Retaining means for limiting movement of a primary packaging container in a first and another longitudinal position

Abstract

This invention relates to a holding device comprising a secondary packaging container (102). A first type of holding element (401) and b. another type of holding element (402) are disposed within the secondary packaging container (102); wherein each first type of holding element (401) is designed and arranged to detachably hold the primary packaging container (101) by contact at a first longitudinal position (403); wherein the other type of holding element (402) is designed and arranged to restrict movement of the primary packaging container (101) in the lateral direction (409) at another longitudinal position (404); wherein the distance (405) between the first longitudinal position (403) and the other longitudinal position (404) of the primary packaging container (101) having a length (406) of L is D; wherein 0.5·L < D < L. Furthermore, this invention relates to an assembly (400) including a holding device and the use of the assembly (400).

Description

Technical Field

[0001] This invention relates to a holding device for holding a plurality of primary packaging containers of a pharmaceutical, medical, or cosmetic composition, the holding device comprising: a secondary packaging container designed and arranged to accommodate the plurality of primary packaging containers; wherein... a. Multiple Class I holding elements, and b. Multiple other types of retaining elements The primary packaging container is disposed within the secondary packaging container; wherein each first type of retaining element is designed and arranged to removably retain the primary packaging container by contacting it at a first longitudinal position within one of a plurality of primary packaging containers; wherein, for each first type of retaining element, the other type of retaining element is designed and arranged to restrict movement of the primary packaging container held by the first type of retaining element at another longitudinal position within the primary packaging container along the lateral direction of the primary packaging container, preferably, along all lateral directions of the primary packaging container; wherein the distance between the first longitudinal position and the other longitudinal position of the primary packaging container is D; wherein the length of the primary packaging container having a distance D is L; wherein 0.5·L < D < L. Furthermore, the present invention relates to an assembly including the retaining device and the use of the assembly for storing, transporting, or filling primary packaging containers. Background Technology

[0002] Containers made of glass, and later of polymers, have long been used for the safe transport of fluids and powders. Over the past few decades, the techniques for transporting fluids and powders using glass and polymer containers have become increasingly diverse and complex. One such technique is the subject of this application: pharmaceutical packaging. In the pharmaceutical industry, containers (such as vials, syringes, ampoules, and cartridges) serve as primary packaging for a wide variety of pharmaceutically related compositions (particularly drugs, such as vaccines) and cosmetic compositions (particularly cosmetic compositions injected into the skin).

[0003] In manufacturing containers for pharmaceutical or cosmetic applications, so-called nesting solutions are now generally preferred, where a plate-like retaining structure (also called a nest) for the container is applied to simultaneously hold or support multiple containers in a given configuration. These nests are typically packaged in transport or packaging containers (also called basins) and shipped to customers, such as pharmaceutical companies or filling machines. For further processing of the containers, the basin is opened. Further processing of the containers typically involves the following automated steps: removing the container from the basin; filling the container with a composition (e.g., a pharmaceutical or cosmetic composition); sealing the pre-filled container, for example, using a hypodermic needle via a Luer connector in the case of a syringe; and vacuum-packing the individual containers in foil bags for retail. Patient safety and the suitability of nests for automated processing can be affected by harsh conditions during transport and by the storage of nests filled with containers. Summary of the Invention

[0004] Overall, one object of the present invention is to overcome at least part of the shortcomings of the prior art.

[0005] Another object of the present invention is to provide a nest. For patient safety, this nest is more suitable for primary packaging containers, such as syringes, vials, cartridges, and ampoules, that contain pharmaceutical, medical, or cosmetic compositions during transport. Here, patient safety specifically refers to the container closure integrity (CCI) of the primary packaging container after transport, or the particle load of the primary packaging container after transport, or both.

[0006] According to another object of the invention, a nesting element is provided for a primary packaging container (e.g., syringe, vial, cartridge, and ampoule) for packaging pharmaceutical, medical, or cosmetic compositions, wherein the nesting element is more suitable for further processing by an automated filling machine.

[0007] The present invention contributes to at least partially achieving at least one, and preferably more than one, of the above-described objectives. The present invention provides preferred embodiments that facilitate at least partially achieving at least one objective.

[0008] Embodiment 1 of a holding device for holding multiple primary packaging containers for pharmaceutical, medical, or cosmetic compositions contributes to solving at least one object of the present invention, said holding device comprising: a secondary packaging container designed and arranged to accommodate multiple primary packaging containers; wherein... a. Multiple Class I holding elements, and b. Multiple retaining elements of another type It is placed in the secondary packaging container; Each of the first type of retaining elements is designed and arranged to preferably non-destructively and removably retain the primary packaging container by contacting it at a first longitudinal position of one of the primary packaging containers; wherein, for each of the first type of retaining elements, the other type of retaining element is designed and arranged to restrict movement of the primary packaging container held by the first type of retaining element at another longitudinal position of the primary packaging container along the lateral direction of the primary packaging container, preferably, along all lateral directions of the primary packaging container; wherein the distance between the first longitudinal position and the other longitudinal position of the primary packaging container is D; wherein the length of the primary packaging container having a distance D is L; wherein 0.5·L < D < L, wherein 0.6·L < D < 0.99·L is preferred, 0.7·L < D < 0.96·L is more preferred, even more preferred is 0.8·L < D < 0.93·L, and 0.85·L < D < 0.9·L is most preferred.

[0009] The longitudinal direction is the length direction of the corresponding primary packaging container. Therefore, the first and second longitudinal positions are different locations along the length of the corresponding primary packaging container. All transverse directions are perpendicular to the length of the corresponding primary packaging container. Therefore, the terms "longitudinal" and "transverse" are based on the corresponding primary packaging container. Here, the length direction of the primary packaging container is the direction in which the container has the maximum extension.

[0010] Each first-class retaining element is designed and arranged to preferably non-destructively and detachably retain the primary packaging container by contacting it at a first longitudinal position within one of a plurality of primary packaging containers. The container is non-destructively and detachably retained by the retaining element if the primary packaging container can be removed from the retaining device without damaging the container and preferably without damaging the retaining device itself. Here, retention specifically means holding it in place against gravity. Therefore, each first-class retaining element is designed and arranged to preferably non-destructively and detachably retain the primary packaging container such that if the retaining device is vertically oriented and no external force other than gravity acts on the retaining device and the primary packaging container, it is held in place within the secondary packaging container.

[0011] In embodiment 2 of the retaining device according to the invention, the retaining device is designed according to embodiment 1, wherein the secondary packaging container includes A. Container opening, and B. Container base, opposite to the container opening.

[0012] In embodiment 3 of the holding device according to the invention, the holding device is designed according to embodiment 1 or 2, wherein a first type of holding element and the other type of holding element are designed and arranged such that for each first type of holding element, the other type of holding element is designed and arranged to prevent the primary packaging container held by the first type of holding element from deviating from its balance orientation by more than 10°, preferably more than 8°, more preferably more than 6°, and most preferably more than 2°. Preferably, each first type of holding element is designed and arranged to hold the primary packaging container preferably non-destructively and detachably, such that if the holding device is vertically oriented and no external force other than gravity acts on the holding device and the primary packaging container, it maintains its balance orientation in the secondary packaging container. Thus, the balance orientation is an orientation of the primary packaging container in which it is held by one of the first type of first holding elements, while the holding device is vertically oriented and no external force other than gravity acts on the holding device and the primary packaging container. The preferred balance orientation is vertical.

