Abstract
A holding structure for concurrently holding a plurality of primary packaging containers for substances for pharmaceutical, medical or cosmetic applications, the holding structure including a plurality of receptacles for accommodating at least a section of the elongated cylindrical body region of the primary packaging container, each receptacle having a depth, an upper end for inserting the primary packaging container into the receptacle, a bottom end having a holding portion configured to limit an axial movement of the primary packaging container in the receptacle, a circumferentially formed side wall extending in a longitudinal direction from the upper end to the bottom end and a longitudinal axis, alignment elements in each receptacle projecting radially into the receptacle to contact the outer surface of the primary packaging container; wherein the alignment elements arranged so that a primary packaging container accommodated in the receptacle in a resting position is tilted by an angle of not more than 2.4 degrees.
Claims
1. A holding structure for concurrently holding a plurality of primary packaging containers for substances for pharmaceutical, medical or cosmetic applications, each primary packaging container including an elongated cylindrical body region having a container longitudinal axis running in a container longitudinal direction through a center of the elongated cylindrical body region, the holding structure comprising: a plurality of receptacles for accommodating at least a section of the elongated cylindrical body region of the primary packaging container, each receptacle having a depth, an upper end for inserting the primary packaging container into the receptacle, a bottom end having a holding portion configured to limit an axial movement of the primary packaging container in the receptacle, a circumferentially formed side wall extending in a longitudinal direction from the upper end to the bottom end and a longitudinal axis running in the longitudinal direction through a center of the receptacle; alignment elements in each receptacle projecting radially into the receptacle and adapted and arranged to contact a part of the outer surface of the elongated cylindrical body region of a primary packaging container accommodated in the receptacle; wherein the alignment elements in each receptacle are adapted and arranged to contact a part of the outer surface of the elongated cylindrical body region in such a way that a primary packaging container accommodated in the receptacle in a resting position is tilted by an angle of not more than 2.4 degrees, the angle being formed between the longitudinal axis and the container longitudinal axis and the resting position being a position where the holding portion limits the axial movement of the primary packaging container accommodated in the in the receptacle.
2. The holding structure as recited in claim 1 wherein the alignment elements in each receptacle are adapted and arranged to contact a part of the outer surface of the elongated cylindrical body region in such a way that a primary packaging container accommodated in the receptacle in a lifting position is still tilted by a lifted tilting angle of not more than 2.4 degrees, the lifted tilting angle being formed between the longitudinal axis and the container longitudinal axis of the primary packaging container accommodated in the receptacle and the lifting position being where the primary packaging container is lifted out of the resting position in a direction away from the bottom end to a lifting height 10 to 50% of the depth of the receptacle.
3. The holding structure as recited in claim 1 wherein the holding structure is formed by injection molding from a plastic material and wherein the side walls of the receptacles are inclined at a draft angle in relation to the longitudinal axis so that an inner diameter of the receptacle constantly increases from the bottom end to the upper end.
4. The holding structure as recited in claim 1 wherein the holding structure is formed by injection molding from a plastic material, wherein the holding structure is designed in such a manner that a two-part original mold with a lower mold and an upper mold is used for production by injection molding from the plastic material such that the side walls of the receptacles are not inclined at a draft angle in relation to the longitudinal axis so that an inner diameter of the receptacle at the bottom end corresponds to the inner diameter at the upper end.
5. The holding structure as recited in claim 1 wherein the receptacles are arranged in a regular arrangement, an upper side of the holding structure is formed as a plate-shaped carrier element, and the receptacles project vertically from the plate-shaped carrier element; wherein the side wall is formed as a common partition between each two directly adjacent receptacles of the plurality of receptacles.
6. The holding structure as recited in claim 1 wherein in each receptacle the alignment elements include a plurality of longitudinal alignment elements running in a longitudinal direction from the upper end to the bottom end of the receptacle and extending over at least 50% of an entirety of the depth of the receptable.
