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EP2193086B1 - Flexibler transportbehälter und herstellungsverfahren dafür - Google Patents

Flexibler transportbehälter und herstellungsverfahren dafür Download PDF

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Publication number
EP2193086B1
EP2193086B1 EP08805564A EP08805564A EP2193086B1 EP 2193086 B1 EP2193086 B1 EP 2193086B1 EP 08805564 A EP08805564 A EP 08805564A EP 08805564 A EP08805564 A EP 08805564A EP 2193086 B1 EP2193086 B1 EP 2193086B1
Authority
EP
European Patent Office
Prior art keywords
bag
sheath
bags
door
inner bag
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.)
Active
Application number
EP08805564A
Other languages
English (en)
French (fr)
Other versions
EP2193086A2 (de
Inventor
Stéphanie Armau
Cedric Lambert
Mathieu Labedan
Bernard Saint Martin
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 Aseptics SAS
Original Assignee
Sartorius Stedim Aseptics SAS
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 Sartorius Stedim Aseptics SAS filed Critical Sartorius Stedim Aseptics SAS
Publication of EP2193086A2 publication Critical patent/EP2193086A2/de
Application granted granted Critical
Publication of EP2193086B1 publication Critical patent/EP2193086B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
    • B65D31/04—Bags or like containers made of paper and having structural provision for thickness of contents with multiple walls
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5861—Spouts
    • B65D75/5866—Integral spouts

