Multi-part closure device for drug containers

Description

Technical field

[0001] The present invention relates to a multi-part closure device for coupling to a medical drug container with a suitable collar, wherein the multi-part closure device comprises a sealing plug, a plug locking device, and optionally a protective cap, wherein the sealing plug can be fixed to the drug container and an opening in a bottle neck by means of the plug locking device, thus sealing and allowing airtight dispensing of liquid drug. Furthermore, the present invention relates to a medical drug container with a multi-part closure device and the use of a multi-part closure device. State of the art

[0002] The aseptic storage and transport of medical devices and active pharmaceutical ingredients in medical containers is of great importance in many areas of medicine. Of particular interest here are medical containers in the form of injection vials, also known as "vials," from which liquid active pharmaceutical ingredients are withdrawn using drawing-up and / or application needles. Specific examples of these medical containers, or vials, include vaccine vials and vaccine ampoules.

[0003] Wherever vaccines are administered in liquid form, it is essential to ensure that the vaccines or vaccine concentrates are not contaminated during storage and that vaccines are not taken from unknowingly opened medical vaccine containers. In addition to aseptic storage, a guaranteed seal must be clearly visible until first use to reliably prevent contamination of the contents. Accordingly, medical vaccine containers are equipped with a one-way closure, as it is not intended that the containers be resealable for extended use. The medical specialties relevant here, in which active ingredients are administered in such medical containers, include, in particular, immunology, virology, and oncology, although this list is not exhaustive.

[0004] Such a locking device is already disclosed in DE 10 2020 210 898.

[0005] A multi-part closure device for a medical drug container is known from EP2948122. The medical drug container has a bottle neck with a collar, in which a rubber stopper is partially inserted into the bottle neck and permanently fixed there by means of a retaining ring. The rubber stopper has a sealing lip which is operatively sealed to the inner surface of the bottle neck. The retaining ring encloses an edge of the rubber stopper and a collar end bead and is formed from a sheet metal part. By pressing the retaining ring onto the bottle neck and bending the bottle-side edge of the retaining ring, the rubber stopper cannot detach from the medical drug container, and vaccines can be stored aseptically. Additional means are provided to form a stopper locking device that further encloses the rubber stopper and the retaining ring, and a movable lid is attached.When the lid is opened and the area at the center of the rubber stopper is exposed, vaccine can be extracted from the inside of the medical drug container by inserting a drawing-up and / or vaccination syringe or a drawing-up and / or application needle through the thinner center of the rubber stopper. EP2948122 specifies complex additional features that go far beyond simply securing the rubber stopper with a metal ring. This design is technically complex and not suitable for mass production.

[0006] In addition to the effort involved in manufacturing the multi-part closure device from EP2948122 and the larger number of different components, the filling and closing of the active ingredient containers also appears to be complex and not possible with simple filling systems. Summary of the invention

[0007] The present invention aims to create a multi-part closure device for a medical drug container which achieves a secure closure with improved tightness, comprises as few components as possible, offers increased security with low weight, and yet allows simplified attachment to the bottle neck opening of the medical drug container, so that the multi-part closure devices can also be easily applied on-site during the filling process.

[0008] The problem underlying the invention is solved by a multi-part locking device with the features of claim 1. Advantageous embodiments of the present invention are listed in the dependent claims.

[0009] Preferably, the multi-part closure device also has a protective cover which provides additional protection to the insertion area, is easily removable before use, and optionally has windows through which the integrity of the closure device can be checked.

[0010] All variations of feature combinations or minor adjustments of the invention can be found in the detailed description, illustrated in the figures and included in the dependent patent claims. Brief description of the drawings

[0011] The subject matter of the invention is described in detail below with reference to the accompanying drawings. Necessary features, details, and advantages of the invention will become apparent from this subsequent description, in which a preferred embodiment of the invention and some additional or optional features are listed in detail.

[0012] Further features, details and advantages of the invention will become apparent from the following description of preferred embodiments of the invention and the drawings. These show: Figure 1 is an exploded view of the neck of a medical drug container and a matching multi-part closure device with a protective cap; Figure 2 is a sectional view of a multi-part closure device with a protective cap, mounted on the neck of a medical drug container; Figure 3 is a partial sectional view of a multi-part closure device with a sealing plug, safety cage, outer cage shell, and protective cap; Figure 4 is a perspective view of a multi-part closure device with a protective cap, without a medical drug container, from below; Figure 5 is a perspective view of a sealing plug alone; Figure 6a is a perspective view of the safety cage in the usable state; Figure 6 is a sectional view of the safety cage. Figure 6ain combination with a sealing plug; Figure 7a a perspective view of an alternative safety cage in the deployable state, Figure 7bin a sectional view of the safety cage made of Figure 7a in combination with a sealing plug; Figure 8 a perspective view of another alternative safety cage in the deployable state; Figure 9a shows a perspective view of the medical drug container with the plug safety device with protective cover, with recesses and plastic windows in the protective cover; Figure 9b an exploded view of a protective cover corresponding to the recesses and window layer as produced on a corresponding plastic injection molding machine; and Figure 10 a cutaway view of a transport container in which prefabricated storage pallets with several unfilled medical drug containers and several unattached multi-part closure devices are stored. Detailed description of the invention

[0013] The present invention is defined by the claims and is explained by way of example with reference to the attached figures.

