Multi-component closure device for a medically active substance container - Patent Application 20070122997

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 fastening device and a protective cover, the sealing plug being fastened to the active substance container with the plug fastening device, thereby sealing the opening in the bottle neck of the active substance container and allowing airtight removal of the liquid active substance. The plug fastening device comprises a fastening cage made of thermoplastic with a central ring, a central opening and side walls, one or more latching elements, in particular a plurality of integrally formed undercut webs, extending from the inner surface of the side walls and projecting away in the direction of the longitudinal axis, a plug engaging edge formed on the fastening cage engaging in a cage recess on the sealing plug, and the protective cover being removably attached to the plug fastening device.

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 a protective cover, the sealing plug being 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 known simply 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 active substance 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. Therefore, the medical active substance container is equipped with a closure device, as this is 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 immunology, virology, and oncology, in particular, 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 complicated and would be impossible at the location of the 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, in particular for medical active substance containers made from glass or plastic, which in itself achieves a secure closure with improved tightness, and which nevertheless consists of few components, has a low weight, but 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 without the use of special tools.

[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 defined in the subclaims.

[0009] Preferably, the integrity of the multi-part closure device can be easily read from the outside, and a special design of the protective cover is provided for that purpose.

[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 object of the present invention will be described in detail below in connection with the accompanying drawings. The necessary features, details and advantages of the present invention can be seen from the following description, in which 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 1a] FIG. 1a 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 1b] FIG. 1b is a cross-sectional view of a multi-piece closure device with a protective cover placed over the neck of the vial. [Figure 1c] FIG. 1c shows a cross-sectional view of the multi-piece closure device with the protective cover in an assembled state but without the vial neck. [Figure 2a] FIG. 2a is a perspective view of an option for a multi-piece closure device with a protective cover, consisting of two rings. [Figure 2b] FIG. 2b is a cross-sectional view of both rings mounted onto the vial neck. [Figure 2c] FIG. 2c is a cross-sectional view of the assembled multi-piece mini-closure device with the protective cover and two rings attached to the vial neck. [Figure 3a] FIG. 3a is a perspective view of a plug securement device with a protective cover mounted on a vial neck, with an additional recess and plastic window in the protective cover. [Figure 3b] FIG. 3b is a schematic illustration of the window layer and protective cover with corresponding recesses as produced on a corresponding plastic injection molding machine. [Figure 4]FIG. 4 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. [Figure 5] FIG. 5 is a cross-sectional view of a multi-piece closure device according to a further embodiment of the present invention. [Figure 6] FIG. 6 is a cross-sectional view of a multi-piece closure device according to a further embodiment of the present invention. 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. 1a shows an embodiment of the present invention in the form of a medical active substance container 1 with a multi-component miniature closure device 2. Such a medical active substance container 1 or vial 1 can be referred to as a vaccine vial, vaccine ampoule, vaccine vial, multi-dose container, or medical vial for the sterile storage and removal of liquid vaccines and vaccine concentrates as medical active substances. These medical active substance containers 1 are made of glass or plastic and are commercially available in standardized sizes. After filling the medical active substance container 1, the multi-component closure device 2 is placed on the bottle neck 10. The multi-component closure device 2 must be mounted on the bottle neck 10 such that it can be removed or disassembled without destroying it, so that no vaccine can escape from the medical active substance container 1 and no unwanted access is possible.

[0016] The contents are not shown here. Contamination of the interior of the medical active substance container 1 during transport and storage must be avoided. After opening the medical active substance container 1 or first use of its contents, there is often only a few hours before the contents, e.g. a vaccine, become unusable.

[0017] 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.

[0018] The closure device 2 is not intended for multiple use, ie the closure device 2 is not intended to be opened or closed, and after attachment to the collar 101 it seals the interior of the medically active substance container 1 and remains immovable.

[0019] The protective cover 22 is intended as an optional part of the multi-part closure device 2, providing additional mechanical protection.

[0020] In Figure 1a the individual components are shown as yet unassembled and are presented individually from bottom to top.

[0021] 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. The multi-part closure device 2 according to the invention is closed with the collar end bead 102 and one part engages behind the collar end bead 102 so that the closure device 2 cannot slide relative to the collar 101 in the assembled state.

[0022] The sealing plug 20 is integrally formed from an elastomer, preferably from rubber or from a thermoplastic elastomer (TPE), and is generally tapered downwards from above, i.e. from the side facing away from the medically active substance container 1, i.e. is essentially conical in shape.

