EP1799174B9 - Speicheranordnung für kontrastmedien - Google Patents

Speicheranordnung für kontrastmedien Download PDF

Info

Publication number
EP1799174B9
EP1799174B9 EP05792129A EP05792129A EP1799174B9 EP 1799174 B9 EP1799174 B9 EP 1799174B9 EP 05792129 A EP05792129 A EP 05792129A EP 05792129 A EP05792129 A EP 05792129A EP 1799174 B9 EP1799174 B9 EP 1799174B9
Authority
EP
European Patent Office
Prior art keywords
connector
storage assembly
packaging container
sealed
assembly according
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.)
Active
Application number
EP05792129A
Other languages
English (en)
French (fr)
Other versions
EP1799174B1 (de
EP1799174A2 (de
Inventor
François Bemer
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.)
Guerbet SA
Original Assignee
Guerbet 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 Guerbet SA filed Critical Guerbet SA
Publication of EP1799174A2 publication Critical patent/EP1799174A2/de
Publication of EP1799174B1 publication Critical patent/EP1799174B1/de
Application granted granted Critical
Publication of EP1799174B9 publication Critical patent/EP1799174B9/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D73/00—Packages comprising articles attached to cards, sheets or webs

Definitions

  • the present invention relates to a storage assembly comprising a pocket designated container for containing an aqueous solution (more especially a contrast medium), a connector for connecting the bag to a device such as a syringe, and a packaging for packaging the bag. pocket so as to protect the aqueous solution contained in the pocket against damage.
  • the invention also relates to the associated storage method.
  • the invention relates to a diagnostic product storage assembly for medical imaging (contrast medium) and liquid pharmaceutical formulation in which, even if the medical fluid is stored for a long time, it will not be subjected to no deterioration such as water loss, and also relates to the associated storage method.
  • this type of container filled with parenteral fluid must have sufficient heat resistance to allow the hot sterilization of their contents (sterilization temperature above 100 ° C).
  • this type of container is preferably made of a transparent material so that their contents can be monitored from the outside.
  • the medical fluid contained in such a container comprises a component subject to deterioration - for example a component sensitive to light and oxidation - it is known to package said container in a packaging material having good gas barrier, for example a material comprising a layer of polyvinyl chloride, and ultraviolet light, for example a material comprising an opaque layer of aluminum.
  • a packaging material having good gas barrier for example a material comprising a layer of polyvinyl chloride, and ultraviolet light, for example a material comprising an opaque layer of aluminum.
  • the product administered to the patient has a high price, which implies having to limit as much as possible the product losses. .
  • An object of the present invention is to provide a storage assembly for bearing at least one of the disadvantages mentioned above.
  • the invention aims to solve other technical problems related to the clinical use of contrast products. It is desired that the bag can be connected to various types of connection and device injectors, such as manual or automatic syringe injectors, or automatic bag injectors.
  • the step of placing a cap on the end of the connector can be performed before or after the step of sealing the conditioning container by means of the connector.
  • the storage assembly includes an overpouch containing a medical pocket.
  • This medical bag comprises an access member on which is placed in force a female luer after filling said bag with a parenteral solution.
  • the female luer has a hood.
  • the figures 1 , 2, 3 and 4 illustrate in front view, in profile, from above and from below a medical bag 3 contained in an overpouch 4.
  • This overpouch 4 has a general shape in a rectangle. It can be peelable or tearable. Overpouch 4 comprises two sheets 1, 2 superimposed of appropriate length and width.
  • the first and second sheets 1, 2 are made of flexible polymer materials or semi-rigid, transparent. These sheets 1, 2 are for example polyamide, polyethylene, polypropylene, polyethylene-polypropylene copolymer.
  • Each of the superposed transparent sheets 1, 2 is preferably composed of laminated films at least one of which is impermeable to gases, moisture and atmospheric bacteria.
  • the first sheet 1 is left transparent over its entire surface so as to allow observation of the quantity of the contents of the medical bag 3 contained in the overpouch 4. It also allows the reading of identification markings on an area 6 of the medical bag 3, such as the name of the product contained in the medical bag, the volume of product contained in the medical bag, the name of the manufacturer and the number of the manufacturing batch to which the medical fluid belongs.
  • the second sheet 2 further comprises an opaque laminate film having ultraviolet barrier and water barrier properties, such as a metal film preferably of aluminum (for example a metallized polyester film), heat-sealed and covering the entire surface of the second leaflet 2.
  • a metal film preferably of aluminum (for example a metallized polyester film)
