Cartridge nest featuring integrated centering of cartridges

Abstract

To provide a nested solution of pharmaceutical, medical, or cosmetic containers which allows filling of the containers accommodated in the nest efficiently without the necessity of using separate positioning means.SOLUTION: A holding structure (100) for concurrently holding a plurality of primary packaging containers comprises: a plurality of receptacles (101) for accommodating at least one section of an elongated cylindrical body region of the primary packaging container; and alignment elements (106) projecting radially into each receptacle and adapted and arranged to come into contact with a part of an outer surface of the elongated cylindrical body region of the primary packaging container accommodated in the receptacle. The alignment elements in each receptacle are adapted and arranged to come into contact with a part of the outer surface of the elongated cylindrical body region of the primary packaging container accommodated in the receptacle. The resting position is a position where a holding portion (105) limits an axial movement of the primary packaging container accommodated in the receptacle.SELECTED DRAWING: Figure 3

Description

[Technical Field]

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

[0002] Containers made from glass, and later also from polymers, have been applied to safely store fluids and powders for long periods of time. Over the past few decades, the technologies by which glass and polymer containers are used to transport fluids and powders have become increasingly diverse and sophisticated. One such technology is 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 all kinds of medicament-related compositions, particularly drugs such as parenteral drugs, including vaccines, as well as cosmetic compositions, particularly those injected into the skin.

[0003] In general, in the processing of containers for use in pharmaceutical or cosmetic applications, so-called nesting solutions are often preferred today, in which a holding structure for containers (also called nests) is used to simultaneously hold or support multiple primary packaging containers in a given configuration. One example of a known nesting solution is commercially available from Schott Pharma AG under the trade name SCHOTT iQ® platform. The nests with the primary packaging containers are typically packaged in a shipping or packaging container (also called a tub) and delivered to a customer, such as a pharmaceutical company or a filler. To further process the primary packaging containers, the tub is opened. Further processing of the primary packaging containers often includes the automated steps of removing the primary packaging containers from the tub, filling the primary packaging containers with a composition, e.g., a pharmaceutical or cosmetic composition, and closing the pre-filled primary packaging containers.

[0004] To fill a container housed in a holding structure, a filling nozzle is used that is inserted to a certain extent into the opening of the container. In such an automated filling process, the container must be positioned as parallel to the axis of the filling nozzle as possible. If this is not the case and the container is positioned at a slight angle, fluctuations in the fill level or even damage to the filling nozzle may occur if the filling needle strikes the tilted container. Furthermore, incorrect positioning of the container may also lead to malfunctions or errors in lifting the container before it is filled, as the crimp may become jammed in the holding feature.

[0005] Prior art automated filling processes use separate positioning aids in the form of perforated plates to ensure parallel positioning of each container housed in the support structure. However, such positioning aids not only represent an additional component required in the automated filling process, but can also be problematic if the container is tilted to a certain extension in the holding structure, as it makes it more difficult to introduce the open end of the container into the perforated plate. Also, handling a machine component such as a perforated plate above an open container that may already contain a drug can lead to contamination within the filled container. Finally, depending on the material quality of the perforated plate typically used to ensure proper container alignment, friction between the perforated plate and the container can cause wear on the glass surface and therefore damage to the container.

[0006] In general, it is an object of the present invention to at least partially overcome the drawbacks arising from the prior art.

[0007] In particular, it is an object of the present invention to provide a nesting solution for pharmaceutical, medical, or cosmetic containers that allows the containers contained in the nest to be filled as efficiently as possible without the need to use separate positioning means. More specifically, the nesting solution should allow the containers contained in the nest to be filled without damage to the containers by the needles used to fill them and with as little fill level fluctuation as possible, even if no additional separate positioning means are used. The nesting solution should also allow the packaging containers to be inserted into and removed from the nest with as little wear as possible on the outer surface of the packaging container.

[0008] A contribution to at least partially solving at least one, preferably two or more of the above mentioned objects is made by the independent claims. The dependent claims provide preferred embodiments that contribute to at least partially solving at least one of the objects.

[0009] |1a| A contribution to solving at least one of the objects according to the present invention is a holding structure for simultaneously holding a plurality of primary packaging containers for substances of pharmaceutical, medical or cosmetic use, each primary packaging container having an elongated cylindrical body region and a longitudinal axis L extending longitudinally through the center of the elongated cylindrical body region. container and the retaining structure comprises an elongated cylindrical body region having: A plurality of receptacles for receiving at least one section of an elongated cylindrical body region of a primary packaging container, each receptacle having a depth h, a top end for inserting the primary packaging container into the receptacle, a bottom end having a retention portion configured to limit axial movement of the primary packaging container in the receptacle, a circumferentially formed sidewall extending longitudinally from the top end to the bottom end, and a longitudinal axis L extending longitudinally through a center of the receptacle. receptacle a plurality of receptacles having an alignment element within each receptacle, the alignment element projecting radially into the receptacle and adapted and arranged to contact a portion of an outer surface of the elongated cylindrical body region of a primary packaging container received in the receptacle; Equipped with The alignment element in each receptacle is adapted and arranged to contact a portion of the outer surface of the elongated cylindrical body region such that a primary packaging container received in the receptacle in a rest position is inclined by an angle α of 2.4 degrees or less, preferably 2.2 degrees or less, more preferably 2.0 degrees or less, even more preferably 1.8 degrees or less, even more preferably 1.6 degrees or less, even more preferably 1.4 degrees or less, even more preferably 1.2 degrees or less, and most preferably 1 degree or less, wherein the angle of inclination α is relative to a longitudinal axis L of the primary packaging container received in the receptacle. receptacle and the longitudinal axis L container and the rest position is a position where the retaining portion restricts axial movement of the primary packaging container received in the receptacle. This is achieved by the first embodiment of the retaining structure. Most preferably, the primary packaging container received in the receptacle in the rest position is not tilted at all, i.e., α is 0 degrees.

[0010] As used herein, the term "plurality of receptacles for receiving primary packaging containers therein at least in sections" indicates that the depth h of the receptacles is less than the height of the primary packaging containers to be accommodated in the receptacles, such that in the rest position, portions of the primary packaging containers protrude from the receptacles.

[0011] To ensure that the primary packaging container in the holding structure is tilted as little as possible within the receptacle, those skilled in the art have considered increasing the guide length, and therefore the depth of the receptacle, or reducing the inner diameter of the receptacle into which the primary packaging container is housed. However, these measures can result in particle generation during the manufacturing process, i.e., the injection molding process, due to wear during the demolding process. In addition, the insertion and removal of the primary packaging container into and from a holding structure with a large contact surface and a low pocket inner diameter can result in various defects, such as particle generation, damage to the surface of the primary packaging container, or clogging of the primary packaging container in the holding structure.

[0012] However, it has surprisingly been observed that the best possible vertical alignment of the primary packaging containers in the holding structure can be ensured by providing alignment elements that are arranged in the receptacles and that contact only part of the outer surface of the primary packaging containers, more precisely only part of the outer surface of the elongated cylindrical body region of these containers. It is therefore not necessary to increase the depth of the receptacles, to reduce their diameter, or to use separate positioning means in order to achieve parallel alignment of the primary packaging containers in the holding structure (although such positioning means may be used so that the alignment elements also facilitate the introduction of the containers into the holes of the positioning means).

