Retaining structure for ready-to-use containers
The retaining structure addresses the challenge of high packing density and precise stopper insertion for high dead weight containers by using engineered webs and frames, ensuring efficient processing in automated systems.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- SCHOTT PHARMA SCHWEIZ AG
- Filing Date
- 2022-10-24
- Publication Date
- 2026-06-03
AI Technical Summary
Existing retaining structures for pharmaceutical and cosmetic containers, particularly those with high dead weight like glass syringes or cartridges, face challenges in achieving high packing density, precise stopper insertion, and high cycle frequency during automated processing, especially when made from thermoplastic polymers pre-sterilized at elevated temperatures.
A retaining structure with precisely engineered webs and frames, characterized by minimal waviness and optimal angles, supports multiple containers with high dead weight, allowing for high packing density and efficient stopper insertion at high cycle frequencies, even after thermal sterilization.
The structure enables dense packing and precise stopper closure of containers with high dead weight at elevated temperatures, ensuring minimal deflection and consistent performance in automated systems.
Smart Images
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Abstract
Description
[Technical Field]
[0001] The present invention relates to a holding structure for simultaneously holding multiple primary packaging containers for pharmaceutical, medical, or cosmetic compositions, wherein the holding structure has multiple receiving sections for accommodating the primary packaging containers, and the receiving sections are formed by peripherally shaped side walls. The present invention also relates to transport or packaging containers, the use of the holding structure, and multiple holding structures.
[0002] For example, drug containers such as syringes, vials, ampoules, or cartridges are widely used as containers for storing medical, pharmaceutical, or cosmetic preparations intended for administration in liquid form, particularly in pre-measured quantities. These drug containers generally have a cylindrical shape, can be manufactured from plastic or glass, and can be produced in large quantities in a cost-effective manner. In this regard, these containers are increasingly being delivered to pharmaceutical manufacturers or subsequent processing operations in a predetermined geometric arrangement within a holding structure, where the containers are held or housed while continuing to be processed. For this purpose, there is a need for cost-effective and robust holding structures in which the containers are held or housed in an arrangement that occupies minimal space.
[0003] An example of a retaining structure suitable for holding pre-filled cartridges is disclosed in International Publication No. 2016 / 166769. The retaining structure has a plurality of tubular housings arranged in the same regular arrangement for housing a plurality of cartridges, with retaining projections formed at the lower ends of the housings that protrude inward, and the sealed cartridges are housed upside down in the housings so that the shoulders of the sealed cartridges are supported by the retaining projections of the housings.
[0004] Another retaining structure for a syringe body, disclosed in International Publication No. 2012 / 126582, has a plate-shaped carrier, the carrier having a plurality of cylindrical housings having peripherally formed side walls. The syringe body is rested on the upper ends of the cylindrical housings by its retaining flange. To reinforce the carrier, the cylindrical housings are connected to each other via connecting webs on the underside of the carrier.
[0005] To make the filling of containers under sterile conditions as economical as possible, these containers are increasingly being delivered to pharmaceutical filling companies in sterile packaging by the container manufacturers, eliminating the need for the pharmaceutical filling companies to wash and sterilize the containers. For this purpose, the containers need to be opened under sterile conditions at the pharmaceutical filling company, e.g., a pharmaceutical company, and then processed. During the filling process, the containers remain within the holding structure of the sterile packaging described above, and a manufacturing concept is increasingly being used in which the containers are filled while they are positioned within the holding structure, which is part of the sterile packaging. In addition to the actual filling process, other subprocesses may be performed while the containers are supported within the holding structure, such as weighing, stopper placement, freeze-drying, and final sealing of the containers with stoppers. As a result, many additional requirements arise for the holding structure, particularly regarding the precision of the container's position within the holding structure.
[0006] When the above-mentioned retaining structures known from the prior art are used to accommodate elongated containers (e.g., syringes or cartridges) at high packing density, it has been observed that certain processing steps, such as filling with pharmaceutical compositions or closing with stoppers, often cannot be performed simultaneously and at a high cycle frequency with the desired precision in an automated system. In particular, in the case of containers with relatively high dead weight, such as filled glass syringes or filled glass cartridges, it has been observed that there is a particular need to improve the precise setting of stoppers for closing the containers at a high cycle frequency after the filling process (i.e., in a retaining structure loaded with containers that should be filled and closed every unit time in an automated filling device). This is especially true for retaining structures made of thermoplastic polymers that have been pre-sterilized by steam and, consequently, under thermal stress.
[0007] Therefore, further improvements are needed in the production of the type of retaining structure described above.
[0008] The object of the present invention is to provide an improved retaining structure for simultaneously holding multiple containers for substances for pharmaceutical, medical, or cosmetic applications, which can be produced in a simple and cost-effective manner and which allows for advantageously high packing density of containers, particularly containers with high dead weight such as glass syringes or glass cartridges. Furthermore, it is desirable that the retaining structure allows such containers to be housed as densely as possible, filled while these containers are housed within the retaining structure, and then closed as evenly as possible with the highest possible cycle frequency by inserting stoppers into the open ends of the containers. This should be particularly effective for retaining structures based on thermoplastic polymers and pre-sterilized at elevated temperatures, particularly at a temperature of at least about 121°C using steam. Furthermore, it is desirable that the retaining structure be characterized by the advantageous properties described above, while at the same time preferably by minimal dead weight.
