Multi-component closure device for an active substance container - Patents.com

Abstract

The present invention relates to a multi-part closure device for coupling to a medical active substance container with a suitable collar, the multi-part closure device comprising a sealing plug, a plug fixation device and preferably a protective cover. The sealing plug is fixed to the active substance container using the plug fixation device and can seal the opening in the bottle neck of the active substance container, allowing for airtight removal of the liquid active substance. The plug fixation device comprises a fixation cage with a central ring, a central opening and a side wall, the fixation cage having a plurality of undercut webs formed along the side wall and adapted to engage on the collar of the bottle neck, the undercut webs being bent in a tilted manner in the direction of the longitudinal axis of the plug fixation device. The plug fixation device further comprises an outer cage shell surrounding the fixation cage in a radially outwardly offset manner and having a central opening.

Description

[Technical Field]

[0001] (Technical field) The present invention relates to a multi-part closure device for coupling to a medical active substance container with a suitable collar, the multi-part closure device comprising a sealing plug, a plug fastening device and preferably a protective cover, the sealing plug being adapted to be fastened to the active substance container with the plug fastening device, thereby sealing an opening in a bottle neck and allowing airtight removal of the liquid active substance.Furthermore, the present invention relates to a medical active substance container with the multi-part closure device and to the use of the multi-part closure device. [Background technology]

[0002] (Cutting edge technology) The sterile storage and transport of medical devices and medical active substances in medical active substance containers is of great importance in many fields of medicine. Of particular interest here are medical active substance containers in the form of medical injection vials, also simply referred to as "vials", whereby liquid medical active substances are removed from such medical active substance containers with the aid of wicking and / or application needles. Vaccine containers, vaccine vials or vaccine ampoules are specific examples of such medical active substance containers or vials.

[0003] In any case where a vaccine is administered in liquid form, care must be taken to ensure that the vaccine or vaccine concentrate is not contaminated during storage or that the vaccine is not unnoticedly withdrawn from an already opened medical vaccine container. In addition to sterile storage, the guaranteed seal must also be recognizable until first use, so that contamination of the contents can be reliably excluded. Medical vaccine containers are therefore equipped with disposable closure devices, as they are not intended to make the medical active substance container resealable for extended use. The medical fields of interest here, in which active substances are administered in such medical active substance containers, are in particular immunology, virology, and oncology, although this is not to be understood as a comprehensive list.

[0004] A multi-part closure device for a medically active substance container is known from EP 2948122. The medically active substance container has a vial neck with a collar, whereby a rubber plug is partially inserted into the vial neck and irremovably secured therein using a retaining ring. The rubber plug has a sealing edge operably connected to the inner surface of the vial neck in a sealing manner. The retaining ring surrounds the edge of the rubber plug and the collar end bead and is formed from a metal sheet. By pressing the retaining ring onto the vial neck and bending the edge of the retaining ring toward the vial, the rubber plug cannot be removed from the medically active substance container, and the vaccine can be stored aseptically. In addition, additional means are provided for forming a plug securing device that encloses the rubber plug and retaining ring and to which a movable lid is attached. When the lid is opened and the area at the level of the center of the rubber plug is exposed, the vaccine can be removed from the inside of the medically active substance container by piercing a wicking and / or inoculation syringe or a wicking and / or application needle through the thinner center of the rubber plug. In EP 2948122, complex additional measures are provided that go far beyond the simple fastening of the rubber plug with a sheet metal ring. This design is technically complex and not suitable for mass production.

[0005] In addition to the complexity of manufacturing the multi-part closure device from EP2948122 and the larger number of different components, filling and closing the active substance container is also complex and would not be possible using a simple filling system. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] European Patent No. 2948122 Summary of the Invention [Means for solving the problem]

[0007] (Summary of the Invention) The present invention aims to create a multi-part closure device for a medical active substance container that achieves a secure closure with improved tightness, consists of as few components as possible, has a low weight and increased fastening effect, and nevertheless allows the most simplified attachment to the bottle neck opening of the medical active substance container, so that the multi-part closure device can also be easily applied on site during the filling process.

[0008] The object underlying the present invention is achieved by a multi-part closure device with the features of claim 1. Advantageous embodiments of the invention are listed in the subclaims.

[0009] Preferably, the multi-part closure device also has a protective cover which additionally protects the puncture area and can be easily removed prior to use, and optionally has a window through which the integrity of the closure device can be checked.

[0010] All variations of the combinations or minor adaptations of the features of the present invention may be found in the detailed description, illustrated in the drawings, and included in the dependent claims. [Brief explanation of the drawings]

[0011] The objects of the present invention are explained in detail below in the context of reference to the accompanying drawings. The necessary features, details and advantages of the present invention result from the following description, whereby preferred embodiments of the present invention and some additional or optional features are listed in detail.

