EP1600139A1 - Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters - Google Patents

Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters Download PDF

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Publication number
EP1600139A1
EP1600139A1 EP20040370016 EP04370016A EP1600139A1 EP 1600139 A1 EP1600139 A1 EP 1600139A1 EP 20040370016 EP20040370016 EP 20040370016 EP 04370016 A EP04370016 A EP 04370016A EP 1600139 A1 EP1600139 A1 EP 1600139A1
Authority
EP
European Patent Office
Prior art keywords
vial
filling
container
cap
filling pipe
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Withdrawn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
EP20040370016
Other languages
English (en)
French (fr)
Inventor
Jean Ringot
Jaouad Zemmouri
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.)
Optical System and Research for Industry and Science OSYRIS SA
Original Assignee
Optical System and Research for Industry and Science OSYRIS SA
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 Optical System and Research for Industry and Science OSYRIS SA filed Critical Optical System and Research for Industry and Science OSYRIS SA
Priority to EP20040370016 priority Critical patent/EP1600139A1/de
Priority to EP20050744593 priority patent/EP1748752A1/de
Priority to US11/597,499 priority patent/US20080011705A1/en
Priority to JP2007513764A priority patent/JP2008500240A/ja
Priority to PCT/EP2005/005489 priority patent/WO2005115302A1/en
Publication of EP1600139A1 publication Critical patent/EP1600139A1/de
Withdrawn legal-status Critical Current

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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
    • 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
    • A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
    • 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
    • A61J1/1468—Containers characterised by specific material properties