[0013] In embodiment 4 of the retaining device according to the invention, the retaining device is designed according to any of the foregoing embodiments, wherein a first type of retaining element and another type of retaining element are designed and arranged such that for each primary packaging container preferably nondestructively and detachably retained by one of the first type of retaining elements, there is another type of retaining element surrounding the periphery of the primary packaging container at another longitudinal position of the primary packaging container, the distance of the other type of retaining element from the primary packaging container being 0.01 to 1.00 mm, preferably 0.02 to 0.90 mm, more preferably 0.03 to 0.60 mm, even more preferably 0.04 to 0.40 mm, and most preferably 0.05 to 0.20 mm.

[0014] In embodiment 5 of the retaining device according to the invention, the retaining device is designed according to any of the preceding embodiments, wherein the plurality of first-type retaining elements are disposed at or on the first plate-like element. Here, the first-type retaining elements are preferably openings in the first plate-like element, more preferably through holes in the first plate-like element. Alternatively, the plurality of first-type retaining elements are integral with the container base. In the latter case, the first-type retaining elements are preferably recesses in the container base or cup-shaped receiving portions formed by the container base.

[0015] In embodiment 6 of the retaining device according to the invention, the retaining device is designed according to embodiment 5, wherein a first type of retaining element forms a first regular pattern in the maximum extension plane of the first plate-like element, and wherein another type of retaining element forms another regular pattern in another plane, wherein the first regular pattern preferably coincides with the other regular pattern. The other plane is preferably parallel to the maximum extension plane of the first plate-like element or parallel to the container base, or both. A preferred other plane is the maximum extension plane of another plate-like element as defined below. The preferred regular pattern forms an array of rows and columns that are preferably perpendicular to each other. The regular pattern is a pattern formed by the repetition of elements in two dimensions.

[0016] In embodiment 7 of the retaining device according to the invention, the retaining device is designed according to any one of the preceding embodiments 2 to 6, wherein the plurality of another type of retaining elements are disposed on the side of the plurality of first type of retaining elements opposite to the container opening or the container base.

[0017] In embodiment 8 of the retaining device according to the invention, the retaining device is designed according to any of the preceding embodiments, wherein the plurality of other type of retaining elements are disposed on or on another plate-like element. This may be the case if the plurality of first type of retaining elements are disposed on or on a first plate-like element or are integral with the container base. Here, the other type of retaining element is preferably an opening in the other plate-like element, more preferably a through hole in the other plate-like element.

[0018] In embodiment 9 of the retaining device according to the invention, the retaining device is designed according to any of the preceding embodiments 1 to 6, wherein the plurality of other type of retaining elements are integral with the container base. Here, the plurality of first type of retaining elements are preferably disposed at or on the first plate-shaped element. Here, the other type of retaining element is preferably a groove in the container base or a cup-shaped receiving portion formed by the container base.

[0019] In embodiment 10 of the holding device according to the invention, the holding device is designed according to any of the foregoing embodiments, wherein, for each first type of holding element, another type of holding element is designed and arranged to restrict the movement of the primary packaging container held by the first type of holding element to prevent D from decreasing by more than 20%, preferably more than 10%, more preferably more than 5%, even more preferably more than 3%, and most preferably more than 1%. The aforementioned movement is preferably along the longitudinal direction, more preferably towards the container base. In another preferred embodiment, for each first type of holding element, another type of holding element is designed and arranged to restrict the movement of the primary packaging container held by the first type of holding element such that D increases with the movement of the primary packaging container. Preferably, each first type of holding element is designed and arranged to form a first positive fit with the primary packaging container held by the corresponding first type of holding element among a plurality of primary packaging containers, preventing movement of the primary packaging container in the longitudinal direction, wherein, for each first type of holding element, another type of holding element is designed and arranged to form another positive fit with the primary packaging container held by the corresponding first type of holding element among a plurality of primary packaging containers, preventing movement of the primary packaging container in the longitudinal direction. The aforementioned other type of retaining element is preferably another type of retaining element that restricts the movement of the primary packaging container in the lateral direction. Preferably, the first and second shapes cooperate to prevent D from decreasing by more than 20%, preferably more than 10%, more preferably more than 5%, even more preferably more than 3%, and most preferably more than 1%. The aforementioned longitudinal direction is preferably oriented towards the container base.

[0020] In embodiment 11 of the retaining device according to the invention, the retaining device is designed according to any of the foregoing embodiments thereto, wherein each first type of retaining element is designed and arranged to preferably non-destructively and detachably retain one of the plurality of primary packaging containers by form fit, friction fit, or a combination of both. A preferred form fit is a form fit with a first end or another end, or both, of the primary packaging container.

[0021] In embodiment 12 of the retaining device according to the invention, the retaining device is designed according to any of the foregoing embodiments thereof, wherein each primary packaging container comprises, along its length, in the following order: a. The first end, including the discharge port, b. Main body, and c. The other end.

[0022] In embodiment 13 of the retaining device according to the invention, the retaining device is designed according to embodiment 12, wherein the main body is cylindrical. In the case of a syringe, the cylindrical main body is generally referred to as a barrel.

[0023] In embodiment 14 of the retaining device according to the invention, the retaining device is designed according to embodiment 12 or 13, wherein the other end is an upright base, or includes another hole, or both. Preferably, the container whose other end is an upright base is a vial or cartridge. Preferably, the container whose other end includes another hole is a syringe. Preferably, the area of ​​the discharge hole of the container is smaller than the area of ​​another hole in the same container. Preferably, the other hole is designed to receive a plunger.

[0024] In embodiment 15 of the retaining device according to the invention, the retaining device is designed according to embodiment 14, wherein, for each of the primary packaging containers, the area of ​​the other hole is larger than the area of ​​the discharge hole.

[0025] In embodiment 16 of the retaining device according to the invention, the retaining device is designed according to embodiment 14 or 15, wherein the other end further includes an edge that protrudes laterally from the body and at least partially, preferably completely, surrounds the other hole.

[0026] In embodiment 17 of the retaining device according to the invention, the retaining device is designed according to any one of the foregoing embodiments 13 to 17, wherein the first type of retaining element and the other type of retaining element are designed and arranged such that the other end of each primary packaging container faces the container opening or the container base when the respective primary packaging container is preferably non-destructively and detachably held by one of the first type of retaining elements.

[0027] In embodiment 18 of the retaining device according to the invention, the retaining device is designed according to any of the preceding embodiments 12 to 17, wherein a first end of each primary packaging container includes a connecting element, wherein the connecting element includes threads for connecting an auxiliary component to the primary packaging container. The preferred auxiliary component is one selected from the group consisting of a needle, a nozzle, and a tube, or a combination of at least two of these. The preferred needle is a hypodermal injection needle.

[0028] In embodiment 19 of the retaining device according to the invention, the retaining device is designed according to any of the preceding embodiments 12 to 18, wherein a first end of each primary packaging container includes a protrusion of a tapered fitting. The preferred tapered fitting is a Luer connector. Typically, a Luer connector may or may not include threads.

[0029] In embodiment 20 of the retaining device according to the invention, the retaining device is designed according to embodiment 19, wherein the protrusion of the tapered fitting includes threads. Preferably, the threads are disposed in the sleeve.

[0030] In embodiment 21 of the retaining device according to the invention, the retaining device is designed according to any of the foregoing embodiments 12 to 22, wherein, for each primary packaging container, for the entire body portion, in each case, the thickness of the container wall is within a range of ±0.3 mm, preferably ±0.2 mm, more preferably ±0.15 mm, more preferably ±0.1 mm, and most preferably ±0.08 mm, based on the average value of the container wall thickness in the body portion of the corresponding primary packaging container.