[0012] Further features, details, and advantages of the present invention are set forth in the following description and drawings of preferred embodiments of the invention.

[0013] [Figure 1] FIG. 1 is an exploded view of a vial neck of a medically active substance container and a matching multi-part closure device with a protective cover. [Figure 2] FIG. 2 is a cross-sectional view of a multi-part closure device with a protective cover placed over the necked portion of a vial of a medically active substance container. [Figure 3] FIG. 3 is a partial cross-sectional view of a multi-piece closure device with a sealing plug, an anchoring cage, an outer cage shell, and a protective cover. [Figure 4] FIG. 4 is a perspective view from below of the multi-part closure device with the protective cover, without the medically active substance container. [Figure 5] FIG. 5 is a perspective view of the seal plug alone. [Figure 6a] FIG. 6a is a perspective view of the anchoring cage in a deployable state. [Figure 6b] FIG. 6b is a cross-sectional view of the anchoring cage from FIG. 6a in combination with a sealing plug. [Figure 7a] FIG. 7a is a perspective view of an alternative anchoring cage in a deployable state. [Figure 7b] FIG. 7b is a cross-sectional view of the anchoring cage from FIG. 7a in combination with a sealing plug. [Figure 8] FIG. 8 is a perspective view of a further alternative anchoring cage in a deployable state. [Figure 9a]FIG. 9a shows a perspective view of a medically active substance container with a plug anchoring device with a protective cover with a recess and a plastic window in the protective cover. [Figure 9b] FIG. 9b is an exploded view of the protective cover and corresponding recesses of the window layer as produced on a corresponding plastic injection molding machine. [Figure 10] FIG. 10 is a cross-sectional view of a shipping container in which a prefabricated storage pallet with several unfilled medically active substance containers and several unattached multi-part closure devices is stored. DETAILED DESCRIPTION OF THE INVENTION

[0014] (Detailed Description of the Invention) The present invention will now be illustrated by way of example with reference to the accompanying figures, which are, however, not intended to limit the scope of protection of the invention.

[0015] FIG. 1 illustrates one embodiment of the present invention in the form of a medically active substance container 1 with a multi-component compact closure device 2. Such a medically active substance container 1 can also be referred to as a vaccine vial, vaccine ampoule, vaccine vial, multi-dose container, or medical vial for the aseptic storage and removal of liquid vaccines and vaccine concentrates as medically active substances. These medically active substance containers 1 are preferably made of glass or plastic and are commercially available in standardized sizes. After filling the medically active substance container 1, the multi-component closure device 2 is placed over the bottle neck 10 of the medically active substance container 1. The multi-component closure device 2 is intended to be stored on the bottle neck 10 in a non-detachable and unremovable manner so that no contents can escape from the medically active substance container 1. The contents are not shown here. Contamination of the interior of the medically active substance container 1 during transportation and storage must be avoided. After opening the medically active substance container 1 or first use of its contents, there is often only a few hours before the contents, e.g., vaccines, become unusable.

[0016] According to one aspect of the invention, the multi-part closure device 2 according to the invention comprises at least one sealing plug 20 and a multi-part plug fastening device 21 by means of which the sealing plug 20 can be fastened to the collar 101 of the vial necking 10. Due to the configuration of the plug fastening device 21 presented here, the multi-part closure device 2 can be pressed onto the collar 101 in the direction of the longitudinal axis L of the medically active substance container 1 by means of engagement of the plug fastening device 21 with the collar 101.

[0017] The closure device 2 is not intended for multiple use, ie for opening and closing the closure device 2, and remains immobile after attachment to the collar 101, sealing the interior of the medically active substance container 1.

[0018] The protective cover 22 is intended as an optional part of the multi-part closure device 2, providing additional mechanical protection.

[0019] In FIG. 1, the individual components are shown as not yet assembled and are presented individually from bottom to top.

[0020] The bottle neck 10 of the medically active substance container 1 has a collar 101 with a collar end bead 102, an outer collar surface 103 and an inner contact surface 104. A multi-part closure device 2 according to the invention is closed with the collar end bead 102, and a part of the closure device 2 engages behind the collar end bead 102 so that the closure device 2 cannot slide relative to the collar 101 in the assembled state.

[0021] The sealing plug 20 is preferably made from an elastomer, in particular from rubber or from a thermoplastic elastomer (TPE), and is generally tapered from above, i.e. from the side facing away from the medically active substance container 1, downwards, i.e. is essentially conical in shape.

