Holding structure for ready-to-use container

Abstract

To provide a holding structure for simultaneously holding a plurality of primary packaging containers for pharmaceutical, medical or cosmetic compositions.SOLUTION: A holding structure (100) includes n-pieces of storage parts (101) for storing a primary container, where n is an integer having a value of at least 10. The storage part (101) is formed by side walls (102) formed in a peripheral edge shape. The holding structure includes: a flat base frame (104) having a maximum length Lx and a maximum width Ly, where the flat base frame (104) has a first side, a second side, and a center recessed part having a length L'x and a width L'y; a plurality of first webs (106); and a plurality of second webs (107). The first and second webs (106, 107) form the side walls (102), and the first and second webs (106, 107) have a shape of a continuous beam member having a maximum waviness wmax of 4.0 mm.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] The present invention relates to a holding structure for simultaneously holding a plurality of primary packaging containers for pharmaceutical, medical or cosmetic compositions, the holding structure having a plurality of receptacles for receiving the primary packaging containers, the receptacles being formed by peripherally shaped side walls. The present invention also relates to a transport or packaging container, the use of the holding structure, and a plurality of holding structures.

[0002] Pharmaceutical containers, such as syringes, vials, ampoules, or cartridges, are widely used as containers for storing medical, pharmaceutical, or cosmetic preparations for administration in liquid form, particularly in pre-measured amounts. These pharmaceutical containers generally have a cylindrical shape, can be manufactured from plastic or glass, and can be obtained in large quantities in a cost-effective manner. In this regard, these containers are increasingly delivered to pharmaceutical manufacturers or subsequent processing operations in a predefined geometric arrangement within a holding structure, and the containers are subsequently processed while held or housed within the holding structure. To this end, there is a need for a cost-effective, durable holding structure in which containers are held or housed in an arrangement that occupies minimal space.

[0003] An example of a holding structure suitable for holding pre-filled cartridges is disclosed in WO 2016 / 166769. The holding structure has a plurality of tubular receiving sections arranged in the same regular arrangement for receiving a plurality of cartridges, with the receiving sections having holding protrusions formed at their lower ends that protrude inward, and the sealed cartridges are received upside down in the receiving sections, so that shoulders of the sealed cartridges are supported by the holding protrusions of the receiving sections.

[0004] Another holding structure for syringe bodies, disclosed in WO 2012 / 126582, has a plate-like carrier in which a number of cylindrical receiving sections with peripherally formed side walls are formed. The syringe bodies are placed with their holding flanges on the upper ends of the cylindrical receiving sections. To reinforce the carrier, the cylindrical receiving sections are connected to one another via connecting webs on the underside of the carrier.

[0005] To make filling containers under sterile conditions as economical as possible, these containers are increasingly being delivered to pharmaceutical filling companies in sterile packaging by the container manufacturer, so that the pharmaceutical filling company does not have to clean and sterilize the containers. For this purpose, the containers must be opened under sterile conditions at the pharmaceutical filling company, e.g., a pharmaceutical company, and then further processed. During the filling process, the containers remain in the holding structure of the above-mentioned sterile packaging, and manufacturing concepts are increasingly being used in which the containers are filled while located in a holding structure that is part of the sterile packaging. In addition to the actual filling process, other sub-processes, such as weighing, stopper placement, freeze-drying, and final sealing of the containers with stoppers, may be performed while the containers are supported in the holding structure. This places many additional demands on the holding structure, particularly with regard to the precision of the container's position within the holding structure.

[0006] It has been observed that when the above-mentioned holding structures known from the prior art are used to accommodate elongated containers (e.g., syringes or cartridges) at a high packing density, certain processing steps, such as filling with pharmaceutical compositions or closing with stoppers, often cannot be performed simultaneously and at high cycle frequencies in an automated system with the desired accuracy. In particular, in the case of containers with a relatively high dead weight, such as filled glass syringes or filled glass cartridges, it has been observed that the accurate setting of stoppers for closing the containers after the filling process at high cycle frequencies (i.e., for a large number of holding structures loaded with containers to be filled and closed per unit time in an automated filling device) needs to be particularly improved. This applies in particular to holding structures made of thermoplastic polymers that have been pre-sterilized by steam and thus under thermal stress.

[0007] Therefore, there is a need for further improvements in the production of retention structures of the type described above.

[0008] The object of the present invention is to provide an improved holding structure for simultaneously holding multiple containers for substances intended for pharmaceutical, medical, or cosmetic use, which can be produced in a simple and cost-effective manner and which advantageously allows for a high packing density of containers, particularly containers with a high dead weight, such as glass syringes or glass cartridges. Furthermore, it is desirable for the holding structure to accommodate such containers as densely as possible, to be filled—while these containers are housed within the holding structure—and then be closed as uniformly as possible with as high a cycle frequency as possible by inserting stoppers into the open ends of the containers. This should be particularly useful for holding structures based on thermoplastic polymers and that have been pre-sterilized at elevated temperatures, particularly at temperatures of at least about 121°C using steam. Furthermore, it is desirable for the holding structure—while characterized by the advantageous properties described above—to simultaneously be characterized, preferably, by a minimal dead weight.

[0009] At least one, preferably two or more of said objects are at least partially solved by the subject matter defined in the independent claims. The dependent claims provide preferred embodiments that at least partially solve at least one of said objects.

[0010] |1| According to the present invention, at least one of the above objects is achieved by a first embodiment of a holding structure 1 for simultaneously holding a plurality of primary packaging containers for pharmaceutical, medical or cosmetic compositions, the holding structure has n receptacles for receiving the primary packaging containers, n being an integer having a value of at least 10, the receptacles being defined by peripherally formed side walls; The holding structure is -Maximum length L x and maximum width L y a flat base frame having a first side and a second side and a length L'; x and width L' y a flat base frame having a central recess with a plurality of first webs extending parallel to one another in a first direction across the central recess; a plurality of second webs extending parallel to one another in a second direction across the central recess; It has the first and second webs are arranged to form side walls of the receptacle; Each of the first and second webs has a maximum waviness w of less than 4.0 mm, preferably less than 3.8 mm, more preferably less than 3.6 mm, even more preferably less than 3.4 mm, even more preferably less than 3.2 mm, even more preferably less than 3.0 mm, even more preferably less than 2.8 mm, even more preferably less than 2.6 mm, even more preferably less than 2.4 mm, even more preferably less than 2.2 mm, even more preferably less than 2.0 mm, even more preferably less than 1.8 mm, even more preferably less than 1.6 mm, even more preferably less than 1.4 mm, even more preferably less than 1.2 mm, even more preferably less than 1.0 mm, even more preferably less than 0.8 mm, even more preferably less than 0.6 mm, even more preferably less than 0.4 mm, even more preferably less than 0.2 mm.max In this case, the maximum waviness w of 0 mm is max (i.e., most preferably, the first and second webs are in the form of substantially straight beam members).

