Embossed film bioprocessing containers and integrity testing of bioprocessing containers
US-12050159-B2 · Jul 30, 2024 · US
US12429397B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12429397-B2 |
| Application number | US-202318297085-A |
| Country | US |
| Kind code | B2 |
| Filing date | Apr 7, 2023 |
| Priority date | Oct 3, 2017 |
| Publication date | Sep 30, 2025 |
| Grant date | Sep 30, 2025 |
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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.
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What is claimed is: 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.
Configuration of multiple channels and/or chambers in a single devices · CPC title
Flexible containers without fluid transport within · CPC title
Manifolds; Distribution pieces (fluid transfer means B01L3/563) · CPC title
disposable or single use · CPC title
flexible (flexible containers for laboratory use B01L3/505) · CPC title
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