6 Important Questions to Ask Before Using a Breast Milk Freeze-Drying Service

Freeze-drying extra breast milk is becoming a more and more popular option among pumping mamas with a freezer stash. The freeze-dried breast milk powder lasts longer than frozen milk, is easy to use, and is convenient for travel.

However, with this rise in popularity has come longer wait-times for many moms looking to use a legitimate breast milk freeze-drying service to save their stash. This has caused many new companies to pop-up in the last 6 months - however due to the lack of current U.S. regulation for this growing industry, there is a concern that many service providers are operating with unsafe practices and undefined quality control standards.

Not all freeze-drying services are the same, and given the immense effort you have put into saving your milk (and the consequences of improper handling) it is well-worth your time to look into a service ahead of time. Keep your stash (and your baby!) safe by thoroughly researching whichever service you choose to freeze-dry your breast milk.

Asking about pricing and shipping logistics is good to know for comparisons, but here is a list of tips and questions that you may not have thought to ask about the operation. Here are 6 questions to ask and tips for what to look for when considering a service offering to freeze-dry your breast milk:

1. Are they operating out of a dedicated breast-milk processing facility?

 

Is the company being transparent with you about where your breast milk is being processed? Recently, individuals have started offering breast milk freeze-drying services out of their homes. It’s very difficult to maintain a sterile environment for processing breast milk in one’s home, and many freeze-dryer owners keep and use them in their garage due to their size and noise from the vacuum pump. Beware that some companies offering a breast milk freeze-drying service are also now using fake addresses or using addresses of other businesses. Do your homework before you ship your milk to someone who has just set up a website. Even if they send you a cooler and have an address for you to ship to - they may be handling your breast milk in their garage or other unsafe setting. Some services may also be shipping your milk to a third-party processing facility - please be aware that both home users and large-scale 3rd party freeze-drying operations typically freeze-dry and package many types of foods, including raw meat, dairy, nuts, poultry, and even pet food. For the same reasons as the home setting, a freeze-dryer in a garage or warehouse space creates an extremely unsafe environment and is by no means an appropriate place to maintain the sterility required for handling and processing breast milk.

 

What to look for:

👀 What else is being freeze-dried in their facility?

Freeze-dryers are used for preserving many types of food. Many people freeze-dry raw meat, pet-food, candy, or other food products. Things like raw meat, dairy, and wheat can introduce allergens and food-borne pathogens to the freeze-dryer, so it is especially important to verify that the service is only freeze-drying breast milk, and that the freeze-dryers are being properly sanitized between batches.

 

👀 Where is their facility located?

GoogleMaps usually verifies information, so that is a good place to start. If it is a home address that is listed - consider asking the company if they are operating out of their home, or if they are shipping it off, ask them to disclose the actual address of their facility. If a facility address is not listed on their website, that's a red flag.

 

👀 Have they published Interior / Exterior pictures?

Most legitimate businesses operating out of a facility have exterior signage for their company. If they do not have pictures posted on their Google Business listing or website, reach out to the service and ask to see pictures of the interior and exterior. This will help you determine if the company is actually operating out of the address they have listed. Interior pictures are also important, especially if they are claiming to have a clean room or other specialized testing or quality control equipment.

 

👀 Are they claiming inspections/approvals by health agencies?

In the U.S., the FDA does not currently regulate breast milk freeze-drying services. The FDA also does not approve facilities of any type (you can verify this on the FDA's website here) Any service claiming the FDA has approved their facility is using deceptive advertising at best. If you have any questions regarding the approval status of any service, you can call the FDA to verify their approval status at 1-888-SAFE FOOD. If the service is claiming to have passed inspections (or that they are approved by any health agency in the U.S. or other countries), they will have a current certificate of compliance or a permit from that regulatory authority that they should be willing to share. This permit will list the date of the last inspection and will have the address of the inspected facility listed.

 

MILKIFY'S ANSWER:

The Milkify facility is one-of-a-kind. It is the only GMP-certified processing facility in the U.S. built for freeze drying breast milk exclusively. Milkify is located at 2501 Central Parkway B-18, Houston, Texas 77092, and all operations are performed in-house. Here is the link to Milkify's Google Business profile. Here are pictures and a description of the Milkify facility, which includes laboratory-grade equipment (ISO5 cleanroom workstations) for all processing operations and a full suite of quality control testing equipment. Milkify's process controls and facility have been inspected and audited in-person by a trained GMP compliance officer (SGS), who issued our GMP certification. Milkify is also regularly inspected by Food Safety International to ensure compliance with state regulations regarding safe food handling practices. Contact us if you would like further information!

2. What is the shelf-life and how did they come up with that number?

Just like any other food that you find in your pantry, freeze-dried breast milk does have an expiration date. Why is this important? The shelf life of your freeze-dried breast milk is the time that it is expected to remain free from microbial growth. Since your milk is not sterile (and is not pasteurized), if there is too much moisture left in your breast milk powder prior to packaging, microbes will be able to grow. Excess moisture can actually cause the freeze-dried breast milk to spoil within just a few weeks or months.

