Quality & Safety: Product Safety
Quality & Safety
Prolacta's proprietary methods for the standardization of human milk provide the highest level of product safety and quality. Consistent with our commitment to make a meaningful difference in the lives of the most vulnerable infants, Prolacta has developed industry leading safeguards that exceed current industry standards, to provide the best product possible.
Pillars of QualityFrom donor to recipient, the life cycle of Prolacta’s human milk formulations consists of donor screening; specific testing/safety measures; processing and pasteurization; filling; final product testing; labeling and packaging; quality review and shipping.
A. Breast Milk Donor Screening
Breast milk donors follow a rigorous screening process based on the blood banking model. Prolacta is the only organization that uses these combined safety steps:
- Similar to the blood donor industry, a potential breast milk donor is screened through a medical history survey. After the screening, the donor is entered into Prolacta’s proprietary database and assigned a donor number.
- Once the potential donor passes the medical history survey, she must obtain written approval from her physician and her baby’s pediatrician before she can continue in the donation process.
- The potential donor measures the temperature in her freezer with a thermometer provided by Prolacta. The temperature must be cold enough to store human milk or, unfortunately, the potential donor may not donate.
- A blood test and a DNA cheek swab are conducted. The blood test screens for several infectious agents including HIV 1&2, HTLV I&II, HBV, HCV, and syphilis. The DNA cheek swab is used to create a donor DNA ID. This DNA ID will be used later to ensure the milk received is from the donor that was blood tested.
- If the potential donor passes the screening and meets all of the requirements outlined above, she is qualified to be a breast milk donor for a four month period. After four months, if she wishes to continue donating, she must complete a new medical history survey and take another blood test.
Incoming donated breast milk is quarantined until acceptance testing is complete, including the following:
- The DNA in the donated breast milk is matched to the donor’s DNA ID to assure the milk comes from the donor that was blood tested.
- Donated breast milk is subjected to drugs of abuse screening.
- Each shipment of milk is screened for Bacillus cereus, a pathogenic bacterium that cannot be removed through pasteurization.
- All processing of milk is done in a clean room environment, similar to the biologics industry.
- At the start of the production process, the milk goes through the following testing:
- PCR testing for the presence of HIV-1, HBV, and HCV.
- Full microbiological panel including Aerobic count, B. cereus, Escherichia coli, Salmonella, Pseudomonas, coliforms, Staphylococcus aureus, yeast and mold.
- Bovine protein testing.
- Donor milk is formulated into fortifier and standardized human milk product to meet specific protein, fat and calorie specifications.
- Each production lot is pasteurized following guidance set by the FDA’s Pasteurized Milk Ordinance.
- Product is filled into polypropylene or high density polyethylene bottles (both BPA free) and frozen.
- The bottles are weighed to ensure that the intended volume is filled into the bottle.
Product is quarantined until all data are reviewed, verified, and approved by Quality Assurance.
- Full microbiological panel including Aerobic count, B. cereus, E. coli, Salmonella, Pseudomonas aeruginosa, coliforms, Staphylococcus aureus, yeast and mold.
- Full nutritional analysis is performed.
- Product is labeled with lot specific nutritional values, “use by” date, and product lot number.
- Color specific labeling for safe storage, mixing, and administration.
- Final verification against product specifications for quality assurance.
- Frozen product is shipped to hospitals in insulated coolers, packed with dry ice.
View Prolacta Safety, Testing and Processing Flowchart
Immunological Components
Human milk is composed of around 100,000 different molecular entities: proteins, lipids, carbohydrates, vitamins and trace minerals[1]. Many of these possess anti-infective or anti-inflammatory properties. Key components include the monomeric immunoglobulin A (IgA) and the dimeric secretory sIgA, which bind microbes in the digestive tract to prevent their passage into other tissues; lysozyme, which disrupts the bacterial cell wall and thus helps to destroy many bacteria; and lactoferrin, which binds the iron that is required by many bacteria for growth. Immunoglobulin (IgA) and secretory IgA were quantitated in human milk samples using sandwich ELISA procedures. Following pasteurization using the Prolacta® HTST process, IgA concentration declined 27 percent, on average, and secretory IgA levels declined 17 percent compared to the corresponding values in untreated human milk samples. Lysozyme content was determined by a microtiter assay using a Micrococcus lysodeikticus suspension as substrate. Vitamin analyses were performed by validated HPLC procedures. Vitamin levels remained unchanged following pasteurization. [1] Jensen RG (ed): Handbook of Milk Composition. San Diego, Academic Press, 1995. [2] Wills ME, Han VEM, Harris DA, Baum JD. Short-term low-temperature pasteurization of human milk. Early Human Develop, 7;71-80, in R.A. Lawrence and R.M Lawrence, "Breastfeeding: A Guide for the Medical Profession", Fifth Edition, C. V. Mosby, 1998, p. 687.
Vitamin analyses were performed by validated HPLC procedures. Vitamin A, vitamin C, and α-, γ-, and δ-tocopherol levels remained unchanged following pasteurization. The vitamin B6 content of human milk slightly decreased to 7.8 μg/100 mL, about 89 percent of the initial concentration of 8.8 µg/100 mL. These results are summarized in Table 2.
Table 2. Effect of Prolacta Pasteurization Conditions on Human Milk Constituents
| Parameter | Untreated Milk | Pasteurized | % Remaining |
| Immunoglobulin A (mg/mL) | 315 | 230 | 73 |
| Secretory IgA | 462 | 379 | 83 |
| Lysozyme (IU/mL) | 39,000 | 22,000 | 57 |
| Lactoferrin (g/100 mL) | 0.24 | 0.033 | 14 |
| Vitamin B6 (µg/100 mL) (g/100 mL) | 8.8 | 7.8 | 89 |