[0014] One embodiment of the invention in the form of a medical drug container 1 with a multi-part compact closure device 2 is described in Figure 1 shown. Such medical active ingredient containers 1 can also be referred to as vaccine vials, vaccine ampoules, vaccine bottles, multi-dose containers, or medicinal vials for the aseptic storage and withdrawal of liquid vaccines and vaccine concentrates as medical active ingredients. These medical active ingredient containers 1 They are preferably made of glass or plastic and are commercially available in standardized sizes. After filling the medical drug container... 1 The multi-part closure device 2 is placed on a bottle neck 10 of the medical drug container1 attached. The multi-part locking mechanism 2 is insoluble and cannot be removed from the bottle neck 10 to store so that no contents escape from the medical drug container 1 It can escape. The contents are not shown here. There must be contamination of the interior of the medical drug container. 1 Avoid contact during transport and storage. After opening or first using the contents of the medical drug container. 1 Often, only a few hours remain before the contents – for example, a vaccine – become unusable.

[0015] According to one aspect of the invention, a multi-part locking device according to the invention comprises 2 at least one sealing plug 20 and a multi-part plug locking device 21 , with which the sealing plug 20 on a collar 101 the bottleneck 10It can be fastened. This is achieved through the design of the plug securing device presented here. 21 can the multi-part locking device 2 in the direction of a longitudinal axis L of the medical drug container 1 on the collar 101 are pressed on and means of the plug securing device 21 grab the collar 101 to.

[0016] The locking device 2 is not for multiple uses, opening and closing the locking mechanism 2 intended, but remains after being attached to the collar 101 the interior of the medical drug container 1 Sealing, immovable.

[0017] A protective cover 22 is an optional part of the multi-part locking device 2 designed to provide additional mechanical protection.

[0018] In Figure 1The individual components are shown in their unassembled state and are presented individually from bottom to top.

[0019] The bottleneck 10 of the medical drug container 1 has a collar 101 on, which has a collar end roll 102, an outer collar surface 103 and an internal installation area 104 The multi-part locking device according to the invention features. 2 is attached to the collar end roll 102 assembled, with part of the locking mechanism 2 behind the collar point 102 intervenes, so that the locking device 2 not relative to the collar when assembled 101 can slip.

[0020] The sealing plug 20is preferably made of an elastomer, in particular of rubber or of a thermoplastic elastomer (TPE), and is entirely formed from above, i.e., from the medical drug container. 1 The side facing away is designed to taper downwards, thus essentially being conical in shape.

[0021] The sealing plug 20 It is profiled and has at least one sealing lip. 201 and a border 202 on the outer circumferential side surface of the sealing plug 20 arranged. Thus, the sealing plug can be 20 in the longitudinal direction L onto the bottle neck 10 They are pressed in and partially projecting into it, and then attached. To increase the seal, three sealing lips have been incorporated. 201 along the outer side surface of the sealing plug 20 proven, which in the assembled state along the inner mounting surface 104 the bottleneck 10to come to rest. The edge 202 protrudes beyond the tapered part of the sealing plug 20 It protrudes radially and remains outside the bottle neck when assembled. 10.

[0022] The tapered part of the sealing plug 20 is installed in the bottleneck during assembly 10 sunken, with the edge 202 of the sealing plug 20 outside the collar 101 and the bottleneck 10 remains. Along the surrounding edge. 202 is a cage support surface 2021 and containing a circumferential cage edge recess 2022 , arranged in the form of an annular groove. Preferably, the cage edge recess has 2022 a circumferential ridge 2023 on, which is created by an undercut in a lower section of the cage edge recess 2022 on a radially inner surface of the cage edge recess 2022 is formed.

[0023] This will facilitate the subsequent removal of contents from the medical drug container. 1 easy access to the interior of the medical drug container 1 Once achieved, a central plug reduction is reached. 203 in the sealing plug 20 provided, also dashed in Figure 1 indicated. Through this plug reduction. 203 This makes it easier to push through a priming and / or application needle.

[0024] The multi-part locking device 2 features, in addition to the sealing plug which is optimized compared to the state of the art 20 a plug safety device 21 which consists of two parts, a safety cage 210 and an outer cage shell 211.