[0011] A "primary packaging container" in the sense of the present invention is a container that can be filled with a pharmaceutical, medical or cosmetic composition, such as a syringe body, vial, ampoule or cartridge, preferably a syringe body or cartridge, most preferably a syringe body, in particular a glass or polymer syringe body. These containers preferably have a rotationally symmetrical body with a first end and a second end, one of which, preferably the lower end, is closed when the container is inserted into the holding structure, and the other end, preferably the upper end, is open, so that the container can be filled with the pharmaceutical, medical or cosmetic composition, preferably via the upper end, while it is held in the holding structure.

[0012] |2| In one preferred embodiment of the holding structure 1 according to the present invention, the holding structure further comprises: - having an outer frame that protrudes from the flat base frame on a first side, a second side, or both sides and is connected to the flat base frame so as to surround a central recess in the base frame; Each of the first and second webs is connected to an outer frame at each end of the web. This preferred embodiment is a second embodiment of the retaining structure 1 according to the present invention and preferably depends on the first embodiment of the present invention.

[0013] According to a particular embodiment of the above-mentioned second embodiment of the holding structure 1 according to the invention, the outer frame has an upper edge, a lower edge, a first side edge and a second side edge, which edges are joined together to form a continuous outer frame, and each of the first and second webs forms an angle α with the edge of the outer frame, α being in the range of 0 to 90°, preferably in the range of 20 to 80°, preferably in the range of 30 to 70°, more preferably in the range of 40 to 60°, and most preferably in the range of 45 to 55°.

[0014] According to another particular embodiment of the above-mentioned second embodiment of the holding structure 1 according to the invention, the bars of the outer frame have a wall thickness in the range of 0.5 to 4.0 mm, preferably in the range of 0.8 to 3.5 mm, more preferably in the range of 1.2 to 3.0 mm, and most preferably in the range of 1.5 to 2.5 mm. The height of the bars of the outer frame is preferably in the range of 5 to 35 mm, more preferably in the range of 10 to 30 mm, even more preferably in the range of 12 to 28 mm, and most preferably in the range of 15 to 25 mm.

[0015] According to another particular embodiment of the above-mentioned second embodiment of the holding structure 1 according to the invention, the maximum area spanned by the flat base frame is greater than the area spanned by the outer frame. Particularly preferred in this respect is that the holding structure further comprises: -Stabilizing member that connects the outer frame to the flat base frame It has the following characteristics.

[0016] Preferably, these stabilizing elements are wing-shaped and are connected to the edge of the outer frame on one side of the stabilizing element and to the flat base frame on the adjacent side of the stabilizing element. In this regard, it is also preferred that each edge of the outer frame is connected to the flat base frame via at least two such stabilizing elements. In this regard, it is also preferred that the holding device further includes an access opening that allows the holding structure to be grasped or guided. Preferably, the holding device has two such access openings recessed in the flat base frame on opposite sides of the holding device.

[0017] |3| In another preferred embodiment of a retention structure 1 according to the present invention, the first and second webs have a wall thickness in the range of 0.1 to 4.0 mm, preferably in the range of 0.2 to 3.5 mm, more preferably in the range of 0.3 to 2.0 mm, and most preferably in the range of 0.5 to 1.0 mm. The height of the first and second webs is preferably in the range of 5 to 35 mm, more preferably in the range of 10 to 30 mm, even more preferably in the range of 12 to 28 mm, and most preferably in the range of 15 to 25 mm. This preferred embodiment is a third embodiment of a retention structure 1 according to the present invention, and preferably depends on the first or second embodiment of the present invention.

[0018] In another preferred embodiment of the retention structure 1 according to the present invention, the flat base frame has a thickness in the range of 0.5 to 3.0 mm, preferably in the range of 0.8 to 2.5 mm, more preferably in the range of 1.0 to 2.0 mm, and most preferably in the range of 1.2 to 1.6 mm. This preferred embodiment is a fourth embodiment of the retention structure 1 according to the present invention, and preferably depends on any one of the first to third embodiments of the present invention.

[0019] |5| In one further preferred embodiment of the holding structure 1 according to the invention, the holding structure has a length of at least 100 mm 4 , preferably at least 200 mm 4 , more preferably at least 300 mm 4 , more preferably at least 400 mm 4 This preferred embodiment is a fifth embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to fourth embodiments of the present invention.

[0020] |6| In another preferred embodiment of the holding structure 1 according to the present invention, the holding structure houses n primary packaging containers, preferably n primary packaging containers selected from the group consisting of syringe bodies, vials, ampoules or cartridges, more preferably n syringe bodies or cartridges, most preferably n syringe bodies, in particular n glass syringe bodies or n polymeric syringe bodies. The n primary packaging containers may be empty (i.e., they do not contain any pharmaceutical, medical or cosmetic composition) or they may be at least partially filled with a pharmaceutical, medical or cosmetic composition. This preferred embodiment is a sixth embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to fifth embodiments of the present invention.

[0021] |7| In another preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure has a deflection D as measured by the test method disclosed herein of less than 0.25 mm, preferably less than 0.22 mm, more preferably less than 0.18 mm, when equipped with n empty or at least partially filled receptacles having a total weight of up to 400 g. This preferred embodiment is a seventh embodiment of the retaining structure according to the present invention, and preferably depends on any one of the first to sixth embodiments of the present invention.

[0022] |8| In another preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure has a deflection D' as measured by the test method disclosed herein of less than 0.4 mm, preferably less than 0.37 mm, more preferably less than 0.34 mm, when equipped with n empty or at least partially filled receptacles having a total weight of up to 800 g. This preferred embodiment is an eighth embodiment of the retaining structure according to the present invention, and preferably depends on any one of the first to seventh embodiments of the present invention.

[0023] |9| In one another preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure has a deflection D'' as measured by the test method disclosed herein of less than 0.5 mm, preferably less than 0.47 mm, more preferably less than 0.44 mm, when equipped with n empty or at least partially filled receptacles having a total weight of up to 1100 g. This preferred embodiment is a ninth embodiment of the retaining structure 1 according to the present invention, and preferably depends on any one of the first to eighth embodiments of the present invention.

