Transport and packaging container for accommodating a plurality of containers for medical, pharmaceutical or cosmetic applications as well as methods and uses thereof
10017294 ยท 2018-07-10
Assignee
Inventors
- Gregor Fritz Deutschle (Wiesbaden, DE)
- Edgar Pawlowski (Stadecken-Elsheim, DE)
- Joern Wassenberg (Mainz, DE)
- Kai Wissner (Hirschberg, DE)
Cpc classification
B65D25/108
PERFORMING OPERATIONS; TRANSPORTING
B65B5/06
PERFORMING OPERATIONS; TRANSPORTING
B65D11/20
PERFORMING OPERATIONS; TRANSPORTING
B65B7/28
PERFORMING OPERATIONS; TRANSPORTING
B65B7/2842
PERFORMING OPERATIONS; TRANSPORTING
B32B3/00
PERFORMING OPERATIONS; TRANSPORTING
B32B3/12
PERFORMING OPERATIONS; TRANSPORTING
International classification
B65D1/24
PERFORMING OPERATIONS; TRANSPORTING
B65D85/38
PERFORMING OPERATIONS; TRANSPORTING
B65D77/00
PERFORMING OPERATIONS; TRANSPORTING
A61L2/00
HUMAN NECESSITIES
A45C11/26
HUMAN NECESSITIES
B65B5/06
PERFORMING OPERATIONS; TRANSPORTING
B65B7/28
PERFORMING OPERATIONS; TRANSPORTING
B65D25/10
PERFORMING OPERATIONS; TRANSPORTING
B32B3/00
PERFORMING OPERATIONS; TRANSPORTING
Abstract
Disclosed is a transport and packaging container for accommodating a plurality of cylindrical containers for substances, comprising at least two segments of which each can be handled separately and which can be assembled or stuck together to jointly form the transport and packaging container, wherein a first segment of the at least two segments has a bottom for supporting the plurality of containers, and positioning devices are provided for positioning the plurality of containers in the interior of the transport and packaging container in a regular arrangement in such a manner that a collision of the directly adjacent containers is prevented, and wherein at least one of the segments comprises sealing means.
Claims
1. A transport and packaging container for accommodating a plurality of cylindrical containers for substances for medical, pharmaceutical or cosmetic applications, comprising: a first segment having a bottom and a plurality of upright side walls protruding perpendicularly from the bottom; and positioning devices for positioning the containers in interior of the transport and packaging container in a regular arrangement in such a manner that a collision of directly adjacent containers is prevented; wherein an upper end of the first segment opposite to the bottom and a side of the first segment are open to enable removal of the containers via the upper end or an open side of the first segment, the upper end of the first segment and the open side of the first segment are covered by a protective foil so that the interior of the transport and packaging container is sterile sealed against the environment, wherein the first segment is formed like a drawer having three upright side walls protruding perpendicularly from the bottom, and Wherein the protective foil is bonded to rims of the first segment for covering the upper end of the first segment and the open side of the first segment.
2. The transport and packaging container according to claim 1, wherein the protective foil is a gas-permeable plastic foil.
3. The transport and packaging container according to claim 2, wherein the gas-permeable plastic foil is a meshwork of synthetic fiber.
4. The transport and packaging container according to claim 1, wherein the positioning devices are formed directly on the bottom of the first segment.
5. The transport and packaging container according to claim 4, wherein the positioning devices are formed as a plurality of pins projecting perpendicularly from the bottom of the first segment, wherein the plurality of pins is arranged in a regular array to form respective receptacles, in which the containers can be accommodated in the regular arrangement.
6. The transport and packaging container according to claim 1, wherein the positioning devices are formed by a plurality of receptacles, which are formed in a carrier that can be inserted into and removed out of the transport and packaging container, the carrier being configured such that the containers can be inserted into associated receptacles, wherein the receptacles extend in a longitudinal direction of the containers and are configured to support sidewall portions of the containers at least partially clamped.
7. The transport and packaging container according to claim 6, wherein the receptacles are formed by continuous side walls and wherein opening widths of the receptacles can be adjusted by a coordinated adjustment of the side walls between a first position, in which the containers can be inserted into the receptacles, and a second position, in which the containers are clamped.
