EP1790569B1 - Method for making and filling a bag - Google Patents
Method for making and filling a bag Download PDFInfo
- Publication number
- EP1790569B1 EP1790569B1 EP05025784A EP05025784A EP1790569B1 EP 1790569 B1 EP1790569 B1 EP 1790569B1 EP 05025784 A EP05025784 A EP 05025784A EP 05025784 A EP05025784 A EP 05025784A EP 1790569 B1 EP1790569 B1 EP 1790569B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- bag
- filling space
- outer portion
- seam
- substance
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000000034 method Methods 0.000 title claims abstract description 17
- 239000000126 substance Substances 0.000 claims abstract description 23
- 230000035764 nutrition Effects 0.000 claims abstract description 18
- 235000016709 nutrition Nutrition 0.000 claims abstract description 18
- 238000004519 manufacturing process Methods 0.000 claims abstract description 6
- 230000008569 process Effects 0.000 claims description 4
- 241001465754 Metazoa Species 0.000 claims description 3
- 238000011065 in-situ storage Methods 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 239000011888 foil Substances 0.000 description 12
- 230000009471 action Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 238000007789 sealing Methods 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000003716 rejuvenation Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Images
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
- B65D81/3261—Flexible containers having several compartments
- B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
-
- 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
- A61J11/00—Teats
- A61J11/0075—Accessories therefor
- A61J11/0095—Seal rupturing means
-
- 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
- A61J9/00—Feeding-bottles in general
- A61J9/005—Non-rigid or collapsible feeding-bottles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/02—Machines characterised by the incorporation of means for making the containers or receptacles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B51/00—Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
- B65B51/10—Applying or generating heat or pressure or combinations thereof
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
- B65B61/18—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for making package-opening or unpacking elements
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/52—Details
- B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
- B65D75/5861—Spouts
- B65D75/5872—Non-integral spouts
- B65D75/5883—Non-integral spouts connected to the package at the sealed junction of two package walls
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2150/00—Flexible containers made from sheets or blanks, e.g. from flattened tubes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2150/00—Flexible containers made from sheets or blanks, e.g. from flattened tubes
- B31B2150/002—Flexible containers made from sheets or blanks, e.g. from flattened tubes by joining superimposed sheets, e.g. with separate bottom sheets
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2160/00—Shape of flexible containers
- B31B2160/20—Shape of flexible containers with structural provision for thickness of contents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B70/00—Making flexible containers, e.g. envelopes or bags
- B31B70/60—Uniting opposed surfaces or edges; Taping
- B31B70/64—Uniting opposed surfaces or edges; Taping by applying heat or pressure
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B70/00—Making flexible containers, e.g. envelopes or bags
- B31B70/74—Auxiliary operations
- B31B70/81—Forming or attaching accessories, e.g. opening devices, closures or tear strings
- B31B70/84—Forming or attaching means for filling or dispensing contents, e.g. valves or spouts
- B31B70/844—Applying rigid valves, spouts, or filling tubes
Definitions
- the invention relates to a method for producing and filling a foil bag for administering enteral nutrition to a human or animal organism.
- the object of the present invention is to provide a method in which an outlet device can be attached in a much simpler manner on or in the foil bag.
- the process for producing a foil bag for administering enteral nutrition to a human or animal organism provides that an aseptic bag blank closed on three sides, namely on a bottom and on side edges, having a front and a back side and a front side provided between the filling space and with a still open outer edge, wherein a front and back of the bag blank connecting peel seam is produced under aseptic conditions, which is guided from a first side edge in the direction of the still open outer edge, such that an opening to the filling space is shortened compared to the maximum width of the film bag and an outer portion separated by the peel seam from the filling space, wherein the filling space is also filled under aseptic conditions with a substance for enteral nutrition and permanently closed by a top seam between peel and second side edge and wherein under no longer aseptic conditions, but preferably in the clean room an outlet in the outer portion is fixed so that the substance for enteral Nutrition after breaking open the peel seam from the filling space to the outlet and can be removed from this through the foil bag.
- the measure according to the invention namely the provision of a peel seam which separates an aseptic area from a non-aseptic area, in particular an absolute germ tightness at the outlet end of the outlet device is no longer absolutely necessary. Rather, a simple sealing cap may be sufficient here, preferably with an open-top seal to indicate initial opening (e.g., ring pull). Accordingly, it is no longer necessary to manufacture the outlet device from a material that guarantees a complete germ and / or gas barrier. Rather, it is possible by the measures according to the invention to use a far greater variety of materials for the outlet device - including "barrier-free" materials - for the production of the outlet device.
