Detection of the integrity of a tight, closed, soft plastic pouch for receiving and protecting a product or a biopharmaceutical device

US9005978B2 · kind B2 · utility

Assignee

• Sartorius Stedim FMT SAS · FR

Inventors

• Lars Böttcher · Schwarzenberg, DE
• Martin Dahlberg · Bovenden, DE

Key dates

• Filing date: Aug 22, 2011
• Grant date: Apr 14, 2015
• Expiry date: Apr 8, 2032

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61L2202/181
• WIPO field: Measurement
• WIPO sector: Instruments

Abstract

A pouch (2) includes: a first, inner, envelope (1) which is closed, delimiting a first space (6) forming a pouch stricto sensu (1) intended for receiving a biopharmaceutical product or device; a second, outer, envelope (8) which is closed, delimiting a second space (9) in which is located the first envelope/pouch stricto sensu (1); a spacer element (11); at least one tracer gas located in the first space (6) or in the intermediate space (14) at a partial pressure different from that of the intermediate space or of the first space; and at least one colorimetric detection layer (12), responding to the concentration of tracer gas which reaches it by changing from a first color to a second color, and being an integral part of a wall (3, 4) of the first envelope/defined pouch (1) and/or of a wall (13) of the second envelope and/or of the spacer element.