Multi-part closure device for medical active substance containers
The multi-part locking device for medical drug containers addresses complexity and assembly challenges by using a sealing plug and plug safety device with a safety cage and outer cage shell, facilitating easy assembly and ensuring a secure seal during filling and transport.
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Patents
- Current Assignee / Owner
- PRESSPART
- Filing Date
- 2023-07-17
- Publication Date
- 2026-07-08
AI Technical Summary
Existing multi-part closure devices for medical drug containers are complex, heavy, and require special tools for assembly, making them unsuitable for mass production and complicating the filling process.
A multi-part locking device with a sealing plug, plug locking device, and optional protective cover, featuring a sealing plug with elastomer material and a plug safety device with a safety cage and outer cage shell, allowing easy attachment to the bottle neck without special tools, ensuring a secure and airtight seal.
The device provides a secure, airtight seal with minimal components and weight, enabling easy assembly during the filling process and ensuring the integrity of the container contents during transport and storage.
Smart Images
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Abstract
Description
Technical field
[0001] The 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 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, thereby sealing and allowing airtight dispensing of liquid drug. Furthermore, the invention relates to a medical drug container with a multi-part closure device and to 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in the form of injection vials, also known as "vials," from which liquid active pharmaceutical ingredients are withdrawn using drawing-up and / or application needles.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 containers. In addition to aseptic storage, a guaranteed seal must be clearly visible until first use to reliably prevent contamination of the contents. Accordingly, the medical containers are equipped with a locking mechanism, as they are not designed to be resealable for extended use. The medical specialties relevant here, in which active ingredients are administered in such containers, include immunology, virology, and oncology, although this list is not exhaustive.
[0004] 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.
[0005] 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 at the location of the filling facilities.
[0006] A multi-part locking device according to the preamble of claim 1 is known from WO2022 / 112353. Summary of the invention
[0007] The present invention aims to create a multi-part closure device for a medical drug container, in particular made of glass or plastic, which achieves a secure closure with improved tightness, yet comprises few components, has little weight but enables 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 without special tools.
[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 defined in the dependent claims.
[0009] Preferably, the integrity of the multi-part locking device can be easily read from the outside, for which a special design of the protective cover is provided.
[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 invention is described in detail below in conjunction with the accompanying drawings. Necessary features, details, and advantages of the invention will become apparent from this subsequent description, which also includes a preferred embodiment of the invention and some additional or optional features.
[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 1a shows an exploded view of the neck of a medical drug container and a matching multi-part closure device with a protective cap; Figure 1b shows a sectional view of the multi-part closure device with protective cap, mounted on a bottle neck; Figure 1c shows a sectional view of the multi-part closure device with protective cap in the assembled state but without the bottle neck; Figure 2a shows a perspective view of an option for the multi-part closure device with protective cap consisting of two rings; Figure 2b shows a sectional view of both rings mounted on a bottle neck; Figure 2c shows a sectional view of the assembled multi-part compact closure device with protective cap and the two rings, attached to a bottle neck; Figure 3a shows a perspective view of the stopper locking device with protective cap, with additional cutouts and plastic windows in the protective cap, mounted on a bottle neck;Figure 3 shows a schematic representation of a window layer and the protective cover with corresponding recesses, as produced on a corresponding plastic injection molding machine; Figure 4 shows a sectional 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; Figure 5 shows a sectional view of a multi-part closure device according to a further embodiment of the invention; and Figure 6 shows a sectional view of a multi-part closure device according to a further embodiment of the invention. Detailed description of the invention
[0013] The present invention is explained by way of example with reference to the attached figures, which, however, are not intended to limit the scope of protection of the invention.
[0014] An embodiment of the invention in the form of a medical drug container. 1with a multi-part compact locking device 2 is in Figure 1a shown. Such medical drug containers 1 or vials 1 These containers can be described 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 agents. 1 They are made of glass or plastic and are commercially available in standardized sizes. After filling the medical drug container... 1 will the multi-part locking device 2 on a bottleneck 10 attached. The multi-part locking mechanism 2 is insoluble and cannot be removed without destruction on the bottle neck 10 to store so that no vaccine escapes from the medical drug container 1escape and no unwanted access is possible.