[0031] In embodiment 22 of the retaining device according to the invention, the retaining device is designed according to any of the foregoing embodiments 12 to 23, wherein, for each primary packaging container, the thickness of the container wall for the entire body portion is 0.2 to 3 mm, preferably 0.3 to 2.5 mm, more preferably 0.4 to 2.2 mm. In a preferred embodiment, for each primary packaging container, the thickness of the container wall for the entire body portion is 1.0 to 1.1 mm. In another preferred embodiment, for each primary packaging container, the thickness of the container wall for the entire body portion is 1.4 to 1.8 mm. In yet another preferred embodiment, for each primary packaging container, the thickness of the container wall for the entire body portion is 0.6 to 2.0 mm.

[0032] In embodiment 23 of the holding device according to the invention, the holding device is designed according to any of the foregoing embodiments, wherein each primary packaging container has a container interior with a volume of 0.5 to 100 ml, preferably 1 to 100 ml, more preferably 1 to 50 ml, even more preferably 1 to 10 ml, and most preferably 2 to 10 ml.

[0033] In embodiment 24 of the holding device according to the invention, the holding device is designed according to any of the foregoing embodiments, wherein the primary packaging container is selected from the group consisting of vials, syringes, cartridges, and ampoules, or a combination of at least two of them. Preferably, the cartridge is designed as a reservoir in a medical component (preferably a portable medical component). A preferred portable medical component is an insulin pump.

[0034] In embodiment 25 of the holding device according to the invention, the holding device is designed according to any of the foregoing embodiments, wherein each primary packaging container includes a container wall that at least partially surrounds the interior of the container, wherein the container wall comprises glass, polymer or both, preferably composed of glass, polymer or both.

[0035] In embodiment 26 of the retaining device according to the invention, the retaining device is designed according to embodiment 25, wherein the polymer is a cyclic olefin copolymer (COC), or a cyclic olefin polymer, or a mixture of both.

[0036] In embodiment 27 of the holding device according to the invention, the holding device is designed according to embodiment 25 or 26, wherein the type of glass is selected from the group consisting of: borosilicate glass (preferably type I glass); aluminosilicate glass; and fused silica; or a combination of at least two of these.

[0037] In embodiment 28 of the holding device according to the invention, the holding device is designed according to any of the foregoing embodiments, wherein the plurality of primary packaging containers are composed of 4 to 500, preferably 9 to 400, more preferably 12 to 300, more preferably 16 to 200, more preferably 16 to 160, more preferably 16 to 100, more preferably 16 to 90, more preferably 16 to 80, more preferably 16 to 70, even more preferably 16 to 60, and most preferably 16 to 50 primary packaging containers.

[0038] In embodiment 29 of the holding device, the holding device includes the plurality of primary packaging containers.

[0039] A further contribution to solving at least one object of the present invention is made by an embodiment 1 of a component comprising the aforementioned holding device and a plurality of primary packaging containers; wherein each of the primary packaging containers is preferably nondestructively and detachably held by one of a first type of holding elements by contacting the primary packaging container at a first longitudinal position of the primary packaging container; wherein the movement of each primary packaging container along the lateral direction of the primary packaging container, preferably, along all lateral directions of the primary packaging container, is limited by one of a second type of holding elements at another longitudinal position of the primary packaging container; wherein the distance between the first longitudinal position of each primary packaging container and the other longitudinal position of the same primary packaging container is D; wherein the length of the primary packaging container having said distance D is L; wherein 0.5·L < D < L, wherein 0.6·L < D < 0.99·L is preferred, 0.7·L < D < 0.96·L is more preferred, even more preferred is 0.8·L < D < 0.93·L, and 0.85·L < D < 0.9·L is most preferred.

[0040] In embodiment 2 of the component according to the invention, the component is designed according to embodiment 1, wherein, in each case, the deflection of each primary packaging container from the equilibrium orientation is limited by one of the first type of retaining elements and one of the other type of retaining elements to not exceed 10°, preferably not more than 8°, more preferably not more than 6°, and most preferably not more than 2°.

[0041] In embodiment 3 of the component according to the invention, the component is designed according to embodiment 1 or 2, wherein each primary packaging container, at another longitudinal position, is at a distance of 0.01 to 1.00 mm, preferably 0.02 to 0.90 mm, more preferably 0.03 to 0.60 mm, even more preferably 0.04 to 0.40 mm, and most preferably 0.05 to 0.20 mm from its periphery to one of another type of retaining elements.

[0042] In embodiment 4 of the component according to the invention, the component is designed according to any of the preceding embodiments 1 to 3, wherein the secondary packaging container is closed by a cap joined to the secondary packaging container. Preferably, the cap is a multi-layer sheet. Additionally or alternatively, preferably, the cap is breathable. Preferably, the cap is joined to the secondary packaging container by gluing or sealing it. In the case of sealing, the joining is formed by a liquid and its curing. Hot melt adhesive can be used here. In the case of gluing, the chemical bonds that create the joining are formed between the interface or surfaces of the two objects to be joined.

[0043] In embodiment 5 of the component according to the invention, the component is designed according to any of the preceding embodiments 1 to 4, wherein the component further includes an outer packaging, preferably a closed outer packaging, wherein the secondary packaging container is disposed within the outer packaging. Additionally or alternatively, the primary packaging container has been purified, preferably sterilized. Preferably, the component has been purified, preferably sterilized. In the context of this application, purification is defined as a broad term encompassing the reduction of the number of microorganisms and biological agents, such as fungi, bacteria, viruses, spore forms, prions, single-celled eukaryotic organisms, etc. The specific terms disinfection and sterilization differ in the amount of these microorganisms and biological agents reduced. Disinfection can only reduce the number of said contaminants, but sterilization can effectively kill, inactivate, or eliminate all forms of life and other biological agents present, i.e., a reduction of 100%. Therefore, disinfection is less effective than sterilization.

[0044] The preferred outer packaging is a small bag, preferably made of plastic film. Additionally or alternatively, the outer packaging preferably provides a barrier against the permeation of inert gases. Additionally or alternatively, the outer packaging is hermetically sealed. Additionally or alternatively, the outer packaging is less permeable to inert gases than the cap. Particularly preferably, the outer packaging provides a barrier against the permeation of inert gases, while the cap is permeable to inert gases.

[0045] In embodiment 6 of the component according to the invention, the component is designed according to embodiment 5, wherein the outer packaging includes an atmosphere, and in each case, based on the volume of the atmosphere, the proportion of inert gas included in the atmosphere is at least 50% by volume, preferably at least 60% by volume, preferably at least 70% by volume, more preferably at least 80% by volume, even more preferably at least 90% by volume, and most preferably at least 95% by volume.

[0046] A further contribution to achieving at least one objective of the invention is made by embodiment 1 of the use of a component according to any component embodiment of the invention, said component being used for storing a primary packaging container, transporting a primary packaging container, or filling a primary packaging container with one or a combination of at least two of the group consisting of pharmaceutical compositions, medical compositions, and cosmetic compositions.

[0047] Features described as preferred in one category of the invention, such as those based on the characteristics of the holding device, are equally preferred in embodiments of other categories of the invention.

[0048] Primary packaging containers The primary packaging container for pharmaceutical, medical, or cosmetic compositions according to the present invention can have any size or shape that a person skilled in the art would consider suitable for the context of the invention. Hereinafter, a container is a primary packaging container if it is used to directly contain the packaged article. Specifically, the primary packaging container referred to herein is designed to contain the pharmaceutical, medical, or cosmetic composition in such a way that the inner side of the container wall, i.e., the side of the container wall facing the interior of the container, directly contacts the pharmaceutical, medical, or cosmetic composition. Preferably, a first end of the primary packaging container includes a drain hole for discharging the pharmaceutical, medical, or cosmetic composition from the interior of the primary packaging container. In that case, the container wall of the primary packaging container only partially surrounds the interior of the container. A preferred primary packaging container is a glass container whose glass wall (container wall) at least partially surrounds the interior of the container. Preferably, the glass wall is a one-piece design. The glass wall can preferably be made by blown glass melt; or by preparing a glass tube (preferably in the form of a hollow cylinder) from one end of the tube to form the bottom of the primary packaging container, thereby closing the tube at that end, and forming the top region of the primary packaging container from the opposite end of the tube. Preferably, the glass wall is transparent. Another preferred primary packaging container has its walls made of polymer. In that case, the container walls are also preferably transparent.

