EP1181920A2 - 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
EP1181920A2
EP1181920A2 EP20010120061 EP01120061A EP1181920A2 EP 1181920 A2 EP1181920 A2 EP 1181920A2 EP 20010120061 EP20010120061 EP 20010120061 EP 01120061 A EP01120061 A EP 01120061A EP 1181920 A2 EP1181920 A2 EP 1181920A2
Authority
EP
European Patent Office
Prior art keywords
bag
chamber
component
filled
film
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.)
Granted
Application number
EP20010120061
Other languages
German (de)
English (en)
Other versions
EP1181920B1 (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, which is filled with a first component, and a second chamber which is filled with a second component. About that the invention also relates to a two-chamber arrangement.
  • Multi-chamber bags are for example from DE 32 38 649, DE 94 01 288 and EP 0 737 468.
  • the well-known two-chamber bags have in common that they have two chambers have, which are separated by a peel seam. In use, the Seam separated so that the components contained in the chambers can be mixed together. To remove the contents of the bag is on one of the two chambers provided a closable outlet opening.
  • the invention is therefore based on the object of specifying a method which a simplified and inexpensive manufacture of a two-chamber arrangement allowed in large numbers.
  • Another object of the invention is one Provide two-chamber arrangement that is simple and inexpensive can be manufactured.
  • the inventive method is based on the fact that not a common Bags with two chambers, but two separate bags with only one each Chamber manufactured and filled, which are connected later become. This means that each bag can be used independently of the other Procedures to be sterilized.
  • the first and second film bags are used to produce the two-chamber arrangement each closed with a separable seam. Then be the two bags put together in such a way that after the two seams have been separated, the two components can be mixed together. Preferably the two bags are welded together after filling. You can but can also be glued together. Sealing each bag with one separable seam has the advantage that its content before joining is tightly enclosed.
  • the foil pouches can be made from one another and on their edges interconnected film webs or from a film tube are manufactured.
  • the first and second peel seams are preferably arranged such that the protruding pouch films form pockets so that the pouches can be easily get connected.
  • the pockets are preferably closed, to keep the bags free of particles. A sticking together of the pouch films is advantageously avoided by an air cushion.
  • the first sachet can be used a carrier solution and the second bag with an active ingredient powder independently are filled from each other at different locations.
  • the first bag can then autoclaved at relatively high temperatures in a known manner and the second bags are radiation-sterilized before filling. After connecting the two bags form the two-chamber arrangement for the user again an easy-to-use unit that allows it to work in one chamber transfer component contained in the other chamber.
  • the first bag containing the carrier solution consists of a weldable polyolefin film, during which the moisture-sensitive active ingredient powder-absorbing second bag from a water and oxygen absorbing aluminum composite film. Too To be able to weld the aluminum foil, this is preferably with a appropriate coating.
  • the two-chamber arrangement can be used as a primary bag in a secondary bag appropriate barrier properties are introduced. You can still Oxygen absorber bag between primary and secondary packaging be provided.
  • the two bags are by means of a tubular connector connected to a break-off part is closed.
  • One end of the connector is in the first bag used, the part of the connecting piece protruding beyond the bag is advantageously protected with a protective cap, which is before insertion the other end of the connector in the second bag is removed.
  • Another variant provides that a first in the first bag Connector piece and a second connector piece inserted into the second bag that are only for mixing the two components together connected, for example screwed or plugged together.
  • Figures 1a to 1c show the individual steps for producing a first Embodiment of the two-chamber arrangement in a greatly simplified Presentation.
  • the two-chamber arrangement consists of two separate ones Foil bags 1, 2, which are filled and sterilized independently of one another.
  • the first film bag 1 is made of two polyolefin films 3 placed one above the other manufactured, initially only on the lower edge 3a and the side edges 3b, 3c be sealed together.
  • a Removal part 4 for connecting an infusion line, not shown, to Withdrawing liquid
  • an injection part 5 for supplying liquid welded by means of an injection needle, not shown.
  • the removal and Injection parts are described in detail in DE 197 28 775, on the explicit reference is made.
  • the open bag 1 is now with a Carrier solution filled and in the area of its upper edge 3d with a peel seam 6 provided, which extends between the side edges 3b, 3c and one Closes first chamber 7 containing carrier solution.
  • the Films 3 also together at the upper edge to form a first pocket 7a sealed.
  • the sealing seam for closing the first pocket is with the Provide reference numeral 3d.