- the core idea of the present invention is therefore based on separating the outlet device from the filling space of the film bag by a peel seam, so that preparation and filling of the filling space under aseptic conditions, but attachment of the outlet device on the opposite side of the peel seam is no longer carried out under aseptic conditions.
- the step of attaching the outlet device to or in the foil bag is achieved with the measures according to the invention, namely the provision of a peel seam, which defines a separation between an aseptic and a non-aseptic region.
- the outlet device is welded to the outer portion of the film bag. Welding results in a particularly durable and cost-effective mounting option.
- a part of the outer portion is removed before or after attachment of the outlet device, in particular cut off.
- the outlet device can be fastened in the outer section such that an antechamber remains between the peel seam and the outlet device. This vestibule may be useful for fluidic purposes for receiving a further substance, for introducing an indicator or other considerations.
- the aseptic bag blank may be made by preparing the bag blank in situ from an aseptic sheet or by sterilizing, particularly by exposure to gamma rays of an already pre-made bag.
- At least the steps of generating the peel seam, filling a substance for enteral nutrition and attaching the outlet device at the outlet section take place in an in-line process.
- the measures necessary for maintaining sterile conditions can thus be concentrated on a process sequence.
- the film bag produced by the method is characterized by a peel seam, which separates the filling space filled under aseptic conditions from an outlet device which is fastened to the foil bag under non-aseptic conditions, but preferably in the clean room.
- an anteroom is provided between the peel seam and the outlet device.
- a substance for mixing with the substance intended for enteral nutrition and / or for use as an indicator may be provided in this vestibule.
- Such an indicator is designed to indicate a condition or change of state of the substance intended for enteral nutrition.
- the volume of the antechamber compared to the filling space is significantly smaller, in particular at least 50 times smaller and narrow relative to the outflow of the substance, so that when breaking the peel seam, the substance for enteral nutrition quickly at the outlet is present and limited in its outlet speed only by the outlet device itself and any subsequent flow obstacles.
- FIG. 1 a first embodiment of a film bag according to the invention is illustrated in a schematic diagram.
- the film bag 11 is made of a sterilized in an H 2 O 2 bath film.
- the film web is first - as known per se - folded in a W-shape.
- spaced parallel side edges 13, 14 are created, wherein for this purpose the superimposed film webs along the side edges 13, 14 are welded.
- a peel seam 16 is now led to the outer edge 15 starting from a first side edge 13, the peel seam 13 being arranged such that a predetermined distance remains from the intersection of the first side edge 13 to the outer edge 15, this distance actually being e.g. 25 mm could be.
- the inner space of the film bag located between the peel seam 16 and the bottom 12 defines a filling space 17 produced under aseptic conditions.
- the region of the film bag which is separated from the filling space 17 by the peel seam 16 is defined as an outer section 18 in which an outlet device is no longer aseptic 20 used and can be fixed there.
- the filling space 17 is filled with substance for enteral nutrition under still aseptic conditions and sealed gas-tight via a top seam 19.
- the outlet 20 may be provided so spaced from the peel seam 16, that by a front 24 and Back 25 of the film bag 11 limited vestibule 21 remains.
- this vestibule 21 it is possible to introduce substances separated from the filling space 17, which substances should be mixed on application of the substance received in the filling space 17 for enteral nutrition. It is also conceivable to introduce an indicator in the vestibule 21, which can provide information on the state of the substance flowing out of the filling space 17 for enteral nutrition at or immediately before application.
- the outlet device 20 has the concrete in FIG. 1 illustrated embodiment, the film bag 11 facing a widened base portion 26 and one of these outgoing narrower in the outer diameter nozzle 27, which may be covered by a cap 28.
- Base portion 26 and nozzle 27 have a passageway (not shown) through which substance for enteral nutrition can flow out of the foil bag 11.
- the outlet device 20 is welded between the front side 24 and the back side 25 of the film bag directly at the base section 26 by a fastening seam 23, wherein the fastening seam 23 defines a direct connection between the front side 24 and the rear side 25 of the film bag 11 next to the outlet device 20.
