EP2834161A1 - Procédé de fabrication d'un bouchon à collerette, bouchon à collerette et récipient muni d'un bouchon à collerette - Google Patents

Procédé de fabrication d'un bouchon à collerette, bouchon à collerette et récipient muni d'un bouchon à collerette

Info

Publication number
EP2834161A1
EP2834161A1 EP13712522.5A EP13712522A EP2834161A1 EP 2834161 A1 EP2834161 A1 EP 2834161A1 EP 13712522 A EP13712522 A EP 13712522A EP 2834161 A1 EP2834161 A1 EP 2834161A1
Authority
EP
European Patent Office
Prior art keywords
plastic
cap
layer
crimp
plastic part
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13712522.5A
Other languages
German (de)
English (en)
Inventor
Ralf DITTMER
Ronny Prosper Elisabeth Vrijens
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Datwyler Pharma Packaging Belgium NV
Original Assignee
Datwyler Pharma Packaging International NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Datwyler Pharma Packaging International NV filed Critical Datwyler Pharma Packaging International NV
Publication of EP2834161A1 publication Critical patent/EP2834161A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D99/00—Subject matter not provided for in other groups of this subclass
    • B29D99/0096—Producing closure members for containers, e.g. closure caps or stoppers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/25—Solid
    • B29K2105/253—Preform
    • B29K2105/256—Sheets, plates, blanks or films
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2009/00—Layered products
    • B29L2009/003—Layered products comprising a metal layer