8. The transport and packaging container according to claim 7, wherein the receptacles are formed as hexagonal receptacles for accommodating the containers, wherein the hexagonal receptacles are formed by two pairs of side walls converging at an obtuse angle which are connected with each other via flexible clamping webs.
9. The transport and packaging container according to claim 8, wherein each of the flexible clamping webs comprises a concave holding portion, wherein connecting webs are formed mirror-symmetrically, so that concave indentations formed on both sides of the clamping webs face the side walls of associated containers.
10. The transport and packaging container according to claim 9, wherein the connecting webs are provided at lower ends of the receptacles for connecting the flexible clamping webs with each other.
11. The transport and packaging container according to claim 10, wherein the flexible clamping webs, bias respective opposite side walls of the receptacles elastically towards each other to enable clamping of containers with different diameters.
12. The transport and packaging container according to claim 10, wherein the flexible clamping webs are configured to press the receptacles of a supporting structure laterally apart, so that the flexible clamping webs with their indentations are pressed against circumferential sidewalls of the containers in the second position and the containers are accommodated with sufficient holding forces in the receptacles.
13. The transport and packaging container according to claim 12, wherein the carrier is configured to be pulled apart in transverse direction for transferring the carrier into a first position so that the containers may be removed from the receptacles without much effort or so that they can be displaced therein.
14. The transport and packaging container according to claim 13, further comprising form-fitting elements having an L-shaped profile are formed on outer walls of outermost hexagonal receptacles of the carrier, the form-fitting elements forming T-shaped receptacles, into which a correspondingly shaped latching rail is inserted, so that the carrier can be pulled apart for expanding all receptacles of the carrier by pulling latching rails in the transverse direction.
15. The transport and packaging container according to claim 6, further comprising that a majority of the bottoms of the containers are freely accessible from below the carrier while being accommodated in the receptacles of the carrier.
16. The transport and packaging container according to claim 6, wherein the receptacles are formed by a plurality of transverse webs extending in parallel with each other, which are connected to each other via S-shaped connecting webs disposed at regular intervals and extending substantially perpendicularly to the transverse webs for defining the regular arrangement, wherein all side walls of the receptacles can be adjusted in a coordinated manner from a first position to a second position upon displacement of the transverse webs by pivoting a first side of the carrier relative to a second side of the carrier opposite to the first side.
17. The transport and packaging container according to claim 6, wherein the carrier and/or the first segment is/are formed of a plastic material.
18. The transport and packaging container according to claim 6, wherein the carrier and/or at least the receptacles of the carrier and/or at least the bottom of the first segment is/are formed of a high-temperature-resistant plastic material, which is resistant to high temperatures of up to 330 C. or up to 350 C.
19. The transport and packaging container according to claim 18, wherein the high-temperature-resistant plastic material is a thermoplastic selected from a group consisting of: polyimide (PI), polyetherketone (PEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketoneetherketoneketone (PEKEEK).
20. The transport and packaging container according to claim 1, wherein at least a bottom of the transport and packaging container is formed of a metal, wherein the metal is coated by a basic coating material consisting of SiO.sub.2, TiO.sub.2, Al.sub.2O.sub.3 or ZrO.sub.2 and then tempered or burned.
21. The transport and packaging container according to claim 1, wherein the side walls of the first segment are provided at least partially with openings, which are closed by bonding a gas-permeable plastic foil.
22. A process for the thermal treatment of a plurality of containers for substances for medical, pharmaceutical or cosmetic applications, comprising: providing a transport and packaging container accommodating the containers sterile sealed against the environment, the transport and packaging container comprising a first segment having a bottom and a plurality of upright side walls protruding perpendicularly from the bottom, and positioning devices for positioning the plurality of containers in interior of the transport and packaging container in a regular arrangement in such a manner that a collision of directly adjacent containers is prevented, wherein an upper end of the first segment opposite to the bottom and a side of the first segment is open to enable removal of the containers via the upper end or an open side of the first segment, and the upper end of the first segment and the open side of the first segment are covered by a protective foil so that the interior of the transport and packaging container is sterile sealed against the environment; opening the transport and packaging container so that the interior of the transport and packaging container is accessible via the upper end and the open side of the first segment by drawing-off the protective foil from the first segment; processing the containers while being supported on the bottom of the first segment or while being supported in a carrier, which is accommodated in the transport and packaging container in the step of providing the transport and packaging container, wherein the first segment is formed like a drawer having three upright side walls protruding perpendicularly from the bottom, and Wherein the protective foil is bonded to rims of the first segment for covering the upper end of the first segment and the open side of the first segment.