[0013] |2a| According to a preferred embodiment of the retaining structure according to the invention, the alignment element in each receptacle is adapted and arranged to contact a portion of the outer surface of the elongated cylindrical body region such that a primary packaging container received in the receptacle in the raised position is still inclined by an angle α' of 2.4 degrees or less, preferably 2.2 degrees or less, more preferably 2.0 degrees or less, even more preferably 1.8 degrees or less, even more preferably 1.6 degrees or less, even more preferably 1.4 degrees or less, even more preferably 1.2 degrees or less, and most preferably 1.0 degrees or less, the inclination angle α' being inclined relative to the longitudinal axis L of the primary packaging container received in the receptacle. receptacle and the longitudinal axis L container a' is the angle formed between a and h, and the lifted position is a position where the primary packaging container is lifted from the rest position in a direction away from the bottom edge to a lifted height, and a is 10 to 50%, preferably 20 to 48%, and more preferably 25 to 45% of the depth h of the receptacle. Most preferably, even in the lifted 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 to 20 mm. This embodiment is a second embodiment of the holding structure according to the present invention, preferably dependent on the first embodiment.

[0014] |3a| According to a further preferred embodiment of the retaining structure according to the invention, a retaining projection acting as a retaining part is provided at the bottom end of the receptacle and extends radially inward into the receptacle. Each receptacle can have, for example, two retaining projections diametrically opposite each other (as shown in Figures 3 and 4). In principle, a single retaining projection is also sufficient to limit the axial movement of the primary packaging container in the receptacle, which may also be designed to be circumferential or essentially circumferential. This embodiment is a third embodiment of the retaining structure according to the invention, preferably dependent on the first or second embodiment.

[0015] |4a| According to a further preferred embodiment of the retaining structure according to the invention, the retaining structure is formed by injection molding from a plastic material, and the side walls of the receptacle are oriented along the longitudinal axis L such that the inner diameter d of the receptacle increases continuously from the bottom end to the top end. receptacle The receptacle is inclined at a draft angle γ relative to the base end of the receptacle. In this regard, 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. Generally, the draft angle γ is on the order of 1 degree or less to facilitate release of the retention structure from an injection mold during manufacture by injection molding. According to a particular embodiment of the retention structure according to the invention, the side walls of the receptacle have a height h at the bottom end of the receptacle, preferably measured from the bottom end of the receptacle, in the range of 1 to 5 mm, preferably 2 to 4 mm. x No tilt at all (draft angle γ = 0 degrees) x Starting at the bottom of the receptacle, the sidewalls of the receptacle are tapered by the aforementioned draft angle to the top of the receptacle. Thus, in such an embodiment, the inside diameter d of the receptacle is measured from the bottom of the receptacle to a height h x The area is constant up to the height h x This embodiment is a fourth embodiment of the holding structure according to the present invention, preferably dependent on any of the first to third embodiments.

[0016] |5a| According to a further preferred embodiment of the retaining structure according to the present invention, the retaining structure is formed by injection molding from a plastic material, and the retaining structure is manufactured by injection molding from a plastic material using a two-part master mold having a lower mold and an upper mold, whereby the side walls of the receptacle are aligned along the longitudinal axis L receptacle Therefore, the receptacle inner diameter d increases continuously from the bottom end to the top end. In this embodiment, the receptacle inner diameter d at the bottom end is bottom is the inner diameter d at the top end top or the inner diameter d at the top top This embodiment is a fifth embodiment of the holding structure according to the present invention, preferably dependent on any of the first to third embodiments.

[0017] |6a| According to a further preferred embodiment of the holding structure according to the invention, The receptacles are arranged in a regular configuration, The upper side of the holding structure is formed as a plate-like support, The receptacle projects perpendicularly from the plate-like support, The side wall is formed as a common partition wall between each two immediately adjacent receptacles of the plurality of receptacles. This embodiment is a sixth embodiment of the retention structure according to the present invention, preferably dependent on any of the first to fifth embodiments.

[0018] According to a further preferred embodiment of the retention structure according to the invention, the partitions are each integrally formed and have no openings when viewed in cross section. This embodiment is a seventh embodiment of the retention structure according to the invention, which is preferably dependent on the sixth embodiment.

[0019] According to a further preferred embodiment of the retaining structure according to the invention, the partition is formed in two or more separate parts when viewed in cross section, and the partition has an opening between two adjacent parts of the partition. This embodiment is an eighth embodiment of the retaining structure according to the invention, which is preferably dependent on the sixth embodiment.

[0020] |9a| According to a further preferred embodiment of the retention structure according to the invention, the receptacles have a polygonal or circular shape when viewed from above. The receptacles may, for example, have a hexagonal shape when viewed in plan view and be arranged directly adjacent to one another in a regular configuration with hexagonal symmetry. The receptacles may also have an octagonal shape when viewed in plan view, with four adjacent receptacles arranged in a diamond configuration. A particularly preferred shape for the receptacles is a diamond shape. This embodiment is a ninth embodiment of the retention structure according to the invention, preferably dependent on any of the first to eighth embodiments.

[0021] |10a| According to a further preferred embodiment of the holding structure according to the present invention, A is a surface of a section of the elongated cylindrical body region of the primary packaging container that is received in the receptacle of the retaining structure; B is the portion of surface A that can contact the surface of an alignment element in a given receptacle when the primary packaging container is received in the receptacle in its rest position; 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 a tenth embodiment of the retention structure according to the present invention, preferably dependent on any of the first to ninth embodiments.

[0022] |11a| According to a further preferred embodiment of the retaining structure according to the invention, in each receptacle, the alignment elements comprise a plurality of longitudinal alignment elements extending from the top to the bottom of the receptacle, 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 being adapted and arranged to contact a portion of the outer surface of the primary packaging container over at least a certain portion of the length of the elongated cylindrical body region accommodated in the receptacle. The longitudinal alignment elements extending from the top to the bottom of the receptacle can be designed as a continuous alignment element without interruption along the way from top to bottom. However, they can also consist of several longitudinal elements arranged one behind the other and separated from each other by interruptions. Furthermore, in each receptacle, there are preferably two or more of these longitudinal alignment elements, more preferably four to six, which are evenly distributed at angular intervals from each other. This embodiment is an eleventh embodiment of the holding structure according to the present invention, preferably dependent on any of the first to tenth embodiments.

[0023] |12a| According to a further preferred embodiment of the retention structure according to the invention, in each receptacle, at least two alignment elements are provided with concave recesses at one or more positions P x The curvature of the concave recess corresponds to the outer diameter of the primary packaging container received in the receptacle, and the alignment elements are adapted and arranged to contact the outer surface of the primary packaging container around at least a portion of the circumference of the elongated cylindrical body region received in the receptacle. x , these positions are such that they are aligned with the longitudinal axis L of the receptacle. receptacle , and are arranged along the different heights. Preferably, these positions P xAt least one of is located in the upper third, and even more preferably in the upper quarter of the receptacle. This embodiment is a twelfth embodiment of the retention structure according to the present invention, preferably dependent on any of the first to tenth embodiments.

