Retention device for flexible processing of pharmaceutical packaging materials

Abstract

A container holding device for holding one or more containers including a top region having a top edge, a bottom edge and an outer diameter d1, a neck region having an outer diameter d2 < d1, a shoulder region and a body region having an outer diameter d3 > d1, the substrate having an upper surface and a bottom surface including one or more holes extending from the upper surface to the bottom surface and having a central axis of symmetry orthogonal to the substrate; two or more holding elements located below the bottom surface of the substrate around each hole; which are adjusted and arranged to contact the bottom edge of the top region with the outer surface of the container placed in the container holding device, so that the container is suspended in the first position of the container holding device, where the holding elements do not exert any force on the outer surface of the container radially with respect to the central axis of symmetry; and contact the shoulder region of the container with the outer surface of the container, so that the container remains stable when rising in the container holding device towards the second position. And a kit having the container holding device and a closure system holding device, a production process of a closed processed container, and uses of the holding device.

Description

Technical Field

[0001] The present invention relates to a container holding device for holding a plurality of containers, each container comprising a top region, a neck region, a shoulder region and a body region, wherein the holding device comprises a substrate and a holding element preferably in the form of a clip. The present invention also relates to a kit comprising a container holding device and a closure system holding device, a method for producing a closed container and the use of the holding device. Background Art

[0002] In the handling of containers for pharmaceutical or medical applications, it is nowadays generally preferred to use so-called nested solutions, in which a holding device for the containers (also referred to as an "insert kit") is used to hold or support a plurality of containers simultaneously in a given configuration. These insert kits are usually packaged in a sterile manner in a transport or packaging container (also referred to as a "bucket") when delivered to customers such as pharmaceutical companies or filling companies. To further process the containers, the bucket is opened under sterile conditions (e.g., in a clean room). Further processing can be carried out either with the insert kit still housed in the bucket or after the insert kit has been removed from the bucket. Further processing of the containers can include the steps of filling the containers with a substance in liquid form (e.g., a pharmaceutical composition); and sealing the pre-filled containers using stoppers, pistons, etc. After further processing, the containers can be re-packaged in a sterile manner in the bucket for delivery to the end customer.

[0003] For so-called clip insert kits, the constricted containers are held at the crimp, i.e., at the widened upper edge adjacent to the narrow neck, by means of elastic holding arms such as clips. The body and bottom of the vial are made freely accessible, which may be required for further processing such as freeze-drying treatment (lyophilization). In the prior art, examples of such known holding devices are, for example, the insert kits disclosed in Figure 2 f of DE 10 2012 110 339 A1. These insert kits comprise a substrate which includes holes defined in an array, wherein elastic fixing tongues are arranged around each hole on the upper side of the substrate. The containers are suspended in the holes of the insert kit and are held in place by the tongues located below the crimp or the containers. In order to close the containers after filling them with a pharmaceutical composition in a sterile drug filling machine and / or after processing the containers (e.g., by lyophilization), the substrate is moved downwards (or, if the containers are standing on a substrate such as a drug filling machine workbench, the containers are moved upwards by raising the workbench), and the containers are closed on the top side. Closing is usually accomplished by pressing a stopper against the open end of the container and then sealing the crimp of the container with a cap. This process can also be carried out by using, for example, Simplify single-component closed systems such as closed systems (ARaymondlife SASU, France), which include a plug and cap combination.

[0004] Generally, the closure of the container in the container insert is accomplished by applying an additional insert (cap insert), which includes a closure system arranged to correspond to the arrangement of the container in the container insert. To close the container, the two inserts are pressed against each other. For the insert disclosed in DE 10 2012 110 339 A1 Figure 2 f, to remove the filled container from the container insert, the first step is to pull the cap insert upward, and the second step is to pull the container upward out of the vial insert.

[0005] The above inserts can also be suitable for weighing the container in the insert. For weighing, the container is also lifted in the clip receiving portion to create sufficient space for the weighing process. However, if the tongue touches the vial, it may affect the weighing result. Therefore, as much available space as possible must be created. Since with today's inserts, the above steps require a very high degree of precision and often only the use of a robot can ensure precision, the vial is usually removed from the insert for the weighing and closing steps. However, removing the container from the insert places certain requirements on the dimensional design of the insert.

[0006] Since the diameter of the hole in the insert disclosed in DE 10 2012 110 339 A1 is at least equal to the outer diameter of the container in the main body region, and sufficient available space must still be retained around the hole to position the clip on the upper surface of the substrate, these prior art inserts are subject to certain limitations in terms of density such that the container can be arranged within the insert. In addition, in the separate process steps of removing the nested cap and removing the container from the container insert, it is still possible to simplify the removal of the filled and sealed container from the insert to improve process economy.