[0049] As used herein, the volume inside a container (also referred to as internal volume) means the total volume inside the container. This volume is determined by filling the container with water to the rim and measuring the volume of water that can be held to the rim. Therefore, the internal volume used herein is not the nominal volume commonly referred to in the pharmaceutical field. The nominal volume may, for example, be about 0.5 times smaller than the internal volume.

[0050] Besides vials, cartridges, and ampoules, a particularly preferred primary packaging container is a syringe. Preferably, all primary packaging containers in a plurality of containers are of the same type, preferably selected from the aforementioned types. The syringe is preferably made of glass or polymer. Additionally or alternatively, the length L of the preferred syringe is 20 to 200 mm, more preferably 25 to 190 mm, even more preferably 30 to 180 mm, and most preferably 40 to 170 mm. Additionally or alternatively, the internal volume of the preferred syringe is 0.5 to 100 ml, preferably 0.5 to 80 ml, and more preferably 0.5 to 60 ml. Additionally or alternatively, the preferred syringe includes a body portion, preferably cylindrical, also referred to as a barrel. The diameter of the syringe barrel is preferably 5 to 50 mm, more preferably 6 to 45 mm, even more preferably 8 to 40 mm, and most preferably 9 to 35 mm. Particularly preferably, the barrel is made of glass or polymer.

[0051] Glass The container wall of each of the plurality of primary packaging containers preferably comprises glass, more preferably substantially composed of such glass. This glass can be any type of glass and can have any composition that a person skilled in the art would consider suitable for the context of this invention. Preferably, the glass is suitable for pharmaceutical packaging. Particularly preferably, the glass belongs to Type I glass according to the definition of glass type in Section 3.2.1 of the 7th edition of the European Pharmacopoeia 2011. Additionally or alternatively, preferably, the glass is selected from the group consisting of borosilicate glass, aluminosilicate glass, and fused silica; or a combination of at least two thereof, with aluminosilicate glass being particularly preferred. In each case, based on the total weight of the glass, the Al₂O₃ content in the aluminosilicate glass, as used herein, is greater than 8% by weight, preferably greater than 9% by weight, and particularly preferably 9 to 20% by weight. In each case, based on the total weight of the glass, the preferred aluminosilicate glass has a B₂O₃ content of less than 8% by weight, preferably less than 7% by weight, and particularly preferably 0 to 7% by weight. In each case, based on the total weight of the glass, the B2O3 content of the borosilicate glass used herein is at least 1 wt%, preferably at least 2 wt%, more preferably at least 3 wt%, more preferably at least 4 wt%, even more preferably at least 5 wt%, and particularly preferably 5 to 15 wt%. In each case, based on the total weight of the glass, the preferred borosilicate glass has an Al2O3 content of less than 7.5 wt%, preferably less than 6.5 wt%, and particularly preferably 0 to 5.5 wt%. On the other hand, in each case, based on the total weight of the glass, the Al2O3 content of the borosilicate glass is 3 to 7.5 wt%, preferably 4 to 6 wt%.

[0052] A further preferred embodiment of the invention is that the glass is substantially free of boron (B). Here, "substantially free of B" means that the glass does not contain B that has been intentionally added to the glass composition. This means that B may still be present as an impurity, but preferably in each case at a proportion not exceeding 0.1% by weight, more preferably not exceeding 0.05% by weight based on the weight of the glass.

[0053] Holding device The retaining device according to the invention can generally be any device that a person skilled in the art would consider to retain multiple primary packaging containers by means of a plurality of first-class and second-class retaining elements. Preferably, it has been prepared by deep drawing or molding, more preferably by injection molding, of one or a combination of at least two of the group consisting of secondary packaging containers, first plate-like elements, and another plate-like element. Additionally or alternatively preferably, one or a combination of at least two of the group consisting of secondary packaging containers, first plate-like elements, and another plate-like element is made of one or more plastics.

[0054] First and another plate-shaped element The first and other plate-like elements of the retaining device can be any plate-like shape or material that a person skilled in the art would deem suitable for the context of this invention. In any case, the first and other plate-like elements have a plate-like shape, meaning that the length and width of the respective elements are both at least 3 times, preferably 5 times, more preferably 10 times, and most preferably 20 times, greater than the thickness of the plate-like element. Additionally, the two opposing faces of the plate-like elements with the largest areas are preferably substantially parallel to each other. Preferably, the first plate-like element or the other plate-like element, or each of the two, is made of one or more plastics. Additionally or alternatively preferably, the first plate-like element or the other plate-like element, or each of the two, has a Shore A hardness of at least 80, more preferably at least 90. The first plate-like element is not integral with the other plate-like element. Neither the first plate-like element nor the other plate-like element is integral with the container base, preferably not with the secondary packaging container. Preferably, the secondary packaging container, more preferably the secondary packaging container wall, is designed and arranged to support the first plate-like element or the other plate-like element, or both.

[0055] Type I and Type II retaining elements The first and second types of retaining elements can generally be any design considered by a technician for holding multiple primary packaging containers in a retaining device. The first type of retaining element is neither identical to nor integral with the second type of retaining element. A preferred first type of retaining element is integrally manufactured with a first plate-like element or with a secondary packaging container, preferably with the container base of the secondary packaging container. A preferred second type of retaining element is integrally manufactured with another plate-like element or with a secondary packaging container, preferably with the container base of the secondary packaging container. Additionally or alternatively, it is preferred that the first type of retaining element or the second type of retaining element, or both, are designed and arranged to hold multiple primary packaging containers by form-fitting or friction-fitting or by both, with form-fitting being particularly preferred. Preferably, if the retaining device is vertically positioned, the form-fitting overcomes gravity to hold the primary packaging containers. In a preferred embodiment, establishing the form-fitting involves elastically deforming the corresponding first or second type of retaining element. Here, the corresponding retaining element can be a clip.

[0056] Each of the plurality of first-type retaining elements preferably includes a first-type receiving portion. Preferred first-type receiving portions are through holes, recesses, or cup-shaped receiving portions. Each of the plurality of other-type retaining elements preferably includes another type of receiving portion. Preferred other-type receiving portions are through holes, recesses, or cup-shaped receiving portions. Preferred through holes have a circular cross-section. Particularly preferred through holes are cylindrical. This means that the side surfaces of the through holes are cylindrical shell surfaces. The retaining device preferably includes 4 to 500, preferably 9 to 400, more preferably 12 to 300, more preferably 16 to 200, more preferably 16 to 160, more preferably 16 to 100, more preferably 16 to 90, more preferably 16 to 80, more preferably 16 to 70, even more preferably 16 to 60, and most preferably 16 to 50 first-type retaining elements. Additionally or alternatively, the retaining device preferably comprises 4 to 500, preferably 9 to 400, more preferably 12 to 300, more preferably 16 to 200, more preferably 16 to 160, more preferably 16 to 100, more preferably 16 to 90, more preferably 16 to 80, more preferably 16 to 70, even more preferably 16 to 60, and most preferably 16 to 50 of another type of retaining element. Preferred retaining devices comprise the same number of both the first and second type of retaining elements. Additionally or alternatively, the holding device of the present invention is preferably configured to hold 4 to 500, preferably 9 to 400, more preferably 12 to 300, more preferably 16 to 200, more preferably 16 to 160, more preferably 16 to 100, more preferably 16 to 90, more preferably 16 to 80, more preferably 16 to 70, even more preferably 16 to 60, and most preferably 16 to 50 primary packaging containers.

