Systems and Methods for Sterilization
Systems for sterilization of tissues, including acellular tissue matrices, comprising a package having a portion permeable to supercritical carbon dioxide and a portion impermeable to moisture are described. Methods of sterilizing acellular tissue matrices from soft tissues or demineralized bone are provided.
1 . A packaging system for a medical device, comprising an outer package, the outer package comprising a first portion and a second portion, wherein the first portion is permeable to supercritical carbon dioxide (SC-CO 2 ) and a sterilant, and wherein when the second portion is sealed it is impermeable to moisture;
an inner structure configured to hold the second portion open during sterilization, wherein the inner structure is separate from the outer package; and
an inner package that is permeable to SC-CO 2 and a sterilant, wherein the inner package is positioned within the inner structure.
2 . The packaging system of claim 1 , wherein the first portion comprises flash spun high-density polyethylene fibers.
3 . The packaging system of claim 1 , wherein the second portion comprises foil.
4 . The packaging system of claim 1 , wherein the inner package comprises flash spun high-density polyethylene fibers.
5 . The packaging system of claim 1 , wherein the inner structure is permeable to supercritical carbon dioxide SC-CO 2 and the sterilant.
6 . The packaging system of claim 5 , wherein the inner structure comprises a mesh cylinder.
7 . A packaged medical device, comprising:
an outer package comprising a first portion and a second portion, wherein when the second portion is sealed it is impermeable to moisture;
an inner structure configured to hold the second portion open during sterilization, wherein the inner structure is separate from the outer package;
an inner package that is permeable to SC-CO 2 and a sterilant and is positioned within the inner structure; and
a medical device contained within the inner package.
8 . The device of claim 7 , wherein the outer package comprises foil.
9 . The device of claim 7 , wherein the inner structure comprises a mesh cylinder.
10 . The device of claim 7 , wherein the medical device is an acellular tissue matrix.