Method for providing a transport vessel for a medically active substance container and filling method for filling a plurality of medically active substance containers - Patents.com

Abstract

The present invention relates in particular to a transport vessel (33) for medically active substance containers (1) for transporting the medically active substance containers (1) for filling with a medically active substance, in which a first storage pallet (31) with a plurality of multi-component closure devices (2) and a second storage pallet (32) with a plurality of empty medically active substance containers (1) are accommodated in the transport vessel (33), and the transport vessel (33) is closed with a box lid (30) or a protective film (30). The multi-component closure devices (2) each have a sealing plug (20), a plug fastening device (21) with a fastening cage (210), and a protective cover (22), and the multi-component closure devices (2) are suitable for being pressed onto and engaging with the collar (101) of the bottle neck (10) of the medically active substance container (1).

Description

[Technical Field]

[0001] (Technical field) The present invention relates to a transport vessel for filling with a medical active substance, the transport vessel comprising a first storage pallet and a second storage pallet with a medical active substance container. The present invention further relates to a filling method for filling a plurality of medical active substance containers and sealing them with associated closure devices. [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] The medical fields of interest here, in which active substances are administered in such medical active substance containers, are in particular immunology, virology and oncology, although this is not to be understood as an exhaustive list.

[0004] Known vials or medical drug containers made of glass or plastic now have different shapes and multi-part closure devices. For example, EP2948122 describes a medically active substance container with a necked portion and a collar, in which a rubber plug is partially inserted into the necked portion and permanently secured therein using a retaining ring. The rubber plug has a sealing edge operably connected to the inner surface of the necked portion of the vial 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 necked portion of the vial 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] Due to the construction requirements according to EP 2948122, filling and sealing of the active substance containers is complicated and is not possible at the site of the filling system: these steps must be carried out at the filling station by a team of specialists using specially designed equipment, which means that the throughput is relatively low. [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 provide a transport container which, as such, makes it possible to make large quantities of medical active substance containers available to a filling system in an efficient manner, as well as a corresponding closure device with which the medical active substance containers can be easily sealed immediately after filling with the active substance on site, without the use of additional tools. In particular, a high degree of sterility and hygiene should also be ensured during the transport of the medical active substance containers.

[0008] The object underlying the present invention is achieved by a transport vessel with the features of claim 1 and by a filling method with the features of claim 11. Advantageous embodiments of the invention are defined in the subclaims. [Brief explanation of the drawings]

[0009] The objects of the present invention are described in detail below in connection with the accompanying drawings. The necessary features, details and advantages of the present invention result from the following description, whereby preferred embodiments of the present invention and some additional or optional features are listed in detail.

[0010] Further features, details, and advantages of the present invention are set forth in the following description and drawings of preferred embodiments of the invention.

[0011] [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 is 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 3] FIG. 3 is a cross-sectional view of a shipping container in which a prefabricated storage pallet with several unfilled medically active substance containers and several unattached multi-part closure devices is stored. DETAILED DESCRIPTION OF THE INVENTION

[0012] (Detailed Description of the Invention) FIG. 1 shows 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 an injection vial, vaccine vial, vaccine ampule, vaccine vial, multi-dose container, or medical vial for the sterile storage and removal of liquid active substances or 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 in such a way 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.

[0013] The contents of the medical active substance container 1 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.

[0014] The multi-part closure device 2 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 removably fastened to the collar 101 of the vial neck 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 medical active substance container 1 by means of the engagement of the plug fastening device 21 with the collar 101. In this way, the multi-part closure device 2 can be stored on the vial neck 10 in a non-removable manner and cannot be removed without destruction by simply pressing it onto the collar 101 in the direction of the longitudinal axis L of the medical active substance container 1 by means of the engagement of the plug fastening device 21 with the collar 101, so that no active substance can escape from the medical active substance container 1 and no undesired access is possible.

[0015] The closure device 2 is not intended for multiple use, i.e., opening and closing of the closure device 2, and remains immovable and non-removable after attachment to the collar 101, sealing the interior of the medically active substance container 1. The protective cover 22 is intended as an optional part of the multi-part closure device 2, providing additional mechanical protection.

[0016] In Figure 1a the individual components are shown as yet unassembled and are presented individually from bottom to top.

[0017] The bottle neck 10 of the medically active substance container 1 has a collar 101 having a collar end bead 102, an outer collar surface 103 and an inner contact surface 104. The multi-part closure device 2 interacts with the collar end bead 102, with one part engaging behind the collar end bead 102 and one part resting against the outer collar surface 103, so that the closure device 2 cannot slide relative to the collar 101.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] A central plug taper 203, also shown by dashed lines in Figure 1a, is provided in the sealing plug 20 to allow easy access to the interior of the medically active substance container 1 once the contents are subsequently removed. This plug taper 203 makes it easier to push through the wicking and / or application needle.