[0007] Moreover, container nesting kits such as those disclosed in DE 10 2012 110 339 A1 are disadvantageous to a certain extent for larger containers with an outer diameter of 40 mm or more, if these containers have to be lifted within the nesting kit as described above for applying a closure system, or have to be removed from the nesting kit during certain process steps. When the tongues hold the container below the crimp, these tongues have to grip the diameter of this edge. In addition, the diameter of the opening of the nesting kit must be at least equal to the body diameter of the container so that the container can be lifted out of the nesting kit. Since the ratio of the diameter of the crimp to the diameter of the body area determines the size of the tongues, and since the tongues have to bridge the diameter difference to hold the vial reliably in the nesting kit, a deviation from the standard diameter ratio (such as an especially large vial) requires very large retaining elements, since the crimp diameter usually does not exceed 20 mm, but the body diameter can reach 40 mm (50R) or 47 mm (100R). Summary of the Invention

[0008] Generally, the object of the present invention is to overcome at least in part the disadvantages existing in the prior art. Another object of the present invention is to provide a container nesting kit, preferably a vial nesting kit, which holds containers, preferably vials, with a greater density compared to the container nesting kits known in the prior art. Another object of the present invention is to provide a container nesting kit, preferably a vial nesting kit, which contributes to improving the process economy in a pharmaceutical filling station, especially when it comes to the step of removing a closed container (preferably a closed vial) from the container nesting kit. Another object of the present invention is to provide a container nesting kit, preferably a vial nesting kit, which allows the container to be easily removed from the nesting kit not only for common DIN-ISO vials such as 2R vials or 4R vials, but also for larger vials such as 50R vials or 100R vials. Another object of the present invention is to provide a nesting kit which can accommodate closure systems and / or vials with different sizes, especially sizes that do not conform to DIN-ISO, and preferably to provide a nesting kit which can accommodate closure systems with custom sizes and / or custom vial sizes.

[0009] The independent claims contribute to achieving at least one, preferably more than one, of the above objects at least in part. The dependent claims provide preferred embodiments which contribute to achieving at least one of the above objects at least in part.

[0010] By means of Embodiment 1 of the container holding device for holding one or more containers, at least one object according to the present invention is contributed to being achieved, each container comprising a top region having a top edge, a bottom edge and an outer diameter d1, a neck region having an outer diameter d2 < d1, a shoulder region, and a body region having an outer diameter d3 > d1. Wherein, the container holding device comprises:

[0011] A substrate having an upper surface and a bottom surface, wherein the substrate comprises one or more holes, each hole extending from the upper surface to the bottom surface and having a central symmetry axis L orthogonal to the substrate 轴 ;

[0012] two or more retaining elements positioned below the bottom surface of the substrate surrounding each aperture;

[0013] The retaining elements are adjusted and arranged such that:

[0014] i) contacting the outer surface of a container placed in the container holding device at the bottom edge of the top region so that the container is suspended in a first position p1 of the container holding device, preferably in which the holding element is oriented relative to the central symmetry axis L of the container 轴 No force is applied to the radially outer surface;

[0015] and

[0016] ii) contact with the outer surface of the container in the shoulder region of the container, thereby holding the container stable while the container is raised upwards towards the second position p2 in the container holding device.

[0017] In the container holding device according to the invention, the bottom surface of the base plate is the surface which, if the container is suspended in position p1 of the holding device, faces the top region of the container, wherein the surface is preferably in the form of a curled edge. Furthermore, the "holding element is disposed at the center symmetry axis L of the container" 轴 The expression "no force is exerted on the radially outer surface" is preferably understood to mean that the holding element does not press against the outer surface of the neck region of the container suspended in the position p1 in the holding device, but the holding element only contacts the outer surface of the container at the bottom edge of the top region, i.e. the holding element preferably contacts the container at the bottom side of the curling. Accordingly, the holding element is preferably adjusted and arranged so that the force required to move the container from position p1 to position p2 is not increased. The holding element is preferably adjusted and arranged so that the container with the curling rests loosely on the holding element with the bottom side of the curling.

[0018] In embodiment 2 of the container holding device according to the present invention, the container holding device is designed according to embodiment 1 thereof, wherein the container is a drug container which is rotationally symmetric around the longitudinal axis of the container and has at least one opening at the top edge of the container.

[0019] In embodiment 3 of the container holding device according to the present invention, the container holding device is designed according to embodiment 2 thereof, wherein the container is selected from the group consisting of a vial, a vartridge, an ampoule, a cartridge or a syringe.

[0020] In Embodiment 4 of the container holding device according to the present invention, the container holding device is designed according to Embodiment 3 thereof, wherein the container is a vial, preferably a vial having a crimped shape in the top region. Accordingly, the container holding device according to the present invention is preferably a holding device for vials, i.e., a vial nesting kit.

[0021] In Embodiment 5 of the container holding device according to the present invention, the container holding device is designed according to any one of Embodiments 1 to 4 thereof, wherein holes are arranged in regularly spaced rows and columns on the substrate, and these rows and columns are regularly offset from each other and form a repeating arrangement. This regular arrangement facilitates the automated handling of the containers.

[0022] In Embodiment 6 of the container holding device according to the present invention, the container holding device is designed according to any one of Embodiments 1 to 5 thereof, wherein holding elements are arranged along a circular arrangement around each hole.

[0023] In Embodiment 7 of the container holding device according to the present invention, the container holding device is designed according to any one of Embodiments 1 to 6 thereof, wherein two, three, four or more holding elements are arranged along a circular arrangement around each hole. In a particularly preferred embodiment of the container holding device according to the present invention, three or four holding elements are arranged on the lower side of the substrate at regular intervals along a circle around each hole.

[0024] In Embodiment 8 of the container holding device according to the present invention, the container holding device is designed according to any one of Embodiments 1 to 7 thereof, wherein the holding elements are designed in the form of clips.

[0025] In Embodiment 9 of the container holding device according to the present invention, the container holding device is designed according to Embodiment 8 thereof, wherein each clip comprises:

[0026] a first region which is adjusted and arranged to contact the outer surface of the container at the bottom edge of the top region if the container is suspended in the first position p1;

[0027] and

[0028] a second region which is adjusted and arranged to contact the outer surface of the container in the shoulder region of the container if the container is stabilized in the second position p2.

