Cassette bottle nesting device with integrated centering feature of cassette bottle

Abstract

The invention relates to a cartridge bottle nesting device with integrated centering features of cartridge bottles. The retaining structure is used for simultaneously retaining a plurality of primary packaging containers and comprises: a plurality of brackets for accommodating at least sections of elongated cylindrical regions of the primary packaging containers; an alignment element in each bracket, the alignment element projecting radially into the bracket and configured to contact a portion of the outer surface of the elongated cylindrical region of the primary packaging container received in the bracket; the alignment element in each holder is configured to contact a portion of the outer surface of the elongated cylindrical region such that the primary packaging container housed in the holder in the rest position is inclined at an angle a of no greater than 2.4 degrees, the inclination angle alpha is an angle formed between the longitudinal axis L receptacle and the longitudinal axis L container of the primary packaging container housed in the receptacle.

Description

Technical Field

[0001] The present invention relates to a holding structure for simultaneously holding a plurality of containers, preferably a plurality of cartridges, of substances for pharmaceutical, medical or cosmetic applications, a device comprising the holding structure and a plurality of containers, a transport unit comprising the device and a secondary packaging container, and the use of the holding structure. Background Art

[0002] Containers made of glass, and later also of polymers, have long been used to safely store liquids and powders. Over the past few decades, the technology for transporting fluids and powders using glass and polymer containers has become increasingly diverse and complex. One such technology relates to the technical field of the present application: pharmaceutical packaging. In the pharmaceutical industry, containers such as vials, syringes, ampoules, and cartridges are used as primary packaging for a variety of pharmaceutical-related compositions, particularly pharmaceuticals (such as parenteral medications, including vaccines), and also for cosmetic compositions, particularly those injected into the skin.

[0003] In the handling of containers for pharmaceutical or cosmetic applications, it is now often preferred to use so-called nesting solutions, in which a plurality of primary packaging containers are simultaneously held or supported in a given configuration using a holding structure for the container (also called a "nesting device"). Examples of known nesting solutions are available from Schott Pharma AG and Schott The nested device with the primary packaging container is commercially available under the trade name of the platform. When delivered to a customer, such as a pharmaceutical company or a filling company, the nested device with the primary packaging container is typically packaged in a transport or packaging container (also called a "tub"). For further processing of the primary packaging container, the tub is opened. Further processing of the primary packaging container often includes the following automated steps: removing the primary packaging container from the tub; filling the primary packaging container with a composition, such as a pharmaceutical composition or a cosmetic composition; and closing the prefilled primary packaging container.

[0004] To fill containers held in the holding structure, filling nozzles are used, which are inserted somewhat into the container's opening. During this type of automated filling process, the container must be positioned as parallel as possible to the axis of the filling nozzle. If this is not the case, and the container is positioned at a slight angle, the filling needle can collide with a tilted container, potentially causing fluctuations in the filling level or even damage to the filling nozzle. Furthermore, incorrect container positioning can lead to malfunctions or errors when lifting the container before filling, as the crimping mechanism can become stuck on the holding feature.

[0005] In prior art automated filling processes, separate positioning aids in the form of multi-well plates are used to ensure parallel positioning of each container housed within the support structure. However, not only do these positioning aids require additional components in the automated filling process, they can also be problematic because if a container is tilted to a certain extent within the holding structure, it becomes more difficult to introduce the open end of the container into the multi-well plate. Furthermore, maneuvering machine components such as multi-well plates over open containers that may already contain medication can lead to contamination of the filled containers. Finally, depending on the material quality of the multi-well plates, which are often used to ensure proper container alignment, friction between the multi-well plates and the containers can cause wear on the glass surface, potentially damaging the containers. Summary of the Invention

[0006] In general, the object of the present invention is to at least partially overcome the disadvantages of the prior art.

[0007] In particular, the present invention aims to provide a nesting solution for pharmaceutical, medical, or cosmetic containers that allows for the most efficient filling of the containers housed in the nesting device without the need for separate positioning devices. More particularly, the nesting solution should allow for filling of the containers in the nesting device without damaging the containers with needles used for filling, and should minimize filling level fluctuations even without the use of additional separate positioning devices. Furthermore, the nesting solution should allow for the insertion and removal of packaging containers into and from the nesting device with minimal wear on the outer surfaces of the packaging containers.

[0008] At least one, preferably more than one, of the above objects is at least partially achieved by the independent claims. The dependent claims provide preferred embodiments, which at least partially achieve at least one of the objects.

[0009] |1a| At least one of the objects according to the present invention is achieved by a first embodiment of a holding structure for simultaneously holding a plurality of primary packaging containers of substances for pharmaceutical, medical or cosmetic applications, each primary packaging container comprising an elongated cylindrical region having a longitudinal axis L 容器 , the longitudinal axis L 容器 In the longitudinal direction passing through the center of the elongated cylindrical region, the retaining structure comprises:

[0010] a plurality of receptacles for receiving at least a section of said elongated cylindrical region of said primary packaging container, each receptacle having a depth h, an upper end, a bottom end, a circumferentially formed side wall and a longitudinal axis L 托座, the upper end is used to insert the primary packaging container into the holder, the bottom end has a retaining portion, the retaining portion is configured to limit the axial movement of the primary packaging container in the holder, the side wall extends in the longitudinal direction from the upper end to the bottom end, and the longitudinal axis L 托座 Passing through the center of the bracket in the longitudinal direction;

[0011] an alignment element in each receptacle, said alignment element protruding radially into said receptacle and configured and adapted to contact a portion of the outer surface of the elongated cylindrical region of the primary packaging container housed in said receptacle;

[0012] wherein the alignment element in each receptacle is configured and adapted to contact a portion of the outer surface of the elongated cylindrical region so that the primary packaging container accommodated in the receptacle in the rest position is tilted at an angle α of not more than 2.4 degrees, preferably not more than 2.2 degrees, more preferably not more than 2.0 degrees, even more preferably not more than 1.8 degrees, even more preferably not more than 1.6 degrees, even more preferably not more than 1.4 degrees, even more preferably not more than 1.2 degrees and most preferably not more than 1 degree, the tilt angle α being a value measured along the longitudinal axis L 托座 with the longitudinal axis L of the primary packaging container accommodated in the receptacle 容器 , and the rest position is a position in which the retaining portion limits the axial movement of the primary packaging container accommodated in the receptacle. Most preferably, in the rest position the primary packaging container accommodated in the receptacle is not tilted at all, i.e. α is 0 degrees.

[0013] As used herein, the term "a plurality of receptacles for receiving primary packaging containers therein at least in sections" means that the depth h of the receptacles is smaller than the height of the primary packaging containers to be accommodated in the receptacles, so that in the rest position, parts of the primary packaging containers protrude from the receptacles.

[0014] To ensure that the primary packaging container in the retaining structure tilts as little as possible in the holder, one could consider increasing the guide length, thereby increasing the holder depth, or reducing the inner diameter of the holder in which the primary packaging container is housed. However, these measures can lead to particle generation during the manufacturing process (i.e., during the injection molding process) due to wear during the demoulding process. Furthermore, inserting and removing a primary packaging container in a retaining structure with a large contact surface and a small pocket inner diameter can lead to various defects, such as particle generation, damage to the primary packaging container surface, or jamming of the primary packaging container in the retaining structure.

[0015] Surprisingly, however, it has been observed that by providing alignment elements arranged in the holder, which contact only a portion of the outer surface of the primary packaging containers, more precisely, only a portion of the outer surface of the elongated cylindrical region of these containers, it is possible to ensure that the primary packaging containers are aligned as vertically as possible in the holding structure. Consequently, in order to achieve parallel alignment of the primary packaging containers in the holding structure, it is not necessary to increase the depth of the holder, nor to reduce its diameter, or to use separate positioning devices (although such positioning devices can still be used, since the alignment elements also facilitate the introduction of the containers into the holes of the positioning devices).

