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WO2012055459A1 - Procédé et installation de remplissage et de fermeture stérile ou aseptique de moyens d'emballage - Google Patents

Procédé et installation de remplissage et de fermeture stérile ou aseptique de moyens d'emballage Download PDF

Info

Publication number
WO2012055459A1
WO2012055459A1 PCT/EP2011/004596 EP2011004596W WO2012055459A1 WO 2012055459 A1 WO2012055459 A1 WO 2012055459A1 EP 2011004596 W EP2011004596 W EP 2011004596W WO 2012055459 A1 WO2012055459 A1 WO 2012055459A1
Authority
WO
WIPO (PCT)
Prior art keywords
packaging
filling
opening
sterile
sterilization
Prior art date
Application number
PCT/EP2011/004596
Other languages
German (de)
English (en)
Inventor
Thomas Niehr
Original Assignee
Khs Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Khs Gmbh filed Critical Khs Gmbh
Publication of WO2012055459A1 publication Critical patent/WO2012055459A1/fr

Links

Classifications

    • 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
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/022—Sterilising, e.g. of complete packages of flexible containers having a filling and dispensing spout, e.g. containers of the "bag-in-box"-type
    • 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
    • B65B61/186—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for making package-opening or unpacking elements by applying or incorporating rigid fittings, e.g. discharge spouts
    • 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
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2835—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying and rotating preformed threaded caps