[0029] In Embodiment 10 of the container holding device according to the present invention, the container holding device is designed according to Embodiment 8 or 9 thereof, wherein the clip is in the form of a flexible holding arm. In this case, it is particularly preferred that the flexible holding arm comprises a holding protrusion which is located at the bottom of the flexible holding arm and is adapted and arranged to hold the container at the bottom edge of the top region, i.e., below the crimp.

[0030] In Embodiment 11 of the container holding device according to the present invention, the container holding device is designed according to any one of Embodiments 8 to 10 thereof, wherein the clip is disposed obliquely below the substrate such that when an object having a diameter equal to or almost equal to the diameter of the hole is introduced from the upper surface of the substrate into the hole, the clip is pushed away from the central axis of symmetry L of the hole by the approaching object 轴 .

[0031] In Embodiment 12 of the container holding device according to the present invention, the container holding device is designed according to Embodiment 11 thereof, wherein the clip includes a substantially planar inner surface that faces the central axis of symmetry L of the hole 轴 , where a straight line that is tangentially applied to the inner surface and extends in the same plane as the central axis of symmetry L of the hole 轴 forms an angle α with the central axis of symmetry L of the hole 轴 .

[0032] In Embodiment 13 of the container holding device according to the present invention, the container holding device is designed according to Embodiment 12 thereof, wherein α is in the range of 1 degree to 45 degrees, preferably in the range of 1 degree to 30 degrees, more preferably in the range of 1.5 degrees to 20 degrees, more preferably in the range of 1.5 degrees to 15 degrees, and even more preferably in the range of 2 degrees to 5 degrees

[0033] In Embodiment 14 of the container holding device according to the present invention, the container holding device is designed according to any one of Embodiments 1 to 13 thereof, wherein the diameter of the hole is d4 = d3, preferably d4 < d3. Thus, in the container holding device according to the present invention, preferably, contrary to the socket kit disclosed in DE 10 2012 110 339 A1, the diameter of the hole in the substrate is smaller than the diameter of the main body region of the container that can be held in the container holding device. As a result, the containers can be held in the container holding device at a higher density

[0034] In Embodiment 15 of the container holding device according to the present invention, the container holding device is designed according to Embodiment 14 thereof, wherein the following conditions are satisfied

[0035] d4 < 0.99×d3;

[0036] Preferably d4 < 0.97×d3;

[0037] More preferably d4 < 0.95×d3;

[0038] Most preferably d4 < 0.93×d3

[0039] In embodiment 16 of the container holding device according to the invention, the container holding device is designed according to any one of embodiments 1 to 15 thereof, wherein the diameter of the hole is d4 > d1. Therefore, in the container holding device according to the invention, it is preferred that the diameter of the hole in the substrate is greater than the diameter of the top region of the container that can be held in the container holding device. Thus, if the container is lifted from position p1 to position p2, the holding element can be adjusted and arranged such that the top region of the container (preferably the crimp of an ampoule) protrudes beyond the upper surface of the substrate, thereby making it easier, for example, to close the container using a closure system.

[0040] In embodiment 17 of the container holding device according to the invention, the container holding device is designed according to embodiment 16 thereof, wherein the following condition is satisfied:

[0041] d4 < 1.25 × d1;

[0042] Preferably d4 < 1.2 × d1;

[0043] More preferably d4 < 1.15 × d1;

[0044] More preferably d4 < 1.1 × d1;

[0045] Most preferably d4 < 1.05 × d1.

[0046] In embodiment 18 of the container holding device according to the invention, the container holding device is designed according to embodiment 16 or 17 thereof, wherein d4 < d3 and wherein the following condition is satisfied:

[0047] d4 > 1.25 × d1;

[0048] Preferably d4 > 1.3 × d1;

[0049] More preferably d4 > 1.35 × d1;

[0050] More preferably d4 > 1.4 × d1;

[0051] More preferably d4 > 1.45 × d1;

[0052] More preferably d4 > 1.5 × d1;

[0053] More preferably d4 > 1.55 × d1;

[0054] Most preferably d4 > 1.6 × d1.

[0055] In embodiment 19 of the container holding device according to the invention, the container holding device is designed according to any one of embodiments 1 to 18 thereof, wherein the following condition is satisfied:

[0056] d1 < d4 < d3.

[0057] In embodiment 20 of the container holding device according to the invention, the container holding device is designed according to any one of embodiments 1 to 19 thereof, wherein the holding element is designed as a holding element preferably in the form of an elastic clip, but when the container holding device is removed from the top region of the container or when the container is pulled downward from the container holding device, the holding element has sufficient elasticity to pivot open or fold up. This can be easily achieved by appropriate sizing, material selection and design of the material thickness of the holding element. Therefore, the holding element is preferably made of a plastic material.

[0058] In embodiment 21 of the container holding device according to the invention, the container holding device is designed according to embodiment 20 thereof, wherein the plastic material satisfies at least one of the following conditions:

[0059] α) The Young's modulus measured according to ISO 527-1 / -2 is in the range of 0.6 GPa to 3.5 GPa, preferably in the range of 0.7 GPa to 3 GPa, and more preferably in the range of 0.8 GPa to 2.7 GPa;

[0060] β) The Shore hardness measured according to ISO 7619-1 is in the range of 55 to 90, preferably in the range of 60 to 85, and more preferably in the range of 65 to 82.

