retention device for the total height of the roughness profile Rt

Abstract

The invention relates to a holding device (100) for holding a plurality of primary packaging containers (304), comprising a plurality of receptacles (103), each receptacle forming a wall having a first opening (107) and a further opening (201), the first and further openings being directly laterally surrounded by at least one first side (109) and at least one further side (203), respectively; wherein the total height Rz of the roughness profile of at least one first side (109) and / or at least one further side (203) of at least 50% of the receptacles (103) is not more than 0.50 millimeter. t 0.50 millimeter. The invention further relates to a further holding device (100), a method (700) for producing one of the aforementioned holding devices (100), an assembly (301) and a transport unit (300) each comprising one of the aforementioned holding devices (100), and a use of one of the aforementioned holding devices (100).

Description

Technical Field

[0001] This invention relates to a holding device for holding multiple primary packaging containers for pharmaceutical, medical, or cosmetic compositions. The holding device includes: -A plate-shaped carrier element including multiple through holes, and - Multiple receiving sections, each designed and configured to accommodate one of the primary packaging containers. Each receiving portion includes a receiving portion wall that partially surrounds the interior of the receiving portion; each receiving portion wall forms a wall body; wherein each wall body - Each wall extends longitudinally along one of the through holes of the plurality of through holes, and -Having a first opening at a first end and another opening at the other end, wherein the other end is opposite to the first end in the longitudinal direction; The first opening of each wall is directly surrounded laterally by at least one first side of the corresponding wall; the other opening of each wall is directly surrounded laterally by at least one other side of the corresponding wall; characterized in that the total height R of the roughness profile of at least 50% of the accommodating portions of at least 50% of the accommodating portions of at least one first side and / or at least one other side is... t Not exceeding 0.50 mm. The present invention also relates to another holding device, a method for producing one of the above-mentioned holding devices, components and a transport unit respectively including one of the above-mentioned holding devices, and the use of one of the above-mentioned holding devices. Background Technology

[0002] For a long time, containers, initially made of glass and later also of polymers, have been used for the safe transport of liquids and powders. Over the past few decades, the techniques for transporting liquids and powders using glass and polymer containers have become increasingly diverse and sophisticated. One such technique falls under the technical field of this application: pharmaceutical packaging. In the pharmaceutical industry, containers such as vials, syringes, ampoules, and cartridges are used as primary packaging for various drug-related compositions (especially vaccines), and also for packaging cosmetic compositions, particularly those intended for injection into the skin.

[0003] In the manufacturing of containers for pharmaceutical or cosmetic applications, the so-called "nested arrangement" is currently the preferred option, where the container's retaining structure (also known as a "nested structure") is used to simultaneously hold or support multiple primary packaging containers in a given configuration. Examples of known nested arrangements can be found from Schott AG by trade name... Purchased from the platform. When delivered to customers such as pharmaceutical companies or bottling plants, nested structures with primary packaging containers are typically packaged in transport or packaging containers (also called boxes). To further process the primary packaging containers, the boxes are opened. Further processing of the primary packaging containers typically includes the following automated steps: removing the primary packaging containers from the boxes; filling the primary packaging containers with a composition, such as a pharmaceutical or cosmetic composition; and sealing the pre-filled primary packaging containers.

[0004] The aforementioned known nested structures are produced by injection molding, in which the mold consists of upper and lower parts. Typically, during the molding process, the polymer melt can enter the tiny, but finite-width gaps between the mold components. This polymer melt forms burrs on the demolded nested structure.

[0005] Furthermore, when separating the mold components after forming the nested structure, the nested structure may adhere to the upper, horizontally aligned component of the mold due to shrinkage. Multiple pushers (typically pins) are used to separate the nested structure from the horizontally aligned mold component to which it adheres. These pushers are distributed along the entire length and width of the nested structure to eject it from the mold component in a manner as horizontally aligned as possible. The greater the angle formed by the nested structure with the horizontal plane during its downward movement, the higher the risk of indentations and scratches. Because multiple pushers need to push the nested structure from above through the mold component, the mold component has openings through which the pushers can reach the nested structure. To allow for forward and backward movement of the pushers, a minimum clearance should exist between the pushers and the mold component. When the polymer melt enters these clearances, more burrs are created on the nested structure.

[0006] Furthermore, the mold has small vents to release air from inside the mold when the polymer melt is injected. Without such vents, the air inside the mold would be highly compressed until it becomes extremely hot and is released explosively. If this happens, the nested structure could burn out. Therefore, vents are needed to expel air from the mold. Of course, these vents also cause burrs to form on the nested structure.

[0007] The aforementioned technical requirements for the nested structures in so-called "nested solutions" used in the production of pharmaceutical and cosmetic packaging indicate that burrs will appear in the nested structures if no countermeasures are taken. Post-processing to deburr the nested structures has long been considered a major source of macroscopic and microscopic particles. If these particles are generated from the material of the nested structure, they will adhere to the primary packaging container held within the nested structure. Such particles on the outer surface of the primary packaging container can hinder optical inspection of the container for quality control. Even more seriously, it poses a risk of such particles entering the primary packaging container (e.g., a container located on a filling line, where pharmaceutical or cosmetic compositions are filled). Worst of all, the particles may eventually be injected into a patient. This must undoubtedly be strictly avoided. Therefore, post-processing to deburr the nested structures has been avoided in the prior art. However, research derived from this invention has unexpectedly shown that, for example, by post-processing to deburr very specific locations of the nested structure (particularly its receiving portion), the overall height R of the roughness profile at these specific locations of the nested structure can be reduced. t This results in a reduction in particles generated during the handling and transport of nested structures (which exceed the particles generated by post-processing itself). Summary of the Invention

[0008] Overall, one object of the present invention is to overcome at least some of the disadvantages of the prior art.

[0009] Another object of the present invention is to provide a nesting scheme for pharmaceutical, medical, or cosmetic packaging that improves patient safety. Furthermore, an object of the present invention is to provide a nesting scheme for pharmaceutical, medical, or cosmetic packaging that reduces particle load on the nested primary packaging containers after transportation in the nested structure. Additionally, an object of the present invention is to provide a nesting scheme for pharmaceutical, medical, or cosmetic packaging that improves quality control of the nested primary packaging containers, particularly through optical inspection.

[0010] Any embodiment of the present invention achieves at least one of the above objectives in part, and preferably more than one.

[0011] A first embodiment of the present invention is a holding device for holding multiple primary packaging containers for pharmaceutical, medical, or cosmetic compositions. The holding device includes: -A plate-shaped carrier element including multiple through holes, and - Multiple receiving sections, each designed and configured to receive one of the primary packaging containers; Each receiving portion includes a receiving portion wall that partially surrounds the interior of the receiving portion; each receiving portion wall forms a wall body; wherein each wall body - Extending longitudinally through one of the plurality of through holes -Having a first opening at a first end and another opening at the other end, wherein the other end is longitudinally opposite to the first end; The first opening of each wall is directly surrounded laterally by at least one first side, preferably at least two first sides, more preferably exactly two first sides of the corresponding wall; the other opening of each wall is directly surrounded laterally by at least one other side, preferably two other sides, more preferably exactly two other sides of the corresponding wall; characterized in that the total height R of the roughness profile of at least 50%, preferably at least 60%, more preferably at least 70%, more preferably at least 80%, more preferably at least 90%, even more preferably at least 95%, further more preferably at least 98%, and most preferably 100% of the accommodating portions is at least 100% of the accommodating portions. t Not exceeding 0.50 mm, preferably not exceeding 0.45 mm, more preferably not exceeding 0.40 mm, more preferably not exceeding 0.35 mm, more preferably not exceeding 0.30 mm, more preferably not exceeding 0.25 mm, more preferably not exceeding 0.20 mm, more preferably not exceeding 0.15 mm, more preferably not exceeding 0.14 mm, more preferably not exceeding 0.13 mm, more preferably not exceeding 0.12 mm, more preferably not exceeding 0.11 mm, more preferably not exceeding 0.10 mm, more preferably not exceeding 0.09 mm. The thickness is 1 meter, more preferably not exceeding 0.08 mm, more preferably not exceeding 0.07 mm, more preferably not exceeding 0.06 mm, more preferably not exceeding 0.05 mm, more preferably not exceeding 0.04 mm, more preferably not exceeding 0.03 mm, more preferably not exceeding 0.02 mm, more preferably not exceeding 0.01 mm, more preferably not exceeding 0.009 mm, more preferably not exceeding 0.008 mm, more preferably not exceeding 0.007 mm, even more preferably not exceeding 0.006 mm, and most preferably not exceeding 0.005 mm.

[0012] In a preferred embodiment of the retaining device, for each of the plurality of receiving portions, the wall has: - The inner surface facing the interior of the receiving part, and - The outer surface opposite to the inner surface.

[0013] This preferred embodiment is the second embodiment of the present invention, which preferably depends on the first embodiment of the present invention.

[0014] In a preferred embodiment of the retaining device, the maximum total height R of the roughness profile of the inner surface of at least 50%, preferably at least 60%, more preferably at least 70%, more preferably at least 80%, more preferably at least 90%, even more preferably at least 95%, still more preferably at least 98%, and most preferably 100% of the plurality of receiving portions is [missing information]. t Not exceeding 0.50 mm, preferably not exceeding 0.45 mm, more preferably not exceeding 0.40 mm, more preferably not exceeding 0.35 mm, more preferably not exceeding 0.30 mm, more preferably not exceeding 0.25 mm, more preferably not exceeding 0.20 mm, more preferably not exceeding 0.15 mm, more preferably not exceeding 0.14 mm, more preferably not exceeding 0.13 mm, more preferably not exceeding 0.12 mm, more preferably not exceeding 0.11 mm, more preferably not exceeding 0.10 mm, more preferably not exceeding 0.09 mm. More preferably, the diameter does not exceed 0.08 mm, more preferably not exceed 0.07 mm, more preferably not exceed 0.06 mm, more preferably not exceed 0.05 mm, more preferably not exceed 0.04 mm, more preferably not exceed 0.03 mm, more preferably not exceed 0.02 mm, more preferably not exceed 0.01 mm, more preferably not exceed 0.009 mm, more preferably not exceed 0.008 mm, even more preferably not exceed 0.007 mm, still more preferably not exceed 0.006 mm, and most preferably not exceed 0.005 mm. This preferred embodiment is the third embodiment of the present invention, which preferably depends on the second embodiment of the present invention.

