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EP1181920B1 - Procédé de réalisation d'un ensemble à deux compartiments - Google Patents

Procédé de réalisation d'un ensemble à deux compartiments Download PDF

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Publication number
EP1181920B1
EP1181920B1 EP20010120061 EP01120061A EP1181920B1 EP 1181920 B1 EP1181920 B1 EP 1181920B1 EP 20010120061 EP20010120061 EP 20010120061 EP 01120061 A EP01120061 A EP 01120061A EP 1181920 B1 EP1181920 B1 EP 1181920B1
Authority
EP
European Patent Office
Prior art keywords
bag
chamber
film
bags
filled
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
EP20010120061
Other languages
German (de)
English (en)
Other versions
EP1181920A2 (fr
EP1181920A3 (fr
Inventor
Hans-Jörg Dr. Müller
Klaus Dr. Sommermeyer
Bernd Eschenbach
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 Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP1181920A2 publication Critical patent/EP1181920A2/fr
Publication of EP1181920A3 publication Critical patent/EP1181920A3/fr
Application granted granted Critical
Publication of EP1181920B1 publication Critical patent/EP1181920B1/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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts

Definitions

  • the invention relates to a method for producing a two-chamber arrangement with a first chamber filled with a first component, and a second chamber filled with a second component. About that In addition, the invention relates to a two-chamber arrangement.
  • Multi-chamber bag are for example from DE 32 38 649, DE 94 01 288 and EP 0 737 468.
  • the known two-chamber bags have in common that they have two chambers, which are separated by a peel seam. In the case of application, the seam becomes separated, so that the components contained in the chambers with each other can be mixed. To remove the bag contents is at one of the two Chambers provided a closable outlet opening.
  • EP 0 733 353 B1 describes a process for the preparation, filling and Sterilization of two separate bags, which will be joined together later.
  • the first bag which is filled with a dry medicine, is submerged Use of radiation sterilized, while the second bag, with a medical fluid is filled, exposed to high pressure steam for sterilization becomes.
  • Both bags are provided with tearable seams, which are interleaved be formed by film strips.
  • the known method is disadvantageous in that sterility is not ensured can be when the two bags are assembled later.
  • JP 2000 197687 A describes a two-chamber arrangement, the bag are welded together to form pockets.
  • the bags have indeed one bag each, but both pockets are not closed by seams, which are separated before assembling the bags. Because the bag a bag is welded only when assembling the bags are the Film layers previously exposed to the environment.
  • the invention is therefore based on the object to provide a method which a simplified and cost-effective production of a two-chamber arrangement in large quantities under sterile conditions.
  • the inventive method is based on the fact that not a common bag with two chambers, but two separate bags with only one chamber produced and filled, which are joined together later. This allows each bag to work independently with different methods be sterilized.
  • the first and second film bags each closed with a separable seam. Then be the two bags are assembled in such a way that after separating the two seams, the two components can be mixed together. Preferably the two bags are welded together after filling. You can but also glued together. Closing each bag with a separable seam has the advantage that its contents prior to assembly is firmly enclosed.
  • the foil pouches can be made from one another and at their edges Connected film webs or made of a film tube become.
  • the first and second peel seam are arranged so that the protruding Bag foils form pockets, so that the bags easily connect to each other to let.
  • the bags are sealed to keep the bags free of particles hold.
  • An adhesion of the bag films is advantageously by a Air cushion avoided.
  • the first bag with a Carrier solution and the second bag with a drug powder independently be filled from each other in different places.
  • the first bag can then autoclaved at relatively high temperatures in a known manner and the second bags are to be radiation-sterilized before filling. After connecting The two bags form the two-chamber arrangement for the user an easy-to-use unit that allows you to keep in one compartment To transfer component into the other chamber.
  • the first bag containing the carrier solution consists of a Weldable polyolefin film is made while the moisture-sensitive Active ingredient powder receiving second bag of a water- and oxygen-absorbing Aluminum composite foil exists.
  • the moisture-sensitive Active ingredient powder receiving second bag of a water- and oxygen-absorbing Aluminum composite foil exists.
  • the two-chamber arrangement can be used as a primary bag in a secondary bag with appropriate barrier properties are introduced. This can still oxygen absorber bag between primary and secondary packaging become.
  • FIGS. 1a to 1c show the individual steps for producing the two-chamber arrangement in a simplistic representation.
  • the two-chamber arrangement consists of two separate foil bags 1, 2, which are independent of each other be filled and sterilized.
  • the first film bag 1 is made of two superimposed polyolefin films. 3 manufactured, the first only at the lower edge 3a and the side edges 3b, 3c with each other to be sealed. In the lower edge 3a of the bag become a sampling part 4 for connecting an infusion line, not shown, for removal of liquid and an injection part 5 for supplying liquid by means of a hypodermic needle, not shown welded.
  • the withdrawal and Injection part are described in DE 197 28 775 in detail, to the express Reference is made.
  • the open bag 1 is now filled with a carrier solution filled and provided in the region of its upper edge 3d with a peel seam 6, which extends between the side edges 3b, 3c and a carrier solution containing first chamber 7 closes.
  • the films are 3 also sealed together at the top to form a first pocket 7a.
  • the sealed seam for closing the first pocket is denoted by the reference numeral 3d Mistake.
  • the bag is autoclaved at 121 ° C. Gluing the between the peel seam 6 and the outer sealed seam 3d superimposed Foils during autoclaving is thereby reliably prevented that the first Bag 7a is filled with air. By a slight air filling have the both slides no longer in contact. But this is only necessary if the Foils tend to stick.
  • the second bag 2 has two superimposed aluminum composite films 8 with oxygen and moisture absorbing layers.
  • the composite films are still provided on their inside with a corresponding coating, so that the films 3, 8 are welded together.
  • the aluminum composite films 8 of the second bag 2 are at the upper edge 8a and the side edges 8b, 8c sealed together and the bag is radiation-sterilized.
  • the aluminum bag is aseptic, optionally under nitrogen protective fumigation as well as moisture exclusion with the active ingredient powder filled.
  • the bag is now in the region of its lower edge 8d with a separable Peel seam 9, which extends between the side edges 8b, 8c and a second chamber 10 containing the active ingredient powder closes. Thereafter, the bag films 8 become a second pocket 10a as well sealed at the bottom.
  • the sealing seam for closing the Bag is provided with the reference numeral 8d (Fig. 1 a).
  • Fig.1c shows the finished two-chamber bag, which together as a primary bag with one or more oxygen absorber bags in a secondary bag with corresponding barrier properties can be introduced.
  • the bag contents can be conveyed by means of an infusion line are removed, which is connected to the removal part 4.
  • the injection part 5 still allows the feeding of additional substances.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Package Specialized In Special Use (AREA)
  • Basic Packing Technique (AREA)
  • Bag Frames (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Physical Deposition Of Substances That Are Components Of Semiconductor Devices (AREA)
  • Combustion Methods Of Internal-Combustion Engines (AREA)

