JP2009517239A - Method for producing a film bag and method for filling a film bag - Google Patents

Method for producing a film bag and method for filling a film bag Download PDF

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JP2009517239A
JP2009517239A JP2008541644A JP2008541644A JP2009517239A JP 2009517239 A JP2009517239 A JP 2009517239A JP 2008541644 A JP2008541644 A JP 2008541644A JP 2008541644 A JP2008541644 A JP 2008541644A JP 2009517239 A JP2009517239 A JP 2009517239A
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discharge device
bag
seam
film bag
substance
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ドレージング フランク
ムート フリードリヒ
ヴァーグナー ヴォルフガング
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Pluemat Plate & Luebeck & Co GmbH
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Pluemat Plate & Luebeck & Co GmbH
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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

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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)
  • Basic Packing Technique (AREA)
  • Laminated Bodies (AREA)
  • Containers And Plastic Fillers For Packaging (AREA)

Abstract

The method involves attaching an outlet device (20) in an outer section (18) under an aseptic condition in a clean room in such a manner that a substance for an enteral nutrition can arrive after leaving peel joint from a filling space to the outlet, and the substance can be taken from a plastic bag. The outlet device is heat sealed with the outer section. A portion of the outer section is removed before or after attachment of the outlet device. An independent claim is also included for a plastic bag which is produced according to the method for producing the plastic bag.

Description

本発明は、フィルム製の袋を製造するための方法、並びにこの方法に従って製造されたフィルム製の袋に関する。例えば腸内摂取の投与のために、フィルム製の袋内に排出装置を固定することは、従来形式でフィルム製の袋の充填と同様に、無菌条件下で実施される。しかしながら、このために必要な装置的な費用は高価であって、取り扱いも非常に複雑である。   The present invention relates to a method for producing a film bag and a film bag produced according to this method. For example, for administration of intestinal ingestion, securing the drainage device in a film bag is performed under aseptic conditions, similar to filling a film bag in a conventional manner. However, the equipment cost required for this is expensive and the handling is very complicated.

そこで本発明の課題は、排出装置を著しく簡単な形式でフィルム製の袋の外側若しくは内部に固定することができるような方法、及びこの方法に従って製造されたフィルム製の袋を提供することである。   Accordingly, an object of the present invention is to provide a method capable of fixing the discharge device to the outside or the inside of a film bag in a remarkably simple manner, and a film bag manufactured according to this method. .

この課題は、本発明によれば請求項１の特徴部に記載した方法、並びに請求項１２の特徴部に記載したフィルム製の袋によって解決された。   This problem has been solved according to the invention by the method described in the characterizing portion of claim 1 and the film bag described in the characterizing portion of claim 12.

本発明のフィルム製の袋を製造するための方法によれば、
フィルム製の袋を製造するための方法において、
表側と裏側と、この表側と裏側との間の充填室と、まだ開放している外側縁部を備えかつ３方側つまり１つの底部と２つの側縁とが閉鎖された無菌の袋中間製品を提供し、
前記袋中間製品の表側と裏側とを接続する、第１の側縁から、まだ開放している外側縁部まで延在する剥離シームを無菌条件下で製作し、この際に、充填室に通じる開口がフィルム製の袋の最大幅に対して短縮され、前記剥離シームによって前記充填室から分離された外側区分が形成されるようにし、
前記充填室を無菌条件下で所定の物質によって充填し、頂部シームを介して前記剥離シームと第２の側縁部とを堅固に閉鎖し、
前記剥離シームを破り開けると前記物質が充填室から排出装置に達し、この排出装置を介してフィルム製の袋から取り出されるように、前記排出装置を前記外側区分内に固定するようにした。 According to the method for producing the film bag of the present invention,
In a method for manufacturing a film bag,
Sterile bag intermediate product with front and back sides, a filling chamber between the front and back sides, an outer edge that is still open and closed on three sides, ie one bottom and two side edges Provide
A peel seam extending from the first side edge connecting the front side and the back side of the bag intermediate product to the outer edge which is still open is produced under aseptic conditions, leading to the filling chamber The opening is shortened relative to the maximum width of the film bag so that an outer section separated from the filling chamber by the peel seam is formed;
Filling the filling chamber with a predetermined substance under aseptic conditions, tightly closing the release seam and the second side edge via a top seam;
When the peel seam is broken open, the discharge device is fixed in the outer section so that the substance reaches the discharge device from the filling chamber and is taken out of the film bag through the discharge device.