[0024] In another preferred embodiment of the retention structure 1 according to the present invention, the outer frame and the first and second webs have a height in the range of 15 to 25 mm, preferably in the range of 16.5 to 22.5 mm, and more preferably in the range of 17 to 20 mm. This preferred embodiment is a tenth embodiment of the retention structure 1 according to the present invention, and preferably depends on any one of the second to ninth embodiments of the present invention.

[0025] |11| In one alternative preferred embodiment of the holding structure 1 according to the present invention, L x is in the range of 200 to 260 mm, preferably in the range of 220 to 240 mm, and L y is in the range of 170 to 230 mm, more preferably in the range of 190 to 210 mm. This preferred embodiment is an eleventh embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to tenth embodiments of the present invention.

[0026] |12| In one alternative preferred embodiment of the retaining structure 1 according to the present invention, L' x is in the range of 170 to 230 mm, preferably in the range of 190 to 210 mm, and L' y is in the range of 140 to 200 mm, preferably in the range of 160 to 180 mm. This preferred embodiment is a twelfth embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to eleventh embodiments of the present invention.

[0027] In one alternative preferred embodiment of the retaining structure 1 according to the invention, the retaining structure in the empty state has a density of 0.5 g / cm 2 less than 0.4 g / cm 2 less than 0.3 g / cm 2 This preferred embodiment is a thirteenth embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to twelfth embodiments of the present invention.

[0028] |14| In one further preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure is based on, and preferably manufactured from, a thermoplastic polymer, preferably having a melting point in the range of 100-300°C. In this context, the thermoplastic material is particularly preferably selected from the group consisting of polyetheretherketone (PEEK), polyphenylsulfone (PPSU), polyacetal homopolymers or copolymers (POM-H or POM-C), polypropylene (PP), polycarbonate, polystyrene, polyamide, polyethylene terephthalate, acrylonitrile / butadiene / styrene copolymers, or a mixture of at least two of these polymers, which may be filled with fillers such as calcium carbonate, kaolin, carbon black, carbon fibers, aluminum hydroxide, alumina trihydrate, talc, dolomite, barium ferrite, wollastonite, wood flour, glass fibers, nanoclay, starch (crystalline and amorphous), calcium sulfate, glass spheres, mica, silica, feldspar, nepheline, graphite, boron nitride, silicon carbide, silicon nitride, aluminum oxide, titanium dioxide, zinc oxide, iron oxide, magnesium oxide, zirconium oxide, or a mixture of at least two of these fillers. Particularly preferred is the use of polypropylene or polypropylene filled with one of the above-mentioned fillers. Also suitable are polymers selected from the group consisting of olefin copolymers, cyclic olefin polymers or mixtures thereof. This preferred embodiment is a 14th embodiment of the retention structure 1 according to the invention, which preferably depends on any one of the 1st to 13th embodiments of the invention.

[0029] In another preferred embodiment of the holding structure 1 according to the present invention, the holding structure is integrally formed by injection molding, 3D printing or a combination of these approaches. This preferred embodiment is a fifteenth embodiment of the holding structure 1 according to the present invention and preferably depends on any one of the first to fourteenth embodiments of the present invention.

[0030] |16| In one further preferred embodiment of the holding structure 1 according to the present invention, - the holding structure, each with a weight m o When n empty primary packaging containers having -m1 is the weight of an empty holding structure, m1 / (n×m o ) is less than 0.24, preferably less than 0.22, more preferably less than 0.20, more preferably less than 0.18, even more preferably less than 0.15, and most preferably less than 0.12. This preferred embodiment is a 16th embodiment of the holding structure 1 according to the present invention, which preferably depends on any one of the first to fifteenth embodiments of the present invention.

[0031] In another preferred embodiment of the retention structure 1 according to the present invention, the retention structure is characterized by a warpage of less than 2.0 mm, preferably less than 1.0 mm, more preferably less than 0.5 mm, determined by the methods disclosed herein before steam sterilization. This preferred embodiment is a 17th embodiment of the retention structure 1 according to the present invention, and preferably depends on any one of the first to sixteenth embodiments of the present invention. This warpage corresponds to bending of the (empty) retention structure after it has been prepared, for example, by 3D printing, injection molding, or a combination of these approaches.

[0032] In another preferred embodiment of the retention structure 1 according to the present invention, the retention structure is characterized by a warpage of less than 4.0 mm, preferably less than 2.0 mm, more preferably less than 1.0 mm, determined by the method disclosed herein after steam sterilization at 122° C. for 22 minutes. This preferred embodiment is an 18th embodiment of the retention structure 1 according to the present invention, and preferably depends on any one of the first to seventeenth embodiments of the present invention.

[0033] In another preferred embodiment of the retention structure 1 according to the present invention, the retention structure is characterized by an expansion limit determined by the method disclosed herein of less than 1%, preferably less than 0.5%, and most preferably less than 0.1%. This preferred embodiment is a 19th embodiment of the retention structure 1 according to the present invention, and preferably depends on any one of the first to eighteenth embodiments of the present invention.

[0034] |20| In another preferred embodiment of a retention structure 1 according to the present invention, the retention structure is a sterilized retention structure that has been sterilized with steam at a temperature in the range of 120-130°C, preferably 121-128°C, more preferably 122-125°C, for 10-60 minutes, preferably 15-40 minutes, more preferably 20-30 minutes. This preferred embodiment is a 20th embodiment of a retention structure 1 according to the present invention, and preferably depends on any one of the first to nineteenth embodiments of the present invention.

[0035] |21| In another preferred embodiment of the holding structure 1 according to the present invention, the primary packaging container that can be held (or in the case of the sixth preferred embodiment, held by the holding structure) is a container selected from the group consisting of a syringe body, a vial, an ampoule, and a cartridge, with a syringe body being particularly preferred. In this regard, it is also preferred that the primary packaging container, preferably the syringe body, is based on glass or a polymer, preferably made of glass or a polymer (and therefore is a glass syringe body). More preferably, the primary packaging container is a glass syringe body, the distal end of which is formed with a discharge opening and the opposite end of which is formed with a filling opening for receiving a plunger or stopper after filling, and the opposite end is provided with an enlarged flange. In this regard, it is also preferred that the syringe body, preferably a glass or polymer syringe body, is received upside down in the receiving portion of the holding structure according to the present invention, with the enlarged flange located above the upper end of the side wall. This preferred embodiment is a 21st embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to twentieth embodiments of the present invention.