- the base section 26 of the outlet device 20 is fluid-tightly received between the front side 24 and the rear side 25 of the film bag 11, wherein a welded or adhesive connection between the front side 24 and the base section 26 or the rear side 25 and the base section 26 also exists in these sections.
- FIG. 2 a modified embodiment of a foil bag is shown. Bottom 12, side edges 13, 14 are as based on FIG. 1 produced under aseptic conditions. Then, a peel seam 16 is created which has a taper 22 and defines an antechamber 21 in relation to a fastening seam 23 for sealing the outlet device 20 in the non-aseptic outer section 18.
- the taper 22 causes the Peelnaht 16 opens under the action of a predetermined pressure of the taper 22 starting in two directions and opens a fluid connection with the vestibule 21.
- the outlet device 20 does not have a base section 26, but only a nozzle 27, which is essentially constant in diameter, and a closure cap 28 for covering this connection 27 at its distal end.
- the nozzle 27 is in this case welded directly into the fastening seam 23.
- Peel seams are known from the prior art per se, such as by the DE 44 47 626 busy.
- a peel seam is thus a weld seam between two film sections, which can be forced onto the substance for enteral nutrition with a predetermined pressure by mechanical action, specifically by application of the substance for enteral nutrition.
- the vestibule 21 described above is thus also suitable for a control before application of the substance for enteral nutrition, whether the peel seam 16 is completely intact or whether the peel seam 16 has burst due to an undesired excessive mechanical action, for example due to incorrect handling during transport.
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Making Paper Articles (AREA)
- Bag Frames (AREA)
- Laminated Bodies (AREA)
- Containers And Plastic Fillers For Packaging (AREA)
- Basic Packing Technique (AREA)
Abstract
Description
Die Erfindung betrifft ein Verfahren zur Herstellung und Befüllung eines Folienbeutels zur Verabreichung enteraler Ernährung an einen menschlichen oder tierischen Organismus.The invention relates to a method for producing and filling a foil bag for administering enteral nutrition to a human or animal organism.
Das Befestigen einer Auslasseinrichtung in einem Folienbeutel zur Verabreichung enteraler Ernährung wird herkömmlicher Weise wie die Befüllung des Folienbeutels selbst unter aseptischen Bedingungen durchgeführt. Allerdings ist der hierfür erforderliche apparative Aufwand erheblich und das Handling sehr kompliziert.The attachment of an outlet device in a foil bag for the administration of enteral nutrition is conventionally carried out as the filling of the foil bag itself under aseptic conditions. However, the equipment required for this is considerable and the handling is very complicated.
Die Aufgabe der vorliegenden Erfindung besteht darin, ein Verfahren anzugeben, bei dem eine Auslasseinrichtung auf wesentlich einfachere Weise am bzw. im Folienbeutel befestigt werden kann.The object of the present invention is to provide a method in which an outlet device can be attached in a much simpler manner on or in the foil bag.
Diese Aufgabe wird mit einem Verfahren nach den Merkmalen des Anspruches 1 gelöst.This object is achieved by a method according to the features of claim 1.
Nach einem Kerngedanken der vorliegenden Erfindung sieht das Verfahren zur Herstellung eines Folienbeutels zur Verabreichung enteraler Ernährung an einen menschlichen oder tierischen Organismus vor, dass ein an drei Seiten, nämlich an einem Boden sowie an Seitenkanten verschlossener aseptischer Beutelrohling mit einer Vorder- und einer Rückseite sowie einem dazwischen befindlichen Befüllungsraum und mit einer noch offenen Außenkante bereitgestellt wird, wobei eine Vorder- und Rückseite des Beutelrohlings verbindende Peelnaht unter aseptischen Bedingungen erzeugt wird, die von einer ersten Seitenkante in Richtung auf die noch offene Außenkante geführt ist, derart, dass eine Öffnung zum Befüllungsraum gegenüber der maximalen Breite des Folienbeutels verkürzt ist und ein durch die Peelnaht vom Befüllungsraum getrennter Außenabschnitt entsteht, wobei der Befüllungsraum ebenfalls unter aseptischen Bedingungen mit einer Substanz zur enteralen Ernährung befüllt und über eine Kopfnaht zwischen Peelnaht und zweiter Seitenkante dauerhaft verschlossen wird und wobei unter nicht mehr aseptischen Bedingen, vorzugsweise jedoch im Reinraum eine Auslasseinrichtung im Außenabschnitt derart befestigt wird, dass die Substanz zur enteralen Ernährung nach Aufbrechung der Peelnaht vom Befüllungsraum an den Auslass gelangen und über diesen aus dem Folienbeutel entnommen werden kann.According to a central idea of the present invention, the process for producing a foil bag for administering enteral nutrition to a human or animal organism provides that an aseptic bag blank closed on three sides, namely on a bottom and on side edges, having a front and a back side and a front side provided between the filling space and with a still open outer edge, wherein a front and back of the bag blank connecting peel seam is produced under aseptic conditions, which is guided from a first side edge in the direction of the still open outer edge, such that an opening to the filling space is shortened compared to the maximum width of the film bag and an outer portion separated by the peel seam from the filling space, wherein the filling space is also filled under aseptic conditions with a substance for enteral nutrition and permanently closed by a top seam between peel and second side edge and wherein under no longer aseptic conditions, but preferably in the clean room an outlet in the outer portion is fixed so that the substance for enteral Nutrition after breaking open the peel seam from the filling space to the outlet and can be removed from this through the foil bag.