[0025] The safety cage is located on the inside, closer to the longitudinal axis L, when assembled. 210is preferably formed from a one-piece, continuous stamped sheet metal part, which has a central ring 2101 and a surrounding side wall 2102 with several undercut ribs 2103 includes the central ring. 2101 leaves a central opening in the safety cage 210 Open, allowing the insertion and / or application needle to be pierced through. The size of the central opening is preferably as large as the diameter of the plug's tapered section. 203 in the sealing plug 20 or even larger.

[0026] The undercut bridges 2103 are in the side wall 2102 arranged so that they have an inclination to the longitudinal axis L point towards and thus engage below the collar end bead in the assembled state 102 to the collar 101 are bringable. In the view according to Figure 1 is a slope from bottom to top in the direction of the longitudinal axis LClearly visible due to the inclination of the undercut ribs. 2103 or tilting in the direction of the longitudinal axis L , is an intervention of the undercut webs 2103 behind the collar point 102 or the undercut under the collar end bead 102 possible. The safety cage 210 and the sealing plug 20 This mechanism efficiently transfers the medical drug container 1 in the axial direction or in the direction of the longitudinal axis L secured and established.

[0027] In the side wall 2102 is a cage edge groove 2104 at least partially arranged around the perimeter. Here is the cage edge groove. 2104 arranged at a height so that, in the assembled state of the multi-part locking device, they 2 between the edge 202 of the sealing plug 20 and the collar point 102 outside the collar 101comes to lie down.

[0028] Also optional is the end of the central ring. 2101 a plug insertion edge 2105 Arranged in a bent-over position. This is achieved by folding the sheet metal of the safety cage. 210 a shape is achieved so that, in the assembled state, the plug engagement edge 2105 into the cage edge recess 2022 of the sealing plug 20 can intervene, thereby disabling the safety cage 210 at the sealing plug 20 is fixed, while the central ring 2101 on the cage support surface 2021 directly rests on it, which in Figure 2 is recognizable. Preferably, the plug engagement edge has 2105 Several frame shapes arranged in the direction of rotation, bent by 90°, i.e. parallel to the longitudinal axis L are converging, so that in the assembled state the frame shapes correspond to the undercut of the cage edge recess. 2022 partially grasp to remove the sealing plug 20relative to the safety cage 210 and thus also to the bottleneck 10 to center. This plug engagement edge 2105 with several frame shapes arranged in the direction of rotation is in Figure 6a even more clearly shown. According to a further embodiment of the invention, the safety cage 210 alternatively or additionally on the sealing plug 20 secured by the sealing plug 20 with the safety cage 210 is firmly connected, e.g. glued, welded or by means of a positive locking mechanism, such as a snap-fit ​​connection.

[0029] About the safety cage 210 An outer cage shell has been thrown. 211 as part of the plug safety device 21 It is intended to be stored. This cage shell is also intended to be stored. 211 It is preferably made of a metal sheet, although a suitably shaped plastic shell would also be possible. The cage shell 211It runs essentially parallel to the safety cage. 210 and is attached to it. The cage shell 211 is an open sleeve with a central opening 2111 and a cage shell groove that at least partially circumferentially 2112 executed. Once in the direction of the longitudinal axis L The cage shell can be assembled 211 no longer easily removed from the safety cage 210 can be removed. Once assembled, the plug locking device can be used. 21 over the sealing plug 20 and the collar 101 are pressed. According to a further embodiment of the invention, the plug securing device 21 first via the sealing plug 20 inserted and connected to this, followed by the assembly of the safety cage 210, Cage shell 211, Protective cover 22 and sealing plugs 20 as a unit over the collar 101is inserted to secure the plug. 21 on the medical drug container 1 to determine. The cage shell 211 encloses the safety cage 210 completely, while only the central surfaces at the top and bottom of the safety cage 210 and the cage shell 211 Remain accessible in the assembled state and allow a winding and / or application needle to be inserted through the central opening. 2111 and the central ring 2101 can be penetrated with a central opening.

[0030] The combination of safety cage 210 and cage shell 211 enable a secure locking mechanism. Safety cage 210 and cage shell 211 can be designed in such a way that the cage shell 211 the safety cage 210tightly encloses. This is particularly advantageous when both elements are made of metal, e.g., stamped sheet metal parts. The dimensions of the closure device are then similar to, or even essentially correspond to, the dimensions, especially in width and height, of regular crimp closures, such as those found on crimped vials. In this way, the closure device is also suitable for use in conjunction with standardized transfer systems, such as drawing-up or inoculation syringes, transfer devices such as transfer cannulas, or syringe adapters. According to a further embodiment of the invention, the cage shell 211 by material bonding, in particular by gluing or welding, to the safety cage 210 connected. This eliminates the need for mechanical forming processes, such as crimp connections. It is of course also possible to connect the cage shell. 211by positive locking or by force locking with the safety cage 210 to connect.

