IP Library › Granted Patent US 12,429,397
Granted Patent B2
US 12,429,397 · App. 18/297,085 · Granted Sep 30, 2025

Embossed film bioprocessing containers and integrity testing of bioprocessing containers

Inventors: Brian Pereira (Woburn, MA); Stephen Proulx (Boxborough, MA)
Assignee: EMD Millipore Corporation
G01M3/3218B01L3/505B01L2300/0861
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Quick Facts
Patent No.
US 12,429,397
App. No.
18/297,085
Granted
Sep 30, 2025
Kind
B2
Abstract

A testing method that includes the steps of evacuating air from a container to a negative atmospheric pressure, the container being a collapsible, flexible container, and comprising at least two opposing flexible walls, wherein a surface of at least one of the walls internal to the container comprises a plurality of channels or recessed features on said at least one wall and monitoring a mass flow or a state of vacuum so as to determine the integrity of the container. The container can be of any size or conformation, with or without attached fittings.

Claims (21)

1. A method for integrity testing a collapsible, flexible bioprocessing container using a system, the method comprising:

a) providing a collapsible, flexible bioprocessing container, wherein the container comprises at least two opposing flexible walls, wherein the surface of the walls internal to the container comprise a plurality of channels on said walls;

b) evacuating air from the container and a reference tank connected to the container to a negative atmospheric pressure;

c) sealing the system, the system comprising the container, the tank, and a tester between the container and the tank; and

d) monitoring vacuum decay in the system using the tester, so as to determine the integrity of the container.

2. The method of claim 1 , wherein the plurality of channels are embossed on said walls.

3. The method of claim 1 , wherein the surface of the walls are matte surfaces.

4. The method of claim 1 , wherein the collapsible, flexible bioprocessing container is pre-folded.

5. The method of claim 1 , wherein the collapsible, flexible bioprocessing container further comprises fittings, tubing, connectors, and a combination thereof.

6. The method of claim 1 , wherein the negative atmospheric pressure is between −1 psi to −14 psi.

7. A method of detecting a 2 micron or larger defect in a collapsible, flexible bioprocessing container, the method comprising:

a) providing a collapsible, flexible bioprocessing container, the container comprising at least two opposing flexible walls, wherein the surface of the walls internal to the container comprise a plurality of channels on said walls;

b) evacuating air from the container and a reference tank connected to the container to a negative atmospheric pressure;

c) sealing the system, the system comprising the container, the tank, and a tester between the container and the tank; and

d) monitoring vacuum decay of the system using the tester, wherein an increase in mass flow indicates the presence of a defect.

8. The method of claim 7 , wherein the plurality of channels are embossed on said walls.

9. The method of claim 8 , wherein the surface of the walls are matte surfaces.

10. The method of claim 7 , wherein the surface of the walls are matte surfaces.

11. The method of claim 7 , wherein the collapsible, flexible bioprocessing container is pre-folded.

12. The method of claim 7 , wherein the container further comprises fittings, tubing, connectors, and a combination thereof.

13. The method of claim 7 , wherein the negative atmospheric pressure is between −1 psi to −14 psi.

Continuity (3)
Division 16644109
Provisional Application 62567266 · Oct 3, 2017
Related Publication 20230324253A1 · Oct 12, 2023
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