[0015] A fourth embodiment of the present invention is a holding device for holding multiple primary packaging containers for pharmaceutical, medical, or cosmetic compositions. The holding device includes: -A plate-shaped carrier element including multiple through holes, and - Multiple receiving sections, each designed and configured to receive one of the primary packaging containers; Each receiving portion includes a receiving portion wall that partially surrounds the interior of the receiving portion; each receiving portion wall forms a wall body; wherein each wall body extends longitudinally through one of the plurality of through holes; for each of the plurality of receiving portions, the wall body has - The inner surface facing the interior of the receiving part, and - The outer surface opposite to the inner surface; Characterized by the fact that the maximum total height R of the roughness profile of the inner surface of at least 50%, preferably at least 60%, more preferably at least 70%, more preferably at least 80%, more preferably at least 90%, even more preferably at least 95%, still more preferably at least 98%, and most preferably 100% of the plurality of accommodating portions is [missing information]. tNot exceeding 0.50 mm, preferably not exceeding 0.45 mm, more preferably not exceeding 0.40 mm, more preferably not exceeding 0.35 mm, more preferably not exceeding 0.30 mm, more preferably not exceeding 0.25 mm, more preferably not exceeding 0.20 mm, more preferably not exceeding 0.15 mm, more preferably not exceeding 0.14 mm, more preferably not exceeding 0.13 mm, more preferably not exceeding 0.12 mm, more preferably not exceeding 0.11 mm, more preferably not exceeding 0.10 mm, more preferably not exceeding 0.09 mm. More preferably not exceeding 0.08 mm, more preferably not exceeding 0.07 mm, more preferably not exceeding 0.06 mm, more preferably not exceeding 0.05 mm, more preferably not exceeding 0.04 mm, more preferably not exceeding 0.03 mm, more preferably not exceeding 0.02 mm, more preferably not exceeding 0.01 mm, more preferably not exceeding 0.009 mm, more preferably not exceeding 0.008 mm, even more preferably not exceeding 0.007 mm, even more preferably not exceeding 0.006 mm, and most preferably not exceeding 0.005 mm.

[0016] In a preferred embodiment of the retaining device, each wall has a first opening at a first end and another opening at a other end, wherein the other end is longitudinally opposite to the first end; the first opening of each wall is directly surrounded laterally by at least one first side, preferably at least two first sides, more preferably exactly two first sides of the corresponding wall; the other opening of each wall is directly surrounded laterally by at least one other side, preferably at least two other sides, more preferably exactly two other sides of the corresponding wall. This preferred embodiment is the fifth embodiment of the present invention, which preferably depends on the fourth embodiment of the present invention.

[0017] In a preferred embodiment of the retaining device, the total height R of the roughness profile of at least 50%, preferably at least 60%, more preferably at least 70%, more preferably at least 80%, more preferably at least 90%, even more preferably at least 95%, still more preferably at least 98%, and most preferably 100% of the plurality of receiving portions is at least 100% of the receiving portions. tNot exceeding 0.50 mm, preferably not exceeding 0.45 mm, more preferably not exceeding 0.40 mm, more preferably not exceeding 0.35 mm, more preferably not exceeding 0.30 mm, more preferably not exceeding 0.25 mm, more preferably not exceeding 0.20 mm, more preferably not exceeding 0.15 mm, more preferably not exceeding 0.14 mm, more preferably not exceeding 0.13 mm, more preferably not exceeding 0.12 mm, more preferably not exceeding 0.11 mm, more preferably not exceeding 0.10 mm, more preferably not exceeding 0.09 mm. More preferably, the diameter does not exceed 0.08 mm, more preferably not exceed 0.07 mm, more preferably not exceed 0.06 mm, more preferably not exceed 0.05 mm, more preferably not exceed 0.04 mm, more preferably not exceed 0.03 mm, more preferably not exceed 0.02 mm, more preferably not exceed 0.01 mm, more preferably not exceed 0.009 mm, more preferably not exceed 0.008 mm, even more preferably not exceed 0.007 mm, still more preferably not exceed 0.006 mm, and most preferably not exceed 0.005 mm. This preferred embodiment is the sixth embodiment of the present invention, which preferably depends on the fifth embodiment of the present invention.

[0018] In a preferred embodiment of the retaining device, for each of the plurality of receiving portions, the wall includes a retaining portion, the retaining portion -Horizontal extension, - The interior of the accommodating portion is restricted in the longitudinal direction or in the opposite direction to the longitudinal direction, and - Including either the first opening or the other opening.

[0019] This preferred embodiment is the seventh embodiment of the present invention, which preferably depends on any one of the first to third, fifth and sixth embodiments of the present invention.

[0020] Preferably, the retaining portion is designed and configured to support, preferably against the gravity of the retaining device when upright, one of the plurality of primary packaging containers (when the primary packaging container is housed in the corresponding receiving portion). Preferably, the retaining portion is designed and configured to prevent the primary packaging container housed in the corresponding receiving portion from falling through the receiving portion along the direction of gravity when the retaining device is upright.

[0021] In a preferred embodiment of the retaining device, for each of the plurality of receiving portions, the first opening or the other opening is laterally restricted by the side surface of the retaining portion, and the maximum total height R of the roughness profile of the side surface of the retaining portion of the retaining portion of at least 50%, preferably at least 60%, more preferably at least 70%, more preferably at least 80%, more preferably at least 90%, even more preferably at least 95%, further more preferably at least 98%, and most preferably 100% of the receiving portions is... t Not exceeding 0.50 mm, preferably not exceeding 0.45 mm, more preferably not exceeding 0.40 mm, more preferably not exceeding 0.35 mm, more preferably not exceeding 0.30 mm, more preferably not exceeding 0.25 mm, more preferably not exceeding 0.20 mm, more preferably not exceeding 0.15 mm, more preferably not exceeding 0.14 mm, more preferably not exceeding 0.13 mm, more preferably not exceeding 0.12 mm, more preferably not exceeding 0.11 mm, more preferably not exceeding 0.10 mm, more preferably not exceeding 0.09 mm. More preferably, the diameter does not exceed 0.08 mm, more preferably not exceed 0.07 mm, more preferably not exceed 0.06 mm, more preferably not exceed 0.05 mm, more preferably not exceed 0.04 mm, more preferably not exceed 0.03 mm, more preferably not exceed 0.02 mm, more preferably not exceed 0.01 mm, more preferably not exceed 0.009 mm, more preferably not exceed 0.008 mm, even more preferably not exceed 0.007 mm, still more preferably not exceed 0.006 mm, and most preferably not exceed 0.005 mm. This preferred embodiment is the eighth embodiment of the present invention, which preferably depends on the seventh embodiment of the present invention.

[0022] In a preferred embodiment of the retaining device, for each of the plurality of receiving portions, the wall further has at least one intermediate surface that is neither part of the inner surface nor part of the outer surface, and faces the longitudinal direction or the opposite direction to the longitudinal direction; wherein the maximum total height R of the roughness profile of the at least one intermediate surface of at least 50%, preferably at least 60%, more preferably at least 70%, more preferably at least 80%, more preferably at least 90%, even more preferably at least 95%, further more preferably at least 98%, and most preferably 100% of the receiving portions is [missing information]. tNot exceeding 0.50 mm, preferably not exceeding 0.45 mm, more preferably not exceeding 0.40 mm, more preferably not exceeding 0.35 mm, more preferably not exceeding 0.30 mm, more preferably not exceeding 0.25 mm, more preferably not exceeding 0.20 mm, more preferably not exceeding 0.15 mm, more preferably not exceeding 0.14 mm, more preferably not exceeding 0.13 mm, more preferably not exceeding 0.12 mm, more preferably not exceeding 0.11 mm, more preferably not exceeding 0.10 mm, more preferably not exceeding 0.09 mm. More preferably, the diameter does not exceed 0.08 mm, more preferably not exceed 0.07 mm, more preferably not exceed 0.06 mm, more preferably not exceed 0.05 mm, more preferably not exceed 0.04 mm, more preferably not exceed 0.03 mm, more preferably not exceed 0.02 mm, more preferably not exceed 0.01 mm, more preferably not exceed 0.009 mm, more preferably not exceed 0.008 mm, even more preferably not exceed 0.007 mm, still more preferably not exceed 0.006 mm, and most preferably not exceed 0.005 mm. This preferred embodiment is the ninth embodiment of the present invention, which preferably depends on any one of the second to eighth embodiments of the present invention.

[0023] In a preferred embodiment of the retaining device, the at least one intermediate surface is adjacent to the inner surface and / or the outer surface. This preferred embodiment is the tenth embodiment of the present invention, which preferably depends on the ninth embodiment of the present invention.

[0024] In a preferred embodiment of the retaining device, the at least one intermediate surface is adjacent to the inner surface but not to the outer surface. This preferred embodiment is the eleventh embodiment of the present invention, which preferably depends on the ninth embodiment of the present invention.

[0025] Preferably, a portion of the plate-shaped carrier element is located between the outer surface and the intermediate surface.

[0026] In a preferred embodiment of the retaining device, for each of the plurality of receiving portions, the opening area of ​​the first opening is larger than the opening area of ​​the other opening, preferably by at least 5%, more preferably by at least 10%, even more preferably by at least 20%, and most preferably by at least 30%. This preferred embodiment is the twelfth embodiment of the present invention, which preferably depends on any one of the first to third embodiments and the fifth to eleventh embodiments of the present invention.

[0027] In a preferred embodiment of the retaining device, for each of the plurality of accommodating portions, the first opening is closer to the plate-shaped carrier element than the other opening. This preferred embodiment is the thirteenth embodiment of the present invention, which preferably depends on any one of the first to third and fifth to twelfth embodiments of the present invention.

[0028] In a preferred embodiment of the holding device, for each of the plurality of accommodating portions, the first side or the other side is laterally surrounded by the plate-shaped carrier element. This preferred embodiment is the fourteenth embodiment of the present invention, which preferably depends on any one of the first to third embodiments and the fifth to thirteenth embodiments of the present invention.

[0029] In a preferred embodiment of the retaining device, for each of the plurality of receiving portions, the first end and / or the other end protrudes from the plate-shaped carrier element in the longitudinal direction or in the opposite direction to the longitudinal direction. This preferred embodiment is the fifteenth embodiment of the present invention, which preferably depends on any one of the first to third embodiments and the fifth to fourteenth embodiments of the present invention.

[0030] In a preferred embodiment of the holding device, for each of the plurality of accommodating portions, the first end or the other end is directly connected to the plate-shaped carrier element. This preferred embodiment is the sixteenth embodiment of the present invention, which preferably depends on any one of the first to third and fifth to fifteenth embodiments of the present invention.

[0031] Preferably, at the first end or the other end, the outer surface of the wall of the corresponding receiving portion is directly connected to the plate-shaped carrier element.

[0032] In a preferred embodiment of the retaining device, the plate-shaped carrier element is integral with each wall. This preferred embodiment is the seventeenth embodiment of the invention, which preferably depends on any of the above embodiments of the invention.

[0033] Preferably, the wall is made of a polymer composition, preferably by a molding method. More preferably, the plate-like carrier element is made of the polymer composition, preferably by the molding method. The molding method is preferably injection molding. The polymer composition is preferably a thermoplastic.

[0034] In a preferred embodiment of the retaining device, the retaining device is designed to non-destructively and removably receive one of the plurality of primary packaging containers in each of the plurality of receiving portions. Preferably, the retaining device is designed to retain the primary packaging container in the receiving portion by form-fitting and / or force-fitting. This preferred embodiment is the eighteenth embodiment of the present invention, which preferably depends on any of the above embodiments of the present invention.

[0035] In a preferred embodiment of the retaining device, the plurality of receiving portions include 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 receiving portions. This preferred embodiment is the nineteenth embodiment of the present invention, which preferably depends on any of the above embodiments of the present invention.

