Method for providing a transport container tray for medical active-ingredient containers and method for filling a plurality of medical active-ingredient containers

Abstract

The invention relates to a transport container tray (33) for medical active-ingredient containers (1), in particular for transporting medical active-ingredient containers (1) in order to be filled with medical active ingredients, wherein a first storage pallet (31) having a plurality of multi-part closure devices (2) and a second storage pallet (32) having a plurality of empty medical active-ingredient containers (1) are received in the transport container tray (33) and the transport container tray (33) is closed by a box lid (30) or a protective film (30). The multi-part closure devices (2) each have a sealing stopper (20), a stopper securing device (21) having a securing cage (210), and a protective lid (22), wherein the multi-part closure devices (2) are suitable for pressing on and latching into collars (101) of bottlenecks (10) of the medical active-ingredient containers (1).

Description

[0001] Drug container and filling method of a plurality of medical drug containers

[0002] Technical area

[0003] The present invention relates to a transport container tray with a first storage pallet and a second storage pallet with medicinal active ingredient containers for filling medicinal active ingredients. The invention further relates to a method for filling a plurality of medicinal active ingredient containers, a closure with associated closure devices.

[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in the form of medical injection vials, also known as "vials," where liquid active pharmaceutical ingredients are withdrawn from such medical drug containers using drawing-off and / or application needles.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] The medical disciplines of interest here, in which active substances are administered in such medical drug containers, are in particular immunology, virology and oncology, but this is not to be understood as an exhaustive list.

[0007] Today, familiar vials or medical drug containers made of glass or plastic feature various shapes and multi-part closure devices. For example, EP2948122 discloses a medical drug container with a bottle neck and collar, with a rubber stopper partially inserted into the bottle neck and permanently secured 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 detach from the medical drug container, allowing vaccines to be stored aseptically.Additional means are provided to form a plug securing device, which additionally encloses the rubber plug and the retaining ring, and a movable lid is attached. When the lid is opened and the area at the center of the rubber plug is exposed, vaccine can be withdrawn from the interior of the medicinal active ingredient container by piercing a draw-off and / or vaccination syringe or a draw-off and / or application needle through the thinner center of the rubber plug. EP2948122 provides complex additional means that go far beyond the simplest possible securing of the rubber plug with a sheet metal ring. This design is technically complex and not particularly suitable for mass production.

[0008] Due to the structural specifications according to EP2948122, filling and sealing the active ingredient containers is complex and not possible at the filling facilities. These steps must be performed by specialists using specially designed equipment at filling stations, resulting in comparatively low throughput.

[0009] Summary of the invention

[0010] The present invention aims to provide a transport container that enables large quantities of medical drug containers to be efficiently made available to the filling plant, as well as corresponding closure devices by means of which the medical drug containers can be easily closed on-site after filling with the active ingredient, without the need for additional tools. In particular, a high degree of sterility and hygiene should be ensured, even during transport of the medical drug containers.

[0011] The object underlying the invention is achieved by a transport container trough having the features of claim 1 and by a filling method having the features of claim 11. Advantageous embodiments of the present invention are defined in the subclaims.

[0012] Short description of the drawings

[0013] The subject matter of the invention is described in detail below in conjunction with the accompanying figures. 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.

[0014] 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:

[0015] Figure 1a shows a view of a bottle neck of a medicinal drug container and a matching multi-part

[0016] Locking device with protective cover in exploded view;

[0017] Figure lb is a sectional view of the multi-part locking device with

[0018] Protective cap placed on a bottle neck;

[0019] Figure lc a sectional view of the multi-part locking device with

[0020] Protective cap in assembled state but without bottle neck; Figure 2a shows a perspective view of an option for the multi-part closure device with a protective cap consisting of two rings;

[0021] Figure 2b a sectional view of both rings mounted on a bottle neck;

[0022] 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; and

[0023] Figure 3 is 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.