  • heat-sealed and covering the entire surface of the second leaflet 2.
  • This second leaflet 2 protects the integrity of the light-sensitive medical fluids contained in the medical bag 3.
  • a contrast medium for scanning such as Xenetix® (Guerbet) typically contains 60 to 80 g of active ingredient according to the concentration used.
  • the first and second superposed sheets 1, 2 are joined together along marginal sectors 10, 11, 12, and 13.
  • overpouch 4 allows a very significant increase in the storage time of the aqueous solution contained in the medical bag 3, which allows compliance with the European Pharmacopoeia that the water loss must be less than 5 % after three months of storage at 40 ° C.
  • the overpouch 4 will have different sealing characteristics.
  • overpockets 4 whose sealing results are shown in the table above is that they are sufficiently watertight to prevent loss of water, but sufficiently permeable to avoid unwanted condensation within said overpockets. .
  • the composition and thickness of the packaging packaging and the packaging container are such that the water permeability is low enough that the contrast medium is not altered despite sterilization and storage over a long period of time.
  • an overpouch will be chosen whose sheets 1, 2 have a thickness of between 50 ⁇ m and 100 ⁇ m, preferably between 60 ⁇ m and 75 ⁇ m, more preferably between 62 ⁇ m and 71 ⁇ m. This thickness makes it possible to have a flexible and pleasant product of handling.
  • the pocket is :
  • the medical bag 3 has two superposed sheets 7, 8 of appropriate length and width and an access member 30.
  • the sheets 7, 8 are made of flexible or flexible materials, such as polymeric materials including polyethylene, polypropylene, and preferably thermoplastic materials.
  • the superimposed sheets 7, 8 forming the medical bag 3 are made of transparent or at least translucent materials to allow observation of the amount of its contents during the storage and administration of the product to the patient.
  • each of the superimposed transparent sheets 7, 8 is preferably made of several layers of laminated thin films, at least one of which constitutes a barrier which is impermeable to gases, moisture and atmospheric bacteria.
  • the film in contact with the aqueous solution (or parenteral solution) is preferably chemically inert and impermeable to gases.
  • the film in contact with the parenteral solution must not contain toxic agents that could spread in the parenteral solution.
  • the sheets 7, 8 forming the medical bag 3 may comprise a stack of polypropylene film (multilayer polypropylene).
  • the sheets 7, 8 forming the medical bag 3 may comprise a polyvinyl chloride film sandwiched between two polyvinyl acetate or polyethylene films.
  • the polyvinyl chloride film constitutes the impermeable barrier.
  • the wall material of the pocket is of multilayer structure with at least 80 to 90% of ethylene polypropylene.
  • the bag is formed of three outer, intermediate, inner layers from: polypropylene homopolymer, propylene / ethylene / butylene copolymer, styrene / ethylene copolymer, copolymer of ethylene carboxylic esters.
  • the superimposed sheets 7, 8 are preferably flat welded together to form a pocket 3 whose volume is zero before it is filled with parenteral solution.
  • the medical bag 3 When the medical bag 3 is filled or partially filled, it has the shape of a cushion.
  • the internal volume capacity of the bag 3 may be 100, 150, 200 or 500 milliliters (ml).
  • the volume can be lowered, for example to 30 or 50 ml.
  • the superimposed sheets 7, 8 forming the medical bag 3 are sealed at their lateral peripheries 20 and 21 for form a pocket 3 of general external appearance rectangular.
  • the medical bag 3 further comprises a non-folding upper portion 22 and a non-folding lower portion 23.
  • the first sheet 7 comprises the zone 6 comprising the identification markings (name, volume, manufacturer, lot number).
  • the upper part 22 of the medical bag 3 comprises: a central sector where the polymer sheets are sealed together and form a hole 24 of elliptical appearance to suspend the medical bag 3 during the administration to the patient of its contents, two ovoid sectors symmetrically placed 25 and 26 extending externally of the hole 24 and sealed at their periphery to make the upper portion 22 less flexible than the polymer sheets which form the inner tank 27.
  • the rounded shape of the upper portion 22 is particularly advantageous for a use of the pocket in an automatic injector as described in the document EP 852 152 because it facilitates the complete evacuation of the product to the outside of the pocket.
  • the lower part 23 of the medical bag 3 (where the access member 30 is located) has two symmetrically placed sectors 28 and 29 extending externally from the center of the medical bag 3 and sealed at their periphery to make the lower part 14 less flexible than the polymer sheets that form the inner tank 27.
  • the inner reservoir 27 of the medical bag 3 ends, at its lower part, with two segments 32, 33.
  • the angle between the segment 32 (respectively 33) and the axis of symmetry AA ' forms an angle of between 10 ° and 85 °, preferably between 60 ° and 80 ° and better still between 67 ° and 68 °. This angle makes it possible to direct and facilitate the flow of the fluid contained in the medial pocket 3 towards the access member 30.
