Method and Apparatus for Producing Primary Packaging Having an Integrated Septum and Primary Packaging Having an Integrated Septum
20190060167 ยท 2019-02-28
Inventors
Cpc classification
A61J1/1481
HUMAN NECESSITIES
B29C2045/14278
PERFORMING OPERATIONS; TRANSPORTING
B29C45/14336
PERFORMING OPERATIONS; TRANSPORTING
B29C45/14778
PERFORMING OPERATIONS; TRANSPORTING
B29C45/14065
PERFORMING OPERATIONS; TRANSPORTING
B29K2621/00
PERFORMING OPERATIONS; TRANSPORTING
B29C45/37
PERFORMING OPERATIONS; TRANSPORTING
B29C45/261
PERFORMING OPERATIONS; TRANSPORTING
B29C45/14262
PERFORMING OPERATIONS; TRANSPORTING
B29L2031/712
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
The invention relates to a method for producing primary packaging having an integrated septum characterised by: a) providing a septum, b) providing an injection-molding die having two die halves, c) positioning the septum in the injection-molding die, d) moving the two die halves of the injection-molding die to form a cavity corresponding to the shape of the primary packaging to be produced, e) injecting a material into the cavity via an injection opening, where the two die halves of the injection-molding die pretensioningly holding the septum, and a rim of the septum is overmolded by the material, f) cooling the injected material while maintaining a holding pressure, g) moving the two die halves of the injection-molding die such that the produced primary packaging means having the integrated septum can be removed from the injection-molding die, and h) removing the produced primary packaging having the integrated septum from the injection-molding die.
Claims
1. A method for producing primary packaging having an integrated septum comprising the steps of: a) providing a septum, b) providing an injection-molding die having two die halves able to be moved relative to one another, c) positioning the septum in the injection-molding die, d) moving the two die halves of the injection-molding die such that a cavity is formed that corresponds to the shape of the primary packaging to be produced, e) injecting a material into the cavity in the injection-molding die via an injection opening in one of the die halves of the injection-molding die, the two die halves of the injection-molding die pretensioningly holding the septum therebetween, and a rim of the septum being overmolded by the material, a region of the septum in contact with the two die halves remaining free of material, f) cooling the injected material while maintaining a holding pressure, as a result of which the primary packaging is formed having an integrated septum, g) moving the two die halves of the injection-molding die such that the produced primary packaging having the integrated septum is removable from the injection-molding die, and h) removing the produced primary packaging having the integrated septum from the injection-molding die.
2. The method according to claim 1, wherein a plastics material is used as the material.
3. The method according to claim 1, wherein the septum is made of an elastomer.
4. The method according to claim 1, wherein before the material is injected, the septum is positioned in a holder of a die half designed as a male mold.
5. The method according to claim 1, wherein before the material is injected, the septum is positioned in a holder of a die half designed as a female mold.
6. The method according to claim 1, wherein a peripheral rim of the septum is overmolded when the material is injected.
7. An apparatus for producing primary packaging comprising an integrated septum according to the method of claim 1, wherein an injection-molding die is provided with two die halves able to be moved relative to one another, one of the die halves being designed as a male mold and the other die half being designed as a female mold, and a holder for the septum being provided on one of the die halves and a stamp being provided on the other die half for pressing the septum against the holder when the material is injected via an injection opening into a cavity.
8. The apparatus according to claim 7, wherein a peripheral channel is provided in the die half designed as a female mold, next to the stamp.
9. The apparatus according to claim 7, wherein the die half designed as a female mold comprises a base and two legs that are positioned substantially perpendicularly thereon, the inner contour of the two legs corresponding to the outer contour of the primary packaging to be produced, and it being possible to move the legs outwardly away.
10. The apparatus according to claim 9, wherein the legs that are positioned substantially perpendicularly on the base are held so as to be movable radially outwardly relative to the base.
11. The apparatus according to claim 7, wherein the outer contour of the die half designed as a male mold corresponds to the inner contour of the primary packaging to be produced.
12. A primary packaging having an integrated septum produced according to the method of claim 1, wherein said primary packaging consists of a plastics material, in which the septum is accommodated in a removal region, the septum separating a pharmaceutical receiving chamber of the primary packaging from the outside thereof.
13. The primary packaging according to claim 12, wherein the removal region comprises a shoulder that faces the receiving chamber.
14. The primary packaging according to claim 12, wherein the primary packaging is provided with a peripheral slope at the end of the pharmaceutical receiving chamber facing the removal region.