[0024] Detailed description of the invention

[0025] Figure 1 shows a medical active ingredient container 1 with a multi-part compact closure device 2. Such medical active ingredient containers 1 or vials 1 can be referred to as injection vials, vaccine vials, vaccine ampoule, vaccine vials, multi-dose containers, medical vials for the aseptic storage and withdrawal of liquid active ingredient or vaccines and vaccine concentrates as medical active ingredients. These medical active ingredient containers 1 are made of glass or plastic and are commercially available in standardized sizes. After the medical active ingredient container 1 has been filled, 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.

[0026] The contents of the medical drug container 1 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 before the contents—for example, a vaccine—become unusable.

[0027] The multi-part closure device 2 comprises at least one sealing plug

[0028] 20 and a multi-part plug securing device 21, with which the sealing plug 20 can be releasably fastened to a collar 101 of the bottle neck 10. Due to the design of the plug securing device presented here

[0029] 21, 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 stopper securing device 21 engage the collar 101. Thus, the multi-part closure device 2 can be stored on the bottle neck 10 in a non-detachable 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 medicinal active ingredient container 1, and means of the stopper securing device

[0030] 21 engage the collar 101 so that no active ingredient can escape from the medicinal agent container 1 and no unwanted access is possible.

[0031] 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 agent container 1 and is immovable and non-removable. A protective cover

[0032] 22 is intended as an optional part of the multi-part locking device 2, which additionally provides mechanical protection.

[0033] In Figure 1a the individual components are shown in a state not yet assembled and are presented individually from bottom to top.

[0034] 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 interacts with the collar end bead 102, with one part engaging behind the collar end bead 102 and one part abutting the outer collar surface 103, so that the closure device 2 cannot slip relative to the collar 101.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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).

[0041] The undercut webs 2103 are arranged in the side wall 2102 such that, in the assembled state, they can be brought into engagement with the collar 101 below the collar end bead 102. In the view according to Figure 1a, an inclination from bottom to top in the direction of the longitudinal axis L is visible. 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.

[0042] 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. A plug engagement edge 2105 is bent over at the end of the central ring 2101. In the assembled state, the safety cage 210 engages with the plug engagement edge 2105 in the cage edge recess 2022 of the sealing plug 20, thereby securing 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. Alternatively or additionally, the safety cage 210 can be fastened to the sealing plug 20 by firmly connecting the sealing plug 20 to the safety cage 210, e.g., glued, welded or by means of a positive fit, such as a snap engagement.

[0043] 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.Alternatively, the plug securing device 21 can first be placed over the sealing plug 20 and connected to it, wherein the assembly comprising the securing cage 210, cage sleeve 211, protective lid 22, and sealing plug 20 is then placed as a unit over the collar 101 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 at the top and bottom of the securing cage 210 and the cage sleeve 211 remain accessible in the assembled state, and a drawing-on and / or application needle can be pierced through the central opening 2111 and the central ring 2101 with the central opening. In an alternative embodiment, the multi-part closure device shown can be equipped without the cage sleeve 211.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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 agent container 1, the safety cage 210 and thus the sealing plug 20 remain immobile.

[0048] 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.

[0049] The sealing lips 201, which protrude radially outwards from the sealing plug 20, are preferably provided here as three stepped sealing lips 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.

[0050] The plug engagement edge 2105 engages the concentrically circumferential cage edge recesses 2022. The cage edge recesses 2022 are recessed radially from the sealing plug 20, inclined 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.

[0051] 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.

[0052] For medical drug containers 1 made of glass, the multi-part closure device 2 can be optionally 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, 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.

[0053] 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.

[0054] The advantage of the multi-part closure device 2, which can be attached to the bottle neck by pressing and hooking, is that several unsealed medicinal active ingredient containers 1 with matching multi-part closure devices 2 and possibly with the ring combination 23, 24 can be transported unfilled and unsealed to an active ingredient filling plant, filled there, and easily sealed there as well. This can be done by the active ingredient or vaccine filler themselves, without the need for special tools at the filling site.

[0055] For this purpose, as shown in Figure 3, 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, are delivered closed with a box lid 30 and / or a protective film 30. The medicinal active ingredient containers 1 are unsealed, i.e. the openings of the medicinal active ingredient containers 1 at the bottle neck 10 are free. One advantage of providing the medicinal active ingredient containers 1 and their multi-part closure devices 2 in a common transport container of an active ingredient filling plant is, among other things, that it ensures that the closures suitable for the medicinal active ingredient containers 1 are also provided. This makes the filling process more efficient and safer, particularly with large production quantities.At the same time, a high level of hygiene is guaranteed.

