EP0322548B1 - Bouchon pour lyophilisation - Google Patents

Bouchon pour lyophilisation Download PDF

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Publication number
EP0322548B1
EP0322548B1 EP88118843A EP88118843A EP0322548B1 EP 0322548 B1 EP0322548 B1 EP 0322548B1 EP 88118843 A EP88118843 A EP 88118843A EP 88118843 A EP88118843 A EP 88118843A EP 0322548 B1 EP0322548 B1 EP 0322548B1
Authority
EP
European Patent Office
Prior art keywords
spigot
longitudinal axis
transverse plane
section
shank
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.)
Expired - Lifetime
Application number
EP88118843A
Other languages
German (de)
English (en)
Other versions
EP0322548A1 (fr
Inventor
Rik Schrooten
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.)
Helvoet Pharma NV
Original Assignee
Helvoet Pharma 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 Helvoet Pharma NV filed Critical Helvoet Pharma NV
Priority to AT88118843T priority Critical patent/ATE91470T1/de
Publication of EP0322548A1 publication Critical patent/EP0322548A1/fr
Application granted granted Critical
Publication of EP0322548B1 publication Critical patent/EP0322548B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/0005—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in one piece
    • B65D39/0023—Plastic cap-shaped hollow plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Rigid containers without fluid transport within
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • 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
    • 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
    • B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying 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
    • B65D2539/00—Details relating to closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D2539/001—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers
    • B65D2539/005—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers provided with slits or gaps for increasing the elasticity