Durch die erfindungsgemäße Maßnahme, nämlich dem Vorsehen einer Peelnaht, die einen aseptischen Bereich von einem nicht-aseptischen Bereich trennt, ist insbesondere eine absolute Keimdichtigkeit am auslaufseitigen Ende der Auslasseinrichtung nicht mehr unbedingt erforderlich. Vielmehr kann hier bereits eine einfache Abdichtkappe vorzugsweise mit einem Aufbrechsiegel zum Anzeigen eines erstmaligen Öffnens (z.B. Ringpull) ausreichend sein. Entsprechend ist es auch nicht mehr notwendig, die Auslasseinrichtung aus einem Material zu fertigen, das eine möglichst vollständige Keim- und/oder Gasbarriere garantiert. Vielmehr wird es durch die erfindungsgemäßen Maßnahmen möglich, eine weit größere Vielfalt an Materialien für die Auslasseinrichtung - auch "barrierefreie" Materialien - für die Herstellung der Auslasseinrichtung zu verwenden.By the measure according to the invention, namely the provision of a peel seam which separates an aseptic area from a non-aseptic area, in particular an absolute germ tightness at the outlet end of the outlet device is no longer absolutely necessary. Rather, a simple sealing cap may be sufficient here, preferably with an open-top seal to indicate initial opening (e.g., ring pull). Accordingly, it is no longer necessary to manufacture the outlet device from a material that guarantees a complete germ and / or gas barrier. Rather, it is possible by the measures according to the invention to use a far greater variety of materials for the outlet device - including "barrier-free" materials - for the production of the outlet device.
Die Kernüberlegung der vorliegenden Erfindung beruht folglich darauf, die Auslasseinrichtung durch eine Peelnaht vom Befüllungsraum des Folienbeutels abzutrennen, so dass Herstellung und Befüllung des Befüllungsraums unter aseptischen Bedingungen, das Befestigen der Auslasseinrichtung auf der gegenüberliegenden Seite der Peelnaht jedoch nicht mehr unter aseptischen Bedingungen vorgenommen wird.The core idea of the present invention is therefore based on separating the outlet device from the filling space of the film bag by a peel seam, so that preparation and filling of the filling space under aseptic conditions, but attachment of the outlet device on the opposite side of the peel seam is no longer carried out under aseptic conditions.
Werkzeuge zur Zuführung sowie zur Befestigung der Auslasseinrichtung am Folienbeutel müssen damit nicht mehr auf den Betrieb unter aseptischen Bedingungen ausgelegt sein. Der Schritt der Befestigung der Auslasseinrichtung am bzw. im Folienbeutel wird mit den erfindungsgemäßen Maßnahmen, nämlich Vorsehen einer Peelnaht, die eine Trennung zwischen einem aseptischen und einem nicht-aseptischen Bereich definiert, erreicht.Tools for feeding and attaching the outlet on the foil bag must therefore no longer be designed for operation under aseptic conditions. The step of attaching the outlet device to or in the foil bag is achieved with the measures according to the invention, namely the provision of a peel seam, which defines a separation between an aseptic and a non-aseptic region.