[0056] The multi-part closure devices 2 shown comprise, as explained above, a sealing plug 20, a plug securing device 21 with a securing cage 210, a cage cover 211 and a protective cover 22. The multi-part closure devices 2 are designed to be pressed onto and snap into place on the collar 101 of the bottle necks 10 of the medical

[0057] Active ingredient container Of course, the

[0058] Transport container tray also in combination with alternative

[0059] Embodiments of the multi-part closure devices can be used, for example in combination with multi-part closure devices that do not have a cage shell or a protective cover.

[0060] Particularly when the plug securing device 21 comprises the already explained securing cage 210 with the central ring 2101, the central opening and the side wall 2102, wherein a circumferential cage edge bead 2104 is formed into the outer surface of the side wall 2102 and the 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 2122 on the sealing plug 20 and the outer cage shell 211 made of metal with the cage shell bead 2112, the central opening 2111 and a cover engagement 2113 is at least partially slipped over the securing cage 210 and the protective cover 22 thus extends over the cover engagement 2113 is detachably attached to the plug securing device 21, the multi-part closure device 2 can be particularly easily snapped into place.

[0061] As Figure 3 further shows, the second storage pallet 32 ​​with empty medical active ingredient containers 1 is arranged in the transport container trough above the first storage pallet 31 with the multi-part closure devices 2. In the illustrated embodiment, the second storage pallet 32 ​​even lies on the first storage pallet 31 with the multi-part closure devices 2. The multi-part closure devices 2 are arranged on the side of the medical active ingredient containers 1 facing away from the bottle necks 10. In other words, the multi-part closure devices 2 are placed under the bottom of the medical active ingredient containers 1. Such an arrangement ensures a high degree of hygiene and sterility during transport of the transport container 3. Because the multi-part closure devices 2 are arranged under the medical active ingredient container 1, for exampleParticles that could detach from the multi-part closure devices 2 during transport due to vibrations or similar events cannot penetrate into the medical drug containers 1. Therefore, it is not necessary to close the medical drug containers 1 individually for transport. Closure by means of the box lid 30 and / or the protective film 30 is sufficient.

[0062] The multi-part closure devices 2 in the first storage pallet 31 are oriented such that the sealing plug 20 is arranged on the side of the protective lid 22 or the safety cage 210 facing away from the bottle necks 10, ie the pointed end of the conical sealing plug 20, which is first inserted into the bottle neck 10 when closing the medicinal active ingredient container 1, is oriented in the same direction as the lower end or the bottom of the medicinal active ingredient container 1. When the medicinal active ingredient container 1 of the second storage pallet 32 ​​has been filled, the first storage pallet 31 with the multi-part closure devices 2 can be positioned for the purpose of closing over the second storage pallet 32 ​​with the filled medicinal active ingredient container 1, without the multi-part closure devices 2 having to be additionally reoriented, e.g.must be turned because the sealing plug 20 is already oriented with its front end in the direction of the opening of the bottle neck 10.

[0063] The arrangement of the multi-part closure devices 2 in the first storage plate 31 and the arrangement of the medicinal active ingredient containers 1 in the second storage pallet 32 ​​are coordinated such that 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 medicinal active ingredient containers 1 and close the respective medicinal active ingredient container 1. This enables simple and quick closing of the medicinal active ingredient containers 1. One possible filling process for the medicinal active ingredient containers 1 is as follows. First, the transport container 3 or the transport container trough 33 is delivered to a filling plant for medicinal 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 brought into the filling station, where the filling of the open medical active ingredient containers 1 arranged locally in the second storage pallet 32 ​​takes place.

[0064] 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 taken from the transport container trough 33, is placed over the second storage pallet 32 ​​so that the sealing plugs 20 come to rest 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, or towards the bottom of the medical active ingredient container 1, i.e. towards the longitudinal axis L of the medical active ingredient container 1, each medical active ingredient container 1 is tightly closed with an associated closure device 31.

