From donor to recipient, the entire life cycle of Prolacta’s human milk–based nutritional products follows a standardised production process, including donor qualification; screening and blood testing; shipping; DNA matching; testing; storage and processing; pasteurisation and manufacturing; and final product testing and quality review.
Hospitals choose Prolacta’s human milk–based nutritional products knowing that they are receiving safe, standardised donor milk products processed under the strictest quality and safety guidelines to protect the health and well-being of their most fragile patients.
After their physician and their child’s pediatrician confirm eligibility and supply of excess milk, each Prolacta donor is carefully screened via blood test and a DNA swab is taken. We were the first company to adopt the safety measure of DNA matching to ensure all milk received comes directly from our carefully screened and vetted donors.
Once the donor milk arrives, we test it for pathogens, viruses, adulterants, and the presence of nicotine, marijuana, opiates, and other substances of abuse.
Our human milk safety laboratories and manufacturing processes are regulated by the United States Food and Drug Administration (U.S. FDA).
We operate the first and only pharmaceutical-grade manufacturing facilities for the testing and processing of human milk. Our stringent processes for donor milk screening and testing human milk were modeled on those used in the U.S. plasma and blood industries and surpass food-product safety standards.
All of our nutritional products are vat pasteurised to ensure the highest quality and safety, using time and temperature profiles defined by the U.S. FDA in its Pasteurised Milk Ordinance (PMO) to destroy pathogenic viruses and bacteria. While there are other pasteurisation and sterilisation processes used in the human milk banking industry,
Prolacta Bioscience chose vat pasteurisation because it provides effective pathogen inactivation while preserving important bioactive components in human milk.1,2,3Additionally, the majority of clinical data supports the benefits of using Prolacta’s vat pasteurisation process over alternative methods.