[0009] The subject matter defined in the independent claim contributes to at least one, preferably two or more, partial solutions of the aforementioned objectives. The dependent claims provide preferred embodiments that contribute to at least one, at least partial solution of the aforementioned objectives.
[0010] |1| Based on the present invention, a first embodiment of a holding structure 1 for simultaneously holding multiple primary packaging containers for pharmaceutical, medical, or cosmetic compositions contributes to solving at least one of the above objectives, The retaining structure has n receiving compartments for accommodating primary packaging containers, where n is an integer with a value of at least 10, and the receiving compartments are formed 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 length L' x and width L' y A flat base frame having a central recess having, - A plurality of first webs extending parallel to each other in a first direction across the central recess, - Multiple second webs extending parallel to each other in a second direction across the central recess and It has, The first and second webs are arranged such that they form the side walls of the containment section. 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, and even more preferably less than 0.2 mm.max The shape of the continuous beam member has a maximum wattage of 0 mm. max This is most preferable (i.e., it is most preferable that the first and second webs are substantially in the shape of straight beam members).
[0011] In the sense of the present invention, "primary packaging container" means 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, particularly a glass syringe body or a polymer syringe body. These containers preferably have a rotationally symmetric body having a first end and a second end, one of which preferably the lower end is closed when the container is inserted into a holding structure, and the other end, preferably the upper end, is open, so that the container can be filled with a pharmaceutical, medical, or cosmetic composition, preferably through the upper end, while the container is held in the holding structure.
[0012] |2| In one preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure further, -It has an outer frame that protrudes from a flat base frame on the first side, the second side, or both sides, and is connected to the flat base frame so as to surround the central recess of the base frame. Each of the first and second webs is joined to the 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 special embodiment of the above-described second embodiment of the holding structure 1 according to the present invention, the outer frame has an upper edge portion, a lower edge portion, a first side edge portion, and a second side edge portion, and these edge portions are joined to each other so as to form a continuous outer frame. Each of the first and second webs forms an angle α with the edge of the outer frame, and α is within the range of 0 to 90°, preferably within the range of 20 to 80°, preferably within the range of 30 to 70°, more preferably within the range of 40 to 60°, and most preferably within the range of 45 to 55°.
[0014] According to another special embodiment of the above-described second embodiment of the holding structure 1 according to the present invention, the bar of the outer frame has a wall thickness within the range of 0.5 to 4.0 mm, preferably within the range of 0.8 to 3.5 mm, more preferably within the range of 1.2 to 3.0 mm, and most preferably within the range of 1.5 to 2.5 mm. The height of the bar of the outer frame is preferably within the range of 5 to 35 mm, more preferably within the range of 10 to 30 mm, further preferably within the range of 12 to 28 mm, and most preferably within the range of 15 to 25 mm.
[0015] According to another special embodiment of the above-described second embodiment of the holding structure 1 according to the present invention, the maximum area spanned by the flat base frame is larger than the area spanned by the outer frame. Particularly preferably in this regard, the holding structure further has - a stabilizing member that joins the outer frame to the flat base frame and has it.
[0016] Preferably, these stabilizing members are in the shape of wings, are joined to the edge of the outer frame on one side of the stabilizing member, and are joined to the flat base frame on the adjacent side of the stabilizing member. In this regard, it is also preferable that each edge of the outer frame is joined to the flat base frame via at least two such stabilizing members. In this regard, it is also preferable that the holding device further includes an access opening that enables the holding structure to be gripped 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 the holding structure 1 according to the present invention, the first and second webs have a wall thickness within the range of 0.1 to 4.0 mm, preferably within the range of 0.2 to 3.5 mm, more preferably within the range of 0.3 to 2.0 mm, and most preferably within the range of 0.5 to 1.0 mm. The height of the first and second webs is preferably within the range of 5 to 35 mm, more preferably within the range of 10 to 30 mm, even more preferably within the range of 12 to 28 mm, and most preferably within the range of 15 to 25 mm. This preferred embodiment is the third embodiment of the holding structure 1 according to the present invention and preferably depends on the first or second embodiment of the present invention.
[0018] |4| In another preferred embodiment of the holding structure 1 according to the present invention, the flat base frame has a thickness within the range of 0.5 to 3.0 mm, preferably within the range of 0.8 to 2.5 mm, more preferably within the range of 1.0 to 2.0 mm, and most preferably within the range of 1.2 to 1.6 mm. This preferred embodiment is the fourth embodiment of the holding 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 another preferred embodiment of the holding structure 1 according to the present invention, the holding structure has a sectional moment of inertia I of at least 100 mm 4 , preferably at least 200 mm 4 , more preferably at least 300 mm 4 , even more preferably at least 400 mm 4 . This preferred embodiment is the 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 one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining 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 polymer 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 filled at least partially with a pharmaceutical, medical or cosmetic composition. This preferred embodiment is a sixth embodiment of the retaining 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 one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure has a deflection D of less than 0.25 mm, preferably less than 0.22 mm, and more preferably less than 0.18 mm, as measured by the test method disclosed herein, when equipped with n empty or at least partially filled housings 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 one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure has a deflection D' of less than 0.4 mm, preferably less than 0.37 mm, and more preferably less than 0.34 mm, as measured by the test method disclosed herein, when equipped with n empty or at least partially filled housings 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 other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure has a deflection D'' of less than 0.5 mm, preferably less than 0.47 mm, and more preferably less than 0.44 mm, as measured by the test method disclosed herein, when equipped with n empty or at least partially filled housings having a total weight of up to 1100 g. This preferred embodiment is the 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] |10| In one other preferred embodiment of the retaining 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 the tenth embodiment of the retaining 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 other preferred embodiment of the retaining structure 1 according to the present invention, L x The range is within 200-260 mm, preferably within 220-240 mm, L y This range is within 170 to 230 mm, more preferably within 190 to 210 mm. This preferred embodiment is the 11th embodiment of the retaining 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 other preferred embodiment of the retaining structure 1 according to the present invention, L' x The range is 170-230 mm, preferably 190-210 mm, and L' y This range is within 140 to 200 mm, preferably within 160 to 180 mm. This preferred embodiment is the twelfth embodiment of the retaining structure 1 according to the present invention, and preferably depends on any one of the first to eleventh embodiments of the present invention.