本発明の手段によれば、つまり無菌領域を無菌ではない領域に対して分離する剥離シームを設けたことによって、排出装置の出口側端部に特に絶対的な無菌シール性を設ける必要はない。むしろ、排出装置の出口側端部に、有利には初めての開放を知らせるための破り開けヒートシールを備えた簡単なシールキャップ（例えばリングプル；Ringpull）を設けるだけで十分である。したがって、排出装置を、できるだけ完全な菌バリヤ及び／又はガスバリヤを保証する材料から製作する必要はない。むしろ、本発明の手段によれば、排出装置を製造するために、排出装置のための多様な材料（バリヤフリー材料でもある）を使用することができる。   According to the means of the present invention, that is, by providing a peel seam that separates the sterile area from the non-sterile area, it is not necessary to provide an absolute aseptic sealability at the outlet end of the discharge device. Rather, it is sufficient to provide a simple sealing cap (for example a ring pull) with a tear-off heat seal at the outlet end of the discharge device, preferably to signal the first opening. It is therefore not necessary to make the discharge device from a material that guarantees as complete a fungal and / or gas barrier as possible. Rather, according to the means of the present invention, various materials (also barrier-free materials) for the discharge device can be used to manufacture the discharge device.

本発明は、排出装置を、フィルム製の袋の充填室に対して剥離シームによって分離したことによって、無菌条件下で充填室を製造し、かつ充填すること、また排出装置を剥離シームとは反対側に固定することは、もはや無菌条件下で行う必要がない、という考え方に基づいている。   The present invention relates to the manufacture and filling of a filling chamber under aseptic conditions by separating the discharging device with a peeling seam from the filling chamber of a film bag, and the discharging device is opposite to the peeling seam. Fixing to the side is based on the idea that it no longer has to be done under aseptic conditions.

無菌条件下とは、一般的に包装機械において前もって滅菌され、若しくは包装機械において無菌状態で製造されたフィルム製の袋内に、滅菌された充填物（本発明では滅菌された物質）が再汚染されることなしに、確実に包装される、ということである。有利な形式で、フィルム製の袋及び／又は機械内室のために、" Einheitsblatt VDMA8742"（単位表ＶＤＭＡ８７４２）に従って４０乗の滅菌が得られる。   Aseptic conditions generally mean that the sterilized filling (sterilized material in the present invention) is recontaminated in a film bag that has been previously sterilized in the packaging machine or manufactured aseptically in the packaging machine. It is surely packed without being done. In an advantageous manner, a power of 40 sterilization is obtained according to "Einheitsblatt VDMA8742" (unit table VDMA8742) for film bags and / or machine interiors.

これによって、フィルム製の袋に供給するめの工具、並びにフィルム製の袋に排出装置を固定するための工具は、無菌条件下にある必要はない。フィルム製の袋の外側に若しくは内部に排出装置を固定する段階において、本発明による手段、つまり無菌の領域と無菌ではない領域とを分離する剥離シームが設けられる。   Thus, the tool for feeding the film bag and the tool for fixing the discharge device to the film bag need not be under aseptic conditions. In the step of fixing the discharge device to the outside or inside of the film bag, a means according to the invention is provided, ie a peel seam separating the aseptic and non-sterile areas.

本発明の方法の有利な実施態様によれば、外側区分内での前記排出装置の固定を、もはや無菌ではない条件下で、しかしながら有利にはクリーンルーム内で実施するようにした。   According to an advantageous embodiment of the method of the invention, the fixing of the drainage device in the outer section is carried out under conditions that are no longer aseptic, but advantageously in a clean room.

本発明による方法の有利な実施態様によれば、排出装置をフィルム製の袋の外側区分に溶接するようにした。溶接によって、特に持続的で、同時に安価な固定の可能性が提供される。   According to an advantageous embodiment of the method according to the invention, the discharge device is welded to the outer section of the film bag. Welding offers the possibility of a particularly durable and at the same time inexpensive fixing.