Definitions

  • the present invention generally relates to an airtight container that is being used for storing a liquid under sterile conditions, and that comprises a cap which is designed to be manually punctured, for example by using a needle or a syringe, in order to empty the container.
  • a preferred application of the invention is a small-sized airtight container that is being used in the pharmaceutical field for storing a medicament such as vaccines or the like.
  • liquid medicaments such as vaccines
  • small-sized airtight containers constituted by a rigid vial that is typically made of glass or plastic, and that is airtight sealed by a cap.
  • the cap is typically made of vulcanized rubber or similar resilient material that neither contaminates nor affects the medicament, and that can be manually punctured by using a sharp element such as a syringe or a needle, in order to empty the vial.
  • a major technical problem in this technical field is to avoid the contamination of the liquid (medicament or the like) stored inside the container, and thus to guarantee the sterility of the inside of the container during the filling process and also after the filling process.
  • the vial and the cap are sterilized separately, then the vial is filled with the medicament or the like, and the cap is assembled to the vial in order to seal the medicament in the vial.
  • One major drawback of this first filling procedure is that it is difficult to maintain the sterility of the cap and vial during the assembly step. In addition, it is difficult to maintain the sterility of the vial and cap during transportation and storage prior filling.
  • a second aseptic filling procedure wherein: in a first step, the cap is assembled to the vial so as to hermetically seal the vial ; in a second step the vial and the cap are sterilized, for example by gamma irradiation or the like ; in a third step, the vial is filled with the medicament by using a sterile syringe or like injection element that is temporarily inserted through the cap.
  • a first major drawback associated with this second aseptic filling procedure is that when the injection member (syringe, needle or the like) is temporarily inserted through the cap, and then withdrawn, a tiny hole is being formed in the cap.
  • the hole resulting from the insertion of the needle or the like shrinks somewhat due to the resiliency of the cap.
  • the tiny hole that is formed in the cap is small enough to keep the medicament from leaking out, but is typically not small enough to prevent air or other gases from passing through the hole and into the vial.
  • a resilient material such as vulcanized rubber is infusible. It is thus not possible to fuse such material in situ, for example with a suitable laser, in order to hermetically close the said tiny hole formed in the cap.
  • the aforesaid second filling procedure is being used, because of this tiny hole resulting from the insertion of the needle or the like, there is still a high risk of spoiling and/or contamination of the medicament stored in the vial.
  • a second major drawback associated with the aforesaid second filling procedure is that the exhaust of the air contained in the vial during the filling step is difficult, because of the very small diameter of the needle used for filling the vial ; said exhaust of air typically involves the use of an additional duct acting as a vent, and it is in practise difficult to correctly measure out the medicament introduced in the vial.
  • a heat resealable cap comprising a first base portion formed of vulcanized rubber or like material known for providing a stable environment for the medicament contained in the vial, and a second heat resealable portion overlying the base portion.
  • the second heat resealable portion is made of low-density polyethylene or like material, that can be manually punctured by a needle or similar.
  • the aforesaid second filling procedure is used for filling the vial with the liquid medicament, and once the needle or the like is being withdrawn, the penetrated region of the cap is fused by laser or direct heat sealing, in order to hermetically seal the needle hole in the cap.
  • the use of said composite cap (heat resealable portion/ vulcanized rubber base portion) disclosed in US patent N° 6,604,561 solves the problem of contamination due to the formation of the needle hole in the cap after filling.
  • a major advantage of the invention is to avoid a perforation of the cap for filling the container.
  • the filling of the container is performed through the filling pipe of the container, once said filling pipe has been temporarily opened ; the invention thus overcomes all the drawbacks of the prior art that were associated to the formation of the hole in the cap after filling, and to the closing of said hole.
  • the cap is being punctured only when emptying the vial ;
  • the structure of the cap can thus be very simple and the cap can be made from any material that is compatible with the liquid and that can be manually punctured. In particular, said material does not need to be resealable.
  • Another advantage of the invention is that in practise the filling pipe can easily have a diameter that is large enough for enabling an easy exhaust of the air contained in the vial, during the filling step.
  • the equipment used for filling the vial or the equipment used for closing the filling pipe comes into contact with the filling pipe only, and does necessarily penetrate inside the vial.
  • Figures 1 and 2 show an empty container 1 of the invention, prior aseptic filling with a liquid, such as for example a medicament or the like.
  • Said container 1 comprises :
  • the vial 2 can be made of any sterilizable and inert material that is compatible with the liquid that has to be stored.
  • the vial 2 can be for example made of glass or plastic.
  • the cap 3 can be made of any sterilizable material that is compatible with the liquid, and that can be easily and manually punctured with a needle, a syringe or the like.
  • the invention is not limited to a rubber vulcanized cap.
  • the filling pipe 5 defines an internal fluid passage 6 (figure 3) having an open proximal end 6a, and is airtightly fixed to the bottom end 2b of the vial 2 by any suitable means, in such a way that the open proximal end 6a of the fluid passage 6 communicates with the bottom filling hole 2c of the vial 2. It is important for the seal between the filling pipe 5 and the vial 2 to be airtight, in order to avoid any risk of contamination of the inside of the vial 2.
  • the filling pipe 5 has a proximal end 5a in the form of a "T", and is locked onto the vial 2 by an additional locking cap 7 which squeezes the proximal end 5a of the filing pipe against the external face of the bottom end 2b of the vial 2.
  • Said fixing means does not limit the scope of the invention, and can be replaced by any other suitable airtight fixing means.
  • the proximal end 5a of the filling pipe 5 could be inserted and airtightly fixed through the bottom filling hole 2c of the vial 2 (as shown on figure 2).
  • Figure 4 shows another variant for airtightly fixing the filling pipe 5 on the vial 2.
  • the filling pipe 5 could be welded on the vial.
  • the filling pipe 5 is made of any sterilizable material that is compatible with the liquid that will be stored inside the vial 2.
  • the pipe is preferably flexible and is for example made of any biocompatible polymer and more particularly any biocompatible elastomer.
  • the distal end 5b of the filling pipe is airtightly closed.
  • the filling pipe 5 thus airtightly seals the filling hole 2c of the vial 2, in order to avoid the accidental penetration of any contaminant (solid, liquid or gaz) inside the vial 2.
  • the opening of the distal end 5b of the filling pipe (during the filling step) can be performed by simply pinching the distal end 5b of the pipe 5, so as to create an internal fluid passage 6 on the whole length of the filling pipe.
  • the pinching pressure is released, the distal end 5b of the filling pipe 5 comes back to its closed state, as illustrated on figure 3 or figure 4.
  • the process for the aseptic filling of the container 1 with a liquid, such as a medicament comprises the following steps.
  • the final closing step (e) can be performed in different ways.
  • the filling pipe 5 is pressed in order to airtightly close the pipe 5, and the distal end 5b of the pipe 5 is thermally sealed (by laser or by using any thermal source for fusing the distal end of the pipe).
  • the filling pipe 5 is preferably fold up as depicted on figure 9. This can be achieved by a mechanical action eventually combined with a local heating of the pipe in order to locally soften the pipe 5.
  • all the equipments used for definitely closing the filling pipe (step e) do not come into contact with the inside of the vial 2
  • a cap 12 is definitely fixed onto the bottom end 2b of the vial 2, said bottom cap 12 defining with the vial 2 an housing 12a for the pipe 5.
  • the pipe 5 is this no longer accessible.
  • the cap 12 protects the filling pipe 5, and avoids any risk of detrimental manipulation thereof.
  • the cap 12 also forms a stable and aesthetic base for the container 1.
  • the liquid is advantageously not subjected to any pressure variations or to any thermal variations. There is thus not modification of the properties of said liquid.
  • the filling pipe 5 is airtightly closed, prior the filling step (b), so as to preclude the penetration of any contaminant inside the vial during the process.
  • the invention is not limited to the particular filling pipe shown in figures 3 and 4.
  • the distal end 5b of the filling pipe 5 is airtightly closed by a removable cap 8.
  • the distal end 5b of the filling pipe 5 is airtightly closed by a removable clip 9.
  • the distal end 5b of the filling pipe 5 could be thermally fused so as to be hermetically closed, and the opening of the pipe (step (b)) could be performed by cutting the closed end the pipe 5 (for example by using a laser or any mechanical cutting means).
  • the final container 1' containing the liquid is shown on figure 11.
  • the emptying of the container 1' is performed by puncturing the cap 3 (in the area 3a that is not surrounded by the locking ring 4) with a needle or syringe, and by sucking through the cap 3 the liquid contained inside the vial 2.

Landscapes

  • 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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
EP20040370016 2004-05-25 2004-05-25 Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters Withdrawn EP1600139A1 (de)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP20040370016 EP1600139A1 (de) 2004-05-25 2004-05-25 Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters
EP20050744593 EP1748752A1 (de) 2004-05-25 2005-05-20 Luftdichter behälter zur aufbewahrung eines produkts und insbesondere eines medikaments und aseptisches füllverfahren für diesen behälter
US11/597,499 US20080011705A1 (en) 2004-05-25 2005-05-20 Airtight Container for Storing a Product, and in Particular a Medicament, and Aseptic Process for Filling Said Container
JP2007513764A JP2008500240A (ja) 2004-05-25 2005-05-20 製品、特に薬剤を貯蔵するための気密容器、及び前記容器を充填するための無菌的方法
PCT/EP2005/005489 WO2005115302A1 (en) 2004-05-25 2005-05-20 Airtight container for storing a product, and in particular a medicament, and aseptic process for filling said container

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20040370016 EP1600139A1 (de) 2004-05-25 2004-05-25 Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters

Publications (1)

Publication Number Publication Date
EP1600139A1 true EP1600139A1 (de) 2005-11-30

Family

ID=34931828

Family Applications (2)

Application Number Title Priority Date Filing Date
EP20040370016 Withdrawn EP1600139A1 (de) 2004-05-25 2004-05-25 Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters
EP20050744593 Withdrawn EP1748752A1 (de) 2004-05-25 2005-05-20 Luftdichter behälter zur aufbewahrung eines produkts und insbesondere eines medikaments und aseptisches füllverfahren für diesen behälter

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP20050744593 Withdrawn EP1748752A1 (de) 2004-05-25 2005-05-20 Luftdichter behälter zur aufbewahrung eines produkts und insbesondere eines medikaments und aseptisches füllverfahren für diesen behälter

Country Status (4)

Country Link
US (1) US20080011705A1 (de)
EP (2) EP1600139A1 (de)
JP (1) JP2008500240A (de)
WO (1) WO2005115302A1 (de)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3537390A1 (de) * 2018-03-07 2019-09-11 Wanzl Metallwarenfabrik GmbH Scanvorrichtung sowie verfahren hierzu

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1600139A1 (de) * 2004-05-25 2005-11-30 Optical System & Research for Industry and Science Osyris Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US274447A (en) * 1883-03-20 William-kentish
US1579996A (en) * 1923-12-08 1926-04-06 Banes Glenn Owen Syringe-filling attachment for bottles
EP0320938A2 (de) * 1987-12-16 1989-06-21 Koken Co. Ltd. Ventil
WO1995013786A1 (en) * 1993-11-19 1995-05-26 Giuseppe Reina Valvular device for the liquid oral feeding of persons
US6364168B1 (en) * 1998-07-17 2002-04-02 Camelbak Products, Inc. Personal hydration system with an improved mouthpiece

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB295184A (en) * 1928-01-20 1928-08-09 Ronald Marshall Improvements in or relating to filling cans for lamps, stoves or other receptacles
US2896619A (en) * 1954-10-14 1959-07-28 Fenwal Lab Inc Apparatus for handling fluid blood
GB1544811A (en) * 1975-05-30 1979-04-25 Stichting Centraal Lab Container for liquids for use in medicine and surgery
GB2032006A (en) * 1978-09-07 1980-04-30 Frutin B D Dispensing liquiform materials
US4867315A (en) * 1988-06-06 1989-09-19 Baldwin Brian E Vial filling, holding and serving tray arrangement and method
JPH0558140U (ja) * 1992-01-17 1993-08-03 株式会社ニッショー 薬液容器
US5817083A (en) * 1993-05-31 1998-10-06 Migda Inc. Mixing device and clamps useful therein
US6604561B2 (en) 2000-02-11 2003-08-12 Medical Instill Technologies, Inc. Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial
EP1600139A1 (de) * 2004-05-25 2005-11-30 Optical System & Research for Industry and Science Osyris Luftdicht verschlossener Behälter zur Aufbewahrung einer flüssigen Substanz, insbesondere einer medizinischen Substanz, und Verfahren zur aseptischen Abfüllung dieses Behälters

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US274447A (en) * 1883-03-20 William-kentish
US1579996A (en) * 1923-12-08 1926-04-06 Banes Glenn Owen Syringe-filling attachment for bottles
EP0320938A2 (de) * 1987-12-16 1989-06-21 Koken Co. Ltd. Ventil
WO1995013786A1 (en) * 1993-11-19 1995-05-26 Giuseppe Reina Valvular device for the liquid oral feeding of persons
US6364168B1 (en) * 1998-07-17 2002-04-02 Camelbak Products, Inc. Personal hydration system with an improved mouthpiece

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3537390A1 (de) * 2018-03-07 2019-09-11 Wanzl Metallwarenfabrik GmbH Scanvorrichtung sowie verfahren hierzu

Also Published As

Publication number Publication date
US20080011705A1 (en) 2008-01-17
JP2008500240A (ja) 2008-01-10
EP1748752A1 (de) 2007-02-07
WO2005115302A1 (en) 2005-12-08

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