[0027] |13| In one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure in an empty state is 0.5 g / cm³ 2 Less than 0.4 g / cm³ is preferable. 2 Less than, more preferably 0.3 g / cm³ 2 It has a mass per unit area of less than . This preferred embodiment is a thirteenth embodiment of the retaining 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 other 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 to 300°. In this regard, particularly preferably, the thermoplastic material is selected from the group consisting of polyetheretherketone (PEEK), polyphenylsulfone (PPSU), homopolymers or copolymers of polyacetals (POM-H or POM-C), polypropylene (PP), polycarbonate, polystyrene, polyamide, polyethylene terephthalate, acrylonitrile / butadiene / styrene copolymer, or a mixture of at least two of these polymers, and these polymers may be filled with fillers such as calcium carbonate, kaolin, carbon black, carbon fiber, aluminum hydroxide, alumina trihydrate, talc, dolomite, barium ferrite, wollastonite, wood flour, glass fiber, 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, etc., or a mixture of at least two of these fillers. Particularly preferred is the use of polypropylene or polypropylene filled with one of the fillers described above. Polymers selected from the group consisting of olefin copolymers, cyclic olefin polymers, or mixtures thereof are also suitable. This preferred embodiment is the 14th embodiment of the retaining structure 1 according to the present invention, and preferably depends on any one of the 1st to 13th embodiments of the present invention.
[0029] |15| In one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure is integrally molded by injection molding, 3D printing, or a combination of these approaches. This preferred embodiment is the 15th embodiment of the retaining structure 1 according to the present invention and preferably depends on any one of the first to 14th embodiments of the present invention.
[0030] |16| In one other preferred embodiment of the retaining structure 1 according to the present invention, - Each holding structure has a weight m o When n empty primary packaging containers having are loaded, -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 the 16th embodiment of the retaining structure 1 according to the present invention, and preferably depends on any one of the first to 15th embodiments of the present invention.
[0031] |17| In one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure is characterized by a curvature of less than 2.0 mm, preferably less than 1.0 mm, and more preferably less than 0.5 mm, as determined by the method disclosed herein before steam sterilization. This preferred embodiment is the 17th embodiment of the retaining structure 1 according to the present invention and preferably depends on any one of the first to 16th embodiments of the present invention. This curvature corresponds to the bending of the (empty) retaining structure after it has been prepared, for example, by 3D printing, injection molding, or a combination of these approaches.
[0032] |18| In one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure is characterized by a curvature of less than 4.0 mm, preferably less than 2.0 mm, and more preferably less than 1.0 mm, as determined by the method disclosed herein after steam sterilization at 122°C for 22 minutes. This preferred embodiment is the 18th embodiment of the retaining structure 1 according to the present invention and preferably depends on any one of the first to 17th embodiments of the present invention.
[0033] |19| In one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure is characterized by an expansion limit of less than 1%, preferably less than 0.5%, and most preferably less than 0.1%, as specified by the method disclosed herein. This preferred embodiment is the 19th embodiment of the retaining structure 1 according to the present invention and preferably depends on any one of the first to 18th embodiments of the present invention.
[0034] |20| In one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure is a sterile retaining structure sterilized by steam at a temperature in the range of 120 to 130°C, preferably 121 to 128°C, more preferably 122 to 125°C for 10 to 60 minutes, preferably 15 to 40 minutes, and more preferably 20 to 30 minutes. This preferred embodiment is the 20th embodiment of the retaining structure 1 according to the present invention and preferably depends on any one of the first to 19th embodiments of the present invention.
[0035] |21| In one other preferred embodiment of the holding structure 1 according to the present invention, the primary packaging container that can be held (or held by the holding structure in the case of the sixth preferred embodiment) is a container selected from the group consisting of syringe bodies, vials, ampoules and cartridges, in which case a syringe body is particularly preferred. In this regard, the primary packaging container, preferably a syringe body, is also preferably based on glass or polymer, and preferably manufactured from glass or polymer (and thus a glass syringe body). More preferably, the primary packaging container is a glass syringe body having a discharge opening at its distal end and a filling opening at the opposite end for accommodating a plunger or stopper after filling, and an expanded flange is provided at this opposite end. In this regard, the syringe body, preferably a glass syringe body or a polymer syringe body, is also preferably housed upside down in the housing of the holding structure according to the present invention, in which case the expanded flange is located above the upper end of the side wall. This preferred embodiment is a 21st embodiment of the retaining structure 1 according to the present invention, and preferably depends on any one of the first to 20 embodiments of the present invention.