本発明による方法の有利な実施態様によれば、前記外側区分の部分を、排出装置の固定前又は固定後に特に切り離しによって、取り除くようにした。可能な実施態様によれば、排出装置は、剥離シームと排出装置との間に前室が形成されるように、外側区分内に固定される。この前室は、その他の物質を流体技術的に受容するために、インジケータを設けるために、又はその他の理由により有利である。   According to an advantageous embodiment of the method according to the invention, the part of the outer section is removed, in particular by disconnection, before or after fixing the discharge device. According to a possible embodiment, the discharge device is fixed in the outer section such that a front chamber is formed between the peeling seam and the discharge device. This anterior chamber is advantageous for receiving other substances fluidically, for providing an indicator, or for other reasons.

有利には、無菌の袋中間製品の準備は滅菌によって行われる。   Advantageously, the preparation of the sterile bag intermediate product is performed by sterilization.

可能な手段によれば、滅菌は、ガンマ光線を作用下で行われる。その他の選択的な手段によれば、滅菌はＨ2Ｏ2によって、例えば浴内で又は蒸気によって行われる。その他の滅菌可能性は、水蒸気を使用することによって得られる。 According to a possible means, sterilization is carried out under the action of gamma light. According to other optional means, sterilization is effected by H 2 O 2 , for example in a bath or by steam. Other sterilization possibilities are obtained by using steam.

袋中間製品は、現場で滅菌される。つまり、フィルムとして、又は現場で予備形成されるか又はその他の形式で準備された袋中間製品として滅菌される。選択的に、袋中間製品は、予め滅菌されて提供されてもよい。   The bag intermediate product is sterilized in the field. That is, it is sterilized as a film or as a bag intermediate product that is preformed on site or otherwise prepared. Optionally, the bag intermediate product may be provided pre-sterilized.

本発明の別の有利な実施態様によれば、少なくとも、剥離シームの形成、物質の充填、及び排出装置を外側区分に固定する作業段階を、インライン処理で行うようにした。この場合、インライン処理とは、機械から袋を取り出すことなしに、連続的に、準連続的に又は断続的に行われる処理作業のことである。従って滅菌条件を維持するために必要な条件は、プロセス連続に集中される。   According to another advantageous embodiment of the invention, at least the work phase of forming the peel seam, filling the material and fixing the discharge device to the outer section is carried out in an in-line process. In this case, in-line processing refers to processing operations performed continuously, semi-continuously or intermittently without removing the bag from the machine. Thus, the conditions necessary to maintain sterilization conditions are concentrated in the process sequence.

本発明の方法に従って製造されたフィルム製の袋は、物質を生体としての人体又は動物に投与するためにしようされる。物質は例えば、腸内摂取用のもの、運動選手のための栄養、食養生的な食品、接着剤又は薬学的なものである。   A film bag manufactured according to the method of the present invention is used to administer a substance to a human body or animal as a living body. The substance is, for example, for intestinal ingestion, nutrition for athletes, dietary foods, adhesives or pharmaceuticals.

本発明の方法に従って製造されたフィルム製の袋は、剥離シームを特徴としており、この剥離シームは、無菌条件下で充填された充填室を、無菌でない条件下で、有利にはクリーンルーム（無塵室）内でフィルム製の袋に固定された排出装置から分離されている。この場合も、本発明の基本的な考え方は、フィルム製の袋に設けられた剥離シームが、無菌の領域を無菌でない領域から分離する、という点にある。   Film bags made according to the method of the invention are characterized by a peel seam, which can be used to remove a filling chamber filled under aseptic conditions, preferably under clean conditions (dust-free). It is separated from the discharge device fixed to the film bag in the chamber. Again, the basic idea of the present invention is that the peel seam provided on the film bag separates the sterile area from the non-sterile area.

有利な実施態様によれば、剥離シームと排出装置との間に前室が設けられている。この前室内に、例えば腸内摂取用の第１の物質と混合するために、かつ／またはインジケータとして使用するために第２の物質が設けられている。このようなインジケータは、例えば、腸内摂取のために設けられた物質の状態若しくは状態変化を示すように、設計されている。   According to an advantageous embodiment, a front chamber is provided between the peeling seam and the discharge device. In this anterior chamber, a second substance is provided, for example for mixing with a first substance for intestinal ingestion and / or for use as an indicator. Such an indicator is designed, for example, to indicate the state or state change of a substance provided for intestinal ingestion.