[0022] The sealing plug 20 has a contoured shape, with at least one sealing lip 201 and one edge 202 arranged on the outer circumferential side surface of the sealing plug 20. In this way, the sealing plug 20 can be arranged and fastened so that it is pressed onto the bottle neck 10 in the longitudinal direction L and partially protrudes into it. To increase the tightness, three sealing lips 201 along the outer surface of the sealing plug 20, which lie along the inner contact surface 104 of the bottle neck 10 in the assembled state, have proven effective. The edges 202 protrude radially beyond the tapered portion of the sealing plug 20 and remain outside the bottle neck 10 in the assembled state.

[0023] The tapered portion of the seal plug 20 is recessed into the bottle neck 10 during assembly, with the edge 202 of the seal plug 20 remaining outside the collar 101 and the bottle neck 10. A cage support surface 2021 and a circumferential cage edge recess 2022 in the form of an annular groove are arranged along the circumferential edge 202. Preferably, the cage edge recess 2022 has a circumferential bead 2023 formed on the radially inner surface thereof by a relief groove in a lower section of the cage edge recess 2022.

[0024] 1 is provided within the sealing plug 20 so that easy access to the interior of the medical active substance container 1 is achieved during subsequent removal of the contents of the medical active substance container 1. This tapered plug 203 makes it easier to push through the wicking and / or application needle.

[0025] In addition to the sealing plug 20 , which is optimized compared to the prior art, the multi-part closure device 2 comprises a plug fixation device 21 consisting of two parts: a fixation cage 210 and an outer cage shell 211 .

[0026] In the assembled state, the inner anchoring cage 210, closer to the longitudinal axis L, is preferably formed from a one-piece continuous sheet metal stamping including a center ring 2101 and a circumferential sidewall 2102 with several undercut webs 2103. The center ring 2101 leaves a central opening in the anchoring cage 210 open so that a wicking and / or application needle can be pushed through. The size of the central opening is preferably as large as or even larger than the diameter of the plug taper 203 in the sealing plug 20.

[0027] The undercut webs 2103 are arranged in the side wall 2102 in such a way that they have a slope towards the longitudinal axis L and can therefore engage beneath the collar end bead 102 on the collar 101 in the assembled state. In the view according to Fig. 1 the slope from bottom to top in the direction of the longitudinal axis L is clearly visible. Due to the slope or tilt of the undercut webs 2103 in the direction of the longitudinal axis L, engagement of the undercut webs 2103 behind the collar end bead 102 or beneath the collar end bead 102 is possible. The fastening cage 210 and the sealing plug 20 are efficiently fastened and fixed to the medically active substance container 1 in the axial direction, i.e. in the direction of the longitudinal axis L, by this mechanism.

[0028] A cage edge bead 2104 is arranged at least partially circumferentially within the side wall 2102. Here, the cage edge bead 2104 is arranged at a height such that in the assembled state of the multi-piece closure device 2, it is positioned on the outside of the collar 101, between the edge 202 of the sealing plug 20 and the collar end bead 102.

[0029] Optionally, the plug engaging edge 2105 is also bent at the end of the central ring 2101. Here, a shape is achieved by folding the sheet metal of the anchoring cage 210 so that, in the assembled state, as can be seen in FIG. 2 , the plug engaging edge 2105 can engage in the cage recess 2022 of the seal plug 20 while the central ring 2101 rests directly on the cage support surface 2021, thereby securing the anchoring cage 210 to the seal plug 20. Preferably, the stop engaging edge 2105 has a plurality of frame shapes that are bent 90°, i.e., extending parallel to the longitudinal axis L, and arranged in the direction of rotation, so that, in the assembled state, the frame shapes partially encompass the undercut grooves of the cage recess 2022 in order to center the anchoring cage 210 and therefore the seal stop 20 relative to the vial necking 10. This stop engagement edge 2105, with several frame shapes arranged in the direction of rotation, is shown even more clearly in Figure 6a. According to a further embodiment of the invention, the anchoring cage 210 is alternatively or additionally secured to the sealing plug 20, for example by firmly connecting the sealing plug 20 to the anchoring cage 210 by adhesive bonding, welding, or with a form closure such as a snap fit.

[0030] An outer cage shell 211 is mounted over the fixation cage 210 as part of the plug fixation device 21. This cage shell 211 is also preferably made from a metal sheet, although a correspondingly molded plastic cover would also be conceivable. The cage shell 211 extends approximately parallel to the fixation cage 210 and rests thereon. The cage shell 211 is designed as an open sleeve with a central opening 2111 and an at least partially circumferential cage shell bead 2112. Once closed together in the direction of the longitudinal axis L, the cage shell 211 can no longer be easily removed from the fixation cage 210. Once closed together in this way, the plug fixation device 21 can be pressed over the sealing plug 20 and the collar 101. According to a further embodiment of the present invention, the plug fixation device 21 is first placed over and connected to the sealing plug 20, and the assembly comprising the fixation cage 210, the cage shell 211, the protective cover 22 and the sealing plug 20 is then placed as a unit over the collar 101 in order to fix the plug fixation device 21 to the medically active substance container 1. The cage shell 211 completely encases the fixation cage 210, while only the top and bottom central surfaces of the fixation cage 210 and the cage shell 211 remain accessible in the assembled state, allowing a wicking and / or application needle to be pushed through the central opening 2111 and the central ring 2101 with a central opening.