[0023] The sealing plug 20 has a contoured shape, with at least one sealing edge 201 and one lip 202 arranged on the outer circumferential side surface of the sealing plug 20. In this way, the sealing plug 20 can be pressed onto the bottle neck 10 in the longitudinal direction L and arranged and fastened so that it partially protrudes into it. To increase tightness, three sealing edges 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 lip 202 protrudes radially beyond the tapered portion of the sealing plug 20 and remains outside the bottle neck 10 in the assembled state.

[0024] The tapered portion of the seal plug 20 is inserted into the bottle neck 10 during assembly, with the lip 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.

[0025] A central tapered plug 203, also shown by dashed lines in Figure 1a, is provided within the sealing plug 20 so that, when the contents are subsequently removed, easy access is achieved to the interior of the medically active substance container 1. This plug taper 203 makes it easier to push through the wicking and / or application needle.

[0026] In addition to the sealing plug 20 , which is optimized compared to the prior art, the multi-part mini-closure device 2 comprises a plug fixation device 21 consisting of two parts: a fixation cage 210 and an outer cage shell 211 .

[0027] The anchoring cage 210, located on the inside, closer to the longitudinal axis L in the assembled state, is preferably manufactured integrally as a continuous unit from a thermoplastic material and comprises a central ring 2101 and a circumferential side wall 2102 with several undercut webs 2103. The central 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. The anchoring cage 210 is particularly preferably made from polybutylene terephthalate (PBT).

[0028] The fastening cage 210 may have one or more latching elements, such as circumferential protrusions or isolated latching tabs, adapted to latch onto the medical active substance container, for example with a suitable latching area provided on the collar 101. The fastening cage can be easily attached to the medical active substance container via the latching elements by placing it over the opening of the medical active substance container 1 or the collar 101 in the direction of the longitudinal axis L and over the fastening cage 210. In the embodiment shown, an undercut web 2103 is provided as a latching element.

[0029] The undercut webs 2103 are arranged in the side wall 2102 in such a way that they can be engaged beneath the collar end bead 102 on the collar 101 in the assembled state. In the view according to Fig. 1a, the slope from bottom to top in the direction of the longitudinal axis L can be seen. Due to the slope of the undercut webs 2103 in the direction of the longitudinal axis L, engagement of the undercut webs 2103 behind the collar 101 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.

[0030] A cage edge bead 2104 is arranged at least partially circumferentially within the side wall 2102. In the assembled state of the multi-piece closure device 2, the cage edge bead 2104 is encapsulated by the outer cage shell 211.

[0031] A plug engaging edge 2105 is bent at the end of the central ring 2101. With the plug engaging edge 2105, which can be seen in Fig. lb, the anchoring cage 210 engages in an assembled state in the cage recess 2022 of the sealing plug 20 while the central ring 2101 rests directly on the cage support surface 2021, thereby securing the anchoring cage 210 to the sealing plug 20. According to a further embodiment of the invention, the anchoring cage 210 is alternatively or additionally secured to the sealing plug 20, in that the sealing plug 20 is rigidly connected to the anchoring cage 210, for example by being glued, welded or by means of a formal closure such as a snap fit.

[0032] An outer cage shell 211 is mounted over the anchoring cage 210 as part of the plug anchoring device 21. This cage shell 211 is preferably made of metal sheet, although a correspondingly molded plastic shell would also be conceivable. The cage shell 211 extends substantially parallel to the anchoring 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 anchoring cage 210. When closed together in this way, the plug anchoring device 21 can be pressed over the sealing plug 20 and the collar 101 so that the sealing plug 20 is finally and irremovably secured to the vial necking 10. 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.

[0033] Additional means are provided for removably fastening an additional protective cover 22 directly to the outer cage shell 211 or indirectly 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 in this case 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.

[0034] The protective cover 22 is preferably made of polycarbonate (PC) or acrylonitrile-butadiene-styrene copolymer (ABS) and is generally rotationally symmetric, having concentric areas with an engagement edge 221. However, a protective cover 22 made of metal, such as aluminum, is also possible. The engagement edge 221 surrounds the inner surface of the cover, 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 portion 2113 engages within the engagement edge 221, thereby releasably holding the protective cover 22 on the outer cage shell 211 and forming part of the multi-piece 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.

[0035] The protective cover 22 is optional and not absolutely necessary, however, to provide 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.

[0036] To attach the protective cover 22 to the closure device 2, the protective cover 22 can also be connected to the outer cage shell 211 or the fastening cage 210 using a material closure, for example by laser welding. Adhesive or form-fit connections are also possible, as explained above. It is also conceivable that the protective cover 22 is manufactured in one piece with the fastening cage 210 or, if present, the outer cage shell 211, for example as a plastic injection mold, whereby a predetermined breaking point is formed for releasing the protective cover 22. Against this background, this is preferred, in particular, if the protective cover 22 and the fastening cage 210 are made of plastic.

