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

• US 10,391,030 B2
• Filed: 03/13/2014
• Issued: 08/27/2019
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Sartorius Stedim Fmt Sas (Sartorius AG)
• Original Assignee: Sartorius Stedim Fmt Sas (Sartorius AG)
• Inventors: Gentile, Cedric, Giovani, Maurizio, Truzzi, Paolo, Aicardi, Laurent, Svete, Sebastien
• Primary Examiner(s): Warden, Jill A
• Assistant Examiner(s): Handy, Dwayne K
• Application Number:
  US14/775,966
• Publication Number:
  US 20160015599A1
• Time in Patent Office: 1,993 Days
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1493 Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• CPC Class Codes: B65D 33/01 Ventilation or drainage of bags
• CPC Class Codes: B67D 7/0261 specially adapted for transferring liquids of high purity

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.

Claims

1. A 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,

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, and

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, and

the outer receptacle and the inner bag form a coherent whole that is disposable.

3. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the outer container consists of the outer receptacle.

4. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 3, wherein the outer receptacle is a flexible outer bag that is non-expandable or expandable with a limited capacity for expansion.

5. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 3, wherein the outer receptacle is a rigid or semi-rigid shell.

6. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, 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.

7. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 6, 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.

8. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 7, 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.

9. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 7, wherein the containment means also comprises one or more rigid side walls, rigidly connecting the two main walls.

10. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, further comprising, or adapted to be associated with, a means adapted such that, at least during draining, the drain port is located towards the lower portion of the inner bag, in particular the lowermost portion of the inner bag.

11. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 10, wherein the means adapted such that the drain port is located towards the lower portion of the inner bag is either a means for suspending the device on the end opposite the drain port or a means for tilting the containment means that the outer container comprises.

12. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the integrated means for bleeding the gas filling the filling line prior to filling with biopharmaceutical fluid is a bag for initially draining the gas filling the filling line, connected by an extrinsic fluid connection to the filling tube, near the inner bag, an opening/closing device being provided on the extrinsic fluid connection and an opening/closing device being provided on the filling tube near the connection to the extrinsic fluid connection and between the latter and the inner bag.

13. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the filling tube and drain tube pass through the wall of the outer receptacle from one side to the other via fluidtight and fixed permanent connections, welded or the like, formed in an end edge section of this wall by two facing areas of this wall, some portions flat against one another, other portions trapping the filling tube and drain tube between them in a snug fit.

14. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the wall of the inner bag comprises an end edge section where the filling port and drain port are located adjacent to one another, and the filling tube and drain tube are located adjacent to one another.

15. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the filling tube and drain tube pass through the wall of the inner bag from the outer side via fluidtight and fixed permanent connections, welded or the like, formed in an end edge section of this wall by two facing areas of this wall, some portions flat against one another, other portions trapping the filling tube and drain tube between them in a snug fit.

16. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the filling tube and drain tube pass through the wall of the outer receptacle from one side to the other in an end edge section of this wall and pass through the wall of the inner bag from the outer side in an end edge section of that wall, the end edge section of the wall of the outer receptacle and the end edge section of the inner bag extending generally parallel to one another and positioned adjacent to one another.

17. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the filling tube and drain tube pass through the wall of the outer receptacle from one side to the other in an end edge section of this wall and pass through the wall of the inner bag from the outer side in an end edge section of that wall, the end edge section of the wall of the outer receptacle and the end edge section of the inner bag being arranged next to one another, the section of filling tube and the section of draining tube that are located between the end edge section of the wall of the outer receptacle and the end edge section of the inner bag being self-supporting and supporting the inner bag.

18. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the port for injecting pressurized draining gas, which is connected in particular to an injection tube having an injection inlet, is arranged in the wall of the outer receptacle with a fluidtight and fixed permanent connection, by welding or the like, formed in an end edge section of this wall by two facing areas of this wall, some portions flat against one another, other portions defining between them the injection port, in particular trapping the injection tube between them in a snug fit.

19. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the wall of the outer receptacle comprises an end edge section where the filling tube, the drain tube, the injection port, in particular the injection tube, are located adjacent to one another.

20. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein, aside from the section of filling tube and the section of drain tube which are located between the end edge section of the wall of the outer receptacle and the end edge section of the inner bag which are arranged next to one another, the inner bag is mounted so as to be unrestrained within the outer receptacle.

21. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein, when the draining gas is injected into the compression chamber, the wall of the inner bag and the wall of the outer receptacle the compression chamber are spaced apart from one another along all or substantially all their lateral periphery.

22. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the inner bag has a wall comprising two main wall portions opposite one another and the outer receptacle is a bag in which the wall comprises two main wall portions opposite one another, such that when the inner bag and the bag of the outer receptacle are empty, the respective walls and thus the bags themselves can be folded flat in a layered arrangement.

23. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the outer receptacle is at least partially transparent to allow viewing the inner bag through the wall.

24. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the deployed inner bag has a capacity of between 8 liters and 60 liters, in particular about 10 to 50 liters, while the deployed outer receptacle has a capacity at least equal to that of the deployed inner bag, in particular at least equal to about 50 liters for a deployed inner bag having a capacity of about 10.

25. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, comprising a means with pressure loss such as a filter associated in fluid communication with the drain tube or the drain outlet of the inner container of biopharmaceutical fluid.

26. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, wherein the drain tube or the drain outlet of the inner container of biopharmaceutical fluid is without a pump such as a peristaltic pump.

27. A system for the reception and transfer of a biopharmaceutical fluid under controlled pressure, comprising:

a device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 1, in particular comprising a means with pressure loss such as a filter associated in fluid communication with the drain tube or drain outlet of the inner container of biopharmaceutical fluid,

a means intended and suitable for supplying a pressurized draining gas, having a pressurized draining gas injection line adapted to be association in fluid communication or associated in fluid communication with the pressurized draining gas injection inlet or port of said device, and

a means for monitoring and controlling the pressure of the pressurized draining gas in the pressurized draining gas injection line.

28. The system for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 27, wherein the means intended and suitable for supplying a pressurized draining gas supplies the draining gas at a pressure equal to at least 70 mbar.

29. The system for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 27, without a pump, such as peristaltic pump, connected to the drain tube or the drain outlet of the inner container of biopharmaceutical fluid.

2. A 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,

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, and

and

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, and

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.

37. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the outer container consists of the outer receptacle.

38. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 37, wherein the outer receptacle is a flexible outer bag that is non-expandable or expandable with a limited capacity for expansion.

39. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 37, wherein the outer receptacle is a rigid or semi-rigid shell.

40. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, 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.

41. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 40, 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.

42. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 41, 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.

43. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 41, wherein the containment means also comprises one or more rigid side walls, rigidly connecting the two main walls.

44. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, further comprising, or adapted to be associated with, a means adapted such that, at least during draining, the drain port is located towards the lower portion of the inner bag, in particular the lowermost portion of the inner bag.

45. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 44, wherein the means adapted such that the drain port is located towards the lower portion of the inner bag is either a means for suspending the device on the end opposite the drain port or a means for tilting the containment means that the outer container comprises.

46. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the integrated means for bleeding the gas filling the filling line prior to filling with biopharmaceutical fluid is a bag for initially draining the gas filling the filling line, connected by an extrinsic fluid connection to the filling tube, near the inner bag, an opening/closing device being provided on the extrinsic fluid connection and an opening/closing device being provided on the filling tube near the connection to the extrinsic fluid connection and between the latter and the inner bag.

47. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the filling tube and drain tube pass through the wall of the outer receptacle from one side to the other via fluidtight and fixed permanent connections, welded or the like, formed in an end edge section of this wall by two facing areas of this wall, some portions flat against one another, other portions trapping the filling tube and drain tube between them in a snug fit.

48. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the wall of the inner bag comprises an end edge section where the filling port and drain port are located adjacent to one another, and the filling tube and drain tube are located adjacent to one another.

49. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the filling tube and drain tube pass through the wall of the inner bag from the outer side via fluidtight and fixed permanent connections, welded or the like, formed in an end edge section of this wall by two facing areas of this wall, some portions flat against one another, other portions trapping the filling tube and drain tube between them in a snug fit.

50. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the filling tube and drain tube pass through the wall of the outer receptacle from one side to the other in an end edge section of this wall and pass through the wall of the inner bag from the outer side in an end edge section of that wall, the end edge section of the wall of the outer receptacle and the end edge section of the inner bag extending generally parallel to one another and positioned adjacent to one another.

51. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the filling tube and drain tube pass through the wall of the outer receptacle from one side to the other in an end edge section of this wall and pass through the wall of the inner bag from the outer side in an end edge section of that wall, the end edge section of the wall of the outer receptacle and the end edge section of the inner bag being arranged next to one another, the section of filling tube and the section of draining tube that are located between the end edge section of the wall of the outer receptacle and the end edge section of the inner bag being self-supporting and supporting the inner bag.

52. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the port for injecting pressurized draining gas, which is connected in particular to an injection tube having an injection inlet, is arranged in the wall of the outer receptacle with a fluidtight and fixed permanent connection, by welding or the like, formed in an end edge section of this wall by two facing areas of this wall, some portions flat against one another, other portions defining between them the injection port, in particular trapping the injection tube between them in a snug fit.

53. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the wall of the outer receptacle comprises an end edge section where the filling tube, the drain tube, the injection port, in particular the injection tube, are located adjacent to one another.

54. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein, aside from the section of filling tube and the section of drain tube which are located between the end edge section of the wall of the outer receptacle and the end edge section of the inner bag which are arranged next to one another, the inner bag is mounted so as to be unrestrained within the outer receptacle.

55. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein, when the draining gas is injected into the compression chamber, the wall of the inner bag and the wall of the outer receptacle the compression chamber are spaced apart from one another along all or substantially all their lateral periphery.

56. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the inner bag has a wall comprising two main wall portions opposite one another and the outer receptacle is a bag in which the wall comprises two main wall portions opposite one another, such that when the inner bag and the bag of the outer receptacle are empty, the respective walls and thus the bags themselves can be folded flat in a layered arrangement.

57. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the outer receptacle is at least partially transparent to allow viewing the inner bag through the wall.

58. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the deployed inner bag has a capacity of between 8 liters and 60 liters, in particular about 10 to 50 liters, while the deployed outer receptacle has a capacity at least equal to that of the deployed inner bag, in particular at least equal to about 50 liters for a deployed inner bag having a capacity of about 10.

59. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, comprising a means with pressure loss such as a filter associated in fluid communication with the drain tube or the drain outlet of the inner container of biopharmaceutical fluid.

60. The device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, wherein the drain tube or the drain outlet of the inner container of biopharmaceutical fluid is without a pump such as a peristaltic pump.

61. A system for the reception and transfer of a biopharmaceutical fluid under controlled pressure, comprising:

a device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure according to claim 2, in particular comprising a means with pressure loss such as a filter associated in fluid communication with the drain tube or drain outlet of the inner container of biopharmaceutical fluid,

a means intended and suitable for supplying a pressurized draining gas, having a pressurized draining gas injection line adapted to be association in fluid communication or associated in fluid communication with the pressurized draining gas injection inlet or port of said device, and

a means for monitoring and controlling the pressure of the pressurized draining gas in the pressurized draining gas injection line.

62. The system for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 61, wherein the means intended and suitable for supplying a pressurized draining gas supplies the draining gas at a pressure equal to at least 70 mbar.

63. The system for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 61, without a pump, such as peristaltic pump, connected to the drain tube or the drain outlet of the inner container of biopharmaceutical fluid.

30. A method for the reception and transfer of a biopharmaceutical fluid under controlled pressure, wherein:

a system is provided for the reception and transfer of a biopharmaceutical fluid under controlled pressure, said system comprising;

a device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure, said device comprising;

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,

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 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, and

a means with pressure loss such as a filter associated in fluid communication with the drain tube or drain outlet of the inner container of biopharmaceutical fluid,

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,

and

the outer receptacle and the inner bag form a coherent whole that is disposable,

a means intended and suitable for supplying a pressurized draining gas, having a pressurized draining gas injection line adapted to be association in fluid communication or associated in fluid communication with the pressurized draining gas injection inlet or port of said device, and

a means for monitoring and controlling the pressure of the pressurized draining gas in the pressurized draining gas injection line,

said system being provided in the state that is empty of biopharmaceutical fluid and of pressurized draining gas, and a biopharmaceutical fluid to be received and transferred under controlled pressure is also provided,

providing a filling line and a drain line,

when the biopharmaceutical fluid is to be received in the device, first the integrated means for bleeding the gas filling the filling line is used, thus bleeding the gas filling the filling line, then the inner container of the inner bag is filled with biopharmaceutical fluid via the filling inlet, next the filling inlet is placed in the closed state, the drain outlet being in the closed state, and biopharmaceutical fluid is left in the inner container of the inner bag as long as desired, and

when it is desired to transfer the biopharmaceutical fluid from the inner container under controlled pressure;

the injection line for pressurized draining gas and the injection inlet for pressurized draining gas of the outer receptacle are connected in fluid communication and the drain outlet is placed in the open state, and

then the pressurized draining gas is injected into the compression chamber between the outer receptacle and the inner bag, the pressure compressing the inner bag and causing the biopharmaceutical fluid contained therein to drain out.

31. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 30, wherein a means with pressure loss such as a filter is associated in fluid communication with the drain tube or drain outlet of the inner container of biopharmaceutical fluid.

32. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 30, wherein, while draining, the drain port is placed towards the lower portion of the inner bag, in particular the lowermost portion of the inner bag.

33. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 30, wherein the draining gas is injected such that the pressure of the biopharmaceutical fluid in the drain outlet is substantially constant throughout the draining.

34. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 30, wherein the draining gas is supplied at a pressure equal to at least 70 mbar.

35. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 30, wherein use is made of an integrated means for bleeding the gas filling the filling line comprising a bag for initial draining, an extrinsic fluid connection to the filling tube, an opening/closing device on the extrinsic fluid connection, and an opening/closing device on the filling tube, and wherein in order to bleed the gas filling the filling line prior to filling with biopharmaceutical fluid, the opening/closing device on the filling tube is closed, then while the opening/closing device on the extrinsic fluid connection is open the filling with biopharmaceutical fluid begins, and when the biopharmaceutical fluid reaches the extrinsic fluid connection the opening/closing device on the extrinsic fluid connection is closed and the opening/closing device on the filling tube is opened.

36. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 30, wherein use is made of a device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure wherein the outer container comprises a flexible outer bag and an external containment means, the outer bag being placed within the external containment means to limit the expansion capacity of the outer bag when pressurized draining gas is being injected into the compression chamber.

64. A method for the reception and transfer of a biopharmaceutical fluid under controlled pressure, wherein:

a system is provided for the reception and transfer of a biopharmaceutical fluid under controlled pressure, said system comprising;

a device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure, said device comprising;

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,

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 forming a coherent whole that is disposable, and

a means with pressure loss such as a filter associated in fluid communication with the drain tube or drain outlet of the inner container of biopharmaceutical fluid, and

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, and

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,

a means intended and suitable for supplying a pressurized draining gas, having a pressurized draining gas injection line adapted to be association in fluid communication or associated in fluid communication with the pressurized draining gas injection inlet or port of said device, and

a means for monitoring and controlling the pressure of the pressurized draining gas in the pressurized draining gas injection line,

the system being provided in the state that is empty of biopharmaceutical fluid and of pressurized draining gas, and a biopharmaceutical fluid to be received and transferred under controlled pressure is also provided,

providing of a filling line and a drain line

when the biopharmaceutical fluid is to be received in the device, first the integrated means for bleeding the gas filling the filling line is used, thus bleeding the gas filling the filling line, then the inner container of the inner bag is filled with biopharmaceutical fluid via the filling inlet, next the filling inlet is placed in the closed state, the drain outlet being in the closed state, and biopharmaceutical fluid is left in the inner container of the inner bag as long as desired, and

when it is desired to transfer the biopharmaceutical fluid from the inner container under controlled pressure;

the injection line for pressurized draining gas and the injection inlet for pressurized draining gas of the outer receptacle are connected in fluid communication and the drain outlet is placed in the open state, and

then the pressurized draining gas is injected into the compression chamber between the outer receptacle and the inner bag, the pressure compressing the inner bag and causing the biopharmaceutical fluid contained therein to drain out.

65. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 64, wherein a means with pressure loss such as a filter is associated in fluid communication with the drain tube or drain outlet of the inner container of biopharmaceutical fluid.

66. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 64, wherein, while draining, the drain port is placed towards the lower portion of the inner bag, in particular the lowermost portion of the inner bag.

67. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 64, wherein the draining gas is injected such that the pressure of the biopharmaceutical fluid in the drain outlet is substantially constant throughout the draining.

68. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 64, wherein the draining gas is supplied at a pressure equal to at least 70 mbar.

69. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 64, wherein use is made of an integrated means for bleeding the gas filling the filling line comprising a bag for initial draining, an extrinsic fluid connection to the filling tube, an opening/closing device on the extrinsic fluid connection, and an opening/closing device on the filling tube, and wherein in order to bleed the gas filling the filling line prior to filling with biopharmaceutical fluid, the opening/closing device on the filling tube is closed, then while the opening/closing device on the extrinsic fluid connection is open the filling with biopharmaceutical fluid begins, and when the biopharmaceutical fluid reaches the extrinsic fluid connection the opening/closing device on the extrinsic fluid connection is closed and the opening/closing device on the filling tube is opened.

70. The method for the reception and transfer of a biopharmaceutical fluid under controlled pressure according to claim 64, wherein use is made of a device for the reception and then the draining of a biopharmaceutical fluid under controlled pressure wherein the outer container comprises a flexible outer bag and an external containment means, the outer bag being placed within the external containment means to limit the expansion capacity of the outer bag when pressurized draining gas is being injected into the compression chamber.