Definitions

  • the invention relates to a method according to the preamble of claim 1 and to a system according to the preamble of claim 9.
  • Packing means are in the context of the invention, in particular pouches (Pourches), especially those made of a single or multilayer material, e.g. Plastic and / or metal foil. Packing means are in the sense of the invention but in principle also other packaging or containers, e.g. in the pharmaceutical sector, in the cosmetics sector and / or in the food sector and are also used in the beverage sector, and u.a. Soft packaging, such as those made of cardboard and / or plastic film and / or metal foil and containers such. As bottles, cans, especially plastic.
  • a germicidal energy radiation i. to sterilize by exposure to a germicidal energy radiation (eg beta or gamma radiation) of an external radiation source, which is often not accepted by consumers and / or inevitably leads to a deterioration in product quality and / or product properties in a variety of products, and therefore is not possible with a variety of products.
  • a germicidal energy radiation eg beta or gamma radiation
  • the object of the invention is to provide a method by which a sterile filling and closing of packaging materials with a high quality of sterilization or with a high rate of sterilization is possible, without the risk of impairment of product quality and / or product properties and in the possibility of a flexible design of the processes, in particular during sterilization, filling and sealing.
  • a method according to claim 1 is formed.
  • a plant is the subject of claim 9.
  • the peculiarity of the method according to the invention is generally that the packaging, which are preferably pouches are hermetically sealed during sterilization of the packaging interior and an opening of the respective filling opening, through which the product or product is introduced into the packaging interior, only in a sterile interior before or immediately before filling takes place.
  • Fig. 1 in a simplified schematic representation of a plant for the sterile filling and closing of packaging in the form of pouches (pouches);
  • Fig. 2 in an enlarged partial view of the bag packaging consisting of a bag and from the inserted into a bag opening and there by welding or sealing tightly connected to the bag spout.
  • the plant is used for the manufacture, sterilization, sterile filling and sterile sealing of the bag packages, generally designated 2 in the figures, wherein, inter alia, the filler and the capper constitute a unit and are therefore not separately identified.
  • the aforementioned pouches consist in the illustrated embodiment in each case of the thin-walled from a single or multilayer flat material, for example, made of a plastic film bag 3 with bag interior 3.1, Furthermore, the bag 3 shown comprises a bag opening 3.2, in which a spout 4 used in a known manner is and there is tightly connected to the bag 3 by welding or other suitable manner.
  • the plant 1 has for this purpose several sections, which are designated in the figure 1 with I - VIII, of which the sections I and II are provided in a system part 1.1 with machine housing 5 and the sections IV - VIII in a system part 1.2 with machine housing 6 ,
  • the section III is, for example, a transport path for the bag packaging 2 between the plant part 1.1 and the plant part 1.2.
  • section I the production of the bag packages 2 by connecting each of a spout 4, each with a bag 3, the this section or the plant part 1.1 via a bag feed 7 according to the arrow A preferably hanging, i. be supplied with the bag opening 3.2 above.
  • the system components 1.1 and 1.2 are each formed in the interior of a machine housing 5 and 6 respectively.
  • the spouts 4 which are preferably made of plastic, each essentially consist of a sleeve-like spout body 8 with a sleeve or spout opening 9, which is open at one, ie at the lower end 8.1 in FIG. 2 and at the upper end 8.2 is hermetically sealed by a molded sleeve body portion or closure 10.
  • the spout 4 at the transition between the closure 10 and the remaining spout body 8 with an axis of the Spout 4 concentrically enclosing ring-shaped predetermined breaking line 11 is provided, which facilitates facilitating removal of the closure 10 and thus a facilitated opening the spout opening 9 at the upper end 8.2 of the spout 8.
  • the spout body 8 in the illustrated embodiment is made in one piece with a projecting beyond the other circumference of the spout 8 annular flange 12, in the area between the predetermined breaking line 1 1 and the lower end 8.1 of the sleeve opening 9.
  • the joining of the bag 3 and the Spout 4 in the section I is made by inserting the respective spout 4 with the lower open end 8.1 of the spout 8 in the bag opening 3.2 and sealing or welding the material of the bag 3 in the region of the bag opening 3.2 with the portion of the Spout 8 between the Flange 12 and the lower end 8.1.
  • the section I has a working or treatment position with corresponding welding or sealing jaws 14.
  • the flange 12 forms in the bag packages 2 thus produced in each case a "neck ring" on which the bag packages 2 suspended, for example, at least one in Figure 1 schematically designated 13 transporter hanging through the sections II - VIII of Appendix 1 in a transport direction ( In the illustrated embodiment, at least in the region of sections II-VIII, the bag packages 2 are clocked with the conveyor 13 designed as a linear conveyor or moved stepwise in the transport direction A.
  • the respective pouch packaging 2 for example, with microwave energy or radiation and / or electron beam or beta radiation, and / or gamma radiation is applied, the intensity of this radiation is chosen so that it penetrates the walls of the bag and the spout 4 and Sterilization or sterilization with the required rate of germination or germ killing rate causes, for example, a germ killing rate of about log 3.55.
  • the section II has a corresponding, in the figure 1 with 15 schematically indicated high-power radiator.
  • the so sterilized and still temporarily hermetically sealed by the respective closure 10 pouches 2 are supplied via the section III of Appendix 1 to the plant part 1.2 and the local section IV, and in accordance with the arrow A.
  • Section IV is a (again) External sterilization of the still tightly closed pouches 2, at least in the area of their spouts 4, for example, by loading the pouches 2 and the sealed spout 4 with a gaseous and / or vapor sterilant, such as vaporized hydrogen peroxide (for example, 20% tiges to 30% tiges H202) and by subsequently activating a precipitate or condensate, which has formed on the outer surfaces of the pouches 2, in particular in the region of the respective spout 4 from the sterilization medium.
  • a gaseous and / or vapor sterilant such as vaporized hydrogen peroxide (for example, 20% tiges to 30% tiges H202) and by subsequently activating a precipitate or condensate, which has formed on the outer surfaces of the pouches 2, in particular in the region of the respective spout 4 from the sterilization medium.
  • the exposure to the vaporized hydrogen peroxide takes place for example with a treatment time
  • the activation takes place in particular when using H 2 O 2 as a sterilization medium by heating, for example by exposure to a hot gaseous and / or vaporous activation medium, for example by exposure to hot, sterile air, for example at a temperature of about 90 ° C. and with a treatment time of about 14 seconds.
  • oxygen radicals are released from H 2 O 2, which ensure sterilization or sterilization of the bag packages 2, in particular also in the area of the outer surfaces of the respective spout 4 with the high rate of sterilization.