[0016] |2a| According to a preferred embodiment of the holding structure according to the present invention, the alignment element in each receptacle is configured and adapted to contact a portion of the outer surface of the elongated cylindrical region so that the primary packaging container accommodated in the receptacle in the raised position remains tilted at an angle α' of not more than 2.4 degrees, preferably not more than 2.2 degrees, more preferably not more than 2.0 degrees, even more preferably not more than 1.8 degrees, even more preferably not more than 1.6 degrees, even more preferably not more than 1.4 degrees, even more preferably not more than 1.2 degrees and most preferably not more than 1.0 degrees, the tilt angle α' being a distance between the longitudinal axis L and the primary packaging container. 托座 with the longitudinal axis L of the primary packaging container accommodated in the receptacle 容器 , and the raised position is a position in which the primary packaging container is raised from the rest position in a direction away from the bottom end to a raised height a, wherein a is 10% to 50%, preferably 20% to 48%, and more preferably 25% to 45% of the depth h of the receptacle. Most preferably, in the raised position, the primary packaging container accommodated in the receptacle is not tilted at all, i.e., α' is 0 degrees. Preferably, a is in the range of 13 mm to 20 mm. This embodiment is a second embodiment of the retaining structure according to the present invention, which is preferably subordinate to the first embodiment.

[0017] |3a| According to another preferred embodiment of the retaining structure according to the present invention, a retaining protrusion serving as a retaining portion is provided at the bottom end of the holder, and the retaining protrusion extends radially inwardly into the holder. For example, each holder may have two retaining protrusions diametrically opposed to each other (e.g., Figure 3 and Figure 4 In principle, a single retaining projection is also sufficient to limit the axial movement of the primary packaging container in the holder, and the retaining projection can also be designed to be annular or substantially annular. This embodiment is the third embodiment of the retaining structure according to the present invention, which is preferably subordinate to the first or second embodiment.

[0018] |4a| According to another preferred embodiment of the holding structure according to the present invention, the holding structure is formed by injection molding of a plastic material, wherein the side wall of the bracket is relative to the longitudinal axis L 托座 Inclined at a draft angle γ, such that the inner diameter d of the bracket increases continuously from the bottom end to the upper end. In this case, the draft angle γ is preferably in the range of 0.01 degrees to 1 degree, more preferably in the range of 0.025 degrees to 0.75 degrees, even more preferably in the range of 0.05 degrees to 0.5 degrees, and most preferably in the range of 0.075 degrees to 0.3 degrees. Typically, the draft angle γ is of the order of 1 degree or less in order to demould the retaining structure from the injection mold during injection molding manufacturing. According to a specific embodiment of the retaining structure according to the present invention, at the bottom end of the bracket, preferably to a height h in the range of 1 mm to 5 mm, preferably 2 mm to 4 mm, measured from the bottom end of the bracket. x , the side wall of the bracket is not tilted at all (draft angle γ = 0 degrees), and x Initially, the sidewalls of the bracket are inclined at the above draft angles up to the upper end of the bracket. Thus, in such embodiments, the inner diameter d of the bracket is the same as the inner diameter d of the bracket from the bottom of the bracket to the height h. x is constant within the region and from height h x This embodiment is the fourth embodiment of the holding structure according to the present invention, and is preferably subordinate to any one of the first to third embodiments.

[0019] |5a| According to another preferred embodiment of the holding structure according to the present invention, the holding structure is formed by injection molding of a plastic material, wherein the holding structure is designed so that it is produced by injection molding of the plastic material using a two-part original mold having a lower mold and an upper mold, so that the side wall of the bracket is not relative to the longitudinal axis L 托座 The inner diameter d of the bracket at the bottom end is inclined at a draft angle γ. 底部 Corresponding to the inner diameter d at the upper end 顶部 In this embodiment, the inner diameter d of the bracket at the bottom end is 底部 Corresponding to the inner diameter d at the upper end 顶部 , or even larger than the inner diameter d at the upper end 顶部 This embodiment is a fifth embodiment of the holding structure according to the present invention, which is preferably subordinate to any one of the first to third embodiments.

[0020] |6a| According to another preferred embodiment of the holding structure according to the present invention,

[0021] - the brackets are arranged in a regular array,

[0022] - the upper side of the holding structure is formed as a plate-shaped support, and

[0023] - the bracket extends vertically from the plate-like support;

[0024] The side wall is formed as a common partition between every two directly adjacent brackets in the plurality of brackets. This embodiment is the sixth embodiment of the holding structure according to the present invention, which is preferably subordinate to any one of the first to fifth embodiments.

[0025] |7a| According to another preferred embodiment of the holding structure according to the present invention, the partition walls are each formed integrally and have no openings when viewed in cross section. This embodiment is the seventh embodiment of the holding structure according to the present invention and is preferably subordinate to the sixth embodiment.

[0026] |8a| According to another preferred embodiment of the retaining structure according to the present invention, the partition wall is formed from two or more separate pieces, as seen in cross section, wherein the partition wall includes an opening between two adjacent pieces of the partition wall. This embodiment is the eighth embodiment of the retaining structure according to the present invention and is preferably subordinate to the sixth embodiment.

[0027] |9a| According to another preferred embodiment of the retaining structure according to the present invention, the brackets are polygonal or circular when viewed from above. For example, when viewed in plan, the brackets may be hexagonal and arranged directly adjacent to each other in a regular, hexagonally symmetrical arrangement. Alternatively, when viewed in plan, the brackets may be octagonal, with four adjacent brackets arranged in a diamond pattern. A particularly preferred shape for the brackets is a diamond. This embodiment is the ninth embodiment of the retaining structure according to the present invention and is preferably subordinate to any of the first to eighth embodiments.

[0028] |10a| According to another preferred embodiment of the holding structure according to the present invention,

[0029] A is the surface of the section of the elongated cylindrical region of the primary packaging container that is received in the receptacle of the holding structure;

[0030] B is the portion of said surface A which can come into contact with the surface of an alignment element in a given receptacle, with said primary packaging container accommodated in said receptacle in the rest position;

[0031] Wherein, B / A is less than 0.1, preferably less than 0.05, more preferably less than 0.03, even more preferably less than 0.02 and most preferably less than 0.01. This embodiment is the tenth embodiment of the holding structure according to the present invention, which is preferably subordinate to any one of the first to ninth embodiments.

[0032] |11a| According to another preferred embodiment of the holding structure according to the present invention, in each receptacle, the alignment elements include a plurality of longitudinal alignment elements extending from the upper end to the lower end of the receptacle and extending over at least 50%, preferably at least 75%, and more preferably at least 90% of the total depth h of the receptacle. The alignment elements are configured to contact a portion of the outer surface of the primary packaging container over at least a portion of the length of the elongated cylindrical region contained in the receptacle. The longitudinal alignment elements extending from the upper end to the lower end of the receptacle can be designed as continuous alignment elements, without interruptions along the way. However, these longitudinal alignment elements can also be composed of several longitudinal elements arranged one after another and separated from each other by interruptions. Furthermore, in each receptacle, preferably two or more longitudinal alignment elements are present, more preferably four to six, with these longitudinal alignment elements evenly spaced apart at regular angular intervals. This embodiment is the eleventh embodiment of the holding structure according to the present invention and is preferably dependent on any of the first to tenth embodiments.

[0033] |12a| According to another preferred embodiment of the holding structure according to the present invention, in each bracket, there is another position P x , at the position P x At least two alignment elements are provided with concave recesses, the curvature of which corresponds to the outer diameter of the primary packaging container to be accommodated in the receptacle, wherein the alignment elements are adapted to contact the outer surface of the primary packaging container at least over a portion of the circumference of the elongated cylindrical region accommodated in the receptacle. x In the case where these alignment elements are provided at positions along the longitudinal axis L of the bracket, 托座 Preferably, these positions P x At least one position is located at the upper third, even more preferably at the upper quarter of the bracket. This embodiment is the twelfth embodiment of the holding structure according to the present invention, which is preferably subordinate to any one of the first to tenth embodiments.