[0024] |13a| According to a further preferred embodiment of the holding structure according to the invention, in each receptacle, one or more positions P are provided with at least two alignment elements. x The alignment elements are adapted and arranged to contact the outer surface of the primary packaging container in a point-like manner in at least a portion of the elongated cylindrical body region that is received in the receptacle. x , these positions are such that they are aligned with the longitudinal axis L of the receptacle. receptacle The heights arranged along the line are also different. In this regard, at a given position P x It is also preferred that there are a plurality of point-like alignment elements evenly distributed at angular intervals from one another in the area of ​​the receptacle. More preferably, the point-like alignment element is located at a first position P1 within at least the area of ​​the top end of the receptacle, preferably in the upper third, more preferably in the upper quarter of the receptacle, and at a second position P2 within the area of ​​the bottom end of the receptacle, preferably in the lower third, more preferably in the lower quarter of the receptacle. In the case of point-like alignment elements located at two positions P1 (within the area of ​​the top end) and P2 (within the area of ​​the bottom end), the alignment element at position P1 is located along a first circle located in a first plane, and the alignment element at position P2 is located along a second circle located in a second plane, the first and second planes being parallel to each other and aligned along the longitudinal axis L. receptacle , and the diameter φ1 of the first circle at the position P1 is preferably greater than the diameter φ2 of the second circle at the position P2. Δh / |φ2-φ1| The term Δh is 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, and Δh is the distance from the longitudinal axis L receptacleIt is preferable that the distance between the position P1 and the position P2 in the direction parallel to the axis of the shaft 14 is the distance between the position P1 and the position P2 in the direction parallel to the axis of the shaft 14. This embodiment is a thirteenth embodiment of the holding structure according to the present invention, preferably dependent on any of the first to tenth embodiments.

[0025] According to a further preferred embodiment of the retaining structure according to the present invention, the alignment element is located at the top of the side wall. This embodiment is a 14th embodiment of the retaining structure according to the present invention, preferably dependent on any of the first to thirteenth embodiments.

[0026] |15a| According to a further preferred embodiment of the holding structure according to the invention, the holding structure comprises: a guide portion adapted and arranged to guide the primary packaging container as it is inserted into the receptacle, the guide portion being formed as a guide rib extending in the longitudinal direction of the receptacle; Furthermore, The alignment elements are located at the top of the guide portions. In this regard, it may be advantageous if lead-in bevels are formed at the top ends of the guide portions that are inclined relative to the guide portions, as disclosed in U.S. Pat. No. 11,464,702, and the alignment elements may also be located at the top of these lead-in bevels. This embodiment is a 15th embodiment of the holding structure according to the present invention, preferably dependent on any of the first to thirteenth embodiments.

[0027] |1b|The contribution of the present invention to solving at least one of the objectives is A holding structure according to the present invention, preferably a holding structure according to any one of the first to fifteenth embodiments; a plurality of primary packaging containers, each primary packaging container received in one of the receptacles of the holding structure; This is achieved by a first embodiment of the configuration comprising:

[0028] Preferably, each of the primary packaging containers is removably received, preferably non-destructively, in one of the receptacles.

[0029] |2b| According to a preferred embodiment of the arrangement according to the present invention, the plurality of primary packaging containers comprises primary packaging containers in a number ranging from 4 to 500, preferably from 9 to 400, more preferably from 12 to 300, more preferably from 16 to 200, more preferably from 16 to 160, more preferably from 16 to 100, more preferably from 16 to 90, more preferably from 16 to 80, more preferably from 16 to 70, even more preferably from 16 to 60, and most preferably from 20 to 160. This embodiment is a second embodiment of the arrangement according to the present invention, which is preferably dependent on the first embodiment.

[0030] |3b| According to a further preferred embodiment of the arrangement according to the invention, each primary packaging container contains a pharmaceutical, medical or cosmetic composition. This embodiment is a third embodiment of the arrangement according to the invention, preferably dependent on the first or second embodiment.

[0031] |4b| According to a further preferred embodiment of the arrangement according to the invention, each of the primary packaging containers is closed. This embodiment is a fourth embodiment of the arrangement according to the invention, preferably dependent on any of the first to third embodiments.

[0032] |5b| According to a further preferred embodiment of the arrangement according to the invention, each of the primary packaging containers is provided along its length with, in the following order: a) a first end having a discharge opening; b) an elongated cylindrical body region; c) a further end and Equipped with.

[0033] This embodiment is a fifth embodiment of the configuration according to the present invention, preferably dependent on any of the first to fourth embodiments.

[0034] |6b| According to a further preferred embodiment of the arrangement according to the invention, the further end is an upright base, or has a further opening, or both. The preferred further orifice is designed to accommodate a plunger. This embodiment is a sixth embodiment of the arrangement according to the invention, preferably dependent on the fifth embodiment.

[0035] |7b| According to a further preferred embodiment of the arrangement 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 arrangement according to the invention, which is preferably dependent on the sixth embodiment.

[0036] |8b| According to a further preferred embodiment of the arrangement according to the invention, the further end portion further comprises a rim that projects laterally from the elongated cylindrical body region and at least partially, preferably completely, borders the further opening. This embodiment is an eighth embodiment of the arrangement according to the invention, which is preferably dependent on the sixth or seventh embodiment.

[0037] |9b| According to a further preferred embodiment of the arrangement according to the invention, the first end of each of the primary packaging containers comprises a connecting element, the connecting element comprising a thread for connecting an auxiliary part to the primary packaging container. Preferred auxiliary parts are selected from the group consisting of needles, nozzles, and tubes, or a combination of at least two thereof. Preferred needles are hypodermic needles. This embodiment is a ninth embodiment of the arrangement according to the invention, preferably dependent on any of the fifth to eighth embodiments.

[0038] |10b| According to a further preferred embodiment of the arrangement according to the invention, the connecting element comprises a thread for connecting the auxiliary part to the respective primary packaging container. This preferred embodiment is a tenth embodiment of the invention, which is preferably dependent on the ninth embodiment of the invention.

[0039] |11b| According to a further preferred embodiment of the arrangement according to the invention, the first end of each of the primary packaging containers comprises a male part of a tapered fitting. A preferred tapered fitting is a Luer taper. In general, a Luer taper may or may not comprise a thread. This embodiment is an eleventh embodiment of the arrangement according to the invention, preferably dependent on any of the fifth to tenth embodiments.

[0040] |12b| According to a further preferred embodiment of the configuration according to the invention, the male part of the tapered joint is provided with a thread. Preferably, the thread is arranged on the sleeve. This preferred embodiment is a twelfth embodiment of the invention, which is preferably dependent on the eleventh embodiment of the invention.

[0041] |13b| According to a further preferred embodiment of the arrangement according to the invention, for each of the primary packaging containers, the thickness of the container wall over the entire elongated cylindrical body region is in each case within the range of ±0.3 mm, preferably ±0.2 mm, more preferably ±0.15 mm, more preferably ±0.1 mm, and most preferably ±0.08 mm, based on the average value of the container wall thickness in the body of the respective primary packaging container. This embodiment is a 13th embodiment of the arrangement according to the invention, which is preferably dependent on any of the fifth to twelfth embodiments.

[0042] |14b| According to a further preferred embodiment of the arrangement according to the invention, for each primary packaging container, the thickness of the container wall is in the range of 0.2 to 3 mm, preferably 0.3 to 2.5 mm, more preferably 0.4 to 2.2 mm over the entire elongated cylindrical body region. This embodiment is a 14th embodiment of the arrangement according to the invention, preferably dependent on any of the 5th to 13th embodiments.

