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WO2006008261A1 - Contenant de produits pharmaceutiques - Google Patents

Contenant de produits pharmaceutiques Download PDF

Info

Publication number
WO2006008261A1
WO2006008261A1 PCT/EP2005/053356 EP2005053356W WO2006008261A1 WO 2006008261 A1 WO2006008261 A1 WO 2006008261A1 EP 2005053356 W EP2005053356 W EP 2005053356W WO 2006008261 A1 WO2006008261 A1 WO 2006008261A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
overcap
container
defects
pharmaceutical product
Prior art date
Application number
PCT/EP2005/053356
Other languages
German (de)
English (en)
Inventor
Albert Louis Victor Jozef Claessens
Original Assignee
Helvoet Pharma Belgium N.V.
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 Helvoet Pharma Belgium N.V. filed Critical Helvoet Pharma Belgium N.V.
Publication of WO2006008261A1 publication Critical patent/WO2006008261A1/fr

Links

Classifications

    • 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
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/245—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with decoration, information or contents indicating devices, labels
    • 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
    • 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
    • B65D2203/00—Decoration means, markings, information elements, contents indicators

Definitions

  • the invention relates to a pharmaceutical product container, for example an ampoule with an inoculating agent or infusion or transfusion ampoule or bottle, with a sealing plug, for example consisting of a natural or synthetic rubber or a thermoplastic elastomer, and having an overcap , wherein further, if necessary, between the overcap and the sealing plug, the closure plug in the container securing, a crimp cap is provided.
  • a pharmaceutical product container for example an ampoule with an inoculating agent or infusion or transfusion ampoule or bottle
  • a sealing plug for example consisting of a natural or synthetic rubber or a thermoplastic elastomer
  • the use properties such as tamper-evident closure and effortless opening, must not be adversely affected, even with rapid handling.
  • the invention has the object, a Pharmaziepro ⁇ dukt container, as described above, to design and further develop that, without adversely affecting the essential properties in the Pharmazie Scheme Ei ⁇ safe detection of the origin of the container thus present is possible.
  • the overcap for identification has point locations, that the point locations are punctiform defects, of the order of magnitude of one or a few tenths of mm, Aus ⁇ are formed and that the arrangement of the defects appears as an arbitrary Anord ⁇ statement.
  • the imperfections can have an order of magnitude starting with one-tenth mm. Usually dimensions of two or more tenths of a mm are given.
  • the defects are arranged in the overcap, moreover preferably on the underside of the overcap, they are not provided on the actual container which is in use. The overcap is torn off before using such a Pharmazie.- container. Nevertheless, it offers the possibility of serving in the desired manner for identification.
  • the invention likewise provides the closure cap as such for a pharmacy product container as described above.
  • purifying points are formed on the upper cap so that the point locations are preferably underside of the overcap as point-like imperfections, in the order of magnitude of one or a few tenths of mm, the arrangement of the imperfections being arbitrary arrangement appears.
  • the defects or point locations can be described as apparent defects. Without further knowledge of the circumstances, when discovered, they will (only) be ranked as non-highest requirements for a flawless product. Only the knowing observer becomes aware of the meaning actually given, which, in particular, can fulfill a conceptual grid to be laid over, even in the chosen arbitrary arrangement. Furthermore, alternatively or additionally, the crimp cap can be provided with such defects. In this connection, it may in particular be preferred to provide the flaws of the crimp cap and the overcap in the same arbitrary arrangement. Only the agreement in the arbitrary arrangement of these imperfections can then be taken as an indication for the examining observer that it is an original product.
  • the overcap may also be formed opaque.
  • the crimp cap is usually an aluminum sheet metal part. This can also have the defects mentioned with laser application.
  • the defects appear in a hole-like manner. They resemble needle-like defects originating in the surface in the plastic. It is further preferred that the imperfections are formed by means of laser impingement in the overcap, after completion of the plastic injection process.
  • the overcap is preferably formed opaque.
  • the flaws are, as already mentioned, formed on the underside of the overcap.
  • the imperfections are also understoodbil ⁇ det in a central region of the overcap. The latter means that the overcap, assigned to a longitudinal center axis of the container on which the overcap is placed, in a region which corresponds to about half, preferably about one third of its diameter, is provided with such defects.
