Multi-envelope bag and systems and methods for detecting a possible loss of integrity of such a bag

Patent metadata

Field	Value
Publication number	US-10585015-B2
Application number	US-201615558624-A
Country	US
Kind code	B2
Filing date	Mar 17, 2016
Priority date	Mar 19, 2015
Publication date	Mar 10, 2020
Grant date	Mar 10, 2020

Abstract

Disclosed is a bag including: a first envelope having at least one fill and/or discharge orifice for a biopharmaceutical fluid and a fill and/or discharge tube associated in a fluidtight manner with the fill and/or discharge orifice, a second envelope within which the first envelope is located, and a spacer element. The first envelope, the second envelope, and the spacer element form a coherent whole, in particular during use of the bag, and the fill and/or discharge tube traverses the second envelope by a fluidtight connection, the fill and/or discharge inlet being located outside the second envelope.

First claim

The invention claimed is:

1. A bag for biopharmaceutical fluid, comprising:
a first envelope which is flexible, closed, fluidtight, and made of plastic, having a wall defining a first inner chamber intended for receiving the biopharmaceutical fluid, the first envelope being provided with at least one fill and/or discharge orifice for filling and/or discharging the biopharmaceutical fluid and at least one fill and/or discharge tube associated in a fluidtight manner with the at least one fill and/or discharge orifice, the at least one fill and/or discharge tube having an inlet for filling and/or discharging the first inner chamber,
a second envelope which is flexible, closed, fluidtight, and made of plastic, having a wall defining a second inner chamber within which the first envelope is located, the second inner chamber defining an intermediate space between the wall of the first envelope and the wall of the second envelope, and
a spacer element interposed between the first envelope and the second envelope, in the intermediate space, suitable for preventing a possible hole in the wall of the first envelope or in the wall of the second envelope from being covered,

wherein the first envelope, the second envelope, and the spacer element form a coherent whole, and wherein the at least one fill and/or discharge tube traverses the second envelope by a fluidtight connection, the fill and/or discharge inlet being located outside the second envelope.

2. The bag according to claim 1 , wherein the spacer element is porous and completely covers the wall of the first envelope.

3. The bag according to claim 1 , wherein the spacer element is porous and comprises an opening to the wall of the first envelope.

4. The bag according to claim 1 , wherein the first envelope is of a 2D type or wherein the first envelope is of a 3D type comprising one or more gussets.

5. The bag according to claim 1 , wherein the spacer element comprises at least one porous layer of woven fabric, non-woven fabric, PE, PP, or PTFE.

6. The bag according to claim 1 , wherein the spacer element is responsive to the biopharmaceutical fluid that reaches it, and wherein the bag further comprises a detection member to detect an interaction between the spacer element and the biopharmaceutical fluid.

7. The bag according to claim 1 , wherein the spacer element is neutral to the biopharmaceutical product.

8. The bag according to claim 1 , wherein the wall of the second envelope comprises a port suitable for being closed or connected in a fluidtight and removable manner to a source of gas or fluid.

9. The bag according to claim 1 , comprising a third envelope which is flexible, closed, fluidtight, and made of plastic, having a wall defining a third inner chamber in which the second envelope is located, the third envelope defining an additional intermediate space between the wall of the second envelope and the wall of the third envelope, the bag further comprising an additional spacer element interposed between the second envelope and the third envelope.

10. The bag according to claim 9 , wherein the first envelope, the second envelope, the third envelope, the spacer element and the additional spacer element form a coherent whole during use of the bag,
and wherein the additional spacer element is suitable for preventing a possible third envelope wall hole from being covered by the wall of the second envelope.

11. The bag according to claim 9 , wherein the at least one fill and/or discharge tube traverses the third envelope by a fluidtight connection, the fill and/or discharge inlet being located outside the third envelope.

12. The bag according to claim 9 , wherein the intermediate space is filled with a tracer gas at a pressure greater than the pressure present in the additional intermediate space and in the first inner chamber.

13. The bag according to claim 12 , wherein the tracer gas is selected from the group comprising carbon dioxide, helium, sulfur hexafluoride, nitrogen, or a mixture thereof.

14. A system for verifying the integrity of a bag, comprising:
a bag according to claim 1 ,
a source of pressurized gas intended to be introduced into the intermediate space of the bag,
a member for measuring the pressure of the gas in the intermediate space in order to compare the pressure drop in the intermediate space once inflated, relative to a predefined pressure drop threshold, and
two fixed expansion-limiting plates, spaced apart from and facing one another, suitable for not obstructing any leak in the wall of the second envelope placed against them.

15. The system according to claim 14 , wherein the expansion-limiting plates are respectively covered with linings that are porous to the gas.

16. The system according to claim 15 , wherein the linings are of the same material as the spacer element.

17. A method for verifying the integrity of a bag in order to detect the existence of a possible hole, wherein:
in a preparation phase:
the system for verifying integrity according to claim 14 is provided,
the bag is placed between the two expansion-limiting plates,
at least one port of the second envelope is connected to the source of gas and the pressure measurement member, in order to be able to send the pressurized gas into the intermediate space,

in a test phase:
the pressurized gas is sent into the intermediate space, the expansion of the bag being restricted when the wall of the second envelope encounters the expansion-limiting plates,
then, in a subsequent step, the pressure drop in the intermediate space is compared to the predefined threshold by means of the pressure measurement member, such that if the pressure drop in the intermediate space is less than the threshold the second envelope is considered to have passed the integrity verification, whereas if the pressure drop in the intermediate space is greater than the threshold the second envelope is considered not to have passed the integrity verification.

18. A system for monitoring the integrity of a bag, wherein the system comprises a gas detection member and the bag according to claim 1 .

19. The system according to claim 18 , further comprising:
a source of pressurized gas intended to be introduced into the intermediate space,
a gas pressure control and management member.

20. The system according to claim 19 , further comprising an outer container adapted and intended for receiving the bag in its entirety.

21. A method for verifying the integrity of a bag in order to detect the existence of a possible hole, wherein:
in a preparation phase:
a system for verifying integrity according to claim 18 is provided,

in a test phase:
the presence of gas outside the second envelope is detected by means of the gas detection member, such that if the gas is not detected the second envelope is considered to have passed the integrity verification, whereas if the gas is detected the second envelope is considered not to have passed the integrity verification.

22. The method according to claim 21 , wherein, in the preparation phase, a system for monitoring the integrity of the bag is provided, the system comprising:
the gas detection member;
a source of pressurized gas intended to be introduced into the intermediate space; and
a gas pressure control and management member;
and wherein at least one port of the second envelope is connected to the source of gas and the gas pressure control and management member, in order to be able to send the pressur

Assignees

• Sartorius Stedim Fmt Sas

Inventors

• Thenard Laurent
• Hogreve Marc
• Menier Marie-Christine

Classifications

• B65D31/10

  with gusseted sides · CPC title

• G01M3/027

  Details with respect to the testing of elastic elements, e.g. gloves, condoms · CPC title

• A61J1/1475

  Inlet or outlet ports · CPC title

• A61J1/10

  Bag-type containers · CPC title

• A61J1/1468

  Containers characterised by specific material properties · CPC title