[0043] |15b| According to a further preferred embodiment of the arrangement according to the invention, the thickness of the container wall is in the range of 1.0 to 1.1 mm over the entire elongated cylindrical body region. In a further preferred embodiment, for each of the primary packaging containers, the thickness of the container wall is in the range of 1.4 to 1.8 mm over the entire elongated cylindrical body region. In an even further preferred embodiment, for each of the primary packaging containers, the thickness of the container wall is in the range of 0.6 to 2.0 mm over the entire elongated cylindrical body region. This embodiment is a 15th embodiment of the arrangement according to the invention, preferably dependent on any of the 5th to 14th embodiments.

[0044] |16b| According to a further preferred embodiment of the arrangement according to the present invention, each of the primary packaging containers has an interior volume in the range of 0.5 to 100 ml, preferably 0.8 to 100 ml, more preferably 1 to 50 ml, and even more preferably 1 to 10 ml. This embodiment is a 16th embodiment of the arrangement according to the present invention, preferably dependent on any of the first to fifteenth embodiments.

[0045] |17b| According to a further preferred embodiment of the arrangement according to the 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. A preferred cartridge is preferably designed to be used as a reservoir of a portable medical device. A preferred portable medical device is an insulin pump. This embodiment is a 17th embodiment of the arrangement according to the invention, preferably dependent on any of the first to sixteenth embodiments.

[0046] |18b| According to a further preferred embodiment of the arrangement according to the present invention, each of the primary packaging containers comprises a container wall at least partially enclosing the interior of the container, the container wall comprising glass, a polymer, or both, preferably consisting of glass, a polymer, or both. This embodiment is an 18th embodiment of the arrangement according to the present invention, preferably dependent on any of the 1 to 17 embodiments.

[0047] |19b| According to a further preferred embodiment of the configuration according to the invention, the polymer is a cyclic olefin copolymer or a cycloolefin polymer or a mixture thereof. This embodiment is a 19th embodiment of the configuration according to the invention, which is preferably dependent on the 18th embodiment.

[0048] |20b| According to a further preferred embodiment of the arrangement according to the 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 a twentieth embodiment of the arrangement according to the invention, which is preferably dependent on the eighteenth embodiment.

[0049] |21b| According to a further preferred embodiment of the arrangement according to the invention, the primary packaging container is decontaminated, preferably sterilized. Preferably, the arrangement is decontaminated, preferably sterilized. In the context of the present application, decontamination is defined as a comprehensive term for reducing the amount of microorganisms and biological agents, such as fungi, bacteria, viruses, spores, prions, and single-cell eukaryotes. The specific terms disinfection and sterilization differ in the amount of reduction. While disinfection only reduces the amount of said contaminants, sterilization effectively kills, inactivates, or eliminates all present forms of life and other biological agents, i.e., a 100% reduction. Therefore, disinfection is not as effective as sterilization. This embodiment is a 21st embodiment of the arrangement according to the invention, preferably dependent on any of the first to 20th embodiments.

[0050] |1c|The contribution of the present invention to solving at least one of the objects is A configuration according to the present invention, preferably a configuration according to any one of the first to twenty-first embodiments thereof; Secondary packaging and Equipped with the retention structure and the plurality of primary packaging containers are completely disposed in the secondary packaging container; This is done by the first embodiment of the transport unit.

[0051] |2c| According to a preferred embodiment of the conveying unit according to the present invention, the container body of the secondary packaging container is A container opening; a container base located on the opposite side of the container opening in the longitudinal direction; Equipped with.

[0052] This embodiment is a second embodiment of the transport unit according to the invention, which is preferably dependent on the first embodiment.

[0053] |3c| According to a further preferred embodiment of the transport unit according to the invention, the first end or the further 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 dependent on the second embodiment.

[0054] According to a further preferred embodiment of the transport unit according to the invention, the secondary packaging container is a tab or tab-shaped. This embodiment is a fourth embodiment of the transport unit according to the invention, preferably dependent on any of the first to third embodiments.

[0055] |5c| According to a further preferred embodiment of the transport unit according to the invention, the secondary packaging container is closed by a lid. Preferably, the lid is bonded to the secondary packaging container. A preferred lid is a multi-layer sheet. Additionally or alternatively, preferably, the lid is gas-permeable. This embodiment is a fifth embodiment of the transport unit according to the invention, preferably dependent on any of the first to fourth embodiments.

[0056] |6c| According to a further preferred embodiment of the transport unit according to the invention, the transport unit further comprises a preferably closed outer casing, and the secondary packaging container is arranged in the outer casing. A preferred outer casing is a pouch, preferably made of a plastic film. Additionally or alternatively, preferably, the outer casing provides a barrier against inert gas permeation. Additionally or alternatively, preferably, the outer casing is hermetically sealed. Additionally or alternatively, preferably, the outer casing is less permeable to inert gas than the lid. Particularly preferably, the outer casing provides a barrier against inert gas permeation, while the lid is permeable to inert gas. This embodiment is a sixth embodiment of the transport unit according to the invention, preferably dependent on any of the first to fifth embodiments.

[0057] |7c| According to a further preferred embodiment of the transport unit according to the invention, the outer packaging contains an atmosphere comprising an inert gas in a proportion of 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, in each case based on the volume of the atmosphere. This preferred embodiment is a seventh embodiment of the transport unit according to the invention, which is preferably dependent on the sixth embodiment.

[0058] |1d|A contribution to solving at least one of the objects according to the present invention is made by the use of a holding structure according to the present invention, preferably a holding structure according to any of the first to fifteenth embodiments, or a configuration according to the present invention, preferably a configuration according to any of the first to twenty-first embodiments, or a transport unit according to the present 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 the use, each of the primary packaging containers contains a pharmaceutical, medical or cosmetic composition.

[0059] |1e| A contribution to solving at least one of the objects according to the invention is a process for filling a pharmaceutical, medical or cosmetic composition into a primary packaging container, comprising: A) providing a configuration according to the present invention, preferably a configuration according to any one of the first to twenty-first embodiments; B) filling, in an automatic filling machine, the liquid pharmaceutical composition into each primary packaging container contained in a receptacle of the holding structure; This is done by a process that includes

[0060] |2e| According to a preferred embodiment of the process for filling primary packaging containers, in an automatic filling machine, a needle is positioned above an opening of the primary packaging container, and the pharmaceutical, medical, or cosmetic composition is then injected into the container through the needle, and the primary packaging container is filled with the pharmaceutical, medical, or cosmetic composition after positioning the needle above the corresponding primary packaging container. This embodiment is a second embodiment of the process for filling primary packaging containers according to the invention, which is preferably dependent on the first embodiment.

[0061] |1f|A contribution to solving at least one of the objects according to the present invention is made by the use of a holding structure of the present invention, preferably a holding structure as described in any of the first to fifteenth embodiments, for holding a plurality of primary packaging containers during a step of filling the primary packaging containers with a pharmaceutical, medical or cosmetic composition.

[0062] holding structure The holding structure of the present invention may generally be any device that a person skilled in the art would consider for holding multiple primary packaging containers. A preferred holding structure is a so-called nested solution carrying structure, as is commonly known in the art of transport packaging for medical, pharmaceutical, and cosmetic primary packaging containers. An example of a known nested solution is commercially available from Schott Pharma AG under the trade name SCHOTT iQ® Platform. A preferred holding structure is prepared by deep drawing or injection molding, with injection molding being particularly preferred. Additionally or alternatively, the holding structure is preferably made from one or more plastics. Preferably, the plate-like carrying element is integral with multiple receptacles. Even more preferably, the holding device is of one-piece design. Preferably, the receptacles form a regular pattern in a top view of the holding device.

