EP1012073B1 - Conteneur rigide de transport pour une poche contenant des produits fluides bio-pharmaceutiques - Google Patents

Conteneur rigide de transport pour une poche contenant des produits fluides bio-pharmaceutiques Download PDF

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Publication number
EP1012073B1
EP1012073B1 EP99929376A EP99929376A EP1012073B1 EP 1012073 B1 EP1012073 B1 EP 1012073B1 EP 99929376 A EP99929376 A EP 99929376A EP 99929376 A EP99929376 A EP 99929376A EP 1012073 B1 EP1012073 B1 EP 1012073B1
Authority
EP
European Patent Office
Prior art keywords
sachet
container
container according
pocket
plate
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
EP99929376A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1012073A1 (fr
Inventor
Bernard Vallot
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
Publication of EP1012073A1 publication Critical patent/EP1012073A1/fr
Application granted granted Critical
Publication of EP1012073B1 publication Critical patent/EP1012073B1/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
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • 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
    • B67D7/0216—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 by squeezing collapsible or flexible storage containers
    • 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
    • B65D88/00—Large containers
    • B65D88/54—Large containers characterised by means facilitating filling or emptying
    • B65D88/58—Large containers characterised by means facilitating filling or emptying by displacement of walls
    • B65D88/60—Large containers characterised by means facilitating filling or emptying by displacement of walls of internal 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
    • 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
    • B65D90/047—Flexible liners, e.g. loosely positioned in the container comprising rigid bracing, e.g. bulkheads