7. The holding structure as recited in claim 1 wherein in each receptacle there are one more positions where at least two alignment elements are provided with a concave recess, a curvature of the concave recess corresponding to an outer diameter of the primary packaging container to be accommodated in the receptacle.
8. The holding structure as recited in claim 1 wherein in each receptacle there are one more positions where at least two alignment elements are provided, wherein the alignment elements are adapted and arranged to punctually contact the outer surface of the primary packaging container on at least the part of the elongated cylindrical body region accommodated in the receptacle.
9. The holding structure as recited in claim 1 wherein the alignment elements are located at a top of the side walls.
10. The holding structure as recited in claim 1 further comprising guide portions adapted and arranged to guide the primary packaging containers as they are inserted into the receptacles, the guide portions being formed as guiding ribs extending in the longitudinal direction; wherein the alignment elements are located at a top of the guide portions.
11. An arrangement comprising: the holding structure as recited in claim 1; a plurality of primary packaging containers, each of the primary packaging containers being accommodated in one of the receptacles of the holding structure.
12. A transport unit comprising: the arrangement as recited in claim 11; and a secondary packaging container, wherein the holding structure and the plurality of primary packaging containers are arranged completely in the secondary packaging container.
13. A process for filling primary packaging containers with a pharmaceutical, medical, or cosmetic composition, the process comprising the steps: A) providing the arrangement as recited in claim 11; B) filling each a primary packaging containers accommodated in the receptacles of the holding structure with the composition in liquid form in an automated filling machine.
14. The process as recited in claim 13 wherein in the automated filling machine a needle is positioned above the opening of the primary packaging container, followed by an injection of the pharmaceutical, medical, or cosmetic composition through the needle into the container, wherein the primary packaging container is filled with the pharmaceutical, medical, or cosmetic composition following the positioning of the needle above the corresponding primary packaging container.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0102] FIG. 1A is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the present invention in the resting position;
[0103] FIG. 1B shows a primary packaging container 200 that can be accommodated in the receptacles 101 of the holding structure 100 according to the present invention;
[0104] FIG. 2 is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the present invention in the lifting position;
[0105] FIG. 3 is a top view of a holding structure 100 according to the present invention in which the alignment elements 106 are attached to the side walls 104 of the receptacles 101;
[0106] FIG. 4 is a further top view of a holding structure 100 according to the present invention in which the alignment elements 106 are located on the top of the guide portions 109;
[0107] FIG. 5 is a cross-sectional view of a receptacle 101 in which the side walls 104 of the receptacles 101 are inclined at a draft angle ;
[0108] FIG. 6 is a cross-sectional view of a receptacle 101 in which the alignment elements 106 are adapted and arranged to contact a part of the outer surface of the primary packaging containers 200 over at least a certain part of the length of the section 201 of the primary packaging container 200 that is accommodated in the receptacle 101;
[0109] FIG. 7 is the top view of the receptacle 101 shown in FIG. 6;
[0110] FIG. 8A is a cross-sectional view of a receptacle 101 in which the alignment elements 106 are provided with a concave recess 108 the curvature of which corresponds to the outer diameter of the primary packaging container 200 to be accommodated in the receptacle 101;
[0111] FIG. 8B is a top view of the alignment elements 106 in the receptacle shown in FIG. 8A;
[0112] FIG. 9 is a cross-sectional view of a receptacle 101 in which the alignment elements 106 are adapted and arranged to punctually contact the outer surface of the primary packaging container 200 accommodated in the receptacle 101 at position P.sub.x;
[0113] FIG. 10 is a side view of a receptacle 101 in a holding structure 100 according to the present invention that is designed in such a manner that a two-part original mold with a lower mold 110 and an upper mold 111 is used for production of the holding structure 101;
[0114] FIG. 11A light microscope image of a part of the outer surface of the container wall from the Comparative Example;
[0115] FIG. 11B light microscope image of a part of the outer surface of the container wall from the Example.