[0036] In a first special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a glass syringe body, and the following conditions are met: i) the syringe body has a nominal capacity in the range of 0.3 to 0.7 ml, preferably in the range of 0.4 to 0.6 ml, and more preferably in the range of 0.45 to 0.55 ml; ii) The syringe body has a barrel length GL in the range of 64 to 84 mm, preferably in the range of 68 to 80 mm, and more preferably in the range of 72 to 76 mm; iii) The syringe body has an outer diameter OD in the range of 5 to 9 mm, preferably in the range of 6 to 8 mm, and more preferably in the range of 6.5 to 7.5 mm.

[0037] In a second special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a glass syringe body, and the following conditions are met: i) the syringe body has a nominal capacity in the range of 0.9 to 1.1 ml, preferably in the range of 0.95 to 1.05 ml, and more preferably in the range of 0.99 to 1.01 ml; ii) The syringe body has a barrel length GL in the range of 70 to 90 mm, preferably in the range of 75 to 85 mm, and more preferably in the range of 78 to 82 mm; iii) The syringe body has an outer diameter OD in the range of 7 to 9 mm, preferably in the range of 7.5 to 8.5 mm, and more preferably in the range of 7.8 to 8.2 mm.

[0038] In a third special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a glass syringe body or a polymer syringe body, in particular a syringe body made from a cyclic olefin copolymer (COC) such as TopPac® (Schott, Germany), and the following conditions are met: i) the syringe body has a nominal capacity in the range of 0.3 to 1.5 ml, preferably in the range of 0.4 to 1.3 ml, and more preferably in the range of 0.5 to 1.0 ml; ii) The syringe body has a barrel length GL in the range of 40 to 85 mm, preferably in the range of 50 to 80 mm, and more preferably in the range of 54 to 73 mm; iii) The syringe body has an outer diameter OD in the range of 8 to 12 mm, preferably in the range of 9 to 11.5 mm, and more preferably in the range of 9.4 to 11 mm.

[0039] In a fourth special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a polymeric syringe body, in particular a syringe body made from a cyclic olefin copolymer (COC) such as TopPac® (Schott, Germany), in which the following conditions are met: i) the syringe body has a nominal capacity in the range of 1.8 to 3.5 ml, preferably in the range of 2 to 3.3 ml, and more preferably in the range of 2.2 to 3 ml; ii) The syringe body has a barrel length GL in the range of 63 to 83 mm, preferably in the range of 68 to 78 mm, and more preferably in the range of 72 to 74 mm; iii) The syringe body has an outer diameter OD in the range of 10.5 to 12.5 mm, preferably in the range of 11 to 12 mm, and more preferably in the range of 11.4 to 11.6 mm.

[0040] In a fifth special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a glass syringe body, and the following conditions are met: i) the syringe body has a nominal capacity within the range of 2.5 to 3.5 ml, preferably within the range of 2.8 to 3.2 ml, and more preferably within the range of 2.9 to 3.1 ml; ii) The syringe body has a barrel length GL in the range of 75 to 95 mm, preferably in the range of 80 to 90 mm, and more preferably in the range of 83 to 87 mm; iii) The syringe body has an outer diameter OD in the range of 13 to 16 mm, preferably in the range of 14 to 15 mm, and more preferably in the range of 14.4 to 14.6 mm.

[0041] In a sixth special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a polymeric syringe body, preferably a syringe body made from a cyclic olefin copolymer (COC) such as TopPac® (Schott, Germany), and the following conditions are met: i) the syringe body has a nominal capacity in the range of 3 to 12 ml, preferably in the range of 4 to 11 ml, and more preferably in the range of 5 to 10 ml; ii) The syringe body has a barrel length GL in the range of 95 to 115 mm, preferably in the range of 100 to 112 mm, and more preferably in the range of 104 to 108 mm; iii) The syringe body has an outer diameter OD in the range of 13 to 17 mm, preferably in the range of 14 to 16 mm, and more preferably in the range of 14.8 to 15.2 mm.

[0042] In a seventh special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a polymeric syringe body, preferably a syringe body made from a cyclic olefin copolymer (COC) such as TopPac® (Schott, Germany), and the following conditions are met: i) the syringe body has a nominal capacity within the range of 15 to 25 ml, preferably within the range of 15.5 to 22.5 ml, and more preferably within the range of 19 to 21 ml; ii) The syringe body has a barrel length GL in the range of 95 to 115 mm, preferably in the range of 100 to 112 mm, and more preferably in the range of 104 to 108 mm; iii) The syringe body has an outer diameter OD in the range of 16 to 20 mm, preferably in the range of 17 to 19 mm, and more preferably in the range of 17.8 to 18.2 mm.

[0043] In an eighth special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a polymeric syringe body, preferably a syringe body made from a cyclic olefin copolymer (COC) such as TopPac® (Schott, Germany), and the following conditions are met: i) the syringe body has a nominal capacity within the range of 15 to 25 ml, preferably within the range of 15.5 to 22.5 ml, and more preferably within the range of 19 to 21 ml; ii) The syringe body has a barrel length GL in the range of 115 to 140 mm, preferably in the range of 120 to 135 mm, and more preferably in the range of 125 to 130 mm; iii) The syringe body has an outer diameter OD in the range of 19 to 23 mm, preferably in the range of 20 to 22 mm, and more preferably in the range of 21.4 to 21.8 mm.

[0044] In a ninth special embodiment of the above-mentioned twenty-first embodiment of the holding structure 1 according to the invention, the primary packaging container is a polymeric syringe body, preferably a syringe body made from a cyclic olefin copolymer (COC) such as TopPac® (Schott, Germany), and the following conditions are met: i) the syringe body has a nominal capacity in the range of 40 to 60 ml, preferably in the range of 45 to 55 ml, and more preferably in the range of 48 to 52 ml; ii) The syringe body has a barrel length GL in the range of 125 to 150 mm, preferably in the range of 130 to 145 mm, and more preferably in the range of 134 to 140 mm; iii) The syringe body has an outer diameter OD in the range of 28 to 35 mm, preferably in the range of 30 to 33 mm, and more preferably in the range of 31 to 32 mm.

[0045] In another preferred embodiment of the holding structure 1 according to the invention, n is at least 20. In this connection, it is particularly preferred that n is selected from the group consisting of 20, 30, 42, 64, 100 and 160. This preferred embodiment is a 22nd embodiment of the holding structure 1 according to the invention, which preferably depends on any one of the first to twenty-first embodiments of the invention.