In einer bevorzugten Ausgestaltung des vorliegenden Verfahrens wird die Auslasseinrichtung am Außenabschnitt des Folienbeutels verschweißt. Ein Verschweißen ergibt eine besonders dauerhafte und gleichzeitig kostengünstige Befestigungsmöglichkeit.In a preferred embodiment of the present method, the outlet device is welded to the outer portion of the film bag. Welding results in a particularly durable and cost-effective mounting option.
In einer weiter bevorzugten Ausgestaltung des vorliegenden Verfahrens wird ein Teil des Außenabschnittes vor oder nach Befestigung der Auslasseinrichtung entfernt, insbesondere abgeschnitten. In einer möglichen Ausgestaltung kann die Auslasseinrichtung so im Außenabschnitt befestigt werden, dass zwischen Peelnaht und Auslasseinrichtung ein Vorraum verbleibt. Dieser Vorraum kann aus strömungstechnischen Zwecken zur Aufnahme einer weiteren Substanz, zum Einbringen eines Indikators oder aus anderen Überlegungen zweckmäßig sein.In a further preferred embodiment of the present method, a part of the outer portion is removed before or after attachment of the outlet device, in particular cut off. In one possible embodiment, the outlet device can be fastened in the outer section such that an antechamber remains between the peel seam and the outlet device. This vestibule may be useful for fluidic purposes for receiving a further substance, for introducing an indicator or other considerations.
Der aseptische Beutelrohling kann wahlweise durch Herstellung des Beutelrohlings in sito aus einer aseptischen Folienbahn oder durch Sterilisieren, insbesondere unter Einwirkung von γ-Strahlen eines bereits vorgefertigten Beutels erfolgen.Optionally, the aseptic bag blank may be made by preparing the bag blank in situ from an aseptic sheet or by sterilizing, particularly by exposure to gamma rays of an already pre-made bag.
Nach einem bevorzugten Aspekt der vorliegenden Erfindung erfolgen mindestens die Schritte Erzeugen der Peelnaht, Befüllen einer Substanz zur enteralen Ernährung und Befestigung der Auslasseinrichtung am Auslassabschnitt in einem Inlineprozess. Die zur Aufrechterhaltung steriler Bedingungen notwendigen Maßnahmen können damit auf einen Prozessablauf konzentriert werden.According to a preferred aspect of the present invention, at least the steps of generating the peel seam, filling a substance for enteral nutrition and attaching the outlet device at the outlet section take place in an in-line process. The measures necessary for maintaining sterile conditions can thus be concentrated on a process sequence.
Der nach dem Verfahren hergestellte Folienbeutel, zeichnet sich durch eine Peelnaht aus, die den unter aseptischen Bedingungen befüllten Befüllungsraum von einer Auslasseinrichtung trennt, welche unter nicht-aseptischen Bedingungen, vorzugsweise jedoch im Reinraum am Folienbeutel befestigt ist.The film bag produced by the method is characterized by a peel seam, which separates the filling space filled under aseptic conditions from an outlet device which is fastened to the foil bag under non-aseptic conditions, but preferably in the clean room.
In einer bevorzugten Ausgestaltung ist zwischen Peelnaht und Auslasseinrichtung ein Vorraum vorgesehen. In diesem Vorraum kann eine Substanz zur Vermischung mit der zur enteralen Ernährung vorgesehenen Substanz und/oder zur Verwendung als Indikator vorgesehen sein. Ein derartiger Indikator ist darauf ausgelegt, einen Zustand bzw. eine Zustandsänderung der zur enteralen Ernährung vorgesehenen Substanz anzuzeigen.In a preferred embodiment, an anteroom is provided between the peel seam and the outlet device. A substance for mixing with the substance intended for enteral nutrition and / or for use as an indicator may be provided in this vestibule. Such an indicator is designed to indicate a condition or change of state of the substance intended for enteral nutrition.
Nach einem weiter bevorzugten Aspekt der vorliegenden Erfindung ist das Volumen des Vorraums im Vergleich zum Befüllungsraum deutlich kleiner, insbesondere mindestens 50 mal kleiner und bezogen auf die Ausströmrichtung der Substanz schmal bemessen, so dass bei Aufbrechen der Peelnaht die Substanz zur enteralen Ernährung rasch an der Auslasseinrichtung ansteht und in ihrer Auslassgeschwindigkeit nur durch die Auslasseinrichtung selbst sowie etwaig nachfolgende Strömungshindernisse beschränkt ist.According to a further preferred aspect of the present invention, the volume of the antechamber compared to the filling space is significantly smaller, in particular at least 50 times smaller and narrow relative to the outflow of the substance, so that when breaking the peel seam, the substance for enteral nutrition quickly at the outlet is present and limited in its outlet speed only by the outlet device itself and any subsequent flow obstacles.