  • the access member 30 is located in the center of the lower portion of the medical bag 3 and is sealed between the superimposed sheets 7, 8.
  • This access member 30 is a tube which may be of multilayer structure, that is, that is to say comprising a stack of films.
  • the composition of the outer film of the access member 30 is compatible with the inner film of the sheets forming the medical bag 3 to ensure good weldability with the pouch sheets.
  • the composition of the inner film of the access member 30 is such that it allows good adhesion to various materials including polycarbonate materials.
  • the single or multilayer tube comprises a polypropylene / ethylene / polyethylene / vinyl acetate / styrene blend.
  • the access member 30 serves to fill the bag 3 with the parenteral fluid and to administer to the patient this fluid. It is very advantageous if the proximal end 31 of the access member 30 coming into contact with the medical liquid is flush or just below a horizontal plane. crossing the center of the lower portion of the inner tank so that all liquid contents can be dispensed from the medical bag 3. However, it is possible to introduce a depression tolerance of the tube, thus allowing the tube to protrude.
  • the luer (or “luer-lock”):
  • the access member 30 is sealed with a frangible female luer 45 (in polycarbonate) on which is placed a cap 39.
  • This luer 45 and this cap 39 are for example polycarbonate of bisphenol A.
  • the cap 39 comprises a cylindrical body 40 extended at one of its ends by a ferrule 41.
  • the cylindrical body 40 comprises a non-through opening at its end farthest from the shell 41.
  • a coaxial tubular portion 42 projecting slightly from the shell 41.
  • the tubular portion 42 and the cylindrical body 40 are separated by a circular wall 43 orthogonal to the axis of symmetry BB 'of the cap 39.
  • the female luer connector 45 comprises a cylindrical body 46 extended at one end by a frangible section 49.
  • the frangible portion 49 is located at inside the access member.
  • the frangible section 49 comprises four fins 47, 48 extending radially outwardly so that when the female luer 45 is engaged with the access member 30, the ends of the fins 47, 48 are in contact with the limb. These fins permit an easier separation by the user of the breakable section 49.
  • the four fins 47, 48 are arranged so that a fin is perpendicular to the two fins which are adjacent thereto.
  • the cylindrical body 46 has a central passage 50 ending, on the frangible section side 49, in the vicinity of a thin bridging rupture 51. At its other end, the passage 50 is open and its diameter corresponds to the outer diameter of the tubular portion 42 of the cap 39. Indeed, the female luer 45 is capable of engaging in the shell 41 of the cap 39, the tubular portion 42 of the cap 39 engaging in the passage 50.
  • the cylindrical body 46 is provided externally opposite the frangible section 49, with two opposite threaded sections 52, 53 cooperating with the thread 54 of the shell 41 of the cap 39, in order to screwably couple the cap 39 and the luer. 45.
  • Each threaded section 52, 53 comprises two lugs extending radially outwardly and forming between them an angle substantially equal to 50 °.
  • the outer wall of the tubular portion 42 is slightly conical in order to seal the connection.
  • the female luer 45 used to seal the medical bag 3 has the advantage of being a connector directly adaptable to a syringe, and therefore very easy to use.
  • the female luer 45 is engaged with the access member 30, the frangible section 49 being inside the access member 30 whose distal end 34 (distal to the pocket 3), engaged by force on the cylindrical body 46, abuts against two projections 54, 55.
  • the seal between the female luer 45 and the access member 30 is thanks to the polycarbonate of bisphenol A which constitutes the female luer 45. Indeed, the polycarbonate of bisphenol A sticks on the access member 30 during the sterilization phase of the medical bag 3.
  • the cylindrical body 46 of the connector 45 has an outer diameter substantially equal to the inner diameter of the access member 30 so that a portion of the access member 30 encircles and contacts a portion of the body cylindrical 40 when the connector is engaged with the access member 30.
  • the cylindrical body 46 of the connector 45 has an internal diameter substantially equal to the outer diameter of the access member 30, so that a portion 888 of the cylindrical body 46 encircles and comes into contact with a portion 887. the access member 30 when the connector 45 is engaged with the access member 30.
  • the cylindrical body 46 of the connector 45 defines an interior space capable of receiving a portion 887 of the access member 30 when the connector 45 is engaged with the access member 30.
  • This embodiment member d access encircling the connector
  • This embodiment is particularly adapted for use with an automatic injector (which will be described in more detail later in the present application). Indeed, this embodiment (access member encircling the connector) makes it possible to avoid leaks that may occur under the effect of the pressure at the level of the connection between the connector 45 and the access member 30.