Definitions

  • the invention relates to a flexible container, in practice disposable for sterile applications, adapted to be used in particular for transfers of products or small equipment such as piston seals or bottle caps and a manufacturing process of such a flexible container.
  • a sealed junction device between two isolated enclosures of an external medium and a disposable enclosure adapted to be implemented in such a device.
  • a disposable enclosure is in principle mobile, while the other enclosure may be a larger and heavier enclosure, for example a sterilization chamber or a reactor.
  • These enclosures are each provided with an opening provided with a flange normally closed by a door, and the sealed junction between these enclosures implements the joint operation of the two doors. These two doors are preferably for single use.
  • these single-use enclosures also called single-use containers, generally consist of the combination of a rigid door (or cover) and a flexible plastic bag (or bag), most often transparent.
  • Such single-use containers can be used to transfer all kinds of products, liquid, solid or powder, to more massive speakers (or even from them).
  • these single-use containers When these single-use containers are intended for the transfer of products or small equipment, they may also comprise a second door, of the same type as the first, so as to allow the entry of products or equipment by one of the doors, and the exit of the products or materials by the other of these doors.
  • the document GB 2354 754 Decuted a flexible transfer container with two access doors.
  • such containers allow the application of a treatment products or materials contained therein, for example a sterilization treatment.
  • This sterilization can be performed by steam, by gamma or beta radiation.
  • Such sterilization can be especially provided when the containers are used for the transfer of small equipment, such as piston seals, plugs, needle shields, etc. which are intended to be in direct contact with injectables.
  • the films constitute not only barriers to microorganisms but also barriers to water vapor (especially in the case of lyophilizates) and so on. It should be noted that, by way of example, these controls are not satisfied when the films are made of a thin-fiber material made of high-density polyethylene known under the trademark "TYVEK” ® from DUPONT, allowing for sterilization with steam.
  • TYVEK high-density polyethylene
  • the controls on the manufacturing steps are more severe.
  • the welds are no longer simply visually inspected, but also undergo sealing tests, methylene blue for example, pressure resistance tests, elongation tests, etc.
  • any intervention is necessarily a source of contamination, reducing the quality of the sheath in question. It follows that the mounting of one or more doors in a sheath initially having a high level of cleanliness in principle implies a deterioration of this level of cleanliness.
  • the object of the invention is to obtain, with a high level of cleanliness, a flexible single-use container provided with two access doors which are in principle only used, intended respectively for an inlet and an outlet of products or materials, while allowing the application of treatments such as sterilization treatment.
  • the invention proposes for this purpose a flexible transfer container comprising an inner bag formed of a flat sleeve closed at one end and whose other end is folded towards the first end, this inner bag being included in an outer bag formed a sheath provided with a first access door passing through the wall of the two bags, near the closed end of the inner bag and a second access door passing through only the wall of the outer bag, opposite a portion of the folded end of the inner bag.
  • the container of the invention comprises an inner bag which houses the products (or materials), and an outer bag in which the inner bag is included.
  • the invention furthermore proposes a method of manufacturing such a container, namely a method of manufacturing a container of the aforementioned type, according to which a first flat duct is produced, leaving there, near a first end. , a hole passing through a single wall of this sheath and by folding the other end, a ring is slid inside this sheath from the first end so as to pass through this hole, a second sheath is also made in which two holes are made, is engaged in one of the holes a first access door and another door is engaged in the other hole, the first door being, after introduction of the inner bag into the outer bag, connected by snapping to the ring while the second door is facing the folded end of the first sheath.
  • FIGS. 1 to 5 represent steps for manufacturing a container according to the invention: this container, denoted 1 as a whole, comprises an internal bag 10, completely included in an outer bag 20.
  • the inner bag 10 is made from a flexible sheath 11 of completely flattened shape (its wall thus forms two superposed layers and in contact with one another so as to minimize the internal volume of this sheath), which is sectioned so as to have first and second ends.
  • One of the ends, noted 12, is left intact while the other end is here modified, by shrinking, for example by welding since the outside, so as to form a horn, noted 13, of smaller section than the other end.
  • a hole 14 is formed in the upper layer of the wall of the inner bag, near the first end, for example by means of a punch (see figure 1 ).
  • a rigid ring 15 is then (see figure 2 ) is slid into the sheath from the first end 12, until it comes to fit in the hole 14.
  • This ring is for example made of rigid plastic material, obtained by injection under conditions of high cleanliness.
  • this setting operation of the ring is the only one that is likely to allow to degrade the cleanliness of the interior of the inner bag since it involves opening the sheath between the end 12 and the hole 14 (this action to open the sheath is exaggerated on the figure 2 , by analogy with the figure 1 ).
  • this action to open the sheath is exaggerated on the figure 2 , by analogy with the figure 1 ).
  • such a degradation is insignificant since this preparation is carried out in clean room.
  • the outer bag 20 is formed of a sheath, in practice slightly wider than the sheath 11, so as to allow easy introduction of the sheath 11.
  • This outer bag 20 is here obtained by simply cutting a flexible tube, and its two ends 21 and 22 are here open (see figure 3 ).
  • This external bag has two holes, one of which, 23, is adapted to come opposite the hole 14 of the inner bag, and comprises an access door 25, cooperating with a hoop 24 cooperating with the access door so as to sandwich the periphery of the hole 23.
  • This door 25 is adapted to cooperate, here by snapping, with the rigid ring 15 (see below about the figure 4 ) and thus ensure a connection between the two bags.
  • the other hole 26, intended to come opposite the horn, is provided with an access door 27, in practice identical to the access door 25.
  • access doors 25 and 27 are advantageously disposable, as is for example described in the document EP - 0 688 020 Cited above. It will be understood that, by the concept of access door, here means the combination of a fixed flange with respect to at least one of the bags and a movable shutter adapted to seal, or not, the formed opening in the flange.
  • the first access door 25 is for loading products or small equipment while the second access door 27 is intended for unloading these products or small equipment, via the horn.
  • This outer bag can be prepared in less clean conditions than the inner bag.
  • the container manufacturer can then introduce the inner bag, after folding the trunk, dragging the assembly and folded; the door 25 is then snapped onto the rigid ring 15 (see Figures 4 and 5 ).
  • the mounting of the two doors is carried out after introduction of the inner bag into the outer bag, it will be noted that the fact of not having, after the sliding of the inner bag in the outer bag, to connect by snapping the first door to the rigid ring has the advantage of minimizing the risk of degradation of the inner bag due to its assembly to the outer bag.
  • the material constituting the internal bag can be made of a material already validated for its qualities of compatibility with the products that are intended to be introduced while the material constituting the outer bag can be chosen for its ability to serve barrier, its resistance to vacuum, its impermeability to oxygen, steam, etc. ; it may especially be a multilayer material.
  • the inner bag is made of a polyethylene film of high degree of cleanliness, with a thickness of about 80 to 120 microns while the outer bag can be made of a polyethylene-polyamide multilayer. polyethylene of thickness substantially equal to about 100 microns.
  • the inner bag 10 is in practice longer than the outer bag 20, which makes it possible to fold the trunk while allowing the part of maximum width of this inner bag to be only slightly shorter than the outer bag (it is observed on the figure 5 that the portion of maximum width of the inner bag occupies about three quarters of the length of the outer bag and has a trapezoidal portion transition to the horn which is almost completely located after the fold of the inner bag.
  • trunk that passes under this door and pulls it outward, to unfold and allow the exit of the products or materials to the outside, for example inside another enclosure to a port which the access door 27 has been fixed.
  • the form of trunk allows a good flow of products when they are liquid or powdery or when the materials are very small parts.
  • section of the horn is preferably slightly less than that of the access door so as to promote the output of products and materials.
  • the two bags may be provided to secure the two bags by an external weld along the dotted line 30 near the left openings of the two bags, which prevents the inner bag is the only one to bear the burden of the products or materials to be transferred or processed. It can also be provided to secure the two bags by an external weld along the dotted line 31 near the folded end of the inner bag, which promotes the retention in the folded position of the inner bag during its filling by the door 25. It can of course be expected that there will be welds near each end of the outer bag, so as to avoid any significant entry of contamination between the two inner and outer bags.
  • the trunk has a length representing about one quarter of the length of the set of two bags.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Bag Frames (AREA)
  • Packages (AREA)
  • Making Paper Articles (AREA)