Since breast milk powder is very hydrophilic (it attracts moisture from the environment very quickly), it's important that it is packaged properly. Milkify has used an outside lab to verify that the barrier properties of our packaging will keep your milk safe from moisture in the air. For our Milkify Singles packaging - the pouch should be resealed and used within 5 days of opening the seal on the pouch. For our Saver packaging option, the powder should be used within 1 month. These guidelines are based on testing done in-house to verify that the moisture content of the powder will remain below a safe threshold even with constant daily openings. Additionally, the use of oxygen/moisture absorber packets is not a substitute for an actual shelf life analysis, which must be done by an outside laboratory.

 

There is no industry standard for the shelf life of freeze-dried breast milk because it is completely dependent on how it is processed, and how it is packaged after freeze-drying, which varies by service provider.

 

The shelf life is dependent on several factors - here are a few important ones:

1. How dry the breast milk powder is before packaging?

This can only be determined by specialized testing equipment (like a water activity meter). Visually looking at the milk does not give enough information to tell if it is dry on a molecular level, and this can mean the difference between a 3 month and 3 year shelf life.

 

2. What type of packaging is used?

The size of the package, how it is sealed, and the material it is made of are extremely important for the shelf life. Small amounts of moisture from humidity in the air eventually makes its way into all types of packaging, so what the bag is made of determines how long this process takes.

 

3. How fast will the powder absorb humidity?

This can only be determined by a laboratory that specializes in this type of testing. The results can vary from one person's milk to another, so an in depth analysis must be performed before shelf life claims can be made.

When a lab performs shelf life testing, all of these factors are accounted for to provide an estimated shelf life. However, the service provider must still set thresholds based on these factors to be able to claim any sort of shelf life for your freeze-dried breast milk powder. Unless the service provider has had shelf life testing performed by an outside lab and routinely tests milk prior to packaging, an accurate shelf life cannot be claimed. Given that many parents freeze-dry their milk to extend the expiration date, this is an important factor to consider before you invest in having your stash freeze-dried - in certain types of packaging, freeze-dried breast milk can expire in as little as one week.

 

What to look for:

👀 Any service that is claiming “x years shelf life” of your freeze-dried breast milk should be able to provide you with details regarding which lab performed this analysis and the results.

You should automatically question any provider claiming to have a 10+ year shelf life - think about the other food in your pantry, does anything else in your kitchen have a 10 year shelf life?

 

👀 Your freeze-drying service should have the testing equipment needed to make sure your milk is dry enough before packaging. The only way to ensure that microbes will not grow is to perform testing and to set proper dryness thresholds prior to packaging.

 

👀 Oxygen/moisture absorber packets are not a substitute for ensuring that the milk is dry enough. The addition of these packets does not mean your breast milk powder will last longer. There are many types of harmful bacteria that will grow in moist environments where oxygen is absent (as in a package of semi-dry powder with an oxygen absorbing packet inside). In addition, the use of these packets requires you to remove them prior to use, which risks contamination of the milk. If you wouldn't stick your bare hand into a bottle of your baby's milk, why would you stick your hand into the breast milk powder?

 

MILKIFY'S ANSWER:

The shelf life of freeze-dried breast milk processed and packaged by Milkify is 3 years from the date of freeze-drying. Milkify's shelf-life testing was performed by Addium (formerly Meter Group). Milkify uses laboratory grade testing equipment (the Aqualab3 water activity meter) to test every batch of freeze-dried breast milk before packaging, to ensure that the 3 year shelf-life estimate we provide is accurate. No oxygen/moisture absorbers are used in packaging by Milkify and each lactation bag provided to Milkify becomes its own pouch of powder.

 

3. Who is handling your breast milk and what experience or certifications do they have?

A freeze-dryer is just a tool. Although breast milk can technically be freeze-dried like other foods (placed on an open tray), it is not a typical food because it requires sterile handling. You spent many hours cleaning and sterilizing breast pump parts and ensuring that your milk was stored safely. Make sure that the person(s) handling your milk treat it with the same level of respect!

Breast milk requires sterile handling. How it is handled before freeze-drying (i.e. how is it prepared to go into the freeze-dryer), and how it is packaged after freeze-drying are just as important as its time in the freeze-dry chamber.

Every U.S. state has its own set of food safety guidelines, however no U.S. state (as of the time of writing) has guidelines for personnel working at a breast milk freeze-drying service. When you pay for a service to freeze-dry your breast milk, you are not only paying for the use of equipment that you may not have, but also for the skill/experience of the person(s) doing the processing.

 

What to look for:

👀 Check the service provider's website for an About Us page. Look at the background of the people that are operating the company and specifically who is handling your milk. A background in the healthcare or research setting means that they will have experience with sterile handling techniques

 

👀 Check out LinkedIn to see more about who is operating the company and what their background is/what kind of training they have.

 

👀 Food handling permits/certifications are a great start, but breast milk is more than a food - it is being fed to infants and requires sterile handling and specialized packaging to ensure safety.

 

MILKIFY'S ANSWER:

The Milkify processing team has over 40 combined years of sterile handling expertise and Milkify's processing team is supervised by trained research laboratory personnel. Only these highly trained personnel with active food safety certifications process the milk and follow strict protocols regulating personnel hygiene, personal protective gear, and equipment sanitization to ensure that your milk is handled safely from start to finish.

See more about out team here.

4. How do they avoid contamination during processing/packaging?

There are several ways to freeze-dry breast milk - but keep in mind that every piece of equipment (blenders, powder dispensers) or utensil (scoops, bowls, spatulas, trays) that touches the milk during processing could introduce contamination.

Types of improper handling before freeze-drying could include thawing the milk, handling without gloves, using a blender to mix the milk into a slushy, or letting the milk contact any utensils or equipment in its frozen state. Breast milk should never be thawed prior to freeze-drying, as unsafe temperatures could allow for microbial growth.

 

After freeze-drying, the breast milk powder has to be packaged. Improper handling during this step can also result in cross-contamination if sterile techniques are not used. Powder dispensers are used by large scale food-processers to evenly distribute equal volumes of powder quickly into many bags. Powder dispensers are notoriously hard to clean, and should not under any circumstance be used in a breast milk freeze-drying operation.

 

What to look for:

👀 Check the company's website for pictures and information about their processing technique. If this information is not present, call the company beforehand to ask.

 

👀 Check social media to see if any videos have been posted of their process. What tools are being used, and how are they being sanitized? Look out for blenders and powder dispensers as this type of equipment is not appropriate for use with breast milk.

 

👀 Is breast milk removed from your lactation bag for processing? How is this process performed?

 

MILKIFY'S ANSWER:

We never touch your milk. Milkify is the only company to have a completely contact-free process from start to finish (absolutely no contact with equipment or utensils at any point in the process). Each bag of frozen milk you provide to Milkify is processed individually inside a specially-designed freeze-drying pouch. Our patent-pending freeze-drying pouches allow water vapor to escape while protecting your milk from contamination. We do not pool milk on trays for processing and each bag you send to Milkify becomes its own pouch of powder. The SafeDry pouches that protect the breast milk during processing and packaging at Milkify are specially manufactured and our patent-pending process has not been licensed out to any other companies. Trained technicians using sterile techniques in ISO5 cleanroom workstations to ensure that no contamination in introduced during the pre-freeze drying or the packaging steps of our process, and every bag is packaged by hand (NO powder dispensers).

5. What kind of quality assurances do they have in place?

There are many steps in the process of freeze-drying breast milk during which quality controls are needed to make sure that your breast milk remains safe. Quality control testing should be used to verify that the end result is safe to send back to you. Recordkeeping and food safety protocols should be in place to ensure the safety of the operation. Regular environmental screening should also be used to ensure that the sanitizing protocols are effective.

 

What to look for:

👀 How do they track orders to make sure that you receive your milk in return? Is your breast milk ever stored unlabeled in an open tray or in the freeze dryer?

 

👀 Do they have quality control testing equipment to make sure that your freeze-dried breast milk powder is safe in its packaging for long term storage?

 

👀 Do they perform environmental testing of their facility on a regular basis to ensure that equipment and utensils are sanitized effectively?

 

👀 Do they have a satisfaction guarantee? If you are unhappy with the result, or if there are any issues with shipping (or extended holds in customs if shipping abroad) what will the company do for you?

 

MILKIFY'S ANSWER:

At Milkify, we track every bag of breast milk with a unique Bag ID from start to finish in our facility -- this includes labeling each bag you send with your full name, and storing your milk in a dedicated bin in one of our freezers (your bin will also have your name on it). Each bag of milk is processed separately in one of our proprietary freeze-drying pouches, which are also labeled with your name and unique Bag ID - this means that your milk remains labeled with your name and tracking numbers even while in the freeze-dryer. We test the water activity ("dryness") of your freeze-dried breast milk powder as soon as it is finished processing. This is how we know that your milk will be safe for storage for 3 years in our packaging. We perform regular environmental testing of our facility and our equipment to ensure that our cleaning and sanitizing practices are safe and effective in preventing the growth of environmental pathogens like Cronobacter sakazakii. We also stand behind the quality of our service by offering a full satisfaction guarantee.

6. Does the service have verified reviews?

 

All freeze-drying services are different, so research what other parents have to say about a specific service. Online reviews are a great way to discern what the service is like to use. Every breastfeeding journey is also different, and everyone experiences a different set of obstacles when it comes to storing breast milk. Google reviews, and stories or posts on social media shared by moms who have used the service are a good place to start. Influencers can be paid for promotions, but real moms that have shared their story are good to review. Consider also asking a breastfeeding/pumping Facebook group if anyone has experience with the company you are considering. Check out reviews from mamