Transport structure for a plurality of vials for pharmaceutical, medical or cosmetic use, sterile packaging structure and process for processing vials
11406984 · 2022-08-09
Assignee
Inventors
Cpc classification
B01L2200/18
PERFORMING OPERATIONS; TRANSPORTING
B01L9/06
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/0609
PERFORMING OPERATIONS; TRANSPORTING
B01L3/5025
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A transport structure for accommodating a plurality of vials for pharmaceutical, medical or cosmetic use under non-sterile conditions is formed by an accommodation member and by a bearing member releasably connected thereto. The accommodation member comprises a plurality of frustro-conical receptacles in a regular arrangement so that the vials can be accommodated upright and while preventing a direct contact between adjacent vials in the receptacles of the accommodation member. The transport structure comprises latching structures for releasable latching of the accommodation member with the bearing member. According to the disclosure, the receptacles are matched to the height of the vials in such a manner that the vials can be completely accommodated therein, wherein the bearing member is formed by a base plate having a flat supporting surface facing the receptacles, so that the vials can be freely displaced on the supporting surface of the base plate after releasing the latching and can be pushed from the bearing member by displacement of the accommodation member relative to the bearing member. The accommodation member and/or the bearing member can be formed in one piece by thermoforming a plastic material, in particular by deep-drawing a thin film or a thin film plate.
Claims
1. A transport structure, comprising: an accommodation member, wherein the accommodation member comprises a plurality of receptacles in a regularly spaced arrangement, wherein each of the plurality of receptacles has a top and a bottom; a bearing member releasably connected to the accommodation member, wherein the bearing member comprises a base plate, and the base plate has a flat supporting surface; a plurality of vials, wherein each of the plurality of vials has an upper end and a bottom end, and a filling opening at the upper end; latching structures for releasably latching the accommodation member with the bearing member; wherein each of the plurality of vials is in a different one of the plurality of receptacles, so that the upper ends of the vials are at the bottoms of the receptacles and adjacent vials do not contact one another, wherein the bearing member covers the bottom ends of the vials, wherein the bearing member has a side wing, wherein the latching structures are on the side wing, so that the latching structures are accessible from a side of the accommodation member for releasing the latching members, and wherein the flat supporting surface faces the receptacles, and wherein the base plate is capable of being pulled in a direction parallel to the flat supporting surface, and wherein the plurality of vials are separated from the bearing member without any movement of the accommodation member relative to the bearing member in a direction perpendicular to the flat supporting surface.
2. The transport structure as claimed in claim 1, wherein the bottoms of each of the plurality of vials are in direct contact with the supporting surface of the bearing member when the plurality of vials are in the associated receptacles.
3. The transport structure as claimed in claim 1, wherein the accommodation member is releasably connected to the bearing member without additional coupling mechanisms.
4. The transport structure as claimed claim 1, wherein the accommodation member is releasably connected to the bearing member without additional clamping on the bearing member or without additional clamping by the bearing member.
5. The transport structure as claimed in claim 1, wherein the latching of the latching structures can be formed and released by adjusting movable members on the bearing member or on the accommodation member without height offset of the accommodation member relative to the bearing member.
6. The transport structure as claimed in claim 5, wherein the latching structures comprise latching structures on the side wing of the base plate of the bearing member and latching structures provided at the edge of the accommodation member, wherein the side wing can be folded from a latching position, in which the side wing embraces an edge of the accommodation member, into a release position, in which the side wing extends in extension of the base plate of the bearing member, and wherein the latching structures of the bearing member are latched with the latching structures of the accommodation member in the latching position.
7. The transport structure as claimed in claim 6, wherein the latching structures of the bearing member can be pressed onto the latching structures of the accommodation member to form the latching.
8. The transport structure as claimed in claim 6, wherein the latching structures corresponding to one another and are in the shape of a mushroom head, in a side view.
9. The transport structure as claimed in claim 6, wherein the accommodation member comprises a base plate on which the receptacles are formed, the base plate having a raised edge, wherein the side wing of the bearing member is foldable along two folding lines spaced apart to each other and extending in parallel with each other, comprising a foldable central portion formed between the two folding lines, the width of which corresponds to the height of the raised edge, and wherein at least one foldable latching portion on which the latching structures of the bearing member are formed.