[0036] In the first special embodiment of the 21st embodiment of the holding structure 1 according to the present invention described above, 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 body length GL within the range of 64 to 84 mm, preferably within the range of 68 to 80 mm, and more preferably within 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 the second special embodiment of the 21st embodiment of the holding structure 1 according to the present invention described above, 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 body length GL within the range of 70 to 90 mm, preferably within the range of 75 to 85 mm, and more preferably within 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 the third special embodiment of the 21st embodiment of the holding structure 1 according to the present invention, the primary packaging container is a glass syringe body or a polymer syringe body, in particular a syringe body manufactured 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 body length GL within the range of 40 to 85 mm, preferably within the range of 50 to 80 mm, and more preferably within 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 the fourth special embodiment of the 21st embodiment of the holding structure 1 according to the present invention, the primary packaging container is a polymer syringe body, in particular a syringe body manufactured 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 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 body length GL within the range of 63 to 83 mm, preferably within the range of 68 to 78 mm, and more preferably within 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 the fifth special embodiment of the 21st embodiment of the holding structure 1 according to the present 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 2.5 to 3.5 ml, preferably in the range of 2.8 to 3.2 ml, and more preferably in the range of 2.9 to 3.1 ml. ii) The syringe body has a body length GL within the range of 75 to 95 mm, preferably within the range of 80 to 90 mm, and more preferably within 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 the sixth special embodiment of the 21st embodiment of the holding structure 1 according to the present invention, the primary packaging container is a polymer syringe body, preferably a syringe body manufactured 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 body length GL within the range of 95 to 115 mm, preferably within the range of 100 to 112 mm, and more preferably within 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 the seventh special embodiment of the 21st embodiment of the holding structure 1 according to the present invention, the primary packaging container is a polymer syringe body, preferably a syringe body manufactured 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 15 to 25 ml, preferably in the range of 15.5 to 22.5 ml, and more preferably in the range of 19 to 21 ml. ii) The syringe body has a body length GL within the range of 95 to 115 mm, preferably within the range of 100 to 112 mm, and more preferably within 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 the eighth special embodiment of the 21st embodiment of the holding structure 1 according to the present invention, the primary packaging container is a polymer syringe body, preferably a syringe body manufactured 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 15 to 25 ml, preferably in the range of 15.5 to 22.5 ml, and more preferably in the range of 19 to 21 ml. ii) The syringe body has a body length GL within the range of 115 to 140 mm, preferably within the range of 120 to 135 mm, and more preferably within 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 the ninth special embodiment of the 21st embodiment of the holding structure 1 according to the present invention, the primary packaging container is a polymer syringe body, preferably a syringe body manufactured 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 body length GL within the range of 125 to 150 mm, preferably within the range of 130 to 145 mm, and more preferably within 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] |22| In one other preferred embodiment of the retaining structure 1 according to the present invention, n is at least 20. In this regard, particularly preferably, n is selected from the group consisting of 20, 30, 42, 64, 100 and 160. This preferred embodiment is the 22nd embodiment of the retaining structure 1 according to the present invention, which preferably depends on any one of the first to 21st embodiments of the present invention.
[0046] |23| In one other preferred embodiment of the retaining structure 1 according to the present invention, positioning ribs for centering a primary packaging container within the containment are provided on the side wall of the containment, and these positioning ribs project radially inward into the containment and extend along the longitudinal direction of the containment. Preferably, for convenience, these positioning ribs are distributed along the circumference of the side wall at the same angular intervals from one another, i.e., 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 container to be contained, so that the container slides into the containment without friction or with minimal friction at any speed as they are inserted vertically into the containment from above, and is thus guided to the centering position. This preferred embodiment is the 23rd embodiment of the retaining structure 1 according to the present invention, and preferably depends on any one of the first to 22 embodiments of the present invention.
[0047] |24| In one other preferred embodiment of the retaining structure 1 according to the present invention, m of the n storage compartments have a parallelogram shape, preferably a square or rhombus shape, more preferably a rhombus shape, in the plan view of the retaining structure, and are arranged at the most densely packed density m ≤ n. In this regard, particularly preferably, the storage compartments have a rhombus shape, and storage compartments arranged side by side horizontally or vertically share a common corner of the rhombus, and storage compartments arranged side by side diagonally share a common side. The side walls of the diagonally arranged storage compartments are preferably formed by the same web extending in a predetermined (first or second) direction within the outer frame. This preferred embodiment is the 24th embodiment of the retaining 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 the first special embodiment of the 24th embodiment of the retaining structure 1 according to the present invention, the following conditions are met: i) Of the n storage compartments, m have a square shape. ii) n=42, iii) m = 20, iv) The weight of m1 (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 the second special embodiment of the 24th embodiment of the retaining structure 1 according to the present invention described above, the following conditions are met: i) Of the n storage compartments, m have a rhombus 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 the third special embodiment of the 24th embodiment of the retaining structure 1 according to the present invention described above, the following conditions are met: i) Of the n storage compartments, m have a rhombus 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 the fourth special embodiment of the 24th embodiment of the retaining structure 1 according to the present invention, the following conditions are met: i) Of the n storage compartments, m have a rhombus 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 one other preferred embodiment of the retaining structure 1 according to the present invention, the retaining structure further has openings formed as through holes at a plurality of positions of the base frame, these openings can be used in particular as positioning holes to enable means to positionally oriented the retaining structure on a retaining structure receiver having corresponding positioning pegs or projections, which is useful, for example, during insertion (nesting), filling, closing or removal (unnesting) of a primary packaging container housed in the retaining structure. This preferred embodiment is the 25th embodiment of the retaining structure 1 according to the present invention, which preferably depends on any one of the first to 24th embodiments of the present invention.
