Method and system, using a colorimetric indicator, for detecting a possible loss of integrity of a flexible bag for biopharmaceutical product

US11898938B2 · kind B2 · utility

Assignee

• Sartorius Stedim FMT SAS · FR

Inventors

• Marc Hogreve · Dransfeld, DE
• Martin Dahlberg · Bovenden, DE

Key dates

• Filing date: Mar 20, 2020
• Grant date: Feb 13, 2024
• Expiry date: Oct 20, 2040

Classification

• Technology area (CPC G): Physics
• CPC primary: G01M3/38
• WIPO field: Measurement
• WIPO sector: Instruments

Abstract

Integrity of a flexible bag already filled with a biopharmaceutical fluid is verified by a receiving and controlling device. The first wall and a second wall, forming two opposite walls on both sides of a longitudinal axis of the bag, are in contact with the fluid and with two parallel restraining plates of the device, while test pressure is controlled. Additionally, an integrity/non-integrity indicator device that comprises a pair of covering walls is provided to be interposed between the bag walls and the restraining plates. A leak through the bag walls can be detected by a color change of at least one continuous colorimetric detection layer, integral with or included in the pair of covering walls. Such continuous colorimetric detection layer is included in a permeable or impregnable layer.