  • the cylindrical body 46 of the connector 45 has a frustoconical portion-shaped outer surface whose diameter decreases from the proximal end 886 to the distal end 885 of the cylindrical body 46. facilitate insertion of the access member into the interior space of the cylindrical body.
  • proximal end refers to the end closest to the access member when the connector and the access member are engaged with each other.
  • the assembly allowing the storage of a parenteral solution comprises an overpouch 4, a medical bag 3, a female luer 45 and a cap 39.
  • the variant of female luer described is not limiting, other structures may be appropriate.
  • the present storage method makes it possible to obtain an efficient and easy-to-use storage assembly enabling the user to easily administer the parenteral solution contained in the patient to a patient. storage set.
  • the first step of the method consists of manufacturing the pocket 3, and the overpouch 4.
  • the bag 3 is placed between two laminated sheets 7, 8 of the type previously described the access member 30 and welded the two laminated sheets 7, 8 and the access member 30 together. In a second time, zone 6 is printed with the identification markings of the parenteral solution. The bag 3 is then ready for the filling operation.
  • the first sheet 1 is left transparent and the second sheet 2 comprises an opaque laminate film.
  • Three of the four marginal edges 11, 12, 13 of the superimposed sheets 1, 2 are then typically thermally welded.
  • Overpouch 4 is then ready to receive the medical bag 3.
  • the second step of the process (which can of course be remote in the time of the first step of the process, the bags being stored empty) consists of filling the bag 3 with the parenteral solution, to seal it with the female luer 45 and the cap 39, and to sterilize the medical bag 3.
  • the access member 30 (tube) is used. Once the amount of parenteral solution introduced into the overpot 4 is sufficient, the female luer 45 is forced into the access member 30, the frangible portion 49 inwardly of the access member 30, so that close it. Then, the cap 39 is screwed onto the female luer 45. Finally, the device consisting of the bag 3 containing the parenteral solution, the access member 30, the female luer 45 and the cap 39 is placed in an autoclave at approximately 121 ° C. ° C for about 20 minutes to sterilize said device. During this sterilization phase, the female luer 45 and the access member 30 stick to each other due to heat. The thermally sealed junction can also be made before sterilization. This makes it possible to avoid any risk of leakage at the level of the female luer 45. Once the sterilization is complete, the device is ready to be placed in the overpot 4.
  • the last step of the method consists in placing in the overpouch 4, the bag 3 containing the parenteral solution and comprising the access member 30 on which is placed the female luer 45 provided with the cap 39.
  • This medical bag 3 is placed in the overpocket 4 so that the zone 6 comprising the identification markings is in contact with the inner face of the first slip 1 left transparent.
  • the medical bag 3 placed in the top 4 it welds the last edge of the top 4.
  • the luer is mounted already clogged and not clogged after the introduction of the luer on the pocket.
  • the storage assembly 5 according to the invention is then ready for use.
  • the storage assembly thus obtained can then be stored in secondary packaging type carton.
  • the user will be opaque to the opaque storage side of the packaging assembly so that the translucent side of the overpouch receives a minimum of light.
  • the injector is in one piece, and encloses an enclosure as described in document EP 852 152 .
  • an injector will be preferred, allowing substantially complete evacuation of the contrast product in order to limit product losses.
  • a solid sleeve comes under the effect of a pressurized fluid applied against the sheets of the bag whose content is then discharged to the patient.
  • the evacuation rate is controlled: about 5 ml / second for a product in X-ray or MRI solution, 10 to 100 times less for a suspension contrast product of iron oxide particles.
  • the large capacities, for example of 500 ml, make it possible to treat several patients "in series".
  • the injector can receive several pockets according to the needs of clinical use, for example an injector can receive several pockets of the same content or different content (contrast medium, physiological saline ). It is also possible to combine in an injector a pouch of low volume contrast product (20 ml for example) with a 100 ml bag, for example.
  • the pockets within the same injector can be connected to a different discharge conduit with a possibly different administration sequence between the products, or to a common evacuation with a Y system.
  • the bag contains an outlet tube offset from the axis of symmetry, and at least one reclosable injection tube into the pocket.
  • a compound such as an additive or a dilution or stabilization buffer.
  • This can be useful especially for products that would give rise to possible problems of crystallization.
  • It may also provide reinforcement means, if necessary adjust the shape of the overpocket, so that the set of conditioning stands without falling.
  • the described storage method is adaptable for pockets whose structure is different from that of packaging containers of another form and / or having different means of evacuation.