Definitions

  • the invention relates to a freeze-drying stopper made of rubber-elastic material, consisting of a spigot intended for insertion into the container neck to be sealed and a flange which is formed integrally with the spigot and protrudes radially above said essentially circular disk, the longitudinal axis of which flange coincides with that of the spigot, which spigot contains a cavity surrounding the pin longitudinal axis, which is open to the free pin end face and extends to a central closed wall part of the flange, the pin containing a first portion of its axial length, which extends radially between one of the pins and the pin extends outwardly projecting boundary surface of the flange and a second transverse plane perpendicular to the longitudinal axis of the pin and has a closed outer peripheral surface with a diameter D of 13 millimeters and adjoins the first section ssenden second section, the outer envelope surface has substantially the same diameter as the first section and which contains at least one passage communicating with the cavity, which extend
  • freeze-drying plug of this type (FR-A-2 096 680; Fig. 7-12)
  • the spigot starting from its free end face over the greater part of its axial length, is designed as an essentially tubular body with an almost constant wall thickness, i.e. the laterally delimiting inner wall surface of its central cavity is approximately a cylindrical surface.
  • freeze-drying stoppers (FR-A-2 096 980; Fig.
  • Frozen food (in particular a medicament), which is contained in a container and is sealed with one of the plugs explained above, is usually removed by piercing the flange of the plug with a cannula and introducing liquid into the container and the solution or suspension with the stopper held down with the cannula. If the cannula is not positioned exactly in the center of the flange and practically parallel to the longitudinal axis of the plug pushed in, there is a risk that the cannula tip hits the inner side wall surface, which can clog the cannula or punch out particles from the material of the pin.
  • the object of the invention is to develop a freeze-drying stopper of the type mentioned in such a way that the possibility of the cannula tip hitting the lateral inner wall surface is reduced even more or less care is required when puncturing the cannula, with other requirements of a freeze-drying stopper, in particular with regard to a small residual volume, inexpensive manufacture, adequate tightness and easy handling in the course of the freeze-drying process.
  • this object is achieved in that the inner wall surface laterally delimiting the cavity, starting from the surface region surrounding the longitudinal axis of the pin, increases its diameter with increasing proximity to the free face of the pin and that this inner wall surface lies completely outside a cone, the axis of which is the longitudinal axis of the journal, the apex of which lies on the first transverse plane and the apex angle ⁇ of which is equal to or greater than 50 ° (old degrees).
  • the inner wall surface of the central wall part of the flange that axially delimits the cavity is in a surface area surrounding the pin longitudinal axis essentially flat and this surface area lies in a transverse plane perpendicular to the longitudinal axis of the pin, which runs close to the first transverse plane.
  • the area of the outer surface of the central wall part of the flange which surrounds the longitudinal axis of the plug is advantageously delimited from the remaining peripheral surface area by a circular arrangement of projections which is concentric with the longitudinal axis of the plug, thereby marking the puncture site for the cannula and in connection with the design according to the invention the inner wall surface of the pin an even greater safety in handling is achieved.
  • the freeze-drying stopper is shown in FIGS. 1 to 4 in a magnification of approximately 5 times. It consists of rubber and contains a pin 1 intended for insertion into the container neck to be closed and a flange 2 formed therewith in one piece.
  • the pin 1 has, in addition to its special design which will be explained in the following, in principle the shape of a hollow cylinder which delimits a cavity 4 which is open to the free end face 3 of the pin.
  • the flange 2 has an edge 2a projecting laterally over the pin 1, on which a lower edge extending radially outward from the pin flat annular boundary surface 5 is formed.
  • This boundary surface lies in a first transverse plane Q 1 penetrated perpendicularly by the longitudinal axis A of the pin, is intended for bearing against the end face of the neck of the container and limits the insertion depth of the pin in its closed position.
  • the closed central wall part 2b of the flange 2 delimits the cavity 4 axially with an inner wall surface 6 which is flat in a surface area surrounding the journal longitudinal axis A and lies in a transverse plane P which runs at a short distance from the first transverse plane Q 1.
