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WO2008040569A1 - Sac souple, système de mélangeur et procédé permettant de fixer un sac souple à l'intérieur d'un contenant rigide - Google Patents

Sac souple, système de mélangeur et procédé permettant de fixer un sac souple à l'intérieur d'un contenant rigide Download PDF

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Publication number
WO2008040569A1
WO2008040569A1 PCT/EP2007/054000 EP2007054000W WO2008040569A1 WO 2008040569 A1 WO2008040569 A1 WO 2008040569A1 EP 2007054000 W EP2007054000 W EP 2007054000W WO 2008040569 A1 WO2008040569 A1 WO 2008040569A1
Authority
WO
WIPO (PCT)
Prior art keywords
flexible bag
cover
wall
functional part
bag according
Prior art date
Application number
PCT/EP2007/054000
Other languages
English (en)
Inventor
José CASTILLO
Florence Bosco
Original Assignee
Artelis
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
Priority claimed from PCT/EP2007/053595 external-priority patent/WO2008040567A1/fr
Application filed by Artelis filed Critical Artelis
Priority to US12/444,049 priority Critical patent/US8292491B2/en
Priority to EP07728456A priority patent/EP2076328B1/fr
Priority to AT07728456T priority patent/ATE520453T1/de
Publication of WO2008040569A1 publication Critical patent/WO2008040569A1/fr
Priority to US13/615,746 priority patent/US8746964B2/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
    • B01F27/81—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis the stirrers having central axial inflow and substantially radial outflow
    • B01F27/811—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis the stirrers having central axial inflow and substantially radial outflow with the inflow from one side only, e.g. stirrers placed on the bottom of the receptacle, or used as a bottom discharge pump
    • B01F27/8111—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis the stirrers having central axial inflow and substantially radial outflow with the inflow from one side only, e.g. stirrers placed on the bottom of the receptacle, or used as a bottom discharge pump the stirrers co-operating with stationary guiding elements, e.g. surrounding stators or intermeshing stators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/45—Magnetic mixers; Mixers with magnetically driven stirrers
    • B01F33/453—Magnetic mixers; Mixers with magnetically driven stirrers using supported or suspended stirring elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/45—Magnetic mixers; Mixers with magnetically driven stirrers
    • B01F33/453—Magnetic mixers; Mixers with magnetically driven stirrers using supported or suspended stirring elements
    • B01F33/4537—Magnetic mixers; Mixers with magnetically driven stirrers using supported or suspended stirring elements the stirring element being suspended by one point
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/50—Mixing receptacles
    • B01F35/51—Mixing receptacles characterised by their material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/50—Mixing receptacles
    • B01F35/513—Flexible receptacles, e.g. bags supported by rigid containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use