Claims (12)

  1. Weicher Transferbehälter (1) mit einem inneren Sack (10), der aus einer an einem Ende (12) geschlossenen Flachhülle gebildet wird, und dessen anderes Ende (13) zum ersten Ende hin gefaltet ist, wobei dieser innere Sack in einen äußeren Sack (20) eingeschlossen ist, der aus einer Hülle gebildet wird, die mit einer ersten Zugangsöffnung (25) versehen ist, die die Wand der beiden Säcke in der Nähe des geschlossenen Endes des inneren Sacks durchquert, und mit einer zweiten Zugangsöffnung (27), die nur die Wand des äußeren Sacks gegenüber von einem Abschnitt des gefalteten Endes des inneren Sacks durchquert.
  2. Behälter nach Anspruch 1, dadurch gekennzeichnet, daß das gefaltete Ende (13) des inneren Sacks (10) als Rohr ausgebildet und schmaler als der Rest des inneren Sacks ist.
  3. Behälter nach Anspruch 1 oder Anspruch 2, dadurch gekennzeichnet, daß der innere Sack (10) eine Breite höchstens gleich derjenigen des äußeren Sacks hat.
  4. Behälter nach einem beliebigen der vorstehenden Ansprüche 1 bis 3, dadurch gekennzeichnet, daß die beiden Säcke in der Nähe des ersten geschlossenen Endes des inneren Sacks verbunden (30) sind.
  5. Behälter nach Anspruch 4, dadurch gekennzeichnet, daß die beiden Säcke durch Verschweißen verbunden sind.
  6. Behälter nach einem beliebigen der vorstehenden Ansprüche 1 bis 5, dadurch gekennzeichnet, daß die beiden Säcke in der Nähe des gefalteten Endes (13) des inneren Sacks verbunden (31) sind.
  7. Behälter nach einem beliebigen der vorstehenden Ansprüche 1 bis 6, dadurch gekennzeichnet, daß die Zugangsöffnungen (25, 27) Öffnungen zur einmaligen Benutzung sind.
  8. Behälter nach einem beliebigen der vorstehenden Ansprüche 1 bis 7, dadurch gekennzeichnet, daß der innere und der äußere Sack aus verschiedenem Material ausgeführt sind, von denen eines eine Fähigkeit zur Partikelbindung hat und das andere Eigenschaften für den mechanischen Schutz.
  9. Verfahren zur Fertigung eines Behälters nach einem beliebigen der vorstehenden Ansprüche 1 bis 8, bei dem eine erste Flachhülle ausgeführt wird, wobei in der Nähe eines ersten Endes (12) ein Loch (14) gestaltet wird, das eine einzige Wand dieser Hülle durchquert, und wobei das andere Ende gefaltet wird, vom ersten Ende aus wird ein Ring (15) in das Innere dieser Hülle eingeschoben, so daß dieses Loch (14) durchquert wird, ferner wird eine zweite Hülle ausgeführt, in der zwei Löcher realisiert werden, in eines der Löcher wird eine erste Zugangsöffnung (25) eingesetzt, und eine andere Zugangsöffnung (27) wird in das andere Loch eingesetzt, wobei die erste Öffnung (25) nach Einführung des inneren Sacks in den äußeren Sack durch Einrasten am Ring (15) verbunden wird, während sich die zweite Öffnung (27) gegenüber dem gefalteten Ende der ersten Hülle befindet.
  10. Verfahren nach Anspruch 9, dadurch gekennzeichnet, daß das gefaltete Ende (13) als Rohr geformt wird.
  11. Verfahren nach Anspruch 9 oder Anspruch 10, dadurch gekennzeichnet, daß die beiden Hüllen in der Nähe (30, 31) von mindestens einem der Enden der ersten Hülle verbunden werden.
  12. Verfahren nach einem beliebigen der vorstehenden Ansprüche 9 bis 11, dadurch gekennzeichnet, daß die beiden Hüllen aus zwei Werkstoffen ausgeführt werden, von denen einer die Fähigkeit der Partikelbindung und der andere Eigenschaften für den mechanischen Schutz hat.
EP08805564A 2007-05-11 2008-05-13 Flexibler transportbehälter und herstellungsverfahren dafür Active EP2193086B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0755036A FR2915974B1 (fr) 2007-05-11 2007-05-11 Conteneur souple de transfert et procede de fabrication.
PCT/FR2008/000660 WO2008155483A2 (fr) 2007-05-11 2008-05-13 Conteneur souple de transfert et procédé de fabrication

