Multipart closure device for medical active substance container
Patent Information
- Application Number
- EP2023742083
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-19
- Filing Date
- 2023-07-17
- Publication Date
- 2025-06-11
- Estimated Expiration
- 2043-07-17
AI Technical Summary
Existing multi-part closure devices for medical active ingredient containers are complex, costly to produce, and not suitable for mass production, with difficulties in filling and closing during the filling process, especially requiring special tools and multiple components.
A multi-part closure device comprising a sealing plug and a stopper securing device with a protective lid, featuring a conically shaped elastomer sealing plug and a two-part plug securing device, which can be easily attached to the bottle neck of medical active ingredient containers, ensuring a secure and airtight seal without the need for special tools, and allowing easy access for needle insertion.
The solution provides a secure, lightweight, and simplified closure system that can be applied on-site during filling, ensuring aseptic storage and transport while reducing production complexity and material usage, allowing for efficient filling and closing of medical active ingredient containers without specialized tools.
Smart Images
Figure 1.1
Abstract
Description
[0001] Multi-part closure device for medical drug containers
[0002] Technical area
[0003] The invention relates to a multi-part closure device for coupling to a medical active ingredient container with a suitable collar, wherein the multi-part closure device comprises a sealing plug, a plug securing device and a protective lid, wherein the sealing plug can be fixed by means of the plug securing device to the active ingredient container and an opening in a bottle neck in a sealing manner and allowing an airtight removal of liquid active ingredient. Furthermore, the invention relates to a medical active ingredient container with a multi-part closure device and the use of a multi-part closure device.
[0004] State of the art
[0005] The aseptic storage and transport of medical devices and active pharmaceutical ingredients in medical drug containers is of great importance in many areas of medicine. Of particular interest here are medical drug containers in the form of medical injection vials, also known as "vials," where liquid active pharmaceutical ingredients are withdrawn from such medical drug containers using drawing-off and / or application needles. Specific examples of these medical drug containers or vials are vaccine containers, vaccine vials, or vaccine ampoules.
[0006] Wherever vaccines are administered in liquid form, care must be taken to ensure that the vaccines or vaccine concentrates are not contaminated during storage and that vaccines are not taken from medical drug containers that have already been unknowingly opened. In addition to aseptic storage, a guaranteed seal must also be visible until first use so that contamination of the contents can be ruled out with certainty. Accordingly, the medical drug containers are provided with a locking device, as there are no plans to reseal them for longer-term use. The medical disciplines of interest here, in which active ingredients are administered in such medical drug containers, are in particular immunology, virology, and oncology, although this is not to be understood as an exhaustive list.
[0007] 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, with a rubber stopper partially inserted into the bottle neck and permanently fixed there by a retaining ring. The rubber stopper has a sealing lip that is sealingly connected 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 metal sheet. By pressing the retaining ring onto the bottle neck and bending the bottle-side edge of the retaining ring, the rubber stopper cannot become detached from the medical drug container, and vaccines can be stored aseptically. Additional means are provided to form a stopper securing device that additionally 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 withdrawn from the interior of the medicinal active ingredient container by inserting a syringe or application needle through the thinner center of the rubber stopper. EP2948122 provides for complex additional means that go far beyond the simplest possible securing of the rubber stopper with a metal ring. This design is technically complex and not particularly suitable for mass production.
[0008] In addition to the effort involved in manufacturing the multi-part closure device from EP2948122 and the large number of different components, the filling and closing of the active ingredient containers also appears to be complex and not possible at the site of the filling equipment.
[0009] Summary of the invention
[0010] The object of the present invention is to create a multi-part closure device for a medical active ingredient container, in particular made of glass or plastic, which achieves a secure closure with improved tightness, yet comprises few components, is lightweight but enables simplified attachment to the bottle neck opening of the medical active ingredient container, so that the multi-part closure devices can also be easily applied on site during the filling process without special tools.
[0011] The object underlying the invention is achieved by a multi-part closure device having the features of claim 1. Advantageous embodiments of the present invention are defined in the subclaims.
[0012] Preferably, the integrity of the multi-part closure device can be easily read from the outside, for which purpose a special design of the protective cover is provided.
[0013] All variations of feature combinations or minor adaptations of the invention can be found in the detailed description, illustrated in the figures and included in the dependent patent claims.
