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What We Do

Safety & Quality

Pasteurization technician pouring donor milk into a 100 ml bottle.
-Photo courtesy Michael Ryan, Four 3rds Creative

Safety - Our Top Priority

We ensure that donor human milk processed in our facility is safe. Numerous safeguards are in place to protect the quality and integrity of every bottle processed, including pasteurization and third-party microbiological testing.

We exceed compliance measures set by the Human Milk Banking Association of North America (HMBANA), which were developed according to the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) and World Health Organization (WHO) standards.

The following flow chart details the continuity of safety measures from screening donors to dispensing pasteurized bottles of donor human milk:

Quality Assurance Measures

  • 100% compliance with HMBANA (Human Milk Banking Association of North America) guidelines
  • In-place monitoring systems and preventative controls
  • FDA-certified pest management
  • Secure, HIPAA compliant data storage
  • Medical database and barcoding system
  • Macronutrient reference testing and validation 
  • Staff training and certification in cGMPs
  • Onsite Preventative Controls Qualified Individual (PCQI)
  • Routine equipment validation and calibration
  • Serological and microbiological testing performed at CLIA-certified laboratories 

Our Stats

Our Video Overview

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  • NEC Society
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