[0031] The combination of the anchoring cage 210 and the cage shell 211 allows for a robust closure device. The anchoring cage 210 and the cage shell 211 can be designed in such a way that the cage shell 211 tightly encloses the anchoring cage 210. This is particularly advantageous when both elements are made of metal, for example, stamped sheet metal parts. The dimensions of the closure device, therefore, in particular width and height, are similar to or even essentially correspond to the dimensions of regular crimp closures, such as crimped vials. In this way, the closure device is also suitable for use with transfer devices, such as suction or injection syringes, transfer needles, or standardized transfer systems, such as syringe adapters. According to a further embodiment of the invention, the cage shell 211 is connected to the anchoring cage 210 by means of a material closure, in particular by gluing or welding. Mechanical formations, such as crimp connections, can therefore be omitted. Of course, it is also possible to connect the cage shell 211 to the anchoring cage 210 by form closure or by force closure.

[0032] Additional means are provided for removably fastening an additional protective cover 22 to the outer cage shell 211 or directly to the fastening cage 210. These additional means are arranged either directly on the fastening cage 210 or, as in the embodiment shown here, directly on the outer cage shell 211. The additional means shown here is a cover engagement portion 2113 formed on the edge of the central opening 2111 as part of the outer cage shell 211. The cover engagement portion 2113 is inclined upwards towards the longitudinal axis L, i.e., in the direction of the protective cover 22.

[0033] The protective cover 22 is preferably designed as a plastic component and is generally rotationally symmetrical, having a concentric area with an engagement edge 221. The engagement edge 221 extends around the periphery of the cover's inner surface, i.e., the area of ​​the surface facing the outer cage shell 211. When the protective cover 22 is mounted on the outer cage shell 211, the cover engagement portions 2113 engage within the engagement edge 221, thereby releasably holding the protective cover 22 on the outer cage shell 211 and forming part of the multi-part closure device 2. The protective cover 22 is contoured and can have a central tapered portion 222, i.e., an optional recess 222, which may be selected to increase stability or to save material.

[0034] The protective cover 22 is optional and not absolutely necessary, however, for better protection against external influences, the protective cover 22 should be removably connected to the outer cage shell 211 or the fixation cage 210 of the plug fixation device 21 so that the protective cover 22 can be removed from the plug fixation device 21 before use.

[0035] 2 shows the assembled state of the multi-part closure device 2 according to the present invention, as shown in FIG. 1 . The arrow on the longitudinal axis L also indicates the direction in which the closure device 2 is pushed or pressed together onto the vial neck 10. Once assembled, the undercut webs 2103 in the side walls 2102 engage concentrically around the collar 101 at several points behind the collar end bead 102, and the position of the sealing plug 20 on the inner contact surface 104 is secured while at least one sealing edge 201 closes in a sealing manner. The side walls 2102 and outer cage shell 211 of the anchoring cage 210 rest against the outer collar surface 103. When pulled away from the medically active substance container 1 in the direction of the longitudinal axis L, the anchoring cage 210, and therefore the sealing plug 20, remain stationary. Due to the bending or pre-tensioning of the undercut webs 2103 in the side walls 2102, the pre-tensioning will be even greater at higher tensile forces so that high resistance to tensile forces is achieved. The effectiveness of the plug fixation device 21 is maximized along with the low material consumption and low weight of the overall plug fixation device 21.

[0036] Figure 3 shows the assembled state of the multi-part closure device 2 according to the invention as shown in Figure 1 without the medically active substance container 1 but with the seal stop 20, the plug anchoring device 21 and the protective cover 22. The plug anchoring device 21 consists of an anchoring cage 210 and an outer cage shell 211 radially surrounding the anchoring cage 210. On the sealing plug 20, the cage edge recess 2022 is radially recessed towards the longitudinal axis L of the sealing plug 20 such that the cage edge recess 2022 has a circumferential bead formed in a lower section of the cage edge recess 2022 on its radially inner surface by an undercut. The annular tab 2106 and plug engagement edge 2105 engage in the present cage edge recess 2022, which in the assembled state has a plurality of frame shapes bent through 90°, i.e. arranged in a rotational direction extending parallel to the longitudinal axis L, so that the frame shapes partially encompass the undercut grooves of the cage edge recess 2022. An undercut web 2103 is shown in the side wall 2102 of the fixation cage 210, which engages behind the collar end bead of a medically active substance container (not shown).

