EP1644105B1 - Systeme clos a usage unique de melange, de stockage et d'homogeneisation de liquides en conditions propres ou steriles - Google Patents

Systeme clos a usage unique de melange, de stockage et d'homogeneisation de liquides en conditions propres ou steriles Download PDF

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Publication number
EP1644105B1
EP1644105B1 EP04767543A EP04767543A EP1644105B1 EP 1644105 B1 EP1644105 B1 EP 1644105B1 EP 04767543 A EP04767543 A EP 04767543A EP 04767543 A EP04767543 A EP 04767543A EP 1644105 B1 EP1644105 B1 EP 1644105B1
Authority
EP
European Patent Office
Prior art keywords
container
mixing
pump
bag
order
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.)
Expired - Lifetime
Application number
EP04767543A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1644105A1 (fr
Inventor
Christian Neumann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sartorius Stedim Biotech SA
Original Assignee
Stedim SA
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 Stedim SA filed Critical Stedim SA
Priority to PL04767543T priority Critical patent/PL1644105T3/pl
Publication of EP1644105A1 publication Critical patent/EP1644105A1/fr
Application granted granted Critical
Publication of EP1644105B1 publication Critical patent/EP1644105B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/06—Liquids or semi-liquids or other materials or articles enclosed in flexible containers disposed within rigid containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/50—Circulation mixers, e.g. wherein at least part of the mixture is discharged from and reintroduced into a receptacle
    • 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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/22—Details
    • B65D77/24—Inserts or accessories added or incorporated during filling of containers
    • B65D77/26—Elements or devices for locating or protecting articles
    • 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
    • B65D90/00—Component parts, details or accessories for large containers
    • B65D90/02—Wall construction
    • B65D90/04—Linings
    • B65D90/046—Flexible liners, e.g. loosely positioned in the container

