EP1067089B1 - Verfahren zum Umfüllen von aseptischen Produkten zwischen zwei Behältnissen und Transportbehälter zur Ausführung des Verfahrens - Google Patents

Verfahren zum Umfüllen von aseptischen Produkten zwischen zwei Behältnissen und Transportbehälter zur Ausführung des Verfahrens Download PDF

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Publication number
EP1067089B1
EP1067089B1 EP00401901A EP00401901A EP1067089B1 EP 1067089 B1 EP1067089 B1 EP 1067089B1 EP 00401901 A EP00401901 A EP 00401901A EP 00401901 A EP00401901 A EP 00401901A EP 1067089 B1 EP1067089 B1 EP 1067089B1
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EP
European Patent Office
Prior art keywords
container
enclosure
interface
door
seal
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
EP00401901A
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English (en)
French (fr)
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EP1067089A1 (de
Inventor
Jean-Pierre Brossard
Philippe Fontcuberta
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.)
Getinge Life Science France SAS
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La Calhene SA
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Filing date
Publication date
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Publication of EP1067089A1 publication Critical patent/EP1067089A1/de
Application granted granted Critical
Publication of EP1067089B1 publication Critical patent/EP1067089B1/de
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67D—DISPENSING, DELIVERING OR TRANSFERRING LIQUIDS, NOT OTHERWISE PROVIDED FOR
    • B67D7/00—Apparatus or devices for transferring liquids from bulk storage containers or reservoirs into vehicles or into portable containers, e.g. for retail sale purposes
    • B67D7/02—Apparatus or devices for transferring liquids from bulk storage containers or reservoirs into vehicles or into portable containers, e.g. for retail sale purposes for transferring liquids other than fuel or lubricants
    • 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
    • B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67C—CLEANING, FILLING WITH LIQUIDS OR SEMILIQUIDS, OR EMPTYING, OF BOTTLES, JARS, CANS, CASKS, BARRELS, OR SIMILAR CONTAINERS, NOT OTHERWISE PROVIDED FOR; FUNNELS
    • B67C7/00—Concurrent cleaning, filling, and closing of bottles; Processes or devices for at least two of these operations
    • B67C7/0073—Sterilising, aseptic filling and closing