[0053] Based on the present invention, a holding structure 2 that simultaneously holds multiple primary packaging containers for pharmaceutical, medical, or cosmetic compositions contributes to solving at least one of the above objectives. The retaining structure has n receiving compartments for accommodating primary packaging containers, where n is an integer with a value of at least 10, and the receiving compartments are formed 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 length L' x and width L' y A flat base frame having a central recess having, - A plurality of first webs extending parallel to each other in a first direction across the central recess, - Multiple second webs extending parallel to each other in a second direction across the central recess and It has, The first and second webs are arranged such that they form the side walls of the housings, and m of the n housings have a parallelogram shape, preferably a square shape or a rhombus shape, more preferably a rhombus shape, in the plan view of the retaining structure, and are arranged at the most densely packed density m ≤ n. In this regard, the housings are particularly preferably rhombus-shaped, and housings arranged side by side horizontally or vertically share a common corner of the rhombus, and housings arranged side by side diagonally share a common side. The side walls of the housings arranged side by side diagonally are preferably formed by the same web extending in a predetermined (first or second) direction within the outer frame.
[0054] A preferred embodiment of this retaining structure is characterized by the features described above in relation to any one of the first to twenty-fifth embodiments of the retaining structure 1 according to the present invention.
[0055] Based on the present invention, a plurality of retaining structures 1 or 2 according to the present invention, preferably a plurality of retaining structures 1 according to any one of the first to twenty-fifth embodiments described above, each empty retaining structure has a deflection D0 as determined by the method disclosed herein, and the dispersion Var[D0] of the deflection D0 in the plurality of retaining structures is less than 0.1, preferably less than 0.05, and more preferably less than 0.01.
[0056] The dispersion Var[D0] of the deflection D0 is preferably,
number
number
[0057] In the sense of the present invention, "multiple retaining structures" preferably includes at least 10 retaining structures, preferably at least 25 retaining structures, more preferably at least 50 retaining structures, even more preferably at least 75 retaining structures, and most preferably at least 100 retaining structures. Furthermore, the multiple retaining structures are preferably arbitrarily assembled and not selected in any particular way in terms of any characteristics.
[0058] In one preferred embodiment of the plurality of retaining structures, each retaining structure has a deflection D as determined by the method disclosed herein, provided that it is equipped with n empty or at least partially filled accommodates having a total weight of up to 400 g, in which case the dispersion Var[D] of the deflection D in the plurality of retaining structures is less than 0.1, preferably less than 0.05, and more preferably less than 0.01.
[0059] In one other preferred embodiment of the plurality of retaining structures, each retaining structure has a deflection D' as determined by the method disclosed herein, when equipped with n empty or at least partially filled receptors having a total weight of up to 800 g, in which case the dispersion Var[D'] of the deflection D' in the plurality of retaining structures is less than 0.1, preferably less than 0.05, and more preferably less than 0.01.
[0060] In one other preferred embodiment of the plurality of retaining structures, each retaining structure has a deflection D'' as determined by the method disclosed herein, when equipped with n empty or at least partially filled receptors having a total weight of up to 1100 g, in which case the dispersion Var[D''] of the deflection D'' in the plurality of retaining structures is less than 0.1, preferably less than 0.05, and more preferably less than 0.01.
[0061] Based on the present invention, a transport or packaging container containing a plurality of primary packaging containers for substances for pharmaceutical, medical or cosmetic applications also contributes to solving at least one of the above objectives, in which case the transport or packaging container is box-shaped, and a retaining structure 1 or 2 according to the present invention, preferably a retaining structure 1 according to any one of the first to 25 embodiments described above, which holds the plurality of primary packaging containers, is housed within the box-shaped transport or packaging container, thereby holding the plurality of primary packaging containers within the transport or packaging container. Particularly preferably in this regard, the transport or packaging container is closed or sealed with a plastic film, particularly a gas-permeable plastic film, particularly a Tyvek® film formed from a gas-permeable plastic fiber knitted fabric, thereby enabling sterilization of the primary packaging containers by gas inflow through the gas-permeable plastic film.
[0062] For sterile transport and storage, a sterile packaging structure can be provided which further comprises at least one transport unit as described above, or at least one transport or packaging container as described above, in which case the at least one transport unit or at least one transport or packaging container is housed in at least one sterile outer bag and is sterilized with respect to its surroundings. In this case, the at least one sterile outer bag may have a gas-permeable portion formed of a plastic fiber knitted fabric, such as polypropylene fiber (PP), in particular.
[0063] Based on the present invention, the use of a retaining structure 1 or 2 according to the present invention, preferably a retaining structure 1 according to any one of the first to twenty-fifth embodiments described above, for holding a plurality of primary packaging containers for pharmaceutical, medical, or cosmetic compositions, also contributes to solving at least one of the above-mentioned objectives.
[0064] Measurement method The following measurement methods may be used in connection with the present invention. Unless otherwise specified, measurements must be performed 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] Measurement of deflection The deflections D0, D, D', and D'' were measured as described in Annex B of ISO 11040-7 (1st edition; 2015-04-01).