[0061] In embodiment 22 of the container holding device according to the invention, the container holding device is designed according to any one of embodiments 1 to 21 thereof, wherein the width of the substrate is in the range of 150 cm to 300 cm, preferably in the range of 175 cm to 275 cm, and most preferably in the range of 200 cm to 250 cm, and the length of the substrate is in the range of 300 cm to 450 cm, preferably in the range of 325 cm to 425 cm, and most preferably in the range of 350 cm to 400 cm.

[0062] In embodiment 23 of the container holding device according to the invention, the container holding device is designed according to any one of embodiments 1 to 22 thereof, wherein the container holding device further includes one or more containers suspended at position p1.

[0063] In embodiment 24 of the container holding device according to the invention, the container holding device is designed according to its embodiment 23, wherein the container holding device is a vial insert kit, the vial insert kit being designated for accommodating vials of size designation "2R", "3R" or "4R" according to DIN EN ISO 8362-1:2016-06, and wherein the container holding device comprises 80 to 140 vials, preferably 90 to 120 vials, even more preferably 100 to 110 vials held in position p1.

[0064] In embodiment 25 of the container holding device according to the invention, the container holding device is designed according to its embodiment 24, wherein the diameter (d4) of the holes in the substrate is in the range of 13 mm to 20 mm, preferably in the range of 15 mm to 19 mm, and more preferably in the range of 16 mm to 18 mm.

[0065] In embodiment 26 of the container holding device according to the invention, the container holding device is designed according to its embodiment 24 or 25, wherein

[0066] d4 < 1.35×d1;

[0067] Preferably d4 < 1.3×d1.

[0068] In embodiment 27 of the container holding device according to the invention, the container holding device is designed according to any one of its embodiments 24 to 26, wherein d4 < d3, and wherein

[0069] d4 > 1.4×d1;

[0070] Preferably d4 > 1.45×d1.

[0071] In embodiment 28 of the container holding device according to the invention, the container holding device is designed according to its embodiment 23, wherein the container holding device is a vial insert kit, the vial insert kit being designated for accommodating vials of size designation "6R", "8R", "10R" or "15R" according to DIN EN ISO 8362-1:2016-06, and wherein the container holding device comprises 40 to 68 vials, preferably 44 to 58 vials, even more preferably 48 to 56 vials held in position p1.

[0072] In embodiment 29 of the container holding device according to the invention, the container holding device is designed according to its embodiment 28, wherein the diameter (d4) of the holes in the substrate is in the range of 20 mm to 35 mm, preferably in the range of 22 mm to 30 mm, and more preferably in the range of 24 mm to 26 mm.

[0073] In embodiment 30 of the container holding device according to the invention, the container holding device is designed according to its embodiment 26 or 27, wherein

[0074] d4 < 1.25 × d1;

[0075] Preferably d4 < 1.2 × d1.

[0076] In embodiment 31 of the container holding device according to the invention, the container holding device is designed according to any one of its embodiments 28 to 30, wherein d4 < d3, and wherein

[0077] d4 > 1.3 × d1;

[0078] Preferably d4 > 1.35 × d1.

[0079] In embodiment 32 of the container holding device according to the invention, the container holding device is designed according to its embodiment 23, wherein the container holding device is a vial insert kit, the vial insert kit being designated for accommodating vials of size designation "20R", "25R" or "30R" according to DIN EN ISO 8362-1:2016-06 and wherein the container holding device comprises 20 to 38 vials, preferably 22 to 36 vials, even more preferably 24 to 30 vials, held in position p1.

[0080] In embodiment 33 of the container holding device according to the invention, the container holding device is designed according to its embodiment 32, wherein the diameter (d4) of the holes in the substrate is in the range from 20 mm to 35 mm, preferably in the range from 22 mm to 30 mm, and more preferably in the range from 24 mm to 26 mm.

[0081] In embodiment 34 of the container holding device according to the invention, the container holding device is designed according to its embodiment 32 or 33, wherein

[0082] d4 < 1.25 × d1;

[0083] Preferably d4 < 1.2 × d1.

[0084] In embodiment 35 of the container holding device according to the invention, the container holding device is designed according to any one of its embodiments 32 to 34, wherein d4 < d3, and wherein

[0085] d4 > 1.3 × d1;

[0086] Preferably d4 > 1.35 × d1.

[0087] In embodiment 36 of the container holding device according to the present invention, the container holding device is designed according to its embodiment 23, wherein the container holding device is a vial insert kit, the vial insert kit is designated to accommodate vials with the size name "50R" according to DIN EN ISO 8362-1:2016-06, and wherein the container holding device includes 10 to 30 vials, preferably 12 to 25 vials, and even more preferably 15 to 20 vials held at position p1.

[0088] In embodiment 37 of the container holding device according to the present invention, the container holding device is designed according to its embodiment 36, wherein the diameter (d4) of the holes in the substrate is in the range of 20 mm to 35 mm, preferably in the range of 22 mm to 30 mm, and more preferably in the range of 24 mm to 26 mm.

[0089] In embodiment 38 of the container holding device according to the present invention, the container holding device is designed according to its embodiment 32 or 33, wherein

[0090] d4 < 1.25×d1;

[0091] Preferably d4 < 1.2×d1.

