WO1997039952A1 - Contenants medicaux perfectionnes - Google Patents

Contenants medicaux perfectionnes Download PDF

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Publication number
WO1997039952A1
WO1997039952A1 PCT/SE1997/000682 SE9700682W WO9739952A1 WO 1997039952 A1 WO1997039952 A1 WO 1997039952A1 SE 9700682 W SE9700682 W SE 9700682W WO 9739952 A1 WO9739952 A1 WO 9739952A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
stopper
fluid
container opening
sealing device
Prior art date
Application number
PCT/SE1997/000682
Other languages
English (en)
Inventor
Gunnar Andersson
Des Mulligan
Original Assignee
Pharmacia & Upjohn Ab
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 Pharmacia & Upjohn Ab filed Critical Pharmacia & Upjohn Ab
Priority to AU27197/97A priority Critical patent/AU715663C/en
Priority to DK97921049T priority patent/DK0904234T3/da
Priority to DE69714992T priority patent/DE69714992T2/de
Priority to JP9537995A priority patent/JP2000508993A/ja
Priority to EP97921049A priority patent/EP0904234B1/fr
Priority to CA002251267A priority patent/CA2251267C/fr
Priority to NZ332178A priority patent/NZ332178A/xx
Priority to SI9730415T priority patent/SI0904234T1/xx
Priority to AT97921049T priority patent/ATE222871T1/de
Publication of WO1997039952A1 publication Critical patent/WO1997039952A1/fr
Priority to NO19984929A priority patent/NO318853B1/no