Definitions

  • the invention relates to a transfer method aseptic products between two enclosures such that a production enclosure and an enclosure of use of these products.
  • infectious products means here, as in the rest of the text, any type of sterile or quality products microbiological that we do not want to degrade by a external contamination, whatever their state (liquid, gaseous, solid, powder, etc.) and what whatever their nature (food products, pharmaceutical, cosmetic, packaging components, etc.).
  • the invention also relates to a container for transport of aseptic products, designed to implements such a transfer process.
  • containers with a unique interface for both filling and filling emptying.
  • some containers have two separate accesses assigned respectively to filling and emptying.
  • transport containers have flexible walls and they are placed in rigid boxes when filling and transport.
  • containers including semi-rigid walls have resistance mechanical enough that they don't need to be placed in crates.
  • a first solution proposed by the company TETRA PAK (Registered trademark) under the name "Tetra StarAsept "(registered trademark), consists in equipping a flexible pocket container with a rigid sleeve delimiting an access opening.
  • the rigid sleeve is linked to a wall of the container and normally closed by a plug carried by the wall opposite this same container.
  • To fill the sleeve is approached on an opening made in a production enclosure and initially closed by a plug.
  • the intermediate volume between the two caps is sterilized by a flow of steam. We open then the two plugs so as to fill the container. New steam sterilization of the next to the top of the container, before it closes.
  • ASTEPO offers an installation of aseptic filling using a principle similar to the device proposed by the company TETRA PAK. This installation has the same disadvantages as the previous.
  • the subject of the invention is precisely a process for transferring aseptic products between two enclosures, whose original design allows it practically avoid any deterioration in quality microbiological products, using a container particularly simple and inexpensive transport Disposable.
  • the term "flexible” should be taken in its broadest sense, as designating any pipe, conduit, sleeve, etc., flexible or articulated, capable of being folded up inside the container during transport and to be deployed in the enclosure to allow the passage of the products to be transferred, without them being in contact with the sealed connection area of the container and enclosure.
  • the transport container is emptied by a different interface from the one used for its filling. Furthermore, since each of the interfaces has a flexible through which products are transferred, these products are never in contact with decontaminated walls during sterilization closed volume. Thanks to these combined features, any degradation, by external contamination, of the microbiological quality of the transferred products becomes practically impossible. In the case of products food, a new pasteurization on the spot of use is therefore no longer necessary, which leads to a significant improvement in quality taste of these products. In addition, in the case of transfer of aseptic components, we avoid new decontamination which is generally difficult and expensive.
  • each of the airlock enclosures provided with sterilization means and normally separated from the interior of the enclosure by the corresponding door, and we connect the interface corresponding of the container on this airlock, to delimit the enclosed volume inside of it.
  • the sterilizer is advantageously sterilized. closed volume by implementing means of pulsed light sterilization, placed around a transparent tube defining this closed volume.
  • shutters with the side facing the outside of the container is reflective.
  • each airlock is advantageously connected to the corresponding enclosure via a sealed transfer device with double door materializing the corresponding door.
  • tear-away shutters which can be cut from the interior of the corresponding enclosure, after having opened the door of this enclosure.
  • the subject of the invention is also a container for transporting aseptic products between a first enclosure and a second enclosure, this container comprising a filling interface and a drain interface, both comprising a opening normally closed by a shutter, characterized in that each of the interfaces of filling and emptying additionally includes a hose initially closed, tightly connected to the corresponding opening, inside the container, the filling interface hose being suitable for be closed after opening.
  • the flexible interface of the filling is provided with a valve means, allowing to close it after opening.
  • the container comprises a flexible wall in which the filling interface is integrated and the drain interface.