[0034] |13a| According to another preferred embodiment of the holding structure according to the present invention, in each bracket, there is another position P x , at the position P x At least two alignment elements are provided at positions P, wherein the alignment elements are adapted to punctually contact the outer surface of the primary packaging container at least on the portion of the elongated cylindrical region received in the receptacle. xIn the case where these alignment elements are provided at positions along the longitudinal axis L of the bracket, 托座 In this case, it is also preferred that at a given position P x At , there are a plurality of point alignment elements which are uniformly distributed with respect to each other at angular intervals. More preferably, the point alignment elements are located at least at a first position P1 in the upper end region of the bracket, preferably in the upper third, more preferably in the upper quarter of the bracket, and at a second position P2 in the bottom end region of the bracket, preferably in the lower third, more preferably in the lower quarter of the bracket. In case the point alignment elements are located at two positions P1 (in the upper end region) and P2 (in the bottom end region), it is also preferred that the alignment element at position P1 is positioned along a first circle located in a first plane and the alignment element at position P2 is positioned along a second circle located in a second plane, the first plane and the second plane being parallel to each other and perpendicular to the longitudinal axis L. 托座 , where the diameter of the first circle at position P1 is Greater than the diameter of the second circle at position P2 In this case, it is preferred that the term

[0035]

[0036] In the range of 0 to 0.01, more preferably in the range of 0 to 0.007 and most preferably in the range of 0 to 0.0035, Δh is a value parallel to the longitudinal axis L. 托座 This embodiment is a thirteenth embodiment of the holding structure according to the present invention, which is preferably subordinate to any one of the first to tenth embodiments.

[0037] |14a| According to another preferred embodiment of the holding structure according to the invention, the alignment elements are located on the top of the side walls. This embodiment is the fourteenth embodiment of the holding structure according to the invention and is preferably subordinate to any one of the first to thirteenth embodiments.

[0038] |15a| According to another preferred embodiment of the holding structure according to the present invention, the holding structure further comprises:

[0039] a guide portion configured and adapted to guide the primary packaging container when the primary packaging container is inserted into the receptacle, the guide portion being formed as a guide rib extending in the longitudinal direction of the receptacle;

[0040] The alignment element is located on top of the guide portion. In this case, it can also be advantageous to form an inclined lead-in surface at the upper end of the guide portion, which is inclined relative to the guide portion (as disclosed in US Pat. No. 11,464,702 B2), wherein the alignment element can also be located on top of this lead-in surface. This embodiment is the fifteenth embodiment of the retaining structure according to the present invention and is preferably subordinate to any of the first to thirteenth embodiments.

[0041] |1b| A first embodiment of an apparatus is provided to facilitate achieving at least one of the objects of the present invention. The apparatus comprises:

[0042] A holding structure according to the present invention, preferably a holding structure according to any one of the first to fifteenth embodiments;

[0043] - a plurality of primary packaging containers, each primary packaging container being accommodated in one of the receptacles of the holding structure.

[0044] Preferably, each of said primary packaging containers is detachably received in one of the receptacles, preferably in a non-destructive manner.

[0045] |2b| According to a preferred embodiment of the device according to the invention, the plurality of primary packaging containers comprises a number of primary packaging containers in the range of 4 to 500, preferably 9 to 400, more preferably 12 to 300, more preferably 16 to 200, more preferably 16 to 160, more preferably 16 to 100, more preferably 16 to 90, more preferably 16 to 80, more preferably 16 to 70, even more preferably 16 to 60, most preferably 20 to 160. This embodiment is a second embodiment of the device according to the invention, which is preferably subordinate to the first embodiment.

[0046] |3b| According to another preferred embodiment of the device according to the invention, each primary packaging container contains a pharmaceutical, medicinal or cosmetic composition. This embodiment is a third embodiment of the device according to the invention and is preferably subordinate to the first or second embodiment.

[0047] |4b| According to another preferred embodiment of the device according to the invention, each primary packaging container is closed. This embodiment is a fourth embodiment of the device according to the invention and preferably belongs to any one of the first to third embodiments.

[0048] |5b| According to another preferred embodiment of the device according to the invention, each primary packaging container comprises, along its length, in the following order:

[0049] a) a first end portion comprising a discharge opening,

[0050] b) an elongated cylindrical region, and

[0051] c) the other end.

[0052] This embodiment is a fifth embodiment of the device according to the invention, which is preferably subordinate to any one of the first to fourth embodiments.

[0053] |6b| According to another preferred embodiment of the device according to the present invention, the other end is a vertical base, or includes another opening, or both. Preferably, the other opening is designed to accommodate a plunger. This embodiment is the sixth embodiment of the device according to the present invention and is preferably subordinate to the fifth embodiment.

[0054] |7b| According to another preferred embodiment of the device according to the invention, for each primary packaging container, the area of ​​the further opening is greater than the area of ​​the discharge opening. This embodiment is a seventh embodiment of the device according to the invention, which is preferably subordinate to the sixth embodiment.

[0055] |8b| According to another preferred embodiment of the device according to the present invention, the other end portion further comprises a rim extending laterally from the elongated cylindrical region, and the rim at least partially, and preferably completely, surrounds the other opening. This embodiment is the eighth embodiment of the device according to the present invention and is preferably dependent on the sixth or seventh embodiment.

[0056] |9b| According to another preferred embodiment of the device according to the present invention, the first end of each primary packaging container includes a connecting element, wherein the connecting element includes a thread for connecting an auxiliary part to the primary packaging container. Preferably, the auxiliary part is one selected from the group consisting of a needle, a nozzle, and a tube, or a combination of at least two thereof. Preferably, the needle is a hypodermic needle. This embodiment is the ninth embodiment of the device according to the present invention and preferably corresponds to any of the fifth to eighth embodiments.

[0057] |10b| According to another preferred embodiment of the device according to the invention, the connecting element comprises a thread for connecting the auxiliary part to the corresponding primary packaging container. This preferred embodiment is the tenth embodiment of the invention and is preferably dependent on the ninth embodiment of the invention.

[0058] |11b| According to another preferred embodiment of the device according to the present invention, the first end of each primary packaging container comprises a male portion of a tapered fitting. The tapered fitting is preferably a Luer fitting. Generally, the Luer fitting may or may not include threads. This embodiment is the eleventh embodiment of the device according to the present invention and is preferably dependent on any of the fifth to tenth embodiments.

[0059] |12b| According to another preferred embodiment of the device according to the present invention, the male portion of the tapered fitting comprises a thread. Preferably, the thread is arranged in the sleeve. This preferred embodiment is the twelfth embodiment of the present invention and is preferably dependent on the eleventh embodiment of the present invention.

[0060] |13b| According to another preferred embodiment of the device according to the invention, for each primary packaging container, the container wall thickness varies throughout the elongated cylindrical region within a range of ±0.3 mm, preferably ±0.2 mm, more preferably ±0.15 mm, even more preferably ±0.1 mm, and most preferably ±0.08 mm, in each case based on an average value of the container wall thickness in the main body of the respective primary packaging container. This embodiment is the thirteenth embodiment of the device according to the invention and preferably belongs to any one of the fifth to twelfth embodiments.

[0061] |14b| According to another preferred embodiment of the device according to the present invention, for each primary packaging container, the thickness of the container wall throughout the elongated cylindrical region is in the range of 0.2 mm to 3 mm, preferably in the range of 0.3 mm to 2.5 mm, and more preferably in the range of 0.4 mm to 2.2 mm. This embodiment is the fourteenth embodiment of the device according to the present invention and is preferably dependent on any one of the fifth to thirteenth embodiments.

[0062] |15b| According to another preferred embodiment of the device according to the present invention, the thickness of the container wall over the entire elongated cylindrical region is in the range of 1.0 mm to 1.1 mm. In another preferred embodiment, the thickness of the container wall over the entire elongated cylindrical region for each primary packaging container is in the range of 1.4 mm to 1.8 mm. In yet another preferred embodiment, the thickness of the container wall over the entire elongated cylindrical region for each primary packaging container is in the range of 0.6 mm to 2.0 mm. This embodiment is the fifteenth embodiment of the device according to the present invention and is preferably dependent on any of the fifth to fourteenth embodiments.

