EP1910172B1 - Mit einer kappe versehene ampulle, die durch vakuum mit einer flüssigkeit gefüllt werden soll und entsprechendes herstellungsverfahren - Google Patents

Mit einer kappe versehene ampulle, die durch vakuum mit einer flüssigkeit gefüllt werden soll und entsprechendes herstellungsverfahren Download PDF

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Publication number
EP1910172B1
EP1910172B1 EP06778110A EP06778110A EP1910172B1 EP 1910172 B1 EP1910172 B1 EP 1910172B1 EP 06778110 A EP06778110 A EP 06778110A EP 06778110 A EP06778110 A EP 06778110A EP 1910172 B1 EP1910172 B1 EP 1910172B1
Authority
EP
European Patent Office
Prior art keywords
ampoule
receptacle
opening
liquid substance
closure means
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.)
Not-in-force
Application number
EP06778110A
Other languages
English (en)
French (fr)
Other versions
EP1910172A2 (de
Inventor
Thierry Chamorot
Christophe Guilbert
Jean-France Baeskens
Christian Vanacker
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.)
Flackpull
Original Assignee
Flackpull
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 Flackpull filed Critical Flackpull
Publication of EP1910172A2 publication Critical patent/EP1910172A2/de
Application granted granted Critical
Publication of EP1910172B1 publication Critical patent/EP1910172B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules

Definitions

  • the field of the invention is that of the packaging of pharmaceutical or para-pharmaceutical products. More specifically, the invention relates to packaging in the form of ampules, intended to contain a liquid substance, drinkable or not.
  • Bottle bulbs are most often used for the packaging of injectable pharmaceutical products or cosmetics.
  • These bulbs are packaged in a special room in a filtered atmosphere. They are made by hot shaping of glass tubes so as to have a flat bottom and a flared or closed opening, a throat being provided between the body of the ampoule and the opening to form a rupture zone at the moment of rupture. 'opening.
  • the closure is performed by a conventional flame shutter technique.
  • the bottles are also made of glass and filled with needle systems or with nozzles. They present commonly screw necks allowing the establishment of a screw cap.
  • the needle filling technique ensures a high accuracy in the amount of product delivered inside the container.
  • Another technique is used to increase filling rates, when it is not necessary to achieve a high level of accuracy.
  • These bulbs are made from glass tubes and have, for filling, a closed tip (flame) and an open tip.
  • the bulbs of this type are arranged in crystallizers.
  • the crystallizers are brought by manipulation into a tank containing the liquid substance for filling the ampoules.
  • the crystallizers are placed in the tray so as to have the open ends directed downwards, at a predetermined level in the liquid substance.
  • the next step is to evacuate the bin so that air is expelled from the inside of the bin and the bulbs. When the vacuum is obtained, the vacuum is "broken" by putting the tank back to atmospheric pressure.
  • the return to atmospheric pressure causes the filling of the ampoules, which behave like pumps that suck the liquid.
  • the filling level depends on the vacuum applied in the tank.
  • the crystallizers are turned over and the open tips that were used for filling are washed with hand warmers with alternating cold water / hot water to clean the tip.
  • the tips thus cleaned are then sealed with a torch.
  • the user To extract the liquid from the ampoules, the user must break a point, present the tip thus opened above a container, then break the other tip for the liquid spill.
  • these bulbs are made from glass tube, which is by nature a brittle material.
  • These glass chips can fall into the container in which the liquid is spilled, or be entrained by the liquid during its discharge from the bulb.
  • the document FR-794 592 discloses a drug product ampoule made of glass, having a drain point and a filling opening at the end of the bulb opposite the tip.
  • the invention aims to overcome the disadvantages of the prior art.
  • the object of the invention is to propose a liquid substance container which makes it possible to use a vacuum filling technique and which avoids, or at least considerably limits, the risk of splinters of the material in which it is produced. the recipient.
  • the invention also aims to provide such a container that is simple and convenient for the user.
  • the invention also aims to provide such a container that is simple in design and easy to implement.
  • Another object of the invention is to provide a method of manufacturing such a container.
  • a bulb forming a container for a liquid substance, made of a brittle thermofusible rigid material, of the type comprising a body presenting a one of its ends a suction filling point of said liquid substance, characterized in that the end opposite said tip forms a drain opening of said container, sealing and removable closure means being attached to said opening.
  • said body has the shape of a cylindrical tube, said opening having a diameter corresponding to that of said tube.
  • the opening can be obtained very simply during the manufacture of the bulb, by simply cutting a tube, without requiring further shaping of the tube.
  • said closure means comprise a cover.
  • said closure means comprise a plug.
  • said closure means are preferably removably attached to said opening by a heat sealing or gluing technique.
  • said opening has a peripheral rim on which said closure means are attached.
  • said flange extends towards the inside of the container.
  • said flange extends outwardly of the container.
  • the bulb is made of glass.
  • the invention also relates to a method of manufacturing a bulb made of a brittle thermofusible rigid material, comprising a hot forming step of a tube so as to obtain a bulb having at one of its ends a filling tip by suction of said liquid substance, characterized in that it comprises a step of hot shaping of the end opposite said tip so as to form a drain opening said container, and a step of reporting on said opening sealing means and sealed removable.
  • said step of reporting on said opening sealing and removable closure means is a heat sealing step of a lid.
  • said heat sealing step is performed while said bulb retains residual heat due to said hot forming steps.
  • the principle of the invention lies in the fact of making a container bulb which has at one of its ends a filling point and at the other end thereof an opening provided with removable closure means .
  • the ampoule and made from a cylindrical glass tube and has at one of its ends a filling point 1, and at its other end an opening 2 whose diameter is identical to that of the body 3 of the bulb.
  • the tip 1 is open or closed.
  • the manufacture of the ampoule and the filling thereof are carried out on separate sites.
  • the bulbs appear with the tip filling open, to allow filling according to a method explained in more detail later.
  • the filling tips are closed and the ampoules are packaged and distributed closed tips.
  • the removable closure means are constituted by a lid 4 attached to the opening 2, for example by a heat-sealing technique (or gluing according to another possible embodiment).
  • the heat-sealing (or bonding) is performed so as to obtain a peelable seal, that is to say designed to withstand a predetermined tensile force, and detach from the bulb beyond this force .
  • Such a cover may consist of a complex comprising aluminum, in thin thickness (for example from 20 to 80 microns) and be assembled to the ampoule with one or more layers of heat-sealable products, possibly adding PVC or PET (or any other suitable material) to reinforce the lid.
  • the seal may further be printed and / or colored.
  • the lid has a tongue 41 facilitating the gripping of the lid at the time of removal thereof.
  • the closure means are constituted by a plug, attached to the bulb also by heat sealing or gluing or other suitable systems.
  • FIGS. 3 and 4 illustrate possible variants according to which the opening 2 has a peripheral rim so as to increase the surface supporting the cover.
  • Such a flange may extend towards the outside of the opening 2 ( figure 3 ) or towards the inside of the opening ( figure 4 ).
  • the tip 1 has a shorter length possible to reduce the overall dimensions of the bulb on the one hand, and on the other hand, to optimize the mechanical strength of the tip.
  • the tip of a bulb according to the invention is not intended to be broken, unlike the tips of the ampules of the prior art.
  • To discharge the liquid content of the ampoule it is sufficient to tear off the lid and reverse the bulb, the opening being largely sufficient to allow the introduction of air simultaneously spill liquid (which n ' was not the case with the "two-pointed" bulbs with which it was necessary to break each point, one serving to pour the liquid and the other to allow the passage of air).
  • the method of manufacturing ampoules according to the invention is as follows.
  • Glass tubes are introduced in rotary machines such as those conventionally used for the production of "two-tip" ampoules of the prior art.
  • Blisters are thus hot-formed so that they have an open point at one of their ends and an opening at the other end of their ends.
  • the bulbs leaving the annealing furnace retain a residual heat used to heat seal the covers.
  • Additional heat is supplied to bring the ampoules to a sufficiently high temperature to allow heat sealing of the caps by pressing the caps on the glass.
  • the temperature of the glass is checked, without contact, to regulate the heating of the glass before the heat sealing of the lid.
  • the sealing of these (operculum side) is controlled by pressure (after cooling the ampoules), using a pressure switch, to eliminate all the bulbs that would not not satisfactory.
  • the filling of the ampoules is carried out according to a technique identical or similar to that described for the filling of ampoules "two points".