23. The process according to claim 22, further comprising: closing the transport and packaging container by covering the upper end of the first segment and the side of the first segment with the protective foil.
24. The process according to claim 22, further comprising: removing the carrier out of the transport and packaging container.
25. The process according to claim 24, further comprising: inserting the carrier together with the containers after the step of processing the containers into the transport and packaging container.
26. The process according to claim 22, wherein the step of processing the containers further comprises: processing the plurality of containers while being supported on the bottom of the first segment or while being supported in the carrier in a thermal processing station at temperatures of up to 330 C. or up to 350 C.
27. The process according to claim 26, wherein the processing of the plurality of containers is performed in a hot oven or hot tunnel at temperatures of up to 330 C. or up to 350 C., so that endotoxins and/or the lysis of bacteria and/or cytokine inducing substances (CIS) are removed thermally in the containers.
28. The process according to claim 26, wherein the processing of the plurality of containers is performed in a hot oven or hot tunnel at temperatures of up to 330 C. or up to 350 C., so that silicone layers are burned-in on inner surfaces of the containers.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The disclosure will now be described by way of example and with reference to the accompanying drawings, from which further features, advantages and problems to be solved will become apparent. In the drawings:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10) In the drawings, identical reference numerals designate identical or substantially equivalent elements or groups of elements.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
(11) According to the present disclosure, a transport and packaging container with or without an additional supporting structure, as described below, is used for concurrently supporting a plurality of containers for storage of substances for medical, pharmaceutical or cosmetic applications in an array configuration, in particular in a matrix configuration with regular intervals between the containers along two different directions in space, preferably along two mutually orthogonal spatial directions.
(12) An example of such containers embodied as vials is shown schematically in the enlarged inserts in
(13) Another example of a medication container in the sense of the present application are ampoules, cartridges and syringes or injection containers.
(14) In the sense of the present disclosure, such containers are used for storage of substances or agents for medical, pharmaceutical or cosmetic applications, which are to be stored in one or several components in solid or liquid form in the container. Especially in the case of glass containers storage periods can amount many years, notably depending on the hydrolytic resistance of the glass type used. While, in the following, cylindrical containers are disclosed, it should be noted that the containers, in the sense of the present disclosure, may also have a different profile, for example a square profile, rectangular profile or polygonal profile.
(15) Inevitably such containers have tolerances due to the production which can be of the order of one or several tenths of a millimeter in particular for glass containers. To compensate for such manufacturing tolerances, while ensuring that all bottoms 3 or bottom ends of the containers can be disposed in a common plane, according to the present disclosure the containers are fixed on a supporting structure by means of a frictional fit or clamping. This frictional fit is implemented either in the region of the cylindrical side wall 4 or at the bottom closed end or bottom of the containers or in accordance with other preferred embodiments in the region of the constricted neck portion 5. In the latter case, at least the great majority of the containers is frictionally supported in the region of the constricted neck portion 5, which, however, according to further embodiments is not intended to exclude that in individual containers with large manufacturing tolerances with respect to their axial length the transition region between the upper rim 6 and the constricted neck portion 5 exceptionally may also be engaged behind or supported in positive fit manner.
(16) For concurrently supporting a plurality of containers, a supporting structure 25 (also referred to as a nest in the prior art) is provided, which will be explained hereinafter with reference to
(17) When the containers are inserted into the receptacles 39 of a supporting structure 25 as shown in
(18) For the transport and packaging of a supporting structure in the sense of the present application with the containers accommodated therein a transport and packaging container 1 (referred to as tub in the prior art) is used as schematically shown in
(19) Such a transport and packaging container 10 is preferably formed of a plastic material, in particular using plastic injection molding technology, and is preferably formed of a clear transparent plastic material to enable an optical visual inspection of the supporting structure 25 accommodated in the transport and packaging container 10 and of the containers 2 supported by it.