[0014] Short description of the drawings
[0015] The subject matter of 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 following description, which details a preferred embodiment of the invention and some additional or optional features.
[0016] Further features, details, and advantages of the invention will become apparent from the following description of preferred embodiments of the invention and the drawings. They show:
[0017] Figure 1a shows a view of a bottle neck of a medicinal drug container and a matching multi-part
[0018] Locking device with protective cover in exploded view;
[0019] Figure lb is a sectional view of the multi-part locking device with
[0020] Protective cap placed on a bottle neck;
[0021] Figure lc a sectional view of the multi-part locking device with
[0022] Shows protective cap in assembled state but without bottle neck;
[0023] Figure 2a is a perspective view of an option for the multi-part closure device with a protective cover made of two rings;
[0024] Figure 2b a sectional view of both rings mounted on a bottle neck;
[0025] Figure 2c is a sectional view of the assembled multi-part compact closure device with protective lid and the two rings, attached to a bottle neck;
[0026] Figure 3a shows a perspective view of the stopper securing device with protective lid, with additional recesses and plastic windows in the protective lid, mounted on a bottle neck; Figure 3b shows a schematic representation of a window position and the protective lid with corresponding recesses, as produced on a corresponding plastic injection molding machine;
[0027] Figure 4 is a sectional view of a transport container in which prefabricated storage pallets with several unfilled medicinal active ingredient containers and several non-attached multi-part closure devices are stored;
[0028] Figure 5 is a sectional view of a multi-part closure device according to a further embodiment of the invention; and
[0029] Figure 6 is a sectional view of a multi-part closure device according to a further embodiment of the invention.
[0030] Detailed description of the invention
[0031] The present invention is explained by way of example with reference to the accompanying figures, which, however, are not intended to limit the scope of the invention.
[0032] An embodiment of the invention in the form of a medical active ingredient container 1 with a multi-part compact closure device 2 is shown in Figure 1a. Such medical active ingredient containers 1 or vials 1 can be referred to as vaccine vials, vaccine ampoule, vaccine vials, multi-dose containers, medicinal vials for the aseptic storage and dispensing of liquid vaccines and vaccine concentrates as a medical active ingredient. These medical active ingredient containers 1 are made of glass or plastic and are commercially available in standardized sizes. After filling the medical active ingredient container 1, the multi-part closure device 2 is placed onto a bottle neck 10. The multi-part closure device 2 is mounted on the bottle neck 10 in a non-detachable manner and cannot be removed without being destroyed, so that no vaccine can escape from the medical active ingredient container 1 and no unwanted access is possible.
[0033] The contents are not shown here. Contamination of the interior of the medical drug container 1 must be avoided during transport and storage. After opening or first use of the contents of the medical drug container 1, there are often only a few hours left before the contents—for example, a vaccine—become unusable.
[0034] According to one aspect of the invention, a multi-part closure device 2 according to the invention comprises at least one sealing plug 20 and a multi-part plug securing device 21, with which the sealing plug 20 can be fastened to a collar 101 of the bottle neck 10. Due to the design of the plug securing device 21 presented here, the multi-part closure device 2 can be pressed onto the collar 101 in the direction of a longitudinal axis L of the medicinal active ingredient container 1, and means of the plug securing device 21 engage the collar 101.
[0035] The closure device 2 is not intended for multiple use, opening and closing of the closure device 2, but remains, after attachment to the collar 101, sealing the interior of the medicinal active substance container 1 and immovable.
[0036] A protective cover 22 is intended as an optional part of the multi-part closure device 2, which additionally provides mechanical protection.
[0037] In Figure 1a the individual components are shown in a state not yet assembled and are presented individually from bottom to top.
[0038] The bottle neck 10 of the medicinal active ingredient container 1 has a collar 101, which has 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 plugged together with the collar end bead 102, with one part engaging behind the collar end bead 102, so that the closure device 2 cannot slip relative to the collar 101 in the assembled state.
[0039] The sealing plug 20 is formed in one piece from an elastomer, preferably from rubber or from a thermoplastic elastomer (TPE) and is designed to taper downwards from the top, i.e. from the side facing away from the medical active substance container 1, i.e. is essentially conically shaped.