  • Each of the interfaces can then be delimited either by an elastic part of the wall, either by a semi-rigid part of the wall.
  • the reference 10 designates generally a sterile transport container according to the invention.
  • the dimensions and shape of this container 10 can be any and depend essentially the intended application, in particular the nature of the aseptic products that one desires to transfer.
  • the cubic shape illustrated in Figure 1 is therefore only given as an example and should not be seen as limiting the scope of the invention.
  • the container 10 comprises a sealed wall 12, internally delimiting a closed volume 14. Nature and the characteristics of the material constituting the wall 12 can be any.
  • the wall 12 is a flexible wall. In this case, the container 10 must be placed inside a rigid box (not shown) when filling and transport.
  • the container 10 is equipped with two access ports constituted by a filling interface 16 and a drainage interface 18.
  • the filling interface 16 is preferably placed on an upper face of the wall 12 of the container 10.
  • the drain interface 16 can be placed at the bottom of a lateral face of the wall 12, as illustrated in Figure 1, or on the face top of this wall, next to the interface of filling 16.
  • emptying the container is made by gravity
  • the second case concerns a container whose emptying is done by pumping (in the case of a liquid or powder product).
  • each of interfaces 16 and 18 includes an opening 20, generally shaped circular, delimited by a part 22, elastic or semi-rigid, from the wall 12 of the container.
  • the opening 20 is normally closed by a shutter 24 produced in a material capable of being torn or cut, as we will see later. When the shutters 24 are intact they close the openings 20 tightly.
  • each of shutters 24 is coated with a reflective material, on its face facing the outside of the container 10.
  • Each of interfaces 16 and 18 includes also, inside the container 10, a flexible 26.
  • This flexible hose 26 is tightly connected by a cuff 28, at part 22 of the flexible wall of the container, delimiting the opening 20.
  • the flexible 26 In its part located between the cuff 28 and the shutter 24, the flexible 26 includes sealing means 30, 30 ' closed when container 10 has not yet been used, as well as a possibly extendable part 32.
  • sealing means 30 which equip the flexible 26 interface of filling 16 must be closed after they open. Therefore, these means shutter are advantageously constituted by valve means such as a valve integrated in the hose or a clamp that can be placed on a flexible part of the hose, to ensure the closing by elastic deformation or by welding.
  • the closing means 30 which equip the drain interface 18 do not need to be closed after opening. So they can be constituted in the same way as the means shutter 30 of the filling interface 16, or simply by an initially closed end of the flexible, able to be cut or perforated.
  • the assembly formed here by the flexible 26 and by cuff 28 can take very forms different from those shown in the figure 1, depending on the type of product you want to transfer. So the small diameter hose illustrated in Figure 1, suitable for the transfer of fluid products, will be replaced by one more flexible large diameter in case the products to be transferred are solid products such as components packaging. In this case, the sleeve 28 can even be removed and the hose 26 connected directly to the part 22 of wall 12.
  • FIG 1 there is also shown a part of a first enclosure 34, constituted by example by a product production enclosure at transfer, on which the container 10 can be connected by its filling interface 16.
  • an airlock of sterilization 44 is mounted on the access port as well formed on the enclosure 34, outside of the latter.
  • the airlock 44 comprises at one from its ends a flange 46 which delimits internally a circular opening 48, normally tightly closed by a door 50.
  • the end opposite of airlock 44 is open and dimensioned in such a way so that part 22 of the fill interface 16 container 10 can be connected to it so waterproof. This can be obtained either by a deformation elastic of part 22, when it is elastic, either by an interlocking of this part on or in the corresponding end of the airlock 44, when it is semi-rigid.
  • the flanges 40 and 46 and the doors 40 and 52 form a device well known double door waterproof transfer technical specialists.
  • the connection of the flange 46 on the flange 40 and the connection of door 50 to door 42 are carried out simultaneously by systems with bayonet. Doors 42 and 50 then form a double door, can be opened from inside the enclosure 34.
  • This device connection is also characterized by the use of annular seals 45, 47 of triangular section, which effectively protect them from contamination surfaces of openings 38 and 48.