[0031] To the additional protective cover 22 directly on the outer cage shell 211 or on the safety cage 210 Additional components are provided for detachable fastening. These additional components are either directly attached to the safety cage. 210 , or, as shown in the embodiment here, directly on the outer cage shell 211 arranged. A lid intervention is included as an additional measure. 2113 , at the edge of the central opening 2111 as part of the outer cage shell 211 molded. The lid opening 2113 is to the longitudinal axis L inclined upwards, in the direction of the protective cover. 22.

[0032] The protective cover 22 is preferably designed as a plastic component, is usually rotationally symmetrical and has a concentric area with an engagement edge221 on. The intervention margin 221 surrounds an area of ​​the inner surface of the lid, the area that forms part of the outer cage shell 211 is facing the protective cover when it is mounted. 22 on the outer cage shell 211 The lid mechanism engages 2113 into the intervention margin 221 one, which causes the protective cover 22 Detachable from the outer cage shell 211 held, part of the multi-part locking device 2 forms the protective cover. 22 can be shaped as a profile and have a central taper 222 or optional cutouts 222 exhibit features that lead to increased stability or are chosen to save material.

[0033] The protective cover 22 It is optional and not strictly necessary. However, to be better protected against external influences, the protective cover should be used. 22 soluble with the outer cage shell211 or the safety cage 210 the plug safety device 21 be connected so that the protective cover 22 before use, remove the stopper safety device 21 is designed to be removable.

[0034] In Figure 2 is the assembled state of the multi-part locking device according to the invention. 2 according to Figure 1 shown. The arrow on the longitudinal axis L simultaneously indicates the direction for assembling or pressing together the locking device. 2 on the bottleneck 10 Once mounted, undercut ribs engage. 2103 in the side wall 2102 behind the collar point 102 concentrically around the collar in several places 101 extending to and the position of the sealing plug 20 on the inner mounting surface 104 is ensured, while at least one sealing lip 201seals tightly. On the outer collar surface 103 The side wall 2102 of the safety cage 210 and the outer cage shell 211. Even when pulled in the direction of the longitudinal axis. L , away from the medical drug container 1, The safety cage remains 210 and thus the sealing plug 20 immobile. Due to the bending or pre-tensioning of the undercut webs 2103 in the side wall 2102 The preload would increase even further at higher tensile forces, resulting in high resistance to tensile forces. The effect of the plug locking device 21 is maximum, with minimal material usage and low weight of the entire plug securing device 21.

[0035] In Figure 3 is the assembled state of the multi-part locking device according to the invention. 2 according to Figure 1 without the medical

[0036] active ingredient container 1, however, with sealing plugs 20, Plug locking device 21 and protective cover 22 shown. Plug locking device 21 is composed of the safety cage 210 and the outer cage shell 211, the safety cage 210 surrounds radially. At the sealing plug. 20 is the cage edge recess 2022 radial to the longitudinal axis L of the sealing plug 20 The cage edge recess is oriented towards the side. 2022 a circumferential bead formed by an undercut in a lower section of the cage edge recess 2022 on a radially inner surface of the cage edge recess 2022 is formed. Into this cage edge recess. 2022 grips a ring tab 2106 as well as a plug insertion edge 2105one that has several frame shapes arranged in the direction of rotation, which are bent by 90°, i.e. parallel to the longitudinal axis L are converging, so that in the assembled state the frame shapes correspond to the undercut of the cage edge recess. 2022 partially grasp. In the side wall 2102 of the safety cage 210 are undercut bridges 2103 shown, which reach behind the collar end ridge of the medical drug container (not shown).

[0037] In the bottle-side view according to Figure 4 from below onto the in Figure 1 , 2 and 3 illustrated multi-part locking device 2 with protective lid 22 and out of the plane of the paper along the longitudinal axis L protruding sealing plug 20 Several preferred features are clearly recognizable. The sealing lips 201, which from the sealing plug 20projecting radially outwards. Here, three stepped elements are preferred, i.e., at different heights parallel to the longitudinal axis. L arranged. The circular cage edge bead 2104 in the safety cage 210 and the cage shell groove running parallel to it 2112 in the outer cage shell 211 These are also preferred features.

[0038] A preferred embodiment of the sealing plug is in Figure 5 shown. On the sealing plug. 20' The cage edge recess is – as before – 2022' radial to the longitudinal axis L of the sealing plug 20' The cage edge recess is oriented towards the side. 2022' a circumferential bead formed by an undercut in a lower section of the cage edge recess 2022' on a radially inner surface of the cage edge recess 2022' is formed. Into this cage edge recess. 2022'engages a ring tab and a plug engagement edge of the safety cage 210 (not shown) one.

[0039] To the sealing plug 20' Several plug beads along the outer surface need to be optimized. 2023 arranged, here four along the surface in the center of the sealing plug 20' and here a total of eight along the outer outer ring surface of the edge 202 of the sealing plug 20'. These plug beads 2023 ensure spacing of the safety cage 210 to the surface of the sealing plug 20'.