Definitions

  • the invention firstly relates to a method for producing a crimp cap for a container for holding a pharmaceutical substance, in particular an ampoule, wherein the crimp cap is formed from a strip of material already having a plastic-coated film layer which is then punched out and formed by deep-drawing. Furthermore, the invention relates to a crimp cap for a container for receiving a pharmaceutical substance, in particular an ampoule, which is covered with a metallic film layer and in any case on the outside of a coating of the film layer forming plastic layer.
  • the invention also relates to a container with a pharmaceutical substance, in particular a container in the form of an ampoule, wherein the container is closed with a crimp cap and the crimp has a metallic film layer which is covered on the outside with a coating of the film layer forming plastic layer ,
  • Such crimping caps as such, without the already coated film layer, have already become known in various respects.
  • EP 663 347 A2 it is already known to form an aluminum crimp cap with an inner cap formed from a plastic film section.
  • a punching / Biegeumformvorgang With regard to the production of a crimp cap in general by a punching / Biegeumformvorgang also reference is made to this document.
  • US Pat. No. 5,794,804 AI it is known to coat a metal foil layer made of aluminum after forming the metal foil layer into the cap shape with a polymeric material in order to avoid particles.
  • the invention procedurally the task of providing an advantageous method for producing a crimp cap, objectively raises the task of providing an advantageous crimp cap and further specify an advantageously sealed with a crimp cap container.
  • a possible solution to the problem is given according to a first idea of the invention in a method in which it is geared to that a plastic part is attached to the plastic layer forming a plastic layer of the crimp cap.
  • the already existing plastic layer due to the use of a plastic-laminated Metallfolien- starting material, can be used to a plastic part, for example.
  • a strip of material which is already plastic-coated having metallic foil layer as a starting material, formed by punching and deep drawing to the crimp cap, wherein on the strip of material further comprises a plastic part is attached.
  • the plastic cover part is preferably a plastic part, which is attached to the outside of the crimp cap, more preferably on the ceiling, but also in addition or alone on a cap wall of the crimp cap.
  • the plastic base is a plastic part, which is preferably fastened to the crimp cap in the interior of the crimp cap, for example on the inside of the cover and / or on the inside of the edge area.
  • the plastic overcap is a part which is arranged over the crimp cap from the outside and extends at least partially both in the ceiling area, as in the region of the cap wall of the crimp cap.
  • a crimp cap is proposed, which is characterized by a metallic film layer and in any case on the outside of the film layer by a coating of the film layer forming plastic layer, wherein further the crimp, eg. At a cap ceiling and / or a cap wall, further example. Outside - or inside, is connected to a plastic part.
  • the plastic part is preferably a plastic injection molding produced plastic part.
  • the compound is achieved by means of the coating of the film layer forming plastic layer.
  • the plastic part may further be a hard plastic part or a soft plastic part. In this respect, it may, for example, consist of polypropylene (PP) or polyethylene (PE) or a thermoplastic elastomer (TPE).
  • the object is achieved in a container which is closed with a crimp cap and wherein the crimp cap a metallic Has film layer, which in any case is covered on the outside with a coating of the film layer forming plastic layer and wherein the crimp cap is arrested with a plastic part in the manner already described.
  • the crimp cap can be produced, for example, by punching out an already plastic-coated film layer and then thermoforming the stamped part.
  • the plastic part can after the described forming the crimp cap - first - be attached to the crimp cap. But it can also be attached to the strip of material prior to punching or before forming. In the latter case, the plastic part is, for example, with punched punched during punching or in such a size (only) provided that it is located within a punching contour. If the plastic part is applied to the punched-out material strip, it is in any case inserted together with the material strip, preferably already in the final composite with the material strip, into the forming tool and deformed together with the material strip to the crimp cap. This is recommended in particular when the plastic part is provided outside areas that undergo substantial deformation, for example in the ceiling area of the crimp cap (only).
  • the arrest with a plastic part provides the opportunity, for example, first to achieve a stabilization of certain areas of the crimp cap. However, as an alternative or in addition, it also provides the opportunity to achieve originality assurance.
  • the plastic part preferably in a not or only partially connected to the crimp cap area, be provided break off or tear-off. This particular and preferred in training of the plastic in the form of an overcap.
  • the tamper-evident security can also be achieved in an area in which the plastic part is adhered flat to the crimp cap by mediating the plastic lamination of the metal foil.
  • the arrest especially in such a case, is preferably made such that the plastic part can only be removed together with the film layer of the crimp cap. Thus, there is a tearing or tearing of the film layer when the plastic part, for instance to release a puncture opening, is attempted to be removed.
  • a destructive effect on the plastic part and / or the crimp is then immediately visually recognizable. This becomes especially clear, and is Therefore, preferred if the plastic layer has a distinctly different color than the then visible at the tear or the tear film position. Further or alternatively, it can also be achieved with the plastic part, if it is applied approximately on the inside of the crimp cap, resulting in a protection of the ampoule mouth during crimping and / or targeted to a closure plug, which covers the crimp cap, approximately at the edge to reinforce the Contact pressure, is acted upon.
  • the cap cover has, in a conventional manner, a, preferably central, passage opening.
  • the plastic part is (only) arrested with lateral, with a round design of the opening radial, distance to an edge edge opening.