  • the airlock 44 is internally delimited by a transparent tube 52, around which are regularly distributed lamps 54, materializing means of pulsed light sterilization. These lamps 54 are surrounded by a protective cover 56.
  • the assembly which has just been described constitutes an interface 57, by which products produced or stored in enclosure 34 can be transferred to inside the container 10, by its interface filling 16, without risk of contamination of these products.
  • the process of transfer according to the invention also implements a second enclosure 58 ( Figures 2C and 2D) called "enclosure
  • This second enclosure 58 is equipped an interface 59 on which the drain interface 18 of container 10 can be connected, to ensure the transfer of products to the enclosure of use.
  • the interface 59 equipping this latter enclosure 58 is, preferably identical or similar to interface 57 which equips the production enclosure 34. Consequently, no detailed description will be given and the comparable elements of the two interfaces 57 and 59 will be designated later by the same numbers reference.
  • a sterilization airlock 44 is connected to the production enclosure 34 (FIG. 2A) and an identical sterilization airlock 44 is connected to the use enclosure 58 (FIG. 2C) as we have previously described with reference to Figure 1.
  • the interior volume 43 of the enclosure 34 and the interior volume 61 of the enclosure 58 and the internal components are sterilized. It goes without saying that the operations concerning the production enclosure and the enclosure of use are carried out completely dissociated, especially when the distance between these pregnant is very important.
  • the closed volume 62 is then sterilized then defined inside the airlock 44, between the shutter 24 the filling interface 16 and the double door 42, 50 separating the airlock 44 from the closed volume 43.
  • the sterilization means are used materialized by the lamps 54 which equip the airlock 44.
  • the reflecting external surface of the cover 24 improves the quality of sterilization of the closed volume 62.
  • the handling means 64 are used for this purpose. that equip this enclosure.
  • the operator opens the shutter 24, by tearing or cutting, from inside the production area 34.
  • the operator opens the closing means 30 which equip the flexible 26, so as to introduce the product to be transferred, such as liquid L, into the container 10.
  • the operator closes the shutter means 30, then disconnect the hose 26 from the delivery tube 66 of the product.
  • the double door materialized by doors 42 and 50 is then replaced and part 22 of the interface 16 of the container 10 is disconnected from the open end of the airlock 44. Transporting the container 10 to the place of use of the liquid L can then be carried out, for example in the cash register 60.
  • part 22 of the interface drain 18 is tightly connected to the open end of the airlock 44 which equips the second use enclosure 58.
  • the volume is then sterilized closed 62 delimited inside airlock 44, between the shutter 24 of the drain interface 18 and the double door 42, 50 separating the airlock from the second enclosure 58.
  • the lamps 54 are used forming the sterilization means which equip the airlock 44.
  • the next operation (figure 2D) consists in tightly connect the end of the hose 26 equipping the drain interface 18 to a system for internal use in enclosure 58, such as system capable of delivering liquid L to packages distribution 70 placed in enclosure 58.
  • the container 10 After opening the sealing means 30 ' equipping the hose 26 with the drain interface 18, the container 10 is emptied, on request, within packaging 70.
  • the container emptying interface is separate from its filling interface and by the fact that the product is transferred, both during filling only when emptying, without ever being at direct contact with walls likely to be contaminated by the outside atmosphere.
  • the invention is not limited to embodiment which has just been described as example.
  • the nature of the products transferred can be arbitrary and determines the form and the dimensions of the container.
  • the pulsed light sterilization technique is particularly advantageous, other means of sterilization of enclosed volumes trapped between container shutters and enclosure doors can be used.
  • these other processes cite in particular sterilization techniques or chemical decontamination, by vapor flow, by plasma, etc.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Basic Packing Technique (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Branching, Merging, And Special Transfer Between Conveyors (AREA)
  • Supplying Of Containers To The Packaging Station (AREA)
  • Closing Of Containers (AREA)
  • Auxiliary Devices For And Details Of Packaging Control (AREA)