10. The transport structure as claimed in claim 9, wherein compensating or stiffening portions extending along the edge of the bearing member are formed on the bearing member between the side wing and the base plate, and wherein additional compensating or stiffening portions are formed on the side wing, to temporarily compensate for an expansion of the material of the side wing when the latching structures are latched.
11. The transport structure as claimed in claim 10, wherein the compensating or stiffening portions are formed as recessed portions by thermoforming or by deep-drawing the material of the bearing member.
12. The transport structure as claimed in claim 6, wherein the bearing member comprises only two foldable side wings on two opposite sides of the bearing member.
13. The transport structure as claimed in claim 1, wherein the supporting surface of the base plate facing the receptacles is a plurality of supporting surfaces which together span a plane and are arranged relative to the receptacles such that the bottoms of the plurality of vials each rest directly on the supporting surfaces, wherein the plurality of supporting surfaces have grooves therebetween, and wherein the width of the grooves is less than the diameter of the vials.
14. The transport structure as claimed in claim 1, further comprising a plurality of troughs on an underside of the base plate facing away from the accommodation member, wherein the plurality of troughs are separated from one another by partitioning webs, wherein the width of the troughs corresponds to an outer diameter of the receptacles at the bottoms of the receptacles of the accommodation member, so that a plurality of transport structures can be stacked one above the other in a stacked arrangement, in which the front ends of the receptacles of the accommodation member of a first transport structure are accommodated directly in the troughs of the bearing member of a second transport structure and secured against lateral slipping.
15. The transport structure as claimed in claim 1, wherein the receptacles have side-walls, and the side-walls are connected to one another with stiffening ribs which are connected to a base plate of the accommodation member and which are formed integrally therewith.
16. The transport structure as claimed in claim 1, wherein there is no sterility cover that covers the accommodation member, the bearing member, and the plurality of vials.
17. The transport structure as claimed in claim 1, wherein the accommodation member and the bearing member are designed such that the accommodation member can be stacked with additional accommodation members of identical configuration and that the bearing member can be stacked with additional bearing members of identical configuration.
18. The transport structure as claimed in claim 1, wherein at least one of the accommodation member and the bearing member is integrally formed by thermoforming a plastic.
19. The transport structure as claimed in claim 18, wherein the thermoforming a plastic comprises deep-drawing from a plate-like plastic material.
20. The transport structure as claimed in claim 19, wherein the at least one of the accommodation member and the bearing member is formed by deep-drawing a thin film or a thin film plate having a material thickness of up to 2.0 mm.
21. The transport structure as claims in claim 1, wherein each of the plurality of receptacles has a frustro-conical shape, wherein each of the plurality of frustro-conical receptacles has a top and a bottom, and wherein each of the plurality of frustro-conical receptacles has a diameter at the bottom that is smaller than a diameter at the top.
22. The transport structure as claimed in claim 1, wherein each of the plurality of vials is completely in the associated receptacle.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) In the following, the disclosure will be described in an exemplary manner and with reference to the appended drawings, from which further features, advantages and problems to be solved will become apparent. In the drawings:
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(14) In the drawings, identical reference numerals designate identical or essentially equivalent elements or groups of elements.
DETAILED DESCRIPTION OF THE DISCLOSURE
(15) As described hereinafter, according to the present disclosure a transport structure serves for the temporary, non-sterile storage and transport of a plurality of vials (hereinafter also referred to as containers) for the storage of substances for medical, pharmaceutical or cosmetic applications in a regular arrangement, for example in a matrix arrangement with regular distances between the containers along two different spatial directions, preferably along two mutually orthogonal spatial directions. For this purpose, the transport structure has no sterility barrier, in particular no circumferential sterile sealing between the bearing member and the accommodation member and no sterile protective foil or film for sterile sealing of the transport structure. Rather, the vials are stored or transported in the transport structure under non-sterile conditions. If sterile conditions are required for storage or transport of the containers, this is rather accomplished by means of at least one sterile outer packaging bag, which accommodates at least one transport structure, for example by means of a plastic tube, in which a gas-permeable, sterile protective film may be provided in portions, which may, for example, be formed by a braid of plastic fibers, such as polypropylene fibers (PP), or a Tyvek® protective film, to allow sterilization of the inner volume of the outer packaging bag and the outside of the transport structure by a flow of a sterilizing gas flowing into the outer packaging bag.