  • a closed peripheral region which has the opening edge edge, preferably un arrested to the plastic part.
  • the area in which there is no adhesion to the plastic part surrounding the peripheral edge of the opening may, for example, correspond to a center of the opening 1/10 to 1/1 of the center from the center point to the peripheral edge of the opening.
  • the further described features may be of importance for the method object of the application as well as for the device objects of the application, ie the crimp cap and the container closed with the crimp cap.
  • the punching and deep drawing is done in a combined single operation. It is further preferred that the punching tool is formed with respect to the production such that at the punching edge a Werner-on-asted of the plastic layer, which leads to the projection of the plastic layer on the punching edge of the film layer adjusts. It has been recognized that by means of a comparatively blunt adjustment of the tool, this Buchverinrung the existing plastic layer can be achieved. The actual sharpness of the punching tool required to achieve this effect - only - can be determined empirically. It may also be different depending on the actual formation of the film layer or the plastic layer and possibly also of the thus arrested plastic part.
  • the extension can be comparatively low. It is preferably measured in the order of magnitude of the thickness of the metallic film layer. This thickness can be, for example, 0.05-0.5 mm.
  • a lacquer layer can be arranged between the plastic layer and the metallic foil layer.
  • the synthetic material layer is preferably transparent or only slightly colored in such a case. The color appearance can then be determined essentially by the coating.
  • the lacquer layer is preferably an epoxy resin-based lacquer.
  • the lacquer layer may have a thickness of, for example, 2 to 5 ⁇ m.
  • the plastic layer is transparent and is connected to a color effect causing, visible through the plastic layer through adhesive with the metallic film layer.
  • a desired color effect can be achieved solely by using a colored adhesive in this respect.
  • the lacquer layer can then come to an end. It is also only necessary to apply as a plastic layer, for example, only a transparent plastic film.
  • This embodiment is preferably realized on the upper side or outer surface of the crimp cap. But it can also be realized in addition to the underside or the inner surface.
  • Said plastic layer may have the same thickness as the metallic film layer, but it may also be thinner or even thicker, for example up to a range of 0.03 to 3 times the thickness of the metallic foil layer or up to 0.8 mm thickness.
  • the plastic layer can also be provided on both sides of the film layer.
  • the plastic layer may be a conventional PP or PE film, for example, which previously applied to the metallic film layer, in particular with the interposition of a pressure-sensitive adhesive layer is bonded to the metallic film layer.
  • the plastic layer can also consist, for example, of polyethylene terephthalate (PET) or polyurethane (PU).
  • the metallic film layer it is preferably an aluminum foil layer.
  • the attachment of the plastic part with the material strip or with the crimp cap can first be made by gluing, ie by applying a separate adhesive layer on the corresponding side of the plastic part and / or the material strip or the crimp cap.
  • an arrest by welding is made.
  • the surface of the strip of material, so the plastic film layer, and / or the corresponding side of the plastic part are heated so that sets a softening to the required welding temperature and then the parts are welded together by Gegenendun.
  • both plastic materials it is obviously advantageous, as also preferred, for both plastic materials to be thermoplastic plastic materials.
  • the welding takes place by means of ultrasound. This continues within a thinned area of the plastic part.
  • an ultrasonic welding process it is advantageously possible, at the same time, to advantageously expel punching oil which has been used during the manufacture of the crimp cap by the ultrasound out of the welding area, by means of vibrations, and thus a washing process which otherwise might be required. can be saved.
  • connection of the crimp cap to the plastic part is achieved only by the aforementioned attachment, by gluing or welding. An otherwise in such cases still given positive connection can be completely eliminated.
  • Another way of connecting the plastic part with the crimping cap is to overspray the crimp cap after completion or even (already) the material strip in the plastic injection process, and then in the latter case the so arrested in the plastic injection process on the material strip plastic part in connected to the material strip Condition to let enforce the punching tool and the forming tool.
  • the ranges and / or ranges of values or multiple ranges given above also include all intermediate values, in particular in one-tenth steps of the respective dimension, if necessary also dimensionless, for example 1/10 ⁇ , a 0.1-fold etc., on the one hand to delimit the said range boundaries from below and / or above, alternatively or additionally but also with regard to the disclosure of one or more singular values from the respective specified range.
  • the invention will be explained further with reference to the accompanying drawing, which, however, represents only one embodiment. Hereby shows:
  • FIG. 2 shows a cross section through the article according to FIG. 1, cut along the line II-II;
  • Fig. 4 is an enlarged detail of Fig. 3;
  • FIG. 5 shows a further detail enlargement of an article according to FIG. 3, in an alternative embodiment
  • FIG. 6 shows a crimp cap connected in cross-section to a plastic part in the form of an overcap, applied to an ampoule
  • FIG. 7 shows an embodiment according to the type of FIG. 6, but with a weakening line arranged in the region of the cap cover;
  • Fig. 8 is a perspective view of another applied to an ampoule, provided with a plastic part crimp cap. Shown and described is first a strip of material M, which has a metallic film layer 1, which, see also Fig. 2, the upper and lower sides with a plastic layer 2, 3 is coated. The coating is performed by an extruded plastic layer 2, 3 (plastic film), which is preferably connected to the metallic film layer 1 by means of a bonding agent layer, not shown. It may alternatively also be, for example, a blow-molded or directly extruded film.
