EP1181920A2 - Process for fabricating a dual compartment assembly - Google Patents
Process for fabricating a dual compartment assembly Download PDFInfo
- 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
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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.
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- 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)
Abstract
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, 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.
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 are used, for example, to store Substances for infusion therapy or for parenteral nutrition Use that are mixed together shortly before administration should. Multi-chamber bags 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 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.
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 of the two chambers is filled with a sensitive substance, however Sterilizing the bag may prove problematic.
Der Erfindung liegt daher die Aufgabe zugrunde, ein Verfahren anzugeben, das eine vereinfachte und kostengünstige Herstellung einer Zweikammer-Anordnung in großen Stückzahlen erlaubt. Eine weitere Aufgabe der Erfindung ist, eine Zweikammer-Anordnung bereitzustellen, die einfach und kostengünstig hergestellt werden kann.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.
Die Lösung dieser Aufgaben erfolgt erfindungsgemäß mit den Merkmalen der
Patentansprüche 1, 10, 11 bzw. 13.According to the invention, these tasks are solved with the features of
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 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.
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.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.
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 on their edges interconnected film webs or from a film tube are manufactured.
Vorzugsweise werden die erste und zweite Peel-Naht derart angeordnet, daß die überstehenden Beutelfolien Taschen bilden, so daß sich die Beutel leicht miteinander verbinden lassen. Die Taschen werden vorzugsweise verschlossen, um die Beutel frei von Partikeln zu halten. Ein Aneinanderkleben der Beutelfolien wird vorteilhafterweise durch ein Luftpolster vermieden. 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.
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.To produce antibiotics or cytostatics, 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.
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, 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.
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 appropriate barrier properties are introduced. You can still Oxygen absorber bag between primary and secondary packaging be provided.
Bei einer zweiten Ausführungsform werden die beiden Beutel mittels eines rohrförmigen Verbindungsstückes verbunden, das mit einem Abbrechteil verschlossen ist. In den ersten Beutel wird das eine Ende des Verbindungsstücks eingesetzt, wobei das über den Beutel hinausragende Teil des Verbindungsstücks vorteilhafterweise mit einer Schutzkappe geschützt wird, die vor dem Einsetzen des anderen Endes des Verbindungsstücks in den zweiten Beutel entfernt wird.In a second embodiment, 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.
Eine weitere Variante sieht vor, daß in den ersten Beutel ein erstes Konnektorstück und in den zweiten Beutel ein zweites Konnektorstück eingesetzt werden, die erst zum Vermischen der beiden Komponenten miteinander verbunden, beispielsweise verschraubt oder zusammengesteckt werden.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.
Im folgenden wird die Erfindung unter Bezugnahme auf die Zeichnungen näher erläutert.In the following the invention with reference to the drawings explained.
Es zeigen:
- Figuren 1a bis 1c
- die einzelnen Schritte zur Herstellung einer ersten Ausführungsform der Zweikammer-Anordnung,
- Figuren 2a und 2b
- die Schritte zur Herstellung einer zweiten Ausführungsform der Zweikammer-Anordnung und
Figuren 3a und 3b- die Schritte zur Herstellung einer weiteren Ausführungsform der Zweikammer-Anordnung.
- Figures 1a to 1c
- the individual steps for producing a first embodiment of the two-chamber arrangement,
- Figures 2a and 2b
- the steps for producing a second embodiment of the two-chamber arrangement and
- Figures 3a and 3b
- the steps for producing a further embodiment of the two-chamber arrangement.
Die Figuren 1a bis 1c zeigen die einzelnen Schritte zur Herstellung einer ersten
Ausführungsform 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.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
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 Entnahmeund
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
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. 1a).The
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, the corresponding
Clean room conditions of the first and
Fig. 3c 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. 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.