Claims (13)

  1. Verfahren zur Übertragung bzw. zum Transport von aseptischen Produkten (L) zwischen einem ersten Gehäuse (34) und einem zweiten Gehäuse (58), die beide mit einer normalerweise geschlossenen Tür (42,50) versehen sind, wobei eine erste Übertragung der Produkte von dem ersten Gehäuse (34) in einen sterilen Behälter (10) über eine Füll-Schnittstelle (16) desselben, die mit einem Verschlusselement (24) versehen ist, ausgeführt wird, der Behälter (10) zu dem zweiten Gehäuse (58) transportiert wird und eine zweite Übertragung der Produkte des Behälters (10) in das zweite Gehäuse (58) über eine mit einem Verschlusselement (24) versehene Auslaß-Schnittstelle (18) des Behälters ausgeführt wird, wobei das Verfahren dadurch gekennzeichnet ist, daß vor dem Ausführen jeder der ersten und zweiten Übertragungen:
    die betreffenden Schnittstellen (16 bzw. 18) und Gehäuse (34 bzw. 58) auf abdichtende Weise verbunden werden,
    ein geschlossenes Volumen 62, das zwischen der betreffenden Tür (42,50) und dem Verschlusselement (24) festgelegt ist, sterilisiert wird,
    die betreffende Tür (42,50) und das Verschlusselement (24) geöffnet werden,
    an das betreffende Gehäuse (34,58) ein anfänglich geschlossener, im Innern des Behälters (10) befindlicher und mit diesem auf abdichtende Weise um das betreffende Verschlusselement (24) herum verbundener, flexibler Schlauch (26) angeschlossen wird, und
    der flexible Schlauch (26) geöffnet wird,
    ferner dadurch gekennzeichnet, daß nach Ausführen der ersten Übertragung der der Füll-Schnittstelle (16) zugeordnete flexible Schlauch (26) wieder geschlossen wird.
  2. Verfahren nach Anspruch 1, wobei jedes der Gehäuse (34,58) außen mit einer mit Sterilisationsmitteln (54) versehenen und normalerweise vom Innern des Gehäuses durch die Tür (42,50) getrennte Schleuse ausgestattet ist und die betreffende Schnittstelle (16,18) des Behälters (10) mit der Schleuse verbunden wird, um das geschlossene Volumen (52) im Innern desselben festzulegen.
  3. Verfahren nach Anspruch 2, wobei das geschlossene Volumen (62) sterilisiert wird, indem Sterilisationsmittel (54) mit gepulstem Licht, die um ein transparentes, das geschlossene Volumen festlegendes Rohr herum plaziert sind, eingesetzt werden.
  4. Verfahren nach Anspruch 3, wobei Verschlusselement (24) verwendet werden, deren zur Außenseite des Behälters (10) gewandte Seite reflektierend ist.
  5. Verfahren nach einem der Ansprüche 2 bis 4, wobei jede Schleuse (44) an dem betreffenden Gehäuse (34,58) über eine dichte Übertragungsvorrichtung, die mit einer die Tür (42,50) bildende Doppeltür versehen ist, angeschlossen wird.
  6. Verfahren nach einem der vorangehenden Ansprüche, wobei zerreißbare Verschlusselement (24) verwendet werden, die vom Innern des betreffenden Gehäuses (34,58) aus nach Öffnen der Tür (42,50) dieses Gehäuses aufgeschnitten werden.
  7. Behälter zum Transport aseptischer Produkte zwischen einem ersten Gehäuse (34) und einem zweiten Gehäuse (58), wobei dieser Behälter (10) eine Füll-Schnittstelle (16) und eine Auslaß-Schnittstelle (18) umfaßt, die beide eine Öffnung (20) aufweisen, welche normalerweise von einem Verschlusselement (24) geschlossen ist, dadurch gekennzeichnet, daß jede der Füll-Schnittstellen (16) und Auslaß-Schnittstellen (18) außerdem einen anfänglich geschlossenen, abdichtend mit der betreffenden Öffnung (20) im Innern des Behälters verbundenen flexiblen Schlauch (26) aufweist, und der flexible Schlauch (26) der Füll-Schnittstelle (16) nach dem Öffnen wieder geschlossen werden kann.
  8. Behälter nach Anspruch 7, wobei jeder Verschlusselement (24) zerreißbar ist.
  9. Behälter nach einem der Ansprüche 7 oder 8, wobei jeder Verschlusselement (24) eine zur Außenseite des Behälters gewandte reflektierende Seite aufweist.
  10. Behälter nach einem der Ansprüche 7 bis 9, wobei der flexible Schlauch (26) der Füll-Schnittstelle (16) mit einem ein Ventil (30) bildenden Mittel versehen ist.
  11. Behälter nach einem der Ansprüche 7 bis 10, mit einer nachgiebigen Wand (12), in der die Füll-Schnittstelle (16) und die Auslaß-Schnittstelle (18) integriert sind.
  12. Behälter nach Anspruch 11, wobei die Öffnung (20) jeder Schnittstelle von einem elastischen Teil (22) der Wand (12) festgelegt ist.
  13. Behälter nach Anspruch 11, wobei die Öffnung (20) jeder Schnittstelle von einem halb-starren Teil (22) der Wand (12) festgelegt ist.
EP00401901A 1999-07-07 2000-07-03 Verfahren zum Umfüllen von aseptischen Produkten zwischen zwei Behältnissen und Transportbehälter zur Ausführung des Verfahrens Expired - Lifetime EP1067089B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9908781 1999-07-07
FR9908781A FR2796040B1 (fr) 1999-07-07 1999-07-07 Procede de transfert de produits aseptiques entre deux enceintes et conteneur de transport pour la mise en oeuvre de ce procede

Publications (2)

Publication Number Publication Date
EP1067089A1 EP1067089A1 (de) 2001-01-10
EP1067089B1 true EP1067089B1 (de) 2002-12-18

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EP00401901A Expired - Lifetime EP1067089B1 (de) 1999-07-07 2000-07-03 Verfahren zum Umfüllen von aseptischen Produkten zwischen zwei Behältnissen und Transportbehälter zur Ausführung des Verfahrens

