Device for conveying a bag comprising a biopharmaceutical fluid and systems and a method using same

Patent metadata

Field	Value
Publication number	US-10532870-B2
Application number	US-201615556567-A
Country	US
Kind code	B2
Filing date	Mar 8, 2016
Priority date	Mar 9, 2015
Publication date	Jan 14, 2020
Grant date	Jan 14, 2020

Abstract

Disclosed is a device for transporting a biopharmaceutical fluid, including an inner bag forming an inner chamber adapted and intended for receiving a biopharmaceutical fluid, an outer container including an outer receptacle, the outer receptacle including a wall forming an outer chamber, an expandable protective element arranged at least partially between the outer receptacle and the inner bag and adapted to receive the inner bag, the expandable protective element being adapted to expand in volume to an expanded state so as to be interposed between the outer receptacle and the inner bag, the expandable protective element in the expanded state surrounding the inner bag and filling the space between the wall of the outer receptacle and the inner bag.

First claim

The invention claimed is:

1. A device for storing and transporting a biopharmaceutical fluid, comprising:
an inner bag made of plastic, flexible and fluidtight, the inner bag forming an inner chamber adapted and intended for receiving a biopharmaceutical fluid, the inner bag being provided with a wall and one orifice for at least one of fill and discharge of biopharmaceutical fluid and at least one of a fill tube and a discharge tube associated in a fluidtight manner with the at least one of fill and discharge orifice,
an outer container comprising an outer receptacle, the outer receptacle comprising a wall forming an outer chamber, both the entire inner bag and the at least one of a fill tube and a discharge tube being located entirely in the outer chamber of the outer container,
an expandable protective element arranged at least partially between the outer receptacle and the inner bag and adapted to receive the inner bag, the expandable protective element being adapted to expand in volume to an expanded state so as to be interposed between the outer receptacle and the inner bag,
wherein the expandable protective element in the expanded state surrounds the inner bag and fills the space between the wall of the outer receptacle and the inner bag.

2. The device according to claim 1 , wherein the outer container consists of the outer receptacle.

3. The device according to claim 1 , wherein the outer receptacle comprises a single foldable wall adapted to form, when folded, the outer receptacle being of a parallelepipedic shape, the outer receptacle comprising a lower wall and a peripheral side wall.

4. The device according to claim 1 , wherein the outer container is of large capacity in order to receive multiple inner bags filled with biopharmaceutical fluid.

5. The device according to claim 1 , wherein the wall of the outer receptacle is partly or entirely translucent so as to allow viewing, through the wall, the expandable protective element and the inner bag.

6. The device according to claim 1 , wherein the wall of the outer receptacle is partly or entirely opaque to light or to ultraviolet rays.

7. The device according to claim 1 , wherein the outer receptacle comprises a first compartment and a second compartment, the first compartment being adapted and intended for receiving the wall of the inner bag, the second compartment being adapted and intended for receiving the at least one of a fill tube and a discharge tube of the inner bag.

8. The device according to claim 7 , wherein the outer receptacle comprises a separation, the separation defining the first compartment and the second compartment of the outer receptacle.

9. The device according to claim 1 , wherein the expandable protective element comprises a flowable material adapted to expand in volume to the expanded state.

10. The device according to claim 1 , wherein the expandable protective element is inflatable, the expandable protective element being provided with an injection orifice providing a passage for injection of inflation gas, the injection orifice being in fluid communication with the protective element, the injection orifice associated by a fluidtight connection with a first end of an injection tube, the injection tube having at an opposite second end an inlet for the injection of inflation gas into the expandable protective element.

11. The device according to claim 10 , wherein the expandable protective element comprises a wall, the wall comprising inflatable elements interconnected in fluid communication so as to form together a protective chamber, the inner bag being suitable for placement in the protective chamber.

12. The device according to claim 10 , wherein the inner bag is arranged in an individual expandable protective element.

13. The device according to claim 10 , wherein the orifice for the injection of inflation gas is formed in an exterior injection orifice of the wall of the outer receptacle.

14. The device according to claim 10 , wherein, when inflation gas is injected into the protective element, the protective element occupies the space between the inner bag and the outer receptacle so as to limit the ability of the inner bag to move within the outer receptacle.

15. The device according to claim 1 , wherein the expandable protective element comprises a first portion and a second portion, the first portion surrounding the wall of the inner bag, the second portion surrounding the at least one of fill and discharge orifice of the inner bag as well as the at least one of a fill tube and a discharge tube.

16. The device according to claim 1 , wherein the at least one of a fill tube and a discharge tube traverses the outer receptacle.

17. The device according to claim 1 , wherein the expandable protective element is partly or entirely, translucent or transparent so as to allow viewing the inner bag.

18. The device according to claim 1 , wherein the expandable protective element is partly or possibly entirely, opaque to light or to ultraviolet rays.

19. The device according to claim 1 , wherein the one orifice for at least one of fill and discharge of biopharmaceutical fluid includes a discharge orifice for association with a discharge member adapted so that the discharge orifice is located in a lower portion of the inner bag.

20. The device according to claim 19 , wherein the discharge member comprises a member for inclining the device, the inclining member having one or more legs associated with the outer receptacle and resting on a horizontal support surface.

21. The device according to claim 19 , wherein said discharge member adapted so that the discharge orifice is positioned in the lower portion of the inner bag comprises a portion of the wall of the expandable protective element.

22. The device according to claim 1 , wherein the outer receptacle comprises a rigid inner wall which enables inclining the inner bag when said bag is arranged in the outer receptacle.

23. A method for receiving and transporting a biopharmaceutical fluid, wherein
a device according to claim 10 is provided, the inner bag having a wall and one orifice for at least one filling with and discharging biopharmaceutical fluid and the at least one of a fill tube and a discharge tube associated in a fluidtight manner with the at least one of fill and discharge orifice, the device then being in a state empty of biopharmaceutical fluid and of pressurized inflation gas, the outer receptacle being open,
the inner bag is placed inside the protective element,
the expandable protective element together with the inner bag are placed inside the receptacle, the inner chamber of the inner bag is filled with biopharmaceutical fluid via the fill orifice,
the expandable protective element is filled with inflation gas, and
the outer receptacle is closed.

24. A method for receiving and transporting a biopharmaceutical fluid, wherein:
a device according to claim 10 is provided, the inner bag having a wall and one orifice for filling with biopharmaceutical fluid and a fill tube associated in a fluidtight manner with the fill orifice, the device then being in a state empty of biopharmaceutical fluid and of pressurized inflation gas, the outer receptacle being open,
the expandable protective element is placed inside the receptacle, one end of the expandable protective element protruding beyond the outer receptacle,
the inner bag is placed inside the receptacle on the protective element, the end of t

Assignees

• Sartorius Stedim Fmt Sas

Inventors

• Baud Stephane
• Gay Isabelle
• Ponassi Danilo

Classifications

• B65D81/052

  filled with fluid, e.g. inflatable elements · CPC title

• B65D77/06 Primary

  Liquids or semi-liquids {or other materials or articles} enclosed in flexible containers disposed within rigid containers · CPC title

• B65D3/02

  characterised by shape · CPC title

• B65D35/28

  for expelling contents · CPC title

• B65D2581/051

  Details of packaging elements for maintaining contents at spaced relation from package walls, or from other contents · CPC title