Humidity-management packaging systems and methods

A packaging system for storing a dry bioprosthetic device, the packaging system comprising:

• a package defining an internal volume when the package is sealed;
• at least one dry bioprosthetic device;
• and
• at least one humidity control device comprising:
• an at least partially gas-permeable enclosure, and
• a humidity control composition disposed within the at least partially gas-permeable enclosure;
• wherein the at least one dry bioprosthetic device and the at least one humidity control device are configured to be contained within the internal volume of the package when the package is sealed;
• wherein the at least one humidity control device is configured to maintain a relative humidity within the internal volume of the package within about +5% of a target relative humidity across a temperature range from about −18° C. to about 45° C., by selectively liberating and absorbing water vapor through the at least partially gas-permeable enclosure;
• and
• wherein the target relative humidity is selected from the range from about 15% to about 95%.

A method of storing at least one bioprosthetic device within a packaging system, the method comprising the steps of:

• selecting a target relative humidity to be substantially maintained within an internal volume of an outer packaging across a temperature range when the outer packaging is sealed;
• providing at least one humidity control device comprising a humidity control composition within an at least partially gas-permeable enclosure, wherein the humidity control composition has a total weight, wherein the humidity control device is configured to maintain a relative humidity within the internal volume of the outer packaging within about +5% of a target relative humidity across a temperature range from about −18° C. to about 45° C., by selectively liberating and absorbing water vapor through the at least partially gas-permeable enclosure, and wherein the target relative humidity is selected from the range from about 15% to about 95%;
• placing the at least one humidity control device and the at least one bioprosthetic device within the internal volume of the outer packaging;
• and
• sealing the outer packaging containing the at least one humidity control device and the at least one bioprosthetic device.