole, which widens when the spike is inserted and automatically contracts again when the spike is withdrawn due to the elasticity of the material.

[0022] The flap located on the inside of the cap is understood to be a pivotable component which is connected to the base body by means of a hinge in order to be opened from the inside onto the underside of the cap when used as intended.

[0023] The flap connects to the base body, primarily by locking it into place, thus securing the sealing element. The sealing element is clamped or compressed by the flap, ensuring sufficient tightness and secure fixation.

[0024] Simultaneously, as provided in a preferred embodiment of the invention, the sealing element can also be positively connected to the closure cap. Such a positive connection can reliably prevent the sealing element from being forced out when the piercing is performed.

[0025] Due to the flap's internal placement, it is securely protected against mechanical manipulation, as it is located inside the sealed container when closed.

[0026] At the same time, a hinged flap enables particularly easy and safe assembly of the closure cap, both when using a machine designed for this purpose and when assembling the closure cap manually.

[0027] The cap is therefore particularly advantageous for use in smaller production facilities where the provision of expensive machinery should be avoided as much as possible.

[0028] In a preferred embodiment of the invention, the base body is pot- or cup-shaped. The base body is formed by the bottom and the side wall. Specifically, the flap is arranged on the inside of the bottom of the base body.

[0029] Preferably, the opened flap is also completely inside the closure cap, i.e., it does not protrude beyond the lower edge of the base body.

[0030] For example, during transport of the closure caps, it is ensured that the flap is not subjected to any mechanical stress.

[0031] In one embodiment of the invention, the sealing element is closed or provided with a tamper-evident seal.

[0032] In particular, the sealing element can be covered with a break-off piece which is connected to the base body of the closure cap via a predetermined breaking point surrounding the sealing element.

[0033] Such a break-off piece offers a high level of safety and can also be supplied together with the base body as a one-piece injection-molded plastic part.

[0034] The predetermined breaking point is specifically designed as a weakening zone that extends directly around one of the top surfaces of the sealing element. This allows the sealing element to be accessed after the break-off piece has been snapped off and, if necessary, wiped clean.

[0035] In one embodiment of the invention, the sealing element comprises a circumferential annular retaining flange or annular web which sits in a groove of the base body and / or the flap.

[0036] Therefore, a positive fit between the sealing element and the base body and / or the flap is ensured at the edge by at least one ring-shaped, axially extending web.

[0037] This prevents the sealing element from being pushed out even under strong mechanical stress during insertion.

[0038] Furthermore, the use of the flap allows for a particularly simple and stable positive fit. In particular, unlike with flanging, the design of the positive fit is not limited by the manufacturing process.

[0039] Preferably, the flap, folded against the base body, is latched to the base body. In the latched state, the flap is preferably arranged parallel to a top surface of the base body.

[0040] The flap can be designed in particular as a plate which includes at least one opening in which a penetration area of ​​the sealing element is located.

[0041] In a preferred embodiment, the hinge is designed as a film hinge. The flap can thus be supplied together with the base body as a one-piece injection-molded plastic part.

[0042] In a further development of the invention, the closure cap comprises at least two, in particular exactly two, connections, each with a sealing element. The closure cap can also have three or more connections.

[0043] The presence of two ports can, for example, be used to fill a medical liquid, such as one containing a pharmaceutical active ingredient, into the medical container via a first port and to remove the resulting mixture via a second port.

[0044] Furthermore, different sealing elements can provide two different connections, for example one connection for a spike (for removal) and another connection for a needle (for insertion).

[0045] Particularly with three ports, an additional Luer connector can be provided, for example, for connecting a Luer syringe or a Luer-lock syringe. In one embodiment, all sealing elements are designed to be wipeable.

[0046] Preferably in these embodiments of the invention, the flap is designed as a single flap which fixes the sealing elements of the at least two connections to or in the closure cap.

[0047] Accordingly, the flap can also have two or more through holes, which, when assembled, overlap with the penetration area of ​​each sealing element.

[0048] The through holes can be arranged particularly close together.

[0049] The flap can have a narrow side and a long side. In particular, the flap can be essentially rectangular with one long side and one narrow side.

[0050] Preferably the hinge is arranged on the long side of the flap and the flap is latched to the base body on the opposite long side when mounted.

[0051] In the assembled state, the flap is preferably connected to the base body over at least half its length.

[0052] The hinge can extend across the entire long side of the flap. This allows for a robust design.