Die Erfindung wird nachstehend auch hinsichtlich weiterer Merkmale und Vorteile anhand der Beschreibung von Ausführungsbeispielen und unter Bezugnahme auf die beiliegenden Zeichnungen näher erläutert. Hierbei zeigen:
- Fig. 1
- eine Prinzipansicht einer ersten Ausführungsform eines erfindungsgemäßen Folienbeutels,
- Fig. 2
- eine Prinzipansicht einer alternativen Ausführungsform eines erfindungsgemäßen Folienbeutels.
- Fig. 1
- a schematic view of a first embodiment of a film bag according to the invention,
- Fig. 2
- a schematic view of an alternative embodiment of a film bag according to the invention.
In
An der dem Boden 12 gegenüberliegenden Seite wird der Folienbeutel 11 nun durch eine Außenkante 15 begrenzt, an der der Folienbeutel 11 noch offen ist.At the
Ebenfalls unter aseptischen Bedingungen wird nun von einer ersten Seitenkante 13 ausgehend eine Peelnaht 16 an die Außenkante 15 geführt, wobei die Peelnaht 13 so angeordnet ist, dass vom Schnittpunkt erste Seitenkante 13 - Außenkante 15 ein vorbestimmter Abstand verbleibt, wobei dieser Abstand konkret z.B. 25 mm betragen könnte.Also under aseptic conditions, a
Der zwischen Peelnaht 16 und Boden 12 befindliche Innenraum des Folienbeutels definiert einen unter aseptischen Bedingungen hergestellten Befüllungsraum 17. Derjenige Bereich des Folienbeutels der durch die Peelnaht 16 getrennt dem Befüllungsraum 17 abgewandt ist wird als Außenabschnitt 18 definiert, in dem unter nicht mehr aseptischen Bedingungen eine Auslasseinrichtung 20 eingesetzt und dort befestigt werden kann.The inner space of the film bag located between the
Zunächst wird allerdings unter noch immer aseptischen Bedingungen der Befüllungsraum 17 mit Substanz zur enteralen Ernährung befüllt und über eine Kopfnaht 19 gasdicht verschlossen.First of all, however, the
Im Außenabschnitt 18 kann nun unter nicht mehr septischen Bedingungen, beispielsweise im Reinraum die bereits erwähnte Auslasseinrichtung 20 eingesetzt werden, wobei die Auslasseinrichtung 20 so von der Peelnaht 16 beabstandet vorgesehen werden kann, dass ein durch Vorderseite 24 und Rückseite 25 des Folienbeutels 11 begrenzter Vorraum 21 verbleibt. In diesem Vorraum 21 können vom Befüllungsraum 17 getrennt Substanzen eingebracht werden, die sich bei Applikation der im Befüllungsraum 17 aufgenommenen Substanz zur enteralen Ernährung vermischen sollen. Denkbar ist auch, im Vorraum 21 einen Indikator einzubringen, der bei bzw. unmittelbar vor Applikation Auskunft über den Zustand der aus dem Befüllungsraum 17 ausströmenden Substanz zur enteralen Ernährung geben kann.In the
Die Auslasseinrichtung 20 weist bei der konkret in
Die Auslasseinrichtung 20 wird zwischen Vorderseite 24 und Rückseite 25 des Folienbeutels direkt am Sockelabschnitt 26 durch eine Befestigungsnaht 23 eingeschweißt, wobei die Befestigungsnaht 23 neben der Auslasseinrichtung 20 jeweils eine unmittelbare Verbindung zwischen Vorderseite 24 und Rückseite 25 des Folienbeutels 11 definiert. Dazwischen ist der Sockelabschnitt 26 der Auslasseinrichtung 20 zwischen Vorderseite 24 und Rückseite 25 des Folienbeutels 11 fluiddicht aufgenommen, wobei auch in diesen Abschnitten eine Schweiß- bzw. Klebeverbindung zwischen der Vorderseite 24 und dem Sockelabschnitt 26 bzw. der Rückseite 25 und dem Sockelabschnitt 26 besteht.The
In
Bei der Ausführungsform nach
Peelnähte sind aus dem Stand der Technik an sich bekannt, wie beispielsweise durch die