[0037] In the side view of the bottle according to Fig. 4, seen from below, of the multi-part closure device 2 shown in Figs. 1, 2, and 3, with the protective cap 22 and sealing plug 20 facing outward from the plane of the paper along the longitudinal axis L, several preferred features are clearly discernible. A sealing edge 201 projects radially outward from the sealing plug 20. Preferably, three stepped sealing edges are arranged at different heights parallel to the longitudinal axis L. A circular circumferential cage edge bead 2104 in the fastening cage 210 and parallel cage shell beads 2112 in the outer cage shell 211 are also preferred features.

[0038] A preferred embodiment of the seal plug is shown in Figure 5. On the seal plug 20', as previously described, the cage edge recess 2022' is recessed radially oriented toward the longitudinal axis L of the seal plug 20' such that the cage edge recess 2022' has a circumferential bead formed on the radially inner surface of the cage edge recess 2022' by an undercut groove in the lower section of the cage edge recess 2022'. An annular tab and plug engagement edge of the anchoring cage 210 (not shown) engage within this cage edge recess 2022'.

[0039] To optimize the seal plug 20', several plug beads 2023 are arranged along the outer surface, here four arranged along the surface at the center of the seal plug 20', here a total of eight arranged along the outer ring surface of the rim 202 of the seal plug 20'. These plug beads 2023 ensure that the anchoring cage 210 is spaced from the surface of the seal plug 20'.

[0040] 6a shows the fixation cage 210 according to FIGS. 1-3 without additional components of the locking device. It has several, preferably three, ring tabs 2106 and several, preferably three, plug engaging edges 2105. The ring tabs 2106 are designed to engage radially outward of the cage recess of a sealing plug (not shown), and the plug engaging edges 2105 have several frame shapes arranged in a rotational direction that are bent through 90° so that, in the assembled state, the frame shapes partially encompass the undercut grooves of the cage recesses 2022.

[0041] Optional means are provided for increasing the stability of the anchoring cage 210, which is a lightweight structure. For example, the undercut webs 2103 in the side walls 2102 are provided with additional web reinforcements 2109. These are in the form of thickenings at the ends of the undercut webs 2103. The side walls 2102 are themselves reinforced by side wall reinforcements 2107 in the form of beading or embossing, where the beads of the side wall reinforcements 2107 extend parallel to the longitudinal axis L along the side walls 2102 in the various edge sections A. The side wall reinforcements 2107 also serve to define a defined distance from the cage shell (not shown).

[0042] A bead extending radially relative to the longitudinal axis L may also be embossed along the shortened central ring 2101 of the anchoring cage 210, which is designated and marked as a ring reinforcement 2108. Like the sidewall reinforcement 2107, the bead or ring reinforcement 2108 also serves to provide a defined distance from the cage shell (not shown).

[0043] In order to obtain an anchoring cage 210 that is as stable as possible, that can be easily connected to the outer cage shell 211, and that, once placed around the sealing plug 20, can be easily attached to the vial neck 10, the anchoring cage 210 is preferably manufactured in a compartmentalized form. This design is ad hoc and independent of the optimization of the sealing plug shape. The one-piece anchoring cage 210 is manufactured from a metal profile that is in a lightweight formation, whereby the metal profile is stamped, provided with beads, and therefore bent.

[0044] The additional optional reinforcement of the anchoring cage 210 according to Fig. 6a is again clearly shown in Fig. 6b, whereby the outer cage shell 211 has been omitted. The operable connection between the anchoring cage 210 and the collar with the inner collar tapered part on the bottle neck of the medically active substance container (not shown) becomes permanent after crimping the multi-part closure device 2 in the direction of the longitudinal axis L.

[0045] According to Fig. 6a, the central ring 2101 holds together several edge sections A via several hinges B. Four edge sections A are selected here, each of which is irremovably connected to one another via a hinge B as a strip between the central ring 2101 and the edge sections A. Two undercut webs 2103 are formed or recessed in each of the edge sections A, which form part of the side wall 2102. Facing the central ring 2101, a part of the cage edge bead 2104 extends into each edge section A (shown in Fig. 6b).

[0046] To bring the fixation cage 210 into an assembled state, the edge sections A are bent through approximately 90° relative to the longitudinal axis L in such a way that they form side walls 2102 that are closed around the central ring 2101, as shown in FIG. 6a. The ends of the edge sections A, i.e., the connection points C, can be shaped to match and interlock with each other in the direction of rotation. This forms circumferentially stable side walls 2102. Optionally, the edge sections A can also be welded together at their ends, i.e., the connection points C; this can be done automatically, for example, by laser welding or spot welding. Other joining methods are also possible.