[0037] lb shows the assembled state of the multi-part closure device 2. Once assembled, the undercut webs 2103 in the side walls 2102 behind the collar 101 concentrically engage at several points, and the position of the sealing plug 20 on the inner contact surface 104 is secured while at least one sealing edge 201 sealingly closes. The side walls 2102 and outer cage shell 211 of the anchoring cage 210 contact the outer collar surface 103. The anchoring cage 210, and therefore the sealing plug 20, remain stationary when pulled away from the medically active substance container 1 in the direction of the longitudinal axis L.

[0038] The effectiveness of the plug securement device 21 is maximized with less material, fewer components, and a lower weight for the overall plug securement device 21 .

[0039] The sealing edge 201 protruding radially outward from the sealing plug 20 is preferably three stepped sealing edges 201, i.e., arranged at different heights parallel to the longitudinal axis L, which can be seen in Figure 1c, when the bottle neck 10 is omitted.

[0040] The plug engagement edge 2105 engages within a concentric circumferential cage recess 2022. The cage edge recess 2022 is recessed from the seal plug 20 at a radial angle relative to the longitudinal axis. A circular circumferential cage edge bead 2104 in the anchoring cage 210 and a parallel cage shell bead 2112 in the outer cage shell 211 are clearly visible and in engagement. The anchoring cage 210 is operatively connected to the outer cage shell 211, surrounds the seal plug 20, and is covered by a cover 22.

[0041] Due to the special design of the cage edge recess 2022, shown here in the direction of the longitudinal axis L, and the engaging plug engaging edge 2105, which is also inclined in the direction of the longitudinal axis L, a portion of the surface of the sealing plug 20 facing the cover 22 is pressed towards the outer cage shell 211 so that the outer cage shell 211 also rests firmly on the sealing plug 20.

[0042] The multi-piece closure device 2 can optionally be adapted for a medically active substance container 1 made from glass. Such medically active substance containers 1 made from glass often have a more simply formed bottle neck 10 without protrusions or protruding collar end beads 102, so proper fastening is often more difficult to produce. In addition to the compact multi-piece closure device 2, an inner thermoplastic ring 23 and an outer metal ring 24 are preferably used here, as shown in FIG. 2a. The inner thermoplastic ring 23 is preferably made from polybutylene terephthalate (PBT), while the outer metal ring 24 is made from aluminum or another metal. The thermoplastic ring 23 has an outer shape that matches the outer shape of the metal ring 24. Due to the thermoplastic design of the thermoplastic ring 23, it can be glued to the metal ring 24. The metal ring 24 has an upper collar 240, a middle section with a through hole 241, and a lower metal ring flange 242. A portion of the plastic ring 23 is melted through the through hole 241 during manufacture so that the two rings 23 and 24 are inseparably joined together. This melting of the thermal plastic ring 23 onto the metal ring 24 can occur directly on the collar 101 or can be done beforehand.

[0043] Figure 2b shows the metal ring 24 and thermoplastic ring 23 mounted onto the vial neck 10 before the multi-piece mini closure device 2 is crimped. Figure 2c shows how such a multi-piece closure device 2, combined with the metal ring 24 and thermoplastic ring 23, can be mounted onto the simplified vial neck 10 after being crimped in the direction of arrow L. An anchoring cage 210 engages a portion of the side wall 2102 below the thermoplastic ring 23 or metal ring 24.

[0044] In addition, 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 designed in several parts, more precisely, in two parts as illustrated in FIGS. 3a and 3b. 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 must 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 fixation 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. 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.

[0045] 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 and possibly ring combinations 23, 24 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.

[0046] For this purpose, as shown in Figure 4, there is a transport container 3, which may also be called a delivery cassette 3, comprising a transport vessel 33 in 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 delivered 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 on the bottle necks 10 is exposed.

[0047] A second storage pallet 32 ​​with empty medically active substance containers 1 rests in a transport basin above the first storage pallet with the multi-part closure device 32 .

[0048] A possible filling process for the medical active substance container 1 is as follows: First, the transport container 3 or transport tub 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 tub 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.

[0049] As soon as all the medical active substance containers 1 of the second storage pallet 32 ​​have been filled, and removed from the transport tub 33, the complete first storage pallet 31 is placed over the bottle necks of the filled medical active substance containers 1, and each medical active substance container 1 is tightly closed with the associated closure device 31 by pressing the first storage pallet 31 towards the bottom of the transport tub. When the first storage pallet 31 is pressed downwards towards the bottom of the transport 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 locking devices 21 are pressed over the openings of the bottle necks 10. The undercut webs 2103 in the side walls 2102 of the fastening cage 210 engage behind the collar end beads 102 and secure the medical active substance containers 1 against unwanted opening.

