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Safety & Quality

We take safety seriously! From the moment a potential milk donor contacts our donor screening team until a bottle of pasteurized donor milk departs the milk bank for its final destination, we adhere to strict protocols to protect the safety and quality of the amazing milk donated to us by our generous donors.  

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We are not alone! We are accredited members of the Human Milk Banking Association of North America (HMBANA), a network of nonprofit milk banks across the US and Canada. All HMBANA milk banks follow a strict set of “Guidelines for Human Milk Banking” to assure safety.   

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We comply with and often exceed all measures set forth by HMBANA, which follow standards set forth by The Centers for Disease Control and Prevention (CDC), U.S Food and Drug Administration (FDA) and World Health Organization (WHO)

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Follow the Milk below to see how we embrace safety and quality with each step. 

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  • A verbal phone screening and a written questionnaire lets us get to know our donors well. They understand the important role their milk will play in a fragile infant’s health.

  • Medical consent from healthcare providers confirms the donor's good health (and the health of their infant(s) if applicable). 

  • Serological testing for HIV 1/2, HTLV 1/2, Syphilis, & Hepatitis B & C by a CLIA Certified Laboratory further ensures the safety of our donors and their milk.

  • Notice of Privacy Practices provided to all potential milk donors. 

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  • Individual containers of milk received are carefully handled and examined for quality and integrity. 

  • Each milk donation is logged into a secure electronic tracking system.  

  • Each deposit of milk is assigned its own unique identifier which follows it through its entire milk bank journey. 

  • Milk containers are safely stored in a freezer system at -18 degrees C until selected for processing.

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  • Milk is thawed carefully and slowly under safe refrigerated temperatures until pourable. 

  • Temperatures are closely monitored and maintained throughout each processing step.  

  • Milk purity is achieved by carefully pouring thawed milk through a sanitized, food-safe strainer.  

  • Milk from multiple donors is combined together to achieve balanced and consistent nutrient levels. 

  • Milk is dispensed into heat-sanitized bottles that are safe for heating and freezing of milk. Both measured glass and BPA-free plastic bottles are used and considered optimum for infant feeding preparation. 

Milk Thawing, Pooling, and Processing 

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  • Milk is treated by Holder pasteurization which warms milk rapidly, holds it at 62.5 degrees C for 30 minutes, then rapidly cools it to 4 Degrees C. This method kills bacteria and viruses but preserves important biological factors unique to human milk. Research shows that Holder pasteurization provides the optimum heat treatment to assure milk safety and protect the unique proteins and biologic factors that newborns need. 

  • Each bottled is labeled with nutritional information and a barcode that contains the milk’s unique identifiers.  

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Heat Treatment 

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  • Nutritional analysis is performed on each milk pool using full spectrum laser spectroscopy technology.  

  • Macronutrient testing is validated using reference methods approved by the Association of Official Analytical Chemists.  

  • Milk containing a higher fat and protein count is reserved for high-risk infants in the NICU. 

  • Careful and stringent quality checks are carried out for each batch of pasteurized milk. 

  • Each batch of milk undergoes quantitative bacterial analysis by a CLIA Certified Laboratory.

Testing for Safety and Quality

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  • Once pasteurized, the milk remains deeply frozen at -20 degrees C while awaiting results of batch testing. 

  • Freezers are electronically monitored to assure optimal temperature ranges are maintained. 

  • Preventive controls, quality assurance checks, and accurate record keeping are verified to qualify milk for dispensation.  

  • Milk approved and ready for release is moved to dedicated freezers before orders are fulfilled and milk is dispensed.  

Milk Approval and Release 

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  • Milk orders, either for hospitals or outpatients, are packed quickly into insulated containers or coolers.  

  • Dry ice is used to keep milk deeply frozen during transport.  

  • Temperature indicators and Cold Chain Verifications are included in all shipments to hospitals and outpatients handled by third-party carriers. 

  • We partner with FedEx and PeriShip to assure milk is transported quickly and safely overnight to areas all across Oregon, Washington, Alaska, and beyond.

Shipping and Transport

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  • 100% compliance with Human Milk Banking Association of North America guidelines. 

  • Secure milk and equipment monitoring system and preventative controls 

  • Staff training and Certification in Food Safety Handling and Current Good Manufacturing Practice (cGMPs). 

  • FDA-certified pest management.

  • Secure electronic medical database and barcoding system.

  • Follows NWMMB Notice of Privacy Practices.

  • Onsite Preventative Controls Qualified Individual (PCQI).

  • Macronutrient validation by approved reference testing. 

  • Routine equipment validation and calibration 

  • Serological and microbiological testing performed by CLIA-certified laboratories.

Quality Assurance Measures 

Learn more about COVID-19 and Human Milk.

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