Definitions

  • the present invention relates to new rigid containers of transport for bags of bio-pharmaceutical fluids.
  • US-A-5 350 080 describes pouches which can be used for cell culture and their rigid transport container.
  • BE 539 623 A described a container according to the preamble of claim 1.
  • the wider bio-pharmaceutical industry is using more and more often flexible bags of 20 to 2,000 L and more, in particular biocompatible, to transport fluids used in this industry, such as culture media, cell cultures, buffer solutions, liquids artificial nutrition, blood products or derivatives such as plasma.
  • fluids used in this industry such as culture media, cell cultures, buffer solutions, liquids artificial nutrition, blood products or derivatives such as plasma.
  • these pockets intended to contain the above-mentioned media and liquid products are by nature provided with a certain number access doors allowing for example filling, racking, mixing, etc. of their content, as well as usually a number of pipes installed on all or part of these doors.
  • These tubes are themselves often provided with one or more rigid material devices such as valves or clamps which can contribute to the abrasion of the part upper pockets when transported over long distances. A piercing on the top of a pocket can be just as serious as elsewhere by example in the case of transporting sterile contents.
  • such a container once emptied from its pocket, should have a volume smaller than that which it occupies during the transport of the pocket, in order to reduce the volume occupied by the container when it returns to its destination original. It should also be simple and inexpensive, without compromised with efficiency.
  • the containment plate fills in particular two functions: on the one hand it maintains firmly by pressure the pocket installed in the container, and on the other hand it protects the top of the abrasion pocket due to friction from connection elements such as pipes and taps installed on the doors on the top of the poached.
  • the containment plate is adjustable to press more or less on said pocket. Under preferential conditions of implementation of the invention, this adjustment is carried out continuously.
  • This continuous adjustment can be obtained for example using a pneumatic system, using for example inflatable bags or mechanical or hydraulic cylinders supported on beams or on a cover installed on the top of the container, but in entirely preferred conditions of realization, this adjustment is obtained using of a screw jack system.
  • a pneumatic system using for example inflatable bags or mechanical or hydraulic cylinders supported on beams or on a cover installed on the top of the container, but in entirely preferred conditions of realization, this adjustment is obtained using of a screw jack system.
  • the above adjustment device advantageously takes support on removable side rails preferably installed parallel to the wall bottom of the container.
  • a simple and efficient way to install these beams is to spare at the top of the container, for example in two opposite side walls of a parallelepiped container, slots passage for inserting the ends of said beams.
  • the fine adjustment of the compression is then obtained using the adjustment system, in particular continuously, such as the cylinders mentioned above.
  • the shape of the container can be varied and especially cylindrical. In such a case, the side members are advantageously installed parallel to a diameter.
  • the beams are for example at number two or three.
  • a preferred container according to the invention has a shape generally parallelepiped
  • the compression plate is provided with a through hole for the door (s) installed on the top of the poached.
  • the passage opening (s) are in number corresponding to the door systems installed on the top of the pocket. So the plate of restraint allows the passage of doors and possibly tubing, and prevents direct contact of these on the pocket by totally reducing the risks of abrasion and rupture due to this effect.
  • the above containment orifice (s) are provided with a guillotine adjustable door lock installed on the top of the pocket.
  • This guillotine adjustable can be adjusted to the dimensions and location of the pocket and, a once the system is in place, can be blocked using a simple means, such as a screw installed perpendicular to the containment plate, blocking after screwing the sliding part (s) of the guillotine against the slides of sliding.
  • the containment plate has its surface facing the interior of the container substantially flat, and advantageously has a surface greater than or equal to 80% of that of the internal surface delimited by the side walls of the rigid container, preferably greater than 90%, in particular greater than 95% and very particularly 98% of this surface.
  • the play of the edges of the containment plate is very limited compared to the sides of the rigid container.
  • the containment plate is substantially adjusted to the internal dimension container.
  • edges of the containment plate directed towards the inside of the container are preferably blunt to avoid risk of damage a pocket during transport.
  • the container is foldable or removable, especially for taking a parallelepiped shape of low height.
  • foldable preferably, a parallelepiped container is produced, and two side walls, preferably of smaller surface and opposite, are removable, while two other side walls, preferably those of larger area remain integral with the lower wall and are foldable one on the other.
  • the bottom of the container is not flat but slightly flared towards the high to facilitate the reflux of the liquid towards the bottom of the bag at the end of emptying.
  • the bottom of the container is provided, preferably towards its middle, with a at least opening allowing the correct centering of the pocket with respect to the container. Therefore, in the case of a non-cylindrical pocket, this orifice has any form of preferably other than round, like elongated oval, triangular, square, hexagonal, etc. allowing, by cooperation with a shape protuberance complementary and corresponding location at the bottom of the pocket, of course center it before filling and at the same time constitute a point anchoring at the bottom of the container, and thereby improving the quality of transport.
  • This orifice can also be used for the circulation of fluids if for example the protrusion of the pocket is constituted by the base of a plug for example emptying.
  • the containers of the invention are used with flexible pockets made of plastic.
  • the present invention also relates to a above container, fitted with a bio-pharmaceutical liquid transport pocket of 50 liters and more, preferably a bellows pocket, the shape is substantially rectangular rectangle once this pocket filled.
  • the above pocket is advantageously a monofilm pocket multilayer.
  • This multi-layer monofilm pocket is preferably three-layer, particularly four-layer and very particularly of the PET (Polyester) / Polyamide / EvOH (Ethylene-Vinyl Alcohol Copolymer) / PE (Polyethylene) type.
  • Figure 1 shows is a top view of a container rigid according to the invention provided with a system for continuously adjusting the pressure the compression plate on the pocket, resting on two side members, said pocket being provided with four upper access doors installed side by side side.
  • FIG. 2 represents a partially exploded view along AA 'of Figure 1.
  • FIG. 3 represents a perspective view of FIG. 1, with a variant of the screw actuation system.
  • the side walls 1, 2, 3, 4 are distinguished from a rigid container according to the invention of rectangular parallelepiped shape. Between these side walls 1, 2, 3, 4 is installed a containment plate 5, installed over more than 98% of the surface available between the side walls 1, 2, 3, 4.
  • Two beams 6, 7 are installed parallel to each other, parallel to the bottom and top of the container and parallel to the side walls 2 and 4. These beams 6, 7 have their ends inserted into slots formed in the larger opposite side walls 1, 3, of the container.
  • These beams 6, 7 each include two threads for screwing a compression screw 8 installed vertically, perpendicular to said side members 6, 7. This compression screw 8 is provided at one end with a crank to facilitate its screwing. Its other end rests on the containment plate 5.
  • This crank comprises an arm 9 extending from each side of the axis of the screw, with a sliding pin 10 perpendicular to arm 9 of the crank so that this crankpin 10 is substantially located above the arm during screwing and unscrewing, and substantially located below the arm, as shown here during transport.
  • the crank pin 10 is of sufficient length to come in support against the beam 7 during transport. Under these conditions, everything accidental unscrewing is impossible since the rotational movement of the crank arm must be less than 180 °. Only one crank has been shown in this figure. On the other hand, we have represented the circles of revolution of the four cranks.
  • a guillotine 12, 13 consisting of two parts 12, 13.
  • the two parts 12, 13 of the guillotine are a larger area than the window in the plate allowing the exit of the doors. They are not guided and are simply installed between the pocket and containment plate 5, which allows on the realization illustrated here a displacement of the two parts 12, 13 of the guillotine in all freedom parallel to the compression plate 5.
  • Such a system allows the efficient locking of the doors, limiting as much as possible the waivers at this level.
  • the two parts 12, 13 of the guillotine are more particularly installed between a foam plate protecting the pocket and the compression plate 5.
  • FIG. 2 a detail of the embodiment of the adjustment of Figure 1.
  • a screw 8 adjustment provided at its end upper of a crank arm 9 in which a crank pin 10 is installed sliding, held by an O-ring 14.
  • the other end of the screw 8 comes take support in a recess 15 formed on the top of the plate support 5.
  • the bottom of the support plate 5 is provided with a plate foam 16 to better protect the pocket.
  • Slots 17 are provided in the side walls 1.3 of the container to insert the ends of the side members 6, 7.
  • the container is also provided with a cover 18.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Bag Frames (AREA)
  • Closures For Containers (AREA)
EP99929376A 1998-07-02 1999-07-01 Conteneur rigide de transport pour une poche contenant des produits fluides bio-pharmaceutiques Expired - Lifetime EP1012073B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9808644A FR2780708B1 (fr) 1998-07-02 1998-07-02 Conteneurs rigides de transport pour poches de produits fluides bio-pharmaceutiques
FR9808644 1998-07-02
PCT/FR1999/001582 WO2000001596A1 (fr) 1998-07-02 1999-07-01 Conteneur rigide de transport pour une poche contenant des produits fluides bio-pharmaceutiques

Publications (2)

Publication Number Publication Date
EP1012073A1 EP1012073A1 (fr) 2000-06-28
EP1012073B1 true EP1012073B1 (fr) 2002-03-06

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP99929376A Expired - Lifetime EP1012073B1 (fr) 1998-07-02 1999-07-01 Conteneur rigide de transport pour une poche contenant des produits fluides bio-pharmaceutiques

Country Status (14)

Country Link
US (1) US6076457A (enExample)
EP (1) EP1012073B1 (enExample)
JP (1) JP4316807B2 (enExample)
KR (1) KR100531696B1 (enExample)
CN (1) CN1168645C (enExample)
AT (1) ATE214027T1 (enExample)
AU (1) AU764887B2 (enExample)
CA (1) CA2302826C (enExample)
DE (1) DE69900968T2 (enExample)
DK (1) DK1012073T3 (enExample)
ES (1) ES2172336T3 (enExample)
FR (1) FR2780708B1 (enExample)
PT (1) PT1012073E (enExample)
WO (1) WO2000001596A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9005978B2 (en) 2010-09-30 2015-04-14 Sartorius Stedim Fmt Sas Detection of the integrity of a tight, closed, soft plastic pouch for receiving and protecting a product or a biopharmaceutical device
US9266657B2 (en) 2009-05-27 2016-02-23 Sartorius Stedim Fmt Sas Rigid container for a flexible pouch for holding a biopharmaceutical fluid, assembly comprising such a flexible pouch and such a container, and method for using such a container

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MXPA03009555A (es) 2001-04-18 2004-12-06 Northfield Lab Sistema de recipiente flexible para almacenamiento de soluciones de hemoglobina estabilizadas.
DE60237405D1 (de) * 2001-10-03 2010-09-30 Levtech Inc Mischbehälter mit einer aufnahmevorrichtung für ein fluidbewegungselement
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US6908223B2 (en) * 2002-04-12 2005-06-21 Hynetics Llc Systems for mixing liquid solutions and methods of manufacture
US6837610B2 (en) * 2002-09-27 2005-01-04 Ilc Dover Lpp Bioprocess container, bioprocess container mixing device and method of use thereof
BRPI0407106A (pt) * 2003-01-29 2006-01-24 Northfield Lab Soluções de hemoglobina polimerizadas com quantidade reduzida de tetrâmero e método para preparação
AU2004210869A1 (en) * 2003-02-13 2004-08-26 Ilc Dover, Inc. Flexible disposable vessel
FR2851241B1 (fr) * 2003-02-13 2005-11-11 Rhodia Chimie Sa Procede de vidange d'un conteneur souple renfermant un produit visqueux
US7431837B2 (en) * 2003-02-13 2008-10-07 Ilc Dover Lp Mixing vessel and method of use
FR2851242B1 (fr) * 2003-02-13 2005-10-21 Rhodia Chimie Sa Procede de vidange d'un conteneur souple renfermant un produit visqueux
WO2004087320A2 (en) * 2003-03-28 2004-10-14 Hyclone Laboratories, Inc. Fluid dispensing bins and related methods
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US7410155B2 (en) 2004-07-28 2008-08-12 Spain Iii Charles J Clamp and sealer for use on flexible conduits in biopharmaceutical applications
FR2880339A1 (fr) * 2004-12-31 2006-07-07 Rhodia Chimie Sa Procede de conditionnement d'un conteneur souple renfermant un produit visqueux
US7682067B2 (en) * 2005-04-22 2010-03-23 Hyclone Laboratories, Inc. Mixing systems and related mixers
EP1978802A2 (en) * 2006-01-24 2008-10-15 Northfield Laboratories, Inc. Polymerized hemoglobin media and its use in isolation and transplantation of islet cells
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EP2114554A1 (en) * 2007-02-21 2009-11-11 Levtech Inc. Roller bearing for a fluid-agitating element and associated vessel
US9090398B2 (en) 2007-05-04 2015-07-28 Emd Millipore Corporation Disposable processing bag with alignment feature
US8177123B2 (en) * 2008-09-24 2012-05-15 Sartorius Stedim North America Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
US9301520B2 (en) 2007-12-21 2016-04-05 Sartorius Stedim North America Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
US7740212B2 (en) * 2008-04-17 2010-06-22 ConeCraft, Inc, Apparatus to retain and position tubing of media bags
FR2946868B1 (fr) * 2009-06-18 2011-07-22 Sartorius Stedim Biotech Sa Detection d'une perte d'integrite d'une poche souple, en matiere plastique non poreuse, fermee.
US9314751B2 (en) 2011-01-07 2016-04-19 Life Technologies Corporation Methods and apparatus for mixing and shipping fluids
US8608369B2 (en) 2011-01-07 2013-12-17 Hyclone Laboratories, Inc. Methods and systems for heating and mixing fluids
US9376655B2 (en) 2011-09-29 2016-06-28 Life Technologies Corporation Filter systems for separating microcarriers from cell culture solutions
FR3017122B1 (fr) 2014-02-06 2016-02-26 Sartorius Stedim Fmt Sas Procede de chargement d'une poche souple 3d a emplir, un systeme de chargement et stockage de cette poche souple et dispositif de support associe.
US8979357B1 (en) 2014-03-17 2015-03-17 Advanced Scientifics, Inc. Transportable mixing system for biological and pharmaceutical materials
EP3266727B1 (en) 2016-07-07 2020-10-21 Sartorius Stedim Fmt Sas System for expanding or collapsing a pouch comprising a shape memory material and method for receiving and transporting biopharmaceutical fluid
EP3266726B1 (en) 2016-07-07 2019-08-21 Sartorius Stedim Fmt Sas Container for transporting a biopharmaceutical fluid comprising a shape memory material and method for transporting a biopharmaceutical fluid
FR3055317B1 (fr) * 2016-08-23 2020-12-25 Sartorius Stedim Fmt Sas Conteneur pour poche souple comprenant deux positions de fonctionnement
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9266657B2 (en) 2009-05-27 2016-02-23 Sartorius Stedim Fmt Sas Rigid container for a flexible pouch for holding a biopharmaceutical fluid, assembly comprising such a flexible pouch and such a container, and method for using such a container
EP3106408A3 (fr) * 2009-05-27 2017-01-11 Sartorius Stedim Fmt Sas Conteneur rigide pour poche souple destinee a contenir un fluide biopharmaceutique et procede de mise en oeuvre d'un tel conteneur
US9005978B2 (en) 2010-09-30 2015-04-14 Sartorius Stedim Fmt Sas Detection of the integrity of a tight, closed, soft plastic pouch for receiving and protecting a product or a biopharmaceutical device

Also Published As

Publication number Publication date
AU4621299A (en) 2000-01-24
AU764887B2 (en) 2003-09-04
FR2780708A1 (fr) 2000-01-07
DE69900968D1 (de) 2002-04-11
CA2302826C (fr) 2007-04-03
EP1012073A1 (fr) 2000-06-28
CN1274332A (zh) 2000-11-22
PT1012073E (pt) 2002-07-31
CA2302826A1 (fr) 2000-01-13
ATE214027T1 (de) 2002-03-15
DK1012073T3 (da) 2002-07-01
KR20010023478A (ko) 2001-03-26
US6076457A (en) 2000-06-20
FR2780708B1 (fr) 2001-01-12
ES2172336T3 (es) 2002-09-16
JP2002519263A (ja) 2002-07-02
CN1168645C (zh) 2004-09-29
DE69900968T2 (de) 2002-11-28
WO2000001596A1 (fr) 2000-01-13
KR100531696B1 (ko) 2005-11-29
JP4316807B2 (ja) 2009-08-19

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