DETAILED DESCRIPTION
[0116] FIG. 1A is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the present invention in the resting position. The receptacle 101 serves to receive the primary packaging containers 200 therein at least in sections 201. Each receptacle 101 has a depth h, an upper end 102 for inserting the primary packaging container 200 into the receptacle 101, a bottom end 103 having a holding portion 104 configured to limit an axial movement of the primary packaging container 200 in the receptacle 101, a circumferentially formed side wall 105 extending in a longitudinal direction from the upper end 102 to the bottom end 103 and a longitudinal axis L.sub.receptable that runs in a longitudinal direction through the center of the receptacle 101. In FIG. 1A the section 201 of the elongated cylindrical body region 201 of the primary packaging container 200 that in the resting position is accommodated in the receptacle is marked by a dashed parallelogram. As shown in FIG. 1A, the holding structure according to the present invention each receptacle 101 comprises alignment elements 106 (in FIG. 1A shown in the form of grey circles) that project radially into the receptacle 101 and that are adapted and arranged to contact a part of the outer surface of the elongated cylindrical body region 201 of a primary packaging container 200 accommodated in the receptacle 101. The alignment elements 106 in each receptacle 101 are adapted and arranged to contact a part of the outer surface of the elongated cylindrical body region 201 in such a way that a primary packaging container 200 accommodated in the receptacle 101 in the resting position is tilted by an angle of not more than 2.4 degrees, wherein the tilting angle is the angle that is formed between longitudinal axis L.sub.receptacle and longitudinal axis L.sub.container of the primary packaging container 200 accommodated in the receptacle 101. The resting position is the position in which the holding portion 104 limits the axial movement of the primary packaging container 200 accommodated in the in the receptacle 101. The resting position is thus the position in which the primary packaging container 200 is accommodated up to the maximum depth in the receptacle 101. As can be seen, in the receptacle 101 shown in FIG. 1A in the resting position the holding portions come into contact with a shoulder 208 of the primary packaging container 200 (see shoulder 208 in FIG. 1B).
[0117] FIG. 1B shows a primary packaging container 200 in the form of a vial that can be accommodated in the receptacles 101 of the holding structure 100 according to the present invention. The primary packaging container 200 may comprise a container wall which partially surrounds a container interior. The container wall forms, in the following sequence from top to bottom, a first end part 202, comprising a discharge orifice 203, an elongated cylindrical body region 201, and a further end part 204. The elongated cylindrical body region 201 is a preferably hollow cylinder. The further end part 204 comprises a standing base 205. Besides the discharge orifice 203, the first end part 202 consists of a flange 206 and a neck 207. The elongated cylindrical body region 201 follows the first end part 202 via the shoulder 208. The further end part 204 follows the elongated cylindrical body region 201 via a heel 209. The container wall is made from type I borosilicate glass. FIG. 1A also solely schematically shows an automated filling machine FM with a needle N for filling the containers 200.
[0118] FIG. 2 is a cross-sectional view of a primary packaging container 200 accommodated in a receptacle 101 of a holding structure 100 according to the present invention in the lifting position. The lifting position is the position in which the primary packaging container 200 is lifted out of the resting position in a direction away from the bottom end 103 to a lifting height a, wherein a is 10 to 50%, preferably 15 to 45% and more preferably 20 to 40% of the depth h of the receptacle. Such a lifting of primary packaging containers in a holding structure occurs, for example, if in an automated filling process optical sensors are used to confirm the correctness of the filling height. As can be seen in FIG. 2, the alignment elements 106 preferably also ensure that even in the lifting position the tilting angle does not exceed a certain maximum value.