[0047] In the assembled state as shown in FIG. 6a, the fixation cage 210 can function as part of the plug fixation device 21 in a manner operatively connected to the outer cage shell 211 as shown in FIGS.

[0048] FIG. 7a shows an alternative fastening cage 210 to that shown in FIG. 6a, which has several ring tabs 2101′, each with a plug-engaging edge 2105′. Four such ring tabs 2101′, whose plug-engaging edges 2105 can engage within cage recesses 2022, 2022′ on the sealing plug 20, are shown here as an example. Optional means for increasing the stability of the fastening cage 210, which is a lightweight structure, are also provided. For example, the undercut webs 2103 in the sidewalls 2102 include additional web reinforcements 2109. These are in the form of thickened portions at the ends of the undercut webs 2103. The sidewalls 2102 themselves are reinforced by sidewall reinforcements 2107 in the form of beading or embossing. Here, the beads of the sidewall reinforcements 2107 extend parallel to the longitudinal axis L along the sidewalls 2102 in various edge sections A. The sidewall reinforcements 2107 also serve to form a defined distance from the cage shell (not shown), i.e., the anchoring cage 210 and the cage shell 211 are kept at a distance from each other, at least in some areas. This means that some air gaps are formed between the anchoring cage 210 and the cage shell 211. As a result, improved sterilization, for example by an ethylene oxide (EtO) sterilization process, is achieved in the assembled state.

[0049] A bead extending radially relative to the longitudinal axis L may also be embossed along the shortened central ring 2101 of the anchoring cage 210, which is designated and marked as a ring reinforcement 2108. Like the sidewall reinforcement 2017, the bead or ring reinforcement 2108 also serves to provide defined spacing.

[0050] The additional optional reinforcement of the anchoring cage 210 is again clearly shown in Figure 7b, whereby the outer cage shell 211 is omitted. The positive connection between the anchoring cage 210 and the collar 101 with the inner collar taper on the vial neck 10 becomes permanent after the multi-part closure device is crimped in the direction of the longitudinal axis L.

[0051] 8 shows an alternative fixation cage 210 according to the invention in a simplified design. According to this embodiment of the fixation cage 210, just like in the other embodiments, the central ring 2101 holds together several edge sections A via several hinges B. Four edge sections A are selected here, each of which is irremovably connected to one another via two hinges B as a strip between the central ring 2101 and the edge sections A. Two undercut webs 2103 are formed or recessed in each of the edge sections A, which form part of the side walls 2102. Facing the central ring 2101, a part of the cage edge bead 2104 extends into each edge section A. After the metal profile has been stamped, the remaining components must be cut and bent accordingly. Optionally, a plug engagement edge 2105″ extending centrally around the central ring 2101 and facing the longitudinal axis L is marked here. This optimizes the fastening between the anchoring cage 210 and the sealing plug 20 .

[0052] Additionally, it may be advantageous to provide a protective cover 22 that allows the integrity of the multi-part closure device 2 to be checked. For this purpose, the protective cover 22 is preferably designed in several parts, more preferably in two parts, as illustrated in FIGS. 9 a and 9 b. In addition to the layer of the protective cover 22 in which the recesses 222 are provided, an additional transparent / semi-transparent window layer 223 with at least one raised window 224 is provided. Here, a decision has been made for a transparent / semi-transparent window layer 223 with three recesses 222 and three window ridges 224. The window layer 223 should be transparent / semi-transparent in such a way that the window ridges 224 provide visibility of the area of ​​the sealing plug 20 or the area of ​​the upper edge of the anchoring cage 210 and the outer cage shell 211. This makes it possible to assess whether the individual multi-part closure device 2 has already been opened or whether one of the components has been destroyed or tampered with. Preferably, the protective cover 22 with the protective cover layer and the transparent / translucent window layer 223 is manufactured in an injection molding process. Transparent / translucent refers to the window layer 223 allowing at least 50% of the incident light to pass through so that conclusions can be drawn about its integrity.

[0053] The advantage of all the multi-part closure devices 2 presented here is that several unsealed medical active substance containers 1 with matching multi-part closure devices 2 can be transported in an unfilled and unsealed state to the active substance filling line where they can be filled and simply closed there by the vaccine or active substance filler itself without the use of special tools at the filling site.

[0054] For this purpose, as shown in Figure 10, a transport container 3, which may also be called a delivery cassette 3, is delivered, comprising a transport container tray 33, on which a first storage pallet 31 with a multi-part closure device 2 and a second storage pallet 32 ​​with medical active substance containers 1 are closed with a box lid 30 and / or a protective film 30. The medical active substance containers 1 are unsealed, i.e. the opening of the medical active substance containers 1 at the bottle neck 10 is exposed.

[0055] A second storage pallet 32 ​​with empty medically active substance containers 1 rests in the shipping container tray above the first storage pallet with the multi-part closure device 32 .

