Reception, draining and transfer of a high quantity of biopharmaceutical fluid under pressure with a view to subsequent treatment

Patent metadata

Field	Value
Publication number	US-2016015599-A1
Application number	US-201414775966-A
Country	US
Kind code	A1
Filing date	Mar 13, 2014
Priority date	Mar 13, 2013
Publication date	Jan 21, 2016
Grant date	—

Abstract

Device for receiving and draining a high quantity of biopharmaceutical fluid under pressure includes an inner bag, having an inner container for receiving the fluid and provided with a filling port, a drain port, a filling tube having a filling inlet for connection to a filling line, a drain tube having a drain outlet for connection to a drain line, an outer container in which the bag is placed, a compression chamber between the outer container and the bag, an injection port for injecting pressurized draining gas into the chamber, sealed bushings passing through the container via the filling and drain tubes, the deformation capacities of the bag and container being such that, when the draining gas is injected into the chamber, the bag is compressed and the biopharmaceutical fluid is emptied. The outer container includes a receptacle forming the outer chamber, the tubes passing therethrough via permanently fixed connections.

First claim

1 - 36 . (canceled)

37 . Device for the reception and then the draining of a large amount of biopharmaceutical fluid, at least equal to about 10 liters, under controlled pressure by a laboratory which prepares pharmaceutical products, for the purposes of further treatment such as filtration, final formulation, and/or filling containers of smaller capacity, wherein the device comprises:
an inner bag made of plastic, flexible and fluidtight, having an inner container intended and suitable for receiving a quantity at least equal to about 10 liters of biopharmaceutical fluid and provided with a filling port for supplying the biopharmaceutical fluid and a drain port for emptying the biopharmaceutical fluid, and connected in a fluidtight manner to the filling port and drain port, a filling tube having an inlet for filling the inner container with biopharmaceutical fluid, adapted to be connected to a filling line for the biopharmaceutical fluid, and a drain tube having an outlet for draining the inner container of biopharmaceutical fluid, adapted to be connected to a drain line for the biopharmaceutical fluid, an outer container into which the inner bag is placed, a compression chamber being formed between the outer container and the inner bag for which the filling inlet and drain outlet are located externally to the outer container, a port for injecting pressurized draining gas into the compression chamber being provided on said outer container, fluidtight passages through the outer container via the filling tube and drain tube, the respective deformation capacities of the inner bag and outer container being chosen such that when injecting the pressurized draining gas into the compression chamber, the inner bag is compressed and the pressure causes the biopharmaceutical fluid contained therein to empty through the drain outlet,
wherein:
the outer container comprises a fluidtight outer receptacle made of plastic, forming an outer chamber into which the inner bag is placed, defining the compression chamber, and comprising the injection port for the pressurized draining gas,
the filling tube and drain tube pass through the outer receptacle via fixed permanent connections, the filling inlet and drain outlet being located externally to the outer receptacle,
the device also comprises an integrated means for bleeding the gas filling the filling line prior to filling with biopharmaceutical fluid, so that this gas does not enter the inner bag,
the outer receptacle and the inner bag form a coherent whole that is disposable.

38 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure, wherein the device comprises:
an inner bag made of plastic, flexible and fluidtight, having an inner container intended and suitable for receiving the biopharmaceutical fluid and provided with a filling port for supplying the biopharmaceutical fluid and a drain port for emptying the biopharmaceutical fluid, and connected in a fluidtight manner to the filling port and drain port, a filling tube having an inlet for filling the inner container with biopharmaceutical fluid, adapted to be connected to a filling line for the biopharmaceutical fluid, and a drain tube having an outlet for draining the inner container of biopharmaceutical fluid, adapted to be connected to a drain line for the biopharmaceutical fluid, an outer container comprising a fluidtight outer receptacle made of plastic, forming an outer chamber into which the inner bag is placed, its filling inlet and drain outlet ( 12 ) being located externally to the outer container, defining a compression chamber between the outer container and the inner bag, a port for injecting pressurized draining gas into the compression chamber being provided on said outer container, the filling tube and drain tube passing through the outer receptacle via fluidtight and fixed permanent connections, the respective deformation capacities of the inner bag and outer container being chosen such that when injecting the pressurized draining gas into the compression chamber, the inner bag is compressed and the pressure causes the biopharmaceutical fluid contained therein to empty through the drain outlet, the outer receptacle and the inner bag forming a coherent whole that is disposable,
wherein:
the inner bag is intended and suitable for receiving an amount at least equal to about 10 liters of biopharmaceutical fluid, and the outer receptacle when deployed has a capacity of at least 40 liters,
the device comprises a section of filling tube and a section of drain tube which are located between the end edge section of the inner bag to which they are adjacent and the end edge section of the wall of the outer receptacle through which they pass via fluidtight and fixed permanent connections, the end edge section of the inner bag and the end edge section of the wall of the outer receptacle being arranged next to and offset from one another,
the device also comprises an integrated means for bleeding the gas filling the filling line prior to filling with biopharmaceutical fluid, so that this gas does not enter the inner bag,

the device being specially adapted for the reception and then the draining of a large amount of biopharmaceutical fluid, at least about 10 liters, under controlled pressure by a laboratory which prepares pharmaceutical products, for the purposes of further treatment such as filtration, final formulation, and/or filling containers of smaller capacity.

39 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 37 , wherein the outer container essentially comprises, in particular consists of, the outer receptacle.

40 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 39 , wherein the outer receptacle is a flexible outer bag that is non-expandable or expandable with a limited capacity for expansion.

41 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 39 , wherein the outer receptacle is a rigid or semi-rigid shell.

42 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 37 , wherein the outer container comprises the outer receptacle which is a flexible outer bag, possibly expandable, and an external containment means adapted to receive the outer bag and able to limit the expansion capacity of the outer bag when the pressurized draining gas is being injected into the compression chamber.

43 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 42 , wherein the containment means comprises two rigid and parallel main walls spaced apart from one another, in particular at a fixed distance, between which is placed the outer bag comprising two main walls on opposite sides.

44 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 43 , wherein the free space at the periphery of the two rigid main walls serves as a passage for placing the outer bag or removing it from between the two main walls.

45 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 43 , wherein the containment means also comprises one or more rigid side walls, rigidly connecting the two main walls.

46 . Device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 37 , further comprising, or adapted to be associated w

Assignees

• Sartorius Stedim Fmt Sas

Inventors

• Gentile Cedric
• Giovani Maurizio
• Truzzi Paolo
• Aicardi Laurent
• Svete Sebastien

Classifications

• A61J1/1493

  Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling · CPC title

• A61M5/1486

  the bags being substantially completely surrounded by fluid · CPC title

• B65D33/01

  Ventilation or drainage of bags · CPC title

• B67D7/0261

  specially adapted for transferring liquids of high purity · CPC title

• A61J1/10 Primary

  Bag-type containers · CPC title