[0065] When the first storage pallet 31 is pressed down, the multi-part closure devices 2 with their sealing plugs 20 and the plug retainer 21 are pressed onto the openings of the bottle necks 10. The previously explained undercut webs 2103 in the side wall 2102 of the retaining cage 210 engage behind the collar end bead 102 and secure the medicinal active ingredient container 1 against unwanted opening. This locks into place, and the multi-part closure devices 2 can no longer be easily removed.

[0066] 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.

[0067] Alternatively, it is also possible to first remove the first and second storage pallets 31 and 32 from the transport container tray 33 and then place the second storage pallet 32 ​​with the empty medical active ingredient containers 1 back into the transport container tray 33. The transport container tray 33, together with the empty medical active ingredient containers 1 arranged therein, is then moved to the filling station for filling. After the filled medical active ingredient containers 1 have been closed, they are sealed as described above by pressing the first storage pallet 31 onto the multi-part closure devices 2. Further transport can then also take place in the transport container tray 33.

[0068] When using medical active ingredient containers 1 made of glass, a thermoplastic ring 23 and a metal ring 24 are additionally mounted on the bottle neck 10 before the transport container tub 33 is closed and transported to a filling plant. The multi-part closure devices 2 are pressed on after filling as usual, then over the bottle neck 10 with ring combination 23, 24.

[0069] 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.

[0070] 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 greatly accelerated. This filling and closing process does not need to be carried out by a specialist company and special equipment. Since several components are delivered for filling in one package, here the transport container 3, a large amount of waste and large transport volumes can be avoided. Above all, the closure can be greatly simplified and the time required for closing minimized. Furthermore, compliance with the necessary sterility during transport is guaranteed.

[0071] List of reference symbols

[0072] 1 medicinal substance container / vial

[0073] 10 Bottleneck

[0074] 101 Collar with inner collar taper

[0075] 102 Collar end bead

[0076] 103 outer collar surface

[0077] 104 inner contact surface

[0078] 2 Multi-part locking device

[0079] 20 sealing plugs (rubber, elastomer, self-closing)

[0080] 201 sealing lips

[0081] 202 Rand

[0082] 2021 cage support surface

[0083] 2022 cage edge recess

[0084] 203 Plug taper

[0085] 21 Plug safety device

[0086] 210 Fuse cage (thermoplastic, PBT)

[0087] 2101 centric ring (with centric opening)

[0088] 2102 side wall

[0089] 2103 Undercut bars in side wall

[0090] 2104 cage edge bead

[0091] 2105 Plug engagement edge (end of the centric ring circumferential,

[0092] 211 outer cage shell (metal, surrounding sheet metal)

[0093] 2111 centric opening

[0094] 2112 Cage shell bead (circumferential engagement edge, analogous to 2104)

[0095] 2113 Lid access (circumferential around 2111)

[0096] 22 protective covers (removable, plastic, profiled, rotationally symmetrical)

[0097] 221 engagement edge (protruding diagonally upwards, can be connected to the lid engagement)

[0098] 222 centric taper / optional recesses

[0099] 223 transparent / translucent window position

[0100] 224 window elevations in 223

[0101] 23 Thermoplastic ring

[0102] 24 metal ring

[0103] 240 upper collar

[0104] 241 through holes

[0105] 242 Metal ring flange

[0106] 3 transport containers / delivery cassettes

[0107] 30 box lids / protective film

[0108] 31 first storage pallet for locking devices

[0109] 32 second storage pallet for active ingredient containers

[0110] 33 Transport container tray

Claims

Patent claims 1. Transport container tray (33) with several empty medicinal active ingredient containers (1), in particular for the transport of several empty medicinal active ingredient containers (1) for filling medicinal active ingredients, wherein a first storage pallet (31) and a second storage pallet (32) are accommodated in the transport container tray (33) and the transport container tray (33) is closed with a box lid (30) or a protective film (30), wherein the first storage pallet (31) has several multi-part closure devices (2) and the second storage pallet (32) has the several empty medicinal active ingredient containers (1), wherein the multi-part closure devices (2) each comprise a sealing plug (20), a plug securing device (21) with a securing cage (210) and a protective cover (22),and wherein the multi-part closure devices (2) are suitable for pressing and snapping onto collars (101) of bottle necks (10) of the medicinal active substance containers (1)., 2. Transport container tray (33) according to claim 1, wherein the second storage pallet (32) with empty medical active substance containers (1) is arranged in the transport container tray (33) above the first storage pallet (32) and the closure devices (2) are arranged on the side of the medical Active ingredient container (1) are arranged.