[0022] 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 .

[0023] The anchoring cage 210, located inwardly, closer to the longitudinal axis L in the assembled state, is preferably integrally manufactured as a continuous unit from a thermoplastic material and comprises a central ring 2101 and a circumferential side wall 2102 with a plurality of undercut webs 2103. The central ring 2101 leaves a central opening in the anchoring cage 210 so that a loading 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).

[0024] 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 is visible. 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.

[0025] 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.

[0026] A plug engaging edge 2105 is bent at the end of the central ring 2101. In the assembled state, which can be seen in FIG. 1 b, the central ring 2101 rests directly on the cage support surface 2021, while the anchoring cage 210 engages in the cage recess 2022 of the sealing plug 20 with the plug engaging edge 2105, thereby securing the anchoring cage 210 to the sealing plug 20. Alternatively or additionally, the anchoring cage 210 can be secured to the sealing plug 20 by, for example, being glued, welded, or by firmly connecting the sealing plug 20 to the anchoring cage 210 using a form closure such as a snap fit.

[0027] 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 approximately 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. Once 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. Alternatively, the plug fixation device 21 is first placed over and connected to the sealing plug 20, and the assembly of 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. While the cage shell 211 completely surrounds the fixation cage 210, 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.

[0028] In an alternative embodiment, the multi-part closure device shown may not include a cage shell 211 .

[0029] 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 shown here is a cover engagement portion 2113 formed on the edge of the central opening 2111 as part of the outer cage shell 211. The cover engagement portion 2113 is inclined upwards towards the longitudinal axis L, i.e., in the direction of the protective cover 22.

[0030] 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.

[0031] 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. 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 fixation 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 fixation 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, especially if the protective cover 22 and the fixation cage 210 are made of plastic.

[0032] 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.

[0033] 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 .

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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, 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.

[0038] Figure 2b shows the metal ring 24 and thermoplastic ring 23 mounted on 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 attached to 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.

[0039] The advantage of a multi-part closure device 2, which can be attached to the bottle neck by crimping and locking, 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 system, where they can be filled and simply closed there by the active substance or vaccine filler itself without the use of special tools at the filling site.

[0040] For this purpose, as shown in FIG. 3 , there is a transport container 3, which may also be referred to as a delivery cassette 3, comprising a transport vessel 33 in which a first storage pallet 31 with a multi-component 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 at the bottle neck 10 is exposed. One advantage of providing the medical active substance containers 1 and their multi-component closure devices 2 within a common transport container of an active substance filling system is, among other things, ensuring that a suitable closure for the medical active substance containers 1 is also provided. This makes the filling process more efficient and safer, especially for large production quantities. At the same time, a high level of hygiene is guaranteed.

[0041] As explained above, each of the shown multi-part closure devices 2 comprises a sealing plug 20, a plug fastening device 21 with a fastening cage 210, a cage shell 211 and a protective cover 22. The multi-part closure device 2 is suitable for crimping and latching onto the collar 101 of the bottle neck 10 of the medically active substance container 1. Of course, the transfer vessel can also be used in combination with alternative embodiments of the multi-part closure device, for example in combination with a multi-part closure device that does not have a cage shell or a protective cover.

[0042] In particular, the multi-piece closure device 2 can be particularly easily engaged when the plug fixation device 21 comprises the already-described fastening cage 210 with a central ring 2101, a central opening, and a side wall 2102, in which a circumferential cage edge bead 2104 is molded into the outer surface of the side wall 2102, a plurality of integrally formed undercut webs 2103 protrude away from the inner surface of the side wall 2102 in the direction of the longitudinal axis L, a plug engagement edge 2105 formed on the fastening cage 210 engages in a cage recess 2022 on the sealing plug 20 and connects the outer metal cage shell 211 and the cage shell bead 2112 via the fastening cage 210, and the central opening 2111 and the cover engagement portion 2113 are slid at least partially over it, and the protective cover 22 is therefore removably secured to the plug fixation device 21 via the cover engagement portion 2113.

[0043] As FIG. 3 further shows, a second storage pallet 32 ​​with empty medically active substance containers 1 is arranged in the transport basin above the first storage pallet 31 with the multi-component closure device 2. In the illustrated embodiment example, the second storage pallet 32 ​​also rests on the first storage pallet 31 with the multi-component closure device 2. In this case, the multi-component closure device 2 is arranged on the side of the medically active substance container 1 facing away from the bottle neck 10. In other words, the multi-component closure device 2 is positioned below the base of the medically active substance container 1. Such an arrangement ensures a high degree of hygiene and sterility during transport of the transport container 3. The fact that the multi-component closure device 2 is arranged below the medically active substance container 1 means that particles that may become detached from the multi-component closure device 2 during transport, for example as a result of vibration or the like, cannot penetrate into the medically active substance container 1. Therefore, it is also not necessary to individually close the medically active substance containers 1 for transport. Closure with a box lid 30 and / or a protective film 30 is sufficient.