[0057] Secondary packaging containers As a secondary packaging container, any container that a person skilled in the art considers suitable for the context of this invention is taken into account. The secondary packaging container includes, preferably, a secondary packaging container wall that at least partially surrounds the interior of the secondary packaging container; wherein first and second types of retaining elements are disposed within the interior of the secondary packaging container. If the primary packaging container is held by the first type of retaining element, the primary packaging container is also disposed within the interior of the secondary packaging container. This is particularly applicable to components according to the invention. The secondary packaging container wall preferably comprises, more preferably, a secondary packaging container polymer. The secondary packaging container polymer is preferably selected from free condensation polymers, preferably polyethylene terephthalate; polyacrylates, preferably polymethyl methacrylate; and polyolefins, preferably one of the group consisting of polypropylene or polyethylene, or a combination of at least two of these. A particularly preferred secondary packaging container is basin-shaped. Additionally or alternatively, the secondary packaging container is preferably obtained by deep drawing.

[0058] Pharmaceutical and cosmetic compositions In the context of this invention, every pharmaceutical composition and every cosmetic composition that a person skilled in the art considers suitable is taken into account. A pharmaceutical composition is a composition comprising at least one pharmaceutical active ingredient. A preferred pharmaceutical active ingredient is a vaccine. A cosmetic composition is a composition comprising at least one cosmetic active ingredient. A preferred cosmetic active ingredient is hyaluronic acid or botulinum toxin. Pharmaceutical or cosmetic compositions can be fluid or solid or both, with fluid compositions being particularly preferred herein. Preferred solid compositions are granular, such as powders, bulk tablets, or bulk capsules. Further preferred pharmaceutical or cosmetic compositions are parenteral medications, i.e., compositions intended for administration via a parenteral route, which can be any non-enteric route. Parenteral administration can be performed by injection, for example using a needle (typically a hypodermic needle) and a syringe, or by inserting an indwelling catheter.

[0059] Test methods The following test methods will be used in the context of this invention. Unless otherwise stated, measurements must be performed at an ambient temperature of 23°C, an ambient pressure of 100 kPa (0.986 atmospheres), and a relative humidity of 50%.

[0060] Wall thickness and wall thickness tolerance The wall thickness and its deviation from the average wall thickness (tolerance) are determined according to the following standards for the corresponding type of container: For vials, DIN ISO 8362-1, Regarding ampoules, DIN ISO 9187-1, DIN ISO 110 4 0- 4, for syringes DIN ISO 13926-1 for cylindrical cartridge cases, and DIN ISO 11040-1 for dental medicine cartridges.

[0061] Transportation Simulation The transportation simulation was conducted according to ASTM D4169–16. Specifically, the transportation simulation consisted of two sequences, performed sequentially using the same sample. The laboratory environmental conditions were: - Temperature: 15 to 35℃ - Relative humidity: < 85% - Atmospheric pressure: 860 to 1060 hPa sample The sample is a pallet unit, consisting of a wooden pallet on which boxes made of corrugated cardboard are stacked, resulting in the following overall dimensions: - Length: 1200 mm - Width: 800 mm - Height: 940 mm.

[0062] These boxes are held together by stretch plastic foil. Each box contains a component of the same type as the component being tested. These boxes do not contain any additional filler material. Therefore, each component consists of a holding device filled with the same empty container.

[0063] first sequence The first sequence was performed according to Schedule A – Mechanical Handling – Group Loading as described in Section 10.3.2 of ASTM D4169–16. A rotating flat drop test was performed according to Method C of ASTM D6179. The drop height was selected from the table in Section 10.3.2.3 of ASTM D4169–16 based on Assurance Level II. The test consisted of one drop from each of the opposite bottom edges of the specimen. One edge of the specimen was supported by the floor. The other side was raised to the drop height and then released to land flat on the impact surface (bottom of the wooden pallet). This process was performed for each opposite bottom edge, for a total of four drops. The following test procedures were performed: 1. Support edge 3-6, raised edge 3-5; drop to surface 3 2. Support edge 3-5, raised edge 3-6, drop to surface 3 3. Support edge 2-3, raise edge 3-2; drop onto surface 3 4. Support edge 3-4, raised edge 3-4; drop onto surface 3 If any sample box has moved on the tray during any of steps 1 through 3, it should be pushed back into place before proceeding to the next step. At the end of step 4, all boxes should be pushed back to their original positions on the tray.

[0064] second sequence The second sequence was performed according to the schedule D-stack-vibration described in Section 12.2 of ASTM D4169–16. Random vibration testing was conducted according to ASTM D4728. During the test, the samples were in normal shipping orientation, i.e., the wooden pallet was at the bottom. The samples were loaded according to Section 11.4 of ASTM D4169–16. The maximum load TL was calculated according to Formula (3) given in Section 11.4 of ASTM D4169–16. Where H = 2.7 m and F = 1. Other parameters for the second sequence are: Transportation loop curve: - 0.40 G rms 40 min - 0.54 G rms 15 min - 0.70 G rms 5 min - Number of loops: 1 - Total duration: 1 hour on surface 3.

[0065] Air curve: - AL II / G rms 1.05 - Test duration: 2 hours on surface 3.

[0066] Particle load after transport simulation Following the transport simulation described above, the particle load on the outer surface of the container of the component under study is then determined within a specific size range (particle category) of particles per square centimeter of the total outer surface area. Between the transport simulation and particle load determination, any further processing of the sample that might lead to the formation of more particles should be avoided.

[0067] Liquid Particle Counting System The particle load in the containers of the component under study was determined using a liquid particle counting system comprising a Pacific Scientific Hiac Royco particle counter, model 9703 (F4-088), and a desktop computer running PharmSpec 3.4.0 software with the particle counter. Typically, the particle counter draws the test liquid through a riser tube and guides it through a diffuse light sensor. The signal from the diffuse light sensor is read out and processed by the software. In this test method, only particle-free water prepared using the H2O-EDI-2-T arium® Advance EDI (10 l / h) desktop system from Sartorius AG, Göttingen, Germany, was used for cleaning, rinsing, and washing as a zero sample for any filter exchange and for preparing the test liquid. This system is designed for preparing Type II pure water. The system has a flow rate of 10 liters per hour.

[0068] Preparation of Particle Counter Fill the container with the necessary flushing medium (particle-free water) and the test medium (test solution) at least 1 hour before testing. Run the particle counter under laminar flow conditions. Before starting the test, clean the entire laminar flow workstation running the workflow with a damp, particle-free cloth. The lifting arm connected to the pipette can be controlled via the control panel. Before the first measurement, the sampler must be cleaned and adjusted so that the pipette is immersed as deeply as possible in the test liquid without touching the bottom of the container. Adjust the container; subsequent measurements will also be performed using this container. Hold the lifting arm in its lowest position, then move it back to the starting position. To clean the sampler, fill the container, which has been flushed 3 times with particle-free water, with at least 35 ml of particle-free water and place it under the lifting arm. Move the lifting arm to the previously held lower position. Again, the lifting arm must not touch the bottom of the container. Start the automatic flushing program. Each cleaning run consumes 10 ml of liquid. Perform 4 cleaning runs. Under no circumstances should air be drawn in. Therefore, the container must contain at least 35 ml of particle-free water. After cleaning, move the lifting arm to the upper position.