Publications (2)

Publication Number Publication Date
EP2193086A2 EP2193086A2 (de) 2010-06-09
EP2193086B1 true EP2193086B1 (de) 2011-01-12

Family

ID=38814396

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08805564A Active EP2193086B1 (de) 2007-05-11 2008-05-13 Flexibler transportbehälter und herstellungsverfahren dafür

Country Status (7)

Country Link
US (1) US8523436B2 (de)
EP (1) EP2193086B1 (de)
JP (1) JP5167346B2 (de)
AT (1) ATE495117T1 (de)
DE (1) DE602008004564D1 (de)
FR (1) FR2915974B1 (de)
WO (1) WO2008155483A2 (de)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2958853B1 (fr) * 2010-04-20 2012-07-13 Sartorius Stedim Biotech Sa Emballage biopharmaceutique sterilisable.
CN110371486A (zh) 2013-02-22 2019-10-25 莱福奈特海尔斯公司 用于储存组织和细胞材料的包装组件
US11434032B2 (en) 2017-12-11 2022-09-06 Glaxosmithkline Intellectual Property Development Limited Modular aseptic production system

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US611207A (en) * 1897-02-16 1898-09-20 Hot-water bottle or ice-compress
US2548359A (en) * 1946-09-10 1951-04-10 Gandhi Manmohandas Varjivandas Bag for medical and hygienic purposes
GB2058011A (en) * 1978-10-12 1981-04-08 Kingsdown Medical Consultants Urostomy bag
US4439191A (en) * 1982-07-14 1984-03-27 Hogan Elizabeth R Ostomy bag cover
WO1984004037A1 (en) * 1983-04-13 1984-10-25 Field Group Res Pty Ltd Enema bag
US5360127A (en) * 1994-02-17 1994-11-01 Calmar Inc. Non-removable container closure
CA2144612A1 (en) * 1994-03-17 1995-09-18 Hl & H Timber Products (Pty) Ltd. High pressure bag
FR2721289B1 (fr) 1994-06-17 1996-08-30 Idc Isolateur Denominateur Dispositif de jonction étanche entre deux enceintes isolées d'un milieu extérieur.
DK138295A (da) * 1995-12-06 1997-06-07 Tetra Laval Holdings & Finance Aseptisk påse för afskiljning av vätska
US5941640A (en) * 1997-08-14 1999-08-24 Ultimate Direction, Inc. Roll top bladder
DE19751489A1 (de) * 1997-11-20 1999-05-27 Nutrichem Diaet & Pharma Gmbh Doppelbeutel zur Applikation einer fluiden Substanz
GB2354754A (en) * 1999-09-30 2001-04-04 Brendan Mckenna Fluid transport container
DE60329090D1 (de) * 2002-04-01 2009-10-15 Ilc Dover Inc Flexible behälterfüllvorrichtung
US20040245144A1 (en) * 2003-06-03 2004-12-09 Hurst William E. Preformed mixing bag for dry powder, apparatus, method and system for using same
US20060251343A1 (en) * 2005-05-09 2006-11-09 True Charles W Flexible independent multi-layer container and method for forming
SG162759A1 (en) * 2005-06-06 2010-07-29 Advanced Tech Materials Fluid storage and dispensing systems and processes
US7896199B2 (en) * 2007-05-01 2011-03-01 Daniel Steven Kaczmarek Portable liquid-dispensing bag
SI2268239T1 (sl) * 2008-04-04 2017-03-31 Convatec Technologies Inc. Izsušljiva stoma vrečka

Also Published As

Publication number Publication date
ATE495117T1 (de) 2011-01-15
JP5167346B2 (ja) 2013-03-21
WO2008155483A3 (fr) 2009-03-26
FR2915974A1 (fr) 2008-11-14
US8523436B2 (en) 2013-09-03
US20100303389A1 (en) 2010-12-02
DE602008004564D1 (de) 2011-02-24
FR2915974B1 (fr) 2009-07-10
EP2193086A2 (de) 2010-06-09
WO2008155483A2 (fr) 2008-12-24
JP2010526741A (ja) 2010-08-05

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