The Milkify Facility

All of our operations are performed in a safe and controlled environment.
Milkify is fully cGMP-compliant (Current Good Manufacturing Practice as defined by the FDA
Food Code, 21CFR117) and adheres to all applicable guidelines set forth by the
Centers for Disease Control and Prevention (CDC) and the Human Milk Banking
Association of North America (HMBANA) for the safe handling of breast milk.

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GMP compliant

Milkify is fully cGMP-compliant. 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. Milkify is the only GMP compliant breast milk processing facility providing freeze-drying services to consumers.

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Sterile Packaging Station

The Milkify facility contains ISO4 and ISO5 laminar flow hoods, allowing for complete control of the environment during the packaging process. All packaging operations are performed within these sterile stations which control the flow of air and ensure that no contamination is introduced during packaging.

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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 20,000 ounces of frozen milk. The freezers keep the milk around -5°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.

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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 vitally important for ensuring that the freeze-dried breast milk powder will remain shelf-stable for up to 3 years with no refrigeration.

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Environmental Testing

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

  • Yeast/mold

  • Listeria monocytogenes

  • Bacillus cereus

  • Staphylococcus aureus