[0046] In another preferred embodiment of the holding structure 1 according to the present invention, positioning ribs for centering the primary packaging containers in the receptacle are provided on the side walls of the receptacle, protruding radially inward into the receptacle and extending in the longitudinal direction of the receptacle. Preferably, the positioning ribs are distributed around the periphery of the side walls at equal angular intervals, i.e., in particular, in a point-symmetric arrangement. The maximum internal width w1 formed by the positioning ribs is slightly larger than the maximum width or maximum outer diameter of the containers to be accommodated, so that the containers slide into the receptacle without friction or with minimal friction at any speed when they are inserted vertically into the receptacle from above and are thus guided to the centering position. This preferred embodiment is a 23rd embodiment of the holding structure 1 according to the present invention and preferably depends on any one of the first to 22nd embodiments of the present invention.

[0047] |24| In another preferred embodiment of the holding structure 1 according to the present invention, m of the n receptacles have a parallelogram shape, preferably a square shape or a diamond shape, more preferably a diamond shape, in the plan view of the holding structure, and are arranged with the densest packing density of m≦n. In this connection, it is particularly preferred that the receptacles have a diamond shape and are arranged so that receptacles arranged side by side horizontally or vertically share common corners of the diamond, and receptacles arranged diagonally side by side share common sides. The side walls of the receptacles arranged diagonally side by side are preferably formed by identical webs extending in a predetermined (first or second) direction within the outer frame. This preferred embodiment is a 24th embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to 23rd embodiments of the present invention.

[0048] In a first special embodiment of the above-mentioned 24th embodiment of the holding structure 1 according to the invention, the following conditions are met: i) m of the n receptacles have a square shape; ii) n=42; iii) m=20; iv) m1 (the weight of the empty holding structure) is in the range of 60 to 80 g, preferably in the range of 64 to 75 g, and more preferably in the range of 67 to 71 g.

[0049] In a second special embodiment of the above-mentioned 24th embodiment of the holding structure 1 according to the invention, the following conditions are met: i) m of the n receiving portions have a diamond shape; ii) n=64; iii) m=42; iv) m1 is in the range of 60 to 80 g, preferably in the range of 63 to 75 g, and more preferably in the range of 66 to 70 g.

[0050] In a third special embodiment of the above-mentioned twenty-fourth embodiment of the holding structure 1 according to the invention, the following conditions are met: i) m of the n receiving portions have a diamond shape; ii) n=100; iii) m=80; iv) m1 is in the range of 60 to 100 g, preferably in the range of 70 to 90 g, and more preferably in the range of 80 to 86 g.

[0051] In a fourth special embodiment of the above-mentioned twenty-fourth embodiment of the holding structure 1 according to the invention, the following conditions are met: i) m of the n receiving portions have a diamond shape; ii) n=160; iii) m=140; iv) m1 is in the range of 70 to 110 g, preferably in the range of 80 to 100 g, and more preferably in the range of 85 to 91 g.

[0052] |25| According to another preferred embodiment of the holding structure 1 according to the present invention, the holding structure further has openings formed as through-holes at a plurality of positions on the base frame, which openings can be used in particular as positioning holes to enable a means for accurately orienting the holding structure on a holding structure receptacle having corresponding positioning pegs or protrusions, which is useful, for example, during insertion (nesting), filling, closing or removal (de-nesting) of a primary packaging container accommodated in the holding structure. This preferred embodiment is a 25th embodiment of the holding structure 1 according to the present invention, and preferably depends on any one of the first to twenty-fourth embodiments of the present invention.

[0053] According to the present invention, at least one of the above objects is achieved by a holding structure 2 for simultaneously holding a plurality of primary packaging containers for pharmaceutical, medical or cosmetic compositions, the holding structure has n receptacles for receiving the primary packaging containers, n being an integer having a value of at least 10, the receptacles being defined by peripherally formed side walls; The holding structure is -Maximum length L x and maximum width L y a flat base frame having a first side and a second side and a length L'; x and width L' y a flat base frame having a central recess with a plurality of first webs extending parallel to one another in a first direction across the central recess; a plurality of second webs extending parallel to one another in a second direction across the central recess; It has The first and second webs are arranged so as to form the side walls of the receptacles, and m of the n receptacles have a parallelogram shape, preferably a square shape or a diamond shape, more preferably a diamond shape, in a plan view of the holding structure, and are arranged with the densest packing density, m≦n. In this connection, it is particularly preferred that the receptacles have a diamond shape and are arranged so that the receptacles arranged side by side, either horizontally or vertically, share common corners of the diamond, and the receptacles arranged diagonally next to each other share common sides. The side walls of the receptacles arranged diagonally next to each other are preferably formed by the same web extending in a given (first or second) direction within the outer frame.

[0054] A preferred embodiment of this holding structure is characterized by each of the features described above in relation to any one of the first to twenty-fifth embodiments of the holding structure 1 according to the invention.

[0055] According to the present invention, the solution of at least one of the above objects is also contributed by a plurality of holding structures 1 or 2 according to the present invention, preferably a plurality of holding structures 1 according to any one of the first to twenty-fifth embodiments described above, wherein each holding structure in an empty state has a deflection D0 determined by the method disclosed in the present specification, and the variance Var[D0] of the deflection D0 among the plurality of holding structures is less than 0.1, preferably less than 0.05, more preferably less than 0.01.

[0056] The variance Var[D0] of the deflection D0 is preferably expressed as

number

number

[0057] A "plurality of retention structures" within the meaning of the present invention preferably includes at least 10 retention structures, preferably at least 25 retention structures, more preferably at least 50 retention structures, even more preferably at least 75 retention structures, and most preferably at least 100 retention structures. Furthermore, the plurality of retention structures is preferably a random collection and is not selected with respect to any particular characteristic.

[0058] In one preferred embodiment of the plurality of holding structures, each holding structure, when equipped with n empty or at least partially filled receptacles having a total weight of up to 400 g, has a deflection D determined by the method disclosed herein, wherein the variance Var[D] of the deflection D among the plurality of holding structures is less than 0.1, preferably less than 0.05, more preferably less than 0.01.

[0059] In another preferred embodiment of one of the plurality of holding structures, each holding structure, when equipped with n empty or at least partially filled receptacles having a total weight of up to 800 g, has a deflection D' determined by the method disclosed herein, wherein the variance Var[D'] of the deflections D' among the plurality of holding structures is less than 0.1, preferably less than 0.05, and more preferably less than 0.01.