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Electrically Operated Instructional Devices (AREA)
  • Indexing, Searching, Synchronizing, And The Amount Of Synchronization Travel Of Record Carriers (AREA)
  • Light Guides In General And Applications Therefor (AREA)
  • Silver Salt Photography Or Processing Solution Therefor (AREA)
  • Refuse Collection And Transfer (AREA)
  • Measurement Of Radiation (AREA)
  • Vending Machines For Individual Products (AREA)

Claims (17)

  1. Doppelt verpackte Speicheranordnung (5) für wässrige medizinische Lösung - insbesondere für Kontrastmittel - eine Verpackungsumhüllung (4) umfassend, in welcher mindestens ein elastischer, mit einer wässrigen Lösung gefüllter und mittels eines Verbindungsstücks (45) mit Kappe (39) versiegelter Verpackungsbehälter (3) verpackt und hermetisch eingeschlossen ist, wobei der Verpackungsbehälter (3) zwei übereinander angeordnete Blätter (7, 8) aus Polymermaterial und ein Zugangsglied (30) mit distalem Ende (34) umfasst, an dem sich das Verbindungsstück (45) und die Kappe (39) befinden, wobei es das Verbindungsstück (45) erlaubt, den Verpackungsbehälter nach Befüllen desselben mit der wässrigen Lösung zu versiegeln, und die Verpackungsumhüllung (4) zwei übereinander angeordnete Bögen (1, 2) aus elastischen oder halbstarren Polymermaterialien umfasst, dadurch gekennzeichnet, dass der erste Bogen (1) auf seiner gesamten Oberfläche durchsichtig ist und der zweite Bogen (2) auf seiner gesamten Oberfläche undurchsichtig.
  2. Speicheranordnung nach Anspruch 1, dadurch gekennzeichnet, dass das Verbindungsstück (45) und die Kappe (39) aus Polycarbonat sind.
  3. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass das Verbindungsstück (45) einen zylindrischen Körper (46) umfasst, von dem ein Innendurchmesser etwa dem Außendurchmesser des Zugangsglieds (30) entspricht, so dass ein Abschnitt (888) des zylindrischen Körpers (48) einen Abschnitt (887) des Zugangsglieds (30) umschließt und mit ihm in Kontakt kommt, wenn das Verbindungsstück (45) mit dem Zugangsglied (30) verbunden ist.
  4. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass das Verbindungsstück (45) eine äußere Oberfläche in Form eines Kegelstumpfteils aufweist.
  5. Speicheranordnung nach vorangehendem Anspruch, dadurch gekennzeichnet, dass der Durchmesser der äußeren Oberfläche in Kegelstumpfform vom proximalen Ende (886) in Richtung distales Ende (885) des zylindrischen Körpers (46) abnimmt.
  6. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass das Verbindungsstück (45) vom Typ weiblicher Luer ist.
  7. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass das Verbindungsstück (45) ein zerbrechbares Segment (49) umfasst, das mit Flügeln (47, 48) ausgestattet ist, die sich radial nach außen erstrecken.
  8. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Bögen (1, 2) der Verpackungsumhüllung (4) aus Schichtstofffolien zusammengesetzt sind, die aus dem Polypropylen, dem Polyamid, dem Polyethylen ausgewählt sind.
  9. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass der zweite Bogen (2) der Verpackungsumhüllung (4) eine undurchsichtige Folie vom Typ metallisiertes Polyester umfasst.
  10. Speicheranordnung nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass der zweite Bogen (2) der Verpackungsumhüllung (4) eine undurchsichtige Folie aus Aluminium umfasst.
  11. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Blätter (7, 8) des Verpackungsbehälters (3) aus Polypropylen-Schichtstofffolien zusammengesetzt sind.
  12. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass das erste Blatt einen Bereich (6) umfasst, der identifizierende Aufschriften aufweist, wie den Namen des Produkts, den Namen des Herstellers, die Menge des in dem Behälter enthaltenen Produkts.
  13. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die übereinander angeordneten und an ihrem Umfang versiegelten Blätter (7, 8) ein inneres Behältnis definieren, wobei der obere Teil (22) des Verpackungsbehälters (3) einen zentralen Sektor umfasst, wo die Blätter gemeinsam versiegelt sind und eine elliptisch aussehende Öffnung (24) bilden, und zwei symmetrisch angeordnete eiförmige Sektoren (25, 26), die sich außerhalb der Öffnung (24) verlängern und an ihrem Umfang versiegelt sind, damit der obere Teil (22) wenige elastisch ist als die Polymerblätter, die das innere Behältnis (27) bilden.
  14. Speicheranordnung nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die übereinander angeordneten und an ihrem Umfang versiegelten Blätter (7, 8) ein inneres Behältnis definieren, wobei der untere Teil (22) des Verpackungsbehälters (3) zwei symmetrisch angeordnete eiförmige Sektoren (25, 26) umfasst, die sich außerhalb der Öffnung (24) verlängern und an ihrem Umfang versiegelt sind, damit der untere Teil (23) wenige elastisch ist als die Polymerblätter, die das innere Behältnis (27) bilden.
  15. Verfahren zum Speichern einer wässrigen medizinischen Lösung in einer doppelt verpackten Speicheranordnung, wobei das Verfahren die Schritte umfasst, die darin bestehen:
    - Befüllen eines Verpackungsbehälters (3) mit einer wässrigen medizinischen Lösung durch ein Zugangsglied (30) des Verpackungsbehälters (3),
    - Versiegeln des Verpackungsbehälters (3) mittels eines Verbindungsstücks (45),
    - Platzieren einer Kappe (39) auf das Ende des Verbindungsstücks (45),
    - Platzieren des Verpackungsbehälters (3), dessen Zugangsglied (30) durch das Verbindungsstück (45) versiegelt ist, in einer Verpackungsumhüllung (4), die zwei übereinander angeordnete Bögen (1, 2) aus elastischen oder halbstarren Materialien umfasst,
    - Versiegeln der Verpackungsumhüllung (4), so dass der Behälter (3), dessen Zugangsglied (30) durch das Verbindungsstück (45) mit Kappe (39) versiegelt ist, hermetisch eingeschlossen wird, dadurch gekennzeichnet, dass das Verfahren weiterhin vor dem Schritt, der darin besteht, den Behälter in die Verpackungsumhüllung zu platzieren, den Schritt umfasst, der darin besteht:
    - die Einheit, die den Verpackungsbehälter, das Verbindungsstück und die Kappe des Verbindungsstücks umfasst, vorzugsweise durch Autoklav bei einer Temperatur zwischen 100 und 150° inklusive während einer Dauer zwischen 10 und 40 Minuten inklusive zu sterilisieren, und dadurch, dass der erste Bogen (1) auf seiner gesamten Oberfläche durchsichtig ist und der zweite Bogen (2) auf seiner gesamten Oberfläche undurchsichtig.
  16. Speicherverfahren nach Anspruch 15, dadurch gekennzeichnet, dass der Schritt, der darin besteht, den Verpackungsbehälter mit Hilfe eines Verbindungsstücks zu versiegeln, darin besteht, den Behälter mit Hilfe eines Verbindungsstücks vom Typ weiblicher Luer zu versiegeln.
  17. Speicherverfahren nach Anspruch 15, dadurch gekennzeichnet, dass es weiterhin vor dem Schritt, der darin besteht, den Behälter in die Verpackungsumhüllung zu platzieren, den Schritt umfasst, der darin besteht:
    - die Einheit, die den Verpackungsbehälter, das Verbindungsstück und die Kappe durch Autoklav bei einer Temperatur von etwa gleich 121° während einer Dauer von etwa gleich 20 Minuten zu sterilisieren.
EP05792129A 2004-09-08 2005-09-08 Speicheranordnung für kontrastmedien Active EP1799174B9 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0409505A FR2874816B1 (fr) 2004-09-08 2004-09-08 Ensemble de stockage pour produits de contraste
PCT/EP2005/054471 WO2006029989A2 (fr) 2004-09-08 2005-09-08 Ensemble de stockage pour produits de contraste

