Method for sterilizing products

Abstract

A method for sterilizing products to inactivate biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas and parasites is disclosed. The method involves irradiating the product at a low dose rate from about 0.1 kGy/hr. to about 3.0 kGy/hr. for a period of time sufficient to sterilize the product. The method does not destroy sensitive materials such as blood and blood components. Further, the method does not require pre-treatment of the product such as freezing, filtration or the addition of chemical sensitizers.

What i claim as my invention is:  
     
         1 . A method for sterilizing a product comprising irradiating the product at ambient temperature with gamma irradiation at a rate from about 0.1 kGy/hr. to about 3.0 kGy/hr. for a period of time sufficient to sterilize the product.  
     
     
         2 . A method according to  claim 1 , wherein said irradiation is provided at a rate of from about 0.25 kGy/hr. to about 2.0 kGy/hr.  
     
     
         3 . A method according to  claim 1 , wherein said irradiation is provided at a rate of from about. 0.5 kGy/hr. to about 1.5 kGy/hr.  
     
     
         4 . A method according to  claim 1 , wherein said irradiation is provided at a rate of from about 0.5 kGy/hr. to about 1.0 kGy/hr.  
     
     
         5 . A method according to  claim 1 , wherein said product is an organic product.  
     
     
         6 . A method according to  claim 1 , wherein said product is a biological product.  
     
     
         7 . A method according to  claim 1 , wherein said product is blood or a component thereof.  
     
     
         8 . A method according to  claim 7 , wherein said blood or blood component is first treated with ethanol.  
     
     
         9 . A method according to  claim 8 , wherein said ethanol is in a final concentration of approximately 0.01% to 0.05% v/v and said blood or blood product is diluted before irradiation in a physiologically acceptable diluent to achieve a final dilution of at least 1:10.  
     
     
         10 . A method according to  claim 9 , wherein said physiologically acceptable diluent is a modified citrate phosphate dextrose solution having a pH in the range of about 6.4 to about 6.7.  
     
     
         11 . A method according to  claim 10 , wherein said citrate phosphate dextrose solution contains about 0.01% v/v ethanol.  
     
     
         12 . A method according to  claim 7 , wherein said product is diluted with a citrate phosphate dextrose solution.  
     
     
         13 . A method according to  claim 1 , wherein said product contains dextrose.  
     
     
         14 . A method according to  claim 1 , wherein said product is a protein.  
     
     
         15 . A method according to  claim 14 , wherein said product is an antibody.  
     
     
         16 . A method according to  claim 1 , wherein said product is in lyophilized form.  
     
     
         17 . A method according to  claim 1 , wherein said product is selected from the group consisting of IgG, albumin, alpha 1 proteinase inhibitor, fibrinogen, Factor VII, Factor VIII and Factor IX.  
     
     
         18 . A method according to  claim 16 , wherein said product is selected from the group consisting of IgG, albumin, alpha 1 proteinase inhibitor, fibrinogen, Factor VII, Factor VIII and Factor IX.