[0036] In a preferred embodiment of the holding device, the primary packaging containers among the plurality of primary packaging containers are selected from vials, syringes, cartridges, ampoules, or combinations of at least two of these. A preferred cartridge is designed to function as a reservoir in a medical device (preferably a portable medical device). A preferred portable medical device is an insulin pump. This preferred embodiment is the twentieth embodiment of the invention, which preferably depends on any of the above embodiments of the invention.

[0037] The twenty-first embodiment of the present invention is a method for producing the holding device according to any one of the preceding claims, the method comprising the following steps: a) Provide i) the first part of the mold and ii) the other part of the mold; b) Position the first component and the other component relative to each other such that the first component and the other component together at least partially surround the interior of the mold; c) Introducing the polymer composition into the interior of the mold; d) Curing the polymer composition inside the mold to obtain a molded body; and e) Demold the molded body.

[0038] In a preferred embodiment of the method, in step c), the polymer composition is in liquid or particulate form. The preferred liquid polymer composition is a polymer melt. This preferred embodiment is the twenty-second embodiment of the present invention, which preferably depends on the twenty-first embodiment of the present invention.

[0039] In a preferred embodiment of the method, the method is an injection molding method. This preferred embodiment is the twenty-third embodiment of the present invention, which preferably depends on the twenty-first or twenty-second embodiment of the present invention.

[0040] In a preferred embodiment of the method, the molded body demolded in step e) is the retaining device. This preferred embodiment is the twenty-fourth embodiment of the present invention, which preferably depends on any one of the twenty-first to twenty-third embodiments of the present invention.

[0041] In a preferred embodiment of the method, the method includes another method step comprising processing the molded body, wherein the holding device is obtained by processing the molded body. This preferred embodiment is the twenty-fifth embodiment of the invention, which preferably depends on any one of the twenty-first to twenty-third embodiments of the invention.

[0042] In a preferred embodiment of the method, the treatment is mechanical treatment and / or heat treatment. Preferred heat treatment includes heating at least a portion of the molded body. Preferably, heating is achieved by irradiation with electromagnetic radiation. Preferred electromagnetic radiation is infrared radiation. This preferred embodiment is the twenty-sixth embodiment of the invention, which preferably depends on the twenty-fifth embodiment of the invention.

[0043] In a preferred embodiment of the method, the other method step is performed before and / or after method step e). This preferred embodiment is the twenty-seventh embodiment of the present invention, which preferably depends on the twenty-fifth or twenty-sixth embodiment of the present invention.

[0044] In a preferred embodiment of the method, method step e) includes the following sub-steps: i) Remove the first component from the molded body; ii) The molded body is ejected from the other component by applying a release force to the molded body.

[0045] This preferred embodiment is the twenty-eighth embodiment of the present invention, which preferably depends on any one of the twenty-first to twenty-seventh embodiments of the present invention.

[0046] In a preferred embodiment of the method, the demolding force is oriented in the longitudinal direction. This preferred embodiment is the twenty-ninth embodiment of the present invention, which preferably depends on the twenty-eighth embodiment of the present invention.

[0047] In a preferred embodiment of the method, the demolding force is applied by a plurality of demolding elements. Preferred demolding elements are pins and / or bolts. This preferred embodiment is the thirtieth embodiment of the invention, which preferably depends on the twenty-eighth or twenty-ninth embodiment of the invention.

[0048] In a preferred embodiment of the method, the molded body includes the plate-shaped carrier element, wherein, in step e), the demolding force is applied at locations distributed along the lateral extension of the plate-shaped carrier element such that the angle formed by the plate-shaped carrier element and the horizontal plane does not exceed 20°, preferably 10°, more preferably 5°, and most preferably 3°. Here, the lateral extension of the plate-shaped carrier element refers to its width and length. This preferred embodiment is the thirty-first embodiment of the present invention, which preferably depends on any one of the twenty-eighth to thirtyth embodiments of the present invention.

[0049] The thirty-second embodiment of the present invention is a holding device that can be obtained by the method of the present invention, preferably by the method of the twenty-first to thirty-first embodiments of the present invention.

[0050] The thirty-third embodiment of the present invention is a component comprising: -The holding device of the present invention, preferably the holding device according to any one of the first to twentieth embodiments or the thirty-second embodiment of the present invention, and -The plurality of primary packaging containers; Each of the primary packaging containers is housed within one of the receiving portions. Preferably, each of the primary packaging containers is housed in one of the receiving portions in a non-destructive and removable manner.

[0051] In a preferred embodiment of the component, the plurality of primary packaging containers 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 primary packaging containers. This preferred embodiment is the thirty-fourth embodiment of the present invention, which preferably depends on the thirty-third embodiment of the present invention.

[0052] In a preferred embodiment of the components, each of the primary packaging containers contains a pharmaceutical, medical, or cosmetic composition. This preferred embodiment is the thirty-fifth embodiment of the invention, which preferably depends on the thirty-third or thirty-fourth embodiment of the invention.

[0053] In a preferred embodiment of the component, each of the primary packaging containers is sealed. This preferred embodiment is the thirty-sixth embodiment of the invention, which preferably depends on any one of the thirty-third to thirty-fifth embodiments of the invention.

[0054] In a preferred embodiment of the component, each of the primary packaging containers comprises, along its length, the following: a) The first end, which includes a discharge port, b) Main body, and c) The other end.

[0055] This preferred embodiment is the thirty-seventh embodiment of the present invention, which preferably depends on any one of the thirty-third to thirty-sixth embodiments of the present invention.

[0056] In a preferred embodiment of the component, the main body is cylindrical. This preferred embodiment is the thirty-eighth embodiment of the present invention, which preferably depends on the thirty-seventh embodiment of the present invention.

[0057] In a preferred embodiment of the component, the other end is a vertical base and / or includes another opening. Preferably, the other opening is designed to receive a plunger. This preferred embodiment is the thirty-ninth embodiment of the invention, which preferably depends on the thirty-seventh or thirty-eighth embodiment of the invention.

[0058] In a preferred embodiment of the component, for each of the primary packaging containers, the area of ​​the other opening is larger than the area of ​​the discharge port. This preferred embodiment is the fortieth embodiment of the invention, which preferably depends on the thirty-ninth embodiment of the invention.

[0059] In a preferred embodiment of the component, the other end further includes an edge that projects laterally from the body portion and at least partially, preferably completely, surrounds the other opening. This preferred embodiment is the forty-first embodiment of the invention, which preferably depends on the thirty-ninth or fortieth embodiment of the invention.

[0060] In a preferred embodiment of the component, the 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 selected from one of a needle, a nozzle, and a tube, or a combination of at least two of them. The preferred needle is a hypodermic needle. This preferred embodiment is the forty-second embodiment of the invention, which preferably depends on any one of the thirty-seventh to forty-first embodiments of the invention.

[0061] In a preferred embodiment of the component, the connecting element includes threads for connecting the auxiliary component to a corresponding primary packaging container. This preferred embodiment is the forty-third embodiment of the invention, which preferably depends on the forty-second embodiment of the invention.

[0062] In a preferred embodiment of the component, the first end of each primary packaging container includes a protrusion of a tapered connector. The preferred tapered connector is a Luer connector. Typically, the Luer connector may or may not include threads. This preferred embodiment is the forty-fourth embodiment of the invention, which preferably depends on any of the thirty-seventh to forty-third embodiments of the invention.

[0063] In a preferred embodiment of the component, the protrusion of the tapered connector includes threads. Preferably, the threads are disposed on the sleeve. This preferred embodiment is the forty-fifth embodiment of the invention, which preferably depends on the forty-fourth embodiment of the invention.

[0064] In a preferred embodiment of the component, for each primary packaging container, the thickness of the container wall in the body portion of the respective primary packaging container is based on the average thickness of the container wall within the range of ±0.3 mm, preferably within the range of ±0.2 mm, more preferably within the range of ±0.15 mm, more preferably within the range of ±0.1 mm, and most preferably within the range of ±0.08 mm. This preferred embodiment is the forty-sixth embodiment of the present invention, which preferably depends on any one of the thirty-seventh to forty-fifth embodiments of the present invention.

[0065] In a preferred embodiment of the component, for each primary packaging container, the thickness of the container wall extending through the body is 0.2 mm to 3 mm, preferably 0.3 mm to 2.5 mm, and more preferably 0.4 mm to 2.2 mm. This preferred embodiment is the forty-seventh embodiment of the present invention, which preferably depends on any one of the thirty-seventh to forty-sixth embodiments of the present invention.

[0066] In a preferred embodiment, for each primary packaging container, the container wall thickness is 1.0 mm to 1.1 mm, extending through the body. In another preferred embodiment, for each primary packaging container, the container wall thickness is 1.4 mm to 1.8 mm, extending through the body. In yet another preferred embodiment, for each primary packaging container, the container wall thickness is 0.6 mm to 2.0 mm, extending through the body.

[0067] In a preferred embodiment of the component, each of the primary packaging containers has an interior volume of 0.5 ml to 100 ml, preferably 1 ml to 100 ml, more preferably 1 ml to 50 ml, even more preferably 1 ml to 10 ml, and most preferably 2 ml to 10 ml. This preferred embodiment is the forty-eighth embodiment of the invention, which preferably depends on any one of the thirty-third to forty-seventh embodiments of the invention.

[0068] In a preferred embodiment of the component, the primary packaging container is selected from vials, syringes, cartridges, ampoules, or combinations of at least two of these. A preferred cartridge is designed for use as a reservoir in a medical device (preferably a portable medical device). A preferred portable medical device is an insulin pump. This preferred embodiment is the forty-ninth embodiment of the invention, which preferably depends on any one of the thirty-third to forty-eighth embodiments of the invention.

[0069] In a preferred embodiment of the component, each of the primary packaging containers includes a container wall that at least partially surrounds the interior of the container, wherein the container wall comprises glass and / or a polymer, preferably composed of glass and / or a polymer. This preferred embodiment is the fiftieth embodiment of the invention, which preferably depends on any one of the thirty-third to forty-ninth embodiments of the invention.

[0070] In a preferred embodiment of the component, the polymer is a cyclic olefin copolymer, a cyclic olefin polymer, or a mixture thereof. This preferred embodiment is the fifty-first embodiment of the invention, which preferably depends on the fiftieth embodiment of the invention.

[0071] In a preferred embodiment of the component, the glass is selected from borosilicate glass (preferably type I glass), aluminosilicate glass, fused silica, or a combination of at least two of the above. This preferred embodiment is the fifty-second embodiment of the present invention, which preferably depends on the fiftieth or fifty-first embodiment of the present invention.

[0072] In a preferred embodiment of the component, the primary packaging container has been purified, and preferably sterilized. This preferred embodiment is the fifty-third embodiment of the present invention, which preferably depends on any one of the thirty-third to fifty-second embodiments of the present invention.