[0050] To ensure simple and quick closure, the arrangement of the closure devices 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 device 2 engages with the bottle necks 10 of the corresponding active substance medical containers 1 and seals the individual active substance medical containers 1. This allows for simple and quick sealing of the medical active substance containers 1.

[0051] After the active substance containers 1 have been filled and sealed, the second storage pallet 32 ​​with the filled and sealed active substance containers 1 can be repositioned in the transport tank 33 and the transport container can be sealed with a box lid 30 and / or a protective film 30.

[0052] If a medical container 1 made from glass is used, a thermoplastic ring 23 and a metal ring 24 are also fitted to the vial neck 10 before the closure device 2 is fitted and shipped in an unsealed condition. After filling, the multi-part closure device 2 is then crimped through the vial neck 10 with the ring combination 23, 24 as usual.

[0053] Known plastics, in particular thermoplastics, can be used as material for the box lid 30, the storage pallets 31, 32, and the transport tub 33. A nonwoven fabric made from high density polyethylene has proven to be particularly suitable as material for the protective film 30.

[0054] By delivering the transport container 3 with the unsealed active substance container, whereby the first storage pallet 31 and the second storage pallet 32 ​​have the coordinated positions of the closure device 2 and the active substance container 1, filling and sealing can be simplified and significantly accelerated. This filling and sealing 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. In addition, compliance with the required sterility conditions during transport is also guaranteed.

[0055] 5 shows a further embodiment of the closure device 2, which differs from the embodiment shown in FIG. 1b, for example, in that it does not have a fastening shell. In this embodiment, the fastening cage 211 is made of plastic and fastens the sealing plug 20 with the help of an undercut web 2103. The protective cover 22 is welded directly to the fastening cage 211.

[0056] Figure 6 shows a further embodiment of a locking device 2, which, similar to Figure lb, has an anchoring shell 211 made from aluminium. In this embodiment, the anchoring shell 211 extends in the longitudinal direction L along the side wall 2102 beyond the lower end of the anchoring cage 210, where it is crimped to the anchoring cage.

[0057] List of reference symbols 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, self-closing) 201 Seal Edge 202 En 2021 Cage Support Surface 2022 Cage edge recess 203 Plug tapered part 21 Plug fixing device 210 Adhesive cage (thermoplastic, PBT) 2101 Central ring (with central opening) 2102 Side wall 2103 Relief groove web in side wall 2104 Cage edge bead 2105 Plug engagement edge (end of circumferential part of center ring) 211 outer cage shell (surrounding sheet metal, 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, rotationally symmetrical) 221 Engagement edge (protruding diagonally upward, can be actually connected to the cover engagement part) 222 Central tapered portion / optional recess 223 Transparent / Semi-transparent window layer 224 Window ridge in 223 23 Thermal Plastic Ring 24 Metal Ring 240 Upper Color 241 Through hole 242 Metal ring flange 3 Shipping Containers / Delivery Cassettes 30 Box Lids / Protective Films 31 First storage pallet for locking devices 32 Second storage pallet for active substance containers 33 Transport tank

Claims

1. A multi-component closure device (2) for coupling to a medical active substance container (1) having a collar (101) having a collar end bead (102), an outer collar surface (103), and an inner contact surface (104), The multi-component closing device (2) comprises a seal plug (20), a plug fixing device (21), and a protective cover (22). The seal plug (20) can be fixed to the active substance container (1) using the plug fixing device (21), seals the opening in the bottle-reduced diameter portion (10) of the active substance container (1), and allows an application needle to be pushed through the seal plug (20) to remove the liquid active substance. The plug fixing device (21) comprises a fixing cage (210) made of thermoplastic plastic, the fixing cage (210) having a central ring (2101), a central opening and side walls (2102), One or more latching elements protrude away from the inner surface of the side wall (2102) in the direction of the vertical axis (L), The plug engagement edge (2105) formed on the fixing cage (210) engages with the cage edge recess (2022) on the seal plug (20), The protective cover (22) is detachably attached to the plug fixing device (21), A multi-component closure device (2) is characterized in that a thermoplastic ring (23) and a metal ring (24) surrounding the thermoplastic ring (23) are part of the multi-component closure device (2), and the fixing cage (210) is configured to engage with a portion of the side wall (2102) below the thermoplastic ring (23) or the metal ring (24) in order to fix itself to the metal ring (24) and / or the thermoplastic ring (23).