本発明の有利な実施態様によれば、前記前室の容積が、前記充填室と比較して著しく小さく、特に少なくとも１／５０倍であって、物質の排出装置に関連して狭く構成されており、それによって、剥離シームを破り開けると腸内摂取のための物質が排出装置に迅速に達し、排出速度が排出装置によってのみ規定され、場合によってはその後の流れの妨害が制限されるようになっている。   According to an advantageous embodiment of the invention, the volume of the anterior chamber is significantly smaller than that of the filling chamber, in particular at least 1/50 times, and is configured narrowly in relation to the substance discharge device. So that when the peel seam is breached, the substance for intestinal ingestion reaches the drainage device quickly, the drainage rate is defined only by the drainage device, and in some cases the subsequent flow obstruction is limited It has become.

以下に本発明のその他の特徴及び利点について、図示の実施例を用いて詳しく説明する。   Other features and advantages of the present invention will be described in detail below using the illustrated embodiments.

図１は、本発明によるフィルム製の袋の第１実施例の原理図、
図２は、本発明によるフィルム製の袋の選択的な実施例の原理図である。 FIG. 1 is a principle diagram of a first embodiment of a film bag according to the present invention,
FIG. 2 is a principle diagram of an alternative embodiment of a film bag according to the present invention.

図１には、本発明によるフィルム製の袋の第１実施例の原理図が示されている。フィルム製の袋（Folienbeutel；パウチ袋とも称呼される）１１は、Ｈ2Ｏ2浴内で滅菌されたシート材料若しくはフィルム材料（Folie）より製造されている。フィルム材料は、有利な形式で複数の個別の層より成る複合体である。具体的な実施例では、外側の層が例えばポリエステルより成っていて、バリア（遮断壁）を支持する中間層はアルミニウムより成っていて、内側層はポリエチレン（ＰＥ）又はポリプロピレン（ＰＰ）より成っている。別の実施例では、Ａｌｏｘ又はＳｉＯｘとしてのポリエステルがバリア機能を満たす。この別の実施例においては、透明な複合体を提供することができる。有利な形式でこのような形式の複合体は、機械的な形状安定性を得るために別の層例えばｏＰＰ又はｏＰＡを有している。 FIG. 1 shows a principle diagram of a first embodiment of a film bag according to the present invention. Film bags (Folienbeutel; also called pouch bags) 11 are made of sheet or film material (Folie) sterilized in an H 2 O 2 bath. The film material is a composite consisting of a plurality of individual layers in an advantageous manner. In a specific embodiment, the outer layer is made of, for example, polyester, the intermediate layer supporting the barrier is made of aluminum, and the inner layer is made of polyethylene (PE) or polypropylene (PP). Yes. In another embodiment, polyester as Alox or SiOx fulfills the barrier function. In this alternative embodiment, a transparent composite can be provided. Advantageously, this type of composite has another layer, for example oPP or oPA, in order to obtain mechanical shape stability.

底部１２を形成するために、フィルムウェブ（帯材状のフィルム）は、まず公知なように、Ｗ字状に折り畳まれる。次いで、互いに間隔を保って平行に延在する側縁部１３，１４を得る。このために、互いに上下に位置するフィルムウェブが側縁部１３，１４に沿って溶接される。ヒートシール層としてのポリエチレンにおいては、安定した結合継ぎ目（Festnaehte）を得るために、≧１２０℃の温度が必要である。ポリプロピレンを使用した場合、≧１６０℃の温度が必要である。前記２つのヒートシール層は、超音波によって溶接されてもよい。   In order to form the bottom 12, the film web (strip-like film) is first folded into a W-shape, as is known. Next, the side edges 13 and 14 extending in parallel with a distance from each other are obtained. For this purpose, the film webs positioned one above the other are welded along the side edges 13, 14. In polyethylene as a heat seal layer, a temperature of ≧ 120 ° C. is required to obtain a stable joint seam (Festnaehte). When polypropylene is used, a temperature of ≧ 160 ° C. is necessary. The two heat seal layers may be welded by ultrasonic waves.

フィルム製の袋１１は、底部１２とは反対側が外側縁部１５によって制限されており、この外側縁部１５においてフィルム製の袋１１はまだ開放している。   The film bag 11 is limited by the outer edge 15 on the side opposite to the bottom 12, and the film bag 11 is still open at the outer edge 15.

