Sterilization of growth factors
AssigneeUnited States Surgical Corporation
InventorsRoss R. Muth, Matthew E. Hermes, Donald S. Kaplan
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Abstract
A human growth factor (HGF), a human growth factor-containing composition or a medical or surgical device such as a wound dressing or suture filled with a human growth factor-containing composition is sterilized employing an ethylene oxide gaseous sterilizant.
Claims3
A process for the sterilization of an article selected from the group consisting of a suture, pad, patch, swab, gauze, bandage, surgical staple, hemostatic clip, prosthetic device and graft, said article containing or filled with a human epidermal growth factor-containing composition of calcium lactate and a member selected from the group consisting of glycerol and sorbitol dissolved in glycerol which comprises contacting the human epidermal growth factor with a gaseous sterilizant containing a concentration of from about 300 to about 1200 mg/l of ethylene oxide under conditions resulting in the sterilization of the human epidermal growth factor and stabilization of the same against loss of biopotency during storage,
- wherein sterilization is carried out at a temperature of from about 75.degree. to about 140.degree. F. for a period of from about 2 to about 12 hours, an ethylene oxide concentration of from about 300 to about 1200 mg/l and a relative humidity of from about 30 to about 80 percent.
Dependencies are inferred from the claim text.