  • an overcap is described below, with nominal tear lines, in which a corresponding tearing and folding takes place in use, the invention also has significance for one-piece overcaps which are torn off substantially as a whole. In this connection, it is even advantageous that the imperfections can be formed over virtually the entire, usually circular disc-shaped surface of the overcap.
  • Figure 2 is a bottom view of the overcap of the article according to
  • FIG. 1 A first figure.
  • FIG. 1 Shown and described, first with reference to FIG. 1, is a cross section through an infusion bottle with a closure cap 1, which consists in detail of a closure stopper 2, a crimp cap 3 and an overcap 4.
  • the sealing plug 2 in the exemplary embodiment consists of a synthetic rubber material. But it can also consist of a thermoplastic Elasto ⁇ mer.
  • the crimp cap 3 is a metallic cap.
  • the crimp cap 3 is made of an aluminum material.
  • the overcap 4 consists of a plastic material, such as a PP or PE.
  • the overcap 4 may be transparent or opaque with respect to the material.
  • this region of the overcap which is a central region of the overcap, they have been introduced by means of laser application after completion of the plastic injection process.
  • the heat of the laser beam causes the plastic to burn away.
  • the arbitrarily appearing arrangement of the defects 5 can follow a certain pattern. This can be seen by considering a corresponding template, not shown. Hereby, further information can be encoded.
  • the closure cap 1 is constructed such that a center recess 6 is provided in the top of the crimp cap 3.
  • the central recess 6 is closed by the overlying center region 7 of the overcap 4, which extends over the entire upper side of the crimp cap 3.
  • the center recess 6 projects from the inside of the overcap 4 aus ⁇ outgoing annular zone 8.
  • the annular zone 8 occurs in a centering position against an umge ⁇ flanged and so defused edge 9 of the central recess. 6
  • the annular zone 8 has a standing height of approximately the thickness of the material of the crimp cap 3 that protrudes from the plane of the ceiling of the overcap 4.
  • the edge 9 flanged by undercreases protrudes into a central depression 10 on the upper side of the closure stopper 2.
  • the depression 10 is such that it also accommodates the overcap 4 on the crimping cap 3 anchoring undercut tongues 11.
  • the under gripping tongues 11 are of an annular collar which is formed as the already ange ⁇ sprochene ring zone 8, from. In the demoulding state, they are realized as a serrated serrated row of teeth.
  • the thus originally axially oriented lower gripping tongues 11 are interrupted by lips 12. It is a total of six Untergreifzept 11, each of equal width, and smaller gaps 12 than the circumferential length of the lower engagement tongues 11.
  • the ratio of gaps 12 to tongues 11 is between 1: 2 and 1: 5, preferably 1: 3.
  • the under gripping tongues 11 can be easily exhibited, so that a thermally / mechanically produced spreading is well prepared for the lower handle direction.
  • the cap 1 and the bottle 13 are rotationally symmetrical structure.
  • the relevant longitudinal central axis is indicated by x-x in the drawing.
  • the overcap 4 has further radially extending desired bending lines 14, cf. Figure 2, on.
  • the desired Rnicklinien 14 are located on the inside of the overcap 2 and are center-oriented.
  • the desired reference lines 14 are given dilution, which is provided at the injection molding of the overcap immediately.
  • the desired bending lines 14 continue to run in a clear radial distance to a center Z of the overcap 4. This radial distance is also the area in which the said defects 5 are formed.
  • the distance further corresponds to half the radius of the flat top-shaped overcap 4.
  • the thinning of the material ends center-directed in a circumferential weakening S running concentric with the center Z of the overcap 4, into which it opens openly.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un contenant de produits pharmaceutiques, par exemple une ampoule contenant un agent d'inoculation ou une ampoule ou un flacon de perfusion ou de transfusion. Ce contenant comprend un bouchon de fermeture (2), constitué sensiblement d'un caoutchouc naturel ou synthétique ou d'un élastomère thermoplastique, ainsi qu'un capuchon (4), une collerette (3) étant par ailleurs disposée éventuellement entre le capuchon (4) et le bouchon de fermeture (2) pour maintenir en place ledit bouchon de fermeture (2) sur le contenant. Selon l'invention, pour que l'origine du contenant puisse être identifiée de manière sûre sans affecter négativement les propriétés essentielles dans le domaine pharmaceutique, le capuchon (4) et/ou la collerette (3) présentent des points d'identification, ces points se présentant sous la forme de trous (5) ponctuels présentant une taille d'un ou de quelques dixièmes de millimètres et disposés selon une configuration arbitraire.
PCT/EP2005/053356 2004-07-20 2005-07-13 Contenant de produits pharmaceutiques WO2006008261A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200410035162 DE102004035162A1 (de) 2004-07-20 2004-07-20 Pharmazieprodukt-Behältnis
DE102004035162.7 2004-07-20