[0119] FIG. 3 is a top view of a holding structure 100 according to the present invention in which the alignment elements 106 are attached to the side walls 104 of the receptacles 101. As can be seen, the receptacles 101 are arranged in a regular arrangement. An upper side of the holding structure 100 is formed as a plate-shaped support 107 and the receptacles 101 project vertically from the plate-shaped support 107. The side wall 104 of each receptacle 101 is formed as a common partition between each two directly adjacent receptacles 101 of the plurality of receptacles 101. As can also be seen in FIG. 3, holding protrusions 105 acting as holding portions 105 are provided at the bottom ends 103 of the receptacles 101, which extend radially inwards into the receptacles 101. Each receptacle 101 may, for example, have two holding protrusions 105 which are diametrically opposite to each other. In the holding structure 100 shown in FIG. 3 the alignment elements 106 are provided as point-engaging contact elements 106 in the upper area of the receptacle 101. Also shown in FIG. 3 solely schematically in cross section is a secondary container 302 with a lid 303. Holding structure 100 forms with the primary packaging containers an arrangement 301 which fits in the secondary container 302 to define a transport unit 300.
[0120] FIG. 4 is a further top view of a holding structure 100 according to the present invention in which the alignment elements 106 are provided as point-engaging contact elements 106 that are located on the top of the guide portions 109 in the receptacles 101. The guide portions 109 are adapted and arranged to guide the primary packaging containers 200 as they are inserted into the receptacles 101. In the holding structure 100 shown in FIG. 4 the guide portions 109 are formed as guiding ribs 109 extending in a longitudinal direction of the receptacles 101.
[0121] FIG. 5 is a cross-sectional view of a receptacle 101 in which the side walls 104 of the receptacles 101 are inclined at a draft angle so that the inner diameter d of the receptacle 101 constantly increases from the bottom end 103 to the upper end 102. In this context the draft angle is preferably in the range from 0.01 to 1 degree, more preferably in the range from 0.025 to 0.75 degrees, even more preferably in the range from 0.05 to 0.5 degrees and most preferably in the range 0.075 to 0.3 degrees.
[0122] FIG. 6 is a cross-sectional view of a receptacle 101 in which the alignment elements 106 are adapted and arranged to contact a part of the outer surface of the primary packaging containers 200 over at least a certain part of the length of the elongated cylindrical body region 201 that is accommodated in the receptacle 101. In the embodiment shown in FIG. 6, these longitudinal alignment elements 106 are located on the top of the guiding ribs 109 and extend over almost the entire length of these guiding ribs 106.
[0123] FIG. 7 is the top view of a part of a holding structure 100 according to the present invention as shown in FIG. 6 in which alignment elements 106 that contact the outer surface of the primary packaging containers 200 accommodated in the receptacle 101 are located on top of the surface of guiding ribs 109 like the arrangement in FIG. 6. In the receptacle 101 shown in FIGS. 6 and 7, the inner diameter of the receptacle 101 as defined by the dimensions of the alignment elements 106 as determined in a position P.sub.2 in a height of 13 mm above the bottom end 103 of the receptacle 101 is 15.95 mm, whereas the inner diameter of the receptacle 101 as defined by the dimensions of the alignment elements 106 determined at a position P.sub.1 in a distance of 33.25 mm from position P.sub.2 is 16.11 mm.
[0124] FIG. 8A is a cross-sectional view of a receptacle 101 in which the alignment elements 106 are provided with a concave recess 108 the curvature of which corresponds to the outer diameter of the primary packaging container 200 to be accommodated in the receptacle 101. In the embodiment shown in FIG. 8A, the receptacle 101 comprises such alignment elements only in the upper area close to the upper end 102 of the receptacle, whereinas shown in FIG. 8 Btwo such alignment elements 106 may be arranged opposite each other in such a way that their concave recesses 108 together form a circular recess in which the elongated cylindrical body region 201 of the primary packaging container 200 is enclosed.