[0073] Preferably, the component has been purified, and more preferably, sterilized. In the context of this application, purification is defined as a hypernym for reducing the number of microorganisms and biological agents (e.g., fungi, bacteria, viruses, spore forms, prions, single-celled eukaryotes). The difference between the hyponyms "disinfection" and "sterilization" lies in the amount of microorganisms and biological agents reduced. Disinfection merely reduces the amount of the contaminants, while sterilization effectively kills, inactivates, or eliminates all forms of organisms and other existing biological agents, i.e., a 100% reduction. Therefore, disinfection is less effective than sterilization.

[0074] The fifty-fourth embodiment of the present invention is a transport unit, comprising: -The component described in this invention, preferably the component described in any one of the thirty-third to fifty-third embodiments of this invention, and - Secondary packaging containers; The retaining device and the plurality of primary packaging containers are completely arranged within the secondary packaging container.

[0075] In a preferred embodiment of the transport unit, the container body of the secondary packaging container includes: - Container opening; and - A container base, wherein the container base is longitudinally opposite the container opening.

[0076] This preferred embodiment is the fifty-fifth embodiment of the present invention, which preferably depends on the fifty-fourth embodiment of the present invention.

[0077] In a preferred embodiment of the transport unit, the first end or the other end of the primary packaging container faces the container opening. This preferred embodiment is the fifty-sixth embodiment of the present invention, which preferably depends on the fifty-fifth embodiment of the present invention.

[0078] In a preferred embodiment of the transport unit, the secondary packaging container is a box or box-shaped container. This preferred embodiment is the fifty-seventh embodiment of the present invention, which preferably depends on any one of the fifty-fourth to fifty-sixth embodiments of the present invention.

[0079] In a preferred embodiment of the transport unit, the secondary packaging container is sealed with a lid. Preferably, the lid is attached to the secondary packaging container. The lid is preferably a multi-layered sheet. Additionally, or preferably, the lid is breathable. This preferred embodiment is the fifty-eighth embodiment of the invention, which preferably depends on any one of the fifty-fourth to fifty-seventh embodiments of the invention.

[0080] In a preferred embodiment of the transport unit, the transport unit further includes outer packaging, preferably a closed outer packaging, wherein the secondary packaging container is disposed within the outer packaging. This preferred embodiment is the fifty-ninth embodiment of the present invention, which preferably depends on any one of the fifty-fourth to fifty-eighth embodiments of the present invention.

[0081] The preferred outer packaging is a bag, preferably a bag made of plastic film. Additionally, or preferably, the outer packaging provides a barrier against the permeation of inert gases. Additionally, or preferably, the outer packaging is hermetically sealed. Additionally, or preferably, the outer packaging is less permeable to the inert gas than the lid. Particularly preferably, the outer packaging provides a barrier against the permeation of the inert gas, while the lid is permeable to the inert gas.

[0082] In a preferred embodiment of the transport unit, the outer packaging contains an atmosphere in which, based on the volume of the atmosphere, the proportion of inert gas 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. This preferred embodiment is the sixtieth embodiment of the invention, which preferably depends on the fifty-ninth embodiment of the invention.

[0083] The sixty-first embodiment of the present invention is a holding device according to the present invention, preferably a holding device according to any one of the first to twentieth or thirty-second embodiments of the present invention; a component according to the present invention, preferably a component according to any one of the thirty-third to fifty-third embodiments of the present invention; and a transport unit according to the present invention, preferably a transport unit according to any one of the forty-eighth to fifty-fourth embodiments of the present invention, wherein the holding device, component or transport unit is used to store or transport the plurality of primary packaging containers.

[0084] In a preferred embodiment of the described use, each of the primary packaging containers contains a pharmaceutical, medical, or cosmetic composition. This preferred embodiment is the sixty-second embodiment of the invention, which preferably depends on the sixty-first embodiment of the invention.

[0085] The sixty-third embodiment of the present invention is a retaining device according to the present invention, preferably used according to any one of the first to twentieth and thirty-second embodiments of the present invention, wherein the retaining device is used to retain the plurality of primary packaging containers in the step of filling the primary packaging containers with a pharmaceutical, medical or cosmetic composition.

[0086] Features described as preferred in one category of the invention (e.g., according to the holding device) are also approximately preferred in embodiments of other categories of the invention (e.g., the methods, components, transport units, and uses).

[0087] Holding device

[0088] The holding device of the present invention can generally be any device that a person skilled in the art would consider suitable for holding the plurality of primary packaging containers. A preferred holding device is a carrier structure in the so-called “nested scheme” because it is well known in the field of transport packaging technology for primary packaging containers in the medical, pharmaceutical, and cosmetic industries. Examples of known nested schemes can be found from Schott AG by trade name... Purchased from the platform. The preferred retaining device is manufactured by deep drawing or injection molding, with injection molding being particularly preferred. Additionally, or preferably, the retaining device is made of one or more plastics. Preferably, the plate-like carrier element is integral with the plurality of receiving portions. More preferably, the retaining device has an integral design. Preferably, the receiving portions form a regular pattern in the top view of the retaining device.

[0089] Plate-shaped carrier element

[0090] The term "plate-like" refers to a carrier element whose width and length are both at least 5 times, preferably at least 10 times, more preferably at least 50 times, and most preferably at least 100 times, the thickness of the carrier element. Preferably, the thickness of the carrier element is 0.5 mm to 5 mm, more preferably 0.5 mm to 3 mm, even more preferably 0.5 mm to 2 mm, and most preferably 1 mm to 2 mm. Additionally, or preferably, the carrier element has a substantially flat upper surface and / or a substantially flat lower surface. Here, the term "plate-like carrier element" refers to a substantially flat element, and the upper or lower surface of the carrier element has no optional visible protrusions. Preferably, the upper and lower surfaces of the plate-like carrier element are substantially rectangular. Here, "substantially" means that the edge regions of the upper or lower surface may have rounded corners and / or recesses.

[0091] Reception wall

[0092] Preferably, the receiving portion wall comprises all the wall elements of the receiving portion. Here, the receiving portion wall may only partially surround the interior of the receiving portion, given that the wall has the first opening and the other opening. The wall is a geometry formed by the receiving portion wall.

[0093] side

[0094] In this paper, an edge refers to a substantially linear portion of a surface along which sub-parts are adjacent to each other and at an angle. According to this definition, each cube has 12 edges, and two sub-parts of each surface of the cube are adjacent to each other and at an angle along their respective edges.

[0095] Primary packaging containers

[0096] Primary packaging containers refer to the packaging containers that provide the tightest protection for products within the product distribution channel. These primary packaging containers can also be called retail or sales packaging containers. Therefore, test tubes are not considered primary packaging containers.

[0097] In the context of this invention, the primary packaging container may have any size or shape that is deemed suitable by those skilled in the art. Preferred primary packaging containers are those for use in medical, pharmaceutical, or cosmetic compositions. Preferably, according to Section 3.2.1 of the 7th edition of the European Pharmacopoeia 2011, the primary packaging container is suitable for packaging parenteralia. Particularly preferred primary packaging containers are vials, syringes, cartridges, or ampoules.

[0098] Preferably, each of the primary packaging containers comprises, along its length, a first end including a discharge port, a body portion, and a second end. Preferably, the first end of the container includes a discharge port that allows a medical, pharmaceutical, or cosmetic composition to be discharged from the interior of the primary packaging container. In this case, the container wall of the primary packaging container only partially surrounds the interior of the container. Preferred primary packaging containers whose first end includes a discharge port are vials, syringes, or cartridges. Preferably, preferred primary packaging containers whose first end does not have a discharge port are ampoules. In this case, the container wall of the primary packaging container completely surrounds the interior of the container. Additionally, or preferably, the second end is an upright base and / or includes another opening. When the second end includes another opening, the primary packaging container is preferably a syringe. When the second end is an upright base, the primary packaging container is preferably a vial, cartridge, or ampoule. For preferred primary packaging containers, the body portion is connected to the first end via a shoulder. The preferred primary packaging container can be a vial, syringe, cartridge, or ampoule, preferably a vial, cartridge, or ampoule. Additionally, or preferably, the other end is connected to the main body via a heel. In this case, the primary packaging container is preferably a vial, cartridge, or ampoule. Preferably, the main body is the lateral region of the primary packaging container. Particularly preferably, the main body of the container wall is formed as a hollow cylinder. In the case of the primary packaging container being a syringe, the cylindrical main body is generally referred to as a tube. Additionally, or preferably, in the top-to-bottom direction of the primary packaging container, the first end includes a flange and a neck, preferably consisting of a flange and a neck. In this case, the primary packaging container is preferably a vial, cartridge, or ampoule.

[0099] Preferably, the primary packaging container is a glass container, the glass wall (container wall) of which at least partially surrounds the interior of the primary packaging container. Preferably, the glass wall is of a one-piece design. Preferably, the glass wall can be made by: blowing glass melt; or by preparing a glass tube, preferably in the form of a hollow cylinder, with one end of the tube forming the bottom of the container, thereby closing the tube at this end and forming the top region of the primary packaging container at the other end of the tube. Preferably, the glass wall is transparent. Alternatively, the container wall is preferably made of a polymer. In this case, the container wall is also preferably transparent.

[0100] For the purposes of this document, the internal volume of the container represents the total volume inside the primary packaging container. This volume can be determined by filling the interior of the primary packaging container with water to the edge and then measuring the volume of the water. Therefore, the internal volume of the container used herein is not the nominal volume commonly referred to in the pharmaceutical technology field. For example, the nominal volume may be approximately 0.5 times smaller than the internal volume.

[0101] Glass

[0102] Preferably, the container walls of each primary packaging container comprise glass, more preferably primarily composed of glass. In the context of this invention, such glass can be any type of glass and can have any composition deemed suitable by those skilled in the art. Preferably, such glass is suitable for pharmaceutical packaging. Particularly preferably, the glass is 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 preferably, the glass is selected from borosilicate glass, aluminosilicate glass, fused silica; or a combination of at least two of these, with aluminosilicate glass being particularly preferred. For use herein, based on the total weight of the glass, aluminosilicate glass is glass with an Al₂O₃ content greater than 8% wt%, preferably greater than 9% wt%, and particularly preferably between 9% wt% and 20% wt%. Preferably, the aluminosilicate glass has a B₂O₃ content less than 8% wt%, preferably at most 7% wt%, and particularly preferably between 0% and 7% wt%. For use herein, based on the total weight of the glass, the borosilicate glass is a glass with a B2O3 content of 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 between 5% wt% and 15% wt%. 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 between 0% and 5.5% wt%. On the other hand, based on the total weight of the glass, the borosilicate glass has an Al2O3 content between 3% wt% and 7.5% wt%, preferably between 4% wt% and 6% wt%.

[0103] A further preferred embodiment of the invention is that the glass is substantially free of boron (B). Here, "substantially free of boron" means that the glass does not contain boron intentionally added to the glass composition. This means that boron may still be present as an impurity, but the weight percentage of boron is preferably no more than 0.1%, more preferably no more than 0.05%, based on the weight of the glass.