[0060] In another preferred embodiment of one of the plurality of holding structures, each holding structure, when equipped with n empty or at least partially filled receptacles having a total weight of up to 1100 g, has a deflection D'' determined by the method disclosed herein, wherein the variance Var[D''] of the deflection D'' among the plurality of holding structures is less than 0.1, preferably less than 0.05, and more preferably less than 0.01.

[0061] The present invention also contributes to the realization of at least one of the above-mentioned objects by providing a transport or packaging container containing a plurality of primary packaging containers for substances for pharmaceutical, medical or cosmetic use, the transport or packaging container being of box-shaped configuration, and a holding structure 1 or 2 according to the present invention, preferably a holding structure 1 according to any one of the above-mentioned first to twenty-fifth embodiments, holding the plurality of primary packaging containers within the box-shaped transport or packaging container. In this connection, it is particularly preferred that the transport or packaging container is closed or sealed, in particular by a gas-permeable plastic film, in particular a plastic film made from a gas-permeable knitted plastic fiber fabric, in particular a Tyvek® film, which allows sterilization of the primary packaging containers by inflow of gas through the gas-permeable plastic film.

[0062] For sterile transport and storage, a sterile packaging structure can also be provided which comprises at least one transport unit as described above or at least one transport or packaging container as described above and in which the container or instrument is accommodated, and in which the at least one transport unit or at least one transport or packaging container is accommodated in at least one sterile outer bag and packaged in a sterile manner with respect to the environment, wherein the at least one sterile outer bag may have a gas-permeable portion formed, in particular, of a knitted plastic fiber, such as polypropylene fiber (PP).

[0063] According to the present invention, the solution of at least one of the above objects also contributes to the use of a holding structure 1 or 2 according to the present invention, preferably a holding structure 1 according to any one of the above-mentioned embodiments 1 to 25, for holding a plurality of primary packaging containers for pharmaceutical, medical or cosmetic compositions.

[0064] Measurement method The following measurement methods may be used in connection with the present invention: Unless otherwise stated, measurements should be made at an ambient temperature of 23°C, an ambient air pressure of 100 kPa (0.986 atm), and a relative atmospheric humidity of 50%.

[0065] Deflection measurement Deflections D0, D, D' and D'' were measured as described in Annex B of ISO 11040-7 (1st edition; 2015-04-01).

[0066] For the measurements, the holding structure was placed in a holder that supported the holding structure at each corner (see Figures 11A and 11B).

[0067] The holder has four 1.5 cm diameter posts 115 positioned at the corners of the plate 114. The posts 115 are spaced apart so that when the support structure 100 (empty or filled with receptacles) is placed on the four posts 115 at the corner, each post 115 has a lateral distance y to its longer outer edge of 1.7 cm and a longitudinal distance x to its shorter outer edge of 1.35 cm (see FIG. 11B). First, the height h1 of the support structure 100 at the corner resting on the posts 115 is measured with a depth gauge at the point indicated by a cross on a circle as shown in FIG. 11B (h1 corresponds to the average value of the four measurement points). Next, the height h2 at the geometric center of the second side 104b of the support structure 100 is measured with a depth gauge; this measurement point is also indicated by a cross on a circle in FIG. 11B. The strain corresponds to the difference in height, calculated as |h1 - h2|. If there is no portion of the web at the geometric center of the support structure from which height can be measured, then the point on the web closest to the geometric center of the second side 104b of the support structure 100 is selected to measure h2.

[0068] Warpage measurement The warpage was measured with the setup used to measure deflection.

[0069] The invention will now be described, by way of example only, with reference to the accompanying drawings, which set forth further features, advantages and objects which it is intended to achieve. [Brief explanation of the drawings]

[0070] [Figure 1] 1 is a three-dimensional plan view of one preferred embodiment of a holding structure 100 according to the present invention. [Figure 2] FIG. 10 shows the measurement of the maximum waviness wmax using a holding structure 100 according to the invention holding 20 primary packaging containers. [Figure 3] 1 is a side view showing a syringe 200 that can be held by a holding structure 100 according to the present invention. [Figure 4] 1 is a side view showing a holding structure 100 according to the present invention holding a syringe body 200. FIG. [Figure 5] 1 is a plan view of a holding structure 100 according to the present invention for holding 20 primary packaging containers. [Figure 6] 1 is a plan view of a holding structure 100 according to the present invention for holding 30 primary packaging containers. [Figure 7] 1 is a plan view of a holding structure 100 according to the present invention for holding 42 primary packaging containers. [Figure 8] 1 is a plan view of a holding structure 100 according to the present invention for holding 64 primary packaging containers. [Figure 9] 1 is a plan view of a holding structure 100 according to the present invention for holding 100 primary packaging containers. [Figure 10] 1 is a plan view of a holding structure 100 according to the present invention for holding 160 primary packaging containers. [Figure 11] 11A and 11B are diagrams illustrating a test setup for measuring the deflections D' and D'' of a support structure 100 according to the present invention. [Figure 12] FIG. 10 is a side view further illustrating measurement of deflections D′ and D″ of a support structure 100 according to the present invention. [Figure 13]13A and 13B show the deflections D, D' and D'' of a retention structure known from the prior art shown in FIG. 13B (left side of FIG. 13A) and of a retention structure 100 according to the invention shown in FIG. 6 (right side of FIG. 13A).

[0071] In the drawings, identical reference numbers represent elements or groups of elements that act identically or substantially identically.

[0072] Figure 1 shows a three-dimensional plan view of one preferred embodiment of a holding structure 100 according to the present invention. The holding structure 100 as shown in Figure 1 has 64 receptacles 101 (42 of which are diamond-shaped) for receiving primary packaging containers 200, each receptacle 101 being formed by a peripherally shaped side wall 102. In the preferred embodiment shown in Figure 1, the side wall 102 of the receptacle 101 is provided with a positioning rib 110 for centering the primary packaging container 200 within the receptacle 101, the positioning rib 110 protruding radially inward into the receptacle 101 and extending in the longitudinal direction of the receptacle 101. In a preferred embodiment of the retention structure 100 shown in FIG. 1, the retention structure 100 further comprises a flat base frame 104 having a first side 104a and a second side (104b; not visible in the view shown in FIG. 1) and a central recess 105 (this central recess corresponds to the white area in the flat base frame and is not fully visible because it is partially covered by first and second webs 106, 107 extending across the outer frame 108; however, the central recess 105 is more visible in the retention structure as shown in FIG. 5). The retaining structure 100 further has an outer frame 108 that protrudes from the flat base frame 104 on a first side 104a, a second side 104b, or both sides 104a, 104b (in FIG. 1, the base frame only protrudes from the first side 104a of the flat base frame) and is connected to the flat base frame 104, such that the outer frame 108 surrounds a central recess in the base frame 104. The retention structure further includes a plurality of first webs 106 extending parallel to one another in a first direction within the outer frame 108, each first web 106 being joined to the outer frame 108 at each end, and a plurality of second webs 107 extending parallel to one another in a second direction within the outer frame 108, each second web 107 also being joined to the outer frame 108 at each end.1, the first and second webs 106, 107 are arranged to form the side walls 102 of the receptacles 101, with 42 of the 64 receptacles 101 arranged in the most densely packed manner, forming a diamond-shaped configuration when viewed in plan view of the retention structure 100. This most densely packed configuration is characterized by each of the receptacles 101a arranged side by side in the longitudinal (or transverse) direction sharing a common corner 109 of a parallelogram (a diamond in the case of the retention structure shown in FIG. 1), and each of the receptacles 101b arranged diagonally side by side sharing a common side 110 of the parallelogram.