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers

Definitions

  • the present invention relates to improved openings for medical containers, especially suitable for containers storing parenterally administerable fluids which preferably should be sterilized by steam after being finally assembled filled and sealed.
  • Flexible containers for storage of parenteral nutrients arc conventionally provided with ports for filling and dispensing of the nutrients.
  • Tubular ports may be attached by means of welding when forming side seams, as performed i n the International Patent Application WO 95/26177 (Fresenius AG).
  • Another manner of providing a flexible container with ports is disclosed in the above mentioned Swedish patent application 9601348-7, wherein a flexible polymer material is introduced in the form of sheets, to which a saddle formed port system comprising two separate ports is attached.
  • two holes are pressed in the sheet for the tubular ports, whereupon the saddle is welded to the sheet which is folded and welded to a bag shaped container by forming two side seams and a top seam.
  • the container may be filled through the saddle formed port, or preferably by one or more temporary ports in connection to the welded seams before it is sterilized.
  • Conventional saddle-formed port systems normally comprise an additive port for the introduction to the container, just before administration, of a complementary perishable fluid, such as a solution of vitamins to a stored parenteral nutrient. It will also comprise a dispensing port for establishing a fluid connection between the container and the patient in need of fluid therapy.
  • the ports are generally tube formed and often of a predetermined different size in order to clearly show their identity to the user .
  • the additive port is often sealed with a stopper made of latex rubber fitted in mouth of the port which can be penetrated by a needle.
  • the dispensing port is typically formed with a membrane of polypropylene which can be pierced with a spike connected to the infusion device.
  • the present invention it is intended to provide pierceable openings for medical containers which can overcome the above mentioned problems both i n saddle port systems for bag formed containers and other types of containers. It is an object of the invention to provide a sealed opening for a medical container which is capable of being correctly sterilized by steam in all parts exposed to the fluid and fluid handling devices. It is another object of the invention to provide a medical package for parenterally administerable fluids where all parts exposed to the fluids or to fluid transferring devices are correctly sterilized in a single operation after it has been finally assembled and filled.
  • a specific object of the present invention is to provide a flexible bag-formed container for storage of parenteral fluids having a saddle-formed port system for introducing fluids to and dispensing fluids from the bag which is possible to sterilize in a single operation, and where all surfaces of the sealed opening which will be exposed to the fluid and fluid handling devices are correctly sterilized by steam.
  • a further specific object of the invention is to provide such a completely sterilizable bag-formed container with a saddle-formed port system which has a cheap environmental friendly construction that can be recycled in the same process without dismembering its parts before its disposal.
  • a still further specific object of the invention is to provide the saddle-formed port system of the container with openings which are possible to attach to a high number different connecting spikes .
  • the present invention is directed to container openings for fluid communication with a container for storing medical fluids, especially for parenteral administration.
  • the container opening comprises a tubular sleeve-formed part with a resilient and pierceable stopper inserted in its mouth and a sealing device covering said mouth and stopper.
  • the tubular sleeve-formed part, the stopper, and the sealing device contain, at least to a substantial amount, the same polyolefinic material, so they can be recycled with same process i n a recycling plant without being dismembered and separately col l ected after use.
  • a sealed contamei open i ng it can be heat steri lized by steam in a single process while all its parts, that will be exposed to, or come in contact with, either with the fluid directly or devices used for handling or transferring the fluid are sterilized by means of direct contact with steam transferred to said parts during the autoclavation.
  • the steam is transported to the space between a cap formed sealing device and the stopper, otherwise unavailable for direct steam sterilization . This space is reached with steam from a steam transporting axially directed annular slit, formed between the peripheral surface of the stopper and the inner peripheral surface of the tubular sleeve formed part during the autoclavation of said container.
  • the cap formed sealing device can be provided with a preformed rupture line so the user can twist off the cap to expose a sterile surface for immediate penetration with a spike or a needle.
  • the inventive container openings are provided with a covering sealing device in the form of peelable foil.
  • This foil can be penetrated by steam during in the autoclave, so the upper pierceable surface beneath the foil and the space between the foil and the stopper is sterilized by direct contact with steam.
  • the stopper besides the polyolefinic material, contains a thermoplastic elastomer.
  • Preferred polyolefinic materials, according to the invention are polypropylene and/or polyethene.
  • the present invention is also directed to a container having at least one of the aforedescribed openings comprising a tubular sleeve-formed part closed with a resilient, pierceable stopper and a sealing device, wherein all parts of the container and its orifice essentially consist of the same polyolefin.
  • the container can either be in the form of a flexible bag having at least one of said orifices or in a conventional bottle formed container of a polyolefin based material with a sealed ori fice havi ng said features.
  • Fie. 1 shows an inventive saddle-formed port systems wi th two port s having openings according to the present invention .
  • Fig. 2 is an enlargement of the steam transporting axial slit between the stopper and the tubular sleeve wall in one of the ports according to
  • Fig. 3 shows an alternative embodiment of an opening according to the present invention.
  • Fig. 4 shows a saddle-formed port system having the alternative opening of Fig. 3 attached.
  • Fig. 1 shows a side view of an inventive saddle-port system 30 with two openings for fluid communication with a container (not shown) constituted by the ports 20 and 20' which are of somewhat different size for easily identifying the dispensing and additive port, respectively.
  • Both ports have sealed openings according to the present invention and are largely identical and consist of a generally cylindrical, tubular sleeves 22, 22' which preferably have slightly beveled part 23, 23 ' of a shape designed to fit various fluid transfer devices, such as a conventional spike-formed connections to an infusion device. It is particularly preferred to have such a shape that fits spikes according to the conventional ISO-standard.
  • a cylindrical resileint and pierceable stopper 24 is positioned in the mouth part 21 of the orifices by means of an insert device 25 which rests on an annular shelf 26.
  • the stopper is made of a resilient thermoplastic elastomer and is designed to fit snugly and sealingly in the mouth. It is conceivable within the context of the present invention to find other suitable designs of the insert device and the annular shelf extended around the inner periphery of the tubular sleeves.
  • the ports can be provided with a fingergrip portion 27 to give the user a more comfortable stability when inserting devices for fluid transfer into the port.
  • the mouth of the opening is sealed with a cap formed sealing device 10 which is provided with a flange 1 1 fitted over the edge of the mouth.
  • the contact surface between the mouth and the cap formed sealing device can be welded together by, for example ultrasonic welding.
  • the cap formed sealing device can also be provided with a preformed rupture li ne (not shown) which pref erably is circular and will burst when it is twisted by the user to provide a round aperture, through which a needle or spike can penetrate the stopper and establish fluid communication with the container