Publications (1)

Publication Number Publication Date
WO2006008261A1 true WO2006008261A1 (fr) 2006-01-26

Family

ID=35197940

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/053356 WO2006008261A1 (fr) 2004-07-20 2005-07-13 Contenant de produits pharmaceutiques

Country Status (2)

Country Link
DE (1) DE102004035162A1 (fr)
WO (1) WO2006008261A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2261104A1 (es) * 2006-06-19 2006-11-01 Grifols, S.A. "tapon para frascos de productos esteriles y utilizacion de dicho tapon en la dosificacion esteril".
WO2011082665A1 (fr) * 2010-01-05 2011-07-14 北京奥星恒迅包装科技有限公司 Interface médicale et son couvercle associé

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2054662A1 (fr) * 1969-07-31 1971-04-23 Siemens Ag
US4471879A (en) * 1983-08-04 1984-09-18 The West Company Metal overcap for pharmaceutical and similar containers
WO2001060699A2 (fr) * 2000-02-18 2001-08-23 Helvoet Pharma Belgium N.V. Dispositif de fermeture pour flacons de perfusion et de transfusion
WO2002056820A1 (fr) * 2001-01-19 2002-07-25 Gmpbio Co., Ltd. Dispositif capuchon de fermeture pour bouteille de medicament a base d'un alliage a memoire de forme

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2054662A1 (fr) * 1969-07-31 1971-04-23 Siemens Ag
US4471879A (en) * 1983-08-04 1984-09-18 The West Company Metal overcap for pharmaceutical and similar containers
WO2001060699A2 (fr) * 2000-02-18 2001-08-23 Helvoet Pharma Belgium N.V. Dispositif de fermeture pour flacons de perfusion et de transfusion
WO2002056820A1 (fr) * 2001-01-19 2002-07-25 Gmpbio Co., Ltd. Dispositif capuchon de fermeture pour bouteille de medicament a base d'un alliage a memoire de forme

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2261104A1 (es) * 2006-06-19 2006-11-01 Grifols, S.A. "tapon para frascos de productos esteriles y utilizacion de dicho tapon en la dosificacion esteril".
ES2261104B1 (es) * 2006-06-19 2007-06-16 Grifols, S.A. "tapon para frascos de productos esteriles y utilizacion de dicho tapon en la dosificacion esteril".
WO2011082665A1 (fr) * 2010-01-05 2011-07-14 北京奥星恒迅包装科技有限公司 Interface médicale et son couvercle associé

Also Published As

Publication number Publication date
DE102004035162A1 (de) 2006-02-16

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