EP0267433A2 - Dispositif de fermeture pour récipient pharmaceutique - Google Patents

Dispositif de fermeture pour récipient pharmaceutique Download PDF

Info

Publication number
EP0267433A2
EP0267433A2 EP87114785A EP87114785A EP0267433A2 EP 0267433 A2 EP0267433 A2 EP 0267433A2 EP 87114785 A EP87114785 A EP 87114785A EP 87114785 A EP87114785 A EP 87114785A EP 0267433 A2 EP0267433 A2 EP 0267433A2
Authority
EP
European Patent Office
Prior art keywords
stopper
crimp cap
container
roughened
closure arrangement
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.)
Ceased
Application number
EP87114785A
Other languages
German (de)
English (en)
Other versions
EP0267433A3 (fr
Inventor
Josef Pfennings
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.)
Pharma-Metall GmbH
Original Assignee
Pharma-Metall GmbH
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 Pharma-Metall GmbH filed Critical Pharma-Metall GmbH
Publication of EP0267433A2 publication Critical patent/EP0267433A2/fr
Publication of EP0267433A3 publication Critical patent/EP0267433A3/fr
Ceased legal-status Critical Current

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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
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Definitions

  • the invention relates to a closure arrangement for pharmaceutical containers according to the preamble of claim 1.
  • the crimp cap secures here, such as. B. from DE-AS 1 207 043 and DE-GM 18 05 239 known the seated in the mouth of the pharmaceutical container.
  • the crimp caps have an inner, central, removable disc part which is releasably attached to the outer upper ring part, for. B. by means of breakable connecting bridges. After removal of this central disk part, access is obtained to the stopper or the disk, hereinafter referred to as the sealing part, which can then be pierced by an injection needle. When piercing with the injection needle, however, problems often occur with this construction.
  • the crimp cap has a roughened area in its inner surface acting on the upper outer surface of the stopper or the washer.
  • the roughened area on the inner surface of the crimp cap significantly reduces the mutual displaceability of the upper sealing part outer surface and the inner crimp surface.
  • the upper outer surface of the sealing part can thus practically no longer be pulled under the crimping cap inner surface acting towards it in the direction of the puncture point.
  • the edge of the sealing part resting on the end face of the container mouth is therefore held in a stable position, clamped between the inner surface of the crimp cap and the end face of the container mouth, even during the puncture. This edge and thus the entire stopper slipping into the container neck is practically impossible.
  • a crimp cap with a surface profile which consists of one or two ring beads of the crimp cap, which are pressed exactly between two ring beads on the end face of the container mouth during flanging.
  • this surface profiling of the previously known crimp cap is essentially intended to serve as a moisture and gas-tight seal for medicament containers in the case of antibiotics sensitive to moisture and / or oxidation.
  • a rubber washer is provided between the end face of the container mouth and the crimp cap, onto which aluminum foils and, if appropriate, additionally plastic foils are glued or laminated on both sides for better sealing.
  • the roughened area is located in the preferably annular edge area of the acting inner surface of the crimp cap, which is opposite the end face of the container mouth. Because in this area the greatest pressure or counter pressure is present on the contact surfaces of the crimp cap and sealing part, because the inner surface of the crimp cap presses the sealing part in this area directly onto the end face of the container mouth. Surface profiling or roughening of the inner surface of the crimp caps therefore has the greatest effect in this annular edge region.
  • the roughened area is shaped by elevations and depressions in the micro area. These elevations and depressions increase the contact area between the seal and the crimp cap.
  • the seal and the crimp cap are "hooked" to a certain extent in the micro range.
  • a generally designated 1 closure arrangement for a pharmaceutical container 2 has a lid 3 and a pierceable (rubber) stopper 4, which is held in place by a crimp cap 5.
  • the aluminum crimp cap 5 encloses a mouth bead 6 of a container neck 7 of the pharmaceutical container 2. In its extension beyond the edge of a container mouth 8 of the container 2, it also encompasses the stopper 4 laterally and acts upon it on its upper outer surface 9, which is from the container mouth surface 10 turned away and runs approximately parallel to it.
  • the crimp cap 5 presses the stopper 4 firmly onto the end face 11 of the mouth bead 6 or the container mouth 8. In its central region it is connected via predetermined breaking points 12 to the cover 3, which when opened opens a central region 13 of the stopper 4, through which one Injection needle can be inserted.
  • the crimp cap 5 is roughened in the micro region in its inner surface 15 which acts on the upper outer surface 9 of the stopper 4.
  • the edge surface of the stopper 4 resting on the end face 11 is firmly held between the inner flange surface 15 and the end face 11 of the bottle bead even when the tensile load on the stopper outer surface 9 is directed inward. Pulling this edge surface of the stopper out of its anchoring and then kinking the edge surface under the pressure of the injection needle is practically impossible. This practically prevents the plug 4 from being pushed into the container mouth 8 by means of the injection needle.
  • the roughening of the crimp cap 5 is in the Area of the crimp cap inner surface 15 which is directly opposite the end face 11 of the container mouth bead 6. This is because the pressure forces between the inner surface 15 of the crimp cap and the outer surface 9 of the stopper are greatest. In this ring-shaped edge region 17, the pull caused by an injection needle along the upper outer surface towards the puncture site still runs essentially tangentially to the outer surface 9. The roughening effect is consequently greatest at this point.
  • the roughening consists of a granular structure which is embossed into the crimp cap 5 without cutting.
  • the closure arrangement can also have a disk to be pierced.
  • the good holding of the plug 4 or the disc can be reinforced by the fact that he / she also on his / her the crimp cap 5 facing surface, for. B. the plug outer surface 9 is roughened in the micro range.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP87114785A 1986-11-14 1987-10-09 Dispositif de fermeture pour récipient pharmaceutique Ceased EP0267433A3 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3638928 1986-11-14
DE19863638928 DE3638928C1 (de) 1986-11-14 1986-11-14 Verschlussanordnung fuer pharmazeutische Behaelter

