System and method for detecting a possible loss of integrity of a flexible bag for biopharmaceutical product

US11846566B2 · kind B2 · utility

Assignee

• Sartorius Stedim FMT SAS · FR

Inventors

• Laurent Thenard · Saint-Victor, FR
• Marc Hogreve · Dransfeld, DE
• Tomasz Urbaniak · Göttingen, DE
• Mandip Nachhattar · Bobigny, FR
• Delphine Philippeau · Marseilles, FR
• Bastien Cattaux · Aubagne, FR

Key dates

• Filing date: Jan 28, 2020
• Grant date: Dec 19, 2023
• Expiry date: Feb 5, 2041

Classification

• Technology area (CPC G): Physics
• CPC primary: G01M3/3281
• WIPO field: Measurement
• WIPO sector: Instruments

Abstract

Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The flexible 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, vacuum suction is performed to obtain vacuum outside the bag in the enclosure. Then, a first amount of helium is diffused in the internal volume of the enclosure through a gas permeable wall, to increase helium partial pressure outside the flexible bag. After, in a test phase while said vacuum suction is still performed, the bag is filled with a second amount of helium. A detector 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.