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Compounds Of Unknown Constitution (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)

Claims (10)

  1. Ampulle, die ein Gefäß für eine flüssige Substanz bildet und aus Glas gefertigt ist, von der Art, die einen Körper (3) umfasst, der an einem seiner Enden eine Spitze (1) zum Füllen aufweist, wobei die besagte Spitze (1) geschlossen ist,
    dadurch gekennzeichnet, dass das der besagten geschlossenen Spitze (1) entgegengesetzt liegende Ende (2) eine Öffnung zum Entleeren des besagten Gefäßes bildet, wobei wasserdichte und abnehmbare Verschlussmittel (4) auf die besagte Öffnung (2) aufgebracht werden, wobei die besagten Verschlussmittel (4) dazu bestimmt sind, entfernt zu werden, um die besagte Substanz aus der besagten Ampulle auszugießen.
  2. Ampulle nach Anspruch 1, die ein Gefäß für eine flüssige Substanz bildet, dadurch gekennzeichnet, dass der besagte Körper (3) die Form eines zylindrischen Rohrs aufweist, wobei der Durchmesser der besagte Öffnung (2) dem des besagten Rohrs entspricht.
  3. Ampulle nach einem der Ansprüche 1 oder 2, die ein Gefäß für eine flüssige Substanz bildet, dadurch gekennzeichnet, dass die besagten Verschlussmittel (4) einen Deckel beinhalten.
  4. Ampulle nach einem der Ansprüche 1 oder 2, die ein Gefäß für eine flüssige Substanz bildet, dadurch gekennzeichnet, dass die besagten Verschlussmittel (4) einen Stopfen aufweisen.
  5. Ampulle nach einem der Ansprüche 1 bis 4, die ein Gefäß für eine flüssige Substanz bildet, dadurch gekennzeichnet, dass die besagten Verschlussmittel (4) in abnehmbarer Weise an die besagte Öffnung mit Hilfe einer Heißversiegelungstechnik, einer Verklebung oder eines beliebigen anderen geeigneten Mittels befestigt sind.
  6. Ampulle nach einem der Ansprüche 1 bis 5, die ein Gefäß für eine flüssige Substanz bildet, dadurch gekennzeichnet, dass die besagte Öffnung eine umlaufende Umrandung aufweist, auf der die besagten Verschlussmittel (4) aufgesetzt sind.
  7. Ampulle nach Anspruch 6, die ein Gefäß für eine flüssige Substanz bildet, dadurch gekennzeichnet, dass sich die besagte Umrandung zum Inneren des Gefäßes hin erstreckt.
  8. Ampulle nach Anspruch 6, die ein Gefäß für eine flüssige Substanz bildet, dadurch gekennzeichnet, dass sich die besagte Umrandung zum Äußeren des Gefäßes hin erstreckt.
  9. Herstellungsverfahren einer Ampulle nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass es einen Schritt der Hitzeformgebung des der besagten Spitze entgegen liegenden Endes aufweist, um eine Öffnung zum Entleeren des besagten Gefäßes zu bilden, sowie einen Schritt zur Heißversiegelung eines Deckels auf der besagten Öffnung der wasserdichten und abnehmbaren Verschlussmittel.
  10. Verfahren nach Anspruch 9, dadurch gekennzeichnet, dass der besagte Schritt zur Heißversiegelung durchgeführt wird, so lange die besagte Ampulle eine von den besagten Schritten zur Hitzeformgebung herrührenden Restwärme aufweist.
EP06778110A 2005-08-03 2006-08-01 Mit einer kappe versehene ampulle, die durch vakuum mit einer flüssigkeit gefüllt werden soll und entsprechendes herstellungsverfahren Not-in-force EP1910172B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0508285A FR2889506B1 (fr) 2005-08-03 2005-08-03 Ampoule operculee destinee a etre remplie d'un liquide par depression et procede de fabrication correspondant
PCT/EP2006/064920 WO2007014955A2 (fr) 2005-08-03 2006-08-01 Ampoule operculee destinee a etre remplie d'un liquide par depression et procede de fabrication correspondant

