WO2005115302A1 - Airtight container for storing a product, and in particular a medicament, and aseptic process for filling said container - Google Patents
Airtight container for storing a product, and in particular a medicament, and aseptic process for filling said container Download PDFInfo
- Publication number
- WO2005115302A1 WO2005115302A1 PCT/EP2005/005489 EP2005005489W WO2005115302A1 WO 2005115302 A1 WO2005115302 A1 WO 2005115302A1 EP 2005005489 W EP2005005489 W EP 2005005489W WO 2005115302 A1 WO2005115302 A1 WO 2005115302A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- vial
- container
- filling
- filling pipe
- cap
- Prior art date
Links
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 product under sterile conditions.
- a preferred application of the invention is a small-sized airtight container that is being used preferably in the pharmaceutical field for storing for example a medicament such as vaccines or the like.
- medicaments such as vaccines
- the closing cap is typically made of vulcanized rubber or similar resilient material that neither contaminates nor affects the medicament, and that can be manually punctured or pierced by using a sharp element such as a syringe or a needle, in order to empty the vial.
- a sharp element such as a syringe or a needle
- the closing cap is manually pierced by using a syringe and is sucked outside of the vial.
- the medicament is a solid, for example a powder
- the closing cap is pierced by using a syringe or the like, and a liquid, for example water, is introduced into the vial by using the syringe.
- the vial is then shaken so as to mix the powder and the liquid, and the solution inside the vial is for example sucked out of the vial, though the closing cap, by using a syringe or the like.
- a major technical problem in this technical field is to avoid the contamination of the product (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.
- 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.
- 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.
- Objective of the invention It is an objective of the invention to propose a new technical solution for storing a product under sterile conditions, and in particular ( but not only) a medicament, in a container, which solution enables to maintain the sterility of the inside of the container, and overcomes all the aforesaid drawbacks of the prior art. Summary of the invention This objective is achieved by the new airtight container of claim 1 and by the aseptic filling process of claim 18.
- a major advantage of the invention is to avoid any perforation of the container part 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 closing cap during the filling step and to the closing of said hole once the filing step is terminated.
- the structure of the said closure element can be very simple and the said closure element can be made of any material that is compatible with the stored product. 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.
- FIG. 1 is a perspective view of an empty container of the invention, prior to the filling step ;
- - Figure 2 is a perspective view of an half of the container of figure 1 showing the inside of the container ;
- - Figure 3 is a cross-sectional view of the bottom part of the container prior to the filling step, and shows a first embodiment for the fixing means of the filling pipe ;
- - Figure 4 is a cross-sectional view of the bottom part of the container prior to the filling step, and shows a second embodiment for the fixing means of the filling pipe;
- - Figure 5 is a cross sectional view of the distal end of a filling pipe closed by a cap ;
- - Figure 6 is a cross-section view of the distal end of a filling pipe closed by a clip ;
- - Figures 7 to 10 schematically shows the successive steps for filling the container of figure 2 with a product (in particular a liquid, or powder or granulates), and
- - Figure 11 is
- FIGS. 1 and 2 show an empty container 1 of the invention, prior aseptic filling with a product (liquid, powder, granulates), such as for example a medicament or the like.
- a product liquid, powder, granulates
- the invention is however not limited to the storage of medicament, but is useful for storing any product, in particular under sterile conditions.
- Said container 1 comprises : - a rigid vial 2 constituted by a cylindrical sidewall 2a and a bottom wall 2b, said bottom wall 2b having a small central filling hole 2c,
- a closure element in the form of a rubber vulcanized cap 3 which is slidably received in the open end of the vial 2 (opposite to the bottom end 2b) ; such a cap 3 is also commonly referred as a "stopper” ; - a locking ring 4, for example made of aluminium or plastic, that is crimped in place onto the vial 2 in order to lockably connect and airtight seal the cap 3 to the vial 2;
- the vial 2 can be made of any sterilizable and inert material that is compatible with the product 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 product stored in the container, and that can be easily and manually punctured or pierced with a sharp element such as a needle or a syringe.
- the cap 3 is preferably (but not necessarily) made of a resilient material, and more preferably made of vulcanized rubber.
- 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.
- 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 product 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 distal end 5b of the filling pipe 5 comes back to its closed state, as illustrated f on figure 3 or figure 4.
- the process for the aseptic filling of the container 1 with a product, such as a medicament comprises the following steps.
- (a) The empty container 1 of figure 1 or figure 2 is sterilized by using any well-known sterilization process and for example by using gamma radiations.
- the external diameter of the filling nozzle 10 has to be smaller than the internal diameter of the filling pipe 5.
- the filling nozzle 10 is removed from the filling pipe 5 and the distal end 5b of the filling pipe is hermetically closed (figure 8), by releasing the pressure exerted by the jaws 11.
- the filling pipe 5 is definitely closed.
- the final closing step (e) can be performed in different ways. For example 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 do not come into contact with the inside of the vial 2
- a housing cap 12 is definitely fixed onto the bottom end 2b of the vial 2, said bottom cap 12 forming with the vial 2 an housing 12a for the pipe 5.