同様に、無菌条件下で、第１の側縁部１３を基点として剥離シーム１６が外側縁部１５に沿って設けられており、この剥離シーム１６は、第１の側縁部１３と外側縁部１５との交点から所定の間隔が保たれるように、配置されており、この間隔は、袋１１の寸法が２５０ｍｍ×１７０ｍｍである場合に、例えば２５ｍｍである。剥離シーム１６は、１０５℃乃至１１５℃の温度範囲有利には１０８℃乃至１１０℃の温度範囲でポリエチレンフィルムにおいて生ぜしめられる。同様に、超音波を用いるか、又は熱と超音波との組み合わせも考えられる。   Similarly, under aseptic conditions, a peel seam 16 is provided along the outer edge 15 with the first side edge 13 as a starting point, and the peel seam 16 is connected to the first side edge 13 and the outer edge. It arrange | positions so that a predetermined space | interval may be maintained from the intersection with the part 15, This space | interval is 25 mm, for example, when the dimension of the bag 11 is 250 mm x 170 mm. The release seam 16 is produced in the polyethylene film in the temperature range of 105 ° C. to 115 ° C., preferably in the temperature range of 108 ° C. to 110 ° C. Similarly, the use of ultrasound or a combination of heat and ultrasound is also conceivable.

剥離シーム１６と底部１２との間に存在するフィルム製の袋の内室は、無菌条件下で製造される充填室１７を規定する。剥離シーム１６によって分離された、充填室１７とは反対側のフィルム製の袋１１の領域は、外側区分１８として規定され、この外側区分１８内に、もはや無菌条件下にはない排出装置２０が設けられ、この外側区分１８に固定される。   The inner chamber of the film bag that exists between the peel seam 16 and the bottom 12 defines a filling chamber 17 that is manufactured under aseptic conditions. The area of the film bag 11, which is separated from the filling chamber 17 by the peeling seam 16, is defined as the outer section 18, in which the discharge device 20 is no longer under aseptic conditions. Provided and fixed to this outer section 18.

まず常に無菌条件下で、充填室１７は、腸内摂取するための物質で満たされ、頂部シーム１９を介してほぼ気密に閉鎖される。   First, always under aseptic conditions, the filling chamber 17 is filled with a substance for intestinal ingestion and is closed almost airtight via the top seam 19.

外側区分１８はもはや無菌条件下になく、例えばクリーンルーム（無塵室）であって、このクリーンルーム内に前記排出装置２０が設けられており、この排出装置２０は、フィルム製の袋１１の表側２４と裏側２５とによって制限された前室２１が形成されるように、剥離シーム１６から間隔を保って設けられている。この前室２１内に、充填室１７から分離された物質が入れられ、この前室２１内に入れられた物質が、充填室１７内に充填された腸内摂取のための物質を投与する際に、この充填室１７内の物質と混合される。前室２１内にインジケータを収容することも考えられる。このインジケータは、投与時に若しくは投与直前に、充填室１７から流出する、腸内摂取のための物質の状態に関する情報を提供する。   The outer section 18 is no longer under aseptic conditions and is, for example, a clean room (dust-free room), and the discharge device 20 is provided in the clean room, and this discharge device 20 is the front side 24 of the film bag 11. And the back side 25 are provided at a distance from the peeling seam 16 so that a front chamber 21 limited by the backside 25 is formed. A substance separated from the filling chamber 17 is placed in the anterior chamber 21, and the substance placed in the anterior chamber 21 administers a substance for intestinal ingestion filled in the filling chamber 17. And mixed with the substance in the filling chamber 17. It is also conceivable to accommodate an indicator in the front chamber 21. This indicator provides information on the state of the substance for intestinal ingestion that flows out of the filling chamber 17 at or just prior to administration.

排出装置２０は、図１に示した具体的な実施例では、フィルム製の袋１１に面した側で、幅の広い差し込み区分２６と、この差し込み区分２６から延在する外径の狭められた接続ピース２７とを有している。この接続ピース２７は閉鎖キャップ２８によって閉鎖できるようになっている。差し込み区分２６と接続ピース２７とは、貫通通路（図示せず）を有しており、この貫通通路を介して腸内摂取のための物質がフィルム製の袋１１から流出する。   In the specific embodiment shown in FIG. 1, the discharge device 20 has a wide insertion section 26 on the side facing the film bag 11 and a narrowed outer diameter extending from the insertion section 26. And a connection piece 27. The connection piece 27 can be closed by a closing cap 28. The insertion section 26 and the connection piece 27 have a through passage (not shown), and a substance for intestinal ingestion flows out of the film bag 11 through the through passage.