Publications (3)

Publication Number Publication Date
EP1799174A2 EP1799174A2 (de) 2007-06-27
EP1799174B1 EP1799174B1 (de) 2009-08-12
EP1799174B9 true EP1799174B9 (de) 2010-07-21

Family

ID=34951102

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05792129A Active EP1799174B9 (de) 2004-09-08 2005-09-08 Speicheranordnung für kontrastmedien

Country Status (10)

Country Link
US (1) US9078806B2 (de)
EP (1) EP1799174B9 (de)
JP (1) JP2008512160A (de)
AT (1) ATE439113T1 (de)
DE (1) DE602005015993D1 (de)
DK (1) DK1799174T3 (de)
ES (1) ES2331012T3 (de)
FR (1) FR2874816B1 (de)
PT (1) PT1799174E (de)
WO (1) WO2006029989A2 (de)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2949195B1 (fr) * 2009-08-24 2011-10-14 Lfb Biomedicaments Poche de stockage de solution therapeutique
US8955208B1 (en) * 2010-03-03 2015-02-17 Scanlan International, Inc. Information holder for medical instrument sterilization containers
KR101507432B1 (ko) * 2011-02-10 2015-03-31 가부시키가이샤 칸쿄우소고 테크노스 영양염 측정용 해수 표준액의 제조방법
JP5705574B2 (ja) * 2011-02-10 2015-04-22 株式会社環境総合テクノス 栄養塩測定用の海水標準液の製造方法
DK3047833T3 (en) * 2015-01-26 2017-06-12 Fresenius Kabi Deutschland Gmbh Container Closure System
BR112021007012A2 (pt) * 2018-10-15 2021-07-13 Alejandro Gamboa Burgos aplicador para soluções oftálmicas em pacotes para dose única e um kit contendo os mesmos
CN111498207B (zh) * 2019-01-30 2023-05-02 百特国际有限公司 医用流体容器制备系统和方法
US20220218565A1 (en) * 2019-05-17 2022-07-14 West Pharmaceutical Services, Inc. Adaptive primary packaging for therapeutic solutions

