Assembly for positioning pharmaceutical containers during filling of pharmaceutical containers
The assembly stabilizes containers with protrusions to address tilting and diameter variations, ensuring efficient and damage-free filling of pharmaceutical and cosmetic compositions.
Patent Information
- Application Number
- JP2025065081
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-04-15
- Filing Date
- 2025-04-10
- Publication Date
- 2025-10-27
Smart Images

Figure 2025162534000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to an assembly including a first structure and another structure adapted and arranged to position a plurality of containers, preferably for pharmaceutical and / or cosmetic compositions, during at least partial filling of the containers. The present invention also relates to a method for at least partially filling a plurality of containers contained in the assembly.
[0002] Background technology Containers, such as those for pharmaceutical and / or cosmetic compositions, are commonly housed and transported using a first structure known as a nest, such as the nest commercially available from SCHOTT Pharma AG & Co. KGaA. The containers often have varying diameters. For example, the containers may be syringes with caps, the barrels of which have a different diameter compared to the diameter of the caps. Therefore, the receptacles within the nest must be sized so that containers with varying diameters can still be housed within the nest. Generally, this requires that the maximum diameter of the container be smaller than the diameter of the receptacle. If the receptacle has ribs or protrusions extending into the receptacle, the maximum diameter of the container must also be small enough to fit between such ribs or protrusions. However, this can lead to containers tilting within the nest, which in turn can lead to problems during filling of the containers while they are housed within the nest. Examples of such problems include variations in the fill height of the containers and damage to the fill needle as a result of contact with the container.
[0003] U.S. Patent Application Publication No. 2005 / 236346 discloses a rack for test tubes having central and lower support panels. U.S. Patent Nos. 4,124,122 and 9,776,188 disclose test tube racks having a base including an opening and at least one support plate spaced from the base. WO 2019 / 030782(A1) discloses a container that can include at least two trays. U.S. Patent Application Publication No. 2012 / 328489 discloses a device for holding pipettes, including a perforated plate and a container positioned below the plate for receiving the tips of the pipettes.
[0004] Summary of the Invention Problems that the invention aims to solve The object of the present invention is to at least partially overcome at least one of the drawbacks encountered in the state of the art.
[0005] Another object of the present invention is to provide an assembly that allows for easy insertion into and / or removal from said assembly.
[0006] Another object of the present invention is to provide an assembly, preferably for at least partially filling a plurality of containers with pharmaceutical and / or cosmetic compositions, which allows for improved positioning of said containers when and / or when housed within said assembly.
[0007] Another object of the present invention is to provide an assembly for at least partially filling, preferably a plurality of containers with pharmaceutical and / or cosmetic compositions, which allows for reduced tilting of said containers when and / or when housed within said assembly.
[0008] Another object of the present invention is to provide an assembly having improved stability, preferably during at least partial filling of the containers contained in the assembly.
[0009] Another object of the present invention is to provide an assembly which allows for faster filling of pharmaceutical and / or cosmetic compositions into multiple containers housed in the assembly.
[0010] Another object of the present invention is to provide an assembly that reduces loss of pharmaceutical and / or cosmetic compositions when filling multiple containers with said compositions, wherein the containers are housed within the assembly.
[0011] Another object of the present invention is to provide an assembly which allows for greater tolerances in the positioning of a device for filling said containers when multiple containers are housed within the assembly.
[0012] Another object of the present invention is to provide an assembly that reduces contamination of pharmaceutical and / or cosmetic compositions filled and contained in a plurality of containers, wherein the containers are contained in the assembly.
[0013] Another object of the present invention is to provide an assembly that reduces damage while housing multiple containers within said assembly.
[0014] Another object of the present invention is to provide an assembly capable of receiving multiple containers, said containers having non-uniform diameters for at least partially filling said containers with pharmaceutical and / or cosmetic compositions.
[0015] Means to solve the problem Contributions to at least partially meeting at least one of the above-mentioned objectives are made by any of the embodiments of the present invention.
[0016] A first embodiment of the present invention is an assembly including a first structure and another structure, a. The first structure is i. adapted and arranged to at least partially contain a plurality of containers, said containers preferably for pharmaceutical or cosmetic compositions; ii. having a first end and another end opposite the first end; a first plurality of receptacles; b.Another structure is i. another plurality of receptacles adapted and arranged to at least partially receive the plurality of containers; ii. having a first surface and another surface opposite the first surface; iii. A. comprising either a first plurality of protrusions extending from a first surface, or another plurality of protrusions extending from another surface, or both; B. the first plurality of protrusions, the second plurality of protrusions, or both, are adapted and arranged to exert a force on the container along a first direction when the container is inserted into and / or removed from another structure along another direction; I. The first direction is perpendicular to a first surface of the other structure; II. The angle α between the first direction and another direction is such that α>0°; c. a first structure and another structure; i. the average distance between the other end of the first plurality of receptacles and the first surface of the other structure is less than 5 cm, preferably less than 3 cm, more preferably less than 1 cm, and even more preferably 0 cm; ii. a first plurality of receptacles is at least partially aligned with another plurality of receptacles; adapted and arranged to be positioned such that It is an assembly.
[0017] In the first embodiment, when the average distance between the other ends of the first plurality of receptacles and the first surface of the other structure is 0 cm, this should be understood to mean that at least a portion of the other ends of the receptacles of the first plurality of receptacles is in contact with the first surface of the other structure. In the first embodiment, the force is preferably exerted when the container is in contact with at least the protrusions, more preferably when the container is being inserted into and / or removed from the other structure. In the first embodiment, the force preferably causes a change in the direction of movement of at least one section of the container when the section is being inserted into and / or removed from the other structure. In the first embodiment, the container preferably has a maximum diameter smaller than the minimum diameter of the first plurality of receptacles, the other plurality of receptacles, or both. In the first embodiment, the first plurality of protrusions preferably exert a force on the container when the container is being inserted into the other structure. In the first embodiment, the other plurality of protrusions preferably exert a force on the container when the container is being removed from the other structure. In a preferred aspect of the first embodiment, the receptacle is adapted and arranged to accommodate a plurality of containers, each of the plurality of containers having a first section and another section, the diameter of the other section preferably being larger than the diameter of the first section. In this aspect, the other section is preferably the body of the container, and the other section is preferably a closure adapted and arranged to close the container. In this aspect, the first section is preferably the barrel of a syringe, and the other section is preferably the cap of the syringe.
[0018] In a preferred embodiment of the assembly, the first structure and the further structure are adapted and arranged to releasably engage. This preferred embodiment is a second embodiment of the invention, which is preferably dependent on the first embodiment of the invention.
[0019] In a preferred embodiment of the assembly, the angle α is between 20° and 170°, preferably between 50° and 130°, more preferably between 70° and 110°, even more preferably between 80° and 100°, and even more preferably 90°. This preferred embodiment is a third embodiment of the present invention, which is preferably dependent on the first and second embodiments of the present invention.
[0020] In a preferred embodiment of the assembly, the first structure includes a first surface and another surface opposite the first surface, and the first structure and the another structure are adapted and arranged to be positioned such that the distance between the another surface of the first structure and the first surface of the another structure is less than 5 cm, preferably less than 3 cm, more preferably less than 1 cm, and even more preferably 0 cm. This preferred embodiment is a fourth embodiment of the present invention, which is preferably dependent on the first to third embodiments of the present invention. In the fourth embodiment, when the distance between the another surface of the first structure and the first surface of the another structure is 0 cm, this should be understood to mean that the another surface of the first structure is in contact with the first surface of the another structure.
[0021] In a preferred embodiment of the assembly, the assembly includes a first plurality of protrusions extending from a first surface of the first structure, and the first structure and the another structure are: a. the protrusion is adapted and arranged to be at least partially received in the first structure; b. when the protrusion is at least partially received in the first structure; i. a first plurality of receptacles at least partially aligned with another plurality of receptacles; ii. Preferably, another end of the first plurality of receptacles contacts a first surface of the other structure.
[0022] This preferred embodiment is a fifth embodiment of the present invention, which is preferably dependent on the first to fourth embodiments of the present invention. In a preferred aspect of the fifth embodiment, the plurality of protrusions are received by the first structure. In the fifth embodiment, when another end of a receptacle of the first plurality of receptacles contacts a first surface of the other structure, this should be understood to mean that preferably at least a part of the another end of a receptacle of the first plurality of receptacles contacts the first surface of the other structure.
[0023] In a preferred embodiment of the assembly, the first structure includes a plurality of recesses adapted and arranged to at least partially receive the first plurality of protrusions. This preferred embodiment is a sixth embodiment of the present invention, which is preferably dependent on the fifth embodiment of the present invention. In a preferred aspect of the sixth embodiment, the first structure includes a first surface and another surface opposite the first surface, and the recesses are arranged in the other surface.