[0066] For measurement purposes, the retaining structure was placed in a holder that supported the retaining structure at each corner (see Figures 11A and 11B).
[0067] The holder has four 1.5 cm diameter support columns 115 positioned at the corners of the plate 114. The columns 115 are spaced such that when the retaining structure 100 (empty or filled with a housing) is placed on the four columns 115 at the corners, each column 115 has a lateral distance y to the longer outer edge of 1.7 cm and a longitudinal distance x to the shorter outer edge of 1.35 cm (see Figure 11B). First, the height h1 of the retaining structure 100 at the corners, resting on the columns 115, is measured by a depth gauge at points represented by a cross on a circle, as shown in Figure 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 by a depth gauge, so this measurement point is also represented by a cross on a circle in Figure 11B. The strain corresponds to the difference in height, calculated as |h1-h2|. If there is no web portion at the geometric center of the support structure whose height can be measured, the web point closest to the geometric center of the second side 104b of the support structure 100 is selected to measure h2.
[0068] Measurement of warping The warp was measured using the same settings as those used to measure deflection.
[0069] The present invention will be described below with reference to the attached drawings illustrating other features, advantages, and objectives to be achieved, as well as with examples. [Brief explanation of the drawing]
[0070] [Figure 1] This is a three-dimensional plan view showing one preferred embodiment of the retaining structure 100 according to the present invention. [Figure 2] This figure shows the measurement of the maximum waviness wmax using the holding structure 100 according to the present invention, which holds 20 primary packaging containers. [Figure 3] This is a side view showing a syringe 200 that can be held by the holding structure 100 according to the present invention. [Figure 4] This is a side view showing a holding structure 100 according to the present invention, which holds the syringe body 200. [Figure 5] This is a plan view showing a holding structure 100 according to the present invention that holds 20 primary packaging containers. [Figure 6] This is a plan view showing a holding structure 100 according to the present invention that holds 30 primary packaging containers. [Figure 7] This is a plan view showing a holding structure 100 according to the present invention that holds 42 primary packaging containers. [Figure 8] This is a plan view showing a holding structure 100 according to the present invention that holds 64 primary packaging containers. [Figure 9] This is a plan view showing a holding structure 100 according to the present invention that holds 100 primary packaging containers. [Figure 10] This is a plan view showing a holding structure 100 according to the present invention that holds 160 primary packaging containers. [Figure 11] Figures 11A and 11B show experimental setups for measuring the deflections D' and D'' of the retaining structure 100 according to the present invention. [Figure 12] This is a side view further illustrating the measurement of the deflections D' and D'' of the retaining structure 100 according to the present invention. [Figure 13]Figures 13A and 13B show the deflections D, D', and D'' of a conventional holding structure (left side of Figure 13A) shown in Figure 13B and the holding structure 100 according to the present invention (right side of Figure 13A) shown in Figure 6.
[0071] In drawings, the same reference number represents the same or substantially the same element or group of elements.
[0072] Figure 1 shows a three-dimensional plan view of one preferred embodiment of the holding structure 100 according to the present invention. The holding structure 100 shown in Figure 1 has 64 accommodating sections 101 (42 of which have a rhombus shape) for accommodating primary packaging containers 200, and the accommodating sections 101 are formed by peripherally formed side walls 102. In the preferred embodiment shown in Figure 1, positioning ribs 110 for centering the primary packaging containers 200 within the accommodating section 101 are provided on the side walls 102 of the accommodating section 101, and the positioning ribs 110 project radially inward into the accommodating section 101 and extend in the longitudinal direction of the accommodating section 101. In a preferred embodiment of the retaining structure 100 shown in Figure 1, the retaining structure 100 further has a flat base frame 104, the base frame 104 having a first side 104a and a second side (104b; not visible in the diagram shown in Figure 1) and a central recess 105 (this central recess corresponds to the white area within the flat base frame and is not fully visible as it is partially covered by the first and second webs 106, 107 extending over the outer frame 108; however, the central recess 105 is more clearly visible in the retaining structure shown in Figure 5). The retaining structure 100 further has an outer frame 108, which protrudes from the flat base frame 104 on a first side 104a, a second side 104b, or both sides 104a, 104b (in Figure 1, the base frame only protrudes from the first side 104a of the flat base frame), and is coupled to the flat base frame 104, so that the outer frame 108 surrounds the central recess of the base frame 104. The holding structure further comprises a plurality of first webs 106 extending parallel to each other in a first direction within the outer frame 108, each first web 106 being joined to the outer frame 108 at its respective end, and a plurality of second webs 107 extending parallel to each other in a second direction within the outer frame 108, each second web 107 also being joined to the outer frame 108 at its respective end.As can be seen in Figure 1, the first and second webs 106 and 107 are arranged to form the side walls 102 of the storage section 101. In this case, 42 of the 64 storage sections 101 have a rhombus shape when viewed in the plan view of the holding structure 100 and are arranged at the most densely packed density. This most densely packed density is characterized in that each storage section 101a arranged side by side in the vertical (or horizontal) direction shares a common corner 109 of a parallelogram (rhombus in the case of the holding structure shown in Figure 1), and storage sections 101b arranged side by side diagonally share a common side 110 of a parallelogram.