Definitions

  • the present invention relates to a closed system for single use of mixing, storage and homogenization of liquids under clean or sterile conditions preferably applicable to bio-pharmaceutical, pharmaceutical and medical industries.
  • this type of mixing operation is generally carried out by means of stainless steel tanks provided with an agitator immersed in said tanks.
  • US-A-5 941 635 discloses a system comprising a pocket provided with several plunger tubes, in which the sampling of the liquid to be mixed is made in the middle of the pocket, using one of the plunger tubes, and the return of said liquid is carried by the bottom of the pocket, through an inner tube comprising a mixing head, connecting the top and the bottom of the pocket.
  • this system involves intervening inside the pocket during its manufacture, in particular to insert the dip tubes and the mixing head. There is therefore a significant risk of introduction of pyrogenic particles.
  • the subject of the present invention is a closed system for single use for mixing, storing and homogenizing liquids, comprising an assembly consisting of a rigid container provided with a non-invasive pump, said container enclosing a pocket for use single generally parallelepipedal shape, characterized in that the lower face of the pocket comprises a liquid outlet orifice to the outside of the pocket, the upper face comprises a liquid return port through which said liquid returns inside of the pocket, said orifices are irremovably connected by means of an external mixing pipe which is inserted into the pump which, in action, allows the circulation in a closed circuit of the liquid taken from the bottom of said pocket, the pump being open so as to be able to insert and extract the mixing duct.
  • the container can of course be reusable.
  • the pocket and its conduit are for single use.
  • the collection of the liquid is carried out completely at the bottom of the bag by the liquid outlet orifice towards the outside of the bag. It then travels through the external mixing duct, moved by the pump. The return of the liquid inside the pocket is effected from above, and it opens on the upper surface of the liquid present in the pocket.
  • the outer mixing pipe is fixed by each of its ends to the surface of the pocket without a dip tube or comprises a short dip tube, with a length of less than 2 cm. , especially less than 1 cm.
  • the noninvasive pump is a peristaltic pump provided with a rotor that compresses the outer mixing duct with two or three pads and thus pushes the product with each rotation towards repression.
  • the set can work as follows:
  • the installation of the liquids to be mixed in the bag can be carried out by aseptic connection under a laminar airflow hood to the sources of these liquids, in particular by a single-use sterile connection device of the type for example KLEENPAK® Connector sold by the company PALL. Corporation and preferably when said pocket is in place in the container.
  • a single-use sterile connection device of the type for example KLEENPAK® Connector sold by the company PALL. Corporation and preferably when said pocket is in place in the container.
  • the term "container” designates for example a stainless steel container, generally parallelepipedal shape, preferably 304L or 316L stainless steel of parallelepipedal shape whose capacity is particularly adapted to that of the bag installed therein, and particularly a container of the type for example described in EP-A-1 012 073.
  • the container is advantageously provided with a metal carcass, especially particularly stainless steel.
  • the pump may be installed above or preferably below the pocket location.
  • the bottom of the container is provided with an elongate slot for insertion and passage of the mixing duct.
  • a particularly movable device parallel to the bottom of the container such as a flattened drawer is advantageously provided to partially close the slot, which allows to pass through the mixing duct while minimizing the free surface of the slot, and thus effectively support the bottom of the slot. poached.
  • the above container comprises one or two side doors to allow the installation of the pocket.
  • the above container is provided with a bottom wall movable horizontally, preferably removable in the manner of a drawer, provided with one or more, in particular two elongated slots.
  • the swinging door edges comprise a U-shaped vertical section, the openings facing each other, in which a profiled plate is slid and adjusted to hold the door leaves in closed position.
  • the central portion of this plate is preferably coplanar with the inner surface of the two doors.
  • the swinging edge of a side door comprises a door provided with closures cooperating with systems provided on the other side door to hold the door leaves in closed position .
  • the central portion of this door is preferably coplanar with the inner surface of the two doors of the container.
  • the swinging edges of two side doors comprise a U-shaped section the openings turning the back, in which is slipped a profiled and adjusted plate comprising two U-shaped returns. openings facing each other, to hold the door leaves in the closed position.
  • the central part of this plate is preferably coplanar with the two doors and advantageously forms a channel in which the mixing duct can be installed to protect it, preferably with the aid of a gate flap.
  • the protection of the mixing duct is integrated into a door of the container and preferably comprises a gate flap.
  • a cover such as that described in EP-A-1 012 073 may advantageously be provided above the bag.
  • the term "pocket” designates for example a container of flexible plastic material of generally parallelepipedal shape, preferably transparent in order to be able to visually observe the turbidity of the contents and particularly one of those described in EP-A-1 012 227.
  • Its capacity may range, for example, from 25 to 3000 liters, preferably from 50 to 1500 liters and particularly from 50 to 500 liters.
  • PE polyethylene
  • EVA vinyl acetate
  • PP polypropylene
  • It may comprise for example from 1 to 8, in particular from 1 to 4 welded or glued tubes on chimneys provided on the top of the pocket, one of the tubes being the above conduit and one or more, in particular 1 or 2 bungs of bottom, one of the bungs communicating with the conduit above.
  • the usable pump is of the non-invasive type.
  • a non-invasive pump is a pump acting on the circulation of a fluid without the pump being in contact with the fluid.
  • the usable pump is preferably a pump with several pump heads and particularly of the peristaltic type. Mention may be made, for example, of those sold by WATSON MARLOW, a 700 series company.
  • the conduit may be made for example of thermoplastic elastomer, preferably MARPRENE® and particularly platinum catalyzed silicone. Its internal diameter may advantageously be between 6 and 40 mm, preferably between 9 and 31 mm, especially between 12.70 and 19.10 mm.
  • the system according to the invention allows the mixing of liquids in a closed circuit.
  • the system of the invention eliminates any risk of cross-contamination between different batches.
  • the systems of the invention allow the preparation of cell culture media for transfer into a bio-reactor, by dissolving a mixture of powders in water for injections.
  • culture media of fetal calf serum for example to produce a medium containing 10% fetal calf serum and obtaining a homogenized mixture.