排出装置２０は、フィルム製の袋の表側２４と裏側２５との間で差し込み区分２６に直に固定シーム２３によって溶接されており、この場合、固定シーム２３は、排出装置２０の隣でそれぞれ、フィルム製の袋１１の表側２４と裏側２５との間の直接的な接続を形成する。固定シーム２３の形成中に、排出装置２０の差し込み区分２６が、フィルム製の袋１１の表側２４と裏側２５との間で液密に受容され、この場合、この区分においても、表側２４と差し込み区分２６若しくは裏側２５と差し込み区分２６との間の溶接接続若しくは接着接続が形成される。   The discharge device 20 is welded to the insertion section 26 directly between the front side 24 and the back side 25 of the film bag by a fixed seam 23, in which case the fixed seam 23 is next to the discharge device 20, respectively. A direct connection between the front side 24 and the back side 25 of the film bag 11 is formed. During the formation of the fixed seam 23, the insertion section 26 of the discharge device 20 is received in a liquid-tight manner between the front side 24 and the back side 25 of the film bag 11, and in this case also in this section, it is inserted into the front side 24. A welded or adhesive connection between section 26 or backside 25 and plug-in section 26 is formed.

図２には、フィルム製の袋の変化実施例が示されている。底部１２、側縁部１３，１４は、図１に示したように無菌条件下で製造される。次いで、剥離シーム１６が形成され、この剥離シーム１６は、先細り部２２を有していて、無菌状態ではない外側区分１８内で排出装置２０をヒートシールするための固定シーム２３に対する前室２１を規定する。先細り部２２は、剥離シーム１６が、所定の圧力作用下で先細り部２２を基点として２方向で開放し、前室２１との流体接続を開放するように、働く。   FIG. 2 shows a modified embodiment of a film bag. The bottom part 12 and the side edge parts 13 and 14 are manufactured under aseptic conditions as shown in FIG. A peel seam 16 is then formed, which has a taper 22 and a front chamber 21 for a fixed seam 23 for heat sealing the discharge device 20 in the outer section 18 which is not sterile. Stipulate. The taper portion 22 functions so that the peeling seam 16 opens in two directions with the taper portion 22 as a base point under a predetermined pressure action and opens a fluid connection with the front chamber 21.

図２の実施例では、排出装置２０は差し込み区分２６を有しておらず、直径がほぼ一定な接続ピース２７と、この接続ピース２７の遠位端部を閉鎖するための閉鎖キャップ２８とを有している。この場合、接続ピース２７は、固定シーム２３に直に溶接されている。   In the embodiment of FIG. 2, the discharge device 20 does not have a plug-in section 26 and comprises a connection piece 27 having a substantially constant diameter and a closure cap 28 for closing the distal end of this connection piece 27. Have. In this case, the connection piece 27 is directly welded to the fixed seam 23.

剥離シームは、従来技術例えばドイツ連邦共和国特許出願第４４４７６２６号明細書により公知である。剥離シームは、２つのフィルム材料区分間の溶接継ぎ目であって、２つのフィルム材料区分は、機械的な作用、具体的には負荷によって腸内摂取のための物質を所定の圧力で押しやることができる。   Exfoliated seams are known from the prior art, for example from DE 44 47 626 A1. An exfoliated seam is a weld seam between two film material sections that can push a substance for intestinal uptake at a given pressure by mechanical action, specifically by loading. it can.

従って、前記前室２１は、剥離シーム１６が完全に無傷であっても、若しくは不都合に高い機械的な作用によって剥離シーム１６が例えば運搬時の間違った取り扱いによって裂けていても、いずれにしても、腸内摂取のための物質の投与をコントロールするために適している。   Thus, the anterior chamber 21 can be used in any case, even if the peel seam 16 is completely intact, or if the peel seam 16 is torn due to wrong handling during transportation due to an undesirably high mechanical action. Suitable for controlling the administration of substances for intestinal ingestion.