[0063] Alignment Elements The alignment element serves to prevent or at least minimize tilting of the primary packaging container held in the receptacle of the holding structure. The tilting of the primary packaging container occurs along the longitudinal axis L of the primary packaging container. container and the longitudinal axis L of the receptacle that receives the primary packaging container receptacle This occurs when there is an angle other than 0 (= inclination angle α) between the longitudinal axis L of the primary packaging container and the container is an axis extending through the center of the elongated cylindrical body region of the primary packaging container, which is preferably rotationally symmetric about this axis, and the longitudinal axis L of the receptacle receptacle is an axis extending vertically centrally through the receptacle in an elongated direction along the depth h of the receptacle.

[0064] The alignment elements can have any shape deemed suitable by those skilled in the art to prevent the container from tilting within the receptacle. For example, they can extend in an elongated direction from the top to the bottom of the receptacle, with two or more such elongated alignment elements being equally spaced from one another around the circumference of the receptacle (as shown in FIG. 6). In such an embodiment, it is particularly advantageous to apply the alignment elements to guide elements arranged in a similar manner. Preferably, the inner diameter of the receptacle ultimately defined by the alignment elements is smaller in the upper area of ​​the receptacle than in the lower area.

[0065] According to a further embodiment, the alignment elements may also have concave recesses whose curvature is adapted to the outer radius of the primary packaging container, so that these alignment elements contact the primary packaging container at specific positions along at least part of their circumference (as shown in Figure 7). Such alignment elements may be located locally at one or more positions along the elongate axis of the receptacle, but are preferably located at least in the upper region of the receptacle, particularly preferably in the upper third, even more preferably in the upper quarter, and at a given position P along the height of the receptacle. x In the embodiment, two such alignment elements are provided, preferably positioned opposite each other (as also shown in FIG. 8).

[0066] However, particularly advantageous are embodiments in which the alignment elements merely allow point contact with the outer surface of the primary packaging container, and such alignment elements also allow for contact at one or more positions P along the height of the receptacle. x , preferably at least locally located in the upper region of the receptacle, particularly preferably in the upper third, even more preferably in the upper quarter, and at a given position P xIn the case of a packaging container, two, three, four, five, six or more such alignment elements are arranged in a circular pattern and uniformly spaced from one another (as shown in Figure 3). If the contact is only point-shaped, friction between the alignment elements and the outer wall of the primary packaging container during insertion and removal of the container can be minimized. As a general rule, the size of the contact surface between the alignment elements and the primary packaging container, or more precisely between the alignment elements and the elongated cylindrical body area of ​​the primary packaging container, should be as small as possible.

[0067] The alignment elements are preferably made of the same material as the retention structure itself. The alignment elements can also be applied already in the injection molding or 3D printing process used to fabricate the retention structure itself, or can be subsequently applied by 3D printing, bonding, or welding to corresponding surface areas within the receptacle of a retention structure fabricated by 3D printing, injection molding, or deep drawing.

[0068] Plate-shaped conveying element The term "plate-like" refers to the width and length of the conveying element, each of which is 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 conveying element. Preferably, the thickness of the conveying element is in the range of 0.5 to 5 mm, more preferably 0.5 to 3 mm, even more preferably 0.5 to 2 mm, and most preferably 0.8 to 2 mm. Additionally or alternatively, preferably, the conveying element has an essentially flat top surface or an essentially flat bottom surface, or both. Here, the term "plate-like conveying element" refers to an essentially flat element without any optional macroscopic protrusions on the top or bottom surface of the conveying element. Preferably, the top and bottom surfaces of the plate-like conveying element are essentially rectangular. Here, "essentially" means that the top or bottom surface may have rounded corners and / or recesses in the rim area.

[0069] Receptacle sidewalls The receptacle wall of the receptacle preferably comprises all wall elements of the receptacle. Here, the receptacle wall may only partially surround the interior of the receptacle, in the sense that the wall body has a first opening and a further opening. The wall body is the geometric body formed by the receptacle wall.

[0070] Information section The guide portions serve 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, and in each receptacle, two or more of these guide ribs are preferably distributed at specific angular intervals from one another. Preferably, these guide portions are not evenly distributed at the same angular intervals from one another within a given receptacle.

[0071] It may be sufficient for the guide ribs to protrude radially inward from the side wall or part of the side wall of the receptacle by a distance that may be relatively small, for example of the order of one millimeter or less. The guide ribs or at least their leading edges may be designed as planar inclined surfaces.

[0072] The guide ribs may extend continuously through substantially the entire depth h of the receptacle. Such guide ribs are preferably aligned with the longitudinal axis L of the receptacle. receptacle The longitudinal axis L is inclined at an inclination angle β, where β 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. receptacle The inclination angle of the guide rib relative to the guide rib is in principle negligible or is on the order of 1 degree or less in order to facilitate the release of the holding structure from the injection mold during production by injection molding.

[0073] In the alternative, the guide rib may also comprise a separate upper portion near the upper end of the receptacle and a lower guide portion near the lower end of the receptacle, as disclosed, for example, in U.S. Pat. No. 11,286,095.

[0074] primary packaging container A primary packaging is a container that provides the closest protection for a product in its distribution channel. Primary packaging may also be called retail or consumer packaging. Thus, test tubes are not primary packaging.

[0075] The primary packaging container can have any size or shape that a person skilled in the art considers appropriate in the context of the present invention.Preferably, the primary packaging container is a primary packaging container for medical, pharmaceutical, or cosmetic compositions.Preferably, the primary packaging container is suitable for packaging parenteral drugs in accordance with Section 3.2.1 of the 2011 European Pharmacopoeia, 7th Edition.Particularly preferred primary packaging containers are vials, syringes, cartridges, or ampoules.

[0076] Preferably, each primary packaging container comprises, in the following order along its length, a first end portion comprising an outlet orifice, an elongated cylindrical body region, and a further end portion. Preferably, the first end portion of the primary packaging container comprises an outlet orifice that allows the medical, pharmaceutical, or cosmetic composition to be discharged from the primary packaging container interior of the primary packaging container. In this case, the container wall of the primary packaging container only partially surrounds the container interior. A preferred primary packaging container whose first end comprises an outlet orifice is a vial, syringe, or cartridge. A preferred primary packaging container whose first end does not comprise an outlet orifice is an ampoule. In this case, the container wall of the primary packaging container completely surrounds the container interior. Additionally or alternatively, preferably, the further end portion is an upright 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 an upright base, the primary packaging container is preferably a vial, cartridge, or ampoule. In the case of a preferred primary packaging container, the elongated cylindrical body region continues to the first end via a shoulder. This preferred primary packaging container may be a vial, syringe, cartridge, or ampoule, with a vial, cartridge, or ampoule being preferred. Additionally or alternatively, preferably, the further end continues to the elongated cylindrical body region via a heel. In this case, the primary packaging container is preferably a vial, cartridge, or ampoule. Preferably, the elongated cylindrical body region is a lateral region of the primary packaging container. Particularly preferably, the elongated cylindrical body region of the container wall forms a hollow cylinder. In the case of a syringe, the elongated cylindrical body region is often referred to as a barrel. Additionally or alternatively, preferably, the first end comprises a flange and a neck from the top to the bottom of the primary packaging container, more preferably consisting of a flange and a neck. In this case, the primary packaging container is preferably a vial, cartridge, or ampoule.