Definitions

  • the present invention relates to a flexible bag; to a mixing system comprising such a flexible bag and to a method for fixing a specific flexible bag into a rigid container.
  • the storage, mixing and/or suspension of solutions is required in many technical fields such as biotechnology, pharmaceuticals and medical.
  • liquid substances for example, in the field of the biotechnology and pharmaceutical industry, it is often necessary to prepare and to complement solutions, buffers, culture medium, suspensions, etc (referred to in general terms hereinafter as liquid substances) and to store these solutions.
  • Some specific applications include dilution, dissolution and/or adjusting and/or measuring pH, salinity conditions, concentration, osmolality, temperature... of a liquid substance of any kind (buffer, culture medium, saline solution, etc.)
  • solutions of culture media, buffers, reagents, etc. used in these fields must be pure and sterile. Accordingly, the mixing tank, mixing device, storage bag and all other reusable components that contact the solution must be carefully cleaned after use to avoid any cross contamination with subsequent batches of solutions. The cleaning of the structural components is labour-intensive, time- consuming, and costly.
  • such mixing device and other functional parts generally protrude inside the bag so that in the case said bag has a flexible wall facing the protruding part, said wall can be damaged by the protrusion before it is filled.
  • inserting the flexible bag into a rigid container is not easy namely because said bag is not easy to handle and/or because some parts must be connected with parts of the container.
  • the present invention aims at solving these problems by providing a system where the flexible bag is prevented from being damaged by a part protruding inside of it; where if said part is not fixed to the bag, it is kept in place during storage and handling of the empty bag; and where said bag is easier to install inside a rigid container.
  • the present invention relates to a flexible bag comprising at least a first wall, a second wall facing the first wall when the flexible bag is folded and at least one functional part having at least a portion protruding from the first wall inside the bag, wherein the second wall comprises protective means intended to prevent damage to said flexible bag and/or to said functional part.
  • the terms "flexible bag” designate a bag or pouch made of walls of similar structure preferably assembled by welding. These walls may be made of a mono- or multilayer film including or not a barrier layer based on a barrier polymer like EVOH (ethylene vinyl alcohol polymer). Generally, these films may have an inner layer (in contact with the contents of the bag when filled) based on a polyolefin, preferably an ULDPE (ultra-low density polyethylene, pref. medical grade).
  • a polyolefin preferably an ULDPE (ultra-low density polyethylene, pref. medical grade).
  • the bag may be of cylindrical shape although cylindrical flexible bags are not easily baffled and difficult to manufacture.
  • a bag with a cubic or parallel-piped shape is preferable namely because it works as a baffled tank which enhances its mixing capacity.
  • the flexible bag according to the present invention comprises at least two facing walls. This means in fact that when said bag is empty, at least two portions of its wall(s) are in contact with each other by their internal surface i.e. their surface intended to be in contact with the contents of the bag.
  • the flexible bag according to the invention may be used to store, mix, handle (for any purpose whatsoever) a fluid.
  • it has a functional part having at least a portion protruding inside of it i.e. extending in the volume defined by the bag's wall(s).
  • This part is protruding from a wall of the tank. This is meant to encompass the cases where the part would be protruding from an angle and potentially damaging an opposite wall or angle.
  • the part must not necessarily by fixed on said wall or corner. It might merely rest on it or pass through an opening therein. If it is fixed to it, it may be by welding, riveting, clamping...
  • This protruding functional part may be any accessory required for at least one active function of the bag.
  • the functional part is preferably chosen between a mixing device; a gas sparger; a dip tube; or a sensor for measurement of temperature pH, conductivity, turbidity, biomass, redox potential, dissolved oxygen or any other signal.
  • the present invention is advantageously applied to large parts so that the protective means can fulfil several functions as will be explained later on.
  • “large” is meant having their biggest dimension in the range of the centimetres (e.g. up to 30 cm).
  • the present invention gives good results when the functional part is a mixing device which may either be a mere impeller protruding inside the bag or a more sophisticated system like the mixing dish from the HyClone® MixtainerTM Bioprocessing System or the LevTech® Disposable Mixing System, or even a combination of a mixing device and gas sparger, or any other part combining a mixing effect with another function.
  • a mixing device which may either be a mere impeller protruding inside the bag or a more sophisticated system like the mixing dish from the HyClone® MixtainerTM Bioprocessing System or the LevTech® Disposable Mixing System, or even a combination of a mixing device and gas sparger, or any other part combining a mixing effect with another function.
  • any kind of mixing device may be used in a flexible bag, it is preferably a device including a magnetic impeller which is driven from the outside as explained above.
  • the present invention gives good results when the mixing device comprises a rotary magnetic impeller located in a compartment delimited by a wall, said mixing device further comprising:
  • deflecting means and/or the wall of this mixing device might indeed comprise angles or other kinds of prominent parts which are susceptible to damage the wall of the bag facing said mixing device.
  • said mixing device is not necessarily secured to the bag when said bag is shipped and handled before use so that the cover of the invention may help (together with the vacuum generally applied to said bag) keeping said part substantially at the place where it should be fixed in use.
  • said mixing device may be by welding or by using at least one of the following: - magnets in extension arms susceptible to work with corresponding magnets disposed in the rigid container; - at least two extension arms welded (or mechanically fixed in any other way) to at least two drains or two other rigid components of the bag.
  • the flexible bag according to the present invention comprises protective means on the wall (or the corner: see previously) opposite to the one where the functional part is located.
  • These protective means may be integral with the bag's wall (for instance: they may consists in a part of the wall being of higher thickness) or they may be fixed to it.
  • These protective means are preferably secured to the wall of the bag and even more specifically, they are preferably secured to on an opening of said wall and more precisely: they are preferably welded or clamped on the periphery of the opening.
  • These means may be of any geometry allowing them to protect the protruding portion of the functional part.
  • they are in the shape of a cover having a cavity sized to accommodate the protruding portion of the functional part.
  • said cavity has a shape substantially matching the external shape of the protruding portion.
  • the lower border of said cover is preferably secured from the inside (welded, clamped or fixed by any other means) to the periphery of said opening i.e. on the inner surface of the bag in order to avoid that the outer layer of the film would be in contact with the liquid. Nevertheless, it can be also secured from the outside of said periphery. In that embodiment, said securing is preferably performed before the final assembly of the bag.
  • the cover is preferably either welded or clamped (using a flange and a gasket) on the periphery of the opening.
  • both flanges are preferably of a size and shape such that the flange of the cover rests on the flange of the functional part when the bag is empty. This allows a good distribution of the pressure between both flanges when the bag is positioned inside a rigid container.
  • said cover is preferably based on a material compatible with the material constituting the outer surface of the bag.
  • a polymer of ethylene is a good choice.
  • a HDPE high density polyethylene
  • EVA Ethylene Vinyl Acetate copolymer
  • LDPE Low Density Polyethylene
  • This cover may be obtained by any method suitable for moulding plastic parts, preferably by injection moulding.
  • injection moulding grades of the above mentioned polymers are preferably used.
  • the cover according to this embodiment of the invention comprises a cavity which is substantially matching the external shape of the protruding portion of the functional part.
  • substantially matching means in fact that the protruding portion fits (can be inserted) inside the cover and can be removed there from i.e. that it has smaller dimensions and an adequate shape to be able to be received (preferably completely) inside the cover.
  • the protruding portion of the functional part does not fit tightly inside the cover so that there is no wear between the surfaces of both parts (except perhaps on their welding flanges or other substantially horizontal contact surface, if any) and this even with the usual manufacturing tolerances.
  • the cover when the cover is used to fix the protruding part to a rigid container (or any other support/part), it may be preferable to fit both pieces more tightly at least on a portion thereof so that a torque exerted on the cover can easily be transmitted to the protruding portion of the part.
  • corresponding portions in relief may be provided on both parts which are in contact when the cover rests on the protruding portion of the functional part so that the torque transmission is improved.
  • the cover has a substantially constant wall thickness which depends on the mechanical resistance required.
  • its outer shape it may be adapted to enhance the ease of handling of the bag and/or the fixation of the protruding part on a support.
  • it may be provided with an extension and/or its cavity may be extended upwards so that it acquires a prehensile shape.
  • the protective means of the bag according to the invention may be equipped with functional means for instance: with port(s) for entry/exit of liquid(s) or gas; with sensors or supports there for; with impeller(s) which may be lowered inside the bag once filled...
  • the present invention also concerns a mixing system comprising a flexible bag as described above and a rigid container supporting said bag.
  • the functional part is a magnetic mixing device and the mixing system comprises a magnetic driver located outside the container, generally below its bottom.
  • a portion of the flexible bag is sandwiched between at least a portion of the mixing device and a portion of the rigid container, these portions being generally part of the bottom wall of the bag and of the rigid container respectively.
  • “Sandwiched” means that said portions are directly in contact and pressed against each other by gravity (if the mixing device rests on the bottom of the mixing bag and the container) and/or by any other means which preferably do not perforate the bag and the container (additional magnets for instance).