[0069] Zero samples Before starting the test, the particle content of the particle-free water used to prepare the test solution must be checked. To do this, the container used for measurement should be rinsed three times with particle-free water. Then, fill the container with 40 ml of particle-free water as a zero sample. After allowing the zero sample to stand for at least 2 minutes to degas, the test can begin. A particle counter measures the number of particles in a given volume of particle-free water. All possible particle sizes must be recorded. To do this, the machine aspirates and tests 5 ml of liquid six times. The first measurement is invalid. The acceptance criterion is set at a maximum of 25 particles with a diameter of at least 10 µm per 25 ml of particle-free water. If this value is not met, the preparation of the particle-free water must be adjusted, and the zero sample measurement must be repeated until the acceptance criterion is met.

[0070] Test liquid Remove the stretch foil from the cardboard box. Remove the box containing the component to be studied from the tray and open it under laminar flow. All further steps are performed under laminar flow. Remove the component to be studied from the box. Prepare a glass beaker containing sufficient particle-free water to immerse a primary packaging container, placed vertically, to half its length. In any case, use at least 40 ml of particle-free water, hereinafter referred to as pool water. Rinse the glass beaker with particle-free water at least 3 times beforehand. Seal all openings of the primary packaging container of the component to be studied with a stopper, which has been rinsed with particle-free water at least 3 times beforehand. Place each primary packaging container vertically, immersing half its length in the pool water (the aforementioned particle-free water), and manually stir to create a stirring motion while maintaining the vertical orientation for 5 seconds. In the case of syringes, vertical orientation means the syringe tip is facing upwards. The test liquid is the pool water in which all primary packaging containers of the component have been rinsed as described above.

[0071] Measurement The test liquid is filled into the container at least one hour before testing. A particle counter measures the number of particles larger than 2 μm, 5 μm, 10 μm, 15 μm, 25 μm, 50 μm, 75 μm, and 100 μm. For this purpose, the machine performs six tests on 5 ml of test liquid, with the first measurement being discarded. Therefore, the minimum volume of test liquid is 35 ml. For each of the above particle size grades, the number of particles per square centimeter is determined by dividing the number of particles in the test liquid as determined by the particle counter by the sum of the outer surface areas of the primary packaging containers in that component.

[0072] The invention is described in more detail below with reference to embodiments and accompanying drawings, wherein the embodiments and drawings are not intended to limit the invention in any way. Furthermore, unless otherwise stated, the drawings are not drawn to scale.

[0073] For each embodiment and comparative example, a syringe of the type specified below was used, in each case fitted with a tip cap and packaged in a nest within a basin-shaped component. The basin-shaped component was covered by a Tyvek® insert placed within the basin-shaped component and sealed with a Tyvek® seal. Each basin-shaped component was packaged in a double-layered polyethylene bag. Figure 1 A schematic diagram illustrating the general principles of the basin-shaped component and the nested component (bag not shown) is provided. These general principles apply to all embodiments and comparative examples.

[0074] In Examples 1 to 3 and Comparative Examples 1 and 2, TopPac, in 50.0 ml sizes, from Schott AG was used. ®These are type-3 syringes. The syringe barrels are made of COC. The discharge port of each syringe is closed by a rigid polymer cap with a TopPac® Rigid Cap type threaded tip and a Dätwyler FM 257 type rubber tip cap. Each nest contains 20 syringes.

[0075] In Examples 4 to 6 and Comparative Examples 3 and 4, syriQ, a 3.0 ml Luer Cone-equipped product from Schott AG, was used. ® Type of syringe. The syringe barrel is made of FIOLAX. ® Made of glass. The discharge port of each syringe is made with syriQ... ® Rigid Cap type threaded tip and Dätwyler FM 27 type rubber tip cap are closed with rigid polypropylene caps. Here, each nested piece contains 100 syringes.

[0076] Different methods of holding the syringe within the nest were investigated in the embodiments and comparative examples. See below for reference. Figures 2 to 6 These methods are described in detail. As shown in the figure, with Figure 2 and Figure 3 Compared to the holding device, Figures 4 to 6 The retaining device allows for a greater number of syringes to be loaded into each nested piece of constant size. This is because, Figures 4 to 6 The device allows for more than Figure 3 The device arranges the syringes in a more space-saving manner. Furthermore, Figures 4 to 6 The device demonstrates reduced plastic warpage of the plate-like carrier element when fitted with a syringe. However, for comparative purposes, the same number of syringes were used in each nesting element in all embodiments and comparative examples using the same type of syringe.

[0077] Table 1 below provides an overview of the types of syringes and holding devices used in the embodiments and comparative examples.

[0078] Table 1 Ten enclosed basin-shaped pieces in the foil bags described above in each embodiment and comparative example were subjected to transport simulations as described in the Test Methods section. Subsequently, syringes were carefully removed one by one from the basin-shaped pieces, and the rigid caps (TopPac) were visually inspected. ® Rigid Cap or syriQ ® Is there a gap between the Rigid Cap and the Luer connector of the discharge port? If any such gap exists, it can be assumed that the CCI has been compromised in the transport simulation.

[0079] After performing transport simulations on the other 10 enclosed basin-shaped components in the foil bag as described in the Test Methods section, the particle load on the outer surface of the syringes was determined according to the description in the Test Methods section. Here, the test liquid was prepared by cleaning all syringes of the 10 nested components of the same embodiment or comparative example in the same pool.

[0080] Then open the additional 10 sealed basin-shaped pieces in the foil bags of each embodiment and comparative example. A laser rangefinder is then used to precisely detect any downward bending of the plate-like carrier due to the weight of the containers.

[0081] The results of the above study are summarized in Table 2 below. "++" indicates a more favorable result than "+", "+" indicates a more favorable result than "0", "0" indicates a more favorable result than "-", and "-" indicates a more favorable result than "--".

[0082] Table 2 In the comparative example, due to the simulated transport, the syringe tip cap is prone to loosening. Therefore, the microbial barrier of the container seal (container seal integrity, CCI) may be breached. This could represent a safety concern for patients receiving treatment with the syringe. In the embodiment, this issue is not present.

[0083] Furthermore, Table 2 shows that polymer syringes generally tend to generate more particles due to wear and tear during transport simulations. However, for both glass and polymer syringes, the number of particles in the examples was significantly reduced compared to the comparative examples. This is particularly important because particles can potentially enter the syringe. Particles in the filled syringe pose a serious safety concern for patients receiving syringe therapy.

[0084] Because the glass syringe is heavier than the polymer syringe, the carrier plate with the glass syringe-embedded insert exhibits greater downward bending than the carrier plate with the polymer syringe-embedded insert. In any case, this degree of bending in the nested inserts of the embodiments is less than that in the comparative examples. The nested inserts of Examples 3 and 6 do indeed exhibit less plastic bending. Problems may arise when processing nested inserts with curvature using an automated filling machine. In particular, it may lead to processing failures. If the downward curvature is too large, the nested insert may even be unable to be processed automatically. Therefore, the nested inserts in the embodiments, especially those in Examples 3 and 6, are well-suited for processing with automated filling machines. Attached Figure Description

[0085] Unless otherwise stated in the instruction manual or specific drawings: Figure 1 A scheme for a common basin-shaped piece with nesting elements for a primary packaging container is shown; Figure 2 An alternative component not provided in this invention is shown; Figure 3 Another component not provided in this invention is shown; Figure 4 This invention illustrates a component provided by the present invention; Figure 5 Another component provided by the present invention is shown; Figure 6 Another component provided by the present invention is shown; and Figure 7 The TopPac® syringe from Schott AG is shown, with a capacity of 1.0 ml. Detailed Implementation

[0086] Figure 1 A scheme for a common basin-shaped component with a nesting element for a primary packaging container 101 is shown. This basin-shaped component is, as referred to herein, a secondary packaging container 102. The secondary packaging container 102 includes a container opening 103 and a container base 104 opposite to the container opening 103. A first plate-shaped element 105 forms the nesting element arranged within the basin-shaped component. The first plate-shaped element 105 holds a plurality of primary packaging containers 101, such as syringes. A cap 106 for closing the container opening 103 has been partially detached from the secondary packaging container 102 to expose the nesting element. The component 400 according to the invention can have, as... Figure 1 All features of the basin-shaped piece shown, including the nesting piece and the primary packaging container 101.