[0063] |16b| According to another preferred embodiment of the device according to the present invention, each primary packaging container has a container interior having a volume in the range of 0.5 ml to 100 ml, preferably in the range of 0.8 ml to 100 ml, more preferably in the range of 1 ml to 50 ml, and even more preferably in the range of 1 ml to 10 ml. This embodiment is the sixteenth embodiment of the device according to the present invention and is preferably subordinate to any one of the first to fifteenth embodiments.

[0064] |17b| According to another preferred embodiment of the device according to the present invention, the primary packaging container is selected from the group consisting of a vial, a syringe, a cartridge, and an ampoule, or a combination of at least two thereof. The preferred cartridge is designed for use as a reservoir in a medical device, preferably a portable medical device. The preferred portable medical device is an insulin pump. This embodiment is the seventeenth embodiment of the device according to the present invention and preferably corresponds to any of the first to sixteenth embodiments.

[0065] |18b| According to another preferred embodiment of the device according to the present invention, each primary packaging container comprises a container wall that at least partially surrounds the container interior, wherein the container wall comprises glass, a polymer, or both, preferably consists of glass, a polymer, or both. This embodiment is the eighteenth embodiment of the device according to the present invention and is preferably dependent on any of the first to seventeenth embodiments.

[0066] |19b| According to another preferred embodiment of the device according to the present invention, the polymer is a cycloolefin copolymer, or a cycloolefin polymer, or a mixture thereof. This embodiment is the nineteenth embodiment of the device according to the present invention, which is preferably subordinate to the eighteenth embodiment.

[0067] |20b| According to another preferred embodiment of the device according to the present invention, the glass is of a type selected from the group consisting of: borosilicate glass, preferably type I glass; aluminosilicate glass; and fused silica; or a combination of at least two thereof. This embodiment is the twentieth embodiment of the device according to the present invention and is preferably subordinate to the eighteenth embodiment.

[0068] |21b| According to another preferred embodiment of the device according to the present invention, the primary packaging containers have been decontaminated, preferably sterilized. Preferably, the device has been decontaminated, preferably sterilized. In the context of this application, decontamination is defined as a general term for reducing the number of microorganisms and biological agents (such as fungi, bacteria, viruses, spore forms, prions, single-cell eukaryotic organisms, etc.). The two specific terms disinfection and sterilization differ in the amount of reduction of these microorganisms and biological agents. Disinfection only reduces the number of contaminants, while sterilization effectively kills, inactivates, or eliminates all forms of life and other biological agents present, i.e., a 100% reduction. Disinfection is therefore less effective than sterilization. This embodiment is the twenty-first embodiment of the device according to the present invention and is preferably subordinate to any of the first to twentieth embodiments.

[0069] |1c| A first embodiment of a transport unit contributes to achieving at least one of the objects according to the present invention, the transport unit comprising:

[0070] - a device according to the present invention, preferably according to any one of the first to twenty-first embodiments, and

[0071] - secondary packaging containers,

[0072] wherein the retaining structure and the plurality of primary packaging containers are completely arranged in the secondary packaging container.

[0073] |2c| According to a preferred embodiment of the transport unit according to the present invention, the container body of the secondary packaging container comprises:

[0074] - the container opening, and

[0075] - a container base, which is opposite to the container opening in the longitudinal direction.

[0076] This embodiment is a second embodiment of a transport unit according to the invention, which is preferably subordinate to the first embodiment.

[0077] |3c| According to another preferred embodiment of the transport unit according to the invention, the first end or the other end of the primary packaging container faces the container opening. This embodiment is a third embodiment of the transport unit according to the invention, which is preferably subordinate to the second embodiment.

[0078] |4c| According to another preferred embodiment of the transport unit according to the present invention, the secondary packaging container is a packaging box or is in the shape of a packaging box. This embodiment is the fourth embodiment of the transport unit according to the present invention, which is preferably subordinate to any one of the first to third embodiments.

[0079] |5c| According to another preferred embodiment of the transport unit according to the present invention, the secondary packaging container is closed with a lid. Preferably, the lid is connected to the secondary packaging container. The lid is preferably made of a multilayer sheet. Additionally or alternatively, the lid is preferably air-permeable. This embodiment is the fifth embodiment of the transport unit according to the present invention and preferably belongs to any of the first to fourth embodiments.

[0080] |6c| According to another preferred embodiment of the transport unit according to the present invention, the transport unit further comprises a preferably closed outer packaging, wherein the secondary packaging container is arranged in the outer packaging. The preferred outer packaging is a pouch, preferably a pouch made of plastic film. Additionally or alternatively preferably, the outer packaging provides a barrier against the permeation of inert gases. Additionally or alternatively preferably, the outer packaging is hermetically sealed. Additionally or alternatively preferably, the outer packaging is less permeable to inert gases than the lid. Particularly preferably, the outer packaging provides a barrier against the permeation of inert gases, while the lid is permeable to inert gases. This embodiment is the sixth embodiment of the transport unit according to the present invention, which is preferably subordinate to any one of the first to fifth embodiments.

[0081] |7c| According to another preferred embodiment of the transport unit according to the invention, the outer packaging comprises an atmosphere containing an inert gas, the proportion of the inert gas being at least 50 vol%, preferably at least 60 vol%, preferably at least 70 vol%, more preferably at least 80 vol%, even more preferably at least 90 vol%, and most preferably at least 95 vol%, in each case based on the volume of the atmosphere. This preferred embodiment is the seventh embodiment of the transport unit according to the invention, which is preferably subordinate to the sixth embodiment.

[0082] |1d| At least one of the objects of the present invention is achieved by the use of a holding structure according to the invention, preferably a holding structure according to any of the first to fifteenth embodiments, or a device according to the invention, preferably a device according to any of the first to twenty-first embodiments, or a transport unit according to the invention, preferably a transport unit according to any of the first to seventh embodiments, in each case for storing or transporting a plurality of primary packaging containers. In a preferred embodiment of this use, each primary packaging container contains a pharmaceutical, medical or cosmetic composition.

[0083] |1e| At least one of the objects according to the present invention is achieved by a process for filling a primary packaging container with a pharmaceutical, medicinal or cosmetic composition, comprising the following steps:

[0084] A) providing a device according to the present invention, preferably a device according to any one of the first to twenty-first embodiments;

[0085] B) filling each primary packaging container received in the receptacle of the holding structure with a liquid pharmaceutical composition in an automatic filling machine.

[0086] |2e| According to a preferred embodiment of the process for filling primary packaging containers, in the automatic filling machine, a needle is positioned above the opening of the primary packaging container, and the pharmaceutical, medical, or cosmetic composition is then injected into the container via the needle. After the needle is positioned above the corresponding primary packaging container, the primary packaging container is filled with the pharmaceutical, medical, or cosmetic composition. This embodiment is a second embodiment of the process for filling primary packaging containers according to the present invention and is preferably subordinate to the first embodiment.

[0087] |1f| At least one of the objects according to the present invention is achieved by the use of the holding structure of the present invention, preferably the holding structure according to any one of the first to fifteenth embodiments, which is to hold a plurality of primary packaging containers during the step of filling the primary packaging containers with pharmaceutical compositions, medical compositions or cosmetic compositions.

[0088] Maintain structure

[0089] The holding structure of the present invention can generally be any device that a person skilled in the art considers to be suitable for holding a plurality of primary packaging containers. Preferred holding structures are carrier structures of so-called nesting solutions, which are well known in the art of transport packaging for medical, pharmaceutical and cosmetic primary packaging containers. Examples of known nesting solutions are available from Schott Pharma AG under the name Schott The platform is commercially available under the trade name . The retaining structure is preferably produced by deep drawing or injection molding, with injection molding being particularly preferred. Additionally or alternatively, the retaining structure is preferably made of one or more plastics. Preferably, the plate-like carrier element and the plurality of brackets are integrally formed. Further preferably, the retaining device is of a one-piece design. Preferably, in a top view of the retaining device, the brackets form a regular pattern.