  • the bag is autoclaved at 121 ° C. Gluing the between the peel seam 6 and the outer sealing seam 3d This ensures that films lying on top of each other during autoclaving are safe prevents the first pocket 7a from being filled with air. By a minor The two foils are no longer in contact with air. But this is only then required if the films tend to stick.
  • the second bag 2 has two aluminum composite films 8 placed one above the other with oxygen and moisture absorbing layers.
  • the composite films are provided with an appropriate coating on the inside, so that the films 3.8 can be welded to one another.
  • the aluminum composite foils 8 of the second bag 2 are at the upper edge 8a and Sides 8b, 8c are sealed together and the bag is radiation sterilized. Then the aluminum bag becomes aseptic, if necessary with protective nitrogen gas and exclusion of moisture with the Active ingredient powder filled.
  • the bag is now 8d in the area of its lower edge provided with a separable peel seam 9, which is between the Side edges 8b, 8c extends and a second containing the active ingredient powder Chamber 10 closes. Then the pouch films 8 are formed to form a second pocket 10a also sealed together at the bottom.
  • the sealed seam for closing the bag is provided with the reference number 8d (Fig. 1a).
  • a second step the corresponding Clean room conditions of the first and second bags 1, 2 put together (FIG 1b).
  • the protruding edges of the bag films of the first or second bag cut along the sealing seams 3d, 8d. Then it will open end of the first bag 1 over the open end of the second bag 2 pushed and both bags are sealed with a circumferential seal 11 welded together.
  • the area between the two peel seams 6, 9 of the first and second bags 1, 2 are sterilized again.
  • a Sterilization process used by flashes of light with a suitable uses spectral energy distribution. This procedure can be done after Fill also to re-sterilize the two bags in the area of the Bags 7a, 10a are used. Because the compartments through the light-flash sterilization process to be sterilized requires cutting off the protruding edges of the pouch films are not under strictly aseptic Conditions that are as germ-free and particle-free as possible but still required.
  • Fig. 3c shows the finished two-chamber bag, which together as the primary bag with one or more oxygen absorber bags in a secondary bag appropriate locking properties can be introduced.
  • the contents of the bag can be transferred to the carrier solution using an infusion line be removed, which is connected to the removal part 4.
  • the Injection part 5 still allows the supply of additional substances.
  • Figures 2a and 2b show the process steps for producing a second Embodiment of the two-chamber arrangement, which differs from the first Embodiment differs in that the two bags are not together welded, but by means of a tubular connecting piece 12 be connected to each other.
  • the chambers of the first and second bag not closed with peel seams.
  • One end of the radiation-sterilized Connection piece 12 is closed with a break-off part 13, while the other end is protected with a breakable protective cap 14.
  • the parts of the embodiment according to Figures 2a and 2b, the parts of the Embodiments according to Figures 1a to 1c correspond to the provided with the same reference numerals.
  • the protective cap 14 extends over the entire part of the connector that protrudes from the first bag. The first bag is then autoclaved.
  • the radiation-sterilized second bag 2 which is not yet sealed at the lower edge 8d, with the active ingredient powder filled.
  • the protective cover 14 of the connector 12 removed and the free end of the connector is welded to the lower edge 8d of the second bag 2.
  • FIGS. 3a and 3b show a further variant.
  • the corresponding ones Parts are again provided with the same reference numbers.
  • the connection of the first and second bag 1, 2 is carried out with two schematically shown Connector pieces 15, 16.
  • the two connector pieces 15, 16 are in front of the Screw tightly closed and only open when the Screw connection.
  • the connector pieces with Be broken off. Both connector pieces are radiation sterilized.
  • the first bag 1 is filled with the carrier solution and at its upper edge 3d sealed. During the welding process, one end of the first Connector piece 15 welded to the upper edge 3d. Then the first bag autoclaved again.
  • the steel-sterilized second bag 2 is also filled the active ingredient powder aseptically. Then the lower edge 8d of the second bag sealed. One end of the second Connector 16 welded into the lower edge.
  • the two connecting pieces 15, 16 are reversible connected together so that the active ingredient powder and carrier solution together can be mixed.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Basic Packing Technique (AREA)
  • Bag Frames (AREA)
  • Package Specialized In Special Use (AREA)
  • Physical Deposition Of Substances That Are Components Of Semiconductor Devices (AREA)
  • Combustion Methods Of Internal-Combustion Engines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
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 true EP1181920A2 (fr) 2002-02-27
EP1181920A3 EP1181920A3 (fr) 2003-12-10
EP1181920B1 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)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9962896B2 (en) 2008-02-27 2018-05-08 Fenwal, Inc. Peelable seals including porous inserts