[0073] 1, the holding structure according to the present invention may further include stabilizing members 111, through which the outer frame 108 is connected to the flat base frame 104. Preferably, these stabilizing members 111 are wing-shaped and are connected to the edges 108a, 108b, 108c, and 108d of the outer frame 108 on one side of the stabilizing member 111 and to the flat base frame on an adjacent side of the stabilizing member 111. In this regard, it is also preferred that each edge 108a, 108b, 108c, and 108d of the outer frame 108 is connected to the flat base frame 104 via at least two such stabilizing members 111. As can also be seen in FIG. 1, the holding structure 100 may further include access openings 112 that allow the holding structure 100 to be grasped or guided. Preferably, the retention structure has two such access openings 112 recessed into the flat base frame 104 on opposite sides of the retention device 100 .

[0074] FIG. 2 shows the maximum swell w using a holding structure 100 according to the present invention holding 20 primary packaging containers 200 (as shown in FIG. 5). max As can be seen in Figure 2, the measurement of w maxTo measure the waviness, two parallel lines are applied to the web (106, 107), which may be wavy, so that one line contacts the web at the crests of the waves and the other line contacts the web at the troughs of the waves. The waviness corresponds to half the distance between these two lines.

[0075] FIG. 3 shows a side view of a syringe 200 that can be held by a holding structure 100 according to the present invention. The syringe preferably has a glass or polymeric syringe body 201 with a discharge opening 202 formed at its distal end and a fill opening 203 formed at its opposite end for receiving a plunger or stopper after filling, the opposite end being provided with an enlarged flange 204. In the syringe shown in FIG. 2, the discharge opening 202 is closed by a cap 205. Such syringes are available from Schott AG, Germany ("syriQ® Luer Lock SRC® Syringe" or "syriQ® Luer Lock OVS® Syringe" or "syriQ® Luer Cone Syringe" or TopPac® syringe). However, the retaining structure 100 according to the invention is also suitable for holding a syringe having a needle at the discharge opening 202 (e.g., a "syriQ® Staked Needle Syringe" or a "syriQ® BioPure® Syringe" available from Schott AG, Germany), in which case the needle is preferably protected by a suitable needle cap. As can be seen in Figure 3, the syringe is characterized by an overall length TL, a barrel length GL, an inner diameter ID, an outer diameter OD and a flange thickness FT.

[0076] 4 shows a side view of a holding structure 100 according to the present invention holding a syringe 200. As can be seen in this view, the syringe 200 is preferably received upside down in the receiving portion 101 of the holding structure 100 according to the present invention, with the extended flange 204 positioned above the upper end of the side wall 102 formed by the first and second webs 106, 107.

[0077] Figure 5 shows in plan view a holding structure 100 according to the invention holding 20 primary packaging containers 200, preferably 20 syringes. In contrast to the holding structures shown in Figures 7, 8, 9 and 10 (where the side walls 102 of the receptacle 101 are formed by continuous, straight webs 106, 107 with no (or almost no) undulations), here the side walls 102 are designed in the form of a curved web with a slight central bulge, which extends at an angle of approximately 45° inside a stabilizing rib 113 that extends in a chess-like manner into the central recess 105.

[0078] FIG. 6 shows a plan view of a holding structure 100 according to the present invention, holding 30 primary packaging containers 200, preferably 30 syringes. Like the holding structure 100 shown in FIG. 5, the side walls 102 are also designed in the form of a curved web with a slight central bulge. However, the undulations of the webs 106, 107 forming the side walls 102 of the receptacle 101 are less pronounced compared to the holding structure shown in FIG. 5. However, in contrast to the design shown in FIG. 5, the webs 106, 107 extend inside the outer frame 108. As a further difference with respect to the holding structure 100 shown in FIGS. 1, 8, 9, and 10, the receptacles 101 in the holding structure 100 shown in FIG. 6 are not arranged in the most densely packed manner.

[0079] Figure 7 shows a holding structure 100 according to the invention, which holds 42 containers. In contrast to the designs shown in Figures 5 and 6, the side walls 102 of the receptacles 101 are formed by continuous, straight webs 106, 107 which extend inside the outer frame 108 and have no (or almost no) undulations. In the embodiment shown in Figure 7, the receptacles have a square shape, and again - as in Figure 6 - the receptacles 101 in the holding structure 100 are not arranged with the densest possible packing density (because the holding structure includes square recesses on the inside of which no positioning ribs 103 are arranged and which are not intended to receive primary packaging containers 200).

[0080] 8, 9, and 10 show plan views of particularly preferred retaining structures 100 according to the present invention for retaining 64 (FIG. 8), 100 (FIG. 9), and 160 (FIG. 10) primary packaging containers 200. As can be seen in these figures, the retaining structure 100 includes a plurality of first webs 106 extending parallel to one another in a first direction (i.e., from lower left to upper right) within an outer frame 108, with each of the first webs 106 being joined to the outer frame 108 at each end. The retaining structure 100 also includes a plurality of second webs 107 extending parallel to one another in a second direction (i.e., from lower right to upper left) within the outer frame 108, with each of the second webs 107 also being joined to the outer frame 108 at each end. (In FIGS. 8, 9, and 10, only one of these first and second webs—shown in bold—is identified by its reference numeral.) As can be seen in Figures 8, 9 and 10, the first and second webs 106, 107 are arranged so that they form the side walls 102 of the storage sections 101, where at least some of the storage sections 101 have a diamond shape in a plan view of the retention structure 100 and are arranged in the most densely packed density.