[0040] In Figure 6a is a safety cage 210 according to Figures 1 to 3 shown without additional components of the locking device. This device has several, preferably three, ring tabs. 2106 as well as several, preferably three, plug engagement edges 2105 open. The ring tabs 2101are designed to engage the radially outer sides of the cage recess of the sealing plug (not shown) and the plug engagement edge 2105 the plug insertion edge 2105 It features several frame shapes arranged in the direction of rotation, which are bent by 90° so that, in the assembled state, the frame shapes form the undercut of the cage edge recess. 2022 partially encompass.

[0041] To ensure the stability of the safety cage 210, Optional means are provided to increase the resistance of the lightweight construction. For example, the undercut webs... 2103 in the side wall 2102 with additional bridge reinforcements 2109 These are provided in the form of thickenings at the end of the undercut ribs. 2103 executed. The side wall 2102 itself is reinforced by side wall reinforcements 2107reinforced in the form of beads or embossing. The beads of the side wall reinforcements run along this line. 2107 parallel to the longitudinal axis L along the side wall 2102 in the various marginal segments A. The side wall reinforcements 2107 They also serve to create a defined distance to the cage shell (not shown).

[0042] also along the shortened central ring 2101 of the safety cage 210 can radial to the longitudinal axis L The grooves running in the direction of the rings are embossed, serving as ring reinforcement. 2108 are designated and marked. The bead or ring reinforcement. 2108 It serves the same purpose as the side wall reinforcements. 2107 also the defined spacing to the cage shell (not shown).

[0043] To create the most stable safety cage possible 210 to obtain, which is simply with the outer cage shell 211is bondable and simply around the sealing plug 20 placed on a bottle neck 10 The safety cage can be attached. 210 Preferably manufactured in segmented form. This design is specific and independent of optimizations to the sealing plug shape. The one-piece safety cage 210 is manufactured from a lightweight metal profile, whereby the metal profile is punched out, provided with beads and bent accordingly.

[0044] The additional optional reinforcements of the safety cage 210 according to Figure 6a are in Figure 6b again clearly shown, with the outer cage shell 211 was omitted. The functional connection between the safety cage 210 and the collar with inner collar taper at the bottle neck of the medical drug container (not shown) is after pressing on the multi-part closure device 2in the direction of the longitudinal axis L permanently given.

[0045] According to Figure 6a the central ring holds 2101 via several hinges B, several marginal segments A together. Here are four edge segments. A selected, each with a hinge B, as a band between a central ring 2101 and edge segment A, are inextricably linked. Into the edge segments A, which are parts of the side wall 2102 Each of the two undercut ribs forms 2103 molded in or recessed. The central ring 2101 The direction of travels in each marginal segment A a part of the cage edge groove 2104 (shown in Figure 6b ).

[0046] To the safety cage 210 To bring the edge segments into the assembled state, they are A at approximately 90° to the longitudinal axis L bent in such a way that they form a ring around the central ring 2101closed surrounding side wall 2102 form, as in Figure 6a shown. The ends of the boundary segments A, so the connection points C, They are shaped to fit together in the direction of rotation and can interlock. This creates a stable, continuous side wall. 2102 trained. Optionally, the edge segments can be A also at their ends, the connection points C, They can be welded together, which can be done automatically using methods such as laser welding or spot welding. Other joining methods are also possible.

[0047] In the assembled state according to Figure 6a can the safety cage 210 with the outer cage shell 211 functionally connected as part of the plug securing device 21 function, as it is in Figures 2 and 3 is shown.

[0048] In Figure 7a is an alternative safety cage 210 to which according to Figure 6ashown which has several ring tabs 2101' each with a plug insertion edge 2105' features. Here are four examples of such ring tabs. 2101' shown, whose plug insertion edge 2105 in cage edge recesses 2022, 2022' at the sealing plug 20 can intervene. To ensure the stability of the safety cage. 210, Optional means are also provided to increase the resistance of the lightweight construction. For example, the undercut webs... 2103 in the side wall 2102 with additional bridge reinforcements 2109 These are provided in the form of thickenings at the end of the undercut ribs. 2103 executed. The side wall 2102 itself is reinforced by side wall reinforcements 2107 reinforced in the form of beads or embossing. The beads of the side wall reinforcements run along this line. 2107 parallel to the longitudinal axis L along the side wall 2102 in the various marginal segmentsA. The side wall reinforcements 2107 They also serve to create a defined distance to the cage shell (not shown), i.e., the safety cage. 210 and the cage shell 211 They are kept at least partially separated from each other. This means that between the safety cage 210 and cage shell 211 Several air gaps are formed. This results in improved sterilization, e.g., through ethylene oxide (EtO) sterilization processes, in the assembled state.