Country Status (8)

Country Link
US (1) US6357488B1 (de)
EP (1) EP1067089B1 (de)
JP (1) JP2001055207A (de)
AT (1) ATE229918T1 (de)
CA (1) CA2314158C (de)
DE (1) DE60001020T2 (de)
DK (1) DK1067089T3 (de)
FR (1) FR2796040B1 (de)

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JP2003111579A (ja) * 2001-07-31 2003-04-15 Asahi Soft Drinks Co Ltd 密閉容器入り飲料の製造方法及び製造装置
ATE437829T1 (de) * 2004-05-04 2009-08-15 Netzhammer Eric Transportbehälter für sterile produkte
FR2907769B1 (fr) * 2006-10-31 2009-02-06 Maco Pharma Sa Recipient equipe d'un systeme de transfert aseptique
US8596316B2 (en) * 2006-12-15 2013-12-03 Gea Pharma Systems Ag Coupling closure, and docking device comprising two of said coupling closures
DE102007060131A1 (de) * 2007-12-13 2009-06-25 Technische Universität Dresden Verfahren und Vorrichtung zum luftfreien Befüllen von Gefäßanschlüssen im Medizinbereich
DE102008049129A1 (de) * 2008-09-26 2010-04-08 Gea Niro Gmbh Kupplungsverschluss sowie Befestigungsmodul und Andockeinrichtung, jeweils enthaltend diesen Kupplungsverschluss
US8887365B2 (en) * 2009-09-24 2014-11-18 Delaware Capital Formation, Inc. Glove port retrofit assembly and method of replacing components
FR2956092B1 (fr) * 2010-02-10 2012-02-24 Sartorius Stedim Biotech Sa Procede et unite d'emplissage sterile d'un conteneur elementaire final avec un contenu destine au domaine biopharmaceutique.
DE102011100560B3 (de) * 2011-05-05 2012-03-15 Leibinger Smb Technik Gmbh Vorrichtung zum Befüllen eines Behältnisses mit einer zum Verzehr bestimmten Flüssigkeit
US10059476B2 (en) * 2013-05-21 2018-08-28 John Bean Technologies S.P.A. Aseptic filler for flowable products
US20140377418A1 (en) * 2013-06-21 2014-12-25 Noble House, LLC Method and Apparatus for Hub and Spoke Aseptic Processing
FR3016794B1 (fr) 2014-01-24 2018-03-02 Pierre Fabre Dermo-Cosmetique Dispositif et procede pour le transfert d'un produit sterile entre deux conteneurs
CN109675079A (zh) * 2018-12-19 2019-04-26 郑琼华 无菌室输送物品机构及无菌室输送物品方法

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US4494363A (en) * 1982-08-20 1985-01-22 Franrica Mfg. Inc. Method and apparatus for aseptically filling containers
US4840017A (en) * 1987-08-03 1989-06-20 Baxter Healthcare Corporation Method for filling collapsible containers
US5289858A (en) * 1991-12-18 1994-03-01 Abbott Laboratories System for accommodating withdrawal of liquid from a bulk supply
US5858016A (en) * 1992-07-14 1999-01-12 Baxter International Inc. Sterile/aseptic connector
US5479955A (en) * 1994-05-31 1996-01-02 Spartanburg Steel Products, Inc. Method and apparatus for aseptically filling containers
US5799830A (en) * 1996-11-08 1998-09-01 Carroll; David C. Pressure vessel access port

Also Published As

Publication number Publication date
DK1067089T3 (da) 2003-03-31
US6357488B1 (en) 2002-03-19
EP1067089A1 (de) 2001-01-10
CA2314158A1 (fr) 2001-01-07
DE60001020T2 (de) 2003-09-25
ATE229918T1 (de) 2003-01-15
FR2796040B1 (fr) 2001-10-19
JP2001055207A (ja) 2001-02-27
FR2796040A1 (fr) 2001-01-12
DE60001020D1 (de) 2003-01-30
CA2314158C (fr) 2007-03-13

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