(16) According to
(17) According to
(18) For stiffening the accommodation member 10, the side-walls 15 are connected to each other via stiffening ribs 18, which in turn are connected to the base plate 11 and which are particularly designed integrally with the base plate. For further reinforcement of the side-walls 15, these comprise several ribs extending in the longitudinal direction of the receptacles 14. The receptacles 14 are disposed in a two-dimensional regular arrangement, namely along rows extending in the y-direction, with adjacent rows being offset to each other by half a distance between the receptacles 14. Other arrangements of the receptacles 14 are also possible, for example in a two-dimensional matrix arrangement along rows and columns in the y-direction and x-direction, respectively, at even distances from each other.
(19) The accommodation member 10 is formed in one piece by thermoforming a plastic material, in particular by deep-drawing a thin film or a thin film plate from a plastic material having a material thickness of up to 1.0 mm, preferably having a material thickness of up to 1.25 mm and even more preferably having a material thickness of up to 2.0 mm. PET, PS or PP is preferred as plastic material, wherein also multi-layer films may be used (e.g. PSEVOHPE/PPEVOHPE . . . ). Conveniently, this plastic material is transparent to allow a visual inspection of the vials accommodated in the receptacles.
(20) As can be concluded from
(21) The side-walls 15 of the receptacles 14 are slightly inclined inwards (cf.
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(24) According to the plan view of
(25) The supporting surfaces 31a jointly span a plane on which the bottoms of the vials rest when they are accommodated in the transport structure. In any case, the grooves 31b are so narrow that the vials can be pushed in any direction over the plane spanned by the supporting surfaces 31a without major ‘jerking’. The grooves 31b serve to further stiffen the base plate 31, which is particularly advantageous if the bearing member 30 is formed from a thin film or a thin film plate of a plastic material by thermoforming, in particular by deep drawing. The vials are conveniently pushed from the base plate 31 in the longitudinal direction of the supporting surfaces 31a for further processing. In principle, however, they may also be pushed from the base plate 31 in any other direction, especially transversely to the grooves 31b, as shown in
(26) Of course, according to other embodiments the upper side of the base plate 31 may also be completely flat, in particular without supporting surfaces 31a and grooves 31b described above.
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(28) Several transport structures as shown in
(29) According to an alternative embodiment, an intermediate plate 5 is placed on the respective underside of the base plate of a bearing member, as shown in
(30) Thus, a plurality of transport structures 1 can be reliably stacked on top of each other to save space. In the stacked arrangement, for example as shown in
(31) On the left-hand and right-hand side of the base plate 31 in
(32) At the upper and lower edge of the base plate 31 in
(33) According to another preferred embodiment (not shown), the upper side wing 39 shown in
(34) The bearing member 30 is formed in one piece by thermoforming a plastic material, in particular by deep-drawing a thin film or a thin film plate from a plastic material having a material thickness of up to 1.0 mm, preferably having a material thickness of up to 1.25 mm and even more preferably having a material thickness of up to 2.0 mm. Preferably, PET, PS or PP is used as the plastic material, wherein also multi-layer films may be used (e.g. PSEVOHPE/PPEVOHPE . . . ). Conveniently, this plastic material is transparent to allow a visual inspection of the vials accommodated in the receptacles.
(35) Referring to
(36) As an alternative to the forming of the transport structure 1 shown in
(37) Or the vials 60 are arranged upright on a work surface (not shown) corresponding to the arrangement of the receptacles 14 of the accommodation member 10. Then the accommodation member 10 with the receptacles facing upwards is lowered onto the bearing member 10 so that the vials 60 are inserted into the receptacles 14 of the accommodation member 10. Then the accommodation member 10 with the vials 60 accommodated therein is pushed onto the upper side of the base plate 11 of the bearing member 10. Then the side wings 35, 39 of the bearing member are folded over and the accommodation member 30 is latched to the bearing member 10, as described above.
(38) Or the vials 60 are inserted upside down into the receptacles 14 of the accommodation member 10 oriented vertically downwards. Then the bearing member 30 with the upper side of the base plate 11 facing downwards is pushed onto the accommodation member 10 with the vials 60 accommodated therein. Then the side wings 35, 39 of the bearing member are folded over and the bearing member 30 is latched to the accommodation member 10, as described above.
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(40) The accommodation member and bearing member are detachably connected to each other via the latching structures. Even though the side wings of the bearing member are folded down twice for latching and the latching structures are latched together, the side wings preferably do not exert any additional frictional coupling. Rather, the position of the accommodation member relative to the bearing member is preferably solely the result of the positive-fit formed by the latching structures.