[0077] The primary packaging container is preferably a glass container, the glass wall of which (container wall) at least partially surrounds the container interior of the primary packaging container. Preferably, the glass wall is of one-piece design. The glass wall may preferably be made by blowing a glass melt or by preparing a glass tube, preferably in the form of a hollow cylinder, optionally forming the bottom of the primary packaging container from one end of the tube, thereby closing the tube at this end, and forming the upper region of the primary packaging container from the opposite end of the tube. Preferably, the glass wall is transparent. Alternatively, the container wall is preferably made from a polymer. In that case, it is preferable that the container wall is also transparent.

[0078] As used herein, the internal volume of the primary packaging container refers to the total volume of the container.This volume can be determined by filling the container with water to the brim and measuring the volume of the amount of water that the container can absorb to the brim.Therefore, the internal volume of the container used herein is not the nominal volume that is often referred to in the pharmaceutical technical field.This nominal volume may be, for example, about 0.5 times smaller than the internal volume.

[0079] Glass The wall of each primary packaging container preferably comprises glass, more preferably consists essentially of glass. The glass may be any type of glass and may have any composition deemed appropriate by a person skilled in the art in the context of the present invention. Preferably, the glass is suitable for pharmaceutical packaging. Particularly preferably, the glass is Type I 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 preferably selected from the group consisting of borosilicate glass, aluminosilicate glass, and fused silica, or a combination of at least two thereof, with borosilicate glass being particularly preferred. As used 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 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% by weight, preferably less than 6.5% by weight, particularly preferably in the range from 0 to 5.5% by weight, in each case based on the total weight of the glass. In a further embodiment, the borosilicate glasses have an Al2O3 content in the range from 3 to 7.5% by weight, preferably in the range from 4 to 6% by weight, in each case based on the total weight of the glass.

[0080] Medical, pharmaceutical, and cosmetic compositions In the context of the present invention, any medical composition, any pharmaceutical composition, and any cosmetic composition deemed appropriate by a person skilled in the art are 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 containing at least one pharmaceutically active ingredient. A preferred pharmaceutically active ingredient is a vaccine. A cosmetic composition is a composition containing at least one cosmetically active ingredient. A preferred cosmetically active ingredient is hyaluronic acid or botulinum toxin. A medical, pharmaceutical, or cosmetic composition may be fluid or solid, or both, with fluid compositions being particularly preferred herein. Preferred solid compositions are in granular form, such as powders, multiple tablets, or multiple capsules. Further preferred medical, pharmaceutical, or cosmetic compositions are parenteral substances, i.e., compositions intended to be administered via a parenteral route, which may be any route other than enteral. Parenteral administration can be performed by injection, for example, using a needle (usually a hypodermic needle) and syringe, or by insertion of an indwelling catheter.

[0081] secondary packaging container The secondary packaging container may generally be any container that a person skilled in the art would consider for accommodating a holding structure, preferably a configuration. A preferred secondary packaging container is a tub. Particularly preferred is a so-called nesting solution tub, as commonly known in the art of transport packaging for medical, pharmaceutical, and cosmetic containers. An example of a known nesting solution is commercially available from Schott AG under the trade name SCHOTT iQ® Platform. Preferred secondary packaging containers are prepared by deep drawing or injection molding, with deep drawing being particularly preferred. Additionally or alternatively, the secondary packaging container is preferably made from one or more plastics. In this regard, preferred plastics are those selected from the group consisting of polycondensation polymers, preferably polyethylene terephthalate, polyacrylates, preferably polymethyl methacrylate, and polyolefins, preferably polypropylene or polyethylene, polystyrene, or a combination of at least two thereof.

[0082] direction The transverse and longitudinal directions referred to herein are perpendicular to each other. The longitudinal direction preferably extends along the length of the receptacle. Preferably, any direction perpendicular to the longitudinal direction is considered as the transverse direction. Thus, multiple transverse directions can originate from a single longitudinal direction. Here, the transverse 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 conveying element. Any cross-section herein is perpendicular to the longitudinal direction. [Brief explanation of the drawings]

[0083] Unless otherwise specified in the specification or in a particular drawing, [Figure 1A] 1 is a cross-sectional view of a primary packaging container 200 received in a receptacle 101 of a holding structure 100 according to the invention in a rest position. [Figure 1B] 1 shows a primary packaging container 200 that can be accommodated in a receptacle 101 of a holding structure 100 according to the present invention. [Figure 2] 1 is a cross-sectional view of a primary packaging container 200 received in a receptacle 101 of a holding structure 100 according to the invention in a raised position. [Figure 3] 1 is a top view of a retention structure 100 according to the present invention, with alignment elements 106 attached to a side wall 104 of a receptacle 101. FIG. [Figure 4] 1 is a further top view of a retaining structure 100 according to the present invention, in which an alignment element 106 is located on top of a guide portion 109. FIG. [Figure 5] 1 is a cross-sectional view of a receptacle 101 in which a side wall 104 of the receptacle 101 is inclined at a draft angle γ. [Figure 6] A cross-sectional view of a receptacle 101 in which an alignment element 106 is adapted and positioned to contact a portion of the outer surface of a primary packaging container 200 over at least a certain portion of the length of a section 201' of the primary packaging container 200 accommodated in the receptacle 101. [Figure 7]FIG. 7 is a top view of the receptacle 101 shown in FIG. [Figure 8A] 1 is a cross-sectional view of a receptacle 101 in which an alignment element 106 is provided with a concave recess 108 whose curvature corresponds to the outer diameter of a primary packaging container 200 received in the receptacle 101. FIG. [Figure 8B] FIG. 8B is a top view of an alignment element 106 in the receptacle shown in FIG. 8A. [Figure 9] 1 is a cross-sectional view of a receptacle 101 in which an alignment element 106 is adapted and positioned to make point contact with the outer surface of a primary packaging container 200 received in the receptacle 101 at a position Px. [Figure 10] 1 is a side view of a receptacle 101 in a retaining structure 100 according to the present invention, in which a two-part master mold having a lower mold 110 and an upper mold 111 is designed to be used to fabricate the retaining structure 101. FIG. [Figure 11A] 1 is an optical microscope image of a portion of the exterior surface of a container wall from a comparative example. [Figure 11B] 1 is an optical microscope image of a portion of the exterior surface of a container wall from an example.