[0090] Align components

[0091] The function of the alignment element is to prevent, or at least to minimize, tilting of the primary packaging container held in the receptacle of the holding structure. 容器 With the longitudinal axis L of the holder for receiving the primary packaging container 托座 When the angle between the longitudinal axis L and the longitudinal axis L is not zero, the primary packaging container will tilt. 容器 is an axis passing through the centre of the elongated cylindrical region of the primary packaging container, about which axis the elongated cylindrical region is preferably rotationally symmetrical, while the longitudinal axis L of the receptacle 托座 It is the axis centered along the depth h of the bracket in the elongated direction and passing perpendicularly through the bracket.

[0092] The alignment element may have any shape that appears suitable to a person skilled in the art to prevent the container from tilting in the holder. For example, the alignment element may extend in an elongated direction from the upper end to the lower end of the holder, with two or more such elongated alignment elements evenly spaced from each other around the circumference of the holder (e.g., Figure 6 In such an embodiment, it is particularly advantageous to apply the alignment element to the guide element arranged in a similar manner. Preferably, the inner diameter of the socket (which is ultimately defined by the alignment element) is smaller in the upper region of the socket than in the lower region.

[0093] According to another embodiment, the alignment elements may also have a concave recess, the curvature of which is adapted to the outer radius of the primary packaging container, so that the alignment elements contact the primary packaging container at certain positions along at least a part of the circumference of the primary packaging container (e.g. Figure 7 Such alignment elements can be arranged at one or more locations along the elongated axis of the bracket, but are preferably arranged locally at least in the upper region of the bracket, particularly preferably in the upper third, even more preferably in the upper quarter, wherein at a given position P along the height of the bracket x At the same time, preferably two such alignment elements are provided which are arranged opposite each other (as also shown in FIG. 8 ).

[0094] However, embodiments are particularly advantageous in which the alignment elements enable only point-like contact with the outer surface of the primary packaging container, such alignment elements also being arranged locally at one or more positions P along the height of the receptacle, preferably at least in the upper region of the receptacle, particularly preferably in the upper third, even more preferably in the upper quarter. x Where, at a given position P x At the same time, two, three, four, five, six or more such alignment elements are arranged in a circular manner and have uniform spacing between each other (e.g. Figure 3 If the contact is only point-like, the friction between the alignment element and the outer wall of the primary packaging container can be minimized during insertion and removal of the container. In principle, the size of the contact surface between the alignment element and the primary packaging container, or more precisely, the size of the contact surface between the alignment element and the elongated cylindrical area of ​​the primary packaging container, should be as small as possible.

[0095] Preferably, the alignment elements are made of the same material as the retaining structure itself. The alignment elements may also already be applied in the injection molding process or 3D printing process used to produce the retaining structure itself, or they may be subsequently applied by 3D printing, bonding or welding to corresponding surface areas in the socket of the retaining structure produced by 3D printing or injection molding or deep drawing.

[0096] Plate-shaped carrier element

[0097] The term "plate-shaped" means that the width and length of the carrier element are both at least 5 times, preferably at least 10 times, more preferably at least 50 times, and most preferably at least 100 times greater than the thickness of the carrier element. Preferably, the thickness of the carrier element is in the range of 0.5 mm to 5 mm, more preferably in the range of 0.5 mm to 3 mm, even more preferably in the range of 0.5 mm to 2 mm, and most preferably in the range of 0.8 mm to 2 mm. Additionally or alternatively, it is preferred that the carrier element has a substantially flat top surface or a substantially flat bottom surface, or both. Here, the term "plate-shaped carrier element" refers to a substantially flat element, the top or bottom surface of which does not have any optional protrusions visible to the naked eye. Preferably, the top and bottom surfaces of the plate-shaped carrier element are substantially rectangular. Here, "substantially" means that the top or bottom surface may form rounded corners and / or recesses in the edge area.

[0098] Side wall of the bracket

[0099] Preferably, the bracket wall of the bracket consists of all the wall elements of the bracket. Here, the bracket wall can only partially close the bracket interior, that is, the wall body has the first opening and the further opening. The wall body is a geometric body formed by the bracket wall.

[0100] Boot section

[0101] The function of the guide portions is to guide the container into the receptacle during insertion. Preferably, these guide portions are formed as guide ribs extending in the longitudinal direction of the receptacle, wherein preferably, in each receptacle, two or more of these guide ribs are distributed at a certain angular distance from one another. Preferably, these guide portions are not uniformly distributed at the same angular distance from one another within a given receptacle.

[0102] It may be sufficient if the guide ribs protrude radially inwards from the side wall or side wall portion of the holder only to a relatively small extent, for example only by a distance of the order of 1 mm or less.The guide ribs or at least their leading edges may be designed as planar inclined surfaces.

[0103] The guide ribs may extend continuously over substantially the entire depth h of the holder. Such guide ribs are preferably oriented with respect to the longitudinal axis L of the holder. 托座 The guide rib is inclined at an inclination angle β, wherein β is preferably in the range of 0.01 to 1 degrees, more preferably in the range of 0.025 to 0.75 degrees, even more preferably in the range of 0.05 to 0.5 degrees, and most preferably in the range of 0.075 to 0.3 degrees. Typically, the guide rib is inclined relative to the longitudinal axis L. 托座The inclination angle can in principle be negligible or is of the order of 1 degree or less in order to demould the holding structure from the injection mold during production by injection molding.

[0104] In an alternative, the guide rib may also comprise a separate upper portion near the upper end of the bracket and a lower guide portion near the lower end of the bracket, as disclosed in, for example, US Pat. No. 1,1286,095 B2.

[0105] Primary packaging container

[0106] A primary container is the container that best protects a product throughout its distribution channel. It can also be called a retail container or consumer container. Therefore, a test tube is not a primary container.

[0107] The primary packaging container can have any size or shape deemed suitable by the skilled person in the context of the present invention. Preferred primary packaging containers are primary packaging containers for medical, pharmaceutical, or cosmetic compositions. Preferably, the primary packaging container is suitable for packaging parenteral medications according to Section 3.2.1 of the European Pharmacopoeia, 7th Edition (2011). Particularly preferred primary packaging containers are vials, syringes, cartridges, or ampoules.

[0108] Preferably, each primary packaging container comprises, in the following order along its length: a first end portion comprising a discharge orifice; an elongated cylindrical region; and a further end portion. Preferably, the first end portion of the primary packaging container comprises a discharge orifice that allows discharge of the medical, pharmaceutical, or cosmetic composition from the primary packaging container interior. In this case, the container wall of the primary packaging container only partially encloses the container interior. Preferred primary packaging containers whose first end portions comprise a discharge orifice are vials, syringes, or cartridges. Preferred primary packaging containers whose first end portions do not comprise a discharge orifice are ampules. In this case, the container wall of the primary packaging container completely encloses the container interior. Additionally or alternatively, preferably, the further end portion is a stand-up base, comprises a further orifice, or both. In the case of a further orifice, the primary packaging container is preferably a syringe. In the case of a stand-up base, the primary packaging container is preferably a vial, cartridge, or ampule. In preferred primary packaging containers, the elongated cylindrical region is immediately followed by a shoulder. The preferred primary packaging container can be a vial, syringe, cartridge, or ampoule, with vials, cartridges, or ampoules being preferred. Additionally or alternatively, the other end portion is immediately downstream of the elongated cylindrical region via a heel. In this case, the primary packaging container is preferably a vial, cartridge, or ampoule. Preferably, the elongated cylindrical region is a lateral region of the primary packaging container. It is particularly preferred that the elongated cylindrical region of the container wall forms a hollow cylinder. In the case of a syringe, the elongated cylindrical region is often referred to as a barrel. Additionally or alternatively, the first end portion, from the top to the bottom of the primary packaging container, comprises a flange and a neck, more preferably consisting of the flange and the neck. In this case, the primary packaging container is preferably a vial, cartridge, or ampoule.