[0049] also along the shortened central ring 2101 of the safety cage 210 can radial to the longitudinal axis L The grooves running in the direction of the rings are embossed, serving as ring reinforcement. 2108 are designated and marked. The bead or ring reinforcement. 2108 It serves the same purpose as the side wall reinforcements. 2017 including the defined spacing.

[0050] The additional optional reinforcements of the safety cage 210 are in Figure 7b again clearly shown, with the outer cage shell 211 was omitted. The functional connection between the safety cage 210 and the collar 101 with inner collar taper at the bottle neck 10 is after pressing on the multi-part locking device in the direction of the longitudinal axis L permanently given.

[0051] In Figure 8 is an alternative safety cage according to the invention 210 shown in a simplified design. According to this embodiment of the safety cage 210 the central ring holds 2101, just like the other embodiments, via several hinges B, several marginal segments A together. Here, four edge segments A are selected, each connected by two hinges. B, as a band between a central ring 2101and edge segment A, are inextricably linked. Into the edge segments A, which parts of the side wall 2102 Each of the two undercut ribs forms 2103 molded in or recessed. The central ring 2101 The direction of travels in each marginal segment A a part of the cage edge groove 2104. After the metal profile has been punched out, the remaining components must be cut and bent accordingly. An option here is the use of a central ring. 2101 centrally rotating, the longitudinal axis L facing plug insertion edge 2105" marked. This optimizes the fastening between the safety cage. 210 and sealing plugs 20.

[0052] Additionally, precautions can be taken in the protective cover. 22 It would be advantageous to ensure the integrity of the multi-part locking mechanism. 2 Have it checked. The protective cover is needed for this. 22preferably designed in multiple parts, preferably in two parts, which in Figures 9a and 9b This is made clear. Besides the position of the protective cover. 22, in which recesses 222 An additional transparent / translucent window layer is planned. 223 with at least one window height increase 224 Three recesses have been planned here. 222 and a transparent / translucent window layer 223 with three window height increases 224 decided. The window position 223 It should be designed to be so transparent / translucent that the window heights allow light to pass through. 224 a view up to the sealing plug 20 or up to the top edge of the safety cage 210 and the outer cage shell 211 This results in an assessment of whether the respective multi-part locking device 2It has already been opened or one of its components has been damaged or tampered with. The protective cover is preferred. 22 with protective cover layer and transparent / translucent window layer 223 Manufactured using an injection molding process. A window layer is created using the transparent / translucent material. 223 denoted as a material that allows at least 50% of the incident light to pass through, so that conclusions can be drawn about its invulnerability.

[0053] The advantage of all the multi-part locking devices presented 2 The issue here is that several unsealed medical drug containers are present. 1 with suitable multi-part locking devices 2 They can be transported unfilled and unsealed to an active ingredient filling plant, filled there, and easily sealed there as well. No special tools are required at the filling site by the vaccine or active ingredient filler themselves.

[0054] This is done, as in Figure 10 shown, a transport container 3, which is also known as a delivery cassette 3 can be described as comprising a transport container tray 33, in which a first storage pallet 31 with multi-part locking devices 2 and a second storage pallet 32 with medical drug containers 1, with a box lid 30 and / or a protective film 30 Delivered sealed. The medical drug containers 1 are unsealed, i.e., the openings of the medical drug containers are open. 1 at the bottleneck 10 are free.

[0055] The second storage pallet 32 with empty medical drug containers 1 It lies in the transport container tray on the first storage pallet with the multi-part locking devices. 32 on.

[0056] A possible filling process for medical drug containers 1 It is as follows. First, the transport container 3 or the transport container tray 33 The product was delivered to and made available at a filling plant for pharmaceutical ingredients. There, the box lid is removed. 30 and / or the protective film 30 removed. Then the second storage pallet is removed. 32 with the medical drug containers 1 from the transport container tub 33 taken and brought into the filling station, where the filling of the open, locally in the second storage pallet 32 arranged medical drug container 1 This has been done.

[0057] Once all medical drug containers 1 the second storage pallet 32 are filled, the entire first storage pallet 31, which also came from the transport container tub 33taken from the bottle necks of the filled medical drug containers 1 placed and by pressing the first storage pallet 31 Towards the bottom of the transport container tray, each medical drug container 1 with an associated locking device 31 tightly sealed. When pressing down the first storage pallet 31 towards the bottom of the transport container tray, or towards the bottom of the medical drug container 1, The multi-part locking devices 2 with their sealing plugs 20 and the plug lock 21 on the openings of the bottle necks 10 pressed. The undercut ribs 2103 in the side wall 2102 of the safety cage 210 reach behind the collar point 102 and secure against unwanted opening of the medical drug containers 1 .