[0104] Medical, pharmaceutical and cosmetic compositions

[0105] In the context of this invention, all medical, pharmaceutical, and cosmetic compositions deemed suitable by those skilled in the art are considered. A medical composition is a composition intended for medical treatment. A medical composition does not necessarily contain an active ingredient. A pharmaceutical composition is a composition containing at least one pharmaceutical active ingredient. A preferred pharmaceutical active ingredient is a vaccine. A cosmetic composition is a composition containing at least one cosmetic active ingredient. A preferred cosmetic active ingredient is hyaluronic acid or botulinum toxin. The pharmaceutical, medical, or cosmetic composition may be liquid and / or solid, and is particularly preferred herein as a liquid composition. Preferred solid compositions are granular, for example, powder, large quantities of tablets, or large quantities of capsules. Further preferred medical, pharmaceutical, or cosmetic compositions are parenteral medications, i.e., compositions intended for administration via a parenteral route (which may be any non-gastrointestinal route). Parenteral administration can be performed by injection (e.g., using a needle (typically a hypodermic needle) and syringe) or by insertion of an indwelling catheter.

[0106] Secondary packaging containers

[0107] The secondary packaging container can generally be any container that a person skilled in the art would consider suitable for accommodating the retaining device, preferably the component. Preferably, the secondary packaging container is a box. Particularly preferably, the secondary packaging container is a box in a so-called "nested scheme," as it is generally known in the field of transport packaging technology for primary packaging containers in the medical, pharmaceutical, and cosmetic industries. Examples of known nested schemes can be found from Schott AG by trade name. Obtained through platform purchase. Preferred secondary packaging containers are manufactured by deep drawing or injection molding, with deep drawing being particularly preferred. Additionally, or preferably, the secondary packaging containers are made of one or more plastics. In this document, preferred plastics are selected from one or more of condensation polymers, polyacrylates, and polyolefins, or combinations of at least two of these, wherein the condensation polymer is preferably polyethylene terephthalate; the polyacrylate is preferably polymethyl methacrylate; and the polyolefin is preferably polypropylene or polyethylene.

[0108] direction

[0109] The lateral and longitudinal directions referred to herein are perpendicular to each other. Preferably, the longitudinal direction extends along the length of the receiving portion. Preferably, any direction perpendicular to the longitudinal direction is considered lateral. Therefore, multiple lateral directions can be derived from a single longitudinal direction. Here, the multiple lateral directions preferably form a plane perpendicular to the longitudinal direction. Preferably, this plane is the plane of the plate-like extension of the plate-like carrier element. Here, any cross-section is perpendicular to the longitudinal direction. Test methods

[0110] 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 atm), and a relative humidity of 50%.

[0111] Wall thickness and wall thickness tolerance

[0112] The wall thickness and its deviation from the average wall thickness (tolerance) are determined according to the following standards for the corresponding container type: DIN ISO 8362-1 for vials; DIN ISO 9187-1 for ampoules; DIN ISO 11040-4 for syringes; DIN ISO 13926-1 for cylindrical cartridge cases; and DIN ISO 11040-1 is for dental medicine cartridges.

[0113] Total height R of roughness profile t

[0114] The total height R of the roughness profile t This refers to the profile roughness parameter. More specifically, the total height R... t It is the difference between the highest (maximum) value and the lowest (minimum) value of the corresponding roughness profile.

[0115] The receiving wall of each receiving portion of the retaining device according to the invention can be composed of a single wall element or multiple wall elements. Furthermore, the receiving wall of each receiving portion can be continuous or interrupted. Therefore, the first side and the other side can be continuous or interrupted, respectively. Additionally, the inner surface, intermediate surface, and side surface of the retaining portion can be interrupted. Accordingly, the total height R used herein to determine the roughness profile... t Any roughness profile can be discontinuous, i.e., have one or more interruptions. In determining the total height R... t At that time, these interruptions will be ignored, especially not considered as the minimum value of the roughness profile.

[0116] To determine the total height R of the roughness profile tAn InfiniteFocus G5 plus digital microscope and its accompanying software from Alicona Imaging GmbH were used for measurements. An objective lens with 4x magnification was employed. The microscope's Real3D mode creates a 3D dataset of the surface of interest. This 3D dataset includes the roughness profile to be studied. Therefore, the first and second ends of the accommodating portion and its inner surface were scanned using the microscope's Real3D mode. If the microscope cannot access the surface to be scanned, for example due to the small diameter of the accommodating portion, the nested structure is cut using hot wire cutting. Here, the accommodating portion is cut into as few parts as possible as needed to make the surface of interest available for 3D scanning. Care must be taken to avoid damaging or modifying the surface to be scanned during the cutting and processing of the nested structure. 3D datasets of multiple portions of the surface of interest are combined.

[0117] Based on the 3D dataset of the corresponding surface of the accommodating part, the total height R of the roughness profile to be determined is derived. t The roughness profiles of the first and second sides can be easily extracted from a 3D dataset containing the corresponding edges. The R-value of this roughness profile... t The value is the difference between its highest (maximum) value and its lowest (minimum) value.

[0118] If the object of study is a surface rather than an edge, such as an intermediate surface, the side surface of the retainer, or the inner surface of the receiving portion, then the surface is completely covered by an imaginary line mesh. The mesh is composed of a first set of equidistant lines and a second set of equidistant lines. The lines in the first set are perpendicular to the lines in the second set. If the object of study is the side surface of the retainer or the inner surface of the receiving portion, each line in the first set is a closed loop perpendicular to the longitudinal direction of the receiving portion, except for any possible interruptions. If the object of study is an intermediate surface, then the intermediate surface is completely covered by a rectangular imaginary line mesh. In this case, the distance between adjacent equidistant lines is 100 micrometers. For each equidistant line in the first and second sets, the total height R of the roughness profile along this line is determined based on the 3D dataset. t The R of the entire surface of interest t The value is R for the first and second groups of lines. t The maximum value. This value is referred to in this paper as the maximum total height R of the roughness profile of the corresponding surface. t .

[0119] Transportation Simulation

[0120] The transport simulation was conducted according to ASTM D4169-16. Specifically, the transport simulation consisted of two sequences, which were performed sequentially, one after the other, using the same sample. Laboratory environmental conditions: -Temperature: 15℃ to 35℃; -Relative humidity: <85%; -Atmospheric pressure: 860hPa to 1060hPa.

[0121] first sequence

[0122] The first sequence was performed according to Appendix A – Mechanical Handling – Combined Loads in Section 10.3.2 of ASTM D4169-16. Method C – Rotating Plane Drop Test was performed according to ASTM D6179. The drop height was selected from the table in Section 10.3.2.3 of ASTM D4169-16 according to Guarantee Class II. The test consisted of one drop from each of the opposite bottom edges of the sample. One edge of the sample was supported by the floor. The other side was raised to the drop height and then released to allow it to fall flat onto the impact surface (bottom of the wooden pallet). This process was performed for each opposite bottom edge, resulting in a total of four drops. The following test steps were performed: 1. When the supporting edge is 3-6 and the lifting edge is 3-5, it falls onto surface 3; 2. When the supporting edge is 3-5 and the lifting edge is 3-6, it falls onto surface 3; 3. When the supporting edge 2-3 and the lifting edge 3-2 are both present, the object falls onto surface 3. 4. When both the supporting edge 3-4 and the lifting edge 3-4 are in place, the object falls onto surface 3.

[0123] If any of the sample boxes were moved on the tray during any of steps 1 to 3 above, they should be pushed back into place before subsequent steps. At the end of step 4, all boxes should be pushed back to their original positions on the tray.

[0124] second sequence

[0125] The second sequence was performed according to Appendix D – Stacking – Vibration in Section 12.2 of ASTM D4169-16. Random vibration testing was performed according to ASTM D4728. During the test, the samples were in normal transport orientation, i.e., the wooden pallet was at the bottom. The samples were loaded according to Section 11.4 of ASTM D4169-16. The top 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 of the second sequence: Transportation cycle overview: 0.40G rms Lasting 40 minutes 0.54G rms Lasting 15 minutes 0.70G rms Last 5 minutes Cycle number: 1 Total duration: 1 hour on surface 3 Air quality overview: Air quality level (AL) II / G rms 1.05 Test duration: 2 hours on surface 3

[0126] Particle load after transport simulation

[0127] After performing the transport simulation described above on the sample, the particle load on the outer surface of the primary packaging container (syringe) under study, which is held in the holding device, is then determined by measuring particles (particles) within a specific size range per square centimeter of the total surface area of ​​the outer surface. Between the transport simulation and the particle load determination, any further processing of the sample that might lead to the formation of additional particles should be avoided.

[0128] Liquid Particle Counting System

[0129] The particle load of the primary packaging container of the holding device under investigation 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 accompanying the particle counter. Typically, the particle counter draws the test liquid through a riser tube and guides it through a light scattering sensor. The signal from the light scattering sensor is read and processed by the software. In this testing method, cleaning, rinsing, and washing were performed using only the H2O-EDI-2-T from Sartorius AG, Göttingen, Germany. The advance EDI (10 L / h) desktop system produces particle-free water as a zero sample for replacing any filter and preparing test liquids. This system is a component for preparing two types of pure water. The system has a flow rate of 10 liters per hour.

[0130] Preparation of Particle Counter

[0131] At least one hour before testing, fill the required media (rinsing (particle-free water) and testing (test liquid) into the vessel. Run the particle counter under laminar flow conditions. Before starting the test, clean the entire laminar flow workstation running in workflow mode with a damp, particle-free cloth. The lifting arm with the attached 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 vessel. Adjustment is made through this vessel, and subsequent measurements are also performed through this vessel. Reserve the lifting arm to its lowest position, then move it back to the starting position. To clean the sampler, inject at least 35 ml of particle-free water into the vessel that has been rinsed three times with particle-free water, then place the vessel under the lifting arm. Move the lifting arm to the reserved lower position as described above. Again, the lifting arm must not touch the bottom of the vessel. Start the automatic rinsing program. Each cleaning run consumes 10 ml of liquid. Perform four cleanings in total. Under no circumstances should air be inhaled. Therefore, the container must contain at least 35 ml of particle-free water. After cleaning, move the lifting arm to the upper position.

[0132] Zero samples

[0133] Before starting the test, the particle content of the particle-free water used to prepare the test liquid must be checked. To do this, the measuring vessel is rinsed three times with particle-free water. Then, 40 mL of particle-free water is injected into the vessel as a zero sample. After the zero sample is allowed to stand for at least 2 minutes to degas, the test can begin. The number of particles in a given volume of particle-free water is measured using the particle counter. At this point, particles of all possible sizes must be recorded. For this purpose, 5 mL of liquid is extracted and tested 6 times. The first measurement is discarded. The acceptance criterion is set at a maximum of 25 particles with a diameter of at least 10 micrometers 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.