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7146781B1 (en) 2004-12-06 2006-12-12 Nathan Albert Cole Apparatus and method for insertion of material into uncontaminated containers
WO2006130818A2 (fr) * 2005-06-01 2006-12-07 Pathways, Llc Appareil et procedes permettant de former un coussin de mousse
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
EP2172181B1 (fr) * 2007-07-19 2014-06-25 Otsuka Pharmaceutical Factory, Inc. Sac à multiples chambres
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
CN107580488B (zh) * 2015-05-13 2020-10-23 费森尤斯卡比德国有限公司 用于医疗液体的容器
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
CN109533629A (zh) * 2018-11-20 2019-03-29 顺丰科技有限公司 一种包装袋

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3238649A1 (de) 1982-10-19 1984-04-19 Hagen Dr. 8520 Erlangen Theuer Mehrkompartimentbeutel fuer mischinfusionsloesungen
DE9401288U1 (de) 1994-01-26 1994-03-17 Fresenius Ag Mehrkammerbeutel
EP0737468A2 (fr) 1995-04-11 1996-10-16 Nissho Corporation Poche souple à deux chambres
DE19728775A1 (de) 1997-07-05 1999-01-21 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen

Family Cites Families (16)

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Publication number Priority date Publication date Assignee Title
US4402402A (en) * 1981-10-14 1983-09-06 Pike Brian R Barrier seal multiple-compartment package
JPS5975059A (ja) * 1982-10-22 1984-04-27 テルモ株式会社 輸液容器
JPS5975058A (ja) * 1982-10-22 1984-04-27 テルモ株式会社 輸液用器具
WO1987003809A1 (fr) * 1985-12-20 1987-07-02 Veech Richard L Preparation de solutions d'electrolytes et recipients les contenant
JPH01198547A (ja) * 1988-02-01 1989-08-10 Morishita Seiyaku Kk 液体等の収納容器とその開栓器具
DE3834566A1 (de) 1988-10-11 1990-04-12 Fresenius Ag Behaelter zur sterilen, getrennten aufbewahrung mindestens zweier substanzen und zur vermischung derselben
DE3926395C1 (en) * 1989-08-10 1991-03-07 Fresenius Ag, 6380 Bad Homburg, De Infusion system for feeding patient - uses two bags held in frame with complementary connection pieces
CZ3869U1 (cs) * 1990-11-07 1995-09-26 Otsuka Pharmaceutical Factory, Inc. Zásobník s větším počtem komor
SE9103395D0 (sv) * 1991-11-18 1991-11-18 Gambro Ab System med anvaendning av ensteril medicinsk loesning innehaallande glukos eller glukosliknande aemnen samt en loesning avsedd foer detta system
JP3016347B2 (ja) * 1995-02-10 2000-03-06 株式会社ニッショー 複室容器の製造方法
JP3016348B2 (ja) * 1995-03-23 2000-03-06 株式会社ニッショー 複室容器
SE507052C2 (sv) * 1995-08-08 1998-03-23 Gambro Ab Behållare avsedd att innehålla steril medicinsk lösning
US5996782A (en) * 1997-04-14 1999-12-07 Sealed Air Corporation Foam in bag packaging system for manual use
JP2000197687A (ja) 1999-01-06 2000-07-18 Terumo Corp 医療用容器および医療用容器の製造方法
JP4476435B2 (ja) * 1999-07-22 2010-06-09 株式会社細川洋行 仕切部材、複室輸液容器および薬剤入り複室輸液容器の製造方法
DE19960226C1 (de) * 1999-12-14 2001-05-10 Fresenius Ag Sterilitäterhaltendes Konnektionssystem für medizinische Systeme und dessen Verwendung

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3238649A1 (de) 1982-10-19 1984-04-19 Hagen Dr. 8520 Erlangen Theuer Mehrkompartimentbeutel fuer mischinfusionsloesungen
DE9401288U1 (de) 1994-01-26 1994-03-17 Fresenius Ag Mehrkammerbeutel
EP0737468A2 (fr) 1995-04-11 1996-10-16 Nissho Corporation Poche souple à deux chambres
DE19728775A1 (de) 1997-07-05 1999-01-21 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9962896B2 (en) 2008-02-27 2018-05-08 Fenwal, Inc. Peelable seals including porous inserts

Also Published As

Publication number Publication date
MXPA01008527A (es) 2003-05-19
US20020023851A1 (en) 2002-02-28
CA2354714C (fr) 2009-02-10
AU5990601A (en) 2002-02-28
AU782287B2 (en) 2005-07-14
DE10041295B4 (de) 2006-06-08
BR0103450A (pt) 2003-06-24
US6712202B2 (en) 2004-03-30
JP2002136571A (ja) 2002-05-14
CA2354714A1 (fr) 2002-02-23
EP1181920B1 (fr) 2005-11-23
ATE310486T1 (de) 2005-12-15
DE10041295A1 (de) 2002-03-14
DE50108143D1 (de) 2005-12-29
JP4886945B2 (ja) 2012-02-29
BR0103450B1 (pt) 2011-09-20
EP1181920A3 (fr) 2003-12-10

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