[0053] Furthermore, the flap can rest against a projection of the base body at the corners opposite the hinge, and in particular be locked to the base body.

[0054] This provides additional security for the flap and prevents mechanical stress on the film hinge in the direction of its axis, such as can occur if a spike is pressed diagonally into the sealing element.

[0055] The flap can be latched, in particular at a corner opposite the hinge, with a latching element of the base body engaging each corner of the flap. The corner can also be rounded for this purpose. In particular, the flap can be designed, at least in sections, as a circular segment extending concentrically to the connection along its circumference. This allows for optimal utilization of the internal space within the closure cap.

[0056] The invention further relates to a container filled with a medical liquid, which is in particular designed as a bottle.

[0057] In one embodiment, the container is a plastic container manufactured using a blow-fill-seal (BFS) process, which is closed with the cap, in particular by welding or bonding. In another embodiment, the container is a container manufactured from a preform using stretch blow molding, which is closed with the cap, in particular by welding or bonding.

[0058] The medical fluid is a liquid used for medical purposes and is preferably administered intravenously. In a preferred embodiment, the medical fluid is an infusion solution or a rinsing solution. Possible examples of such infusion solutions and rinsing solutions include... sterile water; saline solutions, especially solutions containing NaCl, KCl, CaCl and / or Mg; solutions containing carbohydrates, especially glucose solutions; solutions, emulsions and / or suspensions containing nutrients for parenteral nutrition, especially containing lipids, amino acids and / or glucose; colloid solutions, especially for blood replacement therapy (e.g., Voluven®); and / or so-called premixed systems in which an active ingredient has already been added to the medical fluid, e.g., paracetamol.

[0059] Preferably, the container is sterilized. In particular, it can be a sterile container that is aseptically filled and sealed with a sterile cap, or that is subsequently autoclaved.

[0060] The invention further relates to a method for assembling a closure cap for a container filled with a medical liquid.

[0061] In particular, the invention relates to a method for assembling the closure cap described above and, in particular, a container with a medical liquid provided with the closure cap.

[0062] The process includes the following steps: Providing a closure cap which has a base body with at least one opening for a connection, wherein the closure cap has on an inner side a flap with at least one opening which is hinged relative to the base body; inserting a sealing element on the inside in front of the opening of the base body or in front of the opening of the flap; hinged of the flap onto the base body, wherein the flap locks onto the base body in an end position and fixes the sealing element between the opening of the base body and the opening of the flap.

[0063] The method claim describes a method for assembling a closure flap for a container filled with a medical fluid, in particular for a container described above, comprising the steps: Providing a closure cap which has a base body with at least one opening for a connection, wherein the closure cap has on the inside of an underside of the base body a flap with at least one opening which is hinged relative to the base body; inserting a sealing element on the inside in front of the opening of the base body or in front of the opening of the flap; hinged of the flap onto the base body, wherein the flap locks onto the base body in an end position and fixes the sealing element between the opening of the base body and the opening of the flap.

[0064] The process enables simple and safe assembly of the closure cap, both using an automated device and manually.

[0065] In a preferred embodiment, the sealing element is centered and held securely in position or prevented from being lost as soon as it is inserted into the opening of the base body or the flap.

[0066] Depending on the design, the sealing element can be inserted either into the flap or into the base body, where, due to an interference fit and the elastic material, it wedges itself in place so that it cannot accidentally fall out. The sealing element is finally secured by closing and locking the flap. Brief description of the drawings

[0067] The invention will below be described with reference to an embodiment of the invention and the drawings. Figs. 1 to 19 will be explained in more detail. Fig. 1is a perspective view of an embodiment of a closure cap according to the invention. Fig. 2 This is a side view. Fig. 3 is a perspective view from below, in which the inside can be seen. Fig. 4 This is a top view of the underside. Fig. 5 is a top view of the upper surface. Fig. 6 This is a longitudinal section of the cap. Fig. 7 This is a top view of the sealing element. Fig. 8 is a cross-section of the sealing element. Fig. 9 is a longitudinal section of the end cap centered along the connections. Fig. 10 is a detailed view of area A of the Fig. 9 . Fig. 11 is a side view and Fig. 12 a sectional view along line AA of the Fig. 11 . Fig. 13 is a detailed view of area A of the Fig. 12 . Fig. 14 is a side view and Fig. 15 is a longitudinal section along line AA of the Fig. 14 . Fig. 16is a top view of the underside and Fig. 17 a longitudinal section along line AA of the Fig. 16 . Fig. 18 This is a schematic view of a container fitted with a cap. Fig. 19 shows the steps of a method according to the invention for assembling a closure cap according to an embodiment of the invention. Detailed description of the drawings

[0068] Fig. 1 is a perspective view of a closure cap 1 according to an embodiment of the invention.