[0134] Test solution

[0135] Remove the stretch foil from the cardboard box. Remove the box containing the retaining device to be studied from the tray and open it under laminar flow. All subsequent steps are performed under laminar flow. Remove the retaining device and primary packaging container assembly from the box. Prepare a glass beaker containing sufficient particulate-free water, and immerse one of the primary packaging containers (syringes) of the retaining device upright in the water, with half its length submerged. In any case, use at least 40 ml of particulate-free water, referred to below as pool water. Rinse the glass beaker with particulate-free water at least 3 times beforehand. Seal all openings of the primary packaging container of the retaining device to be studied with a stopper that has been rinsed with particulate-free water at least 3 times beforehand. Place each primary packaging container vertically, with half its length submerged in the pool water (the same particulate-free water), and manually agitate it for stirring motion while maintaining vertical orientation for 5 seconds. Since syringes are used as primary packaging containers in the examples and comparative examples below, vertical orientation means the tip of the syringe is facing upwards. The test solution refers to the pool water after all the primary packaging containers of the holding device under study have been cleaned according to the steps described above.

[0136] Measurement

[0137] The test solution was filled into the vessel at least one hour before testing. The number of particles with diameters greater than 2 μm, 5 μm, 10 μm, 15 μm, 25 μm, 50 μm, 75 μm, and 100 μm was measured using the particle counter. For this purpose, the machine tested 5 mL of test solution six times, discarding the first measurement. Therefore, the minimum volume of the test solution was 35 mL. For each of the above particle size grades, the number of particles per square centimeter was determined by dividing the number of particles in the test solution determined by the particle counter by the sum of the outer surface areas of the primary packaging container of the holding device under study.

[0138] The invention will now be described in more detail with reference to examples and accompanying drawings, which are not intended to limit the invention in any way. Furthermore, unless otherwise stated, the drawings are not to scale.

[0139] Preparation of holding device

[0140] Adopting such Figure 1 and Figure 2 The retaining device (also known as a nested structure) of the design shown is made of polypropylene by injection molding. Figure 1 and Figure 2 The description uses the following terms to refer to specific locations of these retaining devices, such as the first side, the other side, the intermediate surface, and the inner surface of the receiving portion. These terms are consistent with the terms used herein to describe the invention.

[0141] After demolding and before loading the syringes as primary packaging containers, no post-processing, particularly deburring, was performed on the retaining devices of the comparative examples. Optical microscopy studies revealed burrs at various locations on the surfaces of these retaining devices, particularly on the first and second sides of the receiving portion, the intermediate surface between the first and second sides, and the inner surface of the receiving portion. The height of these burrs typically ranged from 90 to 150 micrometers. A significant number of burrs exhibited considerably greater heights, for example, exceeding 500 micrometers. Figure 15 The microscope image shows an exemplary burr. The total height R of the roughness profile can be predicted. t It should be at least as high as the highest burr on that roughness profile.

[0142] For each of Examples 1 through 4, a deburring process was performed on specific locations of the retaining device after demolding and before loading the syringe. These locations were selected from those that had burrs before deburring, namely, the first and other sides of the receiving portion, the intermediate surface between the first and other sides, and the inner surface of the receiving portion. Table 1 below summarizes which locations were deburred in which examples. In each case, deburring was performed manually by carefully and thoroughly processing the corresponding location with a deburring knife. When deburring the edges, a GRATTEC Keramicut ROTO 75° deburring knife from IBT Ingenieurbüro Thiermann GmbH, Wiesbaden, Germany, was used. When deburring the surface, a GRATTEC Keramicut I deburring knife, also from IBT Ingenieurbüro Thiermann GmbH, Wiesbaden, Germany, was used. Studies based on optical microscopy have shown that performing this procedure can avoid burrs such as... Figure 15 The burrs shown. Table 1 Comparative example Unremoved burrs Unremoved burrs Unremoved burrs Unremoved burrs Example 1 Deburring Unremoved burrs Unremoved burrs Unremoved burrs Example 2 Deburring Deburring Unremoved burrs Unremoved burrs Example 3 Deburring Deburring Deburring Unremoved burrs Example 4 Deburring Deburring Deburring Deburring

[0143] After the retaining devices in Comparative Examples and Examples 1 to 4 were prepared as described above, the total height R of the roughness profiles of the first and other sides of the receiving portion was determined according to the test method described above. t The maximum total height R of the roughness profile between the intermediate surfaces of the first and the other sides. t And the maximum total height R of the roughness profile of the inner surface. t The total height R of the roughness profile t (also known as R) t The value is determined for each of the 10 optional holding devices in each comparative example and example.

[0144] The results show that, for the comparative example's retaining device with less than 50% of the accommodating portion, the aforementioned R... t The value is 500 micrometers or smaller. For more than half of these accommodating portions, the aforementioned R... t The value is greater than 90 micrometers. For the 10 holding devices in the comparative example, there is actually not a single accommodating portion with an R value. t The value is 20 micrometers or less. The undeburred locations of the retaining devices in Examples 1 to 3 show an R value similar to the corresponding locations of the retaining devices in the comparative examples. t Value. Conversely, in Examples 1 through 4, the R value at the deburring location. t The values ​​are almost all below 500 micrometers. Similarly, the R value at nearly 100% of the deburred locations is... t A value of 90 micrometers or less, with at least 50% of the deburred area having an R value. t The value is 20 micrometers or smaller.

[0145] Transportation Simulation

[0146] Each holding device in Comparative Examples and Examples 1 through 4 is fully loaded with 64 empty syringes with stoppers but without plungers. The syringes are available from Schott AG. 5ml lg type. Figure 5 This is a schematic diagram of such a syringe. The container wall of the syringe is composed of a cyclic olefin copolymer (COC). Figure 10 As illustrated in the diagram, the syringe is held in the receiving portion of the retaining device.

[0147] Place each of the loaded nested structures (holding devices) from the comparative examples and examples 1 to 4 into the box. Typically, the boxes containing the nested structures are as follows: Figure 3 As shown in the figure. The design of the nested structure differs slightly in the figure. Accordingly, the number and arrangement of the receiving parts and thus the syringes differ from the number and arrangement in the actual nested structures of the comparative and example examples. Reference Figure 3 This is only to illustrate the general nature of the nested structure contained within the box. Each filled box is sealed by sealing the vent cap to the top edge of the box with hot melt adhesive. Figure 3 In the middle, the cover has been partially peeled off.

[0148] For each of the comparative examples and examples 1 through 4, a sample was prepared for transport simulation. Each sample was a pallet unit comprising a wooden pallet upon which a corrugated cardboard box was placed, such that the overall dimensions of the sample met the following conditions: Length: 1200 mm; Width: 800 mm; Height: 940 mm.

[0149] These boxes are held together tightly with plastic stretch foil. For each of the comparative examples and examples 1 through 4, the boxes are filled with the same boxes already filled with the nested structure and sealed as described above. The boxes do not contain any additional filler material.

[0150] For each of the comparative examples and examples 1 to 4, the transport simulation was performed according to the test method paragraph described above. After the transport simulation was performed, the particle load on the outer surface of the syringe was determined according to the further description in the test method paragraph.

[0151] Evaluate

[0152] Figure 16a A photograph of a typical syringe for a comparative example is shown after transport simulation of the corresponding sample. Numerous macroscopic particles are clearly visible on the outer surface. Most of these particles originate from a nested structure, and therefore are composed of polypropylene. Figure 16b A photograph of a typical syringe from Example 4 is shown after a transport simulation of the corresponding sample. Figure 16a on the contrary, Figure 16b Only a very small number of particles can be seen on the outer surface of the syringe.

[0153] These results are surprising because the deburring post-processing and handling of the involved nested structures were predicted to result in a large amount of polypropylene particle generation. This is especially true because deburring implies cutting off portions from the retaining device. Cutting is expected to produce a large number of macroscopic and microscopic particles. Contrary to this technically reasonable expectation, the results show that a fairly high R0 during transport simulations... t The particle generation caused by the value far exceeds the particle generation effect of the deburring process.

[0154] The above reference Figure 16a and 16b The qualitative results described are supported by quantitative measurements of particle load on the outer surface of the syringe after transport simulation. Table 2 below summarizes the particle load measurements by comparing the particle loads of two different size classes of syringes provided for comparative examples and examples 1 to 4. In Table 2, ++ indicates fewer than ++ particles, ++ indicates fewer than + particles, + indicates fewer than 0 particles, 0 indicates fewer than - particles, and - indicates fewer than -- particles. Table 2

[0155] The results clearly demonstrate that the loading of particles with a diameter of at least 5 micrometers and the loading of particles with a diameter as small as 2 micrometers are both affected by R. t The value decreases, wherein the Rt The values ​​are 500 micrometers or less, almost all of them are 90 micrometers or less, and at least 50% are 20 micrometers or less.

[0156] In the field of pharmaceutical packaging, particularly when packaging parenteralia, it is crucial to strictly prevent syringes from being contaminated by any type of mobile particle. Specifically, particles as small as 2 micrometers to less than 5 micrometers can pose serious safety problems for syringes because these particles can enter the syringe during the filling process and, in the worst case, could be injected into the patient. Furthermore, larger particles on the syringe surface can hinder optical inspection of the syringe for quality control. As the test results given above demonstrate, this invention can improve the safety of pharmaceutical packaging and further enhance the quality control of primary pharmaceutical packaging containers. Attached Figure Description

[0157] Unless otherwise stated in the instruction manual or specific illustrations:

[0158] Figure 1 A top view schematic diagram of the retaining device according to the present invention is shown;

[0159] Figure 2 It shows Figure 1 A bottom view of the retaining device;

[0160] Figure 3 A schematic diagram of a transport unit according to the present invention is shown;

[0161] Figure 4 A cross-sectional view of the transport unit according to the present invention is shown;

[0162] Figure 5 A schematic diagram of the primary packaging container is shown;

[0163] Figure 6 A schematic diagram of another primary packaging container is shown;

[0164] Figure 7 A flowchart is shown for a method of producing the holding device according to the invention;

[0165] Figure 8 It shows Figure 4 A schematic diagram of the cross-section of the receiving portion of the holding device;

[0166] Figure 9a It shows Figure 8 Another schematic diagram of the cross-section of the receiving part;

[0167] Figure 9b It shows Figure 9a A schematic diagram of the cross-section of the transverse plane in ().