[0109] Preferably, the primary packaging container is a glass container, whose glass wall (container wall) at least partially encloses the container interior of the primary packaging container. Preferably, the glass wall is of one-piece design. The glass wall can preferably be produced by blow molding a glass melt; or it can be produced by preparing a glass tube, preferably in the form of a hollow cylinder, with one end of the tube optionally forming the bottom of the primary packaging container, thereby closing the tube at this end, and the opposite end of the tube forming the top region of the primary packaging container. 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.

[0110] As used herein, the internal volume of a primary packaging container refers to the entire volume of the container's interior. This volume can be determined by filling the container's interior with water up to the brim and measuring the volume of the water the interior can accommodate up to the brim. Thus, the internal volume of a container's interior, as used herein, is not the nominal volume typically referred to in pharmaceutical technology. For example, the nominal volume can be approximately 0.5 times smaller than the internal volume.

[0111] Glass

[0112] The container wall of each primary packaging container preferably comprises glass, more preferably consists essentially of glass. This glass can be any type of glass and can have any composition deemed suitable by a skilled person in the context of the present invention. Preferably, the glass is suitable for pharmaceutical packaging. Particularly preferably, the glass is type I glass according to the definition of glass types in Section 3.2.1 of the European Pharmacopoeia, 7th Edition, 2011. Additionally, or alternatively, the glass is selected from the group consisting of borosilicate glass, aluminosilicate glass, and fused quartz, or a combination of at least two thereof, with borosilicate glass being particularly preferred. For use herein, borosilicate glass is glass having 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 in the range of 5 wt% to 15 wt%, in each case based on the total weight of the glass. Preferred borosilicate glasses have an Al2O3 content of less than 7.5 wt%, preferably less than 6.5 wt%, particularly preferably in the range of 0 to 5.5 wt%, each based on the total weight of the glass. On the other hand, borosilicate glasses have an Al2O3 content in the range of 3 wt% to 7.5 wt%, preferably in the range of 4 wt% to 6 wt%, each based on the total weight of the glass.

[0113] Medical compositions, pharmaceutical compositions and cosmetic compositions

[0114] In the context of the present invention, each medical composition, each pharmaceutical composition and each cosmetic composition that the skilled person deems suitable is contemplated. A medical composition is a composition for use in a medical treatment. A medical composition does not necessarily contain an active ingredient. A pharmaceutical composition is a composition comprising at least one pharmaceutically active ingredient. Preferred pharmaceutically active ingredients are vaccines. Cosmetic compositions are compositions comprising at least one cosmetically active ingredient. Preferred cosmetically active ingredients are hyaluronic acid or botulinum toxin. The medical composition, pharmaceutical composition or cosmetic composition can be fluid or solid or both, with fluid compositions being particularly preferred herein. Preferred solid compositions are granular, such as powders, a large number of tablets or a large number of capsules. Another preferred medical composition, pharmaceutical composition or cosmetic composition is a parenteral, i.e., a composition intended to be administered via a parenteral route, which can be any non-enteral route. Parenteral administration can be performed, for example, by injection using a needle (typically a hypodermic needle) and a syringe, or by inserting an indwelling catheter.

[0115] Secondary packaging container

[0116] The secondary packaging container can generally be any container that is considered by a person skilled in the art to accommodate the holding structure, preferably the device. A preferred secondary packaging container is a packaging box. Particularly preferably, the secondary packaging container is a packaging box of a so-called nesting solution, which is well known in the field of transport packaging technology for medical, pharmaceutical and cosmetic containers. Examples of known nesting solutions are available from Schott Pharma AG under the name Schott The secondary packaging container is commercially available under the trade name of the platform. Preferably, the secondary packaging container is produced by deep drawing or injection molding, with deep drawing being particularly preferred. Additionally, or alternatively, preferably, the secondary packaging container is made of one or more plastics. In this case, the preferred plastic is one selected from the group consisting of a polycondensation polymer (preferably polyethylene terephthalate), a polyacrylate (preferably polymethyl methacrylate), a polyolefin (preferably polypropylene or polyethylene), and polystyrene, or a combination of at least two thereof.

[0117] direction

[0118] As described herein, the lateral and longitudinal directions are perpendicular to each other. Preferably, the longitudinal direction extends along the length of the container. Preferably, any direction perpendicular to the longitudinal direction is considered a lateral direction. Thus, multiple lateral directions can be derived from a single longitudinal direction. Preferably, the lateral directions 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. In this context, any lateral cross-section is perpendicular to the longitudinal direction. BRIEF DESCRIPTION OF THE DRAWINGS

[0119] Unless otherwise indicated in the description or in a particular drawing:

[0120] Figure 1A is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the invention in a rest position;

[0121] Figure 1B shows a primary packaging container 200 that can be accommodated in the receptacle 101 of the holding structure 100 according to the invention;

[0122] Figure 2 is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the invention in a raised position;

[0123] Figure 3 is a top view of a holding structure 100 according to the present invention, wherein an alignment element 106 is attached to a side wall 104 of a holder 101;

[0124] Figure 4 is another top view of the holding structure 100 according to the present invention, wherein the alignment element 106 is located on top of the guide portion 109;

[0125] Figure 5 is a cross-sectional view of the bracket 101 , wherein the side wall 104 of the bracket 101 is inclined at a draft angle γ;

[0126] Figure 6 is a cross-sectional view of the holder 101 , wherein the alignment element 106 is configured and adapted to contact a portion of the outer surface of the primary packaging container 200 at least over a portion of the length of the section 201 ′ of the primary packaging container 200 accommodated in the holder 101 ;

[0127] Figure 7 yes Figure 6 A top view of the bracket 101 shown in FIG;

[0128] Figure 8A is a cross-sectional view of a holder 101 , wherein the alignment element 106 is provided with a concave recess 108 , the curvature of which corresponds to the outer diameter of a primary packaging container 200 to be accommodated in the holder 101 ;

[0129] Figure 8B yes Figure 8A A top view of the alignment element 106 in the bracket shown in FIG;

[0130] Figure 9 is a cross-sectional view of the bracket 101, wherein the alignment element 106 is configured to be adapted to be positioned at position P xPoint contact is made on the outer surface of the primary packaging container 200 accommodated in the holder 101;

[0131] Figure 10 is a side view of a holder 101 in a holding structure 100 according to the present invention, the holder being designed so that a two-part original mold having a lower mold 110 and an upper mold 111 is used to produce the holding structure 101;

[0132] Figure 11A is an optical microscope image of a portion of the outer surface of the container wall in the comparative example;

[0133] Figure 11B is an optical microscope image of a portion of the outer surface of the container wall in the example. DETAILED DESCRIPTION

[0134] Figure 1A 1 is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the invention in a rest position. The purpose of the receptacle 101 is to receive the primary packaging container 200 therein at least in the section 201 '. Each receptacle 101 has a depth h, an upper end 102, a bottom end 103, a circumferentially formed side wall 105 and a longitudinal axis L. 托座 The upper end 102 is used to insert the primary packaging container 200 into the holder 101, the bottom end 103 has a retaining portion 104, the retaining portion 104 is configured to limit the axial movement of the primary packaging container 200 in the holder 101, and the circumferentially formed side wall 105 extends from the upper end 102 to the bottom end 103 in the longitudinal direction, and the longitudinal axis L 托座 Passing through the center of the bracket 101 in the longitudinal direction. Figure 1A In FIG. 2 , a section 201 ′ of the elongated cylindrical region 201 of the primary packaging container 200 in the rest position is accommodated in the receptacle, the section 201 ′ being marked by a dashed parallelogram. Figure 1A As shown, according to the holding structure of the present invention, each bracket 101 includes an alignment element 106 (in Figure 1A 1 (shown in the form of grey circles), these alignment elements radially protrude into the receptacle 101 and are configured and adapted to contact a portion of the outer surface of the elongated cylindrical region 201 of the primary packaging container 200 that is accommodated in the receptacle 101. The alignment element 106 in each receptacle 101 is configured and adapted to contact a portion of the outer surface of the elongated cylindrical region 201 so that the primary packaging container 200 accommodated in the receptacle 101 in the rest position is tilted at an angle α of not more than 2.4 degrees, wherein the tilt angle α is a value about the longitudinal axis L. 托座 The longitudinal axis L of the primary packaging container 200 accommodated in the receptacle 101 容器The rest position is a position where the retaining portion 104 restricts the axial movement of the primary packaging container 200 accommodated in the holder 101. Therefore, the rest position is a position where the primary packaging container 200 is accommodated in the holder 101 to the maximum depth. Figure 1A In the holder 101 shown, the retaining portion is in contact with the shoulder 208 of the primary packaging container 200 in the rest position.