  • the outer surface 7 of the flange 2 facing away from the peg 1 has two projections 8 each running approximately semicircularly, the diameter of which is small with respect to the outer diameter of the flange and which mark a surface area surrounding the longitudinal axis A of the pin intended for the puncture of a sampling cannula. From the surface area of the outer surface 7 surrounding the projections 8, further projections 9 extend radially to the longitudinal axis A of the pin and at equal angular distances, which prevent freeze-drying stoppers with their outer surfaces from sticking to one another or to other objects and thereby hinder their processing.
  • the pin 1 In a first section Z1 of its axial length, which is located between the first transverse plane Q1 and a perpendicular to the longitudinal axis A, the pin length in a rough approximation centrally dividing second transverse plane Q2, the pin 1 is of full-walled design, ie it has a closed outer upper peripheral surface 10a.
  • This peripheral surface is adjacent to the first transverse plane Q 1 narrow and flat annular recess 10 'and an adjoining, axially longer cylindrical surface formed, the latter having a diameter D which is slightly larger than the inside diameter of the container neck and rests sealingly against the container neck with a fully inserted stopper under elastic prestress.
  • a second section Z2 of the axial length of the pin 1, which extends from the second transverse plane Q2 to the free pin end face 3, has an outer cylindrical envelope surface 10b, which has essentially the same diameter D as the upper peripheral surface 10a.
  • the passage 11 has the shape of a slot and contains two side surfaces 12a, 12b, which are substantially flat, run almost parallel to the longitudinal axis A of the pin, widen from the cavity 4 to the mouth 13 and have a mutual mean distance which is approximately the middle Corresponds to the diameter of the cavity.
  • a first inner part 12c bottom surface of the passage 11 lies in a plane parallel to the second transverse plane Q2 and in this respect offset by a small distance to the end face 3 of the pin.
  • the inner part 12c is followed by an outer part 12d of the bottom surface shaped in the form of a sector of a truncated cone, which passes into the peripheral surface 10b with an edge which forms part of the mouth 13 and is located in the second transverse plane Q2.
  • cams 14a-14c When the pin 1 is inserted into the container neck, these cams 14a-14c cause an inhibition by the abutment of their delimitations 15 on the end face of the container neck and define a first position of the stopper in which it is already non-positively connected by elastic deformation of the pin part adjacent to the end face of the pin is held in the neck of the container, but the inside of the container is still open to the environment via the passage 11. Vapors and gases can therefore escape from the material contained in the container during freeze drying to and around the container.
  • the cams 14a-14c are pushed back by the increased application of force to the plug, the cams themselves and the material of the pin 1 surrounding them being deformed.
  • the pin can then be inserted into the container neck up to a second position (closed position), which is defined by the bearing surface 5 of the flange 2 bearing against the end face of the container neck and in which the first section Z 1 of the pin equipped with the closed upper peripheral surface 10 a a complete seal of the container neck causes.
  • the cams 14a-14c each have the shape of semi-circular elongated beads in cross-section, which extend in the circumferential direction of the pin 1, their length in this direction in each case being at least 2.5 times their axial extension.
  • a first cam 14a is arranged diametrically opposite the passage (slot) 11, such that its center lies in a first longitudinal plane L1, which contains the longitudinal axis A of the pin and passes through the middle between the side surfaces 12a, 12b of the passage 11.
  • the centers of the other two cams 14b, 14c are defined by a second longitudinal plane L2 or third longitudinal plane L3, which contain the pin longitudinal axis A containing on different sides of the first longitudinal plane L1 and with this each have the same angle ⁇ 2 or ⁇ 3 of Include approx. 110 ° (old degree).
  • a groove 16 is arranged such that its inner (i.e. adjacent to the flange 2) side wall lies in the third transverse plane Q3.
  • the groove 16 is adjoined by a peripheral surface 17 of the pin 1, the diameter of which is slightly larger than the diameter of the peripheral surface from which the cams 14a-14c project.
  • the peripheral surface closes via one of the easier insertion of the pin 1 into the container neck conical surface 18 on the pin end face.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Prostheses (AREA)