[0168] Figure 10 A schematic cross-sectional view of another receiving portion of the retaining device according to the present invention is shown;

[0169] Figure 11 A schematic cross-sectional view of another receiving portion of the retaining device according to the present invention is shown;

[0170] Figure 12 A schematic cross-sectional view of another receiving portion of the retaining device according to the present invention is shown;

[0171] Figure 13 A schematic cross-sectional view of another receiving portion of the retaining device according to the present invention is shown;

[0172] Figure 14a A schematic cross-sectional view of a portion of the receiving part of the retaining device according to the present invention is shown;

[0173] Figure 14b A schematic cross-sectional view of a portion of another receiving part of the retaining device according to the present invention is shown;

[0174] Figure 15 An optical micrograph of burrs on the edge of the receiving portion is shown;

[0175] Figure 16a A photograph of the syringe used in the comparative example after the transport simulation is shown;

[0176] Figure 16b A photograph of the syringe in Example 4 is shown after the transportation simulation;

[0177] Figure 17a The total height R is shown to determine the roughness profile of the inner surface in each cross-section. t ;

[0178] Figure 17b The total height R is shown to determine the roughness profile of the side surface of the retaining part in each cross section. t ;and

[0179] Figure 17c The roughness profile for each intermediate surface is shown. Detailed Implementation

[0180] Figure 1A schematic diagram of a holding device 100 according to the present invention is shown. The holding device 100 is used to hold a plurality of primary packaging containers 304 for pharmaceutical, medical, or cosmetic compositions. The figure is a top view of the holding device 100, which is made of polypropylene by injection molding. The holding device 100 includes a plate-shaped carrier element 101, which includes a plurality of through holes 102. The term "plate-shaped" means that the width 113 and length 112 of the carrier element 101 are both more than 50 times the thickness of the carrier element. Here, the thickness is 1 mm. Furthermore, the holding device 100 includes a plurality of receiving portions 103. Each receiving portion 103 is designed and configured to receive one of the primary packaging containers 304. Each receiving portion 103 includes a receiving portion wall 104 that partially surrounds the interior 105 of the receiving portion. Each receiving portion wall 104 forms a wall extending longitudinally 106 through one of the plurality of through holes 102. Here, the wall is a hollow cylinder. For each receiving portion 103, the wall has an inner surface 110 facing the interior 105 of the receiving portion and an outer surface 111 opposite to the inner surface 110. Furthermore, each wall has a first opening 107 located at a first end 108. The first opening 107 of each wall is laterally directly surrounded by a first side 109 of the corresponding wall. The total height R of the roughness profile of the first side 109 of each receiving portion 103 is... t No more than 0.5 mm.

[0181] Figure 2 It shows Figure 1 A bottom view of the retaining device 100. As can be seen from this view, each wall also has another opening 201 located at the other end 202, wherein the other end 202 is opposite the first end 108 in the longitudinal direction 106 (see...). Figure 1 Each other opening 201 is laterally directly surrounded by at least one other side 203 of the corresponding wall. The total height R of the roughness profile of the other side 203 of each receiving portion 103 is... t No more than 0.5 mm.

[0182] Figure 3 A schematic diagram of a transport unit 300 according to the invention is shown. The transport unit 300 includes a component 301 according to the invention and a secondary packaging container 302. The latter is a box made of plastic by deep drawing. The box is closed by a vented cover 303, which is attached to the box but has been partially peeled off to expose the component 301 inside the box. The component 301 consists of a retaining device 100 according to the invention and a plurality of primary packaging containers 304. Each primary packaging container is housed in a receiving portion 103 of the retaining device 100.

[0183] Figure 4A cross-sectional view of a transport unit 300 according to the invention is shown; the transport unit 300 also includes a component 301 according to the invention and a secondary packaging container 302. The latter is a box made of plastic by deep drawing. The component 301 consists of a retaining device 100 according to the invention and a plurality of primary packaging containers 304. Each primary packaging container is housed in a receiving portion 103 of the retaining device 100. Here, the primary packaging container 304 is a syringe. The retaining device 100 is made of plastic by injection molding.

[0184] Figure 5 A schematic diagram of a primary packaging container 304 is shown, wherein the primary packaging container 304 is from Schott AG. A 5ml 1g syringe. The syringe includes a container wall 505 that partially surrounds the interior 506 of the container. The container wall 505 is made of a cyclic olefin copolymer (COC) and is formed, in a top-to-bottom order (from right to left in the figure based on the syringe itself), a first end 501 including a discharge port 504, a body portion 502, and a second end 503. The body portion 502, also referred to in the art as a cylinder, is a hollow cylinder. The second end 503 includes another hole 510. The orifice area of ​​the discharge port 504 is smaller than the orifice area of ​​the other hole 510. The other hole 510 receives a plunger 511. The second end 503 also includes a flange 509, also referred to in the art as a flange, which projects laterally from the body portion 502 and surrounds the other hole 510. The container wall 505 is made of a cyclic olefin copolymer. The first end 501 includes a connecting element, which is a protrusion 507 of a Luer connector. The connecting element includes threads for connecting a hypodermic needle to a syringe. The threads are disposed within a sleeve. Figure 4 , Figure 8 and Figures 10 to 13 The syringe in component 301 is Figure 5 The syringe is of the type shown, however, it does not contain plunger 511.

[0185] Figure 6 A schematic diagram of another primary packaging container 304 is shown, which is a vial. The vial includes a container wall 505 that partially surrounds the interior 506 of the container. The container wall 505, from top to bottom, sequentially forms a first end 501 including a discharge port 504, a main body 502, and a second end 503. The main body 502 is a hollow cylinder. The second end 503 includes a vertical base 605. In addition to the discharge port 504, the first end 501 also includes a flange 601 and a neck 602. The main body 502 is connected to the first end 501 via a shoulder 603. The second end 503 is connected to the main body 502 via a heel 604. The container wall 505 is made of type I borosilicate glass.

[0186] Figure 7 A flowchart of a method 700 for producing a retaining device 100 according to the invention by injection molding is shown. Method 700 includes the following steps: a) 701: providing a first part of a mold and another part of a mold; b) 702: positioning the first part and the other part relative to each other such that the first part and the other part together at least partially surround the interior of the mold; c) 703: introducing a polymer melt into the interior of the mold; d) 704: solidifying the polymer melt inside the mold to obtain a molded body; and e) 705: demolding the molded body.

[0187] Figure 8 It shows Figure 4 A schematic cross-sectional view of the receiving portion 103 of the holding device 100. Only a portion of the holding device 100 is shown here. Correspondingly, only a portion of the plate-shaped carrier element 101 is shown. The primary packaging container 304 is... Figure 5 The syringe of the type shown is housed in a receiving portion 103. The receiving portion 103 includes a receiving portion wall 104 that partially surrounds the receiving portion interior 105. The receiving portion wall 104 forms a wall extending along a longitudinal direction 106. A transverse direction 801 is perpendicular to the longitudinal direction 106.

[0188] The wall has an inner surface 110 facing the interior 105 of the receiving portion and an outer surface 111 opposite to the inner surface 110. Furthermore, the wall has a first opening 107 located at a first end 108. The first opening 107 is directly and laterally surrounded by exactly one first side 109 of the wall. Here, the first side 109 is the inner edge at the first end 108 of the receiving portion wall 104. The total height R of the roughness profile of the first side 109 is... t No larger than 0.05 mm. This applies to Figure 4 The wall 104 contains at least 90% of the receiving portion 103 of the holding device 100 of component 301. Furthermore, the wall has another opening 201 located at the other end 202, which is opposite the first end 108 in the longitudinal direction 106. This other opening 201 is directly surrounded laterally by exactly one other side 203 of the wall. Here, the other side 203 is the inner edge at the other end 202 of the receiving portion wall 104. The total height R of the roughness profile of the other side 203 is... t It is also no larger than 0.05 millimeters. This also applies to... Figure 4 The holding device 100 of component 301 contains at least 90% of the receiving portion 103.

[0189] Figure 9a It shows Figure 8 Another schematic diagram of the accommodating portion 103 is shown. This schematic diagram lacks [the following details]. Figure 8The syringe is located in the container. The wall of the receiving portion 103 has two intermediate surfaces 901. The intermediate surfaces 901 are neither part of the inner surface 110 nor the outer surface 111. One of the intermediate surfaces 901 faces the longitudinal direction 106, and the other faces the opposite direction of the longitudinal direction 106. The intermediate surface 901 at the first end 108 is located between the first side 109 and the outer edge of the receiving portion wall 104 at the first end 108. The intermediate surface 901 at the other end 202 is located between the other side 203 and the outer edge of the receiving portion wall 104 at the other end 202. For each of the two intermediate surfaces 901, the maximum total height R of the roughness profile is... t No more than 0.050 mm. This also applies to Figure 4 The holding device 100 of component 301 contains at least 90% of the receiving portion 103. Figure 9a The dashed lines in the middle represent Figure 9b The plane 902 shows the cross-section 904 of the accommodating portion 103. This cross-section 904 is an example of all cross-sections 904 of the accommodating portion 103, which includes a portion of the inner surface 110. The wall is symmetrical about the central longitudinal axis 903. Accordingly, the first opening 107 and the other opening 201 are circular, and the first side 109 and the other side 203 are circular lines (see also...). Figure 9b ).

[0190] Figure 9b It shows Figure 9a A schematic diagram of an exemplary cross-section 904 of the receiving portion 103. The maximum total height R of the roughness profile of the inner surface 110. t No larger than 0.070 mm. This applies to Figure 4 The holding device 100 of component 301 contains at least 80% of the receiving portion 103.

[0191] Figure 10 A schematic diagram of another receiving portion 103 of the retaining device 100 according to the present invention is shown. Figure 8 As shown, only a portion of the holding device 100 and a portion of the plate-shaped carrier element 101 are shown. The primary packaging container 304 is... Figure 5 The syringe of the type shown is housed in the receiving part 103. Figure 10 The accommodating part 103 in the middle is designed as Figure 8 The accommodating part in the middle. However, Figure 10 The receiving portion wall 104 has another side 203, but no outer edge at the other end 202. This is because the other end 202 is flush with the plate-shaped carrier element 101.

[0192] Figure 11 A schematic diagram of another receiving portion 103 of the retaining device 100 according to the present invention is shown. Figure 8As shown, only a portion of the holding device 100 and a portion of the plate-shaped carrier element 101 are shown. The primary packaging container 304 is... Figure 5 The syringe of the type shown is housed in the receiving part 103. Figure 11 The accommodating part 103 in the middle is designed as Figure 8 The accommodating part in the middle. However, Figure 11 The wall of the receiving portion includes a retaining portion 1101. The retaining portion 1101 extends laterally, i.e., along the transverse direction 801, and restricts the interior 105 of the receiving portion in the longitudinal direction 106. Furthermore, the retaining portion 1101 includes another opening 201. Therefore, the receiving portion has two additional sides 203. These two additional sides 203 are the upper and lower edges of the side surface 1102 of the retaining portion 1101. The side surface 1102 directly surrounds the other opening 201. The maximum total height R of the roughness profile of the side surface 1102 is... t No more than 0.050 mm.

[0193] Figure 12 A schematic diagram of another receiving portion 103 of the retaining device 100 according to the present invention is shown. Figure 11 As shown, only a portion of the holding device 100 and a portion of the plate-shaped carrier element 101 are shown. The primary packaging container 304 is... Figure 5 The syringe of the type shown is housed in the receiving part 103. Figure 12 The accommodating part 103 in the middle is designed as Figure 11 The accommodating part in the middle. However, Figure 12 The accommodating wall 104 has a first side 109, but no outer edge at the first end 108. This is because the first end 108 is flush with the plate-shaped carrier element 101.

[0194] Figure 13 A schematic diagram of another receiving portion 103 of the retaining device 100 according to the present invention is shown. Figure 12 As shown, only a portion of the holding device 100 and a portion of the plate-shaped carrier element 101 are shown. The primary packaging container 304 is... Figure 5 The syringe of the type shown is housed in the receiving part 103. Figure 13 The overall design of the accommodating part 103 and Figure 11 The accommodating part is the same as the one in the previous one, only it has been inverted.