[0092] In embodiment 39 of the container holding device according to the present invention, the container holding device is designed according to its embodiments 36 to 38, wherein d4 < d3, and wherein

[0093] d4 > 1.3×d1;

[0094] Preferably d4 > 1.35×d1.

[0095] In embodiment 40 of the container holding device according to the present invention, the container holding device is designed according to its embodiment 23, wherein the container holding device is a vial insert kit, the vial insert kit is designated to accommodate vials with the size name "100R" according to DIN EN ISO 8362-1:2016-06, and wherein the container holding device includes 8 to 20 vials, preferably 10 to 18 vials, and even more preferably 12 to 15 vials held at position p1.

[0096] In embodiment 41 of the container holding device according to the present invention, the container holding device is designed according to its embodiment 40, wherein the diameter (d4) of the holes in the substrate is in the range of 20 mm to 35 mm, preferably in the range of 22 mm to 30 mm, and more preferably in the range of 24 mm to 26 mm.

[0097] In embodiment 42 of the container holding device according to the present invention, the container holding device is designed according to its embodiment 40 or 41, wherein

[0098] d4 < 1.25×d1;

[0099] Preferably, d4 < 1.2×d1.

[0100] In embodiment 43 of the container holding device according to the present invention, the container holding device is designed according to any one of its embodiments 40 to 42, wherein d4 < d3, and wherein

[0101] d4 > 1.3×d1;

[0102] Preferably, d4 > 1.35×d1.

[0103] By an embodiment 1 of a kit, it helps to achieve at least one object according to the present invention, the kit comprising:

[0104] A) A container holding device according to any one of its embodiments 23 to 43;

[0105] B) A closure cap holding device that holds one or more closure systems, wherein the arrangement of the above closure systems in the closure system holding device corresponds to the arrangement of the container in the container holding device.

[0106] In embodiment 2 of the kit according to the present invention, the kit is designed according to its embodiment 1, wherein the closure cap holding device includes a substrate having an upper surface and a bottom surface and a closure system holding element located on the upper surface or the bottom surface of the substrate, wherein the closure system holding element is adjusted and arranged such that when the container holding device and the closure system holding device are pressed together to close the container in the container holding device with the closure system in the closure system holding device, the holding element of the container holding device is pushed away from the central axis of symmetry L by the approaching closure system holding element 轴 .

[0107] In embodiment 3 of the kit according to the present invention, the kit is designed according to its embodiment 1, wherein the closure system in the closure system holding device has an outer diameter d5 such that when the container holding device and the closure system are pressed together to close the container in the container holding device with the closure system in the closure cap holding device, the holding element of the container holding device is pushed away from the central axis of symmetry L by the approaching closure system 轴 .

[0108] In Example 4 of the kit according to the invention, the kit is designed according to any one of its Examples 1 to 3, wherein the closure system comprises an elastic stopper and a closure cap. Such a closure system is disclosed, for example, in US 2012 / 0248057A1 or WO 2015 / 023924A1. Also suitable in this case is to arrange a cap system such as and (West Pharmaceutical Services, Inc., USA) or (ARaymondlife SASU, France) in a suitable insert kit.

[0109] In Example 5 of the kit according to the invention, the kit is designed according to any one of its Examples 1 to 4, wherein the kit further comprises:

[0110] C) a transport and packaging container received in the container holding device.

[0111] By Example 1 of a method for producing a closed container, at least one object of the invention is facilitated. The method comprises the following steps:

[0112] I) providing a container holding device according to any one of Examples 23 to 43 of the container holding device, or a kit according to any one of Examples 1 to 5 of the kit, wherein one or more containers have an opening at the top edge of the top region, and the one or more containers are suspended at position p1 in the container holding device 100;

[0113] II) moving one or more containers from position p1 to position p2;

[0114] III) providing a closure system for the top region of the container.

[0115] In Example 2 of the method for producing a closed container according to the invention, the method is designed according to its Example 1, wherein before providing a closure system for the top region of the container, at least a part of the stopper is introduced into the top region of the container to close the container.

[0116] In Example 3 of the method for producing a closed container according to the invention, the method is designed according to its Example 1, wherein in method step III), a closure system is used which comprises an elastic stopper and a closure cap, and wherein if a closure system is provided for the top region of the container, at least a part of the elastomeric stopper is introduced into the top region of the container. Suitable cap systems are those cap systems already described above in connection with the kit according to the invention.

[0117] In embodiment 4 of the method for producing a closed container according to the invention, the method is designed according to any one of embodiments 1 to 3 thereof, wherein the closing system is arranged in a closing system holding device as defined in embodiment 2 or 3 of the kit according to the invention.

[0118] In embodiment 5 of the method for producing a hermetically sealed container according to the invention, the method is designed according to embodiment 4 thereof, wherein in method step III), adding a closing system to the top region of the container is achieved by pressing the container holding device and the closing system holding device together, and wherein the holding elements of the container holding device are pushed away from the central axis of symmetry L by the approaching closing system and / or the approaching closing system holding elements 轴 。

[0119] In embodiment 6 of the method for producing a hermetically sealed container according to the invention, the method is designed according to any one of embodiments 1 to 5 thereof, and the method further comprises the following steps:

[0120] IV) Removing the closed container from the container holding device by moving the closed container downwards, or by pulling the container holding device upwards.