[0069] The cap 1 is cup-shaped and comprises a base body 20 with a connecting flange 21 for connection to the head of a medical container. The base body 20 is formed by the bottom 20a and the side wall 20b. The side wall 20b extends around the circumference of the bottom 20a. The bottom 20a forms the underside of the base body 20. Since the cap 1 is placed with its open side onto the head 3 of a container 2 (see, for example, the Figure 18 ) the base 20a, when in place, provides the upper closure, so to speak the lid of the closure cap 1.

[0070] In this embodiment, the closure cap 1 includes two connections 10a, 10b on its upper side.

[0071] The connections 10a, 10b each comprise a connection nozzle 22a, 22b, which, in the sense of the terminology of the present invention, is part of the base body 20.

[0072] Within each of the connecting spigots 22a, 22b, a sealing element 40 is arranged, the penetration area 41 of which is covered by a snap-off piece 11a, 11b. The snap-off pieces 11a, 11b each comprise a radially outwardly projecting wing handle 12a, 12b. The wing handles 12a, 12b form a lever that facilitates the removal of the snap-off pieces 11a, 11b.

[0073] As shown in the side view according to Fig. 2 As shown, the connecting nozzles 22a and 22b merge seamlessly in this embodiment. This ensures a particularly space-saving arrangement.

[0074] The break-off pieces 11a, 11b are connected to the base body 20 and the connecting spigots 22a, 22b, respectively, via predetermined breaking points 13a, 13b. The predetermined breaking points 13a, 13b are designed as weakening zones in which the wall thickness of the break-off pieces 11a, 11b decreases to facilitate breaking.

[0075] Each of the two wing handles 12a and 12b has an arrow indicating whether it is for adding or removing liquid. The arrow in wing handle 12a identifies connection 22a as a port for adding a liquid, for example, a medication, into container 2. The arrow in wing handle 12b, on the other hand, identifies connection 22b as a port for removing the medical liquid from container 2. The arrows are represented by recesses in the wing handles.

[0076] Fig. 3 Figure 1 shows a perspective view of the underside or inside of the closure cap. The unmounted state without sealing elements 40 is shown.

[0077] In this embodiment, the connecting flange 21 comprises a circumferential groove 23, which can be placed on the head part 3 of a container 2 and thus welded or glued to the head part 3.

[0078] A flap 30 is arranged on the underside of the base body 20. Specifically, the flap 30 is located on the inside of the base 20a of the base body 20. In its unassembled state, the flap 30 can be positioned at approximately a right angle to the underside of the base body 20.

[0079] The flap 30 is plate-shaped and includes two openings 32a, 32b, which in the assembled state overlap with the insertion area 41 of the sealing element 40.

[0080] The openings 32a, 32b are surrounded by an annular web 31a, 31b, which, in the assembled state, serves as a positive locking element for the sealing element 40, by the web 31a, 31b bearing against a ring 44 of the sealing element 40. The flap 30 can be folded against the underside of the base body 20 via a film hinge 35.

[0081] Fig. 4 Figure 1 shows the end cap 1 in a top view of the underside or inside. The connecting spigots 22a, 22b of the base body also include openings 24a, 24b, which, in the assembled state, overlap with the insertion area 41 of the sealing element 40 and with the openings 31a, 31b of the flap 30.

[0082] Fig. 4 Figure 30 also shows the unmounted state, in which flap 30 is folded downwards. Flap 30 comprises one long side and one short side.

[0083] On the opposite side of the film hinge 35, a locking element 25 is arranged on the underside of the base body opposite the long side of the flap 30.

[0084] Furthermore, two edge-side locking elements 26 extend concentrically around the openings 24a, 24b, which, in the assembled state, enclose the edges of the flap 30 opposite the film hinge 35.

[0085] The sealing elements 40 (see) can be used to mount the end cap. Fig. 7, Fig. 8 ) are inserted into the openings 24a, 24b and then the flap 30 is closed and locked in the assembled state.

