EP0904234B1 - Contenants medicaux perfectionnes - Google Patents

Contenants medicaux perfectionnes Download PDF

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Publication number
EP0904234B1
EP0904234B1 EP97921049A EP97921049A EP0904234B1 EP 0904234 B1 EP0904234 B1 EP 0904234B1 EP 97921049 A EP97921049 A EP 97921049A EP 97921049 A EP97921049 A EP 97921049A EP 0904234 B1 EP0904234 B1 EP 0904234B1
Authority
EP
European Patent Office
Prior art keywords
container
stopper
autoclavable
fluid
container opening
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
EP97921049A
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German (de)
English (en)
Other versions
EP0904234A1 (fr
Inventor
Gunnar Andersson
Des Mulligan
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.)
Fresenius Kabi AB
Original Assignee
Fresenius Kabi AB
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Filing date
Publication date
Application filed by Fresenius Kabi AB filed Critical Fresenius Kabi AB
Priority to SI9730415T priority Critical patent/SI0904234T1/xx
Publication of EP0904234A1 publication Critical patent/EP0904234A1/fr
Application granted granted Critical
Publication of EP0904234B1 publication Critical patent/EP0904234B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers

Definitions

  • the present invention relates to an improved opening 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 are 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 in 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 mouth of such a port is finally sealed before storage by a removable cap or a foil.
  • These ports have a drawback in that the small space between the stopper and the sealing cap or foil will not be reached by sterilizing steam which constitutes a risk for contamination in connection with the penetration.
  • the saddle-formed port systems have either been pre-sterilized by means of radiation before being assembled to the bags or alternatively a water droplet has been introduced in the small space to provide sterilizing vapor during the heat treatment.
  • US-A-4,230,231 and US-A-5,084,040 describe a container opening comprising a tubular sleeve-formed part having a resilient stopper inserted in its mouth and a sealing device covering the mouth.
  • the container opening is made of autoclavable polyolefinic material. The risk of also these container openings is that a small space between stopper and cap will not be properly sterilized by steam in a single process.
  • 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 in a recycling plant without being dismembered and separately collected after use.
  • a sealed container opening according to the present invention It is a characteristic feature of a sealed container opening according to the present invention that it can be heat sterilized 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 inventive container openings are provided with a covering sealing device in the form of a 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 aforedescribed opening comprising a tubular sleeve-formed part closed with a resilient, pierceable stopper and said 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 orifice having said features.
  • Fig. 1 shows only for illustrative purpose a saddle-formed port system with two ports. This system does not fall within the scope of the appended claims.
  • Fig. 2 is an enlargement of a steam transporting axial slit between the stopper and the tubular sleeve wall in one of the ports according to Fig. 1.
  • Fig. 3 shows an embodiment of an opening according to the present invention.
  • Fig. 4 shows a saddle-formed port system having the opening of Fig. 3 attached.
  • Fig. 1 shows a side view of a 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 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 resilient 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 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 11 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 line (not shown) which preferably 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.
  • 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 high compatibility between these parts are also required, because molecules must be exchanged in the contact surface of said parts, in order to form a weak seal.
  • 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 enabling it to be recycled together with the rest of the container.
  • the port system must, consequently, also be compatible with the material of the flexible container, so it can successfully be attached to it by means of welding during the assembly.
  • the stopper must have certain resilience to meet the requirements to obtain a weak welding, as well as being resealable, so it can be penetrated several times and maintain the integrity of the container. It is also a requirement that 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. Excel® has a multilayered structure substantially comprising:
  • 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 117°C and a permanent welding at about 160°C.
  • IPN interpenetrating polymer network
  • FIG. 3 An 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 system, has a generally cylindrical part 22A with a mouth 21A.
  • 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 disclosed 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 foil 12A which is sealingly fitted over an annular outwardly extended protrusion 28A of the mouth 21A.
  • 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.
  • the openings are manufactured in a process wherein the 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 container during storage for standard solutions and other parenteral solutions, even if certain oxygen sensitive products like amino acids and lipid emulsion will require additional protective measures.
  • inventive container opening not only shall be regarded as limited in use to saddle formed port systems connected to flexible bag-formed containers. It is equally useful as a part 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)
  • 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)
  • Glass Compositions (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
  • Materials For Medical Uses (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Packages (AREA)

Claims (7)