[0087] Figure 2 A cross-sectional view of a component 200 not provided in this invention is shown. Here, a basin-shaped secondary packaging container 102 houses a first plate-shaped element 105 comprising through-holes with a regular pattern. These through-holes are arranged in rows and columns to form an array. Each of these through-holes is shaped to hold the primary packaging container 101 (i.e., the syringe). Figure 2 Six syringes in a vertically balanced orientation are shown. Each syringe, held in a through-hole, can deflect from its balanced orientation by a maximum deflection angle of 30°, 201°.

[0088] Figure 3 A cross-sectional view of another component 200 not provided in this invention is shown. This component 200 is similar to... Figure 2 The components differ in that they have an improved first plate element 105, which prevents the primary packaging container 101 (i.e., the syringe) held by the improved first plate element 105 from deflecting more than 20° from their balanced orientation.

[0089] Figure 4A cross-sectional view of a component 400 provided by the present invention is shown. Component 400 includes a secondary packaging container 102 that accommodates a plurality of primary packaging containers 101, the primary packaging containers 101 being part of component 400. Here, the primary packaging containers 101 are... Figure 7 A syringe of the type shown. A plurality of first-type retaining elements 401 are disposed at a first plate-shaped element 105. A plurality of other-type retaining elements 402 are disposed at another plate-shaped element 407. A secondary packaging container 102, the first plate-shaped element 105, and the other plate-shaped element 407 together form a retaining device according to the invention. The first-type retaining elements 401 are through holes in the first plate-shaped element 105, while the other-type retaining elements 402 are through holes in the other plate-shaped element 407. A first regular pattern formed by the first-type retaining elements 401 in the maximum extension plane of the first plate-shaped element 105 corresponds to another regular pattern formed by the other-type retaining elements 402 in the maximum extension plane of the other plate-shaped element 407. The first plate-shaped element 105 and the other plate-shaped element 407, having the first-type retaining elements 401 and the other-type retaining elements 402, are disposed in the secondary packaging container 102, which is... Figure 1The secondary packaging container 102 is a basin-shaped component of the type shown. Therefore, the secondary packaging container 102 includes a container opening 103 and a container base 104 opposite to the container opening 103. A first plate-shaped element 105 and another plate-shaped element 407 are supported by the wall of the secondary packaging container 102. Here, the other plate-shaped element 407 is disposed on the side of the first plate-shaped element 105 opposite to the container opening 103. Therefore, the plurality of other type of retaining elements 402 are disposed on the side of the plurality of first type of retaining elements 401 opposite to the container opening 103. Each syringe is non-destructively and removably retained by one of the first type of retaining elements 401 by contacting the corresponding syringe at a first longitudinal position 403; movement of each syringe in any of its lateral directions 409 is limited by one of the other type of retaining elements 402 at another longitudinal position 404 of the syringe. Here, the first longitudinal position 403 and the other longitudinal position 404 are different positions along the length L 406 of the corresponding syringe, which determines the longitudinal direction 408 of the syringe. If the distance 405 between the first longitudinal position 403 and the other longitudinal position 404 of each syringe is D, then D is 0.9 L. The first type of retaining element 401 and the other type of retaining element 402 are designed and arranged such that for each first type of retaining element 401, the other type of retaining element 402 is designed and arranged to prevent the syringe held by the first type of retaining element 401 from deflecting more than 6° from its vertical equilibrium orientation. Here, D only decreases due to the weight of the syringe when the first plate-shaped element 105 bends downward. This is because each first type of retaining element 401 forms a first shape fit with the syringe held by the corresponding first type of retaining element 401, preventing the syringe from moving toward the container base 104 in the longitudinal direction 408. After the first plate-shaped element 105 bends to a certain extent, the other type of retaining element 402 forms another shape fit with the syringe held by the corresponding first type of retaining element 401, preventing any further movement of the syringe toward the container base 104 in the longitudinal direction 408. Even if the syringe is moved further toward the container base 104 by simultaneously bending the first plate element 105 and the other plate element 407, D will not decrease further. Therefore, the first and other shape fits together prevent D from decreasing by more than 20% due to the movement of the corresponding syringe toward the container base in the longitudinal direction 408.

[0090] Figure 5 A cross-sectional view of another component 400 provided by the present invention is shown. Figure 5 Component 400 and Figure 4The components 400 are the same, except that another plate-shaped element 407 is disposed on the side of the first plate-shaped element 105 opposite to the container base 104. Therefore, the plurality of other type of retaining elements 402 are disposed on the side of the plurality of first type retaining elements 401 opposite to the container base 104. Furthermore, in Figure 5 In this context, D is 0.7 L. Similarly, the secondary packaging container 102, the first plate element 105, and the other plate element 407 together form the holding device according to the invention. The first type of holding element 401 and the other type of holding element 402 are designed and arranged such that for each first type of holding element 401, the other type of holding element 402 is designed and arranged to prevent the syringe held by the first type of holding element 401 from deflecting more than 10° from its vertical equilibrium orientation. Here, if the weight of the syringe causes the lower of the plate elements 105 and 407 to bend downwards, D will even increase rather than decrease. Each first type of holding element 401 forms a first shape fit with the syringe held by the corresponding first type of holding element 401, preventing the syringe from moving toward the container base 104 in the longitudinal direction 408. After the first plate-shaped element 105 is bent to a certain extent, another type of retaining element 402 forms another shape fit with the syringe held by the corresponding first type of retaining element 401, preventing the syringe from moving further toward the container base 104 in the longitudinal direction 408. Even if the syringe is moved further toward the container base 104 by simultaneously bending the first plate-shaped element 105 and the other plate-shaped element 407, D will not change further, and in particular, will not decrease. Thus, the first shape fit and the other shape fit together completely prevent D from decreasing due to the movement of the corresponding syringe toward the container base in the longitudinal direction 408.

[0091] Figure 6 A cross-sectional view of another component 400 provided by the present invention is shown. In addition to the following, Figure 6 Component 400 and Figure 4 The components 400 are the same. Here, the secondary packaging container 102 and the first plate-shaped element 105 together form the holding device according to the invention. Figure 6The component 400 lacks another plate-shaped element 407. Instead, another type of retaining element 402 is integrally formed with the container base 104 of the secondary packaging container 102. More specifically, the other type of retaining element 402 is a cup-shaped receiving portion formed by the container base 104. Therefore, D is 0.8 L. The first type of retaining element 401 and the other type of retaining element 402 are designed and arranged such that for each first type of retaining element 401, the other type of retaining element 402 is designed and arranged to prevent the syringe held by the first type of retaining element 401 from deflecting more than 8° from the vertical balance orientation. Here, D only decreases due to the weight of the syringe when the first plate-shaped element 105 bends downward. This is because each first type of retaining element 401 forms a first shape fit with the syringe held by the corresponding first type of retaining element 401, preventing the syringe from moving toward the container base 104 in the longitudinal direction 408. After the first plate-shaped element 105 bends to a certain extent, another type of retaining element 402 forms another shape fit with the syringe held by the corresponding first type of retaining element 401, preventing any further movement of the syringe toward the container base 104 in the longitudinal direction 408. If the container base 104 bends downward, the syringe can only move further in the same direction. Even if the first plate-shaped element 105 and the container base 104 bend, D will not decrease further. Thus, the first shape fit and the other shape fit together prevent D from decreasing by more than 3% due to the movement of the corresponding syringe toward the container base in the longitudinal direction 408.