[0015] 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.
[0016] 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 of the sealing plugs 20 on a collar 101 the bottleneck 10 It can be fastened. This is achieved through the design of the plug securing device presented here. 21 can the multi-part locking device 2in 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.
[0017] 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 and immovable.
[0018] A protective cover 22 is an optional part of the multi-part locking device 2 designed to provide additional mechanical protection.
[0019] In Figure 1a The individual components are shown in their unassembled state and are presented individually from bottom to top.
[0020] The bottleneck 10of the medical drug container 1 features 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 it behind the collar end bead 102 intervenes, so that the locking device 2 not relative to the collar when assembled 101 can slip.
[0021] The sealing plug 20 is formed in one piece from an elastomer, preferably rubber or a thermoplastic elastomer (TPE), and is entirely sealed 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.
[0022] The sealing plug 20It 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 longitudinal direction L on the bottleneck 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 10 to 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.
[0023] The tapered part of the sealing plug 20 is installed in the bottleneck during assembly 10 sunken, with the edge 202of the sealing plug 20 outside the collar 101 and the bottleneck 10 remains. Along the surrounding edge 202 there 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.
[0024] 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 1a indicated. Through this plug reduction. 203This makes it easier to push through a priming and / or application needle.
[0025] The multi-part compact 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.
[0026] The one that is mounted on the inside, closer to the longitudinal axis L horizontal safety cage 210 is manufactured in one piece, preferably from a thermoplastic material, and comprises a central ring. 2101 and a surrounding side wall 2102 with several undercut ribs 2103. The central ring 2101 leaves a central opening in the safety cage 210Open, 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. The safety cage is particularly preferred. 210 Made from polybutylene terephthalate (PBT).
[0027] The safety cage 210 may have one or more locking elements, such as a circumferential projection or isolated locking lugs, wherein the locking elements are adapted to lock onto the medical drug container, for example with a suitable locking area located on the collar 101 The safety cage is provided. The locking elements allow the safety cage to be easily attached to the medical drug container. 210 in the direction of the longitudinal axis L about the opening or the collar 101 of the medical drug container1 is turned inside out. In the illustrated embodiment, the undercut ribs serve as locking elements. 2103 provided. The undercut webs 2103 are in the side wall 2102 arranged so that, in the assembled state, they engage below the collar end bead 102 to the collar 101 are bringable. In the view according to Figure 1a is a slope from bottom to top in the direction of the longitudinal axis L This is evident from the inclination of the undercut ribs. 2103 in the direction of the longitudinal axis L, is an intervention of the undercut webs 2103 behind the collar 101 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.
[0028] In the side wall 2102is a cage edge groove 2104 arranged at least partially around the perimeter. The cage edge groove 2104 is in the assembled state of the multi-part locking device 2 from the outer cage shell 211 enclosed.
[0029] At the end of the central ring 2101 is a plug insertion edge 2105 Arranged bent over. With the plug's engagement edge. 2105 The safety cage engages 210 in the cage edge recess when assembled 2022 of the sealing plug 20 one, which causes 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 1b This is recognizable. 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 20with 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.
[0030] About the safety cage 210 The outer cage shell has been thrown away. 211 as part of the plug safety device 21 This cage shell is intended for storage. 211 It is preferably made of a metal sheet, although a suitably shaped plastic shell would also be possible. The cage shell 211 It 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 210can be removed. Once assembled, the plug locking device can be used. 21 over the sealing plug 20 and the collar 101 are pressed so that finally the sealing plug 20 insoluble at the bottleneck 10 is attached. 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 101 is inserted to secure the plug. 21 to be determined on the medical drug container 1. 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 211Remain 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.