[0073] As shown in Figure 1, the holding structure according to the present invention may further have stabilizing members 111, through which the outer frame 108 is coupled to a flat base frame 104. Preferably, these stabilizing members 111 are wing-shaped and coupled on one side of the stabilizing member 111 to the edges 108a, 108b, 108c, and 108d of the outer frame 108, and coupled to the flat base frame on the adjacent side of the stabilizing member 111. In this regard, it is also preferable that each edge 108a, 108b, 108c, 108d of the outer frame 108 is coupled to the flat base frame 104 via at least two such stabilizing members 111. As also shown in Figure 1, the holding structure 100 may further include an access opening 112 that allows the holding structure 100 to be gripped or guided. Preferably, the retaining structure has two such access openings 112 recessed in a flat base frame 104 on opposite sides of the retaining device 100.
[0074] Figure 2 shows the maximum wattage using the holding structure 100 according to the present invention, which holds 20 primary packaging containers 200 (as shown in Figure 5). max The measurement of w is shown. As can be seen in Figure 2, maxTo measure the swell, two parallel lines are placed on a web (106,107) which may be wavy, so that one line contacts the web at the crest of the wave and the other line contacts the web at the trough of the wave. The "swell" corresponds to half the distance between these two lines.
[0075] Figure 3 shows a side view of a syringe 200 that can be held by the holding structure 100 according to the present invention. The syringe preferably has a glass syringe body or a polymer syringe body 201, with a discharge opening 202 formed at its distal end and a filling opening 203 formed at the opposite end for accommodating a plunger or stopper after filling, and an extended flange 204 provided at the opposite end. In the syringe shown in Figure 2, the discharge opening 202 is closed by a cap 205. Such syringes are available from Schott AG, Germany ("syriQ® Luer Lock SRC® Syringe", "syriQ® Luer Lock OVS® Syringe", "syriQ® Luer Cone Syringe", or TopPac® syringe). However, the holding structure 100 according to the present invention is also suitable for holding syringes having a needle in the discharge opening 202 (for example, the "syriQ® Staked Needle Syringe" or "syriQ® BioPure® Syringe" available from Schott AG, Germany), in which case the needle is preferably protected by a suitable needle cap. As shown in Figure 3, the syringe is characterized by its total length TL, body length GL, inner diameter ID, outer diameter OD, and flange thickness FT.
[0076] Figure 4 shows a side view of the holding structure 100 according to the present invention, which holds a syringe 200. Preferably, the syringe 200 is housed upside down in the housing 101 of the holding structure 100 according to the present invention, in which case the extended flange 204 is located above the upper end of the side wall 102 formed by the first and second webs 106, 107.
[0077] Figure 5 shows a plan view of a retaining structure 100 according to the present invention that holds 20 primary packaging containers 200, preferably 20 syringes. In contrast to the retaining structures shown in Figures 7, 8, 9, and 10 (where the side walls 102 of the housing 101 are formed by continuous, straight webs 106, 107 with no (or almost no) undulation), here the side walls 102 are designed in the shape of a web that is slightly bulging and curved in the center, and the web extends at an angle of about 45° inward into stabilizing ribs 113 that extend into a central recess 105 like a chess piece.
[0078] Figure 6 shows a plan view of a holding structure 100 according to the present invention, which holds 30 primary packaging containers 200, preferably 30 syringes. Like the holding structure 100 shown in Figure 5, the side walls 102 are also designed in the shape of a web that is slightly bulging and curved in the center. However, the undulation of the webs 106,107 forming the side walls 102 of the containment section 101 is not as pronounced compared to the holding structure shown in Figure 5. However, in contrast to the design shown in Figure 5, the webs 106,107 extend inward into the outer frame 108. As a further difference from the holding structures 100 shown in Figures 1, 8, 9 and 10, the containment section 101 in the holding structure 100 shown in Figure 6 is not arranged at the most densely packed density.
[0079] Figure 7 shows a holding structure 100 according to the present invention that holds 42 containers. In contrast to the designs shown in Figures 5 and 6, the side walls 102 of the dwelling section 101 are formed by continuous, straight webs 106, 107 that extend inward from the outer frame 108 and have no (or nearly) undulation. In the embodiment shown in Figure 7, the dwelling section has a square shape, and in this case as well—as in Figure 6—the dwelling section 101 within the holding structure 100 is not arranged at the most densely packed density (because the holding structure includes a square recess that is not intended to hold primary packaging containers 200 and does not have positioning ribs 103 positioned inside).
[0080] Figures 8, 9, and 10 show in plan view particularly preferred retaining structures 100 according to the present invention for holding 64 (Figure 8), 100 (Figure 9), and 160 (Figure 10) primary packaging containers 200. As seen in these figures, the retaining structure 100 has a plurality of first webs 106 extending parallel to each other in a first direction (i.e., from the lower left to the upper right) within an outer frame 108, in which case each first web 106 is coupled to the outer frame 108 at each end. The retaining structure 100 further has a plurality of second webs 107 extending parallel to each other in a second direction (i.e., from the lower right to the upper left) within the outer frame 108, in which case each second web 107 is also coupled to the outer frame 108 at each end (in Figures 8, 9, and 10, only one of these first and second webs—shown in bold—is identified by its reference number). As can be seen in Figures 8, 9, and 10, the first and second webs 106 and 107 are arranged such that they form the side walls 102 of the housing section 101, in which case at least some of the housing sections 101 have a rhombus shape in the plan view of the retaining structure 100 and are arranged at the most densely packed density.