[0086] As in Fig. 3 As shown, the openings 32a, 32b are surrounded by an annular web 31a, 31b, which serves as a positive locking element for a groove 42 of the sealing element 40.

[0087] Fig. 5This is a top view of the upper side of the closure cap. The wing handles 12a, 12b for breaking off the snap-off pieces 11a, 11b extend approximately to the outer edge of the closure cap 1 in the top view (the connections 10a, 10b are located at the top in the terminology, even if, for example, when using the container 2 for infusion, the connections are located at the bottom, i.e., the container 2 is used upside down).

[0088] Fig. 6 The diagram shows a longitudinal section of the closure cap, running centrally through the connections 10a and 10b. The section is directed towards the downward-folded flap 30, which does not project beyond the underside of the closure cap 1 and extends to the connection flange 21. The flap 30 is plate-shaped.

[0089] In the assembled state, the openings 32a, 32b run concentrically to the openings 24a, 24b of the base body 20 or the nozzles 22a, 22b, in which a sealing element 40 is seated in each in the assembled state.

[0090] A ring-shaped web 28a, 28b extends around the openings 24a, 24b, through which a ring-shaped groove 27a, 27b is formed in each case, which extends axially and in which, in the assembled state, a ring 43 or ring-shaped web of the sealing element 40 sits.

[0091] Furthermore, a chamfer 33 extends at least around the side opposite the film hinge 35 and the narrow sides at the edge of the flap 30, which forms a ramp for pushing away the locking elements 25, 26 when the flap 30 latches when closing.

[0092] The connecting pieces 22a and 22b merge seamlessly, forming a wall in the form of the web 28 between them. From this common web 28, the walls of the connecting pieces 22a and 22b diverge, so that, viewed from above, they each form rings that overlap in the area of ​​the web (see figure). Fig. 5 ).

[0093] Fig. 7 The image shows a sealing element in a top view. This element is circular and made of an elastic material, such as polyisoprene.

[0094] The sealing element 40 comprises a penetration area 41 into which, in this embodiment, a spike (not shown) can be inserted. The penetration area 41 is provided with an annular marking 45. The penetration area 41 is cross-slotted via the slots 46, 47. Such slotted sealing elements are used particularly for connecting a spike for extracting liquid. These are also commonly referred to as stoppers.

[0095] Especially for an inlet port, through which, for example, a pharmaceutically active ingredient can be filled into container 2, non-slotted sealing elements are generally used. These are also commonly referred to as septa (not shown). They can also have a different geometry (not shown).

[0096] A ring-shaped groove 42 runs around the insertion area 41, to which a ring-shaped web 43 extends radially outwards, serving as a positive locking element.

[0097] Fig. 8 The figure shows a central longitudinal section of the sealing element 40. Since the section runs precisely through a slot 47, the material of the insertion area 41, from which the marking 45 protrudes on the upper side, is not hatched in this illustration. The slots 46, 47 do not extend to the underside of the sealing element 40, but end before it. When a spike is first inserted into the sealing element 40, the sealing element tears open below the slots 46, 47. Nevertheless, the sealing element 40 reseals itself when the spike is withdrawn due to the elasticity of the material.

[0098] On its outer edge, the sealing element 40 comprises a circumferential ring 43, 44 or an annular rib, which serves as a positive locking element, both on its upper and on its lower side.

[0099] Fig. 9 Figure 1 is a longitudinal section of the closure cap 1 in the assembled state, running centrally through the connections 10a and 10b. In this embodiment, two identical sealing elements 40 are used. Two different sealing elements 40 can also be used (not shown).

[0100] Fig. 10 is a detailed view of area A of the Fig. 9 , in which the area of ​​one of the sealing elements 40 is shown. The sealing element 40 is now located between the flap 30 and the underside of the closure cap 1. The flap 30 rests against the underside of the base body 20. The upper ring 43 of the sealing element 40 sits in the annular groove 27b of the connecting piece 22b. This creates a positive fit.

[0101] On the underside, the ring 44 of the sealing element 40 sits between the annular web 31b of the flap and the base 20a and the side wall 20b of the base body 20 or of the connecting nozzle 22b.

[0102] Adjacent to the opposite connecting piece 22a, the ring 44 sits between the web 28, which lies between the connecting pieces 22a and 22b. The ring 44 extends into the side walls of the connecting pieces 22a and 22b, starting from the point shown here where the side walls overlap, according to the annular groove in which it sits. The web 28, or the side walls of the connecting pieces 22a and 22b, extend downwards to the flap 30. The ring 44 thus lies in a groove formed by the flap 30 and the opposite base body 20, or the connecting piece 22b.