[0031] To the additional protective cover 22 directly on the outer cage shell 211 or indirectly at 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 22is preferably made of polycarbonate (PC) or acrylonitrile butadiene styrene copolymers (ABS), is generally rotationally symmetrical and has a concentric area with an engagement edge 221 open. However, a protective cover is also possible. 22 made of metal, e.g., aluminum. The insertion edge 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 222exhibit 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 better protect against external influences, the protective cover should be used. 22 soluble with the outer cage shell 211 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 It is designed to be removable. For attaching the protective cover. 22 at the locking device 2 can the protective cover 22 also through material bonding, e.g. by laser welding to the outer cage shell 211 or the safety cage 210 be connected. An adhesive bond or a form-fit connection, as explained above, is also possible. It is also conceivable that the protective cover22 together with the safety cage 210, or, if present, with the outer cage shell 211 manufactured in one piece, for example as plastic injection molding, with predetermined breaking points for removing the protective cover. 22 to be trained. Against this background, it is particularly preferable if protective covers are used. 22 and safety cage 210 are made of plastic.
[0034] In Figure 1b is the assembled state of the multi-part locking device 2 shown. Once mounted, the undercut tabs engage. 2103 in the side wall 2102 behind the collar 101 concentrically at several points and the position of the sealing plug 20 on the inner mounting surface 104 is ensured, while at least one sealing lip 201 seals tightly. On the outer collar surface 103 The side wall 2102of 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 unmoved.
[0035] The effect of the plug locking device 21 is maximum, with minimal material usage, few components and low weight of the entire plug locking device 21.
[0036] The sealing lips 201, which from the sealing plug 20 projecting radially outwards; preferably three stepped ones, i.e., at different heights parallel to the longitudinal axis. L arranged sealing lips 201 planned, which in Figure 1c when omitting the bottleneck 10 is recognizable.
[0037] The plug insertion edge 2105 engages in the concentrically surrounding cage edge recesses 2022one. The cage edge recesses 2022 are inclined radially to the longitudinal axis from the sealing plug 20 Omitted. The circular cage edge groove. 2104 in the safety cage 210 and the cage shell groove running parallel to it 2112 in the outer cage shell 211 are clearly visible and in action. The safety cage 210 is with the outer cage shell 211 functionally connected, encloses the sealing plug 20 and is removed by the lid 22 concealed.
[0038] Due to the special design of the cage edge recess shown here 2022 in the direction of the longitudinal axis L and the engaging plug engagement edge 2105, also in the direction of the longitudinal axis L When tilted, part of the surface of the sealing plug becomes 20, which the lid 22 is facing towards the outer cage shell 211 pressed so that the outer cage shell 211additionally firmly on the sealing plug 20 lies down.
[0039] For medical drug containers 1 Made of glass, the multi-part locking device 2 can be optionally adapted. Since such medical drug containers 1 Glass often has simply shaped bottle necks. 10 without protruding or protruding collar ends 102 These features often make adequate fastening more difficult to achieve. Besides the compact, multi-part locking mechanism... 2 An inner thermoplastic ring is preferably used here. 23 and an outer metal ring 24 for use, as in Figure 2a shown. The inner thermoplastic ring 23 is preferably made of polybutylene terephthalate (PBT), while the outer metal ring 24 is made of aluminum or another metal. The thermoplastic ring 23features a profile tailored to the profile of the metal ring 24 due to the thermoplastic design of the thermoplastic ring 23 can this be attached to the metal ring 24 to be glued in place. The metal ring 24 features an upper collar 240, a middle section with through holes 241 and a lower metal ring flange 242 on. Parts of the thermoplastic ring 23 melt through the through holes 241 during manufacturing, so that both rings 23, 24 They are inextricably bonded together. This melting of the thermoplastic ring 23 on the metal ring 24 can be attached directly to the collar 101 The assembly process must have taken place or been carried out beforehand.
[0040] In Figure 2b are metal rings 24 and thermoplastic ring 23 at the bottleneck 10 mounted before pressing on the multi-part compact locking mechanism 2shown. Figure 2c shows how such a metal ring 24 and thermoplastic ring 23 combined multi-part closure device 2 on a simplified bottle neck 10 It can be attached after pressing in the direction of the arrow. L. The safety cage 210 engages with part of the side wall 2102 under the thermoplastic ring 23 or the metal ring 24.
