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EP1181920B1 - Process for fabricating a dual compartment assembly - Google Patents

Process for fabricating a dual compartment assembly 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
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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
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German (de)
French (fr)
Other versions
EP1181920A2 (en
EP1181920A3 (en
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
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Fresenius Kabi Deutschland GmbH
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Publication date
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Publication of EP1181920A2 publication Critical patent/EP1181920A2/en
Publication of EP1181920A3 publication Critical patent/EP1181920A3/en
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    • 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.

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  • 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)

Abstract

To give a twin-chamber assembly, where each chamber is filled with a different component material, two bags (1,2) are filled separately with the two components and are sterilized. After filling and sterilizing, the bags are linked together so that the contents of one bag can be transferred to the other for the materials to be mixed together. After filling, the bags are closed by a peel seam which can be removed for the ends of the bags to be welded together.

Description

Die Erfindung betrifft ein Verfahren zur Herstellung einer Zweikammer-Anordnung mit einer ersten Kammer, die mit einer ersten Komponente befüllt ist, und einer zweiten Kammer, die mit einer zweiten Komponente befüllt ist. Darüber hinaus bezieht sich die Erfindung auf eine Zweikammer-Anordnung.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.

Derartige Zweikammer-Systeme finden beispielsweise zur Bevorratung von Substanzen für die Infusionstherapie oder zur parenteralen Ernährung Verwendung, die erst kurz vor der Verabreichung miteinander gemischt werden sollen. Mehrkammerbeutel sind beispielsweise aus der DE 32 38 649, DE 94 01 288 und EP 0 737 468 bekannt.Such two-chamber systems find, for example, for the storage of substances for infusion therapy or for parenteral nutrition use, which should be mixed together shortly before administration. Multi-chamber bag are for example from DE 32 38 649, DE 94 01 288 and EP 0 737 468.

Den bekannten Zweikammer-Beuteln ist gemeinsam, daß sie zwei Kammern aufweisen, die von einer Peel-Naht getrennt sind. Im Anwendungsfall wird die Naht aufgetrennt, so daß die in den Kammern enthaltenen Komponenten miteinander gemischt werden können. Zum Entnehmen des Beutelinhalts ist an einer der beiden Kammern eine verschließbare Auslaßöffnung vorgesehen.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.

Die bekannten Zweikammer-Beutel haben sich in der Praxis bewährt. Wenn eine der beiden Kammern jedoch mit einer sensiblen Substanz befüllt ist, kann sich die Sterilisierung des Beutels als problematisch erweisen.The known two-chamber bags have proven themselves in practice. When a However, the two chambers filled with a sensitive substance, the Sterilization of the bag prove problematic.

Die EP 0 733 353 B 1 beschreibt ein Verfahren zur Herstellung, Befüllung und Sterilisierung zweier separater Beutel, die erst später miteinander verbunden werden. Der erste Beutel, der mit einem trockenen Arzneimittel gefüllt ist, wird unter Verwendung von Strahlung sterilisiert, während der zweite Beutel, der mit einer medizinischen Flüssigkeit befüllt wird, zur Sterilisierung Hochdruckdampf ausgesetzt wird. Beide Beutel sind mit aufreißbaren Nähten versehen, die durch Zwischenlage von Folienstreifen gebildet werden.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.

Das bekannte Verfahren ist insofern nachteilig, als die Sterilität dann nicht sichergestellt werden kann, wenn die beiden Beutel erst später zusammengefügt werden.The known method is disadvantageous in that sterility is not ensured can be when the two bags are assembled later.

Die JP 2000 197687 A beschreibt eine Zweikammer-Anordnung, deren Beutel unter Bildung von Taschen miteinander verschweißt sind. Die Beutel weisen zwar jeweils eine Tasche auf, beide Taschen werden aber nicht durch Nähte verschlossen, die vor dem Zusammenfügen der Beutel aufgetrennt werden. Da die Tasche eines Beutels erst beim Zusammenfügen der Beutel verschweißt wird, sind die Folienlagen zuvor der Umgebung ausgesetzt.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.

Der Erfindung liegt daher die Aufgabe zugrunde, ein Verfahren anzugeben, das eine vereinfachte und kostengünstige Herstellung einer Zweikammer-Anordnung in großen Stückzahlen unter sterilen Bedingungen erlaubt.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.

Die Lösung dieser Aufgaben erfolgt erfindungsgemäß mit den Merkmalen des Patentanspruchs 1.The solution of these objects is achieved according to the invention with the features of Patent claim 1.