本発明によるフィルム製の袋の第１実施例の原理図である。1 is a principle view of a first embodiment of a film bag according to the present invention. 本発明によるフィルム製の袋の選択的な実施例の原理図である。FIG. 2 is a principle diagram of an alternative embodiment of a film bag according to the present invention.

符号の説明Explanation of symbols

１１ フィルム製の袋、 １２ 底部、 １３，１４ 側縁部、 １５ 外側縁部、 １６ 剥離シーム（剥離縫い目）、 １７ 充填室、 １８ 外側区分、 １９ 頂部シーム、 ２０ 排出装置、 ２１ 前室、 ２２ 先細り部、 ２３ 固定シーム（固定縫い目）、 ２４ 表側、 ２５ 裏側、 ２６ 差し込み区分、 ２７ 接続ピース、 ２８ 閉鎖キャップ   DESCRIPTION OF SYMBOLS 11 Film bag, 12 Bottom part, 13,14 Side edge part, 15 Outer edge part, 16 Peeling seam (peeling seam), 17 Filling room, 18 Outer section, 19 Top part seam, 20 Discharge device, 21 Front room, 22 Tapered part, 23 Fixed seam (fixed seam), 24 Front side, 25 Back side, 26 Insertion section, 27 Connection piece, 28 Closing cap

Claims (14)