- the pipe 5 is thus no longer accessible.
- the housing cap 12 protects the filling pipe 5, and avoids any risk of detrimental manipulation thereof.
- said housing cap 12 is first sterilized and then assembled to the vial 2, in order to avoid any risk of contamination of the filling pipe 5.
- the housing cap 12 also advantageously forms a stable and aesthetic base for the container 1.
- the external filling pipe 5 there is advantageously no need to perforate the vial 2 or the cap 3 during the filling process. There is thus no risk of contamination of the inside of the vial by particles or the like coming from the vial, the cap or from any equipment used during the aseptic filling process.
- the product stored inside the vial 2 is advantageously not subjected to any pressure variations or to any thermal variations. There is thus no modification of the properties of said product.
- 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 product is shown on figure 11.
- the emptying of the container V 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 product contained inside the vial 2.
- a liquid such as water can be previously introduced inside the vial 2 through the closing cap 3, in order to dilute the powder and form a solution inside the vial 2.
- the invention is not limited to the use of a rubber cap 3 for closing the vial 2.
- the cap 3 can be replaced by any closure element that can be removed from the vial during the emptying step (for example a removable cap screwed onto the vial), or by any closure element that can be pierced, or broken, or torn off the vial, or torn on, for emptying the vial.
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- 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)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
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 (en) | 2004-05-25 | 2005-05-20 | Airtight container for storing products, in particular medicaments, and aseptic method for filling said containers |
EP20050744593 EP1748752A1 (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 (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP04370016.0 | 2004-05-25 | ||
EP20040370016 EP1600139A1 (en) | 2004-05-25 | 2004-05-25 | Airtight container for storing a liquid, and in particular a medicament, and aseptic process for filing said container |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2005115302A1 true WO2005115302A1 (en) | 2005-12-08 |
Family
ID=34931828
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
Country Status (4)
Country | Link |
---|---|
US (1) | US20080011705A1 (en) |
EP (2) | EP1600139A1 (en) |
JP (1) | JP2008500240A (en) |
WO (1) | WO2005115302A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2008500240A (en) * | 2004-05-25 | 2008-01-10 | オプティカル システム アンド リサーチ フォー インダストリー アンド サイエンス オシリス | Airtight container for storing products, in particular medicaments, and aseptic method for filling said containers |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102018105170A1 (en) * | 2018-03-07 | 2019-09-12 | Ait Goehner Gmbh | Scanning device and method for this |
Citations (9)
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 |
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 |
GB2032006A (en) * | 1978-09-07 | 1980-04-30 | Frutin B D | Dispensing liquiform materials |
US4439192A (en) * | 1975-05-30 | 1984-03-27 | Stichting Centraal Laboratorium Van De Bloedtransfusiedienst Van Het Nederlandse Rode Kruis | Container for liquids for use in medicine and surgery |
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 |
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 |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0412986Y2 (en) * | 1987-12-16 | 1992-03-27 | ||
US4867315A (en) * | 1988-06-06 | 1989-09-19 | Baldwin Brian E | Vial filling, holding and serving tray arrangement and method |
JPH0558140U (en) * | 1992-01-17 | 1993-08-03 | 株式会社ニッショー | Chemical solution container |
US5817083A (en) * | 1993-05-31 | 1998-10-06 | Migda Inc. | Mixing device and clamps useful therein |
EP1600139A1 (en) * | 2004-05-25 | 2005-11-30 | Optical System & Research for Industry and Science Osyris | Airtight container for storing a liquid, and in particular a medicament, and aseptic process for filing said container |
-
2004
- 2004-05-25 EP EP20040370016 patent/EP1600139A1/en not_active Withdrawn
-
2005
- 2005-05-20 WO PCT/EP2005/005489 patent/WO2005115302A1/en active Application Filing
- 2005-05-20 EP EP20050744593 patent/EP1748752A1/en not_active Withdrawn
- 2005-05-20 US US11/597,499 patent/US20080011705A1/en not_active Abandoned
- 2005-05-20 JP JP2007513764A patent/JP2008500240A/en active Pending
Patent Citations (9)
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 |
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 |
US4439192A (en) * | 1975-05-30 | 1984-03-27 | Stichting Centraal Laboratorium Van De Bloedtransfusiedienst Van Het Nederlandse Rode Kruis | Container for liquids for use in medicine and surgery |
GB2032006A (en) * | 1978-09-07 | 1980-04-30 | Frutin B D | Dispensing liquiform materials |
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 |
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 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2008500240A (en) * | 2004-05-25 | 2008-01-10 | オプティカル システム アンド リサーチ フォー インダストリー アンド サイエンス オシリス | Airtight container for storing products, in particular medicaments, and aseptic method for filling said containers |
Also Published As
Publication number | Publication date |
---|---|
EP1600139A1 (en) | 2005-11-30 |
EP1748752A1 (en) | 2007-02-07 |
JP2008500240A (en) | 2008-01-10 |
US20080011705A1 (en) | 2008-01-17 |
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