[0024] In a preferred embodiment of the assembly, when the first plurality of protrusions are received in the recesses, gaps are formed between the protrusions and the sidewalls of the first plurality of receptacles. This preferred embodiment is a seventh embodiment of the present invention, which is preferably dependent on the sixth embodiment of the present invention. In a preferred aspect of the seventh embodiment, gaps are formed between the tops of the protrusions and the sidewalls of the first plurality of receptacles. Here, the tops of the protrusions are defined as the portions of the protrusions that are furthest from the first surface of the separate structure.
[0025] In a preferred embodiment of the assembly, the recess is formed in a sidewall of a receptacle of the first plurality of receptacles. This preferred embodiment is an eighth embodiment of the present invention, which is preferably dependent from the sixth to seventh embodiments of the present invention.
[0026] In a preferred embodiment of the assembly, the assembly, more preferably the first structure, is adapted and arranged such that the first plurality of protrusions are removably received in the first structure. This preferred embodiment is a ninth embodiment of the present invention, which is preferably dependent from the fifth to eighth embodiments of the present invention.
[0027] In a preferred embodiment of the assembly, when the first plurality of protrusions is received in the first structure, one of the following applies: a. the average distance between the first plurality of receptacles and the first plurality of protrusions is greater than 0 mm, preferably greater than or equal to 0.1 mm, more preferably greater than or equal to 0.5 mm; or b. The first plurality of protrusions contact the first structure, more preferably contact the sidewalls of the first plurality of receptacles.
[0028] This preferred embodiment is a tenth embodiment of the present invention, which is preferably dependent on the fifth to ninth embodiments of the present invention. In a preferred aspect of the tenth embodiment, feature a., the average distance between the first plurality of receptacles and the first plurality of protrusions is 5 mm or less, more preferably 2 mm or less, and even more preferably 1 mm or less. In the tenth embodiment, feature a., the average distance is measured along a direction perpendicular to the first surface of the separate structure. In a preferred aspect of the tenth embodiment, feature a., the average distance is measured between the sidewalls of the first plurality of receptacles and the first plurality of protrusions.
[0029] In a preferred embodiment of the assembly, the assembly is adapted and arranged such that a first plurality of protrusions are at least partially received within a first plurality of receptacles, preferably such that said protrusions extend into said receptacles. This preferred embodiment is an eleventh embodiment of the present invention, which is preferably dependent from the fifth to tenth embodiments of the present invention.
[0030] In a preferred embodiment of the assembly, the first plurality of protrusions are adapted and arranged to constrain movement of the first structure in at least one dimension, preferably the lateral direction. This preferred embodiment is a twelfth embodiment of the present invention, which is preferably dependent on the fifth to eleventh embodiments of the present invention. In a preferred aspect of the twelfth embodiment, movement of the first structure is constrained to 10 mm or less, more preferably 5 mm or less, and even more preferably 3 mm or less. In a preferred aspect of the twelfth embodiment, the first plurality of protrusions are adapted and arranged to allow movement of the first structure of at least 0.5 mm in the lateral direction, preferably at least 1 mm, and more preferably at least 2 mm. In the twelfth embodiment, the first structure should not be understood as necessarily constrained to be immobile. In a preferred aspect of the twelfth embodiment, the first structure is constrained to allow movement of the first structure of 0.2 to 3 mm, more preferably 0.3 to 2 mm, even more preferably 0.4 to 1 mm, and even more preferably 0.5 to 0.7 mm.
[0031] In a preferred embodiment of the assembly, each receptacle of the separate plurality of receptacles has 2 to 12, preferably 3 to 10, more preferably 4 to 8, and even more preferably 5 to 7 protrusions disposed at least partially around the circumference of the respective receptacle. This preferred embodiment is a thirteenth embodiment of the present invention, which is preferably dependent from the first to twelfth embodiments of the present invention. In the thirteenth embodiment, the protrusions can be protrusions of the first plurality of protrusions, or protrusions from the separate plurality of protrusions, or both.
[0032] In a preferred embodiment of the assembly, a sidewall of a receptacle of the first plurality of receptacles includes a ridge extending into the interior of said receptacle. This preferred embodiment is a fourteenth embodiment of the present invention, which is preferably dependent from the first to thirteenth embodiments of the present invention.
[0033] In a preferred embodiment of the assembly, when the first plurality of protrusions are received in the first structure, the ridges are disposed between the protrusions. This preferred embodiment is preferably a fifteenth embodiment of the present invention, which depends from the fourteenth embodiment of the present invention, if the fourteenth embodiment further depends from any of the fifth to thirteenth embodiments of the present invention. In a preferred aspect of the fifteenth embodiment, the movement of the ridges is constrained laterally by being disposed between the protrusions. In this aspect, the movement of the ridges is preferably constrained to 10 mm or less, more preferably 5 mm or less, and even more preferably 3 mm or less. In this aspect, the first plurality of protrusions are preferably adapted and arranged to allow lateral movement of the ridges of at least 0.5 mm, more preferably at least 1 mm, and even more preferably at least 2 mm.
[0034] In a preferred embodiment of the assembly, the protrusions have at least one of the following geometric shapes: cube, cylinder, semi-cylinder, prism such as triangular prism or trapezoidal prism, cone, pyramid, sphere, hemisphere, or a combination of at least two thereof. This preferred embodiment is a 16th embodiment of the present invention, which is preferably dependent on the 14th to 15th embodiments of the present invention. The protrusions do not all have to have the same shape. For example, some of the protrusions may be cylindrical and the remaining protrusions may be conical.
[0035] In a preferred embodiment of the assembly, the first plurality of protrusions, or the further plurality of protrusions, or both, are disposed at least partially around the periphery of a receptacle of the further plurality of receptacles, and preferably the average distance between the protrusions and said periphery is less than 2 mm, more preferably less than 1 mm, preferably less than 0.5 mm, and even more preferably less than 0.2 mm. This preferred embodiment is a 17th embodiment of the present invention, which is preferably dependent from the first to sixteenth embodiments of the present invention. In the 17th embodiment, the term "protrusions" should be understood to refer to either the first plurality of protrusions, the further plurality of protrusions, or both.
[0036] In a preferred embodiment of the assembly, the first plurality of protrusions, or the further plurality of protrusions, or both, comprise a surface disposed at an angle β relative to a first surface of the further structure, said angle β being less than 90°, preferably β being between 10° and 80°, more preferably between 30° and 70°, even more preferably between 45° and 60°. This preferred embodiment is an 18th embodiment of the present invention, which is preferably dependent from the first to seventeenth embodiments of the present invention.
[0037] In preferred embodiments of the assembly, at least one or all of the following are applied to the first plurality of protrusions, or the other plurality of protrusions, or both: a. the average height of the protrusions is equal to or less than the height of the first structure, and preferably less than the height of the first structure; b. The average height of the protrusions is 0.5 mm to 20 mm, preferably 0.5 to 16 mm, more preferably 1 to 12 mm, even more preferably 1 to 8 mm, even more preferably 1.5 to 6 mm, even more preferably 1.5 to 4 mm, and even more preferably 1.8 to 3 mm.
[0038] This preferred embodiment is a 19th embodiment of the present invention, which is preferably dependent on the first to eighteenth embodiments of the present invention. In the 19th embodiment, the term "protrusions" should be understood to refer to either the first plurality of protrusions, the second plurality of protrusions, or both. In one aspect of the 19th embodiment, all possible combinations of feature a and feature b are preferred aspects of the embodiment. These combinations are, for example, a; b; a + b.
[0039] In a preferred embodiment of the assembly, the upper portions of the first plurality of protrusions, or the other plurality of protrusions, or both, are narrower than the lower portions of the protrusions. The lower portions are located closer to the first surface of the other structure than the upper portions. This preferred embodiment is a twentieth embodiment of the present invention, which is preferably dependent from the first to nineteenth embodiments of the present invention. In the twentieth embodiment, the term "protrusions" should be understood to refer to either the first plurality of protrusions, the other plurality of protrusions, or both.
[0040] In a preferred embodiment of the assembly, either the first plurality of protrusions, the other plurality of protrusions, or both have at least one of the following geometric shapes: cube, cylinder, semi-cylinder, prism such as triangular prism or trapezoidal prism, cone, pyramid, sphere, hemisphere, or a combination of at least two thereof. This preferred embodiment is a 21st embodiment of the present invention, which is preferably dependent on the first to 20th embodiments of the present invention. The protrusions of a plurality of protrusions (e.g., the first plurality, the other plurality) do not all need to have the same shape. For example, some of the protrusions (of the first plurality) may have a conical shape, and the remaining protrusions (of the first plurality) may have a cylindrical shape.
[0041] In a preferred embodiment of the assembly, the first plurality of protrusions, the second plurality of protrusions, or both, are arranged around the periphery of a receptacle of the second plurality of receptacles, and the protrusions have an average diameter in the range of 1.01 to 1.8 times, preferably 1.1 to 1.6 times, more preferably 1.2 to 1.4 times greater than the average diameter of the receptacles of the second plurality of receptacles. This preferred embodiment is a 22nd embodiment of the present invention, which is preferably dependent from the 1st to 21st embodiments of the present invention.