フィルム製の袋を製造するための方法において、
表側（２４）と裏側（２５）と、この表側（２４）と裏側（２５）との間の充填室（１７）と、まだ開放している外側縁部（１５）を備え、かつ３方側つまり１つの底部（１２）と２つの側縁（１３，１４）とが閉鎖されている無菌の袋中間製品を提供し、
前記袋中間製品の表側（２４）と裏側（２５）とを接続する、第１の側縁（１３）から、まだ開放している外側縁部（１５）まで延在する剥離シーム（１６）を無菌条件下で製作し、この際に、充填室（１７）に通じる開口がフィルム製の袋の最大幅に対して短縮され、前記剥離シーム（１６）によって前記充填室（１７）から分離された外側区分（１８）が形成されるようにし、
前記充填室（１７）を無菌条件下で所定の物質によって充填し、頂部シーム（１９）を介して前記剥離シーム（１６）と第２の側縁部（１４）とを堅固に閉鎖し、
前記剥離シーム（１６）を破り開けると前記物質が充填室（１７）から排出装置（２０）に達し、この排出装置（２０）を介してフィルム製の袋から取り出されるように、前記排出装置（２０）を前記外側区分（１８）内に固定する、
ことを特徴とする、フィルム製の袋を製造するための方法。 In a method for manufacturing a film bag,
The front side (24) and the back side (25), the filling chamber (17) between the front side (24) and the back side (25), the outer edge (15) still open, and the three-sided side In other words, providing a sterile bag intermediate product in which one bottom (12) and two side edges (13, 14) are closed,
A peel seam (16) extending from the first side edge (13) connecting the front side (24) and the back side (25) of the bag intermediate product to the outer edge (15) still open. Manufactured under aseptic conditions, with the opening leading to the filling chamber (17) shortened relative to the maximum width of the film bag and separated from the filling chamber (17) by the peel seam (16) An outer section (18) is formed,
Filling the filling chamber (17) with a predetermined substance under aseptic conditions, tightly closing the release seam (16) and the second side edge (14) via a top seam (19);
When the peeling seam (16) is broken open, the substance reaches the discharge device (20) from the filling chamber (17) and is taken out from the film bag through the discharge device (20). 20) is fixed in the outer section (18),
A method for manufacturing a film bag. 外側区分（１８）内での前記排出装置（２０）の固定を、もはや無菌ではない条件下で、有利にはクリーンルーム内で実施する、請求項１記載の方法。   2. The method according to claim 1, wherein the fixing of the discharge device (20) in the outer section (18) is carried out under conditions that are no longer sterile, preferably in a clean room. 前記排出装置（２０）に外側区分（１８）を溶接する、請求項１又は２記載の方法。   The method according to claim 1 or 2, wherein an outer section (18) is welded to the discharge device (20). 前記外側区分（１８）の部分を、排出装置（２０）の固定前又は固定後に取り除く、特に切り離す、請求項１から３までのいずれか１項記載の方法。   4. The method according to claim 1, wherein a portion of the outer section (18) is removed, in particular detached, before or after fixing the discharge device (20). 前記排出装置（２０）を、剥離シーム（１６）と排出装置（２０）との間に前室（２１）が形成されるように、外側区分（１８）内に固定する、請求項１から４までのいずれか１項記載の方法。   The said discharge device (20) is fixed in the outer section (18) such that a front chamber (21) is formed between the peeling seam (16) and the discharge device (20). The method according to any one of the above. 無菌のフィルムウェブから袋中間製品を製作することによって、無菌の袋中間製品を準備する、請求項１から５までのいずれか１項記載の方法。   6. A method according to any one of the preceding claims, wherein the sterile bag intermediate product is prepared by producing the bag intermediate product from a sterile film web. 無菌の袋中間製品を滅菌によって準備する、請求項１から６までのいずれか１項記載の方法。   7. A method according to any one of claims 1 to 6, wherein the sterile bag intermediate product is prepared by sterilization. ガンマ光線の作用によって滅菌を行う、請求項７記載の方法。   The method according to claim 7, wherein the sterilization is performed by the action of gamma light. Ｈ2Ｏ2によって滅菌を行う、請求項７記載の方法。 The method according to claim 7, wherein sterilization is performed with H 2 O 2 . 少なくとも、剥離シーム（１６）の形成、物質の充填、及び排出装置（２０）を外側区分（１８）に固定する作業段階を、インライン処理で行う、請求項１から９までのいずれか１項記載の方法。   10. The method according to claim 1, wherein at least the work steps of forming the peel seam (16), filling the substance and securing the discharge device (20) to the outer section (18) are performed in an inline process. the method of. 生体としての人体又は動物に物質を投与するための、請求項１から１０までのいずれか１項記載のフィルム製の袋を製造するための方法。   The method for manufacturing the bag made from a film of any one of Claim 1-10 for administering a substance to the human body or animal as a biological body. 請求項１から１０までのいずれか１項記載の方法に従って製造されたフィルム製の袋であって、剥離シーム（１６）と、無菌条件下で充填される充填室（１７）と、該充填室（１７）に対して前記剥離シーム（１６）によって分離された排出装置（２０）とを有しており、該排出装置（２０）が、無菌条件下ではないが、有利にはクリーンルーム内でフィルム製の袋に固定されていることを特徴とする、フィルム製の袋。   A film bag manufactured according to the method of any one of claims 1 to 10, comprising a peel seam (16), a filling chamber (17) filled under aseptic conditions, and the filling chamber And a discharge device (20) separated by the peel seam (16) with respect to (17), the discharge device (20) being advantageously not in aseptic conditions but advantageously in a clean room A film bag characterized by being fixed to a bag made of a film. 剥離シーム（１６）と排出装置（２０）との間に前室（２１）が設けられた前室（２１）と、特に腸内摂取のために設けられた第１の物質と混合するために設けられ、かつ／またはインジケータとして設けられた第２の物質とを有している、請求項１２記載のフィルム製の袋。   For mixing with the anterior chamber (21) provided with an anterior chamber (21) between the peeling seam (16) and the discharge device (20) and in particular with a first substance provided for intestinal ingestion 13. A film bag according to claim 12, comprising a second substance provided and / or as an indicator. 前記前室（２１）の容積が、前記充填室（１７）と比較して著しく小さく、特に少なくとも１／５０倍であって、物質の排出装置に関連して狭く構成されており、それによって、剥離シーム（１６）を破り開けると腸内摂取のための物質が排出装置（２０）に迅速に達し、排出速度が排出装置（２０）によってのみ規定され、場合によってはその後の流れの妨害が制限されるようになっている、請求項１２又は１３記載のフィルム製の袋。   The volume of the front chamber (21) is significantly smaller than that of the filling chamber (17), in particular at least 1/50 times, and is configured narrowly in relation to the substance discharge device, thereby Breaking the peel seam (16) will quickly allow material for intestinal ingestion to reach the drainage device (20), the drainage rate being defined only by the drainage device (20), and possibly restricting subsequent flow obstruction The film bag according to claim 12 or 13, wherein the bag is made.
JP2008541644A 2005-11-25 2006-11-23 Method for producing a film bag and method for filling a film bag Pending JP2009517239A (en)

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