[0103] The predetermined breaking point 31b is located approximately at the same level as the upper surface of the piercing area 41 of the sealing element 40, from which the marking 45 may protrude. After breaking off the break-off piece 10b, the piercing area 41 is thus easily accessible, particularly for disinfection by wiping.

[0104] Fig. 11 is a side view of the cap and Fig. 12 is a longitudinal section along line AA of the Fig. 11 . Shown in Figure 12 The flap 30 is shown in its unmounted state, with a chamfer 33 on one long side. The chamfer 33 can be configured as a 30-60° chamfer.

[0105] The locking element 25 is located on the long side of the flap 30 opposite the film hinge 35. As shown in the detail view of area A of the Fig. 12 according to Fig. 13As shown, the locking element 25 is hook-shaped. It comprises a hook 25a which extends radially inwards from the downwardly extending wall of the locking element 25. The hook 25a has an inclined surface 25c on its end face, against which the chamfer 33 of the flap 30 slides when the locking element is engaged, thus springily pushing the locking element 25 to the side. The inclined surface can run at an angle of 30° to 60° to a surface oriented perpendicular to the central axis of the closure cap 1.

[0106] As soon as the flap 30 has reached its end position, the locking element 25 springs back and the contact surface 25b lies, preferably parallel to the flap 30, under the flap 30, so that the flap 30 is now fixed by the locking element 25.

[0107] The film hinge 35 extends downwards from a base 34 in its unmounted state. In its mounted state, the base 34 defines the groove in which the ring 43 of the sealing element 40 sits. The film hinge 35 is formed by a section thinner than the adjacent wall, with a thickness d equal to the thickness of the side wall of the flap 30 in its unmounted state. In this embodiment, the film hinge 35 extends over a length l of the side wall.

[0108] The ratio of length l to thickness d is preferably between 0.5 and 5, particularly preferably between 1 and 3, and most preferably between 1.5 and 2.5. This provides a region of sufficient length to reduce the risk of breakage.

[0109] The thickness d of the film hinge is preferably between 0.2 and 1.0 mm.

[0110] Fig. 14 is a side view of the closure cap 1 and Fig. 15a sectional view along line AA of the Fig. 14 The cut also extends through the lateral locking element 26, which, in the assembled state, encloses the corners of the flap 30 opposite the film hinge 35. The locking element 26 also includes a hook 26a with a contact surface 26b for the flap 30.

[0111] Preferably, unlike the locking element 25, the contact surface of the locking element 26a is not aligned parallel to the plate-shaped flap 30 in the unmounted state, but runs at an angle. In particular, this can facilitate the deflection of the hook 26a when locking. The hooks 26a enclose the corners of the flap 30, so that these cannot deflect like a flat leaf spring as the locking element 25 does on the long side of the flap 30. The locking element 26a can also serve to position the flap 30 and absorbs forces acting in the direction of the axis of the film hinge 36, for example, when a spike is inserted at an angle.

[0112] Fig. 16 is a top view of the underside of the closure cap 1.

[0113] Fig. 17 is a sectional view along line AA, which is opposite the section according to Fig. 15 at another point through the locking element 26. The locking element 26 encloses the corner of the flap 26. The contact surface 26b for the flap is oriented at an angle to the flap 30 in the assembled state.

[0114] Fig. 18 Figure 1 shows a schematic view of a container 2 according to the invention. The cap 1 shown above is connected to a lower part 3, which provides most of the volume of the container 2.

[0115] Fig. 19 shows the steps of a method according to the invention in accordance with an embodiment of the invention.

[0116] First, a closure cap 1 is provided, which has a base body 20 with at least one opening 24a, 24b for a connection 10a, 10b, wherein the closure cap 1 has on its inner side a flap 30 with at least one opening 32a, 32b, which is hinged relative to the base body 20. This can be, in particular, the closure cap 1 shown above.

[0117] Then a sealing element 40 is inserted inside the opening 24a, 24b of the base body or into the opening 32a, 32b of the flap 30.

[0118] The flap 30 is then folded or pivoted onto the base body 20, whereby the flap 30 locks into a final position against the base body 20 and thus fixes the sealing element 40 between the opening 24a, 24b of the base body 20 and the opening 32a, 32b of the flap 30.