[0121] Using a container holding device according to any one of embodiments 1 to 43 of the container holding device for producing a closed container also helps to achieve at least one object according to the invention. Description of the Drawings

[0122] Unless otherwise specified in the specification or in a particular drawing,

[0123] Figure 1A A part of the container holding device 100 according to the invention (i.e., the area around a single hole 107) is shown in a sectional side view;

[0124] Figure 1B The container holding device 100 according to the invention is shown in a top view;

[0125] Figure 2 The area of the container 101 that can be held in the container holding device 100 according to the invention is shown in a sectional view;

[0126] Figure 3 The way of holding the container 101 at position p1 in the container holding device 100 according to the invention is shown in a sectional view;

[0127] Figure 4 The way of holding the container 101 at position p2 in the container holding device 100 according to the invention is shown in a sectional view;

[0128] Figure 5shows the advantage of arranging the holding element 108 inclined on the lower side 106b of the substrate 106;

[0129] Figure 6 shows in a sectional view how the holding element 108 is pushed away from the central axis of symmetry L when a closing system 111 with a diameter d5 is added in the top region of the container 轴 ;

[0130] Figure 7 shows in a sectional view how the container 101 in the container holding device 100 according to the invention can be closed by means of the closing system 111 held in the closing system holding device 114. Detailed Description

[0131] FIG. 1 shows in a sectional side view a part of the container holding device 100 according to the invention (i.e., the area around a single hole 107). As can be seen from Figure 1A the container holding device 100 according to the invention comprises a substrate 106 having an upper surface 106a and a bottom surface 106b, wherein the substrate 106 comprises one or more holes 107, each hole 107 extending from the upper surface 106a to the bottom surface 106b and having a central axis of symmetry L orthogonal to the substrate 106 轴 (see for example Figure 3 ). The container holding device 100 further comprises two or more holding elements 108, which are located below the bottom surface 106b of the substrate 106 around each hole 107, wherein Figure 1A the holding elements of the holding device 100 shown in are designed in the form of clips. As can be seen from Figure 1A a significant difference compared to the vial nesting sets known in the prior art is that the holding element 108 is located at the bottom surface 106b of the substrate 106. The vial 101 thus hangs below the substrate 106. As can be seen from Figure 1B the holes 107 can be distributed in regularly arranged rows and columns on the substrate 106, wherein these rows and columns are regularly offset from each other and form a repeated arrangement. This regular arrangement facilitates the automated handling of the containers 101. In the Figure 1B device 100 shown, three clips 108 can be arranged at regular intervals along a circular arrangement around each hole 107 on the lower side 106b of the substrate 106, but two, four or even more clips 108 can also be arranged. Figure 1A The clip 108 shown in is designed in the form of a flexible holding arm. The flexible holding arm comprises a holding projection 108a, which is located at the bottom of the flexible holding arm and is adjusted and arranged to hold the container 101 at the bottom edge 102b of the top region 102, i.e., below the crimp (as shown in Figure 3 ).

[0132] Figure 2 A cross-sectional view shows the region of a typical container 101 that can be held in a container holding device 100 according to the present invention, where the container 101 is in the form of a vial. The container 101 includes a top region 102 having a top edge 102a, a bottom edge 102b, and an outer diameter d1, a neck region 103 having an outer diameter d2 < d1, a shoulder region 104, and a body region 105 having an outer diameter d3 > d1. As Figure 2 shown, the top region 102 of the container 101 is typically designed in the form of a crimp.

[0133] As the material of the container 101 to be held in the container holding device 100 according to the present invention, any material that those skilled in the art consider suitable for this purpose can be selected. Pharmaceutical containers made of tubular glass are commercially available in different size ranges having dimensions according to the DIN EN ISO 8362-1:2016-06 standard. Molded glass vials are commercially available in different size ranges having dimensions according to the DIN / ISO 8362-4 standard.

[0134] Traditionally, glass has been the only option for container materials, but due to problems such as glass breakage, delamination, particulates generated from glass-to-glass collisions, and the stability of certain products, the development and use of suitable polymer materials have been led to. An example of such a polymer material is cycloolefin polymer. Vials made of polymeric materials are commercially available, and their size ranges and dimensions are generally very similar to those of glass vials. The scratch resistance of polymeric materials is significantly lower than that of glass, and existing aseptic processing equipment has not been redesigned to mitigate the risk of scratching. Scratching of the container surface is a serious problem for the perceived quality of the product, but it also severely limits the inspection of particles in the container. Such inspection is usually a regulatory requirement of good manufacturing practice. Therefore, processing vials in the container holding device 100 according to the present invention is an effective solution to prevent vial scratching, where vial scratching such as typically occurs during single vial processing or during processing of rows of vials simultaneously. These devices are particularly suitable for processing polymeric vials, but can also be well used for processing glass vials.