[0135] Figure 1B A primary packaging container 200 in the form of a vial is shown, which can be accommodated in the receptacle 101 of the holding structure 100 according to the present invention. The primary packaging container 200 can include a container wall that partially surrounds the container interior. The container wall comprises, in the following order from top to bottom, a first end 202 (including a discharge opening 203), an elongated cylindrical region 201, and a further end 204. The elongated cylindrical region 201 is preferably a hollow cylinder. The further end 204 includes a vertical base 205. In addition to the discharge opening 203, the first end 202 consists of a flange 206 and a neck 207. The elongated cylindrical region 201 is connected to the first end 202 via a shoulder 208. The further end 204 is connected to the elongated cylindrical region 201 via a heel. The container wall is made of type I borosilicate glass.

[0136] Figure 2 is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the present invention in a raised position. The raised position is a position in which the primary packaging container 200 is raised from a rest position in a direction away from the bottom end 103 to a raised height a, wherein a is 10% to 50%, preferably 15% to 45% and more preferably 20% to 40% of the receptacle depth h. The raising of the primary packaging container in the holding structure occurs, for example, if an optical sensor is used to confirm the correctness of the fill height during an automatic filling process. For example, Figure 2 As can be seen in FIG, the alignment element 106 preferably also ensures that the tilt angle α′ does not exceed a certain maximum value even in the raised position.

[0137] Figure 3 1 is a top view of a holding structure 100 according to the present invention, wherein alignment elements 106 are attached to side walls 104 of brackets 101. It can be seen that the brackets 101 are arranged in a regular array. The upper side of the holding structure 100 is formed as a plate-shaped support 107, and the brackets 101 extend vertically from the plate-shaped support 107. The side wall 104 of each bracket 101 is formed as a common partition between every two directly adjacent brackets 101 of the plurality of brackets 101. As shown in FIG. Figure 3It can also be seen that at the bottom end 103 of the bracket 101, retaining protrusions 105 are provided, which act as retaining portions 105 and extend radially inwardly into the bracket 101. For example, each bracket 101 may have two retaining protrusions 105 diametrically opposed to each other. Figure 3 In the illustrated holding structure 100 , alignment elements 106 are provided as point-engaging contact elements 106 in the upper region of the receptacle 101 .

[0138] Figure 4 1 is another top view of the holding structure 100 according to the present invention, wherein the alignment element 106 is configured as a point-engaging contact element 106 located on top of a guide portion 109 in the receptacle 101. The guide portion 109 is configured to guide the primary packaging container 200 when the primary packaging container 200 is inserted into the receptacle 101. Figure 4 In the illustrated holding structure 100 , the guide portion 109 is formed as a guide rib 109 extending in the longitudinal direction of the bracket 101 .

[0139] Figure 5 1 is a cross-sectional view of a bracket 101, wherein a side wall 104 of the bracket 101 is inclined at a draft angle γ such that an inner diameter d of the bracket 101 increases continuously from a bottom end 103 to an upper end 102. In this case, the draft angle γ is preferably in the range of 0.01 to 1 degree, more preferably in the range of 0.025 to 0.75 degrees, even more preferably in the range of 0.05 to 0.5 degrees, and most preferably in the range of 0.075 to 0.3 degrees.

[0140] Figure 6 is a cross-sectional view of the receptacle 101 wherein the alignment element 106 is configured and adapted to contact a portion of the outer surface of the primary packaging container 200 over at least a portion of the length of the elongated cylindrical region 201 housed in the receptacle 101. Figure 6 In the embodiment shown, the longitudinal alignment elements 106 are located on top of the guide ribs 109 and extend over almost the entire length of the guide ribs 106 .

[0141] Figure 7 Yes Figure 6 A top view of a portion of a holding structure 100 according to the present invention is shown, wherein the alignment element 106 that contacts the outer surface of the primary packaging container 200 accommodated in the receptacle 101 is located on top of the surface of the guide rib 109, Figure 6 The same arrangement as in . Figure 6 and Figure 7In the illustrated bracket 101, the inner diameter of the bracket 101 defined by the size of the alignment element 106 (determined at position P2 at a height of 13 mm above the bottom end 103 of the bracket 101) is 15.95 mm, while the inner diameter of the bracket 101 defined by the size of the alignment element 106 (determined at position P1 at a distance of 33.25 mm from position P2) is 16.11 mm.

[0142] Figure 8A is a cross-sectional view of a receptacle 101 , wherein the alignment element 106 is provided with a concave recess 108 , the curvature of which corresponds to the outer diameter of the primary packaging container 200 to be accommodated in the receptacle 101 . Figure 8A In the embodiment shown, the bracket 101 comprises such alignment elements only in an upper region close to the upper end 102 of the bracket, wherein Figure 8B As shown, two such alignment elements 106 may be arranged opposite each other such that their concave recesses 108 together form a circular recess in which the elongated cylindrical region 201 of the primary packaging container 200 is enclosed.

[0143] Figure 9 is a cross-sectional view of the bracket 101, wherein the alignment element 106 is configured to be adapted to be positioned at position P x The alignment elements 106 are arranged to contact the outer surface of the primary packaging container 200 accommodated in the holder 101 at points. In the embodiment shown in FIG8 , these point-engaging contact elements 106 can be positioned at three different heights within a given holder, represented by position P1 near the upper end 102 of the holder 101, position P2 near the bottom end 103 of the holder 101, and position P3 between P1 and P2. The alignment elements at position P1 are preferably positioned along a first circle lying in a first plane, and the alignment elements at position P2 are positioned along a second circle lying in a second plane, the first and second planes being parallel to each other and perpendicular to the longitudinal axis L. 托座 , where the diameter of the first circle at position P1 is Greater than the diameter of the second circle at position P2 In the case of the bracket 101 in which the alignment elements 106 are located at three different positions P1, P2 and P3 as shown in FIG8 , it is preferred that the alignment element 101 located at position P3 is also located along a bracket having a diameter The third circle is located, where

[0144] Figure 10is a side view of a holder 101 in a holding structure 100 according to the invention, which holder is designed so that a two-part original mold having a lower mold 110 and an upper mold 111 is used to produce the holding structure 101, wherein the alignment element 106 is located in the portion of the holder formed by the upper mold 111. The use of such a two-part mold allows providing a holder 101 whose side walls are not inclined at all, so that the inner diameter d of the holder at the bottom end is 底部 Corresponding to the inner diameter d at the upper end 顶部 Such a holder allows the accommodation of primary packaging containers which, even when lifted at a lifting height a, have a particularly low tilt angle α.

[0145] Test Method

[0146] To determine the wear of the outer surfaces of primary packaging containers (in the form of cartridges inserted into receptacles of a retaining structure), the cartridges were first tempered in an oven at 250°C for 24 hours. After cooling to approximately 24°C, the cartridges were manually inserted and removed from a nesting device having receptacles with guide ribs by actively rubbing the cartridges along the guide ribs. The outer surfaces of the cartridges were then visually inspected using an optical microscope.

[0147] Example :

[0148] like Figure 6 As shown, in a retaining structure including brackets having a draft angle γ of 0.2 degrees, the guide ribs are modified by attaching alignment elements to the guide ribs in each bracket so that the inner diameter defined by the alignment elements is 15.95 mm at position P2, 13 mm above the bottom end of the bracket, and 16.11 mm at position P1. The vertical distance between heights P1 and P2 is 33.25 mm, and the inclination angle α is 1.16 degrees.

[0149] Comparative Example

[0150] The same retaining structure as in the example is used, the only difference being that the guide ribs are not modified with any alignment elements.

[0151] As in Figure 11A and Figure 11B As can be seen in FIG, the alignment elements help to significantly reduce wear on the outer surface of the cartridge when the cartridge is moved within the holder.

[0152] Reference Signs List

[0153] 100 Maintain structure

[0154] 101 bracket

[0155] 102 upper end of the bracket 101

[0156] 103 bottom end of bracket 101

[0157] 104 side wall of the bracket 101

[0158] 105 holding portion of the bracket 101

[0159] 106 Alignment Components

[0160] 107 plate-shaped carrier element

[0161] 108 concave recess

[0162] 109 guide part

[0163] 110 lower die

[0164] 111 upper mold

[0165] 200 primary packaging containers

[0166] 201 The elongated cylindrical region of the primary packaging container 200

[0167] 201 ′ The section of the elongated cylindrical region 201 of the primary packaging container 200 accommodated in the receptacle 101

[0168] 202 First end portion of the primary packaging container 200

[0169] 203 discharge hole

[0170] 204 The other end of the primary packaging container 200

[0171] 205 vertical base

[0172] 206 flange

[0173] 207 Neck

[0174] 208 shoulder

[0175] 300 Transport unit according to the present invention

[0176] 301 Device according to the present invention

[0177] 302 secondary packaging container

[0178] 303 cover.

Claims

1. A holding structure (100) for simultaneously holding a plurality of primary packaging containers (200) of substances for pharmaceutical, medical or cosmetic applications, each primary packaging container (200) comprising an elongated cylindrical region (201) having a longitudinal axis L 容器 , the longitudinal axis L 容器 Passing through the center of the elongated cylindrical region (201) in a longitudinal direction, the retaining structure (100) comprises: - a plurality of receptacles (101) for receiving at least a section (201') of the elongated cylindrical region (201) of the primary packaging container (200), each receptacle (101) having a depth h, an upper end (102), a bottom end (103), a circumferentially formed side wall (105) and a longitudinal axis L 托座 The upper end is used to insert the primary packaging container (200) into the holder (101), the bottom end has a retaining portion (104), and the retaining portion is configured to limit the axial movement of the primary packaging container (200) in the holder (101), the side wall extends in the longitudinal direction from the upper end (102) to the bottom end (103), and the longitudinal axis L 托座 Passing through the center of the bracket (101) in the longitudinal direction; - an alignment element (106) located in each receptacle (101), said alignment element protruding radially into said receptacle (101) and configured and adapted to contact a portion of the outer surface of the elongated cylindrical region (201) of the primary packaging container (200) housed in said receptacle (101); wherein the alignment element (106) in each holder (101) is configured to contact a portion of the outer surface of the elongated cylindrical region (201) such that the primary packaging container (200) accommodated in the holder (101) in a rest position is tilted at an angle α not greater than 2.4 degrees, the tilt angle α being a value at which the primary packaging container (200) is tilted at the longitudinal axis L 托座 and the longitudinal axis L of the primary packaging container (200) accommodated in the holder (101) 容器 and the rest position is a position where the retaining portion (104) restricts axial movement of the primary packaging container (200) accommodated in the holder (101).

2. The holding structure (100) according to claim 1, wherein: The alignment element (106) in each holder (101) is configured and adapted to contact a portion of the outer surface of the elongated cylindrical region (201) so that the primary packaging container (200) accommodated in the holder (101) in the raised position remains tilted at an angle α' of not more than 2.4 degrees, the tilt angle α' being a distance from the longitudinal axis L to the surrounding area. 托座 and the longitudinal axis L of the primary packaging container (200) accommodated in the holder (101) 容器 and the raised position is a position in which the primary packaging container (200) is raised from the rest position to a raised height a in a direction away from the bottom end (103), wherein a is 10% to 50% of the depth h of the holder.

3. The holding structure (100) according to claim 1 or 2, wherein: The retaining structure (100) is formed by injection molding of a plastic material, and wherein the side wall (105) of the bracket (101) is oriented relative to the longitudinal axis L. 托座 The bracket (101) is tilted at a draft angle γ so that the inner diameter d of the bracket (101) increases continuously from the bottom end (103) to the upper end (102).

4. The holding structure (100) according to any one of claims 1 to 3, wherein: The holding structure (100) is formed by injection molding of a plastic material, wherein the holding structure (100) is designed so that it is produced by injection molding of a plastic material using a two-part original mold having a lower mold and an upper mold, so that the side wall (105) of the bracket (101) is not relative to the longitudinal axis L 托座 The inner diameter d of the bracket (101) at the bottom end (103) is tilted at a draft angle γ. 底部 corresponds to the inner diameter d at the upper end (102) 顶部 .

5. The holding structure (100) according to any one of claims 1 to 4, wherein - the brackets (101) are arranged in a regular arrangement, - the upper side of the holding structure (100) is formed as a plate-shaped carrier element (107), and - the bracket (101) protrudes vertically from the plate-shaped carrier element (107); in, The side wall (104) is formed as a common partition between every two directly adjacent brackets (101) among the plurality of brackets (101).

6. The holding structure (100) according to any one of claims 1 to 5, wherein: In each holder (101), the alignment element (106) comprises a plurality of longitudinal alignment elements (106), which extend in the longitudinal direction from the upper end (102) to the bottom end (103) of the holder (101) and extend over at least 50% of the entire depth h of the holder (101), wherein the alignment elements (106) are configured to contact a portion of the outer surface of the primary packaging container (200) at least over a certain portion of the length of the elongated cylindrical region (201) accommodated in the holder (101).

7. The holding structure (100) according to any one of claims 1 to 5, wherein: In each bracket (101), there is another position P x , at position P x At least two alignment elements (106) are provided with concave recesses (108) having a curvature corresponding to the outer diameter of the primary packaging container (200) to be accommodated in the holder (101), wherein the alignment elements (106) are configured to contact the outer surface of the primary packaging container (200) at least over a portion of the circumference of the elongated cylindrical region (201') accommodated in the holder (101).

8. The holding structure (100) according to any one of claims 1 to 5, wherein: In each bracket (101), there is another position P x , at the position P x At least two alignment elements (106) are provided, wherein the alignment elements (106) are configured to be adapted to point-contact the outer surface of the primary packaging container (200) at least on a portion of the elongated cylindrical region (201) accommodated in the holder (101).

9. The holding structure (100) according to any one of claims 1 to 8, wherein: The alignment element (106) is located on top of the side wall (104).

10. The holding structure (100) according to any one of claims 1 to 9, wherein: The retaining structure (100) further comprises: a guide portion (109) adapted to guide the primary packaging container (200) when the primary packaging container (200) is inserted into the holder (101), the guide portion (109) being formed as a guide rib (109) extending in the longitudinal direction of the holder (101); Wherein, the alignment element (106) is located on top of the guide portion (109).

11. A device comprising: - A holding structure (100) according to any one of claims 1 to 10, - a plurality of primary packaging containers (200), each primary packaging container (200) being accommodated in one of the receptacles (101) of the holding structure (100).

12. A transport unit comprising: - a device according to claim 11, and - secondary packaging containers, wherein the retaining structure (100) and the plurality of primary packaging containers (200) are completely arranged in the secondary packaging container.

13. A process for filling a primary packaging container with a pharmaceutical, medicinal or cosmetic composition, the process comprising the steps of: A) providing a device according to claim 11; B) filling each primary packaging container received in the receptacle of the holding structure with a liquid pharmaceutical composition in an automatic filling machine.

14. The process according to claim 13, wherein In the automatic filling machine, a needle is positioned above the opening of the primary packaging container, and then the pharmaceutical composition, medical composition, or cosmetic composition is injected into the primary packaging container through the needle, wherein the primary packaging container is filled with the pharmaceutical composition, medical composition, or cosmetic composition after the needle is positioned above the corresponding primary packaging container.

15. Use of a holding structure (100) according to any one of claims 1 to 10, or a device according to claim 11, or a transport unit according to claim 12, respectively, in a filling process according to claims 13 and 14.

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