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 - 8 . (canceled)
9 . A method of sterilization, comprising:
selecting a medical device for sterilization;
placing the medical device in a first outer package, wherein the outer package comprises a first portion that is permeable to SC—CO 2 and a sterilant and second portion that is impermeable to moisture; and
treating the medical device with SC—CO 2 and the sterilant.
10 . The method of claim 9 , wherein the device comprises acellular tissue matrix.
11 . The method of claim 9 , wherein the device comprises demineralized bone matrix.
12 . The method of claim 9 , wherein the sterilant comprises peracetic acid (PAA).
13 . The method of claim 9 , wherein the sterilant further comprises a peroxide.
14 . The method of claim 9 , wherein the peroxide is H 2 O 2 .
15 . The method of claim 9 , wherein the concentrations of PAA and H 2 O 2 in the sterilant are 10-14% and 1-3%, respectively.
16 . The method of claim 9 , wherein during the sterilization process, pressure and temperature are kept constant.
17 . The method of claim 9 , further comprising packaging the device in an inner package that is permeable to the sterilant.
18 . The method of claim 9 , further comprising sealing the second portion subsequent to sterilization.
19 . The method of claim 9 , wherein the first portion comprises flash spun high density polyethylene.
20 . The method of claim 9 , wherein the second portion comprises foil.
21 . The method of claim 9 , further comprising positioning a structure inside the outer package to maintain a flow path within the outer package during sterilization.
22 . The method of claim 21 , wherein the inner structure comprises a mesh cylinder.
23 . The method of claim 22 , wherein the device is positioned inside the mesh cylinder.
24 - 29 . (canceled)