  • the present invention gives good results with the second embodiment mentioned above and especially, when the mixing device is not (at least not firmly) secured to the flexible bag so that the cover can help keeping said mixing device substantially in place during storage and handling of the empty bag.
  • the vacuum generally applied on said bag also helps in that regard.
  • the flexible bag of that embodiment may comprise a positioning mechanism to position and maintain the mixing device only approximately at a given location (i.e. said device is not secured to its walls but free to move a little relative to it) when the bag is inserted inside the rigid container
  • This positioning mechanism may include welding tabs, bridges or any other fixation part (like a double annular wall for instance) fixed on the bag wherein the mixing device is retained but can move freely (relative to the bag) in at least one direction of space (and preferably, in the three directions of space) while remaining in a given perimeter (surrounding the driver when the bag is inserted in the rigid container).
  • This embodiment is advantageous because the mixing device will align itself automatically with its driver (through the magnetic forces they both exert on each other) so that there is no need for a perfect mechanical relative alignment between the mixing device, the driver and the rigid container. This embodiment is also advantageous because there is no need for the welding of a (potentially) large circumferential part, what presents quality issues as far as leakages are concerned.
  • the protective means of the bag according to the invention may consist in a cover comprising a portion in relief cooperating with a matching portion in relief on the functional part so that said part can be fixed on the container using the cover.
  • the present invention also concerns a method for fixing a flexible bag as described above inside a rigid container, wherein the cover and the functional part bear complementary relieves and according to which the functional part is fixed to the container using the cover which is then decoupled from said part before filling the bag.
  • Figure 1 shows in detail a mixing device inside the cavity of a protective cover and figure 2, a schematic view of said mixing device and cover respectively in an empty flexible bag (upper part of the figure) and in said bag filled with liquid (lower part of the figure).
  • Figure 1 is an axial cut (i.e. a cut through a plane comprising the symmetry axis) through a mixing device (1, 2) provided with its protective cover (3). Both parts are provided with a welding flange (V, 3') intended to be welded on a flexible bag (not shown) respectively on the inner surface of the bottom wall (under surface of flange 1 ') and on the inner surface of the top wall, on the periphery of an opening there through (upper surface of flange 3').
  • V, 3' welding flange intended to be welded on a flexible bag (not shown) respectively on the inner surface of the bottom wall (under surface of flange 1 ') and on the inner surface of the top wall, on the periphery of an opening there through (upper surface of flange 3').
  • the mixing device illustrated comprised a base (1), a cover (2) and a magnetic impeller (5) rotating on a bearing (4) supported by a protrusion (6) of the base (1).
  • the cover (3) has an internal volume or cavity substantially matching the external shape of the mixing device (1, 2) at its base but having a chimney or a dome shaped extension (7) at its top providing a grip enhancing the ease of handling of the cover and of the flexible bag for which it is intended.
  • This extension can be used to integrate functional means, like ports for inlets or outlets of liquids or gases, probes, impellers or the like
  • the cover (3) has been manufactured by injection moulding and it shows a substantially uniform wall thickness with just a slight increase in the neighbourhood of its injection point (8). It is made of an injection moulding grade of HDPE.
  • Figure 2 illustrates how the cover (3) is welded to the periphery of an opening into a bag comprising 2 facing walls (9, 9'), one of which (9) bearing a protective cover for the mixing device (1, 2) located on its facing wall (9). This welding is made between the upper surface of the cover's welding flange (3') and the inner periphery of the opening in the bag. It also illustrates how the mixing device is welded to the bottom of the bag (9') by the lower surface of its welding flange (V), and how the 2 parts fit to each other when the bag is empty and are separate when the bag is empty.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mixers With Rotating Receptacles And Mixers With Vibration Mechanisms (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un sac souple comprenant au moins une première paroi, une seconde paroi faisant face à la première paroi lorsque le sac souple est plié, et une partie fonctionnelle présentant au moins une partie formant une saillie s'étendant de la première paroi jusqu'à l'intérieur du sac. La seconde paroi comprend un moyen de protection permettant d'empêcher que le sac souple et/ou la partie fonctionnelle ne s'endommage.
PCT/EP2007/054000 2006-10-03 2007-04-24 Sac souple, système de mélangeur et procédé permettant de fixer un sac souple à l'intérieur d'un contenant rigide WO2008040569A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US12/444,049 US8292491B2 (en) 2006-10-03 2007-04-24 Flexible bag, mixing system and method for fixing a flexible bag inside a rigid container
EP07728456A EP2076328B1 (fr) 2006-10-03 2007-04-24 Sac souple, système de mélangeur et procédé permettant de fixer un sac souple à l'intérieur d'un contenant rigide
AT07728456T ATE520453T1 (de) 2006-10-03 2007-04-24 Flexibler beutel, mischsystem und verfahren zur befestigung eines flexiblen beutels in einem starren behälter
US13/615,746 US8746964B2 (en) 2006-10-03 2012-09-14 Flexible bag and mixing system with rigid container