2. The multi-component closing device (2) according to claim 1, wherein the one or more locking elements are a plurality of integrally formed relief groove webs (2103).

3. The thermoplastic ring (23) is fused to the surrounding metal ring (24), and both rings (23, 24) are pre-mounted on the collar (101) of the bottle diameter reduction portion (10), and are then operably connected to the fixing cage (210) and the seal plug (20), according to claim 1 or claim 2.

4. The multi-component closing device (2) according to claim 1 or claim 2, wherein the metal ring (24) has a circumferential upper collar (240), a central region having a plurality of through holes (241), and a lower metal ring flange (242), and the metal ring (24) is shaped such that the metal ring (24) receives the thermoplastic ring (23) and the metal ring (24) engages below the collar (101) on the bottle diameter reduction portion (10).

5. A multi-component closure device (2) according to claim 1 or claim 2, wherein a plurality of radially outward-facing seal edges (201) made of elastomer, TPE (thermoplastic elastomer), or TPU (thermoplastic polyurethane) are arranged on the seal plug (20) along the outer surface of the seal plug (20) as material that protrudes away from the inner contact surface (104) of the collar (101).

6. The multi-component closure device (2) according to claim 5, wherein the three seal edges (201) are arranged as a material that protrudes away from each other in the direction of the inner contact surface (104) of the collar (101).

7. The multi-component closure device (2) according to claim 1 or claim 2, wherein the protective cover (22) is produced in two parts, the protective cover (22) has a recess (222), and the window protrusion (224) of the transparent / translucent window layer (223) protrudes at least partially into the recess (222).

8. The multi-component closing device (2) according to claim 1 or claim 2, wherein the protective cover (22) is fastened to the plug fixing device (21) by material closure.

9. The multi-component closure device (2) according to claim 8, wherein the material closure is achieved by gluing or welding.

10. The protective cover (22) is made of plastic, the multi-component closing device (2) according to claim 1 or claim 2.

11. The multi-component closed device (2) according to claim 10, wherein the plastic is polycarbonate (PC) or acrylonitrile-butadiene-styrene copolymer (ABS).

12. A multi-component closing device (2) according to claim 1 or claim 2, wherein an outer cage shell (211) having a central opening (2111) and a cover engagement portion (2113) is positioned at least partially over the fixing cage (210), and the protective cover (22) is removably fastened to the plug fixing device (21) via the cover engagement portion (2113).

13. The multi-component closure device (2) according to claim 12, wherein the outer cage shell is fixed to the fixing cage by material closure, morphological closure, or force closure.

14. The multi-component closure device (2) according to claim 13, wherein the material closure is achieved by gluing or welding, and the morphological closure is achieved by crimping.

15. A multi-component closure device (2) according to claim 13 or claim 14, wherein a circumferential cage edge bead (2104) is formed within the outer surface of the side wall (2102) of the fixing cage (210), and the outer cage shell (211) has a cage shell bead (2112) for engagement of the fixing cage with the circumferential cage edge bead (2104).

16. The multi-component closure device (2) according to claim 1 or claim 2, wherein the fixing cage (210) is made from polybutylene terephthalate (PBT) and the sealing plug (20) is made from rubber.

17. The central plug tapered body (203) is located within the seal plug (20), and the multi-component closing device (2) is as described in claim 1 or claim 2.

18. The multi-component closing device (2) according to claim 1 or claim 2, wherein the seal plug (20) is attached to the closing device (2) by material closure, shape closure, or force closure.

19. The multi-component closure device (2) according to claim 18, wherein the material closure is achieved by gluing or welding.

20. A medical active substance container (1) having a multi-component closure device (2) according to any one of claims 1 to 19, The medical active substance container (1) is characterized in that it has a bottle diameter reduction portion (10) having an inner contact surface (104), the inner contact surface (104) is matched to the seal plug (20) having at least three seal edges (201) of the seal plug (20), the medical active substance container (1) has a collar (101), the collar (101) is for the non-removable fastening of the multi-component closing device (2) to the collar (101) by pressing it against the longitudinal axis (L).

21. Use of a multi-component closure device (2) according to any one of claims 1 to 19 as a closure device for a medical active substance container (1) to prevent contamination of the inside of the medical active substance container (1), wherein the medical active substance container (1) allows for the removal of the active substance or vaccine from the inside using an aspiration or inoculation syringe, and the multi-component closure device (2) is pressed onto a collar (101) by pressing it in the direction of the longitudinal axis (L) of the medical active substance container (1), and then contacts the inner contact surface (104) to be irremovably held with the seal plug (20).

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