  • a drying of the bag package 2 takes place on its outer surface.
  • Section IV is designed for the aforementioned sterilization with at least one treatment head 16 for applying the sterilization medium to the bag packages 2 and with at least one treatment head 17 for activating the sterilization medium following the treatment head 16 in the transport direction A.
  • section V takes place with suitable measures or means an opening of the respective spout 4 by separating the spout 9 closing temporary closure 10.
  • This separation can be done in different ways or with different means, for example by at least one heated cutting wire, by laser cutting, by at least one motor-driven knife, etc.
  • a rotating blade 18 is indicated in FIG.
  • the separated from the spouts 4 temporary closures 10 are removed from the section V in a suitable manner and collected, as indicated by the arrow B.
  • the now opened bag packages 2 are internally subjected to a sterile gas and / or vapor medium in order to form the respective bag interior 3.1 at least partially for a trouble-free implementation of the subsequent filling process.
  • section VII then takes place the filling of the open bag packages 2 with the contents, in the darg Horen embodiment in each case in two steps at two filling positions on filling tubes 19, which are inserted for filling in the spout 4 of the respective bag package 2 and on the Filling is introduced into the respective bag packaging 2.
  • the filled bag packages 2 are closed at their spouts 4, specifically in the illustrated embodiment by sealing caps 20, which are screwed onto the upper section of the respective spout 4 provided with an external thread and protruding from the bag 3.
  • the caps 20 are suitably sterilized or sterilized prior to application to the spouts 4, for example by exposure to microwave radiation, beta radiation, electron radiation and / or gamma radiation and / or using a suitable gas and / or vapor sterilization medium, for example using of the above-mentioned vaporized H 2 O 2, and then activating and drying with the aforementioned hot gas and / or vapor activation medium.
  • the filled and closed bag packages 2 are fed from the system part 1.2 in the transport direction A for further use.
  • Sections IV - VIII of Appendix 1 are located in a sterile interior 21 of the plant part 1.2, the (interior) u.a. is separated from the environment by the machine housing 6 and the (interior) is acted upon in accordance with the arrows C of Figure 1 with a sterile gas and / or vapor medium, for example with sterile air, in such a way that the pressure in the interior 21 something greater than the ambient pressure.
  • the section II is preferably provided in a sterile interior 22, which is separated from the environment by the machine housing 5. It will be understood that at transitions between non-sterile areas or rooms and the sterile internal spaces 21 and 22, respectively, suitable, germ-preventing sluices are provided. Furthermore, there is also the possibility, in particular the plant part 1.2 to be designed so that the bag packaging 2 included in the individual sections IV - VIII only with its upper, the spout 4 and the spout opening 9 and particularly critical in terms of germination area in the sterile interior 21 while the remainder of each bag package 2 is underneath it in a non-sterile room.
  • the volume of the sterile interior space 21 is substantially reduced, with the advantage, inter alia, of a lower consumption of the sterile interior space supplied sterile vapor and / or gaseous medium. In this case, entry of germ-preventing sluices is only required between the reduced-volume sterile interior 21 and the surroundings.
  • a peculiarity of Appendix 1 or the method carried out with this Appendix is that the bag packages 2 are sterilized internally in a hermetically sealed condition, i. in the interior 2.1 of each bag closed packaging 2 existing germs are killed, and that only after introducing at least the most critical in terms of germination of bag packaging 2 in the sterile interior 21 there the temporary closure 10 and the bag 2 opened and then (after a Outside sterilization in the region of the spout 4) the filling of the bag packages 2 via the spout openings 9 serving as filling openings and sealing with the sterile closures 20 takes place, specifically in the sterile interior 21.
  • the system part 1.2 By dividing the system 1 into two parts of the system 1.1 and 1.2, it is possible to accommodate these parts of a manufacturing plant in different areas, for example when using the system 1 in the medical field, the system part 1.2 in a highly sensitive and specially protected and / or as a clean room trained part or building section of a production and the plant part 1.1 outside of this part or building section.
  • UV emitters in the sterile inner space 21, in particular above the movement path of the bag packages 2, with which the bag packages 2 are exposed to UV radiation externally, at least also in the area of their spouts 4 for further sterilization.
  • the bag packages 2 are closed after filling in section VIII by caps 20, in particular by screw-on caps 20.
  • the bag packages 2 after filling in the section VIII first at the top of their spouts 4 only with a membrane, for example in the form of a thin plastic and / or metal foil, e.g. to close by welding and then apply only outside the sterile room 21, the caps 20 on the spout 4, with the advantage of reducing the design effort for the corresponding Verschoudrestation.
  • the bag packages 2 are each provided with the spout 4.
  • the invention can also be applied to pouches which consist exclusively of the pouch 3, that is to say without a spout 4, also called “spout” or “mouthpiece”.
  • This pouch packaging is then sealed in an analogous manner on all sides to hermetically seal them, and is then sterilized inside in section II, in section IV in an opening to form the filling opening area, for example on the Top of the hanging bag 3 transported sterilized outside and then opened in section IV there to form the filling opening.
  • About the filling opening is then in section VII filling the relevant bag packaging.
  • the respective bag 3 or its filling opening are closed by welding. This final closure can be achieved via a sealing unit, a suitable gluing or otherwise.
  • the packaging in station IV as a whole is aseptically treated from the outside. It is part of the invention and economically very advantageous if in such a system at least in the area of sections IV to VII a first sterile room 21 and a second sterile room 22 is provided, wherein the first sterile room has a higher standard of hygiene than the second sterile room 23. Between the two sterile rooms an opening or a gap must be provided, so that the Packaging can be held or guided such that the head or mouth portion in which or adjacent to which the filling opening (9) is arranged, in the first sterile room 21 projects and the remaining portions of the packaging (9) in the second sterile room 23. Um To prevent contamination, a forced ventilation is provided, so that always at least a partial volume flow of sterile air from the first sterile room 21 into the second sterile room 22 is passed.
  • prefabricated, sterile packaging with a temporary closure made in a location that is spatially separated from the filling and sealing plant are delivered in an outer packaging, from which the packaging must be removed prior to feeding to the filling and sealing system and introduced or introduced into the appropriate means of transport to follow open as described above and aseptically filled or finally closed , These steps can be done manually or automatically.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Basic Packing Technique (AREA)