Claims (7)

  1. Procédé de réalisation d'un ensemble à deux compartiments comprenant un premier compartiment qui est rempli d'un premier composant et un second compartiment qui est rempli d'un second composant et comportant les étapes de procédé suivantes :
    1) Fabrication d'un premier sachet en film (1) qui présente le premier compartiment (7) et remplissage du premier sachet (1) avec le premier composant, un raccord (4) étant mis en place dans le premier sachet pour soutirer le contenu du sachet ; et
       Fabrication d'un second sachet en film (2) qui présente le second compartiment (10) et remplissage du second sachet, opération pendant laquelle :
    a) Le compartiment du premier sachet en film est fermé par une première couture séparable (6) et le compartiment du second sachet en film est fermé par une seconde couture séparable (9) ;
    b) La première et la seconde coutures séparables sont agencées de sorte que les films de sachet en saillie du premier ou du second sachet en film forment une première poche (7a) ou une seconde poche (10a) et la première et la seconde poches sont fermées par une troisième (3d) ou par une quatrième (8d) couture ;
    2) Séparation du film du premier ou du second sachet en film le long de la troisième ou de la quatrième couture ;
    3) Assemblage du premier et du second sachets en film de sorte que, après l'ouverture de la première et de la seconde coutures, il est possible de transférer le composant contenu dans le premier ou dans le second compartiment vers le second ou vers le premier compartiment.
  2. Procédé selon la revendication 1, caractérisé en ce que la première poche est remplie d'air.
  3. Procédé selon la revendication 1 ou 2, caractérisé en ce que le premier et le second sachets en film.sont soudés l'un à l'autre.
  4. Procédé selon l'une des revendications 1 à 3, caractérisé en ce que le premier sachet est rempli d'une solution porteuse et le second sachet est rempli d'un additif en poudre.
  5. Procédé selon l'une des revendications 1 à 4, caractérisé en ce que le premier et le second sachets en film sont stérilisés indépendamment l'un de l'autre avec des procédés différents.
  6. Procédé selon la revendication 5, caractérisé en ce que le premier sachet est autoclavé et le second sachet est stérilisé aux rayons.
  7. Procédé selon l'une des revendications 1 à 6, caractérisé en ce que le premier sachet est fabriqué à partir d'un film en polyoléfine et le second sachet est fabriqué à partir d'un film composite en aluminium.
EP20010120061 2000-08-23 2001-08-21 Procédé de réalisation d'un ensemble à deux compartiments Expired - Lifetime EP1181920B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10041295 2000-08-23
DE2000141295 DE10041295B4 (de) 2000-08-23 2000-08-23 Verfahren zur Herstellung einer Zweikammer-Anordnung