  • an axially extended annular slit 41 between the peripheral surface of stopper and the inner peripheral wall of the tubular sleeve of the orifice.
  • the slit 41 opens for transportation of steam from the interior of the container to the closed space 40 during the autoclavation of the container.
  • Such an axial slit is formed when the tubular sleeve expands more in a radial direction than the stopper during the heat treatment in the autoclave.
  • the slit closes because of a comparable contraction of the stopper and the sleeve and a weak seal is formed in their contact surface
  • the stopper contains a certain amount of a thermoplastic elastomer, such as a dispersed EPDM-rubber or SEBS (styrene-ethylene-butadien- styrene copolymer), so the stopper can exert a balancing pressure when tubular sleeve expands and contracts during the autoclavation process.
  • a thermoplastic elastomer such as a dispersed EPDM-rubber or SEBS (styrene-ethylene-butadien- styrene copolymer)
  • Both the stopper and the tubular orifice sleeve should therefore contain the same polyolefinic material, in order to obtain such a molecular compatibility
  • This requirement that must also be set on the entire port system for enabl i ng it to be recycled together with the rest of the container
  • the poi t system must, consequently, also be compatible with the material of the flexible container, so it can successfully be attached to it by means of weldi ng during the assembly
  • the stopper must have c e r ta i n resilience to meet the requirements to obtain a weak welding, as wel l as being resealable, so it can be penetrated several times and maintain the integrity of the container.
  • the stopper material shall have a certain friction against the connection spike to prevent the spike to be unintentionally displaced from the stopper and to provide a sealing connection with a high number of different types of connecting spikes existing on the market.
  • a suitable material for the stopper is a polyolefin polymer which contains a thermoplastic elastomer.
  • the same polyolefin must be present, both in the remaining parts of the port system and in the container.
  • Suitable polyolefin materials are polyetylenes or polypropylene, their mixtures and copolymers of various medical grades. It has been shown in the present invention that it is surprisingly advantageous to have a high amount of polypropylene in the port system compatible with a polypropylene containing material in the containers.
  • the stopper it is especially preferred to select materials of polypropylene containing a certain amount of a thermoplastic elastomer like Dynaflex® from GLS Corp. comprising polypropylene and SEBS.
  • a thermoplastic elastomer like Dynaflex® from GLS Corp. comprising polypropylene and SEBS.
  • other polypropylene based materials having comparable characteristics can be used in the present invention, such as those having dispersed particles of EPDM-rubber in the matrix like Santoprene® from Monsanto.
  • a stopper made of such a material will also solve the problem with particles torn away as a result of its penetration and it has a high resealing capacity after a penetration.
  • the material of the remaining saddle-formed port system shall preferably be compatible with the material of the infusion bag in order enable a suitable attachment, for example by means of welding.
  • Both materials shall preferably contain the same polyolefinic material so they are capable of being recycled in the process and so a separate collection procedure is avoided.
  • a suitable material for the bag formed infusion container is based on polyolefines, such as polyethylene or polypropylene, their mixture and copolymers.
  • a preferred material is Excel® from McGaw Inc. , generally described in the European patent 0228919.
  • an inner, sealant layer facing the medical flu id consisting of a mixture of a polyethylene/polypropylene copolymer (FIN A Dypro Z 9450) and Kraton® G 1652 from Shell (a sty rene/ethylene/butadien/styrene copol ymer) ;
  • Ecdel® 9965 (or 9566 or 9967) from Eastman Kodak & Co. which is a cycloaliphatic thermoplastic copolyester (a copoly(ester ether), a condensation product of the trans isomer of 1 ,4-dimethyl-cyclohexanedicarboxylate, of cyclohexanedimethanol and hydroxyterminated polytetramethylene glycol).
  • the saddle formed port system suitable contains polypropylene and preferably consists of a mixture of polypropylene and Kraton® which is weldable to the inner layer of the Excel® film. Suitable mixtures are in range of about 80 to 40% polypropylene and 20 to 60% Kraton®.
  • the polypropylene is of homogenous interpenetrating polymer network (IPN) quality, capable of forming weak seals at about 105 to 120 °C, preferably at about 1 17 ° C and a permanent welding at about 160 °C.
  • IPN interpenetrating polymer network
  • FIG. 3 An alternative embodiment of a sealed opening to a medical container, according to the invention, is demonstrated in Fig. 3.
  • This opening is suitable in the previously discussed saddle-formed port systems, has a generally cylindrical part 22A with a mouth 21 A.
  • a resilient and pierceable stopper 24A is sealingly positioned in the mouth and rests on the annular shelf 26A formed in said sleeve 22A.
  • the stopper 24A is made of a resilient pierceable material, suitably a polyolefin containing a certain amount of a thermoplastic elastomer and preferably Dynaflex® or a comparable material as d i sc losed above, while the other parts of the orifice preferably are made of polypropylene with mixtures of Kraton®, as also disclosed above.
  • the opening is sealed before sterilization by a peelable foi l 1 2 A which is seal ingly fitted over an annular outwardly extended proti usion 28A o t the mouth 21 A.
  • steam In order to be able to correctly steam sterilize all parts of the orifice including the connected filled container, steam must the transferred also to the upper surface 40A of the pierceable stopper 24A which shall be penetrated by a needle or a spike. A transfer of steam therefore must be arranged through the peelable foil in the autoclave, while the foil also must be capable of maintaining sterile conditions and prevent airborne or contact contamination of the surface 40A during the subsequent storage.
  • the material of the peelable foil must therefore be selected among steam permeable, but heat resistant materials which otherwise can form an effective sealing barrier for contaminating agents. Suitable materials are found among spun polyolefins, such as Tyvek® from DuPont and among certain qualities of lacquered papers.
  • this type of container opening is preferably connected to the mouth part of the generally cylindrically formed sleeves of a port of a saddle formed port system.
  • the outer peripheral surface of the cylindrical part 22A can be provided with an annular protrusion 29 which is intended to fit in a corresponding annular recess 29' provided in the inner peripheral surface of the sleeve formed port.
  • Dynaflex® is injected into a pre-shaped cylindrical opening by means of two-color mold injection machine, whereupon the foil is assembled in a separate process.
  • the foil 12A When using such a container opening for fluid transfer, the foil 12A will be removed by a simple peeling motion to expose the sterile upper pierceable surface 40A of the stopper which can immediately be pierced by a conventional connection spike or a comparable device for establishing fluid connection without a risk for contamination .
  • the described sealed container openings and the saddle-formed port systems including them will, for many practical applications eliminate the use of a secondary , outer pouch wrapped over the bag- formed contame i during storage for standard solutions and other parenteral so l utions . even if certain oxygen sensitive products like amino acids and lipid emulsion will require additional protective measures.
  • inventive container openings not only shall be regarded as limited in use to saddle formed port systems connected to flexible bag-formed containers. They are equally useful as parts of a bottle shaped more rigid polymer container containing sensitive medical fluids which require autoclavation before storage.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
  • Glass Compositions (AREA)
  • Materials For Medical Uses (AREA)
  • Packages (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