[0042] In a preferred embodiment of the assembly, a first plurality of receptacles has a first average diameter D1 and another plurality of receptacles has another average diameter D2, and one of the following applies: a.D1 is greater than D2, b.D2 is smaller than D1, c. D1 and D2 vary by less than 5%, preferably by less than 3%, more preferably by less than 1.5%.
[0043] This preferred embodiment is a 23rd embodiment of the present invention, which is preferably dependent on the 1st to 22nd embodiments of the present invention. In a preferred aspect of the 23rd embodiment, feature a., D1, is 5% to 25% greater than D2, more preferably 5% to 20%, even more preferably 5% to 15%, and even more preferably 5% to 10% greater. In a preferred aspect of the 23rd embodiment, feature b., D2, is 5% to 25% greater than D1, more preferably 5% to 20%, even more preferably 5% to 15%, and even more preferably 5% to 10% greater. In the 23rd embodiment, feature a. and feature c. are more preferred.
[0044] In preferred embodiments of the assembly, at least one or all of the following apply: a. the average distance between the centers of adjacent receptacles of the first plurality of receptacles is 8 to 60 mm, preferably 10 to 55 mm, and more preferably 12 to 50 mm; b. The average distance between the centers of adjacent receptacles among the other plurality of receptacles is 8 to 60 mm, preferably 10 to 55 mm, and more preferably 12 to 50 mm.
[0045] This preferred embodiment is a 24th embodiment of the present invention, which is preferably dependent on the 1st to 23rd embodiments of the present invention. In one aspect of the 24th embodiment, all possible combinations of feature a and feature b are preferred aspects of the embodiment. These combinations are, for example, a; b; a + b.
[0046] In preferred embodiments of the assembly, at least one or all of the following applies: a. the average diameter of the first plurality of receptacles is 6 to 55 mm, preferably 6 to 50 mm, more preferably 8 to 45 mm, even more preferably 9 to 40 mm, and even more preferably 9.2 to 35 mm; b. The average diameter of the other plurality of receptacles is 6 to 55 mm, preferably 6 to 50 mm, more preferably 8 to 45 mm, even more preferably 9 to 40 mm, and even more preferably 9.2 to 35 mm.
[0047] This preferred embodiment is a 25th embodiment of the present invention, which is preferably dependent on the 1st to 24th embodiments of the present invention. In one aspect of the 25th embodiment, all possible combinations of feature a and feature b are preferred aspects of the embodiment. These combinations are, for example, a; b; a + b.
[0048] In a preferred embodiment of the assembly, the first structure has a height H1 and the other structure has a height H2, where H1\H2 is between 1 and 4, preferably between 1.2 and 3, more preferably between 1.5 and 2.5, and even more preferably between 1.7 and 2.2. This preferred embodiment is a 26th embodiment of the present invention, which is preferably dependent on the first to 25th embodiments of the present invention.
[0049] In a preferred embodiment of the assembly, the following applies to the first structure, the other structure, or both: the height of the structure is less than the width and length of the structure. This preferred embodiment is a 27th embodiment of the present invention, which is preferably dependent on the first to 26th embodiments of the present invention. In the 27th embodiment, the term "structure" should be understood to refer to the first structure, the other structure, or both.
[0050] In a preferred embodiment of the assembly, the height H2 of the separate structure is 5 to 35 mm, more preferably 7 to 25 mm, and even more preferably 9 to 15 mm. This preferred embodiment is a 28th embodiment of the present invention, which is preferably dependent on the 1st to 27th embodiments of the present invention.
[0051] A 29th embodiment of the present invention is an assembly according to the present invention, preferably an assembly according to any of the 1 to 28th embodiments of the present invention, further comprising a plurality of containers containing less than 0.1 ml of the composition, preferably less than 0.05 ml, even more preferably less than 0.01 ml of the composition.
[0052] In a preferred aspect of the twenty-ninth embodiment, each container of the plurality of containers has a first section and another section, and the diameter of the another section is larger than the diameter of the first section. In this aspect, the another section is preferably the body of the container, and the another section is a closure adapted and arranged to close the container. For example, the first section is the barrel of a syringe, and the another section is the cap of the syringe.
[0053] A 30 embodiment of the present invention is an assembly according to the present invention, preferably an assembly according to any of the 1 to 28 embodiments of the present invention, further comprising a plurality of containers at least 20% filled, preferably at least 35%, more preferably at least 50% filled with the composition. In the 30 embodiment, the given percentage values are relative to the nominal volume of the containers.
[0054] In a preferred aspect of the thirtieth embodiment, each container of the plurality of containers has a first section and another section, and the diameter of the another section is larger than the diameter of the first section. In this aspect, the another section is preferably the body of the container, and the another section is a closure adapted and arranged to close the container. For example, the first section is the barrel of a syringe, and the another section is the cap of the syringe.
[0055] A 31st embodiment of the present invention is a method for at least partially filling a plurality of containers, comprising the steps of: a. Providing a first structure of an assembly according to the present invention, preferably an assembly according to any of the first to twenty-ninth embodiments of the present invention, in which a plurality of containers are at least partially housed in a first plurality of receptacles; b. Providing another structure of an assembly according to the present invention, preferably an assembly according to any of the first to twenty-ninth embodiments of the present invention; c. Preferably, the first structure receives a plurality of protrusions, such that: i. a plurality of containers at least partially contained within a plurality of other receptacles; ii. The average distance between the other end of the first plurality of receptacles and the first surface of the other structure is less than 5 cm, preferably less than 3 cm, more preferably less than 1 cm, and even more preferably 0 cm. engaging the first structure with the other structure by d. at least partially filling the container; The method includes:
[0056] In the thirty-first embodiment, if the average distance between the other ends of the first plurality of receptacles and the first surface of the other structure is 0 cm, this should be understood to mean that preferably at least a portion of the other ends of the receptacles of the first plurality of receptacles are in contact with the first surface of the other structure.
[0057] In a preferred embodiment of the method for at least partially filling a plurality of containers, during engagement between the first structure and the other structure (step c. in the 31st embodiment of the present invention), the other structure is moved alternately, more preferably in a direction perpendicular to the first direction. This preferred embodiment is a 32nd embodiment of the present invention, which is preferably dependent on the 31st embodiment of the present invention. Examples of alternately moving the other structure include vibrating the other structure, moving the other structure back and forth, and rocking motion of the other structure.
[0058] In a preferred embodiment of the method for at least partially filling a plurality of containers, at least one or all of the following are applied to the alternating movements of the separate structures: a. The amplitude of the movement of the separate structure is 2 mm or less, preferably 1 mm or less, and more preferably 0.5 mm or less; b. moving another structure for a duration of 2 seconds or less, preferably 1 second or less, and more preferably 0.5 seconds or less; c. The separate structure is moved at a frequency of at least 5 Hz, preferably at least 15 Hz, and more preferably at least 50 Hz.
[0059] This preferred embodiment is a 33rd embodiment of the present invention, which is preferably dependent on the 32nd embodiment of the present invention. In one aspect of the 33rd embodiment, all possible combinations of features a. to c. are preferred aspects of the embodiment. These combinations are, for example, a; b; c; a+b; a+c; b+c; a+b+c.
[0060] A 34th embodiment of the present invention is a plurality of containers at least partially filled with a composition, obtainable according to a method of the present invention for filling a plurality of containers, preferably according to any of the 31st to 33rd embodiments of the present invention.
[0061] A 35th embodiment of the present invention is the use of an assembly comprising a first structure and a further structure removably engaged, preferably in contact with each other, for at least partially filling a plurality of containers at least partially housed in the first structure and the further structure. In a preferred aspect of the 35th embodiment, the first structure and the further structure form part of an assembly according to the present invention, more preferably an assembly according to any of the first to 29th embodiments of the present invention.
[0062] A 36th embodiment of the present invention is the use of an assembly according to the present invention, preferably an assembly according to any of the first to 29th embodiments of the present invention, for at least partially filling a container that is at least partially housed in a first structure and another structure.
[0063] MODE FOR CARRYING OUT THE INVENTION Features described as preferred in one category of the invention, for example due to the assembly, are equally preferred in other categories of embodiments according to the invention, such as the process according to the invention.
[0064] Throughout this specification, disclosures of ranges should preferably be understood to include both endpoints of the range. Moreover, each disclosure of a range herein should preferably be understood to also disclose preferred subranges in which one endpoint or both endpoints are excluded. For example, disclosure of a range from X1 to X2 should be understood to disclose a range inclusive of both endpoints X1 and X2. Furthermore, disclosure of a range from X1 to X2 should also be understood to disclose ranges inclusive of endpoint X1 but not endpoint X2, ranges inclusive of endpoint X1 but including endpoint X2, and ranges inclusive of both endpoints X1 and X2.