Claims (5)

  1. Bouchon de lyophilisation en une matière élastique du type caoutchouc, constitué d'un pivot (1) destiné à être introduit dans le goulot du récipient à rendre étanche et, réalisé en une seule pièce avec ce pivot et faisant saillie radialement sur celui-ci, un collier sensiblement en forme de collier circulaire (2) dont l'axe longitudinal (A) coïncide avec celui du pivot, lequel pivot (1) contient, entourant son axe longitudinal (A), une cavité (4) qui est ouverte en direction du côté frontal libre (3) de ce pivot et s'étend jusqu'à une partie fermée de paroi centrale (2b) du collier (2), tandis que le pivot (1) comporte une première section (Z₁) de sa longueur axiale qui s'étend entre un premier plan transversal (Q₁) formé par la face de délimitation (5) du collier (2) faisant saillie radialement vers l'extérieur à partir du pivot (1) et un deuxième plan transversal (Q₂) perpendiculaire à l'axe longitudinal (A) du pivot et présente une face périphérique extérieure fermée (10a) d'un diamètre (D) de 13 millimètres et contient, faisant suite à la première section (Z₁), une deuxième section (Z₂) dont la face annulaire extérieure (10b) présente un diamètre sensiblement égal à celui de la première section (Z₁), et qui contient, communiquant avec la cavité (4), au moins un passage (11) qui s'étend entre la face frontale du pivot (3) jusqu'à un orifice radial adjacent au deuxième plan transversal (Q₂) et situé dans la deuxième section (Z₂), et tandis que de la deuxième section (Z₂) font saillie vers l'extérieur sur la face annulaire (10b) plusieurs éléments inhibiteurs (14a, 14b, 14c) pouvant être refoulés par déformation élastique dont les limites (15) axialement extérieures sont situées sur un troisième plan transversal (Q₃) perpendiculaire à l'axe longitudinal (A) du pivot et placé entre le deuxième plan transversal (Q₂) et le côté frontal libre (3) du pivot, caractérisé en ce que la face intérieure formant paroi (19) délimitant latéralement la cavité (4) présente un diamètre qui va en augmentant, entre la région plane entourant l'axe longitudinal (A) du pivot, à mesure qu'elle s'approche du côté frontal libre (3) de ce pivot et en ce que cette face intérieure formùant paroi (19) se situe totalement à l'extérieur d'un cône (K) dont l'axe est l'axe longitudinal (A) du pivot, dont le sommet (K) se situe dans le premier plan transversal (Q₁) et dont l'angle au sommet (β) est égal ou supérieur à 50°.
  2. Bouchon de lyophilisation selon la revendication 1, caractérisé en ce que la paroi intérieure (6) de la partie (2b) constituant la paroi centrale du collier (2) qui délimite axialement la cavité (4) est sensiblement plane dans une zone entourant l'axe longitudinal (A) du pivot et que cette zone plane se situe dans un plan ttransversal (P) perpendiculaire à l'axe longitudinal dudit pivot, lequel plan (P) s'étend à proximité du premier plan transversal (Q₁).
  3. Bouchon de lyophilisation selon la revendication 2, caractérisé en ce que la paroi intérieure (6) de délimitation axiale est décalée par rapport au plan (Q₁) en direction de la face extérieure (7) de la partie de paroi centrale (2b).
  4. Bouchon de lyophilisation selon la revendication 1, caractérisé en ce que la zone plane entourant l'axe longitudinal (A) du pivot de la face extérieure de la paroi centrale (2b) du collier (2) est délimitée de la zone plane périphérique restante par des projections (8) disposées en forme de cercle de manière concentrique par rapport à l'axe longitudinal (A) du pivot.
  5. Bouchon de lyophilisation selon la revendication 1, caractérisé en ce que la zone plane entourant l'axe longitudinal (A) du pivot de la face extérieure (7) de la partie de paroi centrale (2b) du collier (2) constitue un creux par rapport à la zone plane périphérique restante.
EP88118843A 1987-12-24 1988-11-11 Bouchon pour lyophilisation Expired - Lifetime EP0322548B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT88118843T ATE91470T1 (de) 1987-12-24 1988-11-11 Gefriertrocknungs-stopfen.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3744174 1987-12-24
DE19873744174 DE3744174A1 (de) 1987-12-24 1987-12-24 Gefriertrocknungs-stopfen