[0044] The multi-component closure devices 2 in the first storage pallet 31 are oriented in such a way that the sealing plugs 20 are in each case arranged on the side of the protective cover 22 or fastening cage 210 facing away from the bottle necks 10, i.e., when the medical active substance containers 1 are closed, the pointed ends of the conical sealing plugs 20, which are initially inserted into the bottle necks 10, are oriented in the same direction as the lower end or base of the medical active substance containers 1. When the medical active substance containers 1 of the second storage pallet 32 ​​are filled, the first storage pallet 31 with the multi-component closure devices 2 is already oriented with the sealing plugs 20 with their front ends facing the openings of the bottle necks 10, so that the multi-component closure devices 2 can additionally be positioned over the second storage pallet 32 ​​with the filled medical active substance containers 1 for sealing purposes without having to be reoriented, e.g. rotated.

[0045] The arrangement of the multi-component closure devices 2 in the first storage pallet 31 and the arrangement of the medical active substance containers 1 in the second storage pallet 32 ​​are adjusted in such a way that by placing the first storage pallet 31 on top of the second storage pallet 32 ​​and pressing them together, the multi-component closure devices 2 engage with the bottle necks 10 of the corresponding medical active substance containers 1 and seal the individual medical active substance containers 1. This allows for quick and easy sealing of the medical active substance containers 1.

[0046] 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 active medical 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.

[0047] As soon as all medical active substance containers 1 of the second storage pallet 32 ​​have been filled, and removed from the transport tank 33, the complete first storage pallet 31 is placed over the second storage pallet 32 ​​so that the sealing plugs 20 rest on the bottle necks of the filled medical active substance containers 1. By pressing the first storage pallet 31 towards the bottom of the transport tank or towards the bottom of the medical active substance containers 1, i.e. in the direction of the longitudinal axis L of the medical active substance container 1, each medical active substance container 1 is tightly sealed with the associated closure device 31.

[0048] When the first storage pallet 31 is pressed downwards, the multi-part closure devices 2 with their sealing plugs 20 and plug fastening devices 21 are pressed onto the openings of the vial necks 10. The previously described undercut webs 2103 in the side walls 2102 of the fastening cage 210 engage behind the collar end beads 102 and secure against unwanted opening of the medically active substance containers 1. This ensures that they are locked in place and that the multi-part closure devices 2 can no longer be easily removed.

[0049] 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.

[0050] Alternatively, it is also possible to first remove the first and second storage pallets 31 and 32 from the transport tank 33, and then return the second storage pallet 32 ​​with the empty medical active substance containers 1 to be placed in the transport tank 33, whereby the transport tank 33 is then moved with the empty medical active substance containers 1 arranged therein into the filling station for filling. After the filled medical active substance containers 1 are sealed, they are sealed as explained above by crimping the first storage pallet 31 with the multi-part closure device 2. Subsequently, further transportation can also occur within the transport tank 33.

[0051] If a medically active substance container 1 made from glass is used, a thermoplastic ring 23 and a metal ring 24 are also fitted into the bottle neck 10 before the transfer vessel 33 is sealed and transported to the filling system. After filling, the multi-part closure device 2 is crimped as usual through the bottle neck 10, in this case with the ring combination 23, 24.

[0052] 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.

[0053] 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 matching positions of the closure device 2 and the active substance container 1, filling and sealing can be simplified and significantly accelerated. This filling and closing process does not need to be carried out by specialized companies and specialized equipment. In this case of the transport container 3, since several components for filling are provided in one package, a large amount of waste and large transport volumes can be avoided. In particular, sealing can be significantly simplified, and the time required for sealing can be minimized. In addition, compliance with the required sterility conditions during transport is also guaranteed.