(20) With reference to
(21) A plurality of pins 324 project perpendicularly from the bottom 323 of the upper segment 320, which act as positioning devices (positioning means) in the sense of the present application, which are arranged in a regular array and which form respective receptacles 325, in which the containers, such as vials, can be accommodated (cf.
(22)
(23) The two segments 320, 330 may be inserted in the manner of drawers, as shown in
(24) The two segments 320, 330 together with the containers positioned by one of the two segments can be inserted into each other. Further measures to seal the transport and packaging container 1 will be described below with reference to
(25)
(26)
(27)
(28) This sealing may be assisted by additional sealing means, which are formed along the lower segment of the two segments, as shown schematically in
(29) Referring to
(30) According to
(31) In the arrangements described above, the containers 2 are arranged in a regular arrangement distributed along two mutually orthogonal directions and in a plane at predetermined constant intervals. In principle also other periodic arrangements are conceivable: for example, adjacent rows or columns of containers 2 may also be offset by a predetermined length from one another, namely in a periodic configuration with a predetermined periodicity. Thus, automated production systems may expect the containers 2 at precise predetermined positions when they are transferred to a processing station, which significantly reduces the automation effort necessary. The further processing of the containers 2 can be performed while they are accommodated in a supporting structure 25 and/or while the containers are accommodated in one of the segments of the transport and packaging container.
(32) For this purpose, it is expedient if the bottom of the transport and packaging container is formed of a metal, wherein the metal is advantageously coated with a plastic material, in particular a thermoplastic, which resists temperatures of up to 330 C. and more preferably of up to 350 C., in particular, polyimide (PI) having a melting point of about 368 C., polyetherketone (PEK) having a melting point of about 375 C., polyetheretherketone (PEEK) having a melting point of about 341 C., polyetherketoneketone (PEKK) having a melting point of about 380 C. or polyetherketoneetherketoneketone (PEKEEK) having a melting point of about 384 C.
(33) For this purpose, it may also be expedient if the bottom of the transport and packaging container is formed of a high-temperature-resistant plastic material, in particular of a thermoplastic or polyimdide (PI) or polyetherketone (PEK) or of polysulfone (PSU) or of polyetheretherketone (PEEK), or preferably of a polyetheretherketon (PEEK) having a melting point above 330 C., more preferably up to 350 C.
(34)
(35) The wave-shaped webs 47 press the receptacles 39 of the supporting structure 25 in the illustration of
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(38) In this embodiment the rectangular basic shape of the supporting structure 25 is achieved by the form-fitting elements 110 having an L-shaped profile, which are disposed on the outer walls of the outer base units, so that an essentially U-shaped receptacle having a longitudinal slot is formed in the base, into which the latching rail 111 is engaged, which is provided with a corresponding T-shaped profile. By means of the latching rail 111 also a fixation of the positions of all the base units 100 may be accomplished, for example by screwing or clamping of the latching rail 111 in any case to the front and rear base units 100 of a column or row of the matrix-shaped supporting structure 25.
(39)
(40) For converting the supporting structure 25 from the first position shown in
(41)
(42) While it was explained in the previous embodiments, that the containers are placed upright and with its open end toward the upper end of the transport and packaging container, the containers can in principle also be reversed, i.e. with their open end pointing toward the bottom of the transport and packaging container.
(43) The upper side or the upper side and bottom side of a supporting structure 25 according to the present disclosure or also of a transport and packaging container 1 according to the present disclosure can be covered by a sterile, gas-permeable protective foil which is bonded and drawn off, if necessary. This is exemplified in
(44)
(45) According to
(46) In order to reduce the base area of the carrier 25 even further, it may be advantageous if the edge portions 150 of the carrier 25 can be removed or pivoted away. This simple measure increases the achievable packing density of the container 2 when loading the hot oven or hot tunnel 220.
(47) For processing the containers 2 at the very high temperatures, it is not necessary to remove them out of the carriers and isolate them, which would be awkward. Rather, the containers 25 are still accommodated reliably in the receptacles of the carrier 25 during processing. To ensure the thermal stability of the carrier 25, the carrier 25 and/or at least the receptacles of the carrier 25 are formed of a high-temperature-resistant plastics material, in particular of a thermoplastic, which can withstand to the high processing temperatures of up to 330 C. and preferably up to 350 C. Preferably the thermoplastic is polyimide (PI), polyetherketone (PEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK) or polyetherketoneetherketoneketone (PEKEEK) having a melting point of up to 330 C. and preferably up to 350 C.