Das erfindungsgemäße Verfahren beruht darauf, daß nicht ein gemeinsamer Beutel mit zwei Kammern, sondern zwei separate Beutel mit nur jeweils einer Kammer hergestellt und befüllt werden, die erst später miteinander verbunden werden. Damit kann jeder Beutel unabhängig voneinander mit unterschiedlichen Verfahren sterilisiert werden.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.

Zur Herstellung der Zweikammer-Anordnung werden der erste und zweite Folien-Beutel jeweils mit einer auftrennbaren Naht verschlossen. Anschließend werden die beiden Beutel derart zusammengefügt, daß nach Auftrennen der beiden Nähte, die beiden Komponenten miteinander gemischt werden können. Vorzugsweise werden die beiden Beutel nach dem Befüllen miteinander verschweißt. Sie können aber auch miteinander verklebt werden. Das Verschließen jedes Beutels mit einer auftrennbaren Naht hat den Vorteil, daß deren Inhalt vor dem Zusammenfügen fest umschlossen ist. To produce the two-chamber arrangement, 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.

Die Folien-Beutel können aus übereinander liegenden und an ihren Rändern miteinander verbundenen Folienbahnen oder auch aus einem Folienschlauch gefertigt werden.The foil pouches can be made from one another and at their edges Connected film webs or made of a film tube become.

Die erste und zweite Peel-Naht werden derart angeordnet, daß die überstehenden Beutelfolien Taschen bilden, so daß sich die Beutel leicht miteinander verbinden lassen. Die Taschen werden verschlossen, um die Beutel frei von Partikeln zu halten. Ein Aneinanderkleben der Beutelfolien wird vorteilhafterweise durch ein Luftpolster vermieden.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.

Zur Herstellung von Antibiotika oder Cytostatika können der erste Beutel mit einer Trägerlösung und der zweite Beutel mit einem Wirkstoffpulver unabhängig voneinander an unterschiedlichen Orten befüllt werden. Der erste Beutel kann dann bei relativ hohen Temperaturen in bekannter Weise autoklaviert und der zweite Beutel vor der Befüllung strahlen-sterilisiert werden. Nach dem Verbinden der beiden Beutel bildet die Zweikammer-Anordnung für den Anwender wieder eine einfach zu handhabende Einheit, die es erlaubt, die in der einen Kammer enthaltende Komponente in die andere Kammer zu überführen.For the production of antibiotics or cytostatics, 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.

Von Vorteil ist, wenn der die Trägerlösung enthaltende erste Beutel aus einer verschweißbaren Polyolefinfolie besteht, während der das feuchtigkeitsempfindliche Wirkstoffpulver aufnehmende zweite Beutel aus einer wasser- und sauerstoffabsorbierenden Aluminium-Verbundfolie besteht. Um auch die Aluminiumfolie verschweißen zu können, ist diese vorzugsweise mit einer entsprechenden Beschichtung versehen.It is advantageous if 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. To the aluminum foil too to be able to weld, this is preferably with a corresponding coating Mistake.

Die Zweikammer-Anordnung kann als Primärbeutel in einen Sekundärbeutel mit entsprechenden Sperreigenschaften eingebracht werden. Dabei können noch Sauerstoff-Absorberbeutel zwischen Primär - und Sekundärverpackung vorgesehen werden.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.

Im folgenden wird die Erfindung unter Bezugnahme auf die Zeichnungen näher erläutert. In the following the invention will become more apparent with reference to the drawings explained.

Es zeigen:

Figuren 1a bis 1c
die einzelnen Schritte zur Herstellung einer Zweikammer-Anordnung.
Show it:
FIGS. 1a to 1c
the individual steps for producing a two-chamber arrangement.

Die Figuren 1a bis 1c zeigen die einzelnen Schritte zur Herstellung der Zweikammer-Anordnung in einer stark vereinfachten Darstellung. Die Zweikammer-Anordnung besteht aus zwei separaten Folienbeuteln 1, 2, die unabhängig voneinander befüllt und sterilisiert werden.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.