  • the material strip M is formed into a crimp cap 22 according to FIG. 3 in a combined punching and forming process, not shown in detail.
  • the crimping cap 22 has a cap cover 23 and a cap wall 24, which extends preferably at right angles to the cap cover 23 and in the use state downwards.
  • an opening 4 is also preferably punched out in the center of the cap cover 23, which can be covered by an overcap 9 in the state finally applied to an ampoule 7, as shown for example in FIG.
  • the exemplary embodiment is an aluminum foil layer.
  • FIGS. 4 and 5 show different configurations of the peripheral edge 6 of the cap wall 24 of the crimp cap 22 according to FIG. 3.
  • a similar training may also result in terms of the opening edge edge 10 of the opening 4.
  • a length of the downwardly bent region here can be relatively low be, for example, 0.5 to 10 times a total thickness d of the film layer 1 correspond.
  • the statements concerning the stretching of the plastic layer 2 or 3 are equally applicable with respect to the opening edge edge 10.
  • Said total thickness d of the film layer 1 with the plastic layer 2 and / or 3 may be, for example, 50-1000 ⁇ .
  • a cutting edge 13 can be seen, in which the two plastic layers 2, 3, as well as the film layer 1 at right angles to the vertical extent of the crimping edge 11, which is shown enlarged here, running cutting edge 13 at about the same height.
  • the outer plastic layer 2 is extended by stretching in the course of the punching process such that an overlapping section 5 has emerged, which is folded over the end face 6 'of the film layer 1 and is connected to the inner plastic layer 3 in the exemplary embodiment , for example adhesively or weld-connected.
  • the crimp cap 22 is applied to the upper region of an ampoule 7.
  • a sealing plug 12 is inserted, which is surrounded by the crimp cap 22 on the upper side and on the flange side.
  • the crimp cap 22 can be seen further bent (crimped) into the lower handle to a ampoule mouth edge 8.
  • the relevant lower flange cap edge 11 can be pressed in the course of applying the crimp cap 22 to the ampoule 7 by a pusher tool to rest on the ampoule 7, in the illustrated lower handle to the ampoule outlet edge 8.
  • a plastic overcap 9 is further applied from above, which is partially, namely in the area 16 with the crimp 22 is arrested.
  • the overcap 9 also has a cross-sectionally U-shaped design. In detail, it has an overcap cover 14 and an overcap wall 15.
  • the overcap 9 is made of a hard plastic.
  • the overcap 9 may have a thickness di in the region of the overcap 14, which corresponds to the thickness of the crimp cap 22 or greater.
  • the thickness di may correspond, for example, to five or ten times the thickness of the crimp cap 22, that is to say the thickness of the laminated metal foil layer.
  • the overcap 9 on the cap wall 15 has a region 16 of reduced thickness.
  • the area of reduced thickness may, for example, have a thickness d 2 which corresponds to one tenth to three quarters of the thickness di.
  • the arrest is still made only with the outside plastic layer 2, and preferably by means of a welding, more preferably by means of an ultrasonic welding.
  • the crimp cap 22 is not arrested in the remaining region, ie in the exemplary embodiment above the region 16, with the plastic part 18, specifically the overcap 9 in this case. It can, for example, by separating along a line of weakness 17, which here preferably in the transition of the Ches 16 is formed to the remaining overcap, further example. By turning corresponding to a screw cap, for example, be removed.
  • the crimp cap 22 also has the already mentioned upper-side opening 4 in the usual way.
  • the opening 4 is covered by the overcap 9 in accordance with the state of FIG. After removal of the rupturable part of the overcap 9, the opening 4 is free for piercing into the sealing plug.
  • Fig. 7 shows a variant of the embodiment of Fig. 6, wherein here the line of weakness 17 is arranged in the region of the plane of the cap blanket.
  • the capping lid thus forms a practically disc-shaped part after separation and with respect to the crimp cap, after capping, practically only the capping cap is exposed.
  • the region 20, as well as the remaining part of the plastic part or a part of the remaining plastic part in turn be arrested with the plastic film layer of the crimp cap.
  • the plastic film layer can be torn open during tearing, so that this also a violation of the originality after tearing is visible.
  • the opening 4 is uncovered by tearing the tear tab 21 in this case as well.
  • a partial removal of the plastic part 18 may also be provided a configuration in which the plastic part 18 can be completely removed. This can be achieved, for example, in that the welding area is very small, so that removal of the plastic part in this area results in removal of the plastic layer which has been welded to this extent.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne tout d'abord un procédé de fabrication d'un bouchon à collerette (22) et un bouchon à collerette pour un récipient, en particulier une ampoule (7), destiné à contenir une substance pharmaceutique. Le bouchon à collerette (22) est constitué d'une bande de matériau (M) présentant une couche de film déjà revêtue d'une matière plastique, qui est ensuite estampée et formée par emboutissage profond. L'invention vise à proposer un procédé avantageux de fabrication d'un bouchon à collerette, ainsi qu'un bouchon à collerette avantageux. A cet effet, un élément en matière plastique (18) est fixé sur le revêtement en matière plastique formant une couche de matière plastique. L'invention concerne par ailleurs un bouchon à collerette pour un récipient (7), en particulier une ampoule (7), destiné à contenir une substance pharmaceutique, qui est constitué d'une couche de film métallique (1), la couche de film (1) étant recouverte dans tous les cas sur sa face extérieure d'une couche de matière plastique (2, 3) formant un revêtement de la couche de film. L'invention concerne en outre un récipient (7) contenant une substance pharmaceutique.
EP13712522.5A 2012-04-03 2013-03-21 Procédé de fabrication d'un bouchon à collerette, bouchon à collerette et récipient muni d'un bouchon à collerette Withdrawn EP2834161A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102012102881A DE102012102881A1 (de) 2012-04-03 2012-04-03 Verfahren zur Herstellung einer Bördelkappe, Bördelkappe und Behältnis mit Bördelkappe
PCT/EP2013/055933 WO2013149844A1 (fr) 2012-04-03 2013-03-21 Procédé de fabrication d'un bouchon à collerette, bouchon à collerette et récipient muni d'un bouchon à collerette