[0119] The invention provides a simple and safe mounting cap for a medical container. Reference symbol list

[0120] 1 Closure cap 2 Container 3 Head 10a, 10b Connection 11a, 11b Break-off piece 12a, 12b Wing handle 13a, 13b Break point 20 Base body 20a Bottom (of the base body) 20b Side wall (of the base body) 21 Connection flange 22a, 22b Connection spigot 23 Groove 24a, 24b Opening 25 Locking element 25a Hook 25b Contact surface 25c Slanted surface 26 Side locking element 26a Hook 26b Contact surface 27a, 27 Ring-shaped groove 28 Web 30 Flap 31a, 31 Ring-shaped web 32a, 32b Opening 33 Chamfer 34 Base 35 Film hinge 40 Sealing element 41 Insertion area 42 Groove 43 Ring 44 Ring 45 Marking 46, 47 Slot

Claims

1. A closure cap (1) for a container (2) filled with a medical liquid, wherein the closure cap (1) has a base body (20) and at least one connection (10a, 10b) with a sealing element (40), which can be pierced with a spike or a needle to remove the medical liquid, characterised in that a flap (30) is arranged on the inside on an underside of the base body (20) of the closure cap (1), which flap is connected to the base body (20) by means of a hinge (35), wherein the sealing element (40) is fixed to the closure cap (1) by the flap (30) folded against the base body (20).

2. The closure cap (1) according to the preceding claim, characterised in that the sealing element (40) is closed with a tamper-evident closure, in particular is covered with a break-off piece (11a, 11b), which is connected to the base body (20) of the closure cap (1) via a predetermined breaking point (13a, 13b) surrounding the sealing element (40).

3. The closure cap (1) according to one of the preceding claims, characterised in that the sealing element (40) has a circumferential ring (43, 44) which is seated in a groove (23) of the base body (1) and / or the flap (30).

4. The closure cap (1) according to one of the preceding claims, characterised in that the flap (30), which is folded against the base body (20), is latched to the base body (1).

5. The closure cap (1) according to one of the preceding claims, characterised in that the flap (30) is in the form of a plate with at least one opening (32a, 32b) in which a piercing region (41) of the sealing element (40) is located.

6. The closure cap (1) according to one of the preceding claims, characterised in that the hinge is in the form of a film hinge (35).

7. The closure cap (1) according to one of the preceding claims, characterised in that the closure cap (1) has at least two, in particular exactly two, connections (10a, 10b) each with a sealing element (40).

8. The closure cap (1) according to the preceding claim, characterised in that the flap (30) is in the form of a single flap which fixes the sealing elements (40) of the at least two connections (10a, 10b) to the closure cap (1).

9. The closure cap (1) according to one of the preceding claims, characterised in that the hinge (35) is arranged on one long side of the flap (30), wherein the flap (30) is latched to the base body (20) on an opposite long side.

10. The closure cap (1) according to the preceding claim, characterised in that a latching body (25) of the base body (20) engages around a corner of the opposite long side of the flap (30).

11. The closure flap (1) according to the preceding claim, characterised in that the corner is rounded.

12. The closure cap (1) according to one of the preceding claims, characterised in that the base body (20) and the flap (30) are part of a one-piece injection-moulded plastic part.

13. A container (2) filled with a medical liquid, in particular a bottle, preferably produced by means of BFS or SBM, comprising a closure cap (1) according to one of the preceding claims, in particular wherein the filled container (2) is sterilised.

14. A method for assembling a closure flap (1) for a container (2) filled with a medical liquid, in particular for a container according to one of the preceding claims, comprising the steps: - providing a closure cap (1) which has a base body (20) with at least one opening (24a, 24b) for a connection (10a, 10b), wherein the closure cap (1) has a flap (30) with at least one opening (32a, 32b) on the inside on an underside of the base body (20), which flap can be folded relative to the base body (20); - inserting a sealing element (40) on the inside in front of the opening (24a, 24b) of the base body (20) or in front of the opening (32a, 32b) of the flap (30); - folding the flap (30) onto the base body (20), wherein the flap (30) is fixed in an end position on the base body (20) and the sealing element (40) is fixed between the opening (24a, 24b) of the base body (20) and the opening (32a, 32b) of the flap (30).

15. The method according to the preceding claim, characterised in that the sealing element (40) is inserted into the opening (24a, 24b, 32a, 32b) of the base body (20) or the flap (30) in such manner that it is centred and held securely in position.