FDA-Registered • SGS cGMP Certified
Quality & Safety
From frozen intake to shelf-stable powder — every step is designed for safe, traceable, contact-free handling of mother's own milk.
Our Patented SafeDry Contact-Free Process
Follow each stage of our controlled process — from frozen bag to shelf-stable powder. Each order is processed separately — milk is never at risk of contacting another client's milk.
Frozen Milk Received
Expressed breast milk arrives frozen at our FDA-registered facility. Each bag is individually labeled with a unique client ID and tracking number. Milk remains continuously frozen — never thawed — avoiding nutrient degradation from freeze-thaw and avoiding temperature danger zones for safe holding.
Cold Chain Integrity
Temperature-controlled storage maintains an unbroken cold chain from the moment the milk arrives. Continuous monitoring ensures milk never enters the danger zone for bacterial growth prior to processing.
Contact-Free Freeze-Drying
Milkify’s patented SafeDry™ process freeze-dries the milk inside a sealed lyophilization pouch. Milk never contacts equipment, trays, or utensils — eliminating cross-contamination risk entirely.
ISO 5 Cleanroom Packaging
Powder packaging is performed in ISO 5 cleanroom workstations under strict hygiene controls. Staff follow sterile handling and food safety protocols throughout every step.
Testing & Verification
Every order undergoes water activity testing to confirm sufficiently low residual moisture, preventing post-drying microbial growth. Macronutrient analysis via the Miris Human Milk Analyzer provides individualized fortification data.
Shelf-Stable MOM Powder
Mother’s own milk is now a shelf-stable powder — safe, traceable, and ready for targeted fortification under provider supervision. Shelf life is validated through process controls, packaging integrity, and critical control limits.
Frozen Milk Received
Expressed breast milk arrives frozen at our FDA-registered facility. Each bag is individually labeled with a unique client ID and tracking number. Milk remains continuously frozen — never thawed — avoiding nutrient degradation from freeze-thaw and avoiding temperature danger zones for safe holding.
Cold Chain Integrity
Temperature-controlled storage maintains an unbroken cold chain from the moment the milk arrives. Continuous monitoring ensures milk never enters the danger zone for bacterial growth prior to processing.
Contact-Free Freeze-Drying
Milkify’s patented SafeDry™ process freeze-dries the milk inside a sealed lyophilization pouch. Milk never contacts equipment, trays, or utensils — eliminating cross-contamination risk entirely.
ISO 5 Cleanroom Packaging
Powder packaging is performed in ISO 5 cleanroom workstations under strict hygiene controls. Staff follow sterile handling and food safety protocols throughout every step.
Testing & Verification
Every order undergoes water activity testing to confirm sufficiently low residual moisture, preventing post-drying microbial growth. Macronutrient analysis via the Miris Human Milk Analyzer provides individualized fortification data.
Shelf-Stable MOM Powder
Mother’s own milk is now a shelf-stable powder — safe, traceable, and ready for targeted fortification under provider supervision. Shelf life is validated through process controls, packaging integrity, and critical control limits.
See Why the Milkify Facility Set the Industry Standard
Since 2019, our top priority has been providing the safest, highest quality product for your baby. Milkify is the only FDA-registered, GMP-certified breast milk freeze-drying service.
GMP-Certified — State of the Art Facility
- Our facility processes breast milk — and only breast milk
- Commercial-grade freezers maintain temperature-controlled storage with 24/7 remote monitoring, and multiple backup generators protect against power disruptions
- Our food safety and HACCP plans are designed by a PCQI-trained Quality Control Officer and certified by SGS
Sterile, Separate Handling
- Each client's milk is stored, processed, and packaged in complete isolation — never pooled, never thawed on shared trays, and never touched by processing equipment
- Every bag is tracked individually through our proprietary Bag ID barcoding system, from intake through the freeze-dry chamber to final packaging
- All orders are packaged by a highly-trained technician, working one client at a time in an ISO 5 laminar flow hood
Precision Freeze-Drying — Professional Equipment
- Our custom-built commercial freeze-dryers feature redundant safety systems and run validated cycles with continuous monitoring
- Precisely controlled temperature profiles protect the heat-sensitive bioactive components that make mother's own milk irreplaceable
- Every finished batch undergoes final quality control testing to verify moisture content and confirm the product meets strict release standards before it ever reaches a family
Deeply Committed Professionals
Behind every order is a team that understands exactly what is at stake. Breast milk is not a commodity — it is the product of a mother's time, effort, and love, and for many NICU families, it is one of the most powerful tools available for their baby's health and recovery.
That is why only rigorously trained, food-safety-certified technicians ever handle the milk. Our personnel follow strict protocols governing hygiene, protective gear, and equipment sanitization — and every order is processed individually, start to finish, by a single trained technician. No shortcuts, no exceptions.
We put safety first because the families who trust us with their milk deserve nothing less.
No Contact Processing
With our patented process, milk never comes into contact with any equipment, trays, or utensils. This prevents contamination during the freeze-drying and packaging process.
NO Thawing
We never thaw milk for processing. Milk remains frozen from start to finish, including during the freeze-drying process. This protects the safety and integrity of the milk.
NO Pooling on Trays
Our specially-engineered freeze-drying pouches allow water to escape while preventing contamination. We never pool milk on reusable trays for processing.
Individual Tracking
Every bag of frozen milk is assigned a unique serial number and labeled with the client's name. Each bag remains separate and labeled even inside the freeze-dryer.
Every Order Tested. Every Time.
Before any order leaves our facility, it passes a final quality control check using a laboratory-grade water activity meter — measuring the precise moisture level of the finished powder. This isn't a spot check or a batch sample. Every single order is tested individually.
Why does it matter? Water activity is the critical determinant of shelf stability. Confirming that moisture has been removed to exacting standards is what allows us to stand behind a shelf life of up to three years — no refrigeration required when stored properly in a cool, dry place.
It is the last step in our process, and one of the most important.
Important Clinical Note
Freeze-drying is not a sterilization step. Safety depends on source milk handling, keeping milk frozen until processing, contamination prevention during processing and packaging, and appropriate post-production controls.
FDA-Registered Facility
Registration #16969346312
SGS cGMP Certified
Certificate #US23/00000165
Dedicated to Breast Milk
Exclusively breast milk processing
Questions about safety and quality?
Reach out to the Milkify Medical team or browse our FAQ.