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP2006066980 2006-10-03
EPPCT/EP2006/066980 2006-10-03
EPPCT/EP2007/053595 2007-04-12
PCT/EP2007/053595 WO2008040567A1 (fr) 2006-10-03 2007-04-12 Sac mélangeur souple, dispositif mélangeur et système mélangeur associé

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/444,049 A-371-Of-International US8292491B2 (en) 2006-10-03 2007-04-24 Flexible bag, mixing system and method for fixing a flexible bag inside a rigid container
US13/615,746 Continuation US8746964B2 (en) 2006-10-03 2012-09-14 Flexible bag and mixing system with rigid container

Publications (1)

Publication Number Publication Date
WO2008040569A1 true WO2008040569A1 (fr) 2008-04-10

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Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/EP2007/053998 WO2008040568A1 (fr) 2005-10-04 2007-04-24 Système de mélangeur comprenant un sac souple, sac souple et système de localisation spécifiques destinés à ce système de mélangeur
PCT/EP2007/054000 WO2008040569A1 (fr) 2006-10-03 2007-04-24 Sac souple, système de mélangeur et procédé permettant de fixer un sac souple à l'intérieur d'un contenant rigide

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/EP2007/053998 WO2008040568A1 (fr) 2005-10-04 2007-04-24 Système de mélangeur comprenant un sac souple, sac souple et système de localisation spécifiques destinés à ce système de mélangeur

Country Status (1)

Country Link
WO (2) WO2008040568A1 (fr)

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US20100220547A1 (en) * 2007-10-04 2010-09-02 Sartorius Stedim Biotech Vessel for processing a biopharmaceutical product including protection means
WO2010109136A1 (fr) * 2009-03-24 2010-09-30 Jean-Pascal Zambaux Bioreacteur jetable et systeme d'agitation a usage unique.
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WO2005068059A1 (fr) 2004-01-07 2005-07-28 Levtech, Inc. Sac melangeur a arroseur integre et receptacle pour detecteur
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EP1961806B1 (fr) 2006-05-13 2019-03-27 Pall Life Sciences Belgium Bioréacteur jetable
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EP2686415B1 (fr) 2011-03-18 2017-11-15 GE Healthcare Bio-Sciences AB Sac flexible pour cultiver des cellules
EP2758158B1 (fr) * 2011-09-16 2019-08-21 GE Healthcare Bio-Sciences Corp. Système de mélange et procédé de mélange
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WO2016083895A1 (fr) * 2014-11-26 2016-06-02 Alf Löfving Ensemble pour agiter ou mélanger des matières
WO2018102566A1 (fr) 2016-12-01 2018-06-07 Life Technologies Corporation Ensembles sacs filtrants de microporteurs et leurs procédés d'utilisation
KR102632721B1 (ko) 2017-10-03 2024-02-01 아벡, 아이엔씨. 반응기 시스템
US11504682B2 (en) 2019-12-23 2022-11-22 Pall Corporation Mixer base assembly for mixing vessels and method of use
US11565222B2 (en) 2019-12-23 2023-01-31 Pall Corporation Mixer base assembly for mixing vessels and method of use

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JP2016504184A (ja) * 2012-11-29 2016-02-12 イー・エム・デイー・ミリポア・コーポレイシヨン フード付き磁気インペラアセンブリを備える容器
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