Publications (3)

Publication Number Publication Date
EP1181920A2 EP1181920A2 (fr) 2002-02-27
EP1181920A3 EP1181920A3 (fr) 2003-12-10
EP1181920B1 true EP1181920B1 (fr) 2005-11-23

Family

ID=7653467

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20010120061 Expired - Lifetime EP1181920B1 (fr) 2000-08-23 2001-08-21 Procédé de réalisation d'un ensemble à deux compartiments

Country Status (9)

Country Link
US (1) US6712202B2 (fr)
EP (1) EP1181920B1 (fr)
JP (1) JP4886945B2 (fr)
AT (1) ATE310486T1 (fr)
AU (1) AU782287B2 (fr)
BR (1) BR0103450B1 (fr)
CA (1) CA2354714C (fr)
DE (2) DE10041295B4 (fr)
MX (1) MXPA01008527A (fr)

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US7146781B1 (en) 2004-12-06 2006-12-12 Nathan Albert Cole Apparatus and method for insertion of material into uncontaminated containers
US20060272289A1 (en) * 2005-06-01 2006-12-07 Shay Pausa Foam cushion forming apparatus and methods
DE102005028068B4 (de) * 2005-06-16 2016-07-14 Georg Menshen Gmbh & Co. Kg Verfahren zum Befüllen eines beutelförmigen Behälters
JP4984228B2 (ja) * 2006-12-20 2012-07-25 大日本印刷株式会社 注出具付き包装袋およびその製造方法
AU2008276916B2 (en) * 2007-07-19 2014-05-15 Otsuka Pharmaceutical Factory, Inc. Multi-chamber bag
US20090214807A1 (en) * 2008-02-27 2009-08-27 Shawn Davis Peelable seals including porous inserts
DE102008057822B4 (de) 2008-11-18 2011-03-31 HSG-IMIT-Institut für Mikro- und Informationstechnik der Hahn-Schickard-Gesellschaft für angewandte Forschung e.V. Vorrichtung zur Aufbewahrung und dermalen Verabreichung einer Substanz
DE102008063592B4 (de) 2008-12-18 2012-01-12 Dirk Schindelhauer Multifunktionaler Laborprozessbeutel für die Reinherstellung von Biomolekülen
ITMI20120643A1 (it) 2012-04-18 2013-10-19 Frattini Paolo Giuseppe Gobbi Sacca per soluzioni liquide miscelabili con sostanze attive disponibili in forma separata, in particolare in polvere o gel, per la formazione di sostanze medicinali o nutrizionali liquide somministrabili a pazienti per instillazione interna.
FR3027220B1 (fr) * 2014-10-21 2016-12-23 Technoflex Ensemble pour le stockage de produits a usage medical
ES2762926T3 (es) * 2015-05-13 2020-05-26 Fresenius Kabi Deutschland Gmbh Recipiente para un líquido médico
DE102015225837A1 (de) 2015-12-18 2017-06-22 Robert Bosch Gmbh Folienbeutel für ein mikrofluidisches Analysesystem, mikrofluidisches Analysesystem, Verfahren zum Herstellen und Verfahren zum Betreiben eines mikrofluidischen Analysesystems
IT201800009131A1 (it) * 2018-10-03 2020-04-03 Orofino Pharmaceuticals Group Srl Cartuccia deformabile per dispositivo di iniezione
CN109533629A (zh) * 2018-11-20 2019-03-29 顺丰科技有限公司 一种包装袋
DE102023102595A1 (de) * 2023-02-02 2024-08-08 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zur Herstellung eines Beutels mit einem stumpfgeschweißten Anschluss

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Also Published As

Publication number Publication date
DE50108143D1 (de) 2005-12-29
EP1181920A2 (fr) 2002-02-27
JP4886945B2 (ja) 2012-02-29
ATE310486T1 (de) 2005-12-15
JP2002136571A (ja) 2002-05-14
AU5990601A (en) 2002-02-28
BR0103450B1 (pt) 2011-09-20
EP1181920A3 (fr) 2003-12-10
US6712202B2 (en) 2004-03-30
CA2354714A1 (fr) 2002-02-23
BR0103450A (pt) 2003-06-24
DE10041295B4 (de) 2006-06-08
MXPA01008527A (es) 2003-05-19
AU782287B2 (en) 2005-07-14
CA2354714C (fr) 2009-02-10
DE10041295A1 (de) 2002-03-14
US20020023851A1 (en) 2002-02-28

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