15. The primary packaging according to claim 12, wherein the septum comprises a base and a peripheral wall region that is positioned substantially perpendicularly thereon.
16. The primary packaging according to claim 15, wherein the peripheral wall region of the septum comprises an inward-facing slope at the free end of said wall region.
17. The primary packaging according to claim 15, wherein the peripheral wall region of the septum comprises an outward-facing slope at the free end of said wall region.
18. The primary packaging according to claim 12, wherein the septum is provided with spacers on the base thereof.
19. The primary packaging according to claim 12, wherein the septum is provided with a peripheral projection on the base thereof.
20. The primary packaging according to claim 12, wherein an opening is provided at the end opposite the septum.
21. The primary packaging according to claim 12, wherein a flange is provided on the opening arranged opposite the septum.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0047] In the drawings:
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DETAILED DESCRIPTION OF THE INVENTION
[0055]
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[0057] The other die half 5 designed as a female mold 10 consists of a base 5a and legs 5b and 5c that are arranged thereon substantially perpendicular to the base 5a. The legs 5b and 5c can be moved radially outwardly relative to the base 5a. Facing inwards and towards the other die half 4 designed as a male mold 9, a stamp 12 is provided on the base 5a, which stamp is surrounded by a peripheral channel 13. The legs 5a and 5b comprise, at the ends thereof facing the base 5a, an undercut 23 which extends entirely around the inner region of the two legs 5b and 5c. Said undercut 23 makes it possible to produce primary packaging of which the outer contour corresponds to that of the conventional glass cartridges, and therefore the consumer does not have to get used to a different design. This undercut 23 makes it necessary, however, for said legs 5b and 5c to be movable radially outwardly relative to the base 6a so that the primary packaging 1 produced by the apparatus according to the invention can be removed from the injection-molding die 3.
[0058] In
[0059]
[0060] As shown in
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[0063] At the same time, the base 2a of the septum 2 is also overmolded on the region thereof facing away from the receiving chamber 16 such that the septum 2 is also securely held in the primary packaging 1 in this way, too. Furthermore, the primary packaging 1 tapers in the removal region 20 thereof and is therefore provided with a slope 15. The receiving region 20 also comprises a peripheral shoulder 14. As a result of this embodiment having the slopes 15 and the shoulder 14, the primary packaging 1 has a shape that is substantially identical to that of conventional glass cartridges, and a greater market acceptance by pharmaceutical customers is therefore ensured. Furthermore, on account of the same internal shape of the primary packaging 1, the flow behaviour for the liquid or the pharmaceutical within the receiving chamber 16 is substantially identical to the flow behaviour in the conventional glass cartridges.
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[0065]
[0066] The other die half 105 designed as a female mold 110 consists of a base 105a and legs 105b and 105c that are arranged thereon substantially perpendicular to the base 105a. The legs 105b and 105c are stationary in relation to the base 5a. Facing inwards and towards the other die half 104 designed as a male mold 109, a stamp 112 is provided on the base 105a, which stamp is surrounded by a peripheral channel 113.
[0067] In
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[0069] As is shown in
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[0072]
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[0074] The other die half 205 designed as a female mold 210 consists of a base 205a and legs 205b and 205c that are arranged thereon substantially perpendicular to the base 205a. The legs 5b and 5c can be moved radially outwardly relative to the base 5a. Facing inwards and towards the other die half 204 designed as a male mold 209, a stamp 212 is provided on the base 205a, which stamp is surrounded by a peripheral channel 213. The legs 205a and 205b comprise, on the outer periphery thereof, a thread 224 which matches pen injection needles that are common on the market such that it is possible to directly mount cannula/injection needles of this kind in keeping with the conventional glass cartridges.
[0075] In
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[0077] As shown in
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[0080] On its base 202a, the septum 202 comprises a peripheral projection 222, which is back-molded by the material when the primary packaging 201 is produced. As a result of this back-molded portion, improved hold of the septum 202 in the primary packaging 201 is achieved. In addition, this also allows any potential pretension in the septum 202 to be better maintained.
[0081] For illustrative purposes, this is shown again in
[0082] As can be clearly seen in
[0083] In the view in
[0084]
[0085] As can be clearly seen here, the base 202a of the septum 202 is again slightly curved such that said base maintains a certain pretension that consistently seals the septum in a reliably sterile manner. Furthermore, it can also be seen in this view that the peripheral projection 222 on the septum 202 has been overmolded with the material and the septum is thus securely accommodated within the primary packaging 201.