[0040] The sealing plug 20 is profiled, and at least one sealing lip 201 and one edge 202 are arranged on the outer circumferential side surface of the sealing plug 20. Thus, the sealing plug 20 can be pressed onto the bottle neck 10 in the longitudinal direction L and arranged and secured so as to partially protrude therein. To increase the tightness, three sealing lips 201 along the outer side surface of the sealing plug 20 have proven effective. In the assembled state, these lips lie along the inner contact surface 104 of the bottle neck 10. The edge 202 protrudes radially beyond the tapered part of the sealing plug 20 and remains outside the bottle neck 10 in the assembled state.
[0041] The tapered part of the sealing plug 20 is countersunk into the bottle neck 10 during assembly, with the edge 202 of the sealing plug 20 remaining outside the collar 101 and the bottle neck 10. A cage support surface 2021 is arranged along the peripheral edge 202, and therein a peripheral cage edge recess 2022 in the form of an annular groove. Preferably, the cage edge recess 2022 has a peripheral bead 2023, which is formed by an undercut in a lower section of the cage edge recess 2022 on a radially inner surface of the cage edge recess 2022.
[0042] To ensure easy access to the interior of the medicinal active ingredient container 1 during subsequent removal of the contents of the medicinal active ingredient container 1, a central stopper taper 203 is provided in the sealing plug 20, also indicated by dashed lines in Figure 1a. A drawing-up and / or application needle can be easily pierced through this stopper taper 203.
[0043] In addition to the sealing plug 20, which is optimized compared to the prior art, the multi-part compact closure device 2 has a plug securing device 21, which consists of two parts, a securing cage 210 and an outer cage shell 211.
[0044] The safety cage 210, which is located on the inside in the assembled state, closer to the longitudinal axis L, is manufactured in one piece, preferably 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 safety cage 210 open, allowing the insertion and / or application needle to be pierced through it. The size of the central opening is preferably as large as the diameter of the plug taper 203 in the sealing plug 20 or even larger. The safety cage 210 is particularly preferably made of polybutylene terephthalate (PBT).
[0045] The safety cage 210 can have one or more locking elements, such as a circumferential projection or individual locking lugs, wherein the locking elements are adapted to lock onto the medical active ingredient container, for example with a suitable locking area provided on the collar 101. The safety cage can be easily fastened to the medical active ingredient container via the locking elements by slipping the safety cage 210 over the opening or collar 101 of the medical active ingredient container 1 in the direction of the longitudinal axis L. In the embodiment shown, the undercut webs 2103 are provided as locking elements. The undercut webs 2103 are arranged in the side wall 2102 in such a way that, in the assembled state, they can be brought into engagement below the collar end bead 102 on the collar 101. In the view according to Figure 1a, an inclination from bottom to top in the direction of the longitudinal axis L can be seen.Due to the inclination 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 securing cage 210 and the sealing plug 20 are efficiently secured and fixed to the medicinal substance container 1 in the axial direction and in the direction of the longitudinal axis L, respectively, by this mechanism.
[0046] A cage edge bead 2104 is arranged at least partially circumferentially in the side wall 2102. The cage edge bead 2104 is enclosed by the outer cage shell 211 when the multi-part closure device 2 is assembled.
[0047] At the end of the central ring 2101, a plug engagement edge 2105 is arranged in a bent manner. With the plug engagement edge 2105, the safety cage 210, in the assembled state, engages into the cage edge recess 2022 of the sealing plug 20, thereby fixing the safety cage 210 to the sealing plug 20, while the central ring 2101 rests directly on the cage support surface 2021, as can be seen in Figure 1b. According to a further embodiment of the invention, the safety cage 210 is alternatively or additionally fastened to the sealing plug 20 by firmly connecting the sealing plug 20 to the safety cage 210, e.g., by gluing, welding, or by means of a positive fit, such as a snap-in engagement.