[0065] Some preferred embodiments and aspects have various combinations of features as alternatives. Where various combinations are disclosed, these combinations are separated by semicolons (";"). For example, a list of preferred embodiments of features "a; a+b; a+c+d" discloses preferred embodiments including feature "a," preferred embodiments including features "a" and "b," and preferred embodiments including features "a," "c," and "d."
[0066] Disclosed preferred embodiments and preferred aspects of the structure should be understood to be preferred embodiments and preferred aspects of both the first structure and the alternative structure. Disclosed preferred embodiments and preferred aspects of the receptacle should be understood to be preferred embodiments and preferred aspects of both the first structure receptacle and the alternative structure receptacle. Disclosed preferred embodiments and preferred aspects of the protrusions should be understood to be preferred embodiments and preferred aspects of both the first plurality of protrusions and the alternative plurality of protrusions.
[0067] In one embodiment of the present invention, the other structure includes a first plurality of protrusions and / or another plurality of protrusions. This should not be understood to mean that the other structure can have only the first plurality of protrusions and / or another plurality of protrusions. For example, the other structure may also have a second plurality of protrusions having some of the features of the first plurality of protrusions and / or another plurality of protrusions. For example, the other structure may include a first plurality of protrusions extending from a first surface of the other structure, each of the protrusions of the first plurality of protrusions having a surface disposed at a 50° angle relative to the first surface of the other structure. Here, the other structure may also include other protrusions extending from the first surface of the other structure but not having a surface disposed at a 50° angle relative to the first surface of the other structure. These other protrusions are included in the second plurality of protrusions. The above also applies mutatis mutandis to other features of the first structure and the other structure. Here, the other features include a first plurality of receptacles, another plurality of receptacles, a protuberance, and a recess.
[0068] The invention will now be illustrated by way of non-limiting examples and exemplary embodiments.
[0069] structure The structure (e.g., first structure, another structure) preferably comprises a polymer. Examples of preferred polymers include polypropylene, polyoxymethylene, polyethylene, polyethylene terephthalate, polystyrene, cyclic olefin copolymer (COC), and cyclic olefin polymer (COP). Here, polypropylene is particularly preferred for the first structure. Here, polyoxymethylene is particularly preferred for the another structure. The structure may be obtained using deep drawing, preferably injection molding, and / or 3D printing.
[0070] The further structure preferably comprises a metal and / or at least one polymer, preferably at least one heat-resistant polymer. Preferred metals include stainless steel, non-rusting steel, etc. Stainless steel is particularly preferred here. A heat-resistant polymer is to be understood as a polymer that is resistant to damage when exposed to temperatures used for sterilization of the structure, said sterilization preferably being carried out using gas and / or steam (sterilization of the structure is often carried out at a temperature of 121°C). A preferred example of a heat-resistant polymer is polyetheretherketone (PEEK). The further structure more preferably comprises a polymer and a metal.
[0071] The first structure may generally be any structure and / or device that a person skilled in the art would consider suitable for housing multiple containers. An example of the first structure is a nest for holding containers, the containers being for housing pharmaceutical and / or cosmetic compositions. Here, the term "nest" should preferably be understood as being used in the pharmaceutical industry.
[0072] The further structure is preferably adapted and arranged to improve centering of the container housed and / or housed in the first structure.
[0073] In a preferred embodiment of the present invention, the first structure is manufactured as a single piece. In a preferred embodiment of the present invention, the other structure is manufactured as a single piece. In another preferred embodiment of the present invention, the other structure is manufactured as two pieces, i.e., comprises two parts. In this embodiment, the other structure preferably comprises a core and an outer layer at least partially surrounding the core. Preferably, the core is removable from the outer layer. In this embodiment, the core preferably comprises a polymer such as polyoxymethylene, and the outer layer preferably comprises a metal such as stainless steel. The first structure and the other structure are preferably manufactured as separate pieces.
[0074] The first structure preferably includes 5 to 250, more preferably 10 to 200, even more preferably 20 to 190, even more preferably 40 to 180, even more preferably 60 to 180, even more preferably 80 to 180, and even more preferably 100 to 160 receptacles. The other structure preferably includes 5 to 250, more preferably 10 to 200, even more preferably 20 to 190, even more preferably 40 to 180, even more preferably 60 to 180, even more preferably 80 to 180, and even more preferably 100 to 160 receptacles. A preferred assembly includes a first structure and another structure having the same number of receptacles.
[0075] In a preferred embodiment of the present invention, the assembly further comprises a further structure. This further structure preferably comprises at least one metal and / or at least one polymer, as described above for the first and further structures. In a preferred embodiment of the present invention, the further structure comprises a first surface adapted and arranged to position the further structure on the first surface of the further structure. In a preferred embodiment of the present invention, the further structure comprises a further plurality of receptacles adapted and arranged to at least partially accommodate a plurality of containers. The further structure preferably comprises several receptacles, as described above for the first and further structures.
[0076] Surface of the structure The first surface and the other surface of the structure are preferably arranged parallel to each other. The surfaces of the structure do not need to be continuous. For example, the first structure has an upper surface from which sidewalls of the receptacles of the first plurality of receptacles extend away from the first surface. Furthermore, the sidewalls of the receptacles do not intersect with each other. In this example, the lower surface of the first structure is at least partially formed by the other end of the receptacle. In this example, the lower surface may also include a surface arranged at the same height as the lower end of the receptacle, the surface arranged around the receptacle and perpendicular to the length of the receptacle.
[0077] Receptacle A container partially housed in a receptacle should preferably be understood to mean that a first section of the container is located inside the receptacle and that another section of the container is not located inside the receptacle, i.e., that another section of the container extends beyond the receptacle in which the container is located. Here, the first section of the container located in the receptacle may, for example, be a section of the container that includes an end of the container, or a section of the container that is located between two ends of the container, where the first section does not include the ends of the container. A container housed in a receptacle should preferably be understood to mean that no section of the container extends beyond the interior of the receptacle.
[0078] A receptacle adapted and arranged to at least partially receive a container should be understood to mean that said receptacle is also adapted and arranged to hold said container. For example, when a container is received in a receptacle, this should be understood to mean that the container is held in the receptacle. When a container is received in a receptacle, this should preferably be understood to refer to the container being inserted into the receptacle and / or the container being removed from the receptacle.
[0079] A receptacle according to the present invention preferably includes a sidewall that surrounds the interior of the receptacle. A receptacle according to the present invention includes at least one opening through which a container can be inserted into and / or removed from the receptacle. When a receptacle has two openings, a first opening and a second opening, the receptacle is preferably adapted and arranged so that a container accommodated in the receptacle extends beyond the first opening and / or the second opening. For example, only the section of the container located between the first end and the second end is surrounded by the sidewall of the receptacle. When a receptacle has only one opening for inserting and / or removing a container, the receptacle is preferably adapted and arranged so that an end of the container is accommodated within the receptacle when the container is accommodated within the receptacle. Preferred receptacles are elongated.
[0080] In a preferred embodiment of the invention, the receptacles of a first plurality of receptacles (of a first structure) each have two openings. In a preferred embodiment of the invention, the receptacles of another plurality of receptacles (of another structure) each have two openings.
[0081] The cross-section of the receptacle can have any shape deemed appropriate by one skilled in the art. For example, the shape can be circular, oval, triangular, diamond-shaped, rectangular, polygonal (e.g., hexagonal), and irregular, or a combination thereof. For example, a first section of the receptacle can have a circular shape, and another section of the receptacle has a diamond-shaped. The shape of the cross-section of the receptacle is the shape of a cross-section taken perpendicular to the length of the receptacle. The opening of the receptacle can have any shape deemed appropriate by one skilled in the art. For example, the shape can be circular, oval, triangular, diamond-shaped, rectangular, polygonal (e.g., hexagonal), and irregular. If the receptacle has two openings, these openings can have the same shape or different shapes.
[0082] In a preferred aspect of the invention, the receptacles of the first plurality of receptacles have the same cross-sectional shape. In a preferred aspect of the invention, the receptacles of the other plurality of receptacles have the same cross-sectional shape. In one aspect of the invention, it is preferred that the receptacles of the first plurality of receptacles and the receptacles of the other plurality of receptacles have the same cross-sectional shape. In an alternative aspect of the invention, it is preferred that the receptacles of the first plurality of receptacles and the receptacles of the other plurality of receptacles have the same but different cross-sectional shapes.
[0083] The receptacle is preferably adapted and arranged to hold the container by a push-fit or a friction fit, or both, with a push-fit being particularly preferred. Preferably, the push-fit holds the container against gravity when the receptacle is positioned upright. In a preferred embodiment, establishing the push-fit includes elastically deforming the receptacle.
[0084] When a first plurality of receptacles of a first structure are at least partially aligned with another plurality of receptacles of another structure, this should be understood to mean that at least one opening of a receptacle from the first plurality of receptacles at least partially overlaps with at least one opening of a receptacle from the other plurality of receptacles.
[0085] protrusion The protrusions preferably comprise metal and / or at least one heat-resistant polymer. Preferred metals include stainless steel, non-rusting steel, etc. Stainless steel is particularly preferred here. A heat-resistant polymer is to be understood as a polymer that is resistant to damage when exposed to temperatures preferably used for sterilization of the structure, said sterilization preferably being carried out using gas and / or steam (the sterilization of the structure is often carried out at a temperature of 121°C). A preferred example of a heat-resistant polymer is polyetheretherketone (PEEK).
[0086] The protrusions are preferably formed integrally with the other structure. If the other structure includes an outer layer, the protrusions are preferably formed integrally with the outer layer. In a preferred embodiment of the present invention, the protrusions extend in a direction substantially perpendicular to either the first surface, the other surface, or both the first and other surfaces of the other structure.
[0087] When the protrusion is at least partially received in the first structure, this should preferably be understood to mean that at least one section of the protrusion extends into a recess and / or opening and / or gap formed in the first structure when the first structure and another structure are engaged.
[0088] A protrusion partially received in the first structure should preferably be understood to mean that a first section of the protrusion is located within a recess and / or opening and / or gap formed in the first structure, and another section of the protrusion is not located within the first structure. A protrusion received in the first structure should preferably be understood to mean that no section of said protrusion is located outside of a recess and / or opening and / or gap formed in the first structure.
[0089] When the protrusion is at least partially received in the receptacle, this should preferably be understood to mean that at least one section of the protrusion extends into the interior of the receptacle when the first structure and the other structure are engaged.
[0090] A protrusion partially received in a receptacle should preferably be understood to mean that a first section of the protrusion is located inside the receptacle and another section of the protrusion is not located inside the receptacle. A protrusion received in a receptacle should preferably be understood to mean that no section of the protrusion is located outside the interior of the receptacle.
[0091] When the protrusion is at least partially received in the recess, this should preferably be understood to mean that at least one section of the protrusion is positioned within the recess when the first structure and the other structure are engaged.
[0092] A protrusion partially received in a recess should preferably be understood to mean that a first section of the protrusion is positioned within the recess and another section of the protrusion is not positioned within the recess. A protrusion received in a recess should preferably be understood to mean that no section of said protrusion is positioned outside of said recess.
[0093] container The container referred to herein comprises a container wall that at least partially surrounds the internal volume of the container. The container referred to herein is designed to contain a composition such that the inside of the container wall (i.e., the side of the container wall facing the internal volume) and / or a coating layer (e.g., a lubricating layer) on the inside of the container wall can directly contact the composition. Preferred containers are suitable for use to contain pharmaceutical compositions and / or cosmetic compositions. Preferred containers may comprise at least one closure at one or both ends of the container. An example of a closure is a cap. An example of a container with a closure is syriQ®, a syringe with a rigid cap (SRC) commercially available from SCHOTT Pharma AG & Co. KGaA.
[0094] The first end of the container preferably includes a first orifice that allows the composition to be filled into the interior volume of the container. Preferably, the first orifice also allows the composition to be expelled from the interior volume.
[0095] The internal volume of the container refers to the total volume of the interior of the container. This volume can be determined by filling the internal volume with water up to the brim of the container and measuring the volume of the amount of water that the internal volume can take up to the brim.Therefore, the internal volume used herein is not the nominal volume that is often referred to in the pharmaceutical technical field.This nominal volume may be, for example, about 0.5 times smaller than the internal volume.
[0096] A container according to the present invention may have any size or shape that a person skilled in the art would deem appropriate in the context of the present invention. Preferred containers have at least one section that is cylindrical. Preferred containers are elongated.
[0097] A preferred container, more preferably a container wall, comprises, or more preferably consists of, at least one glass, at least one polymer, or a combination thereof. The glass may be any type of glass and may have any composition that a person skilled in the art would deem appropriate in the context of the present invention. Preferably, the glass is suitable for pharmaceutical compositions. A preferred glass is Type I according to the glass type definitions in Section 3.2.1 of the European Pharmacopoeia, 7th Edition, 2011. Examples of preferred glasses include borosilicate glass, quartz glass, and combinations thereof. Particularly preferred glasses are borosilicate glass. Examples of preferred polymers include polypropylene, polyoxymethylene, polyethylene, cyclic olefin copolymers (COC), and cyclic olefin polymers (COP). Here, cyclic olefin copolymers (COC) and cyclic olefin polymers (COP) are particularly preferred.
[0098] Examples of preferred containers include cartridges, vials, ampoules, carpules, and syringes. Preferably, all of the containers in the plurality of containers are the same type, preferably selected from the above-mentioned preferred container examples. Preferred syringes are made of glass or polymer. Additionally or alternatively, preferred syringes have an internal volume of 0.5 to 100 ml, preferably 0.5 to 80 ml, and more preferably 0.5 to 60 ml. Additionally or alternatively, preferred syringes include a body portion, which is preferably cylindrical, also referred to as a barrel. Preferred barrels of syringes have a diameter of 5 to 50 mm, more preferably 6 to 45 mm, even more preferably 8 to 40 mm, and most preferably 9 to 35 mm. It is particularly preferred that the barrel be made of glass or polymer.
[0099] A preferred container, more preferably the container wall, more preferably the surface of the container wall facing the internal volume of the container, comprises at least one coating layer. Here, the coating layer is preferably understood as a layer applied by any method known to those skilled in the art working in the pharmaceutical industry. These methods include applying the coating layer by spraying or rubbing the coating layer onto the container wall facing the internal volume of the container. A preferred coating layer is a lubricating layer. A preferred lubricating layer comprises silicon. A preferred lubricating layer reduces friction when a component of the container is moved within the internal volume of the container. Here, an example of a component is a syringe plunger, and the syringe is an example of a container. For example, the lubricating layer reduces the force required to move the plunger inside the syringe barrel.
[0100] A preferred container has a first section and another section, the diameter of which is larger than that of the first section. Here, the another section is preferably the body of the container, and the other section is preferably a closure adapted and arranged to close the container. For example, the first section is the barrel of a syringe, and the other section is the cap of the syringe.
[0101] Pharmaceutical and cosmetic compositions In the context of the present invention, any pharmaceutical composition and any cosmetic composition deemed appropriate by a person skilled in the art are considered. A pharmaceutical composition is a composition containing at least one pharmaceutically active ingredient. A preferred pharmaceutically active ingredient is a vaccine. A cosmetic composition is a composition containing at least one cosmetically active ingredient. A preferred cosmetically active ingredient is hyaluronic acid or botulinum toxin. A pharmaceutical composition and / or cosmetic composition may be fluid or solid, or both, with fluid compositions being particularly preferred herein. Preferred solid compositions are in granular form, such as powders, multiple tablets, or multiple capsules. Further preferred pharmaceutical and / or cosmetic compositions are parenteral substances, i.e., compositions intended to be administered via a parenteral route, which may be any route other than enteral. Parenteral administration can be by injection, for example, using a needle (usually a hypodermic needle) and syringe, or by insertion of an indwelling catheter.
[0102] Further definitions When a first structure and another structure are adapted and arranged to releasably engage, this should be understood to mean that the first structure and another structure can be brought into contact with each other and then separated from each other, preferably without damaging the first structure, the other structure, or both the first structure and the other structure.
[0103] When the assembly, more preferably the first structure, is adapted and arranged such that the first plurality of protrusions are removably received in the first structure, this should be understood to mean that the first plurality of protrusions can be received in and subsequently removed from the first structure, preferably without damaging the first structure, the first plurality of protrusions, or both the first structure and the first plurality of protrusions.
[0104] When a first structure and another structure are releasably engageable, this should be understood to mean that the first structure and another structure can be brought into contact with each other and then separated from each other, preferably without damaging the first structure, the another structure, or both the first structure and the another structure.
[0105] The lateral direction is defined as being parallel to the first surface of the other structure.
[0106] The invention will now be illustrated by way of non-limiting examples and exemplary embodiments.