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4199062A (en) * 1978-04-13 1980-04-22 Baxter Travenol Laboratories, Inc. Liquid container with hang flap
US4412834A (en) * 1981-06-05 1983-11-01 Baxter Travenol Laboratories Antimicrobial ultraviolet irradiation of connector for continuous ambulatory peritoneal dialysis
JPS57206447A (en) * 1981-06-12 1982-12-17 Terumo Corp Plastic container receiving liquid drug pasturized with high pressure steam and production thereof
JP3060132B2 (ja) * 1991-03-02 2000-07-10 株式会社大塚製薬工場 複室容器
US5370221A (en) * 1993-01-29 1994-12-06 Biomet, Inc. Flexible package for bone cement components
DE9408747U1 (de) * 1994-05-28 1994-09-01 Spang & Brands GmbH, 61381 Friedrichsdorf Durch eine Schutzkappe verschließbare Brechkappe
US6024220A (en) * 1995-06-07 2000-02-15 Baxter International Inc. Encapsulated seam for multilayer materials
US5910138A (en) * 1996-05-13 1999-06-08 B. Braun Medical, Inc. Flexible medical container with selectively enlargeable compartments and method for making same
US5728087A (en) * 1996-07-30 1998-03-17 Bracco Diagnostics, Inc. Universal flexible plastic container with multiple access ports of inverted Y shape configuration
FR2758088B1 (fr) * 1997-01-06 1999-04-16 Medex Sa Dispositif d'injection de liquide medical
US6039718A (en) * 1998-01-20 2000-03-21 Bracco Research Usa Multiple use universal connector
US6019751A (en) * 1998-01-20 2000-02-01 Bracco Research Usa Universal connector and a medical container
US5896989A (en) * 1998-02-20 1999-04-27 Bracco Research Usa Flexible medical container packaging
JP2001190639A (ja) * 2000-01-07 2001-07-17 Material Eng Tech Lab Inc 医療用容器
US6613036B1 (en) * 2000-02-01 2003-09-02 Abbott Laboratories Light-protective container assembly and method of making same
JP2001252334A (ja) * 2000-03-08 2001-09-18 Otsuka Pharmaceut Factory Inc 輸液バッグ用の外装袋および外装カバーと、それらを用いた輸液バッグの保存方法および使用方法
US6893428B2 (en) * 2000-11-27 2005-05-17 Benjamin R. Willemstyn Over-wrap bag enclosure for sterile connectors

Also Published As

Publication number Publication date
US9078806B2 (en) 2015-07-14
PT1799174E (pt) 2009-11-17
EP1799174B1 (de) 2009-08-12
FR2874816A1 (fr) 2006-03-10
DK1799174T3 (da) 2009-12-14
WO2006029989A2 (fr) 2006-03-23
JP2008512160A (ja) 2008-04-24
ES2331012T3 (es) 2009-12-18
FR2874816B1 (fr) 2006-12-08
DE602005015993D1 (de) 2009-09-24
EP1799174A2 (de) 2007-06-27
ATE439113T1 (de) 2009-08-15
WO2006029989A3 (fr) 2006-05-11
US20080065043A1 (en) 2008-03-13