[0195] Figure 14a A schematic cross-sectional view of a portion of the receiving portion 103 of the retaining device 100 according to the present invention is shown. More specifically, Figure 14a It shows Figure 8 The first end 108 of the wall of the receiving portion is shown in the figure. The syringe is not shown in this figure. This figure is intended to provide a closer view of the location of the first side 109 and the intermediate surface 901.

[0196] Figure 14b A schematic cross-sectional view of a portion of the receiving portion 103 of the retaining device 100 according to the present invention is shown. More specifically, Figure 14b It shows Figure 2 The first end 108 of the wall of the middle receiving portion. The syringe is not shown in this figure. This figure is intended to provide a closer view of the location of the first side 109 and the intermediate surface 901.

[0197] Figure 15 An optical micrograph 1500 is shown of a burr 1501 on the edge of the receiving portion. The height of the burr 1501 is 146.009 micrometers. The burr 1501 is the highest point on this edge. Furthermore, the height of the burr 1501 is much greater than any valley on the roughness profile of this edge. Therefore, the total height R of the roughness profile of this edge with the burr 1501 is... t It is only slightly higher than 146 micrometers.

[0198] Figure 16a A photograph of the primary packaging container 304 is shown. The primary packaging container 304 is a syringe used as a comparative example after a transport simulation. Numerous macroscopic particles are clearly present on the outer surface of the container wall 505. The syringe edge 509 and another hole 510 are visible from the bottom of the figure.

[0199] Figure 16b A photograph of another primary packaging container, 304, is shown. This primary packaging container is the syringe from Example 4 after the transport simulation. Figure 16a In comparison, far fewer particles are visible on the outer surface of container wall 505.

[0200] Figure 17a The maximum total height R is shown to define the roughness profile of the inner surface 110 of the cylindrical portion. t The grid formed by the imaginary lines 1701 of the first set of equidistant lines and 1702 of the second set of equidistant lines completely covers the inner surface 110. A distance 1703 exists between two adjacent equidistant lines. The R-value of each roughness profile along the lines 1701 of the first set of equidistant lines and 1702 of the second set of equidistant lines is determined. t Values. These R values. t The maximum value is the maximum total height R of the roughness profile of the inner surface 110. t .

[0201] Figure 17b The maximum total height R is shown to define the roughness profile of the side surface 1102 of the retaining part 1101. t The retaining part 1101 is a hollow cylindrical shape. Figure 12This retaining part 1101 is shown. The side surface 1102 of the retaining part 1101 is the inner surface of a hollow cylinder. Therefore, the side surface 1102 is cylindrical. The grid formed by the imaginary lines 1701 of the first set of equidistant lines and the imaginary lines 1702 of the second set of equidistant lines completely covers the side surface 1102. There is a distance 1703 between two adjacent equidistant lines. The R of each roughness profile along the lines 1701 of the first set of equidistant lines and the lines 1702 of the second set of equidistant lines is determined. t Values. These R values. t The maximum value is the maximum total height R of the roughness profile of the side surface 1102 of the retaining part 1101. t .

[0202] Figure 17c The maximum total height R is shown to determine the roughness profile of intermediate surface 901. t Such an intermediate surface 901 can be seen at the first end 108 and the other end 202 of the accommodating portion 103, as... Figure 9a As shown. These intermediate surfaces 901 are annular. In Figure 17c In this context, the intermediate surface 901 surrounds the interior 105 of the container. A rectangular grid formed by imaginary lines 1701 of the first set of equidistant lines and imaginary lines 1702 of the second set of equidistant lines completely covers the intermediate surface 901. A distance 1703 exists between two adjacent equidistant lines. For each of lines 1701 and 1702, the total height R of the roughness profile along that line is determined. t These R t The maximum value is the maximum total height R of the roughness profile of the intermediate surface 901. t . Explanation of reference numerals in the attached figures 100 Holding device according to the invention 101 Plate-shaped carrier element 102 Through Hole 103. Storage Unit 104 Reception Wall 105. Interior of the accommodating section 106 Vertical 107 First Opening 108 First End 109 First side 110 Inner Surface 111 Outer surface 112 Length 113 width 201 Another opening 202 The other end 203 On the other side 300 Transport unit according to the present invention 301 Components according to the present invention 302 Secondary Packaging Container 303 lid 304 primary packaging containers 501 First end 502 Main Body 503 The other end 504 emission outlet 505 container wall 506 Inside the container 507 Luer connector protrusion 508 Plug 509 edge 510 Another hole 511 plunger 601 flange 602 Neck 603 Shoulder 604 Follow-up Department 605 Vertical Base 700 Method for producing the holding device of the present invention 701 Method and Steps a) 702 Method and Steps (b) 703 Method Steps c) 704 Method and Step d) 705 Method and Step e) 801 Horizontal 901 Intermediate Surface 902 The plane containing the cross-section 903 Central longitudinal axis 904 cross-section 1101 Maintenance Department 1102 Side Surface 1500 optical micrographs 1501 Burrs 1701 First set of equidistant lines 1702 Second set of equidistant lines 1703 Distance between adjacent equidistant lines

Claims

1. A holding device (100) for holding a plurality of primary packaging containers (304) for pharmaceutical, medical, or cosmetic compositions, said holding device (100) comprising: - A plate-shaped carrier element (101) including multiple through holes (102); and - Multiple receiving portions (103), each of which is designed and configured to receive one of the primary packaging containers (304); Each accommodating portion (103) includes a accommodating portion wall (104) that partially surrounds the interior (105) of the accommodating portion. Each accommodating part wall (104) forms a wall body; Each wall - Extends longitudinally (106) through one of the multiple through holes (102). - It has a first opening (107) at a first end (108) and another opening (201) at the other end (202), wherein the other end (202) is opposite to the first end (108) in the longitudinal direction (106); In this case, the first opening (107) of each wall is directly surrounded laterally by at least one first side (109) of the corresponding wall; In this case, another opening (201) of each wall is directly surrounded laterally by at least one other side (203) of the corresponding wall; The feature is that the total height R of the roughness profile of at least 50% of the plurality of accommodating portions (103) of at least one first side (109) and / or at least one other side (203) is [missing information]. t No more than 0.50 mm, For each of the plurality of accommodating portions (103), the wall includes a retaining portion (1101), the retaining portion (1101) - Extend laterally - The interior (105) of the accommodating portion is restricted in the longitudinal direction (106) or in the opposite direction of the longitudinal direction (106), and - Including the first opening (107) or the other opening (201); In each of the plurality of accommodating portions (103), the first opening (107) or the other opening (201) is laterally restricted by the side surface (1102) of the retaining portion (1101). Among them, the maximum total height R of the roughness profile of the side surface (1102) of the holding portion (1101) of at least 50% of the plurality of accommodating portions (103) is... t No more than 0.50 mm.

2. The holding device (100) according to claim 1, wherein, For each of the plurality of accommodating portions (103), the wall has - The inner surface (110) facing the interior (105) of the accommodating portion, and - The outer surface (111) opposite to the inner surface (110).

3. A holding device (100) for holding a plurality of primary packaging containers (304) for pharmaceutical, medical, or cosmetic compositions, said holding device (100) comprising: - A plate-shaped carrier element (101) including multiple through holes (102), and - Multiple receiving portions (103), each of which is designed and configured to receive one of the primary packaging containers (304). Each accommodating portion (103) includes a accommodating portion wall (104) that partially surrounds the interior (105) of the accommodating portion. Each accommodating part wall (104) forms a wall body; Each wall extends longitudinally (106) through one of the plurality of through holes (102). Wherein, for each of the plurality of accommodating portions (103), the wall has - The inner surface (110) facing the interior (105) of the accommodating portion, and - The outer surface (111) opposite to the inner surface (110); Characterized by the fact that the maximum total height R of the roughness profile of the inner surface (110) of at least 50% of the plurality of accommodating portions (103) is [missing information]. t No more than 0.50 mm, Each wall has a first opening (107) at a first end (108) and another opening (201) at a second end (202), the second end (202) being opposite the first end (108) in the longitudinal direction (106). For each of the plurality of accommodating portions (103), the wall includes a retaining portion (1101), the retaining portion (1101) - Extend laterally - The interior (105) of the accommodating portion is restricted in the longitudinal direction (106) or in the opposite direction of the longitudinal direction (106), and - Including the first opening (107) or the other opening (201); In each of the plurality of accommodating portions (103), the first opening (107) or the other opening (201) is laterally restricted by the side surface (1102) of the retaining portion (1101). Among them, the maximum total height R of the roughness profile of the side surface (1102) of the holding portion (1101) of at least 50% of the plurality of accommodating portions (103) is... t No more than 0.50 mm.

4. The holding device (100) according to claim 3, wherein, The first opening (107) of each wall is directly surrounded laterally by at least one first side (109) of the corresponding wall; The other opening (201) of each wall is directly surrounded laterally by at least one other side (203) of the corresponding wall.

5. The retaining device (100) according to any one of claims 2 to 4, wherein, For each of the plurality of accommodating portions (103), the wall body further has at least one intermediate surface (901), the at least one intermediate surface (901) - Not part of the inner surface (110) nor part of the outer surface (111), and - Towards the longitudinal direction (106) or the opposite direction of the longitudinal direction (106), Among them, the maximum total height R of the roughness profile of at least 50% of the intermediate surfaces (901) of the plurality of accommodating portions (103) is... t No more than 0.50 mm.

6. The holding device (100) according to any one of the preceding claims, wherein, The primary packaging container (304) of the plurality of primary packaging containers (304) is selected from vials, syringes, cartridges, ampoules, or combinations of at least two of them.

7. A method (700) for producing a holding device (100) according to any one of the preceding claims, the method comprising the following steps: a) Provide i) the first part of the mold and ii) the other part of the mold; b) Position the first component and the other component relative to each other such that the first component and the other component together at least partially surround the interior of the mold; c) Introducing the polymer composition into the interior of the mold; d) Curing the polymer composition inside the mold to obtain a molded body; and e) Demold the molded body.

8. The method (700) according to claim 7, wherein, The molded body demolded in step e) of the method is the retaining device (100); and / or The method (700) includes another method step, which includes processing the molded body, the holding device (100) being obtained from the molded body through the processing.

9. A component (301), comprising: - The holding device (100) according to any one of claims 1 to 6, or the holding device (100) obtainable by the method (700) according to claim 7 or 8; and - The plurality of primary packaging containers (304); Each of the primary packaging containers (304) is housed in one of the receiving portions (103).

10. A transport unit (300), comprising: - The component (301) according to claim 9; and - Secondary packaging container (302); The retaining device and the plurality of primary packaging containers are completely arranged in the secondary packaging container.

11. Use of the holding device according to any one of claims 1 to 6, or use of the holding device obtainable by the method according to claim 7 or 8, or use of the component according to claim 9, or use of the transport unit according to claim 10, respectively for storing or transporting the plurality of primary packaging containers.

12. Use of the retaining device according to any one of claims 1 to 6, or use of the retaining device obtainable by the method according to claim 7 or 8, wherein the retaining device is used to retain the plurality of primary packaging containers during the step of filling the primary packaging containers with a pharmaceutical, medical, or cosmetic composition.

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