[0041] 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. 22 Here it is designed in multiple parts, more precisely in two parts, which in Figures 3a and 3b 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 224Three 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 must 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 2 It has already been opened or one of its components has been damaged. 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. 223denoted as a material that allows at least 50% of the incident light to pass through, so that conclusions can be drawn about its integrity.
[0042] 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 and possibly with the ring combination 23, 24 They can be transported empty 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.
[0043] This is done, as in Figure 4 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 31with 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 container 1 at the bottle neck are open. 10 are free.
[0044] 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.
[0045] 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.
[0046] 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 tray 33 taken 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 31tightly 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.
[0047] To ensure simple and quick sealing, the arrangement of the sealing devices in the first storage pallet is 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 31onto 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.
[0048] After filling and sealing the active ingredient containers 1 can the second storage pallet 32 with the filled and sealed medical drug containers 1 back in the transport container tray 33 positioned and the transport container with the box lid 30 and / or a protective film 30 be sealed.
[0049] In the case of using medical drug containers 1 made of glass, with an additional thermoplastic ring 23 and metal ring 24 at the bottleneck10 installed before the locking devices 2 The entire package is placed on top and transported unsealed. The pressing on of the multi-part locking devices. 2 After filling, the process proceeds as usual, then via the bottle neck. 10 with ring combination 23, 24.
[0050] 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 In particular, a nonwoven fabric made of high-density polyethylene has proven to be suitable.
[0051] By delivering the transport container 3 with unsealed active ingredient containers, the first storage pallet 31 and the second storage pallet 32 Coordinated positions of the locking devices 2 and the active ingredient container 1This allows for simplified and significantly faster filling and sealing processes. This filling and sealing procedure 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 ready for filling, this prevents a large amount of waste and a large transport volume. Furthermore, the necessary sterility during transport is guaranteed.
[0052] Figure 5 shows another embodiment of a locking device 2, which differ from the e.g. in Figure 1b The embodiment shown differs in that it does not have a safety housing. In this embodiment, the safety cage is 211 made of plastic and secures the sealing plug 20 using the undercut ribs 2103. The protective cover 22 is directly attached to the safety cage 211 welded on.
[0053] Figure 6 shows another embodiment of a locking device 2, which are similar to those in Figure 1b a security sleeve 211 made of aluminum. In this embodiment, the safety sleeve extends 211 in longitudinal direction L along the side wall 2102 over the lower end of the safety cage 210 out and is crimped there with the safety cage. Reference symbol list
[0054] 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 stopper (rubber, elastomer, self-closing) 201 Sealing lips 202 Rim 2021 Cage bearing surface 2022 Cage rim recess 203 Stop taper 21 Stop locking device 210 Locking cage (thermoplastic, PBT) 2101 Concentric ring (with centric opening) 2102 Side wall 2103 Undercut ribs in side wall 2104 Cage rim bead 2105 Stop engagement rim (end of the centric ring circumferentially) 211 Outer cage shell (metal, surrounding sheet) 2111 Concentric opening 2112 Cage shell bead (circumferential engagement edge, analogous to 2104) 2113 Cover engagement (circumferential around 2111) 22 Protective cover (removable, plastic, profiled, rotationally symmetrical) 221Intervention edge (projecting obliquely upwards, functionally connectable with lid intervention) 222 centric taper / optional recesses 223 transparent / translucent window layer 224 window extensions in 223 23 thermoplastic ring 24 metal ring 240 upper collar 241 through holes 242 metal ring flange 3 transport container / delivery cassette 30 box lid / protective film 31 first storage pallet for closure devices 32 second storage pallet for active ingredient container 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), wherein the multi-part closure device (2) comprises a sealing plug (20), a plug securing device (21) and a protective cover (22), wherein the sealing plug (20) can be fixed to the active substance container (1) by means of the plug securing device (21), sealing an opening in a bottle neck (10) of the active substance container (1) and permitting airtight removal of a liquid active substance, the plug securing device (21) comprises a securing cage (210) made of a thermoplastic with a central ring (2101), a central opening and a side wall (2102), wherein one or more latching elements, in particular a plurality of integrally formed undercut webs (2103), project away from the inner surface of the side wall (2102) in the direction of the longitudinal axis (L), wherein one or more latching elements, in particular a plurality of integrally formed undercut webs (2103), project away from the inner surface of the side wall (2102) in the direction of the longitudinal axis (L), wherein a plug engagement edge (2105) formed on the securing cage (210) engages into a cage edge recess (2022) on the sealing plug (20), wherein the protective cover (22) is detachably attached to the plug securing device (21), characterized in that a thermoplastic ring (23) and a metal ring (24) surrounding the thermoplastic ring (23) are part of the multi-part closure device (2), wherein the securing cage (210) is suitable for securing itself to the metal ring (24) and / or thermoplastic ring (23), in particular for latching.