(41) A plurality of such transport structures can be stacked on top of each other. Here, intermediate plates are preferably arranged between the transport structures, as shown in
(42) In the configuration of
(43) If a transport in the transport structure according to the present disclosure is nevertheless desired under sterile conditions, for example the transport of cleaned and sterilized vials to a pharmaceutical filling company in a ‘ready to use’ (RTU) state, the transport structure with the vials accommodated therein is cleaned and sterilized and placed in at least one sterile outer packaging bag, for example in a plastic tube, which is then sterile sealed. This sterile outer packaging bag(s) is then opened again under suitable sterile processing conditions for further processing, for example at a pharmaceutical filling company.
(44) The procedure for opening the transport structure of
(45) First, the transport structure together with the bearing member facing downwards is placed on a work surface. Then the latching of the latching structures 38, 42 of the bearing member 30 with the latching structures 21, 23 of the accommodation member 10 is released from above the transport structure 1, i.e. from the side of the accommodation member, without lifting the accommodation member 10. For a manual handling, the gaps between the side wings 39 and the latching structures 38 or laterally of the side wings 35 are available, as shown in
(46) The vials are then pushed from the supporting surfaces 31a and from the base plate 31 by a relative displacement of the accommodation member 10 and the bearing member 30. The relative displacement between accommodation member 10 and bearing member 30 may be guided laterally and may only be possible in one direction, namely in the y-direction, for which purpose, for example, the two side wings 35 may be used in a position folded halfway upwards. For the relative displacement, preferably the bearing member 30 is temporarily fixed, for example on the supporting surface, and only the bearing member 10 is displaced in the y-direction.
(47) In this way, the vials 60 are pushed from the base plate 31 of the bearing member 30 and thus fed to the downstream processing station. According to the present disclosure, no turning of the transport structure 1 is required for feeding.
(48) According to a preferred embodiment, the bearing member comprises only two folding side wings disposed along two opposite sides. This offers additional advantages, especially for processing stations to be loaded manually or semi-automatically with prior separation of the vials, for example by means of an insulator with a rotary carousel. For this purpose, the accommodation member and the bearing member are rectangular if viewed in a plan view, with longer sides, on which, for example, the two side wings may be provided on the bearing member, and with two shorter sides. First, the transport structure is placed on a supporting surface which merges into a conveyor path to the processing station, wherein the width of the conveyor path corresponds to the length of the shorter sides. When being placed on the supporting surface, the longer sides are aligned transversely to the conveyor path. First, the latching structures are released. The transport structure is then rotated by 90 degrees so that the longer sides extend in parallel with the conveyor path. Then the two side wings are folded down. The accommodation member is then moved in the direction of the conveyor path. In this process, the vials accommodated in the accommodation member are pushed from the bearing member onto the conveyor belt via one of the two shorter sides, from where they are then conveyed to the processing station, for example via a conveyor belt or via a rotary carousel of an insulator for separating the vials.
LIST OF REFERENCE NUMERALS
(49) 1 transport structure 5 intermediate plate 6 trough on intermediate plate 5 7 circumferential peripheral web on intermediate plate 5 8 partitioning web 10 accommodation member 11 base plate 12 lateral edge 13 lower edge 14 receptacle 15 cylindrical side-wall of receptacle 14 16 closed upper end of receptacle 14 17 base of cylindrical side-wall 15 of receptacle 14 18 connecting rib 19 protrusion at closed upper end 16 of receptacle 14 20 protrusion 21 inner latching structure 21a transition portion 21b constricted portion 21c latching head 21d cavity 22 connecting web 23 outer latching structure 24 connecting web 30 bearing member 31 base plate 31a supporting surfaces 31b groove 32 trough 32a bottom of trough 32 33 partitioning web 34 rounded end of trough 32 35 first side wing 35a inner folding line 35b outer folding line 36 recessed portion 37 recessed portion 38 first latching structure 39 second side wing 39a inner folding line 39b outer folding line 40 recessed portion 41 recessed portion 42 second latching structure 42a transition portion 42b constricted portion 42c latching head 60 vial 61 cylindrical side-wall of vial 60 62 constricted neck portion of vial 60 63 expanded upper rim of vial 60 64 bottom of vial 60 65 filling opening of vial 60