Der erste Folienbeutel 1 wird aus zwei übereinander gelegten Polyolefinfolien 3 gefertigt, die zunächst nur am unteren Rand 3a und den Seitenrändern 3b, 3c miteinander versiegelt werden. In den unteren Rand 3a des Beutels werden ein Entnahmeteil 4 zum Anschließen einer nicht dargestellten Infusionsleitung zum Entnehmen von Flüssigkeit und ein Zuspritzteil 5 zum Zuführen von Flüssigkeit mittels einer nicht dargestellten Injektionsnadel eingeschweißt. Das Entnahme- und Zuspritzteil sind in der DE 197 28 775 im einzelnen beschrieben, auf die ausdrücklich Bezug genommen wird. Der offene Beutel 1 wird nun mit einer Trägerlösung befüllt und im Bereich seines oberen Randes 3d mit einer Peel-Naht 6 versehen, die sich zwischen den Seitenrändern 3b, 3c erstreckt und eine die Trägerlösung enthaltende erste Kammer 7 verschließt. Anschließend werden die Folien 3 auch am oberen Rand unter Bildung einer ersten Tasche 7a miteinander versiegelt. Die Siegelnaht zum Verschließen der ersten Tasche ist mit dem Bezugszeichen 3d versehen. Zum Schluß wird der Beutel bei 121 C° autoklaviert. Ein Verkleben der zwischen der Peel-Naht 6 und der äußeren Siegelnaht 3d übereinander liegenden Folien während des Autoklavierens wird dadurch sicher verhindert, daß die erste Tasche 7a mit Luft gefüllt wird. Durch eine geringfügige Luftfüllung haben die beiden Folien keinen Kontakt mehr. Dies ist aber nur dann erforderlich, wenn die Folien zum Verkleben neigen.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. Subsequently, 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. Finally, 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.

Der zweite Beutel 2 weist zwei übereinander gelegte Aluminium-Verbundfolien 8 mit sauerstoff- und feuchtigkeitsabsorbierenden Schichten auf. Die Verbundfolien sind an ihrer Innenseite noch mit einer entsprechenden Beschichtung versehen, so daß die Folien 3, 8 miteinander verschweißbar sind. Die Aluminium-Verbundfolien 8 des zweiten Beutels 2 werden am oberen Rand 8a und den Seitenrändern 8b, 8c miteinander versiegelt und der Beutel wird strahlen-sterilisiert. Anschließend wird der Aluminiumbeutel aseptisch, gegebenenfalls unter Stickstoff-Schutzbegasung sowie Feuchtigkeits-Ausschluß mit dem Wirkstoffpulver befüllt. Der Beutel wird nun im Bereich seines unteren Randes 8d mit einer auftrennbaren Peel-Naht 9 versehen, die sich zwischen den Seitenrändern 8b, 8c erstreckt und eine das Wirkstoffpulver enthaltende zweite Kammer 10 verschließt. Daraufhin werden die Beutelfolien 8 unter Bildung einer zweiten Tasche 10a auch am unteren Rand miteinander versiegelt. Die Siegelnaht zum Verschließen der Tasche ist mit dem Bezugszeichen 8d versehen (Fig. 1 a).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. Subsequently, 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).

In einem zweiten Arbeitsschritt werden unter entsprechenden Reinraumbedingungen der erste und zweite Beutel 1, 2 zusammengefügt (Figur 1b). Hierzu werden die überstehenden Ränder der Beutelfolien des ersten bzw. zweiten Beutels längs der Siegelnähte 3d, 8d abgeschnitten. Daraufhin wird das offene Ende des ersten Beutels 1 über das offene Ende des zweiten Beutels 2 geschoben und beide Beutel werden mit einer umlaufenden Siegelnaht 11 miteinander verschweißt. Der Bereich zwischen den beiden Peel-Nähten 6, 9 des ersten und zweiten Beutels 1, 2 wird nochmals sterilisiert. Hierfür wird ein Steriliserungsverfahren eingesetzt, das von Lichtblitzen mit einer geeigneten spektralen Energieverteilung Gebrauch macht. Dieses Verfahren kann nach dem Befüllen auch zum nochmaligen Sterilisieren der beiden Beutel im Bereich der Taschen 7a, 10a eingesetzt werden. Da die Kompartimente durch das Licht-Blitz-Sterilisationsverfahren sterilisiert werden, braucht das Abschneiden der überstehenden Ränder der Beutelfolien nicht unter streng aseptischen Bedingungen erfolgen, ein möglichst keimfreies und partikelfreies Arbeiten ist aber dennoch erforderlich.In a second step, under appropriate clean room conditions the first and second bags 1, 2 joined together (Figure 1b). To do this the protruding edges of the bag films of the first and second bag longitudinally the sealing seams 3d, 8d cut off. Then the open end of the first Bag 1 is pushed over the open end of the second bag 2 and both bags are welded together with a circumferential sealing seam 11. The area between the two peel seams 6, 9 of the first and second bags 1, 2 is sterilized again. For this purpose, a sterilization method is used, the of light flashes with a suitable spectral energy distribution use power. This procedure can also be used for sterilization after filling the two bags are used in the region of the pockets 7a, 10a. There the compartments are sterilized by the light-flash sterilization method, does not need to cut off the overhanging edges of the bag films under strictly aseptic conditions, as germ-free as possible and particle-free However, work is still required.

Fig.1c zeigt den fertigen Zweikammer-Beutel, der als Primärbeutel zusammen mit einem oder mehreren Sauerstoff-Absorberbeuteln in einen Sekundärbeutel mit entsprechenden Sperreigenschaften eingebracht werden kann. 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.

Im Anwendungsfall werden die beiden Peel-Nähte 6, 9 der Zweikammer-Anordnung durch Druck geöffnet und das Wirkstoffpulver aus der ersten Kammer 7 wird in die zweite Kammer 10 überführt. Nach dem Lösen des Wirkstoffpulvers in der Trägerlösung kann der Beutelinhalt mittels einer Infusionsleitung entnommen werden, die an dem Entnahmeteil 4 angeschlossen wird. Das Zuspritzteil 5 erlaubt noch das Zuführen von zusätzlichen Substanzen.In the application, the two peel seams 6, 9 of the two-chamber arrangement opened by pressure and the drug powder from the first chamber 7 is transferred to the second chamber 10. After dissolving the active ingredient powder in the carrier solution, 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.

Claims (7)

  1. 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, whereby the method comprises the following process steps:
    1) the fabrication of a first film bag (1), which has the first chamber (7), and the filling of the first bag (1) with the first component, whereby a connection (4) for removal of the bag contents is inserted into the first bag, and
    the fabrication of a second film bag (2), which has the second chamber (10), and the filling of the second bag, whereby
    a) the chamber of the first film bag is sealed with a first separable seam (6) and the chamber of the second film bag is sealed with a second separable seam (9),
    b) the first and second separable seams are arranged in such a way that the protruding bag films of the first and second film bags form respectively a first (7a) and second (10a) pocket, and
    c) the first and second pocket are sealed respectively with a third (3d) and forth (8d) seam;
    2) the separation of the bag film of the first and second film bag along the third and fourth seam respectively,
    3) the jointing together of the first and second bag in such a way that, after the separation of the first and second seam, the component contained in the first or second chamber is transferable to the second or first chamber respectively.
  2. The method according to claim 1, characterised in that the first pocket is filled with air.
  3. The method according to claim 1 or 2, characterised in that the first and second film bags are welded to one another.
  4. The method according to any one of claims 1 to 3, characterised in that the first bag is filled with a carrier solution and the second bag with an active-substance powder.
  5. The method according to any one of claims 1 to 4, characterised in that the first and second film bags are sterilised independently of one another by different methods.
  6. The method according to claim 5, characterised in that the first bag is autoclaved and the second bag sterilised by radiation.
  7. The method according to any one of claims 1 to 6, characterised in that the first bag is produced from a polyolefin film and the second bag from an aluminium-composite film.
EP20010120061 2000-08-23 2001-08-21 Process for fabricating a dual compartment assembly Expired - Lifetime EP1181920B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10041295 2000-08-23
DE2000141295 DE10041295B4 (en) 2000-08-23 2000-08-23 Method for producing a two-chamber arrangement

Publications (3)

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EP1181920A2 EP1181920A2 (en) 2002-02-27
EP1181920A3 EP1181920A3 (en) 2003-12-10
EP1181920B1 true EP1181920B1 (en) 2005-11-23

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

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DE102008063592B4 (en) 2008-12-18 2012-01-12 Dirk Schindelhauer Multifunctional laboratory process bag for the pure production of biomolecules
ITMI20120643A1 (en) 2012-04-18 2013-10-19 Frattini Paolo Giuseppe Gobbi BAG FOR LIQUID SOLUTIONS THAT CAN BE MIXED WITH ACTIVE SUBSTANCES AVAILABLE IN SEPARATE SHAPE, IN POWDER OR GEL IN PARTICULAR, FOR THE FORMATION OF MEDICINAL OR LIQUID NUTRITIONAL SUBSTANCES ADMINISTABLE TO PATIENTS FOR INTERNAL INSTILLATION.
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Also Published As

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

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