[0056] A possible filling process for the medical active substance container 1 is as follows: First, the transport container 3 or transport container tray 33 is delivered to and made available to a filling system for medical active substances, where the box lid 30 and / or protective film 30 are removed. The second storage pallet 32 ​​with the medical active substance container 1 is then removed from the transport container tray 33 and placed in a filling station, where the open medical active substance containers 1 arranged locally in the second storage pallet 32 ​​are filled.

[0057] As soon as all the medical active substance containers 1 of the second storage pallet 32 ​​have been filled, and also removed from the shipping container tray 33, the complete first storage pallet 31 is placed over the bottle necks of the filled medical active substance containers 1, and by pressing the first storage pallet 31 towards the bottom of the shipping container tray, each medical active substance container 1 is tightly closed with the associated closure device 31. When the first storage pallet 31 is pressed downwards towards the bottom of the shipping container or towards the bottom of the medical active substance containers 1, the multi-part closure devices 2 with their sealing plugs 20 and plug fastening devices 21 are pressed over the openings of the bottle necks 10. The undercut webs 2103 in the side walls 2102 of the fastening cages 210 engage behind the collar end beads 102 and secure the medical active substance containers 1 against unwanted opening.

[0058] To ensure simple and quick closure, the arrangement of the closure devices 2 in the first storage pallet 31 is matched to the arrangement of the active substance containers in the second storage pallet 32, i.e., by placing the first storage pallet 31 on top of the second storage pallet 32 ​​and pressing them together, the multi-part closure devices 2 engage with the bottle necks 10 of the corresponding active substance medical containers 1 and close the individual active substance medical containers 1. This allows simple and quick closure of the medical active substance containers 1.

[0059] After filling and closing the medical active substance container 1, the second storage pallet 32 ​​with the filled and closed medical active substance container 1 can be repositioned in the shipping container tray 33 and the shipping container 3 can be closed using a box lid 30 and / or a protective film 30.

[0060] Known plastics, in particular thermoplastics, can be used as materials for the box lids 30, storage pallets 31, 32, and shipping container trays 33. Nonwoven fabrics, made for example from high density polyethylene, have proven to be suitable materials for the protective film 30.

[0061] By delivering the transport container 3 with the unsealed medical active substance container 1, whereby the first and second storage pallets 31, 32 are aligned with the sealing device 2 and the medical active substance container, filling and sealing can be simplified and significantly accelerated. This filling and closing process does not have to be carried out by a specialized company. In this case of the transport container 3, since several components for filling are supplied in one package, a large amount of waste and large transport volumes can be avoided.

[0062] List of Reference Numbers 1 Medical Active Substance Container / Vial 10 Bottle narrowing section 101 Collar with inner collar tapered section 102 Collar end bead 103 Outer color surface 104 Inner contact surface 2. Multi-component closure device 20 Seal plugs (rubber, elastomer, TPE, self-closing) 201 Seal Edge 202 En 2021 Cage Support Surface 2022 Cage edge recess (concentric, circumferential) 2022' Cage edge recess (radially aligned with respect to the longitudinal axis L) 2023 plug bead 203 Plug tapered part 21 Plug fixing device 210 Fixation Cage 2101 Central ring (with central opening) (1 piece) 2101' ring tabs (several) with plug engaging edges 2105' 2102 Side wall 2103 Relief groove web in side wall 2104 Cage edge bead 2105 Plug engagement edge (with some frame shapes arranged in the direction of rotation) 2105' Plug engagement edge (end of ring section) 2105'' plug engagement edge (end of circumferential part of center ring) 2106 Ring knob 2107 Side edge reinforcement 2108 Ring reinforcement 2109 Web reinforcement A. Edge section B Hinge C Connection Point 211 outer cage shell (preferably metal, surrounding sheet metal) 2111 Center opening 2112 Cage shell bead (circumferential engaging edge, similar to 2104) 2113 Cover engagement portion (circumferentially around 2111) 22 Protective cover (removable, plastic, shaped) 221 Engagement edge (protruding diagonally upward, can be effectively connected to the lid engagement part) 222 Central tapered portion / voluntary recess 223 Transparent / Semi-transparent window layer 224 Window ridge in 223 3 Shipping Containers / Delivery Cassettes 30 Box Lids / Protective Films 31 First storage pallet for locking devices (plurality of pallets arranged in an aligned state) 32 Second storage pallet for medically active substance containers 1 (with a plurality of aligned and unsealed medically active substance containers 1) 33 Shipping Container Tray

Claims

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

2. The multi-part closure device (2) of claim 1, wherein a plug engagement edge (2105) is formed on the central ring (2101) or on a plurality of ring tabs (2101') arranged on the central ring (2101) on the side of the central ring (2101) facing the longitudinal axis (L) toward the central opening, and the fixation cage (210) can additionally be operably connected to a circumferential cage edge recess (2022, 2022') on the seal plug (20) so as to be fixed against radial movement.