Abstract

L'invention concerne un procédé et une installation de remplissage et de fermeture stérile de moyens d'emballage, en particulier d'emballages sous forme de sachets. Les moyens d'emballage sont fermés temporairement de manière hermétique respectivement à l'aide d'une fermeture temporaire, puis au moins l'espace intérieur des moyens d'emballage est stérilisé avant le remplissage, ces derniers étant ensuite amenés jusqu'à une installation de remplissage aseptique, dans laquelle l'ouverture de remplissage est à nouveau formée ou ouverte. Les moyens d'emballage sont ensuite remplis dans au moins un espace stérile exempt de bactéries par l'intermédiaire d'une ouverture de remplissage, et sont fermés hermétiquement dans l'espace ou les espaces stériles exempts de bactéries après le remplissage.
PCT/EP2011/004596 2010-10-25 2011-09-13 Procédé et installation de remplissage et de fermeture stérile ou aseptique de moyens d'emballage WO2012055459A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102010049263.9 2010-10-25
DE102010049263A DE102010049263A1 (de) 2010-10-25 2010-10-25 Verfahren sowie Anlage zum sterilen oder aseptischen Füllen und Verschließen von Packmitteln

Publications (1)

Publication Number Publication Date
WO2012055459A1 true WO2012055459A1 (fr) 2012-05-03

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PCT/EP2011/004596 WO2012055459A1 (fr) 2010-10-25 2011-09-13 Procédé et installation de remplissage et de fermeture stérile ou aseptique de moyens d'emballage

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DE (1) DE102010049263A1 (fr)
WO (1) WO2012055459A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150059288A1 (en) * 2013-09-02 2015-03-05 Aesculap Implant Systems, Llc Flexible container, system and method of manufacture
US9751677B2 (en) 2015-09-21 2017-09-05 Scholle Ipn Corporation Pouch assembly having a plug
WO2017168322A1 (fr) 2016-03-30 2017-10-05 Guala Pack S.P.A. Système de gestion de la stérilisation de poches souples
US10035614B2 (en) 2015-09-21 2018-07-31 Scholle Ipn Corporation Method for aseptic filling of pouches
FR3064609A1 (fr) * 2017-04-03 2018-10-05 Laurent Lelievre Sachet souple destine a contenir un produit liquide ou semi-liquide, comportant a demeure des moyens de deversement incluant un tube plongeur et un tuyau externe
US10189591B2 (en) 2015-09-21 2019-01-29 Scholle Ipn Corporation Rotary filling device for aseptic filling of pouches
US10245336B2 (en) 2015-07-01 2019-04-02 Guala Pack S.P.A. System for handling sterilisation of thin-body flexible containers (POUCH)
US20220144523A1 (en) * 2019-05-09 2022-05-12 Guala Pack S.P.A. Spout for flexible thin-walled packagings
US11999519B2 (en) 2022-08-04 2024-06-04 Scholle Ipn Corporation Filler assembly and method of filling a pouch

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102012206297A1 (de) * 2012-04-17 2013-10-17 Krones Ag Verfahren und Vorrichtung zur Dosenherstellung und Dosenabfüllung
DE102014003871B3 (de) * 2014-03-07 2014-11-27 Flex&Fill Solutions Limited Ausgießer für einen Behälter zur aseptischen Aufnahme eines fließfähigen Produkts sowie Behälter und Verfahren zum aseptischen Befüllen
DE102014116151B3 (de) * 2014-11-06 2016-01-28 Flex&Fill Solutions Limited Verschlusseinrichtung für einen Behälter zur aseptischen Aufnahme eines fließfähigen Produkts sowie Behälter und Verfahren zum aseptischen Befüllen
EP3127859B1 (fr) * 2015-08-07 2020-07-08 INDAG Pouch Partners GmbH Procede de remplissage aseptique d'un recipient, dispositif de remplissage sterile correspondant et machine aseptique