3. Transport container trough (33) according to claim 1 or 2, wherein the second storage pallet (32) rests on the first storage pallet (31), in particular rests loosely thereon.

4. Transport container tray (33) according to one of the preceding claims, wherein the multi-part closure devices (2) are arranged in the first storage pallet (31) such that the sealing plug (20) is arranged on the side of the securing cage (210) facing away from the bottle necks (10).

5. Transport container tray (33) according to one of the preceding claims, wherein the arrangement of the multi-part closure devices (2) in the first storage plate (31) and the arrangement of the medicinal active substance containers (1) in the second storage pallet are coordinated with one another such that by placing and pressing the first storage pallet (31) onto the second storage pallet (32), the multi-part closure devices (2) snap into place on the bottle necks (10) and close the respective medicinal active substance container (1).

6. Transport container tray (33) according to one of the preceding claims, wherein the first storage pallet (31) and the second storage pallet (32) are separated from one another by a cover or a protective film.

7. Transport container trough (33) according to one of the preceding claims, wherein the plug securing device (21) comprises an outer cage shell (211) which is at least partially placed over the securing cage (210).

8. Transport container trough (33) according to one of the preceding claims, wherein the plug securing device (21) comprises a protective cover (22).

9. Transport container tray (33) according to one of the preceding claims, wherein a metal ring (24) and / or thermoplastic ring (23) is mounted on the bottle neck (10) of each empty medicinal active ingredient container (1) in the second storage pallet (32), wherein the securing cage (211) is suitable for snapping onto the metal ring (24) and / or thermoplastic ring (23).

10. Transport container tray (33) according to one of the preceding claims, wherein the empty medicinal active substance containers (1) are made of glass.

11. Method for filling a plurality of medicinal active ingredient containers (1) in a second storage pallet (32) and closure with associated multi-part closure devices (2) in a first storage pallet (31) after provision of both storage pallets (31, 32) of a closed transport container tray (33) according to one of claims 1 to 10, at the site of the active ingredient filler, characterized by the steps: - Opening the transport container tray (33) by removing the box lid (30) and / or the protective film (30), - Placing the second storage pallet (32) with empty medicinal product containers (1) in a filling plant, - Filling the active ingredient or vaccine into the majority of the medical active ingredient containers (1), - Closing the filled medical active ingredient containers (1) by placing and pressing on the first storage pallet (31) with multi-part closure devices (2), which are arranged analogously to the medical active ingredient containers (1) in the second storage pallet (32), in the direction of the longitudinal axis (L) of the multi-part closure devices (2) or the medical active ingredient containers (1).

12. Filling method according to claim 11, wherein the first storage pallet (31) with the multi-part closure devices (2) and the second The storage pallet (32) with the empty medicinal active substance containers (1) can be removed from the transport container tray (33) after the transport container tray (33) has been opened.

13. Filling method according to claim 11 or 12, wherein the second storage pallet (32) is placed back into the transport container trough (33) as a unit after filling and pressing the first storage pallet (31) with closure devices (2) onto the filled medicinal active ingredient containers (1).

14. Filling method according to claim 11 or 12, wherein the first storage pallet (31) is filled with the multi-part closure devices (2) and the second storage pallet (32) is filled with the empty medical The active ingredient container (1) is removed from the transport container tray (33) after the transport container tray (33) has been opened, and the second storage pallet (32) is placed back in the transport container tray (33) before the first storage pallet (31) is filled and pressed onto the filled medical active ingredient container (1) with closure devices (2).

15. Filling method according to one of claims 11 to 14, wherein the filled, sealed medical active substance containers (1) are transported away by means of the transport container tray (33), wherein the transport container tray (33) is closed with the box lid (30) and / or another cover, such as a protective film.

Images