2. Multi-part closure device (2) according to claim 1, wherein the thermoplastic ring (23) is fused to the surrounding metal ring (24) and both rings (23, 24) are mounted in advance on the collar (101) of the bottle neck (10) and are then operatively connected to the securing cage (210) and the sealing plug (20).
3. Multi-part closure device (2) according to any one of claims 1 or 2, wherein the metal ring (24) has a circumferential upper collar (240), a central region with a plurality of through holes (241) and a lower metal ring flange (242) and is thus profiled in such a way that the metal ring (24) receives the thermoplastic ring (23) and engages under the collar (101) on the bottle neck (10).
4. Multi-part closure device (2) according to any one of the preceding claims, wherein a plurality of radially outwardly pointing sealing lips (201) made of an elastomer, TPE (thermoplastic elastomer) or a TPU (thermoplastic polyurethane) is arranged on the sealing plug (20) along the outer surface of the sealing plug (20), 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).
5. Multi-part closure device (2) according to any one of the preceding claims, wherein the protective cover (22) 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.
6. Multi-part closure device (2) according to any one of the preceding claims, wherein the protective cover (22) is fastened to the plug securing device (21) by material closure, in particular by gluing or welding.
7. Multi-part closure device (2) according to any one of the preceding claims, wherein the protective cover (22) is made of plastic, in particular of polycarbonate (PC) or of acrylonitrile-butadiene-styrene copolymers (ABS).
8. Multi-part closure device (2) according to any one of the preceding claims, wherein an outer cage shell (211), preferably made of aluminum, with a central opening (2111) and a cover engagement (2113) is at least partially put over the securing cage (210) and the protective cover (22) is detachably fastened to the plug securing device (21) via the cover engagement (2113).
9. Multi-part closure device (2) according to claim 8, wherein the outer cage shell is fixed to the securing cage by material closure, in particular by gluing or welding, by form closure, in particular by crimping, or by force closure.
10. Multi-part closure device (2) according to claim 9, wherein a circumferential cage edge bead (2104) is formed into the outer surface of the side wall (2102) of the securing cage (210) and the outer cage shell (211) has a cage shell bead (2112) for engagement with the circumferential cage edge bead (2104) of the securing cage.
11. Multi-part closure device (2) according to any one of the preceding claims, wherein the securing cage (210) is made of polybutylene terephthalate (PBT), and wherein the sealing plug (20) is preferably made of rubber.
12. Multi-part closure device (2) according to any one of the preceding claims, wherein a central plug tapering (203) is present in the sealing plug (20).
13. 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 gluing or welding, by form closure or by force closure.
14. 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) which is matched to the sealing plug (20) with at least three sealing lips (201) of the sealing plug (20) and has a collar (101) for non-detachable fastening of the multi-part closure device (2) to the collar (101) by pressing it on once in the direction of the longitudinal axis (L).
15. Use of a multi-part closure device (2) according to any one of claims 1 to 13 as a closure of a medical active substance container (1) for preventing contamination of the interior of the medical active substance container (1), which allows the removal of active substance or vaccine from the interior by means of a draw-up or inoculation syringe, wherein the multi-part closure device (2) can be pressed onto a collar (101) by pressing it on in the direction of the longitudinal axis (L) of the medical active substance container (1) and is then held non-detachably with the sealing plug (20) in contact with the inner contact surface (104).