  • the adjustment of the pH or of the conductivity of a culture medium can also be mentioned by means of acidic, basic or saline solutions and homogenization of the mixture.
  • the mixtures are carried out under sterile conditions, whatever the stage of the process. biotechnological process, according to the requirements or recommendations of the regulatory authorities.
  • a traditional application is for example, in traditional pharmacy, the bulk pharmaceutical formulation of solutions of injectable products, in particular cytotoxic as anticancer, and their bulk storage before pharmaceutical distribution in their final unit packaging, for example in injectable ampoules.
  • Such an operation can be carried out thanks to the system according to the invention in a single step, or be split into two steps, first of all for the preparation of a concentrated solution, and then of dilution.
  • an application is for example, in parenteral nutrition, the preparation of mother batches of nutrient mixtures to be subsequently distributed in multiple administration pockets, from solutes or base suspensions such as amino acid solutions, glucose solutions, and / or lipid emulsions.
  • the closed systems for single use according to the invention are intended for mixing liquids.
  • the present application also relates to a compound mixing process, characterized in that a single-use disposable pouch is installed in a rigid container equipped with a non-invasive pump, the lower surface of which is the upper face are irremovably connected by means of a mixing pipe, the pipe is inserted into the pump, and the pump is actuated to create a closed circuit circulation of the liquid or liquids installed in the container for mix.
  • the pump gives the mixture a circulation rate of 6 to 1500. liters per minute, preferably 10 to 1000 liters per minute, especially 10 to 750 liters per minute.
  • the system of generally parallelepiped shape is arranged to create turbulence during recirculation through the conduit, which facilitates the mixing of the content.
  • FIG 1 there is a container 1 containing a single-use bag 2 of generally parallelepiped shape.
  • the lower face of the bag 2 comprises a liquid outlet orifice towards the outside of the bag, and the upper face comprises a liquid return orifice through which said liquid opens into the inside of the bag 2.
  • the two orifices of the pocket 2 are irremovably connected via a pipe 3 of mixing.
  • This irremovable conduit 3 mixture is functionally inserted in a pump 4 located above the pocket, and which, by its rotation, allows the flow of liquid, for example the bottom of the pocket to its top, according to the arrows shown.
  • a lateral opening of the container 1 is possible thanks to two doors 5, 6 allowing the lateral opening of the container 1. It is thus easy to insert the bag 2 with its irremovable conduit 3 into the container 1, and to insert the conduit 3 mixing in operational position in the pump 4.
  • Figure 2 is a variant of Figure 1, wherein the pump is installed below the bag instead of being installed above the bag as in Figure 1.
  • the doors 5, 6 of the container. have been represented in semi open position.
  • the bottom 7 is provided with an elongated slot 8 for insertion and passage of the immovable conduit 3 mixture.
  • FIG 3 there is a pocket 2 for carrying out the method according to the invention.
  • This pocket 2 for single use of the type for example described in EP-A-1 012 227 comprises in particular a bottom wall 10 which comprises a liquid outlet orifice to the outside of the pocket, and a top wall 11 which comprises a liquid return port in the pocket.
  • An irremovable conduit 3 mixture connects in fluid communication the outlet orifice and the return orifice formed on the top wall 11.
  • This conduit is of sufficient length to be inserted into a pump 4 forcing a liquid contained in the pocket 2 to circulate being drawn by the bottom 10 of the bag 2 to be returned to the pocket back by its top wall 11.
  • the external mixture duct 3 is fixed by each of its ends directly to the surface of the pocket without a dip tube.
  • the pocket 2 shown here further comprises in addition to the access door inside the pocket 12 on which is installed the immovable conduit 3 mixing, three other access doors inside the pocket, 13 , 14, 15 can be used in particular for the addition of various liquids to achieve a mixture.
  • the top magnifying glass is shown a variant in which a bypass 16 has been installed on the irremovable conduit 3 mixing.
  • the bottom magnifying glass illustrates a variant in which a bypass 17 has been installed at the bottom of the mixing duct 3.
  • Figure 4 which shows a container 1 according to the invention (without the pump) can be better distinguished an elongated slot 8 for the passage of an immovable conduit 3 mixture.
  • a drawer 20 allows to close the slot partially, to allow passage to the conduit 3 mixing and thus support the bottom of the pocket.
  • FIG. 5 shows a container 1 according to the invention provided with a removable bottom wall 10 in the manner of a drawer provided with two elongated slots 8.
  • FIG. 6 shows a closing detail of doors 5, 6 of a container 1 according to the invention.
  • the sleeping song of the doors 5,6 is conventional but the swinging songs comprise a U-shaped section, the openings facing each other, in which one slips a profiled plate and adjusted 21 to hold the door leaves 5.6 in the closed position.
  • the central portion 22 of this plate is coplanar with the two doors 5,6.
  • FIG. 7 shows a detail of another type of door closure 5, 6 of a container 1 according to the invention.
  • the side edge of the side door 5 is conventional and the swinging song comprises a gate 23 provided with closures cooperating with systems provided on the other door 6 to hold the doors of doors 5,6 of the container in the closed position.
  • the central portion 22 of this door 23 is coplanar with the two doors 5,6 of the container.
  • FIG 8 can be observed a detail of closing doors 5.6 of a container 1 according to the invention.
  • the sill of the doors 5.6 of the container is conventional but the swinging songs include a U-profile openings to the back, in which one slips a profiled plate and adjusted 24 to hold the door leaves 5.6 in the closed position .
  • the central portion 22 of this plate is coplanar with the two doors 5,6 and forms a channel in which the mixing duct 3 can be installed to protect it, with the aid of a gate flap.
  • the protection of the mixing duct 3 is integrated with the door 6 of the container and also comprises a door leaf.
  • Figures 10 and 11 illustrate how to close the bottom wall of the container on the pipe 3 mixing after installation of a pocket.
  • FIG. 12 illustrates a top view of a variant of FIG. 10, provided with particular door leaves 5, 6, shown in the closed position in FIG. 13.
  • FIG. 13 illustrates, in a view from above, in particular the closing of the bottom slot 8 of the container, after passage and installation of the irremovable duct 3 (not shown), by means of a rotary guillotine closure system 27, as well as the closing the front face of the container, after passage of the immovable duct 3, by means of a U-shaped section 24 slid between the door leaves, according to the embodiment of Figure 8.
  • the non-removable conduit 3 crosses the plane of this figure in two places, namely the bottom plate 7 (conduit not shown) and the central space of the closure profile 24 (conduit 3 shown).

