Methods of obtaining sterile milk and compositions thereof

Abstract

The disclosure provides a simple and effective methods for sterilization of milk without degradation or loss of biologically active agents in the milk and the products produced by such methods.

In the claims: 
     
         1 . A method for obtaining a human milk composition comprising:
 filtering whole milk through at filter of about 100-400 microns;   heat treating the whole milk at about 58-65° C. for about 20-40 minutes;   separating the whole milk into a skim portion and a fat portion;   filtering the skim portion through one or more skim filters to obtain a permeate portion and a protein rich skim portion;   heating the fat portion to a temperature of about 90-120° C. for about one hour sufficient to reduce the bioburden of the fat portion; and   mixing a fraction of the processed fat portion with the protein rich skim portion to obtain a human milk composition.   
     
     
         2 . The method of  claim 1 , wherein the whole milk comprises pooled human milk. 
     
     
         3 . The method of  claim 1 , further comprising testing a sample of the whole milk for the presence of HIV, HBV, HCV or any combination thereof prior to filtration. 
     
     
         4 . The method of  claim 1 , wherein the filtering of whole milk is performed through a filter-screen of about 200 microns. 
     
     
         5 . The method of  claim 1 , wherein the heat treating of the whole milk is at about 63° C. for about 30 minutes. 
     
     
         6 . The method of  claim 1 , wherein the skim portion following separation comprises about 0.69% fat, about 1.07% protein, and about 7.14% lactose. 
     
     
         7 . The method of  claim 1 , wherein the fat portion following separation comprises about 46% fat, about 2% protein, and about 10% lactose. 
     
     
         8 . The method of  claim 1 , wherein the fat portion is further processed to obtain additional skim. 
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 1 , further comprising adjusting the skim portion with fat portion prior to filtration of the skim portion to obtain a fat concentration in the skim portion of about 55% to about 65% of the protein content of the skim portion. 
     
     
         11 . The method of  claim 1 , wherein the protein rich skim portion comprises about 8% protein. 
     
     
         12 . The method of  claim 1  further comprising washing the one or more skim filters with permeate to obtain a protein wash and adding the protein wash to the protein rich skim portion. 
     
     
         13 . (canceled) 
     
     
         14 . The method of  claim 1 , wherein the human milk composition is pasteurized. 
     
     
         15 . (canceled) 
     
     
         16 . A pasteurized human milk composition comprising
 a protein constituent of about 20-70 mg/ml;   a fat constituent of about 35-85 mg/ml,   a carbohydrate constituent of about 70-115 mg/ml; and   
       wherein the composition comprises human IgA. 
     
     
         17 . The pasteurized human milk composition of  claim 16 , wherein the composition comprises:
 50 mg/ml protein constituent;   75 mg/ml fat constituent; and   105 mg/ml carbohydrate constituent.   
     
     
         18 . The pasteurized human milk composition of  claim 16 , wherein the composition comprises:
 31 mg/ml protein constituent;   44 mg/ml fat constituent; and   79 mg/ml carbohydrate constituent.   
     
     
         19 . The pasteurized human milk composition of  claim 16 , further comprising constituents selected from vitamin A, vitamin C, calcium, iron, phosphorus, magnesium, chlorine, zinc, copper, manganese, sodium, potassium, lysozyme, lactoferrin, vitamin B6 and any combination thereof. 
     
     
         20 . (canceled) 
     
     
         21 . The pasteurized human milk composition of  claim 16 , wherein the IgA comprises from about 100-600 mg/ml. 
     
     
         22 . (canceled) 
     
     
         23 . The pasteurized human milk composition of  claim 19 , wherein the lysozyme comprises 22,000 IU/ml. 
     
     
         24 . The pasteurized human milk composition of  claim 19 , wherein the lactoferrin comprises 0.33 mg/ml. 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . A method of providing supplemental nutrients to preterm infants comprising adding the human milk composition of  claim 16  to human milk and administering the resultant mixed human milk to a premature infant. 
     
     
         28 .- 31 . (canceled)