[0135] Figure 3 A cross-sectional view shows the manner in which the container 101 is held at a position p1 in the container holding device 100 according to the present invention, while Figure 4 a cross-sectional view shows the manner in which the container 101 is held at a position p2. It can be seen that the holding element 108 is adjusted and arranged to contact the outer surface of the container 101 placed in the container holding device 100 at the bottom edge 102b of the top region 102 (at Figure 3In the vial 101 shown, the holding element 108 holds the vial 101 below the lower edge of the crimp, such that the container is suspended at a first position p1 of the container holding device 100, at which first position p1 the holding element 108 does not exert any force on the outer surface of the container 101 that is radial with respect to the central symmetry axis L 轴 Thus, the holding element 108 does not press against the outer surface of the neck region 103 of the container 101, and thus the container 101 rests loosely on the holding element 108 with the bottom side of the crimp (more precisely, with the bottom side 102b of the crimp 102 on the holding projection 108b of the holding element 108). Thus, the holding element 108 is preferably adjusted and arranged such that it does not increase the force required to move the container along the path x from the first position p1 to the second position p2 (see Figure 3 and Figure 4 ). At the second position p2, the holding element 108 contacts the outer surface of the container 101 at the shoulder region 104 of the container 101, thereby stabilizing the container 101 in the container holding device 100 when the container 101 is raised towards the second position p2. Raising the container 101 from the first position p1 to the second position p2 can be accomplished, for example, by moving the substrate 106 downwards, or as Figure 3 and Figure 4 shown, by raising the substrate 113 (such as the workbench of a drug filling machine) on which the container 101 is placed.

[0136] From Figure 3 and Figure 4 it can also be seen that the diameter d4 of the hole 107 in the substrate 106 need not be as large as the outer diameter d3 of the container 101 in the body region 105 of the container, since the container is suspended below the substrate 106. However, it is preferred that the diameter d4 of the hole 107 in the substrate 106 is at least as large as the diameter d1 of the container 101 in the top region (i.e., the diameter of the crimp), such that when the container 101 is lifted from position p1 to position p2, the top region 102 of the container 101 protrudes beyond the upper surface 106a of the substrate 106. This helps to attach a closure system to the top region 102 of the container 101.

[0137] Figure 5 shows the advantage of arranging the holding element 108 inclined on the lower side 106b of the substrate 106. As shown in this figure, the holding element 108, also designed in the form of a clip 108, is arranged inclined below the substrate 106, such that when an object 109 such as a closure system (see Figure 6 ) or a holding element of a closure system holding device (see Figure 7 ) is introduced from the upper surface 106a of the substrate 106 into the hole 107, the clip 108 is pushed away from the central symmetry axis L of the hole 107 by the approaching object 109轴 , wherein the diameter of the object 109 is the same as or substantially the same as the diameter of the hole 107. Such an arrangement can be achieved by means of a clip 108 which includes a substantially planar inner surface 108b that faces the central axis of symmetry L of the hole 107 轴 , wherein a straight line 110 which is applied tangentially to the inner surface 108b and extends in the same plane as the central axis of symmetry L of the hole 107 轴 forms an angle α with the central axis of symmetry L of the hole 107. Pushing the clip 108 away from the central axis of symmetry L of the hole 107 轴 facilitates, for example, pulling the container 101 downward out of the container holding device 101 or pulling the container holding device 100 upward after enclosing the container 101 with a closed system 轴 .

[0138] Figure 6 A cross-sectional view shows how the holding element 108 is pushed away from the central axis of symmetry L when a closed system 111 having a diameter d5 is added to the top region 102 of the container 101 轴 . Preferably, the closed system is in the form of a closed system holding device 114, as Figure 7 shown. Since Figure 6 the diameter of the closed system shown in is greater than the distance of the clip 108 immediately below the substrate 106, the holding element 108 of the container holding device 100 is pushed away from the central axis of symmetry L by the approaching closed system 轴 . Similarly as Figure 6 shown, the closed system preferably includes a closed cap 111 and an integral flexible plug 112. A part of the flexible plug 112 is introduced into the top region 102 of the container 101 to close the container 101 at the open end

[0139] Figure 7 A cross-sectional view shows how the container 101 in the container holding device 100 according to the invention can be closed using a closed system held in a closed system holding device 114. As can be seen in Figure 7 , the closed system holding device 114 includes a substrate 115 having an upper surface 115a and a bottom surface 115b, and a closed system holding element 116 which is located at the bottom surface 115b of the substrate 115 and is also preferably designed in the form of a flexible holding arm. The closed system holding element 116 is adjusted and arranged such that when the container holding device 100 and the closed system holding device 114 are pressed together (i.e., if along Figure 7When the directions of the two arrows shown in [Figure] are moved downward to hold the closing system holding device 114 so that the container 101 in the container holding device 100 is closed by the closing system in the closing system holding device 114, the holding element 108 of the container holding device 100 is pushed away from the central axis of symmetry L by the approaching closing system holding element 116 ( Figure 7 not shown). 轴 Pushing the clip 108 away from the central axis of symmetry L of the hole 107 轴 facilitates pulling the container holding device 100 upward after closing the container 101 with the closing system, where the two nesting sets (i.e., the container holding device 100 and the closing system holding device 114) can both be pulled to the same side simultaneously.