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Catching Or Destruction (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Package Specialized In Special Use (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
EP04767543A 2003-07-04 2004-07-01 Systeme clos a usage unique de melange, de stockage et d'homogeneisation de liquides en conditions propres ou steriles Expired - Lifetime EP1644105B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL04767543T PL1644105T3 (pl) 2003-07-04 2004-07-01 Zamknięty system jednorazowego użytku do mieszania, magazynowania i homogenizacji płynów w czystych albo sterylnych warunkach

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0308203A FR2856940B1 (fr) 2003-07-04 2003-07-04 Systeme clos a usage unique de melange, de stockage et d'homogeneisation de liquides en conditions propres ou steriles
PCT/FR2004/001700 WO2005011852A1 (fr) 2003-07-04 2004-07-01 Systeme clos a usage unique de melange, de stockage et d’homogeneisation de liquides en conditions propres ou steriles

Publications (2)

Publication Number Publication Date
EP1644105A1 EP1644105A1 (fr) 2006-04-12
EP1644105B1 true EP1644105B1 (fr) 2007-01-31

Family

ID=33522774

Family Applications (1)

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EP04767543A Expired - Lifetime EP1644105B1 (fr) 2003-07-04 2004-07-01 Systeme clos a usage unique de melange, de stockage et d'homogeneisation de liquides en conditions propres ou steriles

Country Status (17)

Country Link
US (1) US7784997B2 (ja)
EP (1) EP1644105B1 (ja)
JP (1) JP4177411B2 (ja)
KR (1) KR20060131717A (ja)
CN (1) CN100421774C (ja)
AT (1) ATE353028T1 (ja)
AU (1) AU2004261432A1 (ja)
BR (1) BRPI0412191A (ja)
CA (1) CA2531124A1 (ja)
DE (1) DE602004004592T2 (ja)
DK (1) DK1644105T3 (ja)
ES (1) ES2279432T3 (ja)
FR (1) FR2856940B1 (ja)
NO (1) NO20056177L (ja)
PL (1) PL1644105T3 (ja)
PT (1) PT1644105E (ja)
WO (1) WO2005011852A1 (ja)

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FR2856940B1 (fr) * 2003-07-04 2007-02-09 Stedim Sa Systeme clos a usage unique de melange, de stockage et d'homogeneisation de liquides en conditions propres ou steriles
US7326355B2 (en) * 2004-03-31 2008-02-05 Hyclone Laboratories, Inc. Mobile filtration facility and methods of use
US7810674B2 (en) * 2005-07-26 2010-10-12 Millipore Corporation Liquid dispensing system with enhanced mixing
US7950547B2 (en) * 2006-01-12 2011-05-31 Millipore Corporation Reservoir for liquid dispensing system with enhanced mixing
JP4955289B2 (ja) * 2006-03-16 2012-06-20 日立アロカメディカル株式会社 水薬調剤装置
US9090398B2 (en) 2007-05-04 2015-07-28 Emd Millipore Corporation Disposable processing bag with alignment feature
EP2103547B1 (en) * 2008-03-22 2013-03-20 Pall Corporation Biocontainer
EP2103548B1 (en) * 2008-03-22 2014-10-01 Pall Corporation System comprising a tote and a flexible container
US7740212B2 (en) * 2008-04-17 2010-06-22 ConeCraft, Inc, Apparatus to retain and position tubing of media bags
US20100122992A1 (en) 2008-11-14 2010-05-20 Veltek Associates, Inc. Apparatus and method for mixing and dispensing
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PL2593943T3 (pl) * 2010-07-15 2015-03-31 Mallinckrodt Nuclear Medicine Llc Dozownik zawiesiny do wytwarzania izotopów promieniotwórczych
DE102011106162B3 (de) * 2011-06-30 2012-09-13 Sartorius Stedim Biotech Gmbh Bioreaktorbehälter und Integritätsprüfungsverfahren für Bioreaktorbehälter
CN103906503B (zh) * 2011-11-04 2016-12-14 日东电工株式会社 用于无菌制备脂质-核酸颗粒的单次使用系统
EP2825299B1 (en) * 2012-03-16 2020-01-22 GE Healthcare Bio-Sciences AB Mixing system
US8979357B1 (en) 2014-03-17 2015-03-17 Advanced Scientifics, Inc. Transportable mixing system for biological and pharmaceutical materials
BR112018014583A2 (pt) * 2016-01-22 2018-12-11 Saint Gobain Performance Plastics Corp sistema de mistura de fluidos
FR3087659B1 (fr) * 2018-10-25 2021-03-05 Ferring Bv Dispositif miniaturise de fabrication automatisee de compositions pharmaceutiques, et procede associes
EP4247529A1 (en) 2021-11-03 2023-09-27 Leon-Nanodrugs GmbH Apparatus and method for mixing small liquid volumes, and use of the apparatus
WO2024069014A1 (en) 2022-09-30 2024-04-04 Leon-Nanodrugs Gmbh Apparatus and method for operating a static mixing device
WO2024069012A1 (en) 2022-09-30 2024-04-04 Leon-Nanodrugs Gmbh Cassette system for aseptic mixing process

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Also Published As

Publication number Publication date
WO2005011852A1 (fr) 2005-02-10
DK1644105T3 (da) 2007-06-04
FR2856940A1 (fr) 2005-01-07
CN100421774C (zh) 2008-10-01
NO20056177L (no) 2006-03-22
AU2004261432A1 (en) 2005-02-10
US7784997B2 (en) 2010-08-31
CA2531124A1 (fr) 2005-02-10
DE602004004592D1 (de) 2007-03-22
CN1812829A (zh) 2006-08-02
KR20060131717A (ko) 2006-12-20
JP4177411B2 (ja) 2008-11-05
EP1644105A1 (fr) 2006-04-12
PL1644105T3 (pl) 2007-04-30
PT1644105E (pt) 2007-05-31
FR2856940B1 (fr) 2007-02-09
US20070064519A1 (en) 2007-03-22
ATE353028T1 (de) 2007-02-15
ES2279432T3 (es) 2007-08-16
DE602004004592T2 (de) 2007-11-15
BRPI0412191A (pt) 2006-08-22
JP2007527306A (ja) 2007-09-27

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