The Milkify facility is one-of-a-kind. It is the only GMP-certified processing facility in the U.S. dedicated to freeze-drying breast milk exclusively. Milkify also follows all guidelines put forth by the CDC and HMBANA for the safe handling of breast milk.
Milkify is the only GMP certified breast milk freeze-drying facility. cGMP regulations (as defined by the FDA) address matters including appropriate personal hygienic practices, design and construction of the facility, maintenance of the facility and equipment, sanitary operations, facility sanitation, and production and process controls during the processing of food.
The Milkify facility contains ISO5 laminar flow hoods, allowing for complete control of the environment during the packaging process. All packaging operations are performed within these sterile cleanroom workstations which control the flow of air and ensure that no contamination is introduced during packaging. Each customer order is processed separately.
Controlled Freezer Storage
Breast milk is stored frozen at all times while in the Milkify facility. Our commercial-grade freezers provide controlled storage capacity for more than 50,000 ounces of frozen milk. The freezers keep the milk around -10°F, and are remotely monitored for temperature and power outages. Our facility is equipped with back-up generators to power our freezers in case of outages.
The Milkify QC lab also houses the Miris - an FDA-approved human milk analyzer. Milkify is the first and only freeze-drying service in the world to have one! With this testing, you can receive a customized report detailing the nutritional composition of your freeze-dried milk, including the calories, carbs, fats, and proteins.
Quality Control Testing
As part of our final quality control check, we measure the water activity (“dryness”) of the freeze-dried milk using laboratory-grade testing equipment. Our Aqualab3 water activity meter and testing procedure are the only way to ensure that the freeze-dried breast milk powder will remain shelf-stable for up to 3 years with no refrigeration.
Regular environmental testing of our facility and equipment ensure that sanitization practices are effective at preventing contamination during processing. We routinely test for the following:
- Total aerobic plate counts
- Coliform/ E. coli
- Listeria monocytogenes
- Bacillus cereus
- Staphylococcus aureus
- Cronobacter sakazakii