[0107] The figures are used to illustrate the invention and should not be considered as limiting the invention. Furthermore, the figures are not drawn to scale. [Brief explanation of the drawings]
[0108] [Figure 1] 1 is a schematic diagram of a cross section of an assembly according to the invention; [Figure 2] 2 is a schematic cross-sectional view of the assembly according to FIG. 1, with a first structure and another structure releasably engaged; [Figure 3] FIG. 1 is a schematic diagram showing how protrusion dimensions and parameters are measured. [Figure 4] 1 is a schematic diagram showing an isometric view of an assembly according to the present invention; FIG. [Figure 5] FIG. 10 is a schematic diagram showing an isometric view of another structure according to the present invention. [Figure 6] FIG. 10 is an enlarged view of a section of another structure showing the protrusions. [Figure 7] FIG. 10 is an enlarged view of a section of the assembly showing a first structure releasably engaged with another structure. [Figure 8] 3 is a flow chart illustrating steps of a method for filling a plurality of containers in accordance with the present invention. [Figure 9] FIG. 1 is a schematic diagram of a cross section of an assembly showing a first structure releasably engaged with another structure. [Figure 10]10 is a schematic cross-sectional view of an alternative embodiment of another structure according to the present invention; [Figure 11A] 10A-10C are schematic diagrams of alternative embodiments of another and yet another structure, both according to the present invention; [Figure 11B] 10A-10C are schematic diagrams of alternative embodiments of another and yet another structure, both according to the present invention; [Figure 11C] 10A-10C are schematic diagrams of alternative embodiments of another and yet another structure, both according to the present invention; [Figure 11D] 10A-10C are schematic diagrams of alternative embodiments of another and yet another structure, both according to the present invention;
[0109] Text description of the illustration image022.gif. FIG. 1 shows a schematic cutaway view of an assembly 100 according to the present invention. The assembly includes a first structure 101. The first structure 101 includes a first plurality of receptacles, such as receptacles 102A and 102B. Each receptacle in the first plurality of receptacles has a first end 103 and another end 104, the other end 104 being opposite the first end 103. Each receptacle in the first plurality of receptacles has a sidewall and an interior enclosed by the sidewall. For example, receptacle 102B has a sidewall 105 that encloses interior 106. The sidewall of the receptacle in first structure 101 also has a recess, such as 107, located at the other end 104 of the receptacle. The first structure also has a first surface 108 and another surface 109 opposite first surface 108. In FIG. 1, a first surface 108 is the top surface and another surface 109 is the bottom surface.
[0110] FIG. 1 also shows another structure 201 of assembly 100. The another structure 201 includes another plurality of receptacles, such as 202. Each receptacle of the another plurality of receptacles also has a sidewall, such as 203, and an interior 204 surrounded by the sidewall. The another structure 201 has a first surface 205 and another surface 206 opposite the first surface 205. In FIG. 1, the first surface 205 is the top surface, and the another surface 206 is the bottom surface. As shown in FIG. 1, the another structure 201 also has a first plurality of protrusions, such as protrusion 207, extending from the first surface 205. The protrusions are adapted and positioned to exert a force along another direction 209 on the container (e.g., another end of the container) when the container is inserted into the another structure 201. In other words, the protrusions enable improved positioning of the container in the receptacle. Another direction 209 makes an angle α 210 with the first direction 208, said first direction 208 being perpendicular to the first surface 205 of the first structure. In Figure 1 , α = 90°, i.e. the protrusions are adapted and arranged to exert a force along the lateral direction upon insertion of the container into the another structure 201 when the container is in contact with the protrusions.
[0111] The first and second receptacles of FIG. 1 are also adapted and arranged to at least partially accommodate a plurality of containers. As shown in FIG. 1, a container 301 (in this case, a syringe) is partially accommodated in a receptacle of the first structure 101. The container 301 has a first end 302, which in this case is a syringe flange, and a second end 303, which in this case is a syringe cap. The container 301 also has a barrel 304. The diameter of the barrel 304 is smaller than the diameter of the second end 303 (here, the diameters are measured along the second direction 209). Thus, a gap is formed between the barrel 304 of the container 301 and the sidewall of the receptacle in which the container 301 is accommodated. This gap may be 0.5 mm or even larger. As a result, the container 301 can move along the second direction 209 within the receptacle that accommodates the container. It is also possible for the container 301 to tilt within the receptacle that houses it. The aforementioned gap may exist even if a receptacle in the first plurality of receptacles includes a protrusion (such as a rib) that extends into the interior of the receptacle. The first end 302 and the other end 303 of the container 301 extend beyond the first structure. In other words, the length of the container 301 is longer than the length of the receptacle in the first structure 101, where the length is measured along the first direction 208. The diameters of the other end 303 and barrel 304 of the container 301 are also smaller than the diameter of the receptacle in the first structure 101 (where the diameter is measured along the other direction 209).
[0112] 2 is a schematic diagram of a cross section of the assembly according to FIG. 1 in which a first structure and another structure are removably engaged. A protrusion, such as 207, is received in a receptacle of a first plurality of receptacles (such as 102A and 102B). More specifically, the protrusion is received in a recess, such as recess 107, in a sidewall of a receptacle of the first plurality of receptacles. Another surface 109 of the first structure 101 also contacts a first surface 205 of another structure 201. Furthermore, a first end, such as first end 104, of the receptacle of the first structure 101 contacts a first surface 205 of the another structure. As a result, the average distance between the another end of the first plurality of receptacles and the first surface 205 of the another structure 201 is 0 mm. The receptacles of the first structure 101 are also aligned with the receptacles of the another structure 201. When the first structure 101 and the another structure 201 initially engage, the protrusion 207 can exert a force in the other direction 209 on the other end 303 of the container 301, for example, if the container 301 is not centered in the receptacle of the first structure 101 and / or if the first plurality of receptacles are not aligned with the other plurality of receptacles. As a result, the protrusion 207 allows the container 301 to be more easily inserted into the receptacle of the other structure 201. During engagement between the first structure 101 and the other structure 201, the other structure 201 can be alternately moved parallel to the other direction 209 (e.g., the other structure 201 is vibrated).
[0113] FIG. 3 is a schematic diagram illustrating how protrusion dimensions and parameters are measured. Structure 201 has a first plurality of protrusions, such as 207A-207D. Protrusions 207A and 207B are located on the periphery of a receptacle having interior 204A, and protrusions 207C and 207D are located on the periphery of a receptacle having interior 204B. Distance 211 is the distance between protrusion 207C and the periphery of the receptacle with interior 204B. Distance 211 is measured from the point on protrusion 207C closest to the periphery. Protrusion height 212 is measured from first surface 205 of another structure 201 to the point on the protrusion farthest from said first surface 205. Height 212 is measured along a first direction 208 perpendicular to first surface 205 of another structure 201. Figure 3 also shows that the protrusion has a surface such as 213 disposed at an angle β 214 relative to a first surface 205 of another structure 201. To determine angle β 214, a first imaginary line 215 is drawn tangent to surface 213 and a second imaginary line is drawn tangent to first surface 205 of another structure 201. The angle enclosed by imaginary lines 214, 215 determines angle β 214. Figure 3 also shows how a diameter 217 of a receptacle of another structure 201 is measured. Diameter 217 is measured parallel to first surface 205. The diameter of the receptacle of the first structure is measured similarly.
[0114] Figure 4 is a schematic diagram showing an isometric view of an assembly according to the present invention, in which a first structure 101 is removably engaged with another structure 201. Figure 4 also shows a container 301 partially contained within the assembly, with another end 303 of the container 301 extending below the assembly.
[0115] Figure 5 is a schematic diagram showing an isometric view of another structure 201 according to the invention, in which it can be seen how a first plurality of protrusions 207 are arranged around the periphery of another plurality of receptacles 202.
[0116] FIG. 6 is an enlarged view of a section of another structure. In FIG. 6, it can be seen that some of the protrusions in the first plurality of protrusions are arranged around the periphery 218 of a receptacle in another plurality of receptacles. It can also be seen that not all of the protrusions, such as protrusions 207A and 207B, have the same shape. Protrusion 207A has a shape that can be described as a combination of a solid triangle and a cube. Protrusion 207B has a shape that can be described as a trapezoidal prism. FIG. 6 also shows how the diameter 219 of the protrusions arranged around the periphery of the receptacle is measured. As can be seen, the diameter 219 is defined as the maximum distance between two points arranged on two different protrusions, and a third imaginary line connecting these two points passes through a fourth imaginary line. The third imaginary line is arranged perpendicular to the fourth imaginary line. The fourth imaginary line is arranged parallel to the length of the receptacle and passes through the center of the receptacle.
[0117] FIG. 7 is an enlarged view of a section of the assembly showing the first structure 101 removably engaged with the second structure 201. As shown in FIG. 7, the second surface 109 of the first structure 101 rests on (is in contact with) the first surface 205 of the second structure 201. It can also be seen that a section of the sidewall 105 of the receptacle of the first structure 101 rests on the first surface 205. Thus, the distance between the receptacle of the first structure 101 and the receptacle of the second structure 201 is 0 mm. FIG. 7 further shows that the sidewall 105 has recesses, such as recess 107. These recesses are adapted and positioned to receive protrusions of a first plurality of protrusions, such as protrusion 207. It can also be seen that there is a gap between the top of the protrusion and the recess. FIG. 7 further shows that the protrusions, such as 207, are partially received within the interior of the receptacle of the first structure. In other words, the protrusions extend into the interior of the receptacle. The sidewall 105 of the receptacle of the first structure also has a ridge 110 that extends into the interior of the receptacle. Also seen in Figure 7 is that ridge 110 is positioned between two protrusions, including protrusion 207. Such an arrangement allows for lateral movement of the first structure relative to another structure to be limited.