[0058] To ensure simple and quick closing, the arrangement of the closing devices 2 in the first storage pallet 31 on the arrangement of the active ingredient containers in the second storage pallet 32 coordinated, i.e., that by placing and pressing down the first storage pallet 31 onto the second storage pallet 32 the multi-part locking devices 2 at the bottle necks 10 corresponding medical drug container 1 snap into place and insert the respective medical drug container. 1 Seal. This allows for easy and quick sealing of the medical drug containers. 1.

[0059] After filling and sealing the medical drug containers 1 can the second storage pallet 32 with the filled and sealed medical drug containers 1back in the transport container tray 33 positioned and the transport container 3 with the box lid 30 and / or a protective film 30 be sealed.

[0060] as material for the box lid 30, the storage pallets 31, 32 and the transport container tub 33 Common plastics, especially thermoplastics, can be used as material for the protective film. 30 For example, a nonwoven fabric made of high-density polyethylene has proven suitable.

[0061] By delivering the transport container 3 with unsealed medical drug containers 1, where the first storage pallet 31 and the second storage pallet 32 Coordinated positions of the locking devices 2and the medical drug containers, filling and sealing can be simplified and significantly accelerated. This filling and sealing process does not need to be carried out by a specialized company. Since several components are contained in one package, in this case the transport container, 3, Delivered for filling, this can prevent a large amount of waste and large transport volume. Reference symbol list

[0062] 1 Medical drug container / Vial 10 Bottle neck 101 Collar with inner collar taper 102 Collar end bead 103 Outer collar surface 104 Inner contact surface 2 Multi-part closure device 20 Sealing plug (rubber, elastomer, TPE,self-closing) 201 Sealing lips 202 Edge 2021 Cage bearing surface 2022 Cage edge recess (concentrically circumferential) 2022' Cage edge recess (radially aligned to the longitudinal axis L) 2023 Plug bead 203 Plug taper 21 Plug securing device 210 Securing cage 2101 Concentric ring (with concentric opening) (one) 2101' Ring tab with plug engagement edge 2105' (several) 2102 Side wall 2103 Undercut webs in side wall 2104 Cage edge groove 2105 Plug engagement edge (with several frame shapes arranged in the circumferential direction) 2105' Plug engagement edge (end of the ring segment) 2105" Plug engagement edge (end of the concentric ring circumferentially) 2106 Ring tabs 2107 Side wall reinforcement 2108 Ring reinforcement 2109 Web reinforcement A Edge segment B Hinge C Connection points 211 Outer cage shell (preferably metal, surrounding sheet metal) 2111 Central opening 2112 Cage shell bead (circumferential engagement edge,analogous to 2104) 2113 Lid engagement (around 2111) 22 Protective cover (removable, plastic, profiled) 221 Engagement edge (projecting diagonally upwards, functionally connectable with lid engagement) 222 Central taper / optional recesses 223 Transparent / translucent window position 224 Window extensions in 223 3 Transport container / delivery cassette 30 Box lid / protective film 31 First storage pallet for closure devices (arranged in multiples) 32 Second storage pallet for medical active ingredient containers 1 (unsealed medical active ingredient containers 1 arranged in multiples) 33 Transport container tray,

Claims

1. Multi-part closure device (2) for coupling to a medical active substance container (1) with a suitable collar (101) connected to a bottle neck (10) of the active substance container (1); wherein the multi-part closure device (2) comprises a sealing plug (20), a plug securing device (21) and preferably a protective cover (22), wherein the sealing plug (20) is adapted be secured to the active substance container (1) by means of the plug securing device (21), thereby sealing an opening in the bottle neck (10) of the active substance container (1) and permitting airtight removal of liquid active substance, characterized in that the plug securing device (21) comprises a securing cage (210) with a centric ring (2101), a central opening and a side wall (2102), wherein the securing cage (210) has a plurality of undercut webs (2103) formed along the side wall (2102) and adapted to engage the collar (101) of the bottle neck (10), the undercut webs (2103) being bent in a tilted manner in the direction of a longitudinal axis (L) of the plug securing device (21); and the plug securing device (21) has an outer cage shell (211) which surrounds the securing cage (210) in a radially outwardly offset manner and has a central opening (2111); wherein the cage shell (211) is made of metal or of plastic and / or wherein the cage shell (211) is connected to the securing cage (210) by material closure, in particular by gluing or welding, by form closure or by force closure.

2. Multi-part closure device (2) according to claim 1, wherein plug engagement edges (2105) are formed on the centric ring (2101) or on a plurality of ring tabs (2101') arranged on the centric ring (2101), on the side of the centric ring (2101) facing the longitudinal axis (L) towards the central opening, which can be operatively connected to a circumferential cage edge recess (2022, 2022') on the sealing plug (20), so that the securing cage (210) is additionally secured against radial movements.