Similar Documents

Publication Publication Date Title
EP1799174B9 (de) Speicheranordnung für kontrastmedien
EP0295204B1 (de) Mehrkammerbehälter zur Aufbewahrung und nachfolgenden Mischung aktiver Komponenten
EP0816252B1 (de) Verpackung für biologische Flüssigkeiten mit aufreissbarer Folie zur Einführung einer Sonde
EP2645981B1 (de) Beutel zum verteilen eines produkts zur biopharmazeutischen verwendung im allgemeinen zustand einer flüssigkeit oder paste über mehrere auslassports
EP2598412B1 (de) Einwegsverpackung
WO2000004131A1 (fr) Poches souples pour le transport de produits fluides bio-pharmaceutiques
JPH11276550A (ja) 柔軟な医薬品容器の包装
EP2662307B1 (de) Erkennung der Unversehrtheit einer dichten, geschlossenen, flexiblen Tasche aus Plastik zur Aufnahme und zum Schutz eines biopharmazeutischen Produkts oder einer biopharmazeutischen Vorrichtung
FR2719018A1 (fr) Procédé pour remplir dans des conditions aseptiques un récipient obturé.
US20150157534A1 (en) Flexible container with outlet
FR2639914A1 (fr) Nouveau dispositif distributeur pour preparations liquides
RU2558829C2 (ru) Заполнение емкости
EP0102302B1 (de) Beutel für medizinischen Gebrauch, insbesondere bestimmt für parenterale Ernährung
JP2000245810A (ja) 柔軟医療容器の賦形装置
WO2010146296A1 (fr) Poche a temoin de perte d'integrite incorpore, procede de realisation d'une telle poche et procede d'utilisation
JP6125501B2 (ja) 医療器具の包装容器及び医療器具包装体並びに医療器具包装体の製造方法
EP2193775B1 (de) Flexibler Behälter für den medizinischen Einsatz
JP5449864B2 (ja) 医療用容器、医療用容器の製造方法、及び輸液入り医療用容器の製造方法
FR2814968A1 (fr) Dispositif distributeur avec buse integrale et capuchon
WO2018091809A1 (fr) Poche à usage médical à deux compartiments comportant une languette
WO2023180671A1 (fr) Poche destinée à contenir des substances médicales pour injection intraveineuse
WO2007125261A1 (fr) Systeme de conditionnement sterilisable par autoclavage et son procede de fabrication

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20070406

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

DAX Request for extension of the european patent (deleted)
17Q First examination report despatched

Effective date: 20080616

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

Free format text: NOT ENGLISH

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

REF Corresponds to:

Ref document number: 602005015993

Country of ref document: DE

Date of ref document: 20090924

Kind code of ref document: P

REG Reference to a national code

Ref country code: CH

Ref legal event code: NV

Representative=s name: MICHELI & CIE SA

REG Reference to a national code

Ref country code: SE

Ref legal event code: TRGR

Ref country code: PT

Ref legal event code: SC4A

Free format text: AVAILABILITY OF NATIONAL TRANSLATION

Effective date: 20091110

REG Reference to a national code

Ref country code: DK

Ref legal event code: T3

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2331012

Country of ref document: ES

Kind code of ref document: T3

LTIE Lt: invalidation of european patent or patent extension

Effective date: 20090812

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20091212

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

REG Reference to a national code

Ref country code: IE

Ref legal event code: FD4D

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20091112

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

Ref country code: IE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20100517

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20091113

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: HU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20100213

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20090812

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: LU

Payment date: 20140828

Year of fee payment: 10

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: MC

Payment date: 20140819

Year of fee payment: 10

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20150908

Ref country code: MC

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20150930

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 12

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 13

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 14

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20200929

Year of fee payment: 16

Ref country code: DK

Payment date: 20200929

Year of fee payment: 16

Ref country code: GB

Payment date: 20200928

Year of fee payment: 16

Ref country code: TR

Payment date: 20200826

Year of fee payment: 16

Ref country code: NL

Payment date: 20200926

Year of fee payment: 16

Ref country code: PT

Payment date: 20200818

Year of fee payment: 16

Ref country code: FR

Payment date: 20200925

Year of fee payment: 16

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: IT

Payment date: 20200923

Year of fee payment: 16

Ref country code: SE

Payment date: 20200929

Year of fee payment: 16

Ref country code: AT

Payment date: 20200819

Year of fee payment: 16

Ref country code: BE

Payment date: 20200928

Year of fee payment: 16

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: ES

Payment date: 20201001

Year of fee payment: 16

Ref country code: CH

Payment date: 20201002

Year of fee payment: 16

REG Reference to a national code

Ref country code: DE

Ref legal event code: R119

Ref document number: 602005015993

Country of ref document: DE

REG Reference to a national code

Ref country code: DK

Ref legal event code: EBP

Effective date: 20210930

REG Reference to a national code

Ref country code: SE

Ref legal event code: EUG

REG Reference to a national code

Ref country code: NL

Ref legal event code: MM

Effective date: 20211001

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

REG Reference to a national code

Ref country code: AT

Ref legal event code: MM01

Ref document number: 439113

Country of ref document: AT

Kind code of ref document: T

Effective date: 20210908

REG Reference to a national code

Ref country code: BE

Ref legal event code: MM

Effective date: 20210930

GBPC Gb: european patent ceased through non-payment of renewal fee

Effective date: 20210908

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: PT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20220308

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NL

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20211001

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210909

Ref country code: GB

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210908

Ref country code: FR

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210930

Ref country code: DE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20220401

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210930

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210930

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210930

Ref country code: AT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210908

REG Reference to a national code

Ref country code: ES

Ref legal event code: FD2A

Effective date: 20221027

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210908

Ref country code: DK

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210930

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: ES

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20210909