[0086] Having now fully described the present invention in some detail by way of illustration and examples for purposes of clarity of understanding, it will be obvious to one of ordinary skill in the art that the same can be performed by modifying or changing the invention within a wide and equivalent range of conditions, formulations and other parameters without affecting the scope of the invention or any specific embodiment thereof, and that such modifications or changes are intended to be encompassed within the scope of the appended claims.
[0087] When a group of materials, compositions, components or compounds is disclosed herein, it is understood that all individual members of those groups and all subgroups thereof are disclosed separately. Every formulation or combination of components described or exemplified herein can be used to practice the invention, unless otherwise stated. Whenever a range is given in the specification, for example, a temperature range, a time range, or a composition range, all intermediate ranges and subranges, as well as all individual values included in the ranges given are intended to be included in the disclosure. Additionally, the end points in a given range are to be included within the range. In the disclosure and the claims, and/or means additionally or alternatively. Moreover, any use of a term in the singular also encompasses plural forms.
[0088] As used herein, comprising is synonymous with including, containing, or characterized by, and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. As used herein, consisting of excludes any element, step, or ingredient not specified in the claim element. As used herein, consisting essentially of does not exclude materials or steps that do not materially affect the basic and novel characteristics of the claim. Any recitation herein of the term comprising, particularly in a description of components of a composition or in a description of elements of a device, is understood to encompass those compositions and methods consisting essentially of and consisting of the recited components or elements.
[0089] One of ordinary skill in the art will appreciate that starting materials, device elements, analytical methods, mixtures and combinations of components other than those specifically exemplified can be employed in the practice of the invention without resort to undue experimentation. All art-known functional equivalents, of any such materials and methods are intended to be included in this invention. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Headings are used herein for convenience only.
[0090] All publications referred to herein are incorporated herein to the extent not inconsistent herewith. Some references provided herein are incorporated by reference to provide details of additional uses of the invention. All patents and publications mentioned in the specification are indicative of the levels of skill of those skilled in the art to which the invention pertains. References cited herein are incorporated by reference herein in their entirety to indicate the state of the art as of their filing date and it is intended that this information can be employed herein, if needed, to exclude specific embodiments that are in the prior art.
LIST OF REFERENCE NUMERALS
[0091] 1 primary packaging [0092] 2 septum [0093] 2a base [0094] 2b wall region [0095] 3 injection-molding die [0096] 4 die half [0097] 5 die half [0098] 5a base [0099] 5b leg [0100] 5c leg [0101] 6 cavity [0102] 7 injection opening [0103] 8 holder [0104] 9 male mold [0105] 10 female mold [0106] 11 rim [0107] 12 stamp [0108] 13 channel [0109] 14 shoulder [0110] 15 slope [0111] 16 receiving chamber [0112] 17 flange [0113] 18 slope [0114] 19 spacer [0115] 20 removal region [0116] 21 slope [0117] 23 undercut [0118] 25 opening [0119] 26 cap [0120] 101 primary packaging [0121] 102 septum [0122] 102a base [0123] 102b wall region [0124] 103 injection-molding die [0125] 104 die half [0126] 105 die half [0127] 105a base [0128] 105b leg [0129] 105c leg [0130] 106 cavity [0131] 107 injection opening [0132] 108 holder [0133] 109 male mold [0134] 110 female mold [0135] 111 rim [0136] 112 stamp [0137] 113 channel [0138] 114 shoulder [0139] 115 slope [0140] 116 receiving chamber [0141] 117 flange [0142] 118 slope [0143] 119 spacer [0144] 120 removal region [0145] 121 slope [0146] 125 opening [0147] 126 cap [0148] 201 primary packaging [0149] 202 septum [0150] 202a base [0151] 202b wall region [0152] 203 injection-molding die [0153] 204 die half [0154] 205 die half [0155] 205a base [0156] 205b leg [0157] 205c leg [0158] 206 cavity [0159] 207 injection opening [0160] 208 holder [0161] 209 male mold [0162] 210 female mold [0163] 211 rim [0164] 212 stamp [0165] 213 channel [0166] 214 shoulder [0167] 215 slope [0168] 216 receiving chamber [0169] 217 flange [0170] 218 slope [0171] 219 spacer [0172] 220 removal region [0173] 221 slope [0174] 222 projection [0175] 224 thread [0176] 225 opening [0177] 226 cap