[0084] 1A is a cross-sectional view of a primary packaging container 200 received in a receptacle 101 of a retention structure 100 according to the present invention in a rest position. The receptacle 101 serves to receive the primary packaging container 200 therein at least in section 201′. Each receptacle 101 has a depth h, a top end 102 for inserting the primary packaging container 200 into the receptacle 101, a bottom end 103 having a retention portion 105 configured to limit axial movement of the primary packaging container 200 in the receptacle 101, a circumferentially formed sidewall 104 extending longitudinally from the top end 102 to the bottom end 103, and a longitudinal axis L extending longitudinally through the center of the receptacle 101. receptacle1A, a section 201' of the elongated cylindrical body region 201 of the primary packaging container 200 received in the receptacle in the rest position is indicated by a dashed parallelogram. As shown in FIG. 1A, in a retention structure according to the present invention, each receptacle 101 includes an alignment element 106 (shown in the form of a grey circle in FIG. 1A) that protrudes radially into the receptacle 101 and is adapted and arranged to contact a portion of the outer surface of the elongated cylindrical body region 201 of the primary packaging container 200 received in the receptacle 101. The alignment element 106 in each receptacle 101 is adapted and arranged to contact a portion of the outer surface of the elongated cylindrical body region 201 such that the primary packaging container 200 received in the receptacle 101 in the rest position is inclined by an angle α of 2.4 degrees or less, the inclination angle α being equal to or less than the longitudinal axis L of the primary packaging container 200 received in the receptacle 101. receptacle and the longitudinal axis L container The rest position is the angle formed between the retaining portion 105 and the shoulder 208 of the primary packaging container 200. The rest position is the position where the retaining portion 105 limits the axial movement of the primary packaging container 200 received in the receptacle 101. The rest position is therefore the position where the primary packaging container 200 is received to its maximum depth within the receptacle 101. As can be seen, with the receptacle 101 shown in Figure 1A in the rest position, the retaining portion contacts the shoulder 208 of the primary packaging container 200.

[0085] 1B shows a primary packaging container 200 in the form of a vial that can be accommodated in the receptacle 101 of the holding structure 100 according to the present invention. The primary packaging container 200 can comprise a container wall that partially surrounds the interior of the container. The container wall forms, in the following order from top to bottom, a first end 202 with a discharge orifice 203, an elongated cylindrical body region 201, and a further end 204. The elongated cylindrical body region 201 is preferably a hollow cylinder. The further end 204 comprises an upstanding base 205. In addition to the discharge orifice 203, the first end 202 comprises a flange 206 and a neck 207. The elongated cylindrical body region 201 continues to the first end 202 via a shoulder 208. The further end 204 continues to the elongated cylindrical body region 201 via a heel 209. The container wall is made of Type I borosilicate glass.

[0086] FIG. 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 its rest position away from the bottom edge 103 to a lifting height a, where a is 10-50%, preferably 15-45%, and more preferably 20-40% of the receptacle depth h. Such lifting of the primary packaging container within the holding structure occurs, for example, in automated filling processes when optical sensors are used to verify the accuracy of the fill height. As can be seen from FIG. 2, the alignment element 106 also preferably ensures that the tilt angle α' does not exceed a certain maximum value, even in the raised position.

[0087] FIG. 3 is a top view of a retention structure 100 according to the present invention, in which alignment elements 106 are attached to side walls 104 of the receptacles 101. As can be seen, the receptacles 101 are arranged in a regular configuration. The upper side of the retention structure 100 is formed as a plate-like support 107, from which the receptacles 101 protrude perpendicularly. The side wall 104 of each receptacle 101 is formed as a common partition between every two directly adjacent receptacles 101 of the plurality of receptacles 101. As can be seen in FIG. 3, a retention protrusion 105 acting as a retention portion 105 is provided at the bottom end 103 of the receptacle 101 and extends radially inward into the receptacle 101. Each receptacle 101 may have, for example, two retention protrusions 105 diametrically opposed to each other. In the retention structure 100 shown in FIG. 3, the alignment elements 106 are provided as point-engagement contact elements 106 on the upper area of ​​the receptacle 101 .

[0088] Figure 4 is a further top view of a retaining structure 100 according to the invention, in which the alignment elements 106 are provided as point-engagement contact elements 106 located on top of guide portions 109 in the receptacle 101. The guide portions 109 are adapted and arranged to guide the primary packaging container 200 as it is inserted into the receptacle 101. In the retaining structure 100 shown in Figure 4, the guide portions 109 are formed as guide ribs 109 extending in the longitudinal direction of the receptacle 101.

[0089] 5 is a cross-sectional view of a receptacle 101 in which the sidewall 104 of the receptacle 101 is sloped at a draft angle γ such that the inner diameter d of the receptacle 101 continuously increases from the bottom end 103 to the top end 102. In this regard, 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.

[0090] Figure 6 is a cross-sectional view of a receptacle 101 in which alignment elements 106 are adapted and arranged to contact a portion of the outer surface of the primary packaging container 200 over at least a certain portion of the length of the elongated cylindrical body region 201 received in the receptacle 101. In the embodiment shown in Figure 6, these longitudinal alignment elements 106 are located on top of the guiding ribs 109 and extend over substantially the entire length of these guiding ribs 106.

[0091] Figure 7 is a top view of a portion of the retaining structure 100 according to the present invention shown in Figure 6, in which the alignment element 106 that contacts the outer surface of the primary packaging container 200 received in the receptacle 101 is located on top of the surface of the guide rib 109, similar to the configuration in Figure 6. In the receptacle 101 shown in Figures 6 and 7, the inner diameter of the receptacle 101 defined by the dimension of the alignment element 106 determined at position P2, which is 13 mm above the bottom end 103 of the receptacle 101, is 15.95 mm, while the inner diameter of the receptacle 101 defined by the dimension of the alignment element 106 determined at position P1, which is 33.25 mm away from position P2, is 16.11 mm.

[0092] Figure 8A is a cross-sectional view of a receptacle 101 in which an alignment element 106 is provided with a concave recess 108 whose curvature corresponds to the outer diameter of the primary packaging container 200 received in the receptacle 101. In the embodiment shown in Figure 8A, the receptacle 101 is provided with such alignment elements only in an upper area near the top end 102 of the receptacle, and as shown in Figure 8B, two such alignment elements 106 may be positioned opposite each other such that their concave recesses 108 together form a circular recess in which the elongated cylindrical body region 201 of the primary packaging container 200 is enclosed.

[0093] FIG. 9 shows alignment element 106 at position P x8 is a cross-sectional view of a receptacle 101 adapted and arranged to make point-engaging contact with the exterior surface of a primary packaging container 200 received in the receptacle 101 at a predetermined angle. In the embodiment shown in FIG. 8, these point-engaging contact elements 106 can be localized at three different heights within a given receptacle, shown as position P1 near the top end 102 of the receptacle 101, position P2 near the bottom end 103 of the receptacle 101, and P3 located between P1 and P2. The alignment elements at position P1 preferably lie along a first circle located in a first plane, and the alignment elements at position P2 lie along a second circle located in a second plane, the first and second planes being parallel to one another and aligned along a longitudinal axis L. receptacle , and the diameter φ1 of the first circle at position P1 is greater than the diameter φ2 of the second circle at position P2. As shown in Figure 8, for a receptacle 101 with alignment elements 106 located at three different positions P1, P2, and P3, the alignment element 101 at position P3 is preferably also located along a third circle having a diameter φ3, where φ1 > φ3 > φ2.

[0094] 10 is a side view of a receptacle 101 in a retention structure 100 according to the present invention, where a two-part master mold having a lower mold part 110 and an upper mold part 111 is designed to be used to fabricate the retention structure 101, and the alignment element 106 is located in the portion of the receptacle formed by the upper mold part 111. By using such a two-part component mold, the inner diameter d of the receptacle at the bottom end can be reduced. bottom is the inner diameter d at the top top It is then possible to provide a receptacle 101 whose side walls are not inclined at all, so as to correspond to the angle a of the container. Such a receptacle allows the accommodation of a primary packaging container at a particularly low angle of inclination α, even when the container is lifted at a lifting height a.

