Safe Handling and Processing for your Breast Milk 

As a mom, there's nothing more important than ensuring that your baby is healthy and safe. And for moms who want to freeze dry their breast milk, the safety and quality of the process is of utmost importance. That's why it's critical to work with a company that takes the safety and quality of handling breast milk as seriously as Leche does.

Freeze drying is not a new technology but the handling of mom’s individual breast milk has to be done with strict protocols and care to ensure the safety of your little one. While a mom’s own breast milk is NOT an FDA regulated product, we are working to be the leader and setting the standard for regulation in this space. For us, this includes the extra steps we take on testing your milk prior to freeze drying to ensure that no harmful bacteria is present prior to freeze drying. Leche is the ONLY breast milk freeze drying company to take this critical safety step, a standard set in conjunction with our laboratory experts who process hospital-grade donor milk.

How does Leche's freeze-drying process work?

Freeze-drying is globally recognized as the superior method for preserving food and pharmaceuticals. This technique creates an ideal environment for a process known as sublimation, wherein the product remains completely frozen while its water content is efficiently removed. This method ensures the preservation of the quality and longevity of the product you are freeze-drying. This brief video explains the science behind the “sublimation” or freeze drying process. And this is exactly why we use this method for your breast milk! Your breast milk remains completely frozen during the entire process while controlled heat is applied exclusively to only the trays in each chamber to evaporate water from your breast milk. This water is then extracted as gas through vacuuming, resulting in the breast milk being transformed into a powdered form while ensuring all nutrients are preserved. 

How does Leche ensure the safety and quality of freeze-dried breast milk?

Leche collaborates with top scientists and manufacturing partners, adhering to strict protocols in both food production and laboratory research. Leche is the ONLY breast milk freeze-drying service currently conducting extensive pre-production testing to ensure no harmful bacteria are present in the breast milk. 

Why is bacterial testing crucial when freeze-drying breast milk?

One of the key advantages of freeze-drying is its ability to preserve the product in its original state, including nutrients and taste. However, this preservation method also carries certain risks when not done properly and safely. Unlike many other food preservation and production methods, freeze-drying does not incorporate a 'kill step' to ensure the elimination of harmful bacteria. A "kill step" in food production, as recognized by regulatory agencies like the U.S. Food and Drug Administration (FDA) and other industry standards, refers to a specific process or treatment designed to eliminate or reduce harmful microorganisms (like bacteria, viruses, and parasites) to safe levels in food products. This step is crucial for ensuring food safety and preventing foodborne illnesses. Infants, particularly newborns and premature babies, have underdeveloped immune systems, making them more susceptible to health risks from bacterial contamination. Rigorous testing is crucial to ensure the safety of freeze-dried breast milk. This testing helps ensure that the milk is safe for consumption while also preserving the beneficial bacteria and the essential nutrients present in moms' breast milk.   

How does Leche ensure the highest standards in processing and packaging?

Leche operates within federal and state guidelines, follows Good Manufacturing Practices (GMPs) and goes a step further beyond any other processing facility by incorporating laboratory testing for every customer order. We have a dedicated facility for freeze-drying production as well as a dedicated breast milk laboratory for in-depth testing, scientific research and development.  

What safety measures does Leche take during the freeze-drying process from start to finish?

Leche’s safety measures include temperature checks upon arrival, bacterial testing with specialized plates designed specifically for breast milk, dedicated freeze-drying chambers, and sterile laminar hood packaging. Each step is logged and monitored for strict adherence to safety standards.

Is breast milk regulated by the FDA?

While a mom’s own breast milk is not an FDA-regulated product, Leche is dedicated to setting high standards for regulation in the breast milk freeze-drying space.

What packaging options does Leche offer for freeze-dried breast milk?

Leche provides convenient on-the-go travel packs (Leche Premier) and resealable pouches (Everyday Leche) for at home use. Leche Premier and Everyday Leche are packaged using Mylar, a material renowned for its exceptional preservation qualities in the food industry. This packaging is not only lightweight but also highly resistant to moisture, ensuring the product's freshness and quality.

We Value Your Family’s Safety 

While Good Manufacturing Practices (GMPs) are important and required by law for all food facilities, we at Leche knew that incorporating pharmaceutical and laboratory testing was equally, if not even more important. We not only have a dedicated breast milk processing facility, but we also have a separate dedicated breast milk laboratory specifically designed for in depth testing and quality control. 

Choosing the right breast milk freeze-drying service is a decision that should carefully take into consideration the safety standards of processing, packing and shipping. At Leche, we prioritize the safety and quality of our products and take every step to ensure that our facility adheres to the highest food safety standards. As moms, we understand the emotional attachment that moms have with their breast milk and are committed to providing the best possible service to our customers. With Leche, you can trust that your breast milk is in good hands and will be processed with the utmost care and attention to detail.