[0118] 8 is a flow chart illustrating steps of a method for filling a plurality of containers according to the present invention. In step 801, a first structure of an assembly according to the present invention is provided. The first structure includes a plurality of containers partially received in a first plurality of receptacles. In step 802, another structure of an assembly according to any of the present invention is provided. The another structure has a first plurality of protrusions extending from a first surface of the another structure. In step 803, the first structure and the another structure are removably engaged by allowing the plurality of protrusions to be received in the first structure, thereby at least partially receiving the plurality of containers within the other plurality of receptacles and bringing the first structure and the another structure into contact with each other. In step 804, the plurality of containers are partially filled with a pharmaceutical composition.
[0119] FIG. 9 is a cross-sectional schematic diagram of an assembly showing a first structure removably engaged with another structure. FIG. 9 shows the same features as FIG. 7 . Additionally, FIG. 9 also shows a container 301 housed within the assembly. The container has a first end 302, another end 303, and a barrel 304. It can be seen that the another end 303 has a larger diameter compared to the diameter of the barrel 304. FIG. 9 also shows that the another structure 201 has a core 220 and an outer layer 221 partially surrounding the core 220. The core 220 is made of polyoxymethylene, and the outer layer 221 is made of stainless steel. The protrusions 207 are integrally formed with the outer layer 221. The core 220 is also movable relative to the outer layer 221, as indicated by arrow 222 in FIG. 9 (the core can also be moved in a direction opposite to direction 222). Moving the core 220 allows the diameters of the other receptacles of the another structure 201 to be reduced.
[0120] Figure 10 is a schematic diagram of a cutaway view of an alternative embodiment of the alternative structure. The alternative structure 201 of Figure 10 is similar to the alternative structure 201 of Figure 1. However, the alternative structure 201 of Figure 10 further includes a plurality of additional protrusions, such as protrusion 223, extending from a surface 206 of the alternative structure 201. The plurality of additional protrusions facilitate removal of the container from the alternative structure during disengagement of the first and alternative structures.
[0121] Figures 11A-11D are schematic diagrams illustrating alternative embodiments of an alternative structure and a further alternative structure, both according to the present invention. Note that it is not necessary that the alternative and further alternative structures shown in Figures 11A-11D be used in combination. Figures 11A-11D illustrate preferred embodiments of the present invention.
[0122] 11A shows a schematic side view of another structure 201 and yet another structure 401. The another structure 201 has a first surface 205 and another surface 206, with multiple protrusions 207 extending from the first surface 205. Similarly, the yet another structure 401 has a first surface 405 and another surface 406. The first surface 405 of the yet another structure 401 is adapted and arranged to place the another structure 201 on the first surface 405 (e.g., the first surface 405 is flat). Although not shown, the yet another structure 401 has multiple receptacles for partially accommodating multiple containers. The another structure 201 and yet another structure 401 are adapted and arranged such that when the another structure 201 is placed on the first surface 405 of the yet another structure, the receptacles of the another structure 201 and the receptacles of the yet another structure 401 are at least partially aligned.
[0123] 11B is a side isometric view of the alternative structure 201 shown in FIG. 11A and yet another alternative structure 401. Yet another alternative structure 401 can be seen to have a core 420 and an outer layer 421 that partially surrounds the core 420. The core 420 is made from polyoxymethylene, and the outer layer 421 is made from stainless steel. Furthermore, the first surface 405 is largely formed by the core 420. As described for the core 220 of the alternative structure 201 of FIG. 9, the core 420 of FIG. 11B is movable relative to the outer layer 421.
[0124] Figure 11C is a side isometric view of the alternative structure 201 and the further alternative structure 401 shown in Figure 11A. Here, it can be seen that the protrusions 207 are only partially disposed around the periphery of the receptacle 202 of the alternative structure 201. Figure 11D is a top view of the alternative structure 201 of Figure 11A, again showing that the protrusions 207 are only partially disposed around the periphery of the receptacle 202 of the alternative structure 201.
[0125] Test Method The following test methods were utilized within the context of the present invention: Unless otherwise stated, measurements were made at an ambient temperature of 23° C., an ambient pressure of 100 kPa (0.986 atm) and a relative air humidity of 50%.
[0126] average distance The average distance between the other end of the first plurality of receptacles and the first surface of the other structure is determined as follows.
[0127] The first structure is engaged with another structure. For each receptacle of the first structure, the section of the sidewall closest to the first surface of the other structure is identified. The distance between the section and the first surface is measured along a distance perpendicular to the first surface. For example, FIG. 7 shows that the sidewall of the receptacle has a section that rests on the first surface of the other structure and also has a section with a recess. Therefore, the distance is measured at the location of the section that rests on the first surface of the other structure. The distance is measured using a caliper.
[0128] The above procedure is repeated for each receptacle of the first plurality of receptacles to obtain the distance for each receptacle. An average distance is then calculated from these individual distances. This average distance is defined as the average distance between the other end of the first plurality of receptacles and the first surface of the other structure. Note that the aforementioned distance is not measured between the other end of the first plurality of receptacles and the first plurality of protrusions.
[0129] The average distance between the protrusions and the periphery of the receptacle of the separate structure is determined as follows: Measure the distance between each of the protrusions and the receptacle closest to the respective receptacle (see Figure 3). The distance is measured using a caliper. An average value is then calculated from these individual distances. This average distance defines the average distance between the protrusions and the periphery of the receptacle of the separate structure.
[0130] The average diameter of the protrusions of the first plurality of receptacles when disposed around the circumference of the receptacle is determined as follows: The diameter is measured for each receptacle (i.e., for each set of protrusions disposed around the respective receptacle) as shown in Figure 6 (see also the accompanying figure legend). The diameter is measured using a caliper. The average diameter is then determined from these individual measurements.
[0131] The distance between another surface of the first structure and the first surface of the other structure is defined as the shortest distance between said surfaces, and it is noted that said distance is not measured between the other surface of the first structure and the first plurality of protrusions.
[0132] The average distance between the centers of adjacent receptacles (of the plurality of receptacles) is determined by first measuring the distance between the centers of each pair of adjacent receptacles of the plurality of receptacles, and then determining an average value from these individual measurements.
[0133] Height and average height The height of a structure is defined as the maximum distance between a first surface and another surface of said structure.
[0134] The average height of the protrusions is determined by measuring the individual heights of the protrusions and averaging these measurements. The height of the protrusions is measured using a caliper.
[0135] Receptacle Diameter The diameter of a receptacle is measured between two points on the sidewall of the receptacle that are closest to each other, with the line connecting the two points passing through the center of the receptacle. If the receptacle includes ridges (or other structures) that extend into the interior of the receptacle (see, for example, FIG. 7), the two closest points may be located on the two ridges (or other structures). An example of another structure is a protrusion, such as a rib.
[0136] The average diameter of the plurality of receptacles is determined by measuring the diameter of each receptacle in the plurality of receptacles. The diameter is measured using a caliper. The average diameter is then calculated from the individual diameters.
[0137] angle Angles are measured using a protractor.
[0138] Example The present invention will be further illustrated by the following examples, but the present invention is not limited to these examples.
[0139] Example 1.1 of the present invention A first structure is provided as shown in Figure 1. The first structure has 140 receptacles (first plurality of receptacles) each holding a syringe (container) such that another end of the container protrudes from another end of the receptacle (see Figure 1). The height of the first structure is 19 mm. The other end of the receptacle has a diameter larger than the diameter of the barrel.
[0140] The first structure (having a syringe) is placed in a filling station having a filling needle for partially filling the syringe with a pharmaceutical composition, the filling needle being positioned above a first end of the syringe (see Figures 1 and 2).
[0141] Next, another structure is provided as shown in Figures 1 to 6. The another structure also has 140 receptacles (another plurality of receptacles). The height of the another structure is 10 mm. Furthermore, the another structure has a plurality of protrusions extending from a first surface of the another structure (e.g., Figures 5 and 6). Each protrusion includes at least one surface that forms an angle β=50° with the first surface of the another structure. The average height of the protrusions is 2 mm.
[0142] The first structure and the other structure are then removably engaged (e.g., as in FIGS. 2, 5, and 7). As a result, the syringe is partially housed in the receptacles of the first structure and the other structure. Due to the presence of the protrusions, the syringe is guided toward the center of the interiors of the first and other receptacles during engagement between the first and other structures (the protrusions exert a lateral force on the syringe). The protrusions also help position the first and other structures relative to each other while simultaneously restricting lateral movement of the first structure relative to the other structure.
[0143] The syringe is filled with the pharmaceutical composition when the first structure and the second structure are releasably engaged, and then the first structure and the second structure are disengaged, and the first structure with the partially filled syringe is transported from the filling station.
[0144] Example 1.2 of the present invention Example 1.2 of the present invention is the same as Example 1.1, with the following differences: In addition to the protrusions extending from the first surface of the separate structure, the separate structure also has protrusions extending from another surface of the separate structure (see FIG. 10). These protrusions extending from the other surface also include at least one surface that forms an angle β=50° with another surface of the separate structure. The average height of these additional protrusions is also 2 mm. Furthermore, like the protrusions extending from the first surface, the protrusions extending from the other surface are arranged around the periphery of the separate plurality of receptacles.
[0145] Comparative Example 1.3 and Comparative Example 1.4 The examples are performed as described for Example 1.1, with the following differences: In Example 1.3, the alternative structure does not have a protrusion; In Example 1.4, the alternative structure is not provided or used during syringe filling.
[0146] Table 1 below shows a comparison of the technical effects between Examples 1.1 to 1.4. [Table 1]
[0147] The technical effects of Table 1 are as follows: Syringe Insertion: How easily can a syringe be inserted into another receptacle (of another structure) during engagement of the first structure with the other structure? A "+" indicates easier syringe insertion, and a "-" indicates more difficult syringe insertion. Increasing ease of insertion is desirable. Syringe Tilt Reduction: How well the syringe stays upright within the assembly when inserted into another structure. "+" indicates less tilt and "-" indicates more tilt. Reduced tilt is desirable. Assembly Stability: The structural stability of the assembly, i.e., how well the assembly can withstand deforming forces. "+" indicates greater stability, "-" indicates less stability. Higher stability is desirable. Fill Speed: The rate at which the syringe can be filled. "+" indicates a faster fill speed and "-" indicates a slower fill speed. A faster fill speed is desirable. Reducing composition loss during filling: During filling of a syringe with a pharmaceutical composition, a portion of the composition is lost due to imprecise positioning of the syringe within the assembly. A "+" indicates less composition is lost, and a "-" indicates more composition is lost. Reducing composition loss is desirable. Filling needle positioning tolerance: How precisely must the filling needle be positioned to minimize composition loss when filling the syringe? A "+" indicates a larger tolerance is possible without increasing composition loss. A "-" indicates a smaller tolerance. A larger tolerance is desirable. Reducing impurities in the composition: When a pharmaceutical composition is filled into a syringe, impurities can be introduced into the internal volume of the syringe. A "+" indicates less introduced impurities and a "-" indicates more introduced impurities. Reducing introduced impurities is desirable. Syringe Removal After Filling: How easily the syringe can be removed from another structure after filling (when the first structure and the other structure are disengaged). The syringe is easier to remove, for example, when less force is required. A "+" indicates the syringe is easier to remove, and a "-" indicates the syringe is more difficult to remove. Increasing ease of removal is desirable. Reduced composition loss upon syringe removal after filling: the amount of composition lost when a first structure disengages from another structure. A "+" indicates reduced composition loss, and a "-" indicates more composition loss. Reducing composition loss is desirable.
[0148] Example 2 of the present invention Example 1.1 is repeated using different protrusions. In particular, the angle α that at least one surface of each protrusion makes with a first surface of another structure is varied as shown in Table 2 below. In Example 2.4, the angle 90° should be understood to mean that the protrusions in this particular example have a cubic shape. [Table 2]
[0149] The technical effects of Table 2 are the same as those described in Table 1. In addition, Table 2 has the following technical effects: Reduced Damage During Engagement: Engagement of a first structure with another structure can cause damage to a container contained therein. A "+" indicates less damage occurring and a "-" indicates more damage occurring. It is desirable to reduce the damage that can occur. Usability for syringes with varying diameters: whether the assembly can be used with syringes with varying diameters (e.g., syringes with caps that have a diameter larger than the diameter of the syringe barrel). A "+" indicates that the assembly allows for use with syringes with a large variation in diameter. A "-" indicates that the assembly can only be used with syringes with little or no variation in diameter. It is desirable that the assembly be usable with syringes with a larger variation in diameter. [Explanation of symbols]
[0150] 100 Assembly 101 First Structure 102 receptacle of the first plurality of receptacles 103 a first end of a receptacle of the first plurality of receptacles 104 another end of the first plurality of receptacles 105 sidewall of a receptacle of the first plurality of receptacles 106 inside a receptacle of the first plurality of receptacles 107 Recess in sidewall of receptacle of first plurality of receptacles 108 First surface of first structure 109 Another surface of the first structure 110 Ridge 201 Alternative Structure 202 Receptacle of a plurality of other receptacles 203 Side walls of a receptacle among a plurality of other receptacles 204 Inside a receptacle of another plurality of receptacles 205 First surface of another structure 206 Different Surfaces of Different Structures 207 protrusions of the first plurality of protrusions 208 First Direction 209 Another Direction 210 Angle α between a first direction and another direction 211 Distance between protrusion and receptacle 212 Height of protrusion 213 A surface arranged at an angle to a first surface of another structure 214 Inclination angle β 215 First Virtual Line 216 Second Virtual Line 217 Diameter of receptacle of different construction 218 The outer periphery of a receptacle among a plurality of other receptacles 219 Diameter of protrusions located around the periphery of the receptacle 220 Cores with Alternative Structures 221 Outer layer of another structure 222 Directions in which the core can move 223 A protrusion among several other protrusions 301 Container 302 first end of container 303 Another end of the container 304 barrels 401 Yet another structure 405 First surface of yet another structure 406 Another surface of yet another structure 420 Yet another structural core 421 Yet another outer layer of structure
Claims
1. An assembly including a first structure and another structure, a. the first structure comprises: i. adapted and arranged to at least partially contain a plurality of containers; ii. having a first end and another end opposite the first end; a first plurality of receptacles; b. The alternative structure is i. a second plurality of receptacles adapted and arranged to at least partially receive said plurality of containers; ii. a first surface and another surface opposite the first surface; iii. A. either a first plurality of protrusions extending from the first surface, or a second plurality of protrusions extending from the second surface, or both; B. the first plurality of protrusions, the second plurality of protrusions, or both, are adapted and arranged to exert a force on the container along a first direction when the container is inserted into and / or removed from the second structure along another direction; I. the first direction is perpendicular to the first surface of the other structure; II. The angle α between the first direction and the other direction is such that α>0°; c. the first structure and the other structure are: i. the average distance between the other end of the first plurality of receptacles and the first surface of the other structure is less than 5 cm; ii. the first plurality of receptacles are at least partially aligned with the other plurality of receptacles; 2. The assembly, adapted and arranged to be positioned such that:
2. The assembly of claim 1 , wherein the first structure and the further structure are adapted and arranged to releasably engage.
3. 3. The assembly according to claim 1, wherein the angle α is between 20° and 170°.
4. The assembly includes the first plurality of protrusions extending from the first surface of the first structure, and the first structure and the another structure are: a. the protrusion is adapted and positioned to be at least partially received in the first structure; b. when the protrusion is at least partially received in the first structure; i. the first plurality of receptacles are at least partially aligned with the other plurality of receptacles; ii. Preferably, the other ends of the first plurality of receptacles contact the first surface of the other structure; 4. An assembly according to any one of claims 1 to 3.
5. The assembly of claim 4 , wherein the other surface includes a plurality of recesses adapted and arranged to at least partially receive the first plurality of protrusions.
6. The assembly of claim 5 , wherein the recess is formed in a sidewall of the receptacle of the first plurality of receptacles.
7. 7. The assembly of claim 4, wherein the assembly is adapted and arranged such that the first plurality of protrusions are at least partially received in the first plurality of receptacles.
8. 8. The assembly of claim 4, wherein the first plurality of protrusions are adapted and arranged to constrain movement of the first structure in at least one dimension.
9. The assembly of any one of claims 1 to 8, wherein each receptacle of the other plurality of receptacles has between 2 and 12 protrusions disposed around the periphery of the respective receptacle.
10. 10. The assembly of claim 1, wherein the first plurality of protrusions, or the further plurality of protrusions, or both, include a surface disposed at an angle β relative to the first surface of the further structure, the angle β being less than 90°.
11. 11. The assembly of claim 1, further comprising a plurality of containers containing less than 0.1 ml of the composition.
12. 11. The assembly of any one of claims 1 to 10, further comprising a plurality of containers at least 20% filled with the composition.
13. a) providing a first structure of the assembly of any one of claims 1 to 11, wherein a plurality of containers are at least partially received in a first plurality of receptacles; b) Providing another construction of the assembly of any one of claims 1 to 11; c. engaging said first structure with said another structure, resulting in: i. the plurality of containers are at least partially received in another plurality of receptacles; ii. the average distance between the other end of the first plurality of receptacles and the first surface of the other structure is less than 5 cm; Steps and d. at least partially filling said container; 10. A method for at least partially filling a plurality of containers, comprising:
14. A plurality of containers at least partially filled with a composition obtainable according to the method of claim 13.
15. Use of an assembly including a first structure and another structure removably engaged for at least partially filling a plurality of containers at least partially received in the first structure and another structure.