Method of sterilization
First Claim
1. A process for sterilization of material, which process comprises treating such material with a solution containing an effective amount of a coupling agent capable of creating amide bonds and maintaining such treatment for a time and at a temperature which is sufficient to kill microorganisms carried by such material, which treating is effective to cause at least a log 6 reduction in spores and bacteria that may have a resistance to chemical sterilants as great as that of Bacillus subtilis.
1 Assignment
0 Petitions
Accused Products
Abstract
Heart valves or other components for replacement of heart or other bodily organs and tissue prostheses or synthetic prosthetic materials are effectively sterilized by treatment with a carbodiimide coupling agent known to create amide linkages between amines and carboxylic acids. Such treatment has been shown to be bactericidal when carried out using an effective concentration of such a carbodiimide at a temperature of at least about 35° C. for a sufficient period of time, e.g. treatment for about 9 hours at a concentration of at least about 50 mM. The sterilization treatment preferably employs EDC as a water-soluble coupling agent. Such sterilization treatment of biological tissue that has previously been fixed by subjection to stabilizing cross-linking is preferably carried out in a buffered aqueous solution and leaves no residuals other than ones which are nontoxic and biocompatible; moreover, it does not affect the desirable characteristics of resistance to thermal denaturation and to digestion by proteolytic enzymes, which are a product of such prior fixing, and may actually increase the resistance of such fixed biological tissue to degeneration and calcification.
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Citations
19 Claims
- 1. A process for sterilization of material, which process comprises treating such material with a solution containing an effective amount of a coupling agent capable of creating amide bonds and maintaining such treatment for a time and at a temperature which is sufficient to kill microorganisms carried by such material, which treating is effective to cause at least a log 6 reduction in spores and bacteria that may have a resistance to chemical sterilants as great as that of Bacillus subtilis.
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11. A process for sterilization of biological tissue that has been previously subjected to cross-linking to improve stability, which process comprises treating such biological tissue at a temperature of at least about 35°
- C. with an aqueous solution containing a concentration of at least about 25 mM of a water-soluble carbodiimide coupling agent that is capable of creating amide bonds for a period of concentration-time units sufficient to effectively kill any bacteria and spores carried by such biological tissue.
- View Dependent Claims (12, 13, 14, 15)
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16. A process for sterilization of biological material, which process comprises treating such material with an aqueous solution containing a concentration of at least about 50 mM of a water-soluble carbodiimide coupling agent capable of creating amide bonds, at a temperature of at least about 40°
- C., and maintaining such treatment for a time which is sufficient for said coupling agent to effectively kill spores and bacteria that may be carried by such material.
- View Dependent Claims (17, 18, 19)
Specification