Publications (1)

Publication Number Publication Date
EP2834161A1 true EP2834161A1 (fr) 2015-02-11

Family

ID=47998419

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13712522.5A Withdrawn EP2834161A1 (fr) 2012-04-03 2013-03-21 Procédé de fabrication d'un bouchon à collerette, bouchon à collerette et récipient muni d'un bouchon à collerette

Country Status (7)

Country Link
US (1) US20150298414A1 (fr)
EP (1) EP2834161A1 (fr)
CN (1) CN104245529A (fr)
DE (1) DE102012102881A1 (fr)
IN (1) IN2014DN08171A (fr)
RU (1) RU2014143483A (fr)
WO (1) WO2013149844A1 (fr)

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IT201700020789A1 (it) * 2017-02-23 2018-08-23 Brev Angela Srl Dispositivo di chiusura a tenuta stagna per contenitore asettico e procedimento per la sua realizzazione
DE102017107619A1 (de) 2017-04-10 2018-10-11 Datwyler Pharma Packaging International Nv Verfahren zur Herstellung einer Vielzahl von Aluminium-Verschlusskappen, sowie Verwendung von bedruckten Teilen einer Aluminium-Verschlusskappe
JP7277381B2 (ja) * 2017-12-07 2023-05-18 藤森工業株式会社 ポート付バッグおよびキャップ付バッグ
CN109158504A (zh) * 2018-11-08 2019-01-08 苏州斯莱克精密设备股份有限公司 冲压装置和多通道罐盖冲压***
CN110902129A (zh) * 2019-01-22 2020-03-24 晟薇药业(上海)有限公司 冻干瓶
WO2021122688A1 (fr) 2019-12-18 2021-06-24 Datwyler Pharma Packaging Belgium Dispositif de fermeture pour récipient comprenant une substance pharmaceutique
EP4253276A1 (fr) 2022-03-30 2023-10-04 Datwyler Pharma Packaging Belgium Bouchons pour récipients contenant des substances médicales ou pharmaceutiques

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Also Published As

Publication number Publication date
DE102012102881A1 (de) 2013-10-10
WO2013149844A1 (fr) 2013-10-10
RU2014143483A (ru) 2016-05-27
US20150298414A1 (en) 2015-10-22
IN2014DN08171A (fr) 2015-05-01
CN104245529A (zh) 2014-12-24

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