Der vorstehend beschriebene Vorraum 21 eignet sich somit auch zu einer Kontrolle vor Applikation der Substanz zur enteralen Ernährung, ob die Peelnaht 16 vollständig intakt ist bzw. ob durch eine ungewollte zu hohe mechanische Einwirkung die Peelnaht 16 beispielsweise durch falsches Händling beim Transport aufgeplatzt ist.The
- 1111
- Folienbeutelfoil pouch
- 1212
- Bodenground
- 13, 1413, 14
- Seitenkantenside edges
- 1515
- Außenkanteouter edge
- 1616
- Peelnahtpeel seam
- 1717
- Befüllungsraumfilling space
- 1818
- Außenabschnittouter portion
- 1919
- Kopfnahthead seam
- 2020
- Auslasseinrichtungoutlet
- 2121
- Vorraumanteroom
- 2222
- Verjüngungrejuvenation
- 2323
- Befestigungsnahtfastening seam
- 2424
- Vorderseitefront
- 2525
- Rückseiteback
- 2626
- Sockelabschnittbase section
- 2727
- StutzenSupport
- 2828
- Verschlusskappecap
Claims (7)
- Method of fabricating and filling a sheet bag for administering enteral nutrition to a human or animal organism,- wherein an aseptic bag blank closed at three sides, namely at a bottom (12) as well as at side edges (13, 14), having a front side (24) and a rear side (25), as well as a filling space (17) situated in between and having a still open outer edge (15) is provided,- wherein a peel seam (16) is produced under aseptic conditions connecting the front side (24) and the rear side (25) of the bag blank and being guided from a first side edge (13) towards the still open outer edge (15) such that an opening to the filling space (17) is shortened with respect to the maximum width of the sheet bag, and an outer portion (18) separated from the filling space (17) by the peel seam (16) is provided,- wherein the filling space (17) is likewise filled under aseptic conditions with a substance for enteral nourishment, and is permanently closed via a head seam (19) between the peel seam (16) and the second side edge (14),- and wherein under no longer aseptic conditions but preferably in the clean-room, an outlet means (20) is attached in the outer portion (18) such that after breaking the peel seam (16), the substance for enteral nourishment may reach the outlet (20) from the filling space (17) and may be withdrawn via the same from the sheet bag.
- Method according to claim 1,
characterized in that
the outlet means (20) is heat-sealed to the outer portion (18). - Method according to claim 1 or claim 2,
characterized in that
a part of the outer portion (18) is removed, in particular cut off prior to or after the attachment of the outlet means (20). - Method according to any one of claims 1 through 3,
characterized in that
the outlet means (20) is attached in the outer portion (18) such that an anteroom (21) remains between the peel seam (16) and the outlet means (20). - Method according to any one of claims 1 through 4,
characterized in that
the provision of the aseptic bag blank takes place by manufacturing the bag blank in situ from an aseptic sheeting. - Method according to any one of claims 1 through 4,
characterized in that
the provision of the aseptic bag blank takes place by sterilizing an already prefabricated bag, in particular by exposure to gamma rays. - Method according to any one of claims 1 through 6,
characterized in that
at least the following steps take place in an inline process: creating the peel seam (16), filling with a substance for enteral nourishment, and attaching the outlet means (20) at the outer portion (18).