[0092] Figure 7 A TopPac® syringe from Schott AG, with a capacity of 1.0 ml, is shown. This syringe is the primary packaging container 101 as referred to in the context of this invention. The syringe includes a container wall 707 partially surrounding the container interior 708. The container wall 707 is formed from top to bottom in the following order: a first end 701, which includes an outlet orifice 704; a body portion 702; and another end 703. The body portion 702, also referred to in the art as a barrel, is a hollow cylinder. The other end 703 includes another orifice 710. The orifice area of ​​the outlet orifice 704 is smaller than the orifice area of ​​the other orifice 710. The other orifice 710 receives a plunger 711. The other end 703 also includes an edge, also referred to in the art as a flange, which laterally projects beyond the body portion 702 and surrounds the other orifice 710. The container wall 707 is made of a cyclic olefin copolymer. The first end 701 includes a connecting element, which is a protrusion 705 of a Luer connector. The connecting element includes threads for connecting a hypodermic needle to the syringe. The thread is provided in the sleeve. Figures 2 to 6 The 400 syringe is Figure 7 A syringe of the type shown, but without the plunger 711.

[0093] Explanation of reference numerals in the attached figures:

Claims

1. A holding device for holding a plurality of primary packaging containers (101) of a pharmaceutical, medical, or cosmetic composition, said holding device comprising: Secondary packaging container (102), which is designed and arranged to accommodate the plurality of primary packaging containers (101). in, a. Multiple Class I holding elements (401), and b. Multiple holding elements of another type (402) It is disposed in the secondary packaging container (102); Each of the first type of retaining elements (401) is designed and arranged to removably retain the primary packaging container (101) by contacting the primary packaging container (101) at a first longitudinal position (403) of one of the primary packaging containers (101). For each of the first type of retaining elements (401), the other type of retaining element (402) is designed and arranged to restrict the movement of the primary packaging container (101) held by the first type of retaining element (401) in the lateral direction (409) of the primary packaging container (101) at another longitudinal position (404) of the primary packaging container (101); Wherein, the distance (405) between the first longitudinal position (403) and the other longitudinal position (404) of the primary packaging container is D; Wherein, the length (406) of the primary packaging container (101) having the distance (405)D is L; Where, 0.5·L < D < L, Each primary packaging container (101) comprises, along its length, the following order: a. The first end portion (701) includes a discharge port (704). b. Main body (702), and c. The other end (703); The main body (702) is cylindrical; Each of the first type of retaining elements (401) is designed and arranged to form a first shape fit with the primary packaging container (101) held by the corresponding first type of retaining element (401) in the plurality of primary packaging containers, to prevent the primary packaging container (101) from moving in the longitudinal direction (408). For each of the first type of retaining elements (401), the other type of retaining element (402) is designed and arranged to form another shape fit with the primary packaging container (101) held by the corresponding first type of retaining element (401) among the plurality of primary packaging containers, to prevent the primary packaging container (101) from moving in the longitudinal direction (408). The first shape fit and the other shape fit together prevent D from decreasing by more than 3%.

2. The holding device according to claim 1, wherein, The secondary packaging container (102) includes A. Container opening (103), and B. Container base (104), which is opposite to the container opening (103).

3. The holding device according to claim 1, wherein, For each of the first type of retaining elements (401), the other type of retaining element (402) is designed and arranged to restrict the movement of the primary packaging container (101) held by the first type of retaining element (401) in all lateral directions (409) of the primary packaging container (101) at another longitudinal position (404) of the primary packaging container (101).

4. The holding device according to claim 1, wherein, The first type of retaining element (401) and the other type of retaining element (402) are designed and arranged such that for each of the first type of retaining element (401), the other type of retaining element (402) is designed and arranged to prevent the primary packaging container (101) held by the first type of retaining element (401) from deflecting more than 10° from the balance orientation.

5. The retaining device according to any one of claims 1 to 4, wherein, The first type of retaining element (401) and the other type of retaining element (402) are designed and arranged such that for each primary packaging container (101) which is detachably held by one of the first type of retaining elements (401), there is another type of retaining element (402) surrounding the periphery of the primary packaging container at another longitudinal position of the primary packaging container, the other type of retaining element being 0.01 to 1.00 mm away from the primary packaging container.

6. The retaining device according to any one of claims 1 to 4, wherein, The plurality of first-type retaining elements (401) are disposed at or on the first plate-shaped element (105).

7. The holding device according to claim 6, wherein, The first type of retaining element (401) forms a first regular pattern in the maximum extension plane of the first plate-shaped element, and wherein the other type of retaining element forms another regular pattern in another plane.

8. The holding device according to claim 7, wherein, The first regular pattern is consistent with the other regular pattern.

9. The retaining device according to any one of claims 1 to 4, wherein, The plurality of other type of retaining elements (402) are disposed on the side of the plurality of first type of retaining elements (401) opposite to the container opening (103) of the secondary packaging container (102).

10. The retaining device according to any one of claims 1 to 4, wherein, The plurality of other type of retaining elements (401) are disposed at or on another plate-shaped element (407).

11. The retaining device according to any one of claims 1 to 4, wherein, The plurality of other type of retaining elements (402) are integral with the container base (104) of the secondary packaging container (102).

12. The retaining device according to any one of claims 1 to 4, wherein, The first type of retaining element (401) and the other type of retaining element (402) are designed and arranged such that the other end (703) of each primary packaging container (101) faces the container opening (103) or container base (104) of the secondary packaging container (102) when the respective primary packaging container (101) is detachably held by one of the first type of retaining elements (401).

13. The retaining device according to any one of claims 1 to 4, wherein, The plurality of primary packaging containers (101) consists of 4 to 500 primary packaging containers (101).

14. An assembly (400) comprising a holding device according to any one of the preceding claims and a plurality of primary packaging containers (101). in, Each primary packaging container (101) is removably held by one of the first type of holding elements (401) by contacting the primary packaging container (101) at a first longitudinal position (403); The movement of each primary packaging container (101) along the lateral direction (409) of the primary packaging container (101) is restricted by one of the other type of retaining elements (402) at another longitudinal position (404) of the primary packaging container (101).

15. The component (400) according to claim 14, wherein, The movement of each primary packaging container (101) in all lateral directions (409) of the primary packaging container (101) is restricted by one of the other type of retaining elements (402) at another longitudinal position (404) of the primary packaging container (101).

16. The component (400) according to claim 14 or 15, wherein, The secondary packaging container (102) is closed by a lid (106) attached to the secondary packaging container (102). and / or The component (400) also includes outer packaging. The secondary packaging container (102) is disposed inside the outer packaging. and / or The primary packaging container (101) has been purified.

17. The component (400) according to claim 16, wherein, The outer packaging is sealed.

18. The component (400) according to claim 16, wherein, The primary packaging container (101) has been sterilized.

19. The use of the component (400) according to any one of claims 14 to 18 for storing the primary packaging container (101), transporting the primary packaging container (101), or filling the primary packaging container (101) with one or a combination of at least two of the group consisting of pharmaceutical compositions, medical compositions, and cosmetic compositions.

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