[0125] FIG. 9 is a cross-sectional view of a receptacle 101 in which the alignment elements 106 are adapted and arranged to punctually contact the outer surface of the primary packaging container 200 accommodated in the receptacle 101 at position P.sub.x. In the embodiment shown in FIG. 8, these point-engaging contact elements 106 may be localized in three different heights within a given receptacle, indicated as positions P.sub.1 near the upper end 102 of the receptacle 101, P.sub.2 near the bottom end 103 of the receptacle 101 and P.sub.3 located between P.sub.1 and P.sub.2. The alignment elements at position P.sub.1 are preferably located along a first circle located in a first plane and the alignment elements at position P.sub.2 are located along a second circle located in a second plane, the first and the second plane being parallel to each other and being perpendicular to longitudinal axis L.sub.receptable, wherein the diameter .sub.1 of the first circle at position P.sub.1 is larger than the diameter .sub.2 of the second circle at position P.sub.2. In case of a receptacle 101 in which the alignment elements 106 are located at three different positions P.sub.1, P.sub.2 and P.sub.3 as shown in FIG. 8, the alignment elements 101 at position P.sub.3 are preferably also located along a third circle having a diameter .sub.3, wherein .sub.1>.sub.3>.sub.2.
[0126] FIG. 10 is a side view of a receptacle 101 in a holding structure 100 according to the present invention that is designed in such a manner that a two-part original mold with a lower mold 110 and an upper mold 111 is used for production of the holding structure 101, wherein the alignment elements 106 are located in part of the receptacle formed by the upper mold 111. Using such a two-component mold allows the provision of receptacles 101 the side walls of which are not inclined at all so that the inner diameter d.sub.bottom of the receptacle at the bottom end corresponds to the inner diameter d.sub.top at the upper end. Such a receptacle allows the accommodation of primary packaging containers with a particularly low tilting angle even if the containers are lifted in a lifting height a.
Test Methods
[0127] For the determination of the abrasion of the outer surface of the primary packaging containers in the form of a cartridge inserted into the receptacle of a holding structure the cartridge was first tempered for 24 hours at 250 C. in an oven. After the cartridges had cooled down to around 24 C., they were manually inserted into a nest with receptacles comprising guiding ribs and removed by actively rubbing the cartridges along these guiding ribs. The outer surface of the cartridges was then visually inspected using light microscopy.
EXAMPLE
[0128] In a holding structure as shown in FIG. 6 comprising receptacles with a draft angle of 0.2 degrees the guiding ribs were modified by attaching thereto within each receptacle alignment elements such that the inner diameter defined by these alignment elements is 15.95 mm at a position P.sub.2 13 mm above the bottom end of the receptacle and 16.11 mm at a position P.sub.1. The vertical distance between heights P.sub.1 and P.sub.2 is 33.25 mm and the tilting angle is 1.16 degrees.
COMPARATIVE EXAMPLE
[0129] The same holding structure was used as in the Example, with the sole difference that the guiding ribs were not modified with any alignment elements.
[0130] As can be seen in FIGS. 11A and 11B, the alignment elements help to significantly reduce the abrasion of the outer surface of the cartridges when they are moved inside the receptacles.
LIST OF REFERENCE NUMBERS
[0131] 100 holding structure [0132] 101 receptacle [0133] 102 upper end of receptacle 101 [0134] 103 bottom end of receptacle 101 [0135] 104 side wall of receptacle 101 [0136] 105 holding portion of receptacle 101 [0137] 106 alignment elements [0138] 107 plate-shaped carrier element [0139] 108 concave recess [0140] 109 guide portions [0141] 110 lower mold [0142] 111 upper mold [0143] 200 primary packaging container [0144] 201 elongated cylindrical body region of the primary packaging container 200 [0145] 201 section of the elongated cylindrical body region 201 of the primary packaging container 200 that is accommodated in the receptacle 101 [0146] 202 first end part of the primary packaging container 200 [0147] 203 discharge orifice [0148] 204 further end part of the primary packaging container 200 [0149] 205 standing base [0150] 206 flange [0151] 207 neck [0152] 208 shoulder [0153] 300 transport unit according to the invention [0154] 301 arrangement according to the invention [0155] 302 secondary packaging container [0156] 303 lid
