Maintaining high levels of quality of human donor milk is essential for safe and effective use for highly vulnerable infants. Medolac is an evidence based organization offering the most rigorous Milk Banking Safety and Quality Program on a global level. These standards include testing every drop of milk that enters the processing plant before processing for a variety of safety and quality factors.
Why is this important?
Vegetative cells, spores and toxins can and do survive pasteurization of donor milk. Bacillus cereus is a pathogen of particular concern in donor milk banking. Medical professionals may be unaware of the differences between commercial sterility and pasteurization and the methods used by process authorities to professionally process a wide range of food, now including human donor milk. There are many technical and legal aspects of thermal processing methods as well scientific literature that supports the need for commercially sterile milk for fragile neonates. These are emerging areas of concern in milk banking Learn more. 
Donor Screening:
Breast milk donors to a Medolac affiliated milk bank must successfully complete a detailed medical history questionnaire and blood screening. Medolac breast milk donors must be found negative for the blood tests listed below. To continue providing donor milk, donors must repeat this process every six months. Through a partnership with The American Red Cross for serology screening, Medolac is able to utilize enhanced screening for emerging pathogens in addition to the tests found below.
  • Hepatitis B Surface Antigen
  • Antibody to Syphilis
  • HIV: Antibody to Human Immunodeficiency Virus, Types 1 and 2
  • HBC: Antibody to Hepatitis B Core
  • HT1: Antibody to Human T-lymphotropic Virus, Types I and II
  • HCV: Antibody to Hepatitis C Virus
  • CMV: Antibody to Cytomegalovirus
  • HIV-1/HCV/HBV (NAT)
  • WNV: West Nile Virus (NAT)
  • Chagas Disease: Trypanosoma cruzi
  • Immunity to Rubella
  • ​Tuberculosis
Milk Screening:
Any donor breast milk that does not meet Medolac quality standards is immediately segregated. The person who provided such donor milk is contacted and a quality intervention is performed to help her determine the cause of the problem. At Medolac, less than 10% of all shipments do not meet our Quality Standards. Medolac Donor Milk Screening tests for:
  • Aerobic Plate Count 
  • ​Enterobacteriaceae
  • Staphylococcus Aureus
  • Total Coliforms
  • Drugs of Abuse
  • Yeast
  • Mold
  • Adulterants (water, other types of milk, etc.)
  • Heavy Metals
  • Alcohol
Donor Milk Processing:
Medolac Safety & Quality
Medolac frequently conducts on-site microbiological studies and inspections of our donor milk processing areas, equipment and ventilation systems. Proper monitoring and cleaning procedures are critical to prevent development of biofilms. Additionally, Medolac employs the use of:
  • Class 100,000 clean room for milk handling and processing 
  • Current Good Manufacturing Practices (CGMPs) for food, as outlined by the US Food and Drug Administration and other international, federal and local requirements. 
  • FDA approved process for sterilization of Co-op Donor Milk

Homogenization
Co-op Donor Milk is homogenized. According to anecdotal data this may help reduce clogged feeding tubes. Data indicate homogenization of human donor milk may improve fat absorption in preterm infants, click here for more information. 

Commercial-sterility
Treating the incoming raw milk in specially-designed equipment ensures the safety and wholesomeness of the product while not affecting the quality of the milk. Medolac processed donor milk is the ONLY donor milk that is commercially-sterile. Commercial sterility renders the milk free of:
  • Microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution; and
  • Viable microorganisms (including spores) of public health significance; or
  • By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution.

Nutrient Retention & Composition
With excellent retention of critical human milk components, Medolac is pleased to supply information about amino acid content, immune factors, micro and macro nutrient composition. Request more information here. 
Packaging
  • BPA-free packaging
  • Each product case is labeled with a Nutritional Facts Panel specific to each lot
  • Full traceability on each human milk product through use of electronic record keeping
  • Medolac Milk Tracking Module available for NICU use through a partnership with SafeBaby 
  • Compliance with GS1 Healthcare Data Standardization 
Resources
The resources below provide an excellent starting point for understanding issues around the Safety and Quality of Donor Milk. Be sure to visit our Publications section for additional resources.
  • The U.S. Food and Drug Administration (FDA) is part of the U.S. Department of Health and Human Services. The FDA has issued standards of identity for milk and whey ingredients as part of the U.S. Code of Federal Regulations. Of particular relevance is the Pasteurized Milk Ordinance (2009 revision).
  • Internationally, the Codex Alimentarius Commission, created by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO), is charged with protecting the health of consumers and ensuring fair trade practices. It serves as a source for international standards, codes of practice, guidelines, and recommendations with respect to food safety and food production. Not only does it cover ingredient standards, but it also provides standards on the feeding of special populations.