[0048] The outer cage shell 211 is provided over the safety cage 210 and is mounted as part of the plug securing device 21. This cage shell 211 is preferably made of sheet metal, although a correspondingly shaped plastic shell would also be possible. The cage shell 211 runs essentially parallel to the safety cage 210 and rests against it. 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 assembled in the direction of the longitudinal axis L, the cage shell 211 can no longer be easily removed from the safety cage 210. Once assembled in this way, the plug securing device 21 can be pressed over the sealing plug 20 and the collar 101, so that the sealing plug 20 is finally permanently attached to the bottle neck 10.According to a further embodiment of the invention, the plug securing device 21 is first placed over the sealing plug 20 and connected thereto, wherein the assembly comprising the securing cage 210, cage sleeve 211, protective cover 22 and sealing plug 20 is then placed as a unit over the collar 101 in order to secure the plug securing device 21 to the medical active ingredient container 1. The cage sleeve 211 completely encloses the securing cage 210, while only the central surfaces above and below of the securing cage 210 and the cage sleeve 211 remain accessible in the assembled state and a drawing and / or application needle can be pierced through the central opening 2111 and the central ring 2101 with the central opening.
[0049] Additional means are provided to releasably attach the additional protective cover 22 directly to the outer cage shell 211 or indirectly to the safety cage 210. These additional means are arranged either directly on the safety cage 210 or, as shown in the embodiment here, directly on the outer cage shell 211. As an additional means, a cover recess 2113 is formed on the edge of the central opening 2111 as part of the outer cage shell 211. The cover recess 2113 is inclined toward the longitudinal axis L, namely upwards, in the direction of the protective cover 22.
[0050] The protective cover 22 is preferably made of polycarbonate (PC) or acrylonitrile-butadiene-styrene copolymers (ABS), is generally rotationally symmetrical, and has a concentric region with an engagement edge 221. However, a protective cover 22 made of metal, e.g., aluminum, is also possible. The engagement edge 221 surrounds an area of the inner surface of the cover, the surface facing the outer cage shell 211. When the protective cover 22 is mounted on the outer cage shell 211, the cover engagement 2113 engages in the engagement edge 221, whereby the protective cover 22 is releasably held on the outer cage shell 211 and forms part of the multi-part closure device 2. The protective cover 22 can be shaped as a profile and have a central taper 222 or optional recesses 222, which lead to increased stability or are selected to save material.
[0051] The protective cover 22 is optional and not mandatory. However, to provide better protection against external influences, the protective cover 22 should be detachably connected to the outer cage shell 211 or the safety cage 210 of the plug securing device 21, so that the protective cover 22 can be removed from the plug securing device 21 before use. 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 safety cage 210 by a material bond, e.g., by laser welding. An adhesive bond or a form-fit connection, as explained above, is also possible. It is also conceivable for the protective cover 22 to be manufactured in one piece together with the safety cage 210, or, if present, with the outer cage shell 211, for example, as a plastic injection molding, with predetermined breaking points being formed for releasing the protective cover 22.Against this background, it is particularly preferred if the protective cover 22 and the fuse cage 210 are made of plastic.
[0052] Figure 1b shows the assembled state of the multi-part closure device 2. Once assembled, the undercut webs 2103 engage concentrically at several points in the side wall 2102 behind the collar 101, and the position of the sealing plug 20 on the inner contact surface 104 is secured, while at least one sealing lip 201 forms a sealing seal. The side wall 2102 of the safety cage 210 and the outer cage shell 211 rest against the outer collar surface 103. Even when pulled in the direction of the longitudinal axis L, away from the medicinal substance container 1, the safety cage 210 and thus the sealing plug 20 remain immobile.
[0053] The effect of the plug securing device 21 is maximum, with little material expenditure, few components and low weight of the entire plug securing device 21. The sealing lips 201, which protrude radially outwards from the sealing plug 20, here preferably three stepped sealing lips 201 are provided, 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.
[0054] The plug engagement edge 2105 engages the concentrically circumferential cage edge recesses 2022. The cage edge recesses 2022 are recessed from the sealing plug 20 at an angle radially to the longitudinal axis. The circular cage edge bead 2104 in the securing cage 210 and the cage shell bead 2112 running parallel to it in the outer cage shell 211 are clearly visible and engaged. The securing cage 210 is operatively connected to the outer cage shell 211, encloses the sealing plug 20, and is concealed by the cover 22.
[0055] 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 engagement edge 2105, also inclined in the direction of the longitudinal axis L, a part of the surface of the sealing plug 20, which faces the cover 22, is pressed in the direction of the outer cage shell 211, so that the outer cage shell 211 additionally rests firmly on the sealing plug 20.