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP05025784A EP1790569B1 (en) | 2005-11-25 | 2005-11-25 | Method for making and filling a bag |
ES05025784T ES2313190T3 (en) | 2005-11-25 | 2005-11-25 | PROCEDURE FOR THE MANUFACTURE AND FILLING OF A LAMINATED BAG. |
DE502005004965T DE502005004965D1 (en) | 2005-11-25 | 2005-11-25 | Method for producing and filling a foil bag |
AT05025784T ATE403602T1 (en) | 2005-11-25 | 2005-11-25 | METHOD FOR PRODUCING AND FILLING A FILM BAG |
PL05025784T PL1790569T3 (en) | 2005-11-25 | 2005-11-25 | Method for making and filling a bag |
PCT/EP2006/011257 WO2007059975A1 (en) | 2005-11-25 | 2006-11-23 | Method of producing and filling a sheet-material bag |
CNA2006800512319A CN101360650A (en) | 2005-11-25 | 2006-11-23 | Method of producing and filling a sheet-material bag |
JP2008541644A JP2009517239A (en) | 2005-11-25 | 2006-11-23 | Method for producing a film bag and method for filling a film bag |
KR1020087015280A KR101177290B1 (en) | 2005-11-25 | 2006-11-23 | Method of Producing and Filling a Sheet-Material Bag |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP05025784A EP1790569B1 (en) | 2005-11-25 | 2005-11-25 | Method for making and filling a bag |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1790569A1 EP1790569A1 (en) | 2007-05-30 |
EP1790569B1 true EP1790569B1 (en) | 2008-08-06 |
Family
ID=36072067
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP05025784A Active EP1790569B1 (en) | 2005-11-25 | 2005-11-25 | Method for making and filling a bag |
Country Status (9)
Country | Link |
---|---|
EP (1) | EP1790569B1 (en) |
JP (1) | JP2009517239A (en) |
KR (1) | KR101177290B1 (en) |
CN (1) | CN101360650A (en) |
AT (1) | ATE403602T1 (en) |
DE (1) | DE502005004965D1 (en) |
ES (1) | ES2313190T3 (en) |
PL (1) | PL1790569T3 (en) |
WO (1) | WO2007059975A1 (en) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2623007A3 (en) | 2012-02-02 | 2014-07-02 | Laco Energy Systems GmbH | Cleaning Device |
US10329041B2 (en) * | 2013-04-19 | 2019-06-25 | Scholle Ipn Ip Bv | System and method for the assembly and collection of non-filled spouted pouches |
DE202014102819U1 (en) | 2014-06-19 | 2014-06-26 | Larco Energy Systems Gmbh | cleaning device |
JP2017165447A (en) * | 2016-03-16 | 2017-09-21 | オリヒロエンジニアリング株式会社 | Film packaging bag and manufacturing method and manufacturing device of the same |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4198972A (en) * | 1978-04-17 | 1980-04-22 | Pharmachem Corporation | Blood and blood component storage bags |
DE4410876A1 (en) | 1994-03-29 | 1995-10-05 | Fresenius Ag | Medical multi-chamber bag and process for its manufacture |
JP3016348B2 (en) * | 1995-03-23 | 2000-03-06 | 株式会社ニッショー | Double chamber container |
US5910138A (en) * | 1996-05-13 | 1999-06-08 | B. Braun Medical, Inc. | Flexible medical container with selectively enlargeable compartments and method for making same |
US20050194060A1 (en) * | 2004-03-03 | 2005-09-08 | Vincent Houwaert | Peelable seal closure assembly |
DE19955578C1 (en) * | 1999-11-18 | 2001-09-06 | Fresenius Medical Care De Gmbh | Multi-chamber container, with glucose concentrate compartment and hydrochloric acid concentrate compartment |
-
2005
- 2005-11-25 ES ES05025784T patent/ES2313190T3/en active Active
- 2005-11-25 DE DE502005004965T patent/DE502005004965D1/en active Active
- 2005-11-25 PL PL05025784T patent/PL1790569T3/en unknown
- 2005-11-25 EP EP05025784A patent/EP1790569B1/en active Active
- 2005-11-25 AT AT05025784T patent/ATE403602T1/en active
-
2006
- 2006-11-23 KR KR1020087015280A patent/KR101177290B1/en active IP Right Grant
- 2006-11-23 JP JP2008541644A patent/JP2009517239A/en active Pending
- 2006-11-23 CN CNA2006800512319A patent/CN101360650A/en active Pending
- 2006-11-23 WO PCT/EP2006/011257 patent/WO2007059975A1/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
ATE403602T1 (en) | 2008-08-15 |
DE502005004965D1 (en) | 2008-09-18 |
ES2313190T3 (en) | 2009-03-01 |
CN101360650A (en) | 2009-02-04 |
WO2007059975A1 (en) | 2007-05-31 |
KR20080072064A (en) | 2008-08-05 |
EP1790569A1 (en) | 2007-05-30 |
PL1790569T3 (en) | 2009-02-27 |
JP2009517239A (en) | 2009-04-30 |
KR101177290B1 (en) | 2012-08-28 |
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