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
Die Figuren 2a und 2b zeigen die Verfahrensschritte zur Herstellung einer zweiten
Ausführungsform der Zweikammer-Anordnung, die sich von der ersten
Ausführungsform dadurch unterscheidet, daß die beiden Beutel nicht miteinander
verschweißt, sondern mittels eines rohrförmigen Verbindungsstücks 12
miteinander verbunden werden. Im übrigen werden die Kammern des ersten und
zweiten Beutels nicht mit Peel-Nähten verschlossen. Das eine Ende des strahlensterilisierten
Verbindungsstücks 12 ist mit einem Abbrechteil 13 verschlossen,
während das andere Ende mit einer abbrechbaren Schutzkappe 14 geschützt ist.
Die Teile der Ausführungsform gemäß der Figuren 2a und 2b, die den Teilen des
Ausführungsbeispiels gemäß der Figuren 1a bis 1c entsprechen, sind mit den
gleichen Bezugszeichen versehen.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
Nach dem Befüllen des ersten Beutels 1 mit der Trägerlösung wird das mit dem
Abbrechteil 13 verschlossene Ende des Verbindungsstücks 12 in den oberen Rand
3d des ersten Beutels eingeschweißt. Die Schutzkappe 14 erstreckt sich dabei über
den gesamten Teil des Verbindungsstücks, der aus dem ersten Beutel herausragt.
Anschließend wird der erste Beutel autoklaviert.After filling the
In einem separaten Arbeitsschritt wird der strahlen-sterilisierte zweite Beutel 2,
der an dem unteren Rand 8d noch nicht versiegelt ist, mit dem Wirkstoffpulver
befüllt. Unter aseptischen Bedingungen wird anschließend die Schutzhülle 14 von
dem Verbindungsstück 12 entfernt und das freie Ende des Verbindungsstücks
wird mit dem unteren Rand 8d des zweiten Beutels 2 verschweißt.In a separate step, the radiation-sterilized
Zum Mischen von Wirkstoffpulver und Trägerlösung wird im Anwendungsfall
das Abbrechteil 13 von dem Verbindungsstück 12 abgebrochen und das
Wirkstoffpulver wird aus dem zweiten Beutel 2 in den ersten Beutel 1 überführt.For mixing active ingredient powder and carrier solution is used in the application
the break-off
Eine weitere Variante zeigen die Figuren 3a und 3b. Die einander entsprechenden
Teile sind wieder mit den gleichen Bezugszeichen versehen. Die Verbindung des
ersten und zweiten Beutels 1, 2 erfolgt mit zwei schematisch dargestellten
Konnektorstücken 15, 16. Die beiden Konnektorstücke 15, 16 sind vor dem
Verschrauben dicht verschlossen und öffnen sich erst beim Herstellen der
Schraubverbindung. Beispielsweise können die Konnektorstücke mit
Abbrechteilen verschlossen sein. Beide Konnektorstücke werden strahlen-sterilisiert.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
Der erste Beutel 1 wird mit der Trägerlösung befüllt und an seinem oberen Rand
3d versiegelt. Während des Schweißvorgangs wird das eine Ende des ersten
Konnektorstücks 15 mit dem oberen Rand 3d verschweißt. Anschließend wird der
erste Beutel wieder autoklaviert.The
In einem separaten Arbeitsschritt wird der stahlen-sterilisierte zweite Beutel 2 mit
dem Wirkstoffpulver aseptisch befüllt. Anschließend wird der untere Rand 8d des
zweiten Beutels versiegelt. Dabei wird das eine Ende des zweiten
Verbindungsstücks 16 in den unteren Rand eingeschweißt.In a separate step, the steel-sterilized
Im Anwendungsfall werden die beiden Verbindungsstücke 15, 16 reversibel
miteinander verbunden, so daß Wirkstoffpulver und Trägerlösung miteinander
gemischt werden können.In the application, the two connecting
Claims (13)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE2000141295 DE10041295B4 (en) | 2000-08-23 | 2000-08-23 | Method for producing a two-chamber arrangement |
DE10041295 | 2000-08-23 |
Publications (3)
Publication Number | Publication Date |
---|---|
EP1181920A2 true EP1181920A2 (en) | 2002-02-27 |
EP1181920A3 EP1181920A3 (en) | 2003-12-10 |
EP1181920B1 EP1181920B1 (en) | 2005-11-23 |
Family
ID=7653467
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20010120061 Expired - Lifetime EP1181920B1 (en) | 2000-08-23 | 2001-08-21 | Process for fabricating a dual compartment assembly |
Country Status (9)
Country | Link |
---|---|
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) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9962896B2 (en) | 2008-02-27 | 2018-05-08 | Fenwal, Inc. | Peelable seals including porous inserts |
WO2024160911A1 (en) * | 2023-02-02 | 2024-08-08 | Fresenius Medical Care Deutschland Gmbh | Method and device for producing a bag with a butt-welded connection |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
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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 |
WO2006130818A2 (en) * | 2005-06-01 | 2006-12-07 | Pathways, Llc | Foam cushion forming apparatus and methods |
DE102005028068B4 (en) * | 2005-06-16 | 2016-07-14 | Georg Menshen Gmbh & Co. Kg | Method for filling a bag-shaped container |
JP4984228B2 (en) * | 2006-12-20 | 2012-07-25 | 大日本印刷株式会社 | Packaging bag with pouring tool and method for producing the same |
KR101479367B1 (en) * | 2007-07-19 | 2015-01-05 | 가부시키가이샤 오츠까 세이야꾸 고죠 | Multi-chamber bag |
DE102008057822B4 (en) | 2008-11-18 | 2011-03-31 | HSG-IMIT-Institut für Mikro- und Informationstechnik der Hahn-Schickard-Gesellschaft für angewandte Forschung e.V. | Device for storage and dermal administration of a substance |
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. |
FR3027220B1 (en) * | 2014-10-21 | 2016-12-23 | Technoflex | ASSEMBLY FOR STORING MEDICAL USE PRODUCTS |
CN107580488B (en) * | 2015-05-13 | 2020-10-23 | 费森尤斯卡比德国有限公司 | Container for medical liquids |
DE102015225837A1 (en) * | 2015-12-18 | 2017-06-22 | Robert Bosch Gmbh | Film bag for a microfluidic analysis system, microfluidic analysis system, method for producing and method for operating a microfluidic analysis system |
IT201800009131A1 (en) * | 2018-10-03 | 2020-04-03 | Orofino Pharmaceuticals Group Srl | Deformable cartridge for injection device |
CN109533629A (en) * | 2018-11-20 | 2019-03-29 | 顺丰科技有限公司 | A kind of packaging bag |
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DE3238649A1 (en) | 1982-10-19 | 1984-04-19 | Hagen Dr. 8520 Erlangen Theuer | Multicompartment bag for mixed infusion solutions |
DE9401288U1 (en) | 1994-01-26 | 1994-03-17 | Fresenius Ag, 61350 Bad Homburg | Multi-chamber bags |
EP0737468A2 (en) | 1995-04-11 | 1996-10-16 | Nissho Corporation | Flexible dual-chambered container |
DE19728775A1 (en) | 1997-07-05 | 1999-01-21 | Fresenius Ag | Security seal for packs containing medical fluids, especially infusion or transfusion bags |
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US4402402A (en) * | 1981-10-14 | 1983-09-06 | Pike Brian R | Barrier seal multiple-compartment package |
JPS5975059A (en) * | 1982-10-22 | 1984-04-27 | テルモ株式会社 | Infusion liquid container |
JPS5975058A (en) * | 1982-10-22 | 1984-04-27 | テルモ株式会社 | Infusion liquid instrument |
EP0258273A1 (en) * | 1985-12-20 | 1988-03-09 | VEECH, Richard L. | Preparation of electrolyte solutions and containers |
JPH01198547A (en) * | 1988-02-01 | 1989-08-10 | Morishita Seiyaku Kk | Liquid container and unplugging instrument thereof |
DE3834566A1 (en) | 1988-10-11 | 1990-04-12 | Fresenius Ag | CONTAINER FOR STERILE, SEPARATE STORAGE OF AT LEAST TWO SUBSTANCES AND FOR MIXING THEREOF |
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 |
EP0513364B1 (en) * | 1990-11-07 | 1995-07-19 | Otsuka Pharmaceutical Factory, Inc. | Multi-chamber vessel |
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DE19960226C1 (en) * | 1999-12-14 | 2001-05-10 | Fresenius Ag | Connection system, for two or more sterile systems, comprises male and female connectors with threshold breakage points inside the fluid supply system. |
-
2000
- 2000-08-23 DE DE2000141295 patent/DE10041295B4/en not_active Expired - Fee Related
-
2001
- 2001-08-03 CA CA002354714A patent/CA2354714C/en not_active Expired - Lifetime
- 2001-08-09 US US09/925,894 patent/US6712202B2/en not_active Expired - Lifetime
- 2001-08-16 AU AU59906/01A patent/AU782287B2/en not_active Ceased
- 2001-08-21 AT AT01120061T patent/ATE310486T1/en not_active IP Right Cessation
- 2001-08-21 DE DE50108143T patent/DE50108143D1/en not_active Expired - Lifetime
- 2001-08-21 BR BRPI0103450-2A patent/BR0103450B1/en not_active IP Right Cessation
- 2001-08-21 EP EP20010120061 patent/EP1181920B1/en not_active Expired - Lifetime
- 2001-08-22 MX MXPA01008527A patent/MXPA01008527A/en active IP Right Grant
- 2001-08-23 JP JP2001252224A patent/JP4886945B2/en not_active Expired - Fee Related
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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DE3238649A1 (en) | 1982-10-19 | 1984-04-19 | Hagen Dr. 8520 Erlangen Theuer | Multicompartment bag for mixed infusion solutions |
DE9401288U1 (en) | 1994-01-26 | 1994-03-17 | Fresenius Ag, 61350 Bad Homburg | Multi-chamber bags |
EP0737468A2 (en) | 1995-04-11 | 1996-10-16 | Nissho Corporation | Flexible dual-chambered container |
DE19728775A1 (en) | 1997-07-05 | 1999-01-21 | Fresenius Ag | Security seal for packs containing medical fluids, especially infusion or transfusion bags |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9962896B2 (en) | 2008-02-27 | 2018-05-08 | Fenwal, Inc. | Peelable seals including porous inserts |
WO2024160911A1 (en) * | 2023-02-02 | 2024-08-08 | Fresenius Medical Care Deutschland Gmbh | Method and device for producing a bag with a butt-welded connection |
Also Published As
Publication number | Publication date |
---|---|
ATE310486T1 (en) | 2005-12-15 |
DE50108143D1 (en) | 2005-12-29 |
BR0103450B1 (en) | 2011-09-20 |
EP1181920A3 (en) | 2003-12-10 |
CA2354714C (en) | 2009-02-10 |
EP1181920B1 (en) | 2005-11-23 |
MXPA01008527A (en) | 2003-05-19 |
AU5990601A (en) | 2002-02-28 |
JP4886945B2 (en) | 2012-02-29 |
DE10041295A1 (en) | 2002-03-14 |
BR0103450A (en) | 2003-06-24 |
US20020023851A1 (en) | 2002-02-28 |
US6712202B2 (en) | 2004-03-30 |
CA2354714A1 (en) | 2002-02-23 |
JP2002136571A (en) | 2002-05-14 |
AU782287B2 (en) | 2005-07-14 |
DE10041295B4 (en) | 2006-06-08 |
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