Multi-Layer Bag with Loss of Integrity Means of Detection

摘要

A multi-layer bag comprising a porous portion configured to allow a sterilizing gas to penetrate into the bag and a gas-impervious portion, characterized in that the gas-impervious portion comprises an outer layer, an inner layer and an intermediate layer integrally formed together so that the intermediate layer is sealingly enclosed between the outer layer and the inner layer so as to be physically isolated from inner and outer environment of the bag, and the intermediate layer comprises a matrix and at least one pigment distributed within the matrix, the pigment being configured to change at least one optical property in reaction to an environment change resulting from a damage of the outer and/or inner layer.