[0095] Test Method To determine the wear on the exterior of a primary packaging container in the form of a cartridge inserted into a receptacle of a retention structure, the cartridge was first tempered in an oven at 250°C for 24 hours. After the cartridge had cooled to approximately 24°C, it was manually inserted into a nest having a receptacle with guide ribs and removed by actively scraping the cartridge along these ribs. The exterior of the cartridge was then visually inspected using an optical microscope.

[0096] Example In a retention structure such as that shown in Figure 6 with a receptacle having a draft angle γ of 0.2 degrees, guide ribs were modified by mounting them to the retention structure within each receptacle alignment element so that the inner diameter defined by these alignment elements was 15.95 mm at position P2, 13 mm above the bottom edge of the receptacle, and 16.11 mm at position P1. The vertical distance between heights P1 and P2 was 33.25 mm, and the inclination angle α was 1.16 degrees.

[0097] Comparative Example The same retaining structure as in the example was used, the only difference being that the guide ribs were not modified by any alignment elements.

[0098] As can be seen from Figures 11A and 11B, the alignment elements help to significantly reduce wear on the exterior surface of the cartridge as it moves inside the receptacle. [Explanation of symbols]

[0099] 100 retention structure 101 Receptacle 102 Top end of receptacle 101 103 bottom end of receptacle 101 104 Side wall of receptacle 101 105 Retaining portion of receptacle 101 106 Alignment Elements 107 Plate-shaped conveying element 108 Concave recess 109 Information section 110 Lower mold 111 Upper mold 200 Primary packaging containers 201 elongated cylindrical body region of primary packaging container 200 201' Section of the elongated cylindrical body region 201 of the primary packaging container 200 received in the receptacle 101 202 First end of primary packaging container 200 203 Discharge Orifice 204 Further end of primary packaging container 200 205 Upright base 206 flange 207 Neck 208 Shoulder 300 Transport unit according to the present invention 301 Configuration according to the present invention 302 Secondary packaging containers 303 Lid

Claims

1. A holding structure (100) for simultaneously holding a plurality of primary packaging containers (200) for substances for pharmaceutical, medical or cosmetic use, each primary packaging container (200) having an elongated cylindrical body region (201) with a longitudinal axis L extending longitudinally through the center of said elongated cylindrical body region (201). ｃｏｎｔａｉｎｅｒ and said retaining structure (100) comprises an elongated cylindrical body region (201) having: a plurality of receptacles (101) for receiving at least one section (201') of the elongated cylindrical body region (201) of the primary packaging container (200), each receptacle (101) having a depth h, a top end (102) for inserting the primary packaging container (200) into the receptacle (101), a bottom end (103) having a retaining portion (105) configured to limit axial movement of the primary packaging container (200) in the receptacle (101), a circumferentially formed sidewall (104) extending longitudinally from the top end (102) to the bottom end (103), and a longitudinal axis L extending longitudinally through a center of the receptacle (101); ｒｅｃｅｐｔａｃｌｅ a plurality of receptacles (101) having an alignment element (106) in each receptacle (101), the alignment element (106) protruding radially into said receptacle (101) and adapted and arranged to contact a portion of the outer surface of said elongated cylindrical body region (201) of a primary packaging container (200) received in said receptacle (101); Equipped with The alignment element (106) in each receptacle (101) is adapted and arranged to contact a portion of the outer surface of the elongated cylindrical body region (201) such that a primary packaging container (200) received in the receptacle (101) in a rest position is inclined by an angle α of 2.4 degrees or less, the inclination angle α being equal to or less than the longitudinal axis L of the primary packaging container (200) received in the receptacle (101). ｒｅｃｅｐｔａｃｌｅ and the longitudinal axis L ｃｏｎｔａｉｎｅｒ and the rest position is a position where the holding portion (105) limits the axial movement of the primary packaging container (200) accommodated in the receptacle (101). Retaining structure (100).

2. The alignment element (106) in each receptacle (101) is adapted and arranged to contact a portion of the outer surface of the elongated cylindrical body region (201) such that a primary packaging container (200) received in the receptacle (101) in a raised position is still tilted by an angle α' of 2.4 degrees or less, the tilt angle α' being equal to or less than the longitudinal axis L of the primary packaging container (200) received in the receptacle. ｒｅｃｅｐｔａｃｌｅ and the longitudinal axis L ｃｏｎｔａｉｎｅｒ and the lifting position is a position where the primary packaging container (200) is lifted from the rest position in a direction away from the bottom end (103) to a lifting height a, where a is 10-50% of the depth h of the receptacle.

3. The retaining structure (100) is formed by injection molding from a plastic material, and the side wall (104) of the receptacle (101) is oriented along a longitudinal axis L such that the inner diameter d of the receptacle (101) increases continuously from the bottom end (103) to the top end (102). ｒｅｃｅｐｔａｃｌｅ The retaining structure (100) according to claim 1 or 2, wherein the retaining structure (100) is inclined at a draft angle γ relative to the retaining structure (100).

4. The retaining structure (100) is formed by injection molding from a plastic material, and a two-part master mold having a lower mold and an upper mold is used for fabricating the retaining structure (100) by injection molding from the plastic material, so that the side wall (104) of the receptacle (101) is aligned along the longitudinal axis L. ｒｅｃｅｐｔａｃｌｅ and therefore the inner diameter d of the receptacle (101) at the bottom end (103) is ｂｏｔｔｏｍ is the inner diameter d at the upper end (102) ｔｏｐ The retaining structure (100) according to any one of claims 1 to 3, which is designed to accommodate:

5. The receptacles (101) are arranged in a regular configuration; The upper side of said holding structure (100) is formed as a plate-like carrying element (107), The receptacle (101) projects perpendicularly from the plate-like carrying element (107), The side wall (104) is formed as a common partition between each two immediately adjacent receptacles (101) of the plurality of receptacles (101). A retaining structure (100) according to any one of claims 1 to 4.

6. 6. The retaining structure (100) according to claim 1, wherein in each receptacle (101), the alignment elements (106) extend longitudinally from the top end (102) to the bottom end (103) of the receptacle (101) and comprise a plurality of longitudinal alignment elements (106) extending across at least 50% of the entire depth h of the receptacle (101), the alignment elements (106) being adapted and arranged to contact a portion of an outer surface of the primary packaging container (200) across at least a certain portion of the length of the elongated cylindrical body region (201) received in the receptacle (101).

7. In each receptacle (101), at least two alignment elements (106) are provided with concave recesses (108) at one or more positions P ｘ a curvature of the concave recess (108) corresponds to an outer diameter of the primary packaging container (200) received in the receptacle (101), and the alignment element (106) is adapted and arranged to contact the outer surface of the primary packaging container (200) over at least a portion of the circumference of the elongated cylindrical body region (201′) received in the receptacle (101).

8. In each receptacle (101), one or more positions P are provided with at least two alignment elements (106). ｘ and the alignment element (106) is adapted and arranged to make point contact with the outer surface of the primary packaging container (200) in at least a portion of the elongated cylindrical body region (201) that is received in the receptacle (101).

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

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

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

12. The configuration according to claim 11; Secondary packaging and Equipped with the retaining structure (100) and the plurality of primary packaging containers (200) are completely disposed in the secondary packaging container; Transport unit.

13. 1. A process for filling a pharmaceutical, medical, or cosmetic composition into a primary packaging container, comprising: A) providing an arrangement according to claim 11; B) filling, in an automatic filling machine, the liquid pharmaceutical composition into each primary packaging container contained in the receptacle of the holding structure; The process includes:

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

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

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