3. The multi-part closure device (2) according to any one of the preceding claims, wherein a cage edge bead (2104) is provided circumferentially in the side wall (2102) of the securing cage (210).

4. Multi-part closure device (2) according to any one of the preceding claims, wherein the undercut webs (2103) in the side wall (2102) are provided with web reinforcements (2109).

5. Multi-part closure device (2) according to any one of the preceding claims, wherein a plurality of side edge reinforcements (2107) in the form of beads or embossments are arranged in the side wall (2102) so as to extend parallel to the longitudinal axis (L).

6. Multi-part closure device (2) according to any one of the preceding claims, wherein the securing cage (211) is made in one piece and / or of metal, in particular of a stamped metal profile, or of plastic.

7. Multi-part closure device (2) according to any one of the preceding claims, wherein the securing cage (210) comprises a plurality of edge segments (A) attached to the centric ring (2101) via hinges (B), wherein the edge segments (A) form the side wall (2102) of the securing cage (210), to which the plurality of undercut webs (2103) is molded, wherein the securing cage (210) is preferably made in one piece and preferably from a stamped metal profile.

8. Multi-part closure device (2) according to claim 7, wherein the edge segments (A) have connection points (C) at their ends in the direction of rotation, which are designed to engage with one another in the connection points (C) of the respective adjacent edge segments (A); or whereby adjacent edge segments (A) are welded together at their connection points (C).

9. Multi-part closure device (2) according to any one of the preceding claims, wherein the sealing plug (20) is attached to the closure device (2), preferably to the securing cage (210), by material closure, in particular by bonding or welding, by form closure or by force closure; and / or wherein the sealing plug (20) is detachably attached to the closure device (2).

10. Multi-part closure device (2) according to claim 1, wherein the outer cage shell (211) has a circumferentially molded-in cage shell bead (2112) which, in the assembled state, runs offset perpendicular to the longitudinal axis (L) at least approximately parallel to the cage edge bead (2104).

11. Multi-part closure device (2) according to any one of claims 1 to 10, wherein a circumferential cover engagement (2113) is formed along the central opening (2111) of the outer cage shell (211), to which cover engagement an engagement edge (221) arranged on the protective cover (22) can be fastened.

12. Multi-part closure device (2) according to any one of claims 1 to 11, wherein a plurality of side edge reinforcements (2107) in the form of beads or embossments are arranged in the side wall (2102) so as to extend parallel to the longitudinal axis (L), wherein the side edge reinforcements are designed in such a way that the securing cage (210) and the outer cage shell (211) are kept at a distance from each other, at least in certain regions.

13. Multi-part closure device (2) according to any one of the preceding claims, wherein a plurality of radially outwardly pointing sealing lips (201) is arranged along the outer surface of the sealing plug (20) (20), the sealing lips (201) being made of an elastomer, in particular of rubber, TPE (thermoplastic elastomer) or TPU (thermoplastic polyurethane), in particular three sealing lips (201) are arranged as material projecting away in the direction of an inner contact surface (104) of the collar (101); preferably whereby a central plug tapering (203) is recessed in the center of the sealing plug (20).

14. The multi-part closure device (2) according to claim 13, wherein a plurality of plug beads (2023) is formed along a cage support surface (2021) on the edge (202) of the sealing plug (20) and / or along the outer surface of the edge (202) in the center of the sealing plug (20).

15. Multi-part closure device (2) according to any one of the preceding claims, wherein the multi-part closure device (2) has a protective cover (22) which is produced in two parts and has recesses (222) into which window elevations (224) of a transparent / translucent window layer (223) project at least partially.

16. Medical active substance container (1) with a multi-part closure device (2) according to any one of the preceding claims, characterized in that the medical active substance container (1) has a bottle neck (10), with an inner contact surface (104) matched to the sealing plug (20) with at least one sealing lip (201) of the sealing plug (20), with a collar (101) and a collar end bead (102) for non-detachably fastening the multi-part closure device (2) to the collar (101); preferably whereby the collar (101) has an outer collar surface (103) with a circumferential bead which is suitable for engaging with the undercut webs (2103).

17. Use of a multi-part closure device (2) according to any one of claims 1 to 15 as a closure of a medical active substance container (1) for preventing contamination of the interior of the medical active substance container (1), the container (1) allowing the removal of active substance or vaccine from the interior by means of draw-up or inoculation syringes, transfer devices such as transfer cannulas, or syringe adapters, wherein the multi-part closure device (2) can be pressed onto a collar (101) with a collar end bead (102), which collar is connected to a bottle neck (10) of the active substance container (1), by pressing it in the direction of the longitudinal axis (L) of the active substance container (1) and is then held in non-detachable contact with the sealing plug (20) against the inner contact surface (104), wherein the plurality of undercut webs (2103) formed along the side wall (2102) of the securing cage (210) engage on the collar (101) of the bottle neck (10).