On décrit une ouverture de contenant scellée, conçue pour une communication fluidique avec un contenant de stockage de fluides médicaux, et comprenant une partie tubulaire (22, 22A) en forme de manchon présentant un bouchon élastique (24, 24A), lequel peut être percé et est inséré dans l'ouverture (21, 21A) de cette partie tubulaire, ainsi qu'un dispositif couvrant (10, 10A), formant scellement. Cette ouverture de contenant scellée contient le même matériau polyoléfinique, pouvant passer à l'autoclave, que le contenant. Toutes les parties de cette ouverture de contenant, exposées aux fluides ou aux dispositifs de manipulation des fluides, sont stérilisées en un seul processus au moyen de vapeur transmise à celles-ci lors de leur séjour dans l'autoclave. On décrit également des systèmes à deux orifices formant chacun une branche d'un U et que l'on peut fixer sur des contenants flexibles.
PCT/SE1997/000682 1996-04-23 1997-04-23 Contenants medicaux perfectionnes WO1997039952A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
AU27197/97A AU715663C (en) 1996-04-23 1997-04-23 Improved medical containers
DK97921049T DK0904234T3 (da) 1996-04-23 1997-04-23 Medicinsk beholder
DE69714992T DE69714992T2 (de) 1996-04-23 1997-04-23 Medizinischer behälter
JP9537995A JP2000508993A (ja) 1996-04-23 1997-04-23 改良された医療用容器
EP97921049A EP0904234B1 (fr) 1996-04-23 1997-04-23 Contenants medicaux perfectionnes
CA002251267A CA2251267C (fr) 1996-04-23 1997-04-23 Contenants medicaux perfectionnes
NZ332178A NZ332178A (en) 1996-04-23 1997-04-23 Medical containers and opening made of polyolefinic material able to sterilized in single process
SI9730415T SI0904234T1 (en) 1996-04-23 1997-04-23 Improved medical containers
AT97921049T ATE222871T1 (de) 1996-04-23 1997-04-23 Medizinischer behälter
NO19984929A NO318853B1 (no) 1996-04-23 1998-10-22 Forseglet beholderapning