(48) The processing of the plurality of containers 2 in the hot oven or hot tunnel at tem-temperatures of up to 330 C. and preferably up to 350 C. is performed in such a manner that endotoxins and/or the lysis of bacteria and/or cytokine inducing substances in the containers 2 can be removed thermally.
(49) The processing of the plurality of containers 2 in the hot oven or hot tunnel at tem-temperatures of up to 330 C. and preferably up to 350 C. can also be performed in such a manner that silicon layers on inner surfaces of the containers 2, and in particular on a bottom 3 and bottom portion thereof, are burnt-in. Applying the silicon layer (siliconization) is performed by applying an amount of silicone oil or emulsion on at least a portion of the inner surface of each container. For this purpose a predetermined amount of silicone may be applied. In addition, it can be provided to remove excess silicone immediately, for example by wiping or rinsing. The deposited silicone oil is then fixed or baked by heat treatment at temperatures between 150 C. and 350 C. For this purpose it may be further provided that unbound or non-covalently bound silicone is removed completely or partially by wiping or rinsing.
(50) Of course, the aforementioned processing of the containers does not rule out that these are e.g. displaced temporarily by lifting to a different level. This can be achieved for example by means of a coordinated adjustment of all receptacles 39 of the carrier 25, as shown for example in
(51) According to an alternative embodiment (not shown), the containers are processed in the hot oven or hot tunnel at the very high temperatures of up to 330 C. and preferably up to 350 C. while they are accommodated in a transport and packaging container, as described above and while they are positioned reliably by the positioning devices in the array configuration. To ensure the thermal stability of the transport and packaging container and of its positioning devices, the transport and packaging container, or at least its bottom portion, which may be formed by one segment, as described above, is formed of a high-temperature-resistant plastic material, in particular of a thermoplastic that can withstand temperatures of up to 330 C. and more preferably up to 350 C., in particular of polyimide (PI), polyetherketone (PEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK) or polyetherketoneetherketoneketone (PEKEEK).
(52) According to an alternative embodiment the transport and packaging container, or at least its bottom portion, is formed of a metal that can withstand the temperatures during the processing of up to 330 C. and preferably up to 350 C.
(53) For the processing the transport and packaging container can be opened first, as described above, by shifting or releasing at least one segment of the plurality of segments 320, 330 (see
(54) In this open state, or alternatively, while the transport and packaging container is closed, the processing in the hot oven or hot tunnel is performed at the very high temperatures of up to 330 C. and preferably up to 350 C., while the containers are positioned in the regular array configuration by the positioning devices or by a carrier disposed in the transport and packaging container.
(55) If the transport and packaging container has been opened for the processing, the assembling or sticking together of the segments for closing again the transport and packaging container is performed in such a manner that the sealing means seal the interior of the transport and packaging container sterile against the environment.
(56) Referring to the schematic flow diagram of
(57) In step S1, the transport and packaging container (in
(58) In the optional step S4, the transport container can be opened again to provide access to the containers accommodated therein or to the carrier accommodated therein. Unless the thermal treatment of the containers should not be carried out directly in the transport container, the optional method step S5 follows, in which the carrier is removed from the transport container.
(59) Then, in step S6 a thermal treatment of the containers is performed, either while they are accommodated in the preferably closed transport container or while they are accommodated in the carrier after the carrier has been removed out of the transport container. The thermal treatment can in particular take place at very high temperatures of up to 330 C. and preferably up to 350 C.
(60) Then, the containers can be processed either immediately, e.g. they can be filled and then sealed sterile and packaged, or they are inserted together with the carrier again into the transport container, which is then sealed again in the optional process step S7, as described above. In the latter state, the heat treated containers can then be sterile stored or transported in the transport container.
(61) It will be readily apparent for the person skilled in the art upon reading the above description that the various aspects and features of the embodiments described above may be combined in any manner with one another, resulting in numerous further embodiments and modifications. It will be readily apparent for the person skilled in the art upon reading the above description that all such further embodiments and modifications shall be comprised by the present disclosure, as long as these do not depart from the general solution and scope of the present disclosure, as defined in the appended claims.