  1. Ouverture de récipient rendue étanche, conçue pour une communication par fluide avec un récipient pour l'entreposage de fluides médicaux, comprenant une partie tubulaire en forme de manchon (22A) comportant un bouchon résilient (24A) apte à être percé qui est inséré dans l'entrée (21A) de ladite partie et un dispositif d'étanchéisation par recouvrement (10A), dans laquelle ladite ouverture de récipient contient une matière polyoléfinique apte au passage à l'autoclave, caractérisée en ce que ledit dispositif d'étanchéisation par recouvrement se présente sous la forme d'une mince feuille pelliculable (32A) manifestant une perméabilité à la vapeur de stérilisation dans le but de stériliser l'espace ménagé entre ladite feuille mince et le bouchon (24A).
  2. Ouverture de récipient selon la revendication 1, caractérisée en ce que la matière polymère est du polypropylène ou du polyéthylène, leurs mélanges ou leurs copolymères.
  3. Ouverture de récipient selon la revendication 1 ou 2, caractérisée en ce que le bouchon (24A) comprend en outre un élastomère thermoplastique.
  4. Récipient apte au passage à l'autoclave pour l'entreposage de fluides médicaux comportant au moins une ouverture de récipient selon l'une quelconque des revendications 1 à 3, dans lequel ledit récipient contient la même matière polyoléfinique apte au passage à l'autoclave que celle de l'ouverture du récipient.
  5. Récipient apte au passage à l'autoclave selon la revendication 4, comportant un corps de récipient flexible. constitué d'une matière multicouche contenant une polyoléfine, dans lequel toutes les parties du récipient sont constituées essentiellement de la même polyoléfine.
  6. Récipient apte au passage à l'autoclave selon la revendication 5, dans lequel ladite polyoléfine est du polypropylène.
  7. Récipient apte au passage à l'autoclave comprenant un système d'orifice en forme d'agrafe comportant au moins une desdites ouvertures selon l'une quelconque des revendications 1 à 3 pour introduire un fluide supplémentaire destiné à être mélangé audit fluide médical et au moins une desdites ouvertures de récipient selon l'une quelconque des revendications 1 à 3 apte à être raccordée à un dispositif de transfert de fluide.
EP97921049A 1996-04-23 1997-04-23 Contenants medicaux perfectionnes Expired - Lifetime EP0904234B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
SI9730415T SI0904234T1 (en) 1996-04-23 1997-04-23 Improved medical containers

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9601540 1996-04-23
SE9601540A SE9601540D0 (sv) 1996-04-23 1996-04-23 Improved medical containers
PCT/SE1997/000682 WO1997039952A1 (fr) 1996-04-23 1997-04-23 Contenants medicaux perfectionnes

Publications (2)

Publication Number Publication Date
EP0904234A1 EP0904234A1 (fr) 1999-03-31
EP0904234B1 true EP0904234B1 (fr) 2002-08-28

Family

ID=20402307

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97921049A Expired - Lifetime EP0904234B1 (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)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6720044B2 (en) 1997-02-20 2004-04-13 Pharmacia Ab Polyolefinic closures comprising penetrable plugs and annular channels
SE9700597D0 (sv) * 1997-02-20 1997-02-20 Pharmacia & Upjohn Ab Method of manufacturing pharmaceutical articles
DE10313760B3 (de) * 2003-03-27 2004-06-03 Fresenius Kabi Deutschland Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten
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
KR100799716B1 (ko) 2006-12-19 2008-02-01 박종현 밀봉캡유니트 및 상기 밀봉캡유니트가 결합되는 멸균용기
CA2804814C (fr) * 2010-07-16 2015-11-10 Stevanato Group International A.S. Processus de fabrication pour emballage de preparations injectables
WO2012105646A1 (fr) 2011-02-04 2012-08-09 テルモ株式会社 Conteneur de stockage de médicament
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
WO2013084791A1 (fr) * 2011-12-05 2013-06-13 テルモ株式会社 Récipient de stockage de joint

Citations (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

Family Cites Families (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
SE501925C2 (sv) * 1993-09-24 1995-06-19 Kabi Pharmacia Ab Behållare för medicinska vätskor samt förfarande för dess försegling

Patent Citations (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

Also Published As

Publication number Publication date
NO984929L (no) 1998-12-15
DE69714992T2 (de) 2003-01-02
ES2183165T3 (es) 2003-03-16
CA2251267C (fr) 2005-10-11
NZ332178A (en) 2000-01-28
NO318853B1 (no) 2005-05-18
ATE222871T1 (de) 2002-09-15
EP0904234A1 (fr) 1999-03-31
PT904234E (pt) 2003-01-31
WO1997039952A1 (fr) 1997-10-30
AU715663B2 (en) 2000-02-10
AU2719797A (en) 1997-11-12
ZA973434B (en) 1997-11-19
DE69714992D1 (de) 2002-10-02
CA2251267A1 (fr) 1997-10-30
DK0904234T3 (da) 2002-12-30
JP2000508993A (ja) 2000-07-18
SE9601540D0 (sv) 1996-04-23
NO984929D0 (no) 1998-10-22

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