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9601540A SE9601540D0 (sv) 1996-04-23 1996-04-23 Improved medical containers
SE9601540-9 1996-04-23

Publications (1)

Publication Number Publication Date
WO1997039952A1 true WO1997039952A1 (fr) 1997-10-30

Family

ID=20402307

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1997/000682 WO1997039952A1 (fr) 1996-04-23 1997-04-23 Contenants medicaux perfectionnes

Country Status (13)

Country Link
EP (1) EP0904234B1 (fr)
JP (1) JP2000508993A (fr)
AT (1) ATE222871T1 (fr)
CA (1) CA2251267C (fr)
DE (1) DE69714992T2 (fr)
DK (1) DK0904234T3 (fr)
ES (1) ES2183165T3 (fr)
NO (1) NO318853B1 (fr)
NZ (1) NZ332178A (fr)
PT (1) PT904234E (fr)
SE (1) SE9601540D0 (fr)
WO (1) WO1997039952A1 (fr)
ZA (1) ZA973434B (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6322739B1 (en) 1997-02-20 2001-11-27 Fresemus Kabi Ab Method of manufacturing pharmaceutical articles
EP0961735B1 (fr) * 1997-02-20 2002-09-11 Fresenius Kabi AB Procede de fabrication de fermetures pharmaceutiques et fermeture pharmaceutique
KR100799716B1 (ko) 2006-12-19 2008-02-01 박종현 밀봉캡유니트 및 상기 밀봉캡유니트가 결합되는 멸균용기
CN100408013C (zh) * 2003-03-27 2008-08-06 费森尤斯卡比德国有限公司 用于包含药液的包装件的连接器和用于药液的包装件
WO2013058373A1 (fr) * 2011-10-19 2013-04-25 ラジエ工業株式会社 Procédé pour empêcher la détérioration d'une protéine, et procédé pour produire une protéine
US9101532B2 (en) 2011-02-04 2015-08-11 Terumo Kabushiki Kaisha Medicine storage container

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4060247B2 (ja) * 2003-07-14 2008-03-12 株式会社大塚製薬工場 薬剤容器用の口部材
JP4575084B2 (ja) * 2003-08-22 2010-11-04 テルモ株式会社 輸液用容器および輸液用容器の製造方法
BR112013001033A2 (pt) * 2010-07-16 2019-09-24 Safety Syringes Inc processo de fabricação pela embalagem de injetáveis
WO2013084791A1 (fr) * 2011-12-05 2013-06-13 テルモ株式会社 Récipient de stockage de joint

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4230231A (en) * 1979-04-16 1980-10-28 Coulter Electronics, Inc. Closure cap
US4297316A (en) * 1980-01-07 1981-10-27 Baxter Travenol Laboratories, Inc. Maintaining the dimensional integrity of thermoplastic tubing ends for receiving a luer
WO1995008317A1 (fr) * 1993-09-24 1995-03-30 Pharmacia Ab Contenant pour liquides medicaux

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5084040A (en) * 1990-01-25 1992-01-28 The West Company, Incorporated Lyophilization device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4230231A (en) * 1979-04-16 1980-10-28 Coulter Electronics, Inc. Closure cap
US4297316A (en) * 1980-01-07 1981-10-27 Baxter Travenol Laboratories, Inc. Maintaining the dimensional integrity of thermoplastic tubing ends for receiving a luer
WO1995008317A1 (fr) * 1993-09-24 1995-03-30 Pharmacia Ab Contenant pour liquides medicaux

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6322739B1 (en) 1997-02-20 2001-11-27 Fresemus Kabi Ab Method of manufacturing pharmaceutical articles
EP0961735B1 (fr) * 1997-02-20 2002-09-11 Fresenius Kabi AB Procede de fabrication de fermetures pharmaceutiques et fermeture pharmaceutique
US6720044B2 (en) 1997-02-20 2004-04-13 Pharmacia Ab Polyolefinic closures comprising penetrable plugs and annular channels
CN100408013C (zh) * 2003-03-27 2008-08-06 费森尤斯卡比德国有限公司 用于包含药液的包装件的连接器和用于药液的包装件
KR100799716B1 (ko) 2006-12-19 2008-02-01 박종현 밀봉캡유니트 및 상기 밀봉캡유니트가 결합되는 멸균용기
US9101532B2 (en) 2011-02-04 2015-08-11 Terumo Kabushiki Kaisha Medicine storage container
WO2013058373A1 (fr) * 2011-10-19 2013-04-25 ラジエ工業株式会社 Procédé pour empêcher la détérioration d'une protéine, et procédé pour produire une protéine

Also Published As

Publication number Publication date
ES2183165T3 (es) 2003-03-16
EP0904234B1 (fr) 2002-08-28
DE69714992D1 (de) 2002-10-02
NO984929D0 (no) 1998-10-22
CA2251267C (fr) 2005-10-11
EP0904234A1 (fr) 1999-03-31
PT904234E (pt) 2003-01-31
NO318853B1 (no) 2005-05-18
NZ332178A (en) 2000-01-28
AU2719797A (en) 1997-11-12
NO984929L (no) 1998-12-15
ZA973434B (en) 1997-11-19
JP2000508993A (ja) 2000-07-18
DE69714992T2 (de) 2003-01-02
DK0904234T3 (da) 2002-12-30
SE9601540D0 (sv) 1996-04-23
AU715663B2 (en) 2000-02-10
ATE222871T1 (de) 2002-09-15
CA2251267A1 (fr) 1997-10-30

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