[0081] 11A, 11B, and 12 show a test setup for measuring deflections D, D', and D'' of a holding structure 100 according to the present invention. As can be seen, the apparatus for measuring the deflection of the holding structure 100 is a holder having a base plate 114 and four support posts 115 on which the holding structure 100 is positioned at the four corners. For measurement, the holding structure 100 is positioned on the holder. Using a depth gauge, the height difference between the center of the holding structure 100 and the four corners was measured.

[0082] FIG. 13A shows the deflections D, D′ and D″ of a holding structure known from the prior art (shown in FIG. 13B), which has a predetermined maximum waviness w max 13A ) and the holding structure 100 according to the invention as shown in FIG. 6 (n=30; w max = 2 mm). Both nests are filled with 30 empty syringes (additional syringe weight = 413 g), half-filled syringes (additional syringe weight = 800 g), or fully-filled syringes (additional syringe weight = 1100 g). The syringes used are syriQ® Luer Lock TC Syringes, 20 ml (Schott AG, Germany). As can be seen in Figure 13A, the waviness reduction helps to significantly reduce the deflection of the nest when it is filled with empty, half-filled, or fully-filled syringes. [Explanation of symbols]

[0083] 100 holding structure 101 Storage unit 101a Storage compartments arranged side by side, either vertically or horizontally 101b Storage units arranged diagonally side by side 102 Side wall forming the storage section 103 Positioning rib 104 a flat base frame having a first side 104a and a second side 104b 104a: First side of base frame 104 104b second side of base frame 104 105 Central recess 106 The First Web 107 The Second Web 108 Outer Frame 108a Upper edge of outer frame 108 108b Lower edge of outer frame 108 108c: first side edge of outer frame 108 108d: second side edge of outer frame 108 109 Common Corner 110 Common Side 111 Stabilizing member 112 Access opening 113 Stabilizing Rib 114 Base Plate 115 Support columns where retaining structures are placed at corners 116 Measuring points for measuring the height of the support structure 200 A container that can be held by a holding structure, preferably a syringe, more preferably a ready-to-use pre-filled syringe 201 Syringe body 202 Release aperture 203 Filling opening 204 flange 205 Closure system, preferably a cap

Claims

1. A holding structure (100) for simultaneously holding a plurality of primary packaging containers (200) for a pharmaceutical, medical or cosmetic composition, wherein the holding structure (100) has n accommodating portions (101) for accommodating the primary packaging containers (200), n being an integer having a value of at least 10, and the accommodating portions (101) are formed by a peripherally formed side wall (102), the holding structure (100) is Maximum length L ｘ and maximum width L ｙ A flat base frame (104) having a first side (104a) and a second side (104b) and having a length L' ｘ and a width L' ｙ and having a central recess (105) having, a flat base frame (104), a plurality of first webs (106) extending parallel to each other in a first direction across the central recess (105), and a plurality of second webs (107) extending parallel to each other in a second direction across the central recess (105) and having, wherein the first and second webs (106, 107) are arranged such that the first and second webs (106, 107) form the side wall (102) of the accommodating portion (101), Each of the first and second webs (106, 107) has a maximum corrugation w of 4.0 mm ｍａｘ and is in the form of a continuous rib member holding structure (100).

2. The holding structure (100) further has an outer frame (108) protruding from the flat base frame (104) on the first side (104a), the second side (104b) or both sides (104a, 104b) and coupled to the flat base frame (104) so as to surround the central recess (105) of the base frame (104), wherein each of the first and second webs (106, 107) is coupled to the outer frame (108) at each end of the web. The holding structure (100) according to claim 1.

3. The holding structure (100) is at least 100 mm ４ The holding structure (100) according to claim 1 or 2, which has a second moment of area I of the cross section of.

4. The holding structure (100) has a deflection D of less than 0.25 mm as determined by the method disclosed herein when equipped with n empty or at least partially filled accommodating portions (101) having a total weight of up to 400 g. The holding structure (100) according to claim 1 or 2.

5. The holding structure (100) has a deflection D' of less than 0.4 mm as determined by the method disclosed herein when equipped with n empty or at least partially filled accommodating portions (101) having a total weight of up to 800 g. The holding structure (100) according to claim 1 or 2.

6. The holding structure (100) according to claim 1 or 2, wherein when equipped with n empty or at least partially filled receiving parts (101) having a total weight of at most 1100 g, has a deflection D'' of less than 0.5 mm as determined by the method disclosed herein.

7. The above-mentioned L ｘ is within the range of 200 to 260 mm, preferably within the range of 220 to 240 mm, and the above-mentioned L ｙ is within the range of 170 to 230 mm, preferably within the range of 190 to 210 mm, for the holding structure (100) according to claim 1 or 2.

8. The holding structure (100) in the empty state has a mass per unit area of less than 0.5 g / cm ２ The holding structure (100) according to claim 1 or 2, having a mass per unit area of less than.

9. The holding structure (100) according to claim 1 or 2, wherein the primary packaging container (200) is a glass syringe body or a polymer syringe body.

10. The holding structure (100) according to claim 1 or 2, wherein the n is selected from the group consisting of 20, 30, 42, 64, 100 and 160.

11. The holding structure (100) according to claim 1 or 2, wherein a positioning rib (103) for centering the primary packaging container (200) within the receiving part (101) is provided on the side wall (102) of the receiving part (101), and the positioning rib (103) projects radially inwards into the receiving part (101) and extends in the longitudinal direction of the receiving part (101).

12. The holding structure (100) according to claim 1 or 2, wherein m of the n receiving parts (102) have a parallelogram shape in a plan view of the holding structure (100) and are arranged at the densest packing density with m ≤ n.

13. A plurality of holding structures (100) including a plurality of the holding structures (100) according to claim 1 or 2, wherein each of the holding structures (100) in an empty state has a deflection D specified by the method disclosed herein ０ and the deflection D in the plurality of holding structures ０ has a variance Var[D ０ of less than 0.1, the plurality of holding structures (100).

14. A transport or packaging container containing a plurality of primary packaging containers (200) for substances for pharmaceutical, medical or cosmetic use, wherein the transport or packaging container has a box-shaped configuration, and the holding structure (100) according to claim 1 or 2 that holds the plurality of primary packaging containers (200) is housed within the box-shaped transport or packaging container, whereby the plurality of primary packaging containers (200) are held within the transport or packaging container.

15. Use of a holding structure (100) as defined in claim 1 or 2 for holding a plurality of primary packaging containers (200) for pharmaceutical, medical or cosmetic compositions.

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