Publications (2)

Publication Number Publication Date
EP0267433A2 true EP0267433A2 (fr) 1988-05-18
EP0267433A3 EP0267433A3 (fr) 1989-02-01

Family

ID=6313941

Family Applications (1)

Application Number Title Priority Date Filing Date
EP87114785A Ceased EP0267433A3 (fr) 1986-11-14 1987-10-09 Dispositif de fermeture pour récipient pharmaceutique

Country Status (5)

Country Link
EP (1) EP0267433A3 (fr)
DE (1) DE3638928C1 (fr)
DK (1) DK589487A (fr)
FI (1) FI875034A (fr)
NO (1) NO874741L (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19754625C2 (de) * 1997-12-09 2002-01-24 Helvoet Pharma Stopfen zum Verschließen von Infusionsflaschen

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB995030A (en) * 1961-12-15 1965-06-10 Abbott Lab Closure assembly
DE1207043B (de) * 1961-04-04 1965-12-16 West Co Verschlusskappe fuer pharmazeutische Flaschen
DE8600054U1 (de) * 1986-01-03 1986-08-07 Wimmer GmbH, 5180 Stolberg Stopfen für Flaschen mit pharmazeutischen Produkten

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1805239B2 (de) * 1968-10-25 1976-11-25 Schloemann-Siemag AG, 4000 Düsseldorf Einer mehrstranggiessanlage nachgeordnete quertransporteinrichtung fuer abgetrennte strangabschnitte

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1207043B (de) * 1961-04-04 1965-12-16 West Co Verschlusskappe fuer pharmazeutische Flaschen
GB995030A (en) * 1961-12-15 1965-06-10 Abbott Lab Closure assembly
DE8600054U1 (de) * 1986-01-03 1986-08-07 Wimmer GmbH, 5180 Stolberg Stopfen für Flaschen mit pharmazeutischen Produkten

Also Published As

Publication number Publication date
EP0267433A3 (fr) 1989-02-01
DK589487A (da) 1988-05-15
DE3638928C1 (de) 1988-05-05
DK589487D0 (da) 1987-11-10
NO874741D0 (no) 1987-11-13
FI875034A (fi) 1988-05-15
FI875034A0 (fi) 1987-11-13
NO874741L (no) 1988-05-16

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Inventor name: PFENNINGS, JOSEF