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

摘要

The package i.e. three-dimensional (3D) stricto sensu pouch (1), has a flexible main outer wall (3) for assuring gas and pathogenic germ sealing, and an opening/closing unit e.g. colorimetric detection layer (12), for closing and opening an intake passage (7) with a sterilization gas permeable membrane forming a downstream distribution opening (9). The wall, the passage and the unit are connected together to form the package enclosing the biopharmaceutical content subjected to differential pressure integrity tests requiring gas sealing for the package at any desired time after sterilization. An independent claim is also included for a method for implementing a sterilisable biopharmaceutical package.