[0081] Figures 11A, 11B, and 12 show experimental setups for measuring the deflections D, D', and D'' of the retaining structure 100 according to the present invention. As can be seen, the apparatus for measuring the deflection of the retaining structure 100 is a holder having a base plate 114 and four support columns 115, with the retaining structure 100 positioned on the support columns 115 at its four corners. For measurement, the retaining structure 100 is placed on the holder. A depth gauge was used to measure the height difference between the center of the retaining structure 100 and the four corners.
[0082] Figure 13A shows the deflections D, D', and D'' of a conventional support structure (shown in Figure 13B), which has a predetermined maximum waviness w. max It does not have first and second webs in the shape of a continuous beam member having, in this case the first and second webs are the side walls of the housing (left side in Figure 13A; n=30) and the retaining structure 100 (n=30; w) according to the present invention as shown in Figure 6. max The syringes are positioned to form side walls of 2 mm thickness. Each nest is 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 Sylinge, 20 ml (Schott AG, Germany). As seen in Figure 13A, the reduction in swell helps to significantly reduce the flexing of the nests when they are filled with empty syringes, half-filled syringes, 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 compartments arranged diagonally side by side 102 Side walls forming the housing section 103 Positioning rib 104 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 section 110 Common edges 111 Stabilizing member 112 Access opening 113 Stabilizing Rib 114 Base Plate 115 Support column where the retaining structure is positioned at the corner. 116 Measurement points for measuring the height of the retaining structure 200 A container that can be held by a holding structure, preferably a syringe, more preferably a pre-filled syringe that is ready for immediate use. 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 multiple primary packaging containers (200) for pharmaceutical, medical, or cosmetic compositions, The retaining structure (100) has n storage compartments (101) for accommodating the primary packaging container (200), where n is an integer having a value of at least 10, and the storage compartments (101) are formed by peripherally formed side walls (102). The aforementioned retaining 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 length L' ｘ and width L' ｙ A flat base frame (104) having a central recess (105) having, A plurality of first webs (106) extending parallel to each other in a first direction across the central recess (105), A plurality of second webs (107) extending parallel to each other in a second direction across the central recess (105) and It has, The first and second webs (106, 107) are arranged such that they form the side walls (102) of the housing (101). Each of the first and second webs (106, 107) has a maximum undulation w of 4.0 mm. ｍａｘ It has the shape of a continuous beam member having, A holding structure (100).
2. The aforementioned retaining structure (100) further, The outer frame (108) is attached to the flat base frame (104) so as to surround the central recess (105) of the base frame (104), and protrudes from the flat base frame (104) on the first side (104a), the second side (104b), or both of the aforementioned sides (104a, 104b). The retaining structure (100) according to claim 1, wherein each of the first and second webs (106, 107) is coupled to the outer frame (108) at each end of the web.
3. The retaining structure (100) has a minimum of 100 mm ４ The retaining structure (100) according to claim 1 or 2, having a second moment of area I.
4. The retaining structure (100) according to claim 1 or 2, wherein the retaining structure (100) is equipped with n empty or at least partially filled housings (101) having a total weight of up to 400 g, and has a deflection D of less than 0.25 mm as determined by the method disclosed herein.
5. The retaining structure (100) according to claim 1 or 2, wherein the retaining structure (100) is equipped with n empty or at least partially filled housings (101) having a total weight of up to 800 g, and has a deflection D' of less than 0.4 mm as determined by the method disclosed herein.
6. The retaining structure (100) according to claim 1 or 2, wherein the retaining structure (100) is equipped with n empty or at least partially filled housings (101) having a total weight of up to 1100 g, and has a deflection D'' of less than 0.5 mm as specified by the method disclosed herein.
7. Said L ｘ The range is within 200 to 260 mm, preferably within 220 to 240 mm, and the L ｙ The holding structure (100) according to claim 1 or 2, wherein the length is in the range of 170 to 230 mm, preferably in the range of 190 to 210 mm.
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 ２ .
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 retaining structure (100) according to claim 1 or 2, wherein n is selected from the group consisting of 20, 30, 42, 64, 100, and 160.
11. A positioning rib (103) for centering the primary packaging container (200) within the housing portion (101) is provided on the side wall (102) of the housing portion (101), and the positioning rib (103) protrudes radially inward into the housing portion (101) and extends in the longitudinal direction of the housing portion (101), as described in claim 1 or 2, for the holding structure (100).
12. The retaining structure (100) according to claim 1 or 2, wherein m of the n storage sections (102) have a parallelogram shape in the plan view of the retaining structure (100) and are arranged at the most densely packed density where m ≤ n.
13. A plurality of retaining structures (100) comprising a plurality of retaining structures (100) according to claim 1 or 2, wherein each empty retaining structure (100) has a deflection D determined by the method disclosed herein. ０ The plurality of holding structures have the deflection D ０ Variance Var[D ０ Multiple retaining structures (100) whose value is less than 0.
1.
14. A transport or packaging container containing a plurality of primary packaging containers (200) for a substance 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, which holds the plurality of primary packaging containers (200), is housed inside the box-shaped transport or packaging container, thereby holding the plurality of primary packaging containers (200) inside the transport or packaging container.
15. Use of a retaining structure (100) as defined in claim 1 or 2 for holding a plurality of primary packaging containers (200) for pharmaceutical, medical, or cosmetic compositions.