[0056] For medical drug containers 1 made of glass, the multi-part closure device 2 can optionally be adapted. Since such medical drug containers 1 made of glass often have simply shaped bottle necks 10 without protruding or projecting collar end beads 102, sufficient fastening is often more difficult to produce. In addition to the compact multi-part closure device 2, an inner thermoplastic ring 23 and an outer metal ring 24 are preferably used here, as shown in Figure 2a. 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 23 has a profile matched to the profile 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 through holes 241, and a lower metal ring flange 242. Parts of the thermoplastic ring 23 melt through the through holes 241 during production, so that both rings 23, 24 are permanently connected to each other. This melting of the thermoplastic ring 23 onto the metal ring 24 can occur directly mounted on the collar 101 or can be performed beforehand.
[0057] Figure 2b shows the metal ring 24 and the thermoplastic ring 23 mounted on the bottle neck 10 before the multi-part compact closure device 2 is pressed on. Figure 2c shows how such a multi-part closure device 2 combined with the metal ring 24 and the thermoplastic ring 23 can be attached to a simplified bottle neck 10 after pressing on in the direction of arrow L. The safety cage 210 engages with a part of the side wall 2102 under the thermoplastic ring 23 or the metal ring 24.
[0058] Additionally, precautions in the protective cover 22 may be advantageous, allowing 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 Figures 3a and 3b. In addition to the layer of the protective cover 22, in which recesses 222 are provided, an additional transparent / translucent window layer 223 with at least one window elevation 224 is provided. Here, three recesses 222 and one transparent / translucent window layer 223 with three window elevations 224 were chosen. The window layer 223 must be designed to be so transparent / translucent that the window elevations 224 allow a view up to the sealing plug 20 or up to the upper edge of the safety cage 210 and the outer cage shell 211. This makes it possible to assess whether the respective multi-part closure device 2 has already been opened once orone of the components has been destroyed. The protective cover 22 is preferably manufactured with a protective cover layer and a transparent / translucent window layer 223 using an injection molding process. Transparent / translucent refers to a window layer 223 that transmits at least 50% of the incident light, so that conclusions can be drawn regarding its integrity.
[0059] The advantage of all presented multi-part closure devices 2 is that several unsealed medicinal drug containers 1 with matching multi-part closure devices 2 and possibly with the ring combination 23, 24 can be combined unfilled and unsealed to form a
[0060] They can be transported to the active ingredient filling plant, filled there, and easily sealed there as well. Without the need for special tools, they can be filled at the filling site by the vaccine or active ingredient filler themselves.
[0061] For this purpose, as shown in Figure 4, a transport container 3, which can also be referred to as a delivery cassette 3, comprising a transport container trough 33, in which a first storage pallet 31 with multi-part closure devices 2 and a second storage pallet 32 with medicinal active ingredient container 1, sealed with a box lid 30 and / or a protective film 30, is delivered. The medicinal active ingredient containers 1 are unlocked, ie the openings of the medicinal active ingredient containers 1 at the bottle neck 10 are free.
[0062] The second storage pallet 32 with empty medicinal active ingredient container Item 1 lies in the transport container tray on the first storage pallet with the multi-part closure devices 32.
[0063] A possible filling process for the medical active ingredient containers 1 is as follows. First, the transport container 3 or the transport container tray 33 is delivered to a filling plant for medical active ingredients and made available there. There, the box lid 30 and / or the protective film 30 is removed. Subsequently, the second storage pallet 32 with the medical active ingredient containers 1 is removed from the transport container tray 33 and placed in the filling station, where the filling of the open medical active ingredient containers 1, located locally in the second storage pallet 32, takes place.As soon as all medical active ingredient containers 1 of the second storage pallet 32 are filled, the complete first storage pallet 31, which is also removed from the transport container trough 33, is placed on the bottle necks of the filled medical active ingredient containers 1. By pressing the first storage pallet 31 towards the bottom of the transport container trough, each medical active ingredient container 1 is tightly closed with an associated closure device 31. When the first storage pallet 31 is pressed down towards the bottom of the transport container trough, or towards the bottom of the medical active ingredient container 1, the multi-part closure devices 2 with their sealing plugs 20 and plug retainers 21 are pressed onto the openings of the bottle necks 10. The undercut webs 2103 in the side wall 2102 of the securing cage 210 engage behind the collar end bead 102 and secure the medical active ingredient container 1 against unwanted opening.