[0140] List of reference numerals

[0141] 100 Container holding device

[0142] 101 Container, preferably vial

[0143] 102 Top region of the container 101, preferably in the form of a crimp

[0144] 102a Top edge of the top region 102

[0145] 102b Bottom edge of the top region 102

[0146] 103 Neck region of the container 101

[0147] 104 Shoulder region of the container 101

[0148] 105 Body region of the container 101

[0149] 106 Substrate

[0150] 106a Upper surface of the substrate 106

[0151] 106b Bottom surface of the substrate 106

[0152] 107 Hole

[0153] 108 Holding element, preferably in the form of a clip

[0154] 108a Holding projection, which is located at the lower part of the clip

[0155] 108b Inner surface of the clip 108

[0156] 109 Object

[0157] 110 Straight line applied tangentially to the inner surface 108b

[0158] 111 Closing cap

[0159] 112 Flexible plug

[0160] 113 Substrate

[0161] 114 Closed system holding device

[0162] 115 Substrate of the closed system holding device 114

[0163] 115a Upper surface of the substrate 115

[0164] 115b Bottom surface of the substrate 115

[0165] 116 Closed system holding element

Claims

1. A container holding device (100) for holding one or more containers (101), each of said containers (101) comprising a top region (102) having a top edge (102a), a bottom edge (102b) and an outer diameter d1, a neck region (103) having an outer diameter d2 < d1, a shoulder region (104) and a body region (105) having an outer diameter d3 > d1, wherein said container holding device (100) comprises: A substrate (106) having an upper surface (106a) and a bottom surface (106b), wherein the substrate (106) includes one or more holes (107), each of the holes (107) extending from the upper surface (106a) to the bottom surface (106b) and having a central axis of symmetry L orthogonal to the substrate (106). 轴 , wherein the hole (107) has a diameter d4≥d1; Two or more holding elements (108) located below the bottom surface (106b) of the substrate (106) around each hole, and designed in the form of flexible holding arms, said flexible holding arms comprising holding protrusions (108a) located at the bottom of the flexible holding arms; Wherein, said holding elements (108) are adjusted and arranged such that i) At the bottom edge (102b) of the top region (102), the holding protrusion (108a) contacts the outer surface of the container (101) placed in the container holding device (100), such that the container is suspended at a first position p1 of the container holding device (100); and ii) In the shoulder region (104) of the container (101), the holding protrusion (108a) contacts the outer surface of the container (101), so as to keep the container (101) stable when the container (101) is lifted upwards towards a second position p2 in the container holding device (100).

2. The container holding device (100) according to claim 1, wherein, The holding elements (108) are adjusted and arranged such that i) The holding element (108) does not exert any force on the outer surface of the container (101) that is radial with respect to the central axis of symmetry L at the first position p1. 轴 ​ 3. The container holding device (100) according to claim 1, wherein, The container (101) is selected from vials, ampoules, cartridges or syringes.

4. The container holding device (100) according to claim 1, wherein two, three, four or more holding elements (108) are arranged in a circular pattern around each hole (107).

5. The container holding device (100) according to any one of claims 1 to 4, wherein the holding element (108) is designed in the form of a clip, and the clip is arranged obliquely below the substrate (106) such that when an object having a diameter the same as or almost the same as the diameter of the hole (107) is introduced from the upper surface (106a) of the substrate (106) into the hole (107), the clip is pushed away from the central symmetry axis L of the hole (107) by the approaching object 轴 .

6. The container holding device (100) according to claim 5, wherein the clip includes a substantially planar inner surface (108b), and the inner surface (108b) faces the central axis of symmetry L of the hole (107). 轴 , wherein a straight line (110) that is applied tangentially to the inner surface (108b) and extends in the same plane as the central axis of symmetry L of the hole (107). 轴 The central axis of symmetry L of the hole (107). 轴 forms an angle α.

7. The container holding device (100) according to claim 6, wherein, α is in the range of 1 degree to 45 degrees.

8. The container holding device (100) according to any one of claims 1 to 4, wherein, The hole (107) has a diameter d4 < d3.

9. The container holding device (100) according to any one of claims 1 to 4, wherein, The container holding device (100) further comprises one or more containers (101) suspended at position p1.

10. Use of the container holding device (100) according to any one of claims 1 to 9 in the production of a closed container.

11. A kit, comprising: A) The container holding device (100) according to claim 9; B) A closed system holding device (114) that holds one or more closed systems, wherein the arrangement of the closed systems in the closed system holding device (114) corresponds to the arrangement of the containers (101) in the container holding device (100).

12. The kit according to claim 11, wherein, The one or more closed systems comprise a closure cap (111) and an integral flexible plug (112).

13. The kit according to claim 11 or 12, wherein the enclosed system holding means (114) comprises: A substrate (115) having an upper surface (115a) and a bottom surface (115b), and a closure system holding element (116) located on the upper surface (115a) or the bottom surface (115b) of the substrate (115), wherein the closure system holding element (116) is adjusted and arranged such that when the container holding device (100) and the closure system holding device (114) are pressed together to close the container (101) in the container holding device (100) with the closure system in the closure system holding device (114), the holding element (108) of the container holding device (100) is pushed away from the central axis of symmetry L by the approaching closure system holding element (116). 轴 .

14. The kit according to claim 13, wherein the closure system in the closure system holding device (114) has an outer diameter d5 such that when the container holding device (100) and the closure system holding device (114) are pressed together to close the container (101) in the container holding device (100) using the closure system in the closure system holding device (114), the holding element (108) of the container holding device (100) is pushed away from the central axis of symmetry L by the approaching closure system 轴 .

15. A method for producing a closed container, comprising the following steps: I) Provide a container holding device (100) according to claim 9 or a kit according to any one of claims 11 to 14, wherein one or more containers (101) have an opening at the top edge (102a) of the top region (102), and the one or more containers (101) are suspended at a position p1 in the container holding device (100); II) Move the one or more containers (101) from the position p1 to the position p2; III) Provide a closing system for the top region (102) of the container (101).

16. The method according to claim 15, wherein step III) provides a closing system for the top region (102) of the container (101), the closing system comprising a closing cap (111) and an integral flexible plug (112).

17. The method according to claim 15 or 16, wherein the closing system is arranged in a closing system holding device (114) of a kit according to any one of claims 11 to 14.

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