Pouch with incorporated loss of integrity indicator, method for making such a bag, and method for using same
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United States of America Patent
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Sep 22, 2015
Grant Date -
May 24, 2012
app pub date -
Jun 14, 2010
filing date -
Jun 18, 2009
priority date (Note) -
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Abstract
A pouch includes: a first closed, inner casing, made of at least one non-porous plastic material with a high-capacity gas barrier, delimiting a first space, forming a pouch stricto sensu for accommodating a biopharmaceutical product or device, 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 pouch stricto sensu is located, spacer elements, at least one selected tracer gas, located in the first or second space outside of the pouch stricto sensu, with a higher partial pressure than in the second space outside of the pouch stricto sensu or in the first space, at least one colorimetric detector located, respectively, in the second space outside of the pouch stricto sensu or in the first space responsive to the concentration of the tracer gas, by switching from a first color to a second different color.
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