[0064] To ensure simple and quick closing, the arrangement of the closure devices in the first storage pallet 31 is coordinated with the arrangement of the active ingredient containers in the second storage pallet 32, i.e., by placing and pressing the first storage pallet 31 onto the second storage pallet 32, the multi-part closure devices 2 engage the bottle necks 10 of corresponding medical active ingredient containers 1 and close the respective medical active ingredient container 1. This enables simple and quick closing of the medical active ingredient containers 1.
[0065] After filling and closing the active ingredient containers 1, the second storage pallet 32 with the filled and closed medical active ingredient containers 1 can be positioned again in the transport container tray 33 and the transport container can be closed with the box lid 30 and / or a protective film 30.
[0066] When using glass medical drug containers 1, a thermoplastic ring 23 and a metal ring 24 are additionally mounted on the bottle neck 10 before the closure devices 2 are applied and the entire container is transported unsealed. The multi-part closure devices 2 are pressed on as usual after filling, then over the bottle neck 10 with the ring combination 23 and 24.
[0067] Known plastics, particularly thermoplastics, can be used as the material for the box lid 30, the storage pallets 31, 32, and the transport container tray 33. A nonwoven fabric made of high-density polyethylene has proven particularly suitable as the material for the protective film 30.
[0068] By delivering the transport container 3 with the active ingredient container unsealed, with the first storage pallet 31 and the second storage pallet 32 having coordinated positions of the closure devices 2 and the active ingredient container 1, filling and closing can be simplified and significantly accelerated. This filling and closing process does not need to be performed by a specialist company. Since several components are delivered in one package, in this case the transport container 3 for filling, a large amount of waste and large transport volumes can be avoided. Furthermore, compliance with the necessary sterility during transport is ensured.
[0069] Figure 5 shows a further embodiment of a closure device 2, which differs from the embodiment shown, for example, in Figure 1b in that it does not have a securing sleeve. In this embodiment, the securing cage 211 is made of plastic and secures the sealing plug 20 using the undercut webs 2103. The protective cover 22 is welded directly to the securing cage 211.
[0070] Figure 6 shows a further embodiment of a closure device 2, which, similar to Figure 1b, has a fuse sleeve 211 made of aluminum. In this embodiment, the fuse sleeve 211 extends in the longitudinal direction L along the side wall 2102 beyond the lower end of the fuse cage 210 and is crimped there to the fuse cage.
[0071] 1 medicinal substance container / vial
[0072] 10 Bottleneck
[0073] 101 Collar with inner collar taper
[0074] 102 Collar end bead
[0075] 103 outer collar surface
[0076] 104 inner contact surface
[0077] 2 Multi-part locking device
[0078] 20 sealing plugs (rubber, elastomer, self-closing)
[0079] 201 sealing lips
[0080] 202 Rand
[0081] 2021 cage support surface
[0082] 2022 cage edge recess
[0083] 203 Plug taper
[0084] 21 Plug safety device
[0085] 210 Fuse cage (thermoplastic, PBT)
[0086] 2101 centric ring (with centric opening)
[0087] 2102 side wall
[0088] 2103 Undercut bars in side wall
[0089] 2104 cage edge bead
[0090] 2105 Plug engagement edge (end of the centric ring circumferential,
[0091] 211 outer cage shell (metal, surrounding sheet metal)
[0092] 2111 centric opening
[0093] 2112 Cage shell bead (circumferential engagement edge, analogous to 2104)
[0094] 2113 Lid access (circumferential around 2111)
[0095] 22 protective covers (removable, plastic, profiled, rotationally symmetrical)
[0096] 221 engagement edge (protruding diagonally upwards, can be connected to the lid engagement)
[0097] 222 centric taper / optional recesses
[0098] 223 transparent / translucent window position
[0099] 224 window elevations in 223
[0100] 23 Thermoplastic ring
[0101] 24 metal ring
[0102] 240 upper collar
[0103] 241 through holes
[0104] 242 Metal ring flange
[0105] 3 transport containers / delivery cassettes
[0106] 30 box lids / protective film
[0107] 31 first storage pallet for locking devices
[0108] 32 second storage pallet for active ingredient containers
[0109] 33 Transport container tray
Claims
Patent claims 1. A multi-part closure device (2) for coupling to a medical active ingredient 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 lid (22), wherein the sealing plug (20) can be secured to the active ingredient container (1) by means of the plug securing device (21) in a manner that seals an opening in a bottle neck (10) of the active ingredient container (1) and allows an airtight removal of liquid active ingredient, characterized in that 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 locking elements, in particular a plurality of molded undercut webs (2103), protrude 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 in a cage edge recess (2022) on the sealing plug (20), wherein the protective cover (22) is detachably attached to the plug securing device (21).
2. Multi-part closure device (2) according to claim 1, wherein 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 fixing, in particular locking, to the metal ring (24) and / or thermoplastic ring (23).
3. Multi-part closure device (2) according to claim 2, wherein the thermoplastic ring (23) is fused to the surrounding metal ring (24) and both rings (23, 24) are previously fixed to the collar (101) of the bottle neck (10) and are then operatively connected to the safety cage (210) and the sealing plug (20).
4. Multi-part closure device (2) according to one of claims 2 to 3, 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 such that the metal ring (24) receives the thermoplastic ring (23) and engages under the collar (101) on the bottle neck (10).
5. Multi-part closure device (2) according to one of the preceding claims, wherein a plurality of radially outwardly pointing sealing lips (201) are arranged on the sealing plug (20) made of an elastomer, TPE (thermoplastic elastomer) or a TPU (thermoplastic polyurethane) along the outer surface of the sealing plug (20), in particular three sealing lips (201) are arranged as material projecting in the direction of an inner contact surface (104) of the collar (101).
6. Multi-part closure device (2) according to one of the preceding claims, wherein the protective cover (22) is made in two pieces and has recesses (222) into which window elevations (224) of a transparent / translucent window layer (223) protrude at least partially.
7. Multi-part closure device (2) according to one of the preceding claims, wherein the protective cover (22) is fastened to the plug securing device (21) by means of a material connection, in particular by gluing or welding.
8. Multi-part closure device (2) according to one of the preceding claims, wherein the protective cover (22) is made of plastic, in particular made of polycarbonate (PC) or acrylonitrile-butadiene-styrene copolymers (ABS).
9. Multi-part closure device (2) according to 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 slipped over the safety cage (210), and the protective cover (22) is releasably fastened to the plug securing device (21) via the cover engagement (2113).
10. Multi-part closure device (2) according to claim 9, wherein the outer cage shell is fixed to the safety cage by a material connection, in particular by gluing or welding, by a form fit, in particular by crimping, or by a force fit.
11. Multi-part closure device (2) according to claim 10, wherein a circumferential cage edge bead (2104) is formed into the outer surface of the side wall (2102) of the safety cage (210) and the outer cage shell (211) has a cage shell bead (2112) for engagement in the circumferential cage edge bead (2104) of the safety cage.
12. Multi-part closure device (2) according to 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.
13. Multi-part closure device (2) according to one of the preceding claims, wherein a central plug taper (203) is present in the sealing plug (20).
14. Multi-part closure device (2) according to one of the preceding claims, wherein the sealing plug (20) is fixed to the closure device (2), preferably to the safety cage (210), by means of a material connection, in particular by gluing or welding, by form fitting or by frictional locking.
15. Medical active ingredient container (1) with a multi-part closure device (2) according to one of the preceding claims, characterized in that the medical active ingredient container (1) has a bottle neck (10) with an inner contact surface (104) matched to the sealing plug (20) with at least three sealing lips (201) of the sealing plug (20) with a collar (101) for non-detachable fastening of the multi-part closure device (2) to the collar (101) by means of a single pressing in the direction of the longitudinal axis (L).
16. Use of a multi-part closure device (2) according to one of claims 1 to 14 as a closure of a medical active ingredient container (1) for preventing contamination of the interior of the medical active ingredient container (1), which allows the removal of active ingredient or vaccine from the interior by means of a draw-off or vaccination syringe, wherein the multi-part closure device (2) can be pressed onto a collar (101) by pressing in the direction of the longitudinal axis (L) of the medical active ingredient container (1) and is then held in a non-detachable manner by the sealing plug (20) against the inner contact surface (104).