Publications (2)

Publication Number Publication Date
EP1910172A2 EP1910172A2 (de) 2008-04-16
EP1910172B1 true EP1910172B1 (de) 2010-12-15

Family

ID=36204346

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06778110A Not-in-force EP1910172B1 (de) 2005-08-03 2006-08-01 Mit einer kappe versehene ampulle, die durch vakuum mit einer flüssigkeit gefüllt werden soll und entsprechendes herstellungsverfahren

Country Status (9)

Country Link
US (1) US20080296198A1 (de)
EP (1) EP1910172B1 (de)
AT (1) ATE491644T1 (de)
CA (1) CA2617295A1 (de)
DE (1) DE602006018940D1 (de)
ES (1) ES2358127T3 (de)
FR (1) FR2889506B1 (de)
HK (1) HK1118779A1 (de)
WO (1) WO2007014955A2 (de)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2266881A1 (de) 2009-06-24 2010-12-29 José Luis Flores Agell Hohlglasbehälter
WO2011035449A2 (de) * 2009-09-22 2011-03-31 Medmix System Ag Versiegelter behälter mit verschiebbarem kolben
FR2955844B1 (fr) * 2010-02-03 2012-04-27 Saint Gobain Emballage Procede d'ouverture facile d'un opercule thermoscelle sur le buvant d'un recipient en verre
US20130112578A1 (en) * 2011-11-04 2013-05-09 Kyle Matthew Lemke Novelty Shot Glass
FR3031668A1 (fr) 2015-01-20 2016-07-22 Philippe Perovitch Dispositif d'administration d'un principe actif par voie per-muqueuse buccale.
FR3053244A1 (fr) 2016-07-01 2018-01-05 Philippe Perovitch Dispositif d'administration d'au moins un principe actif par voie per-muqueuse buccale.

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US32109A (en) * 1861-04-16 de beame
US2028241A (en) * 1934-06-15 1936-01-21 United States Radium Corp Method of making self-luminous element
FR794592A (fr) * 1935-09-04 1936-02-20 Ampoule distributrice
US2383098A (en) * 1942-07-21 1945-08-21 Jr Frank H Wheaton Double-mouthed bottle
FR1241230A (fr) * 1959-08-04 1960-09-16 Prolabo Sa Ampoule pour le conditionnement de réactifs
USRE32109E (en) * 1979-10-19 1986-04-15 Brockway Inc. (Ny) Preparation of glass container for thermoplastic closure
US4990016A (en) * 1988-12-16 1991-02-05 David Seidler Liquid applicator sampler tube
US5470537A (en) * 1993-08-25 1995-11-28 National Scientific Company Supporting stand for conical-bottom limited-volume vial
IT1287450B1 (it) * 1996-06-27 1998-08-06 Lameplast Srl Contenitore richiudibile e relativo metodo di fabbricazione
US6682518B1 (en) * 2000-06-16 2004-01-27 Labtest Associates, Inc. Injectable micro-glass vial
US7168581B2 (en) * 2001-12-21 2007-01-30 Rexam Medical Packaging Inc. Closure for a retort processed container having a peelable seal

Also Published As

Publication number Publication date
CA2617295A1 (en) 2007-02-08
DE602006018940D1 (de) 2011-01-27
FR2889506A1 (fr) 2007-02-09
ATE491644T1 (de) 2011-01-15
HK1118779A1 (en) 2009-02-20
EP1910172A2 (de) 2008-04-16
US20080296198A1 (en) 2008-12-04
ES2358127T3 (es) 2011-05-05
FR2889506B1 (fr) 2010-08-27
WO2007014955A3 (fr) 2007-05-03
WO2007014955A2 (fr) 2007-02-08

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