Publications (2)

Publication Number Publication Date
EP0322548A1 EP0322548A1 (fr) 1989-07-05
EP0322548B1 true EP0322548B1 (fr) 1993-07-14

Family

ID=6343657

Family Applications (1)

Application Number Title Priority Date Filing Date
EP88118843A Expired - Lifetime EP0322548B1 (fr) 1987-12-24 1988-11-11 Bouchon pour lyophilisation

Country Status (4)

Country Link
US (1) US4872572A (fr)
EP (1) EP0322548B1 (fr)
AT (1) ATE91470T1 (fr)
DE (2) DE3744174A1 (fr)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5060812A (en) * 1990-09-06 1991-10-29 International Medication Systems, Limited Medication container stopper which can be punctured by nozzle of a hypodermic syringe
US5232109A (en) * 1992-06-02 1993-08-03 Sterling Winthrop Inc. Double-seal stopper for parenteral bottle
US5845797A (en) * 1996-07-31 1998-12-08 Daikyo Seiko, Ltd. Rubber plug for drug vessel
US6243938B1 (en) 1998-03-17 2001-06-12 Becton, Dickinson And Company Low silicone plastic prefillable syringe
US6200627B1 (en) 1998-03-17 2001-03-13 Becton, Dickinson And Company Low silicone glass prefillable syringe
US6907679B2 (en) * 1998-11-12 2005-06-21 Qlt Usa, Inc. Method for lyophilizing an active agent
US6722054B2 (en) 1998-11-12 2004-04-20 Atrix Laboratories, Inc. Process and delivery container for lyophilizing active agent
EP1234614A1 (fr) * 2001-02-27 2002-08-28 Pentapharm Gmbh Récipient-doseur subdivisé par des nervures pour la réception des réagents, sa fabrication et son usage
US20030121878A1 (en) * 2001-12-27 2003-07-03 Finneran James G. Versatile vial and plug system
AU2005203743B1 (en) * 2005-01-21 2006-02-02 Jody Horan A Plug for a Hydraulic Fitting
JP2009506879A (ja) * 2005-09-07 2009-02-19 コヴィディエン・アクチェンゲゼルシャフト 注射器構造体
US7934614B2 (en) * 2006-06-07 2011-05-03 J. G. Finneran Associates, Inc. Two-piece seal vial assembly
GB2448709A (en) * 2007-04-24 2008-10-29 Pentapharm Ag Cap for sealing a vial
US20090001042A1 (en) * 2007-06-26 2009-01-01 Robert Sever Container-closure system for use in lyophilization applications
HUE026463T2 (en) * 2007-10-18 2016-05-30 Daikyo Seiko Ltd rubber Stopper
CN101411671B (zh) * 2008-10-16 2013-08-21 应城市恒天药业包装有限公司 新型药用冻干瓶塞
EP2662303A1 (fr) 2012-05-09 2013-11-13 B. Braun Melsungen AG Capuchon de fermeture
US9278790B2 (en) 2014-06-10 2016-03-08 The United States Of America As Represented By The Secretary Of The Navy Lyophilization tray lid
EP3274265B1 (fr) * 2015-03-23 2023-09-27 West Pharmaceutical Services, Inc. Bouchon de flacon médicinal
EP3411647A4 (fr) 2016-02-05 2019-09-25 Tolmar Therapeutics, Inc. Plaque de recouvrement ventilée pour un groupement de seringues
CN109789953A (zh) * 2016-09-28 2019-05-21 费森尤斯卡比德国有限公司 用于接收医疗液体的容器的封闭盖
IT201700047199A1 (it) * 2017-05-02 2018-11-02 Goglio Spa Tappo a pressione e contenitore ermetico dotato di tale tappo a pressione
USD908916S1 (en) 2018-06-19 2021-01-26 Tolmar Therapeutics, Inc. Syringe restrictor plate
CN113474083A (zh) * 2019-01-04 2021-10-01 仪器实验室公司 用于高刺穿计数应用的容器塞子
KR102870998B1 (ko) * 2020-12-23 2025-10-16 가부시끼가이샤 다이쿄 세이코 고무마개
KR20240051170A (ko) * 2021-08-19 2024-04-19 솜펙스 임- 운트 엑스포르트, 한델스게젤샤프트 미트 베쉬룅크터 하프퉁 운트 코. 코만디트게젤샤프트 등기구 및 조명 장치
JP7795331B2 (ja) * 2021-11-19 2026-01-07 株式会社日立ハイテク チューブ用フランジ付きマルチキャップ
US12434889B2 (en) 2022-12-09 2025-10-07 Instrumentation Laboratory Company Sealing systems

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Publication number Priority date Publication date Assignee Title
US1375471A (en) * 1919-10-17 1921-04-19 Arthur G Sherman Bottle-stopper
US2927709A (en) * 1959-07-07 1960-03-08 Faultless Rubber Co Bottle stopple
FR1255197A (fr) * 1960-04-14 1961-03-03 Pelcerf Ets Bouchon pour obturation de flacons sous vide
US3653528A (en) * 1970-03-03 1972-04-04 West Co Stopper for medicament flasks
FR2096680B1 (fr) * 1970-05-29 1973-12-21 Barville Jean
US3834571A (en) * 1972-11-20 1974-09-10 Warner Lambert Co Container closure for lyophilized products
FR2416848A1 (fr) * 1978-02-08 1979-09-07 Rumpler Jean Jacques Bouchon de recipient de produits medicamenteux
GB2026995B (en) * 1978-08-01 1983-04-27 Coulter Electronics Closure caps
CA1136077A (fr) * 1979-06-04 1982-11-23 Masaki Shimizu Dispositif pour la culture des microorganismes
US4293078A (en) * 1979-11-01 1981-10-06 Becton, Dickinson And Company Vacuum indicator closure for a blood collection tube
US4286389A (en) * 1980-03-03 1981-09-01 Ims Limited Apparatus and method for lyophilizing aseptic substances

Also Published As

Publication number Publication date
DE3744174A1 (de) 1989-07-06
DE3882350D1 (de) 1993-08-19
US4872572A (en) 1989-10-10
ATE91470T1 (de) 1993-07-15
EP0322548A1 (fr) 1989-07-05

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