3. The multi-piece closure device (2) of claim 1, wherein a cage edge bead (2104) is provided circumferentially within the sidewall (2102) of the anchoring cage (210).

4. 2. The multi-piece closure device (2) of claim 1, wherein the undercut web (2103) in the side wall (2102) comprises a web reinforcement (2109).

5. 2. The multi-component closure device (2) of claim 1, wherein a plurality of side edge reinforcements (2107) in the form of beads or embossments are arranged within the side wall (2102) to extend parallel to the longitudinal axis (L).

6. 2. A multi-part closure device (2) according to claim 1, wherein the anchoring cage (211) is made in one piece and / or from metal, in particular from a stamped metal profile, or from plastic.

7. 2. The multi-piece closure device (2) of claim 1, wherein the fastening cage (210) comprises a plurality of edge sections (A) attached to the central ring (2101) via hinges (B), the edge sections (A) forming the side walls (2102) of the fastening cage (210), the plurality of undercut webs (2103) being molded into the side walls (2102), and the fastening cage (210) is preferably made in one piece, preferably from a stamped metal profile.

8. The edge sections (A) have connection points (C) at their ends in the direction of rotation, and the edge sections are designed to engage with each other at the connection points (C) of the individual adjacent edge sections (A), or A multi-part closure device (2) according to claim 7, whereby adjacent edge sections (A) are welded together at their connection points (C).

9. the sealing plug (20) is attached to the closure device (2), preferably to the fastening cage (210), by material closure, in particular by bonding or welding, by form closure or by force closure; and / or The multi-piece closure device (2) of claim 1, wherein the sealing plug (20) is removably attached to the closure device (2).

10. 2. The multi-piece closure device (2) of claim 1, wherein the outer cage shell (211) has a circumferentially molded cage shell bead (2112) that, in an assembled state, is at least approximately parallel to the cage edge bead (2104) and extends offset perpendicularly to the longitudinal axis (L).

11. 2. The multi-part closure device (2) according to claim 1, wherein a circumferential cover engagement portion (2113) is formed along the central opening (2111) of the outer cage shell (211), and a cover engagement portion of an engagement edge (221) arranged on the protective cover (22) can be fastened to the circumferential cover engagement portion.

12. 2. The multi-component closure device (2) of claim 1, 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), and the side edge reinforcements are designed in such a way that the anchoring cage (210) and the outer cage shell (211) are kept at a distance from each other at least in certain areas.

13. a plurality of radially outwardly directed sealing edges (201) are arranged along the outer surface of the sealing plug (20), the sealing edges (201) being made of elastomer, in particular rubber, TPE (thermoplastic elastomer) or TPU (thermoplastic polyurethane), in particular three sealing edges (201) being arranged as material projecting apart in the direction of the inner contact surface (104) of the collar (101); 2. A multi-part closure device (2) according to claim 1, whereby preferably a central plug taper (203) is recessed in the center of said sealing plug (20).

14. 14. The multi-component closure device (2) of claim 13, wherein a plurality of plug beads (2023) are formed along a cage support surface (2021) on the edge (202) of the seal plug (20) and / or along the outer surface of the edge (202) at the center of the seal plug (20).

15. 2. The multi-component closure device (2) of claim 1, wherein the multi-component closure device (2) has a protective cover (22), the protective cover (22) being produced in two parts and having a recess (222), and a window ridge (224) of a transparent / semi-transparent window layer (223) protruding at least partially into the recess (222).

16. A medically active substance container (1) with a multi-part closure device (2) according to any one of claims 1 to 15, The medically active substance container (1) has a bottle neck (10) whose inner contact surface (104) is adapted to fit against the sealing plug (20) with at least one sealing edge (201) of the sealing plug (20), and a collar (101) and collar end beads (102) for irremovably 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 suitable for engaging with the undercut web (2103).

17. Use of a multi-part closure device (2) according to any one of claims 1 to 15 as a closure for a medically active substance container (1) to prevent contamination of the interior of said container, comprising:

1. Use of a multi-part closure device (2), wherein the container (1) allows removal of an active substance or vaccine from its interior using a transfer device such as a wicking or inoculation syringe, a transfer cannula, or a syringe adapter, and wherein the multi-part closure device (2) can be pressed onto a collar (101) with a collar end bead (102) that connects the collar to the 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 irremovable contact with the sealing plug (20) against the inner contact surface (104), and the plurality of relief groove webs (2103) formed along the side wall (2102) of the fastening cage (210) engage onto the collar (101) of the bottle neck (10).

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