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EP0667284A1 (fr) * 1994-02-15 1995-08-16 Tetra Laval Holdings & Finance SA Remplissage expansif d'emballages et ensuite aspiration du contenu jusqu'à ce que l'emballage arrive à un volume déterminé au préalable
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US20050173020A1 (en) * 2002-06-19 2005-08-11 Daniel Py Sterile filling machine having needle filling station within E-Beam chamber
EP1598274B1 (fr) 2004-05-21 2007-10-24 DEUTSCHE SISI-WERKE GmbH & Co. Betriebs KG Dispositif et procédé pour remplir des sachets flexibles en feuille

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Publication number Priority date Publication date Assignee Title
US4742667A (en) 1981-11-14 1988-05-10 Mueller Horst Method of and apparatus for sterilizing packaging material, especially container-type packages
EP0667284A1 (fr) * 1994-02-15 1995-08-16 Tetra Laval Holdings & Finance SA Remplissage expansif d'emballages et ensuite aspiration du contenu jusqu'à ce que l'emballage arrive à un volume déterminé au préalable
WO1997031826A1 (fr) * 1996-02-28 1997-09-04 Tetra Laval Holdings & Finance S.A. Methode de sterilisation de recipients clos
US20050173020A1 (en) * 2002-06-19 2005-08-11 Daniel Py Sterile filling machine having needle filling station within E-Beam chamber
WO2004076288A1 (fr) * 2003-02-25 2004-09-10 Glaxosmithkline Biologicals S.A. Appareil et procede permettant d'introduire un medicament dans un recipient
EP1598274B1 (fr) 2004-05-21 2007-10-24 DEUTSCHE SISI-WERKE GmbH & Co. Betriebs KG Dispositif et procédé pour remplir des sachets flexibles en feuille

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9856045B2 (en) * 2013-09-02 2018-01-02 Aesculap Implant Systems, Llc System and method for manufacturing an E-beam sterilized flexble bag
US20150059288A1 (en) * 2013-09-02 2015-03-05 Aesculap Implant Systems, Llc Flexible container, system and method of manufacture
US10245336B2 (en) 2015-07-01 2019-04-02 Guala Pack S.P.A. System for handling sterilisation of thin-body flexible containers (POUCH)
US9751677B2 (en) 2015-09-21 2017-09-05 Scholle Ipn Corporation Pouch assembly having a plug
CN109562852B (zh) * 2015-09-21 2021-01-05 肖勒Ipn公司 无菌产品灌装方法
US10035614B2 (en) 2015-09-21 2018-07-31 Scholle Ipn Corporation Method for aseptic filling of pouches
CN109562852A (zh) * 2015-09-21 2019-04-02 肖勒Ipn公司 无菌产品灌装方法
US10189591B2 (en) 2015-09-21 2019-01-29 Scholle Ipn Corporation Rotary filling device for aseptic filling of pouches
JP2022016518A (ja) * 2016-03-30 2022-01-21 グアラ パック エッセ．ピー．アー． 可撓性パウチの殺菌を管理する方法
US20190106233A1 (en) * 2016-03-30 2019-04-11 Guala Pack S.P.A. System for handling the sterilisation of flexible pouches
WO2017168322A1 (fr) 2016-03-30 2017-10-05 Guala Pack S.P.A. Système de gestion de la stérilisation de poches souples
JP2017178456A (ja) * 2016-03-30 2017-10-05 グアラ パック エッセ．ピー．アー．ＧＵＡＬＡ ＰＡＣＫ Ｓ．ｐ．Ａ． 可撓性パウチの殺菌を管理する方法
US11267601B2 (en) 2016-03-30 2022-03-08 Guala Pack, S.P.A. System for handling the sterilisation of flexible pouches
US11383868B2 (en) 2016-03-30 2022-07-12 Guala Pack S.P.A. System for handling the sterilisation of flexible pouches
FR3064609A1 (fr) * 2017-04-03 2018-10-05 Laurent Lelievre Sachet souple destine a contenir un produit liquide ou semi-liquide, comportant a demeure des moyens de deversement incluant un tube plongeur et un tuyau externe
US20220144523A1 (en) * 2019-05-09 2022-05-12 Guala Pack S.P.A. Spout for flexible thin-walled packagings
US11999519B2 (en) 2022-08-04 2024-06-04 Scholle Ipn Corporation Filler assembly and method of filling a pouch

Also Published As

Publication number Publication date
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