[0054] List of Reference Numbers 1 Medical active substance container / vial 10 Bottle narrowing section 101 Collar with inner collar tapered section 102 Collar end bead 103 Outer color surface 104 Inner contact surface 2. Multi-component closure device 20 Seal plugs (rubber, elastomer, self-closing) 201 Seal Edge 202 En 2021 Cage Support Surface 2022 Cage edge depression 203 Plug tapered body 21 Plug fixing device 210 Adhesive cage (thermoplastic, PBT) 2101 Central ring (with central opening) 2102 Side Panel 2103 Undercut web in side panel 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 transport vessel (33) with a plurality of empty medically active substance containers (1), said transport vessel (33) being in particular intended to transport a plurality of empty medically active substance containers (1) for filling with a medically active substance; The first storage pallet (31) and the second storage pallet (32) are housed in the transport tub (33), and the transport tub (33) is closed with a box lid (30) or a protective film (30); said first storage pallet (31) comprising a plurality of multi-component closure devices (2) and said second storage pallet (32) comprising a plurality of empty medically active substance containers (1); Each of the multi-part closure devices (2) comprises a sealing plug (20), a plug fixation device (21) with a fixation cage (210), and a protective cover (22); The multi-part closure device (2) is pressed onto the collar (101) of the bottle neck (10) of the medically active substance container (1), and is suitable for engaging with the collar (101) of the bottle neck (10) of the medically active substance container (1).

2. 2. The transport tank (33) of claim 1, wherein the second storage pallet (32) with empty medically active substance containers (1) is arranged in the transport tank (33) above the first storage pallet (32), and the closure device (2) is arranged on the side of the medically active substance container (1) facing away from the bottle neck (10).

3. 2. A transport tank (33) according to claim 1, wherein the second storage pallet (32) rests, in particular loosely, on the first storage pallet (31).

4. 2. The transport tank (33) according to claim 1, wherein the multi-component closure devices (2) are arranged in the first storage pallet (31) in such a way that the sealing plug (20) is each arranged on the side of the fastening cage (210) facing away from the bottle neck (10).

5. 2. A transport tank (33) according to claim 1, wherein the arrangement of the multi-component closure devices (2) in the first storage pallet (31) and the arrangement of the medically active substance containers (1) in the second storage pallet are matched to each other in such a way that by placing the first storage pallet (31) on the second storage pallet (32) and pressing them together, the multi-component closure devices (2) engage onto the bottle necks (10) and seal the individual medically active substance containers (1).

6. 2. The transport tub (33) of claim 1, wherein the first storage pallet (31) and the second storage pallet (32) are separated from each other by a lid or a protective film.

7. 2. The transport vessel (33) of claim 1, wherein the plug anchoring device (21) comprises an outer cage shell (211) that is slid at least partially over the anchoring cage (210).

8. 2. The transport vessel (33) of claim 1, wherein the plug securing device (21) comprises a protective cover (22).

9. 2. The transport tank (33) according to claim 1, wherein a metal ring (24) and / or a thermoplastic ring (23) is mounted on the bottle neck (10) of each empty medically active substance container (1) in the second storage pallet (32), and the fastening cage (211) is adapted to engage with the metal ring (24) and / or the thermoplastic ring (23).

10. 2. A transfer vessel (33) according to claim 1, wherein the empty medically active substance container (1) is made of glass.

11. 11. A method for filling a plurality of medical active substance containers (1) in the second storage pallet (32) and sealing them with the associated multi-part closure device (2) in the first storage pallet (31) at the site of an active substance filler after providing both storage pallets (31, 32) of a sealed transport vessel (33) according to any one of claims 1 to 10, said method comprising: - opening the transport tank (33) by removing the box lid (30) and / or the protective film (30); - placing said second storage pallet (32) with empty medically active substance containers (1) in a filling system; - filling an active substance or a vaccine into said plurality of medical active substance containers (1); - sealing the filled medical active substance container (1) by placing and pressing it in the direction of the longitudinal axis (L) of the multi-component closure device (2) or the medical active substance container (1) onto the first storage pallet (31) with the multi-component closure device (2) arranged in the same way as the medical active substance container (1) in the second storage pallet (32); A filling method characterized by:

12. 12. The method of claim 11, wherein the first storage pallet (31) with the multi-component closure device (2) and the second storage pallet (32) with the empty medically active substance containers (1) are removed from the transport tank (33) after the transport tank (33) has been opened.

13. 12. The method of claim 11, wherein the second storage pallet (32) is returned as a unit to be placed in the transport tank (33) after filling the first storage pallet (31) with closure devices (2) and pressing them onto the filled medically active substance containers (1).

14. 12. The method of claim 11, wherein the first storage pallet (31) with the multi-component closure device (2) and the second storage pallet (32) with the empty medical active substance containers (1) are removed from the transport tank (33) after the transport tank (33) has been opened, and the second storage pallet (32) is returned to be placed in the transport tank (33) before filling the first storage pallet (31) with the closure device (2) and pressing it onto the filled medical active substance containers (1).

15. 12. The method of claim 11, wherein the filled, closed medically active substance container (1) is transported away using the transport vessel (33), which is closed with the box lid (30) and / or another cover such as a protective film.

Images