System and method for detecting a possible loss of integrity of a flexible bag for biopharmaceutical product
US12018998B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Jun 17, 2020 |
| Grant date | Jun 25, 2024 |
| Priority date | — |
| Expiry date | Apr 8, 2041 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01M3/3281
- WIPO fieldMeasurement
- WIPO sectorInstruments
Abstract
Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The bag is preliminary placed in vacuum chamber of a fluid-tightly isolated enclosure. After connecting a port of the bag to a helium feeding pipe and after pre-pressurizing the bag with nitrogen, a test is performed in a vacuum suction mode for a detection area outside the bag in the enclosure. Before starting the test phase, the bag is additionally filled with an amount of helium. A detection detects information representative of helium partial pressure in the internal volume, to allow detection of helium escaping from the bag, by analysis of a helium partial pressure drop. A small amount of nitrogen is sufficient to decrease leak rate mean value, so that uncertainty regarding integrity of some bags decreases.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.