Patent ID: 9139348
Filing Date: 2015-09-22
Classification: B65B,B65D,G01N

Abstract:
1. A pouch comprising: a first flexible, closed, inner casing made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a first space pouch configured to accommodate a fluid biopharmaceutical product or device, the inner casing including a second, closed, outer casing made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a second space in which the first space pouch is located for detection of a loss of integrity of the first space pouch including a spacer means interposed between the first space pouch and the second casing, an inner surface of the second casing being configured to not conceal a zone of loss of integrity of an outer surface of the first space pouch, the spacer means being or including porous material; at least one tracer gas that is located respectively in one of the first space or in the second space, the second space being outside of the first space pouch, having a higher partial pressure than a pressure in the other of the first space and the second space; and an incorporated loss of integrity indicator including at least one colorimetric detector that detects the at least one tracer gas, the at least one colorimetric detector being responsive to a concentration of the tracer gas in an environment in which the detector is located, by switching from a first color to a second color that is different from the first color, the at least one colorimetric detector being located in one or more of the second space outside of the first space pouch and in the first space, wherein the colorimetric detector is configured to visually indicate one of the first color, signifying that the first space pouch has kept its integrity, and the second color, signifying that the first space pouch has lost its integrity, after the pouch with the incorporated loss of integrity indicator is manufactured and at least before the time when the first space pouch is evacuated, extracted, or removed from the second casing and the biopharmaceutical product or device is introduced into the first space pouch, and the colorimetric detector is configured to detect the at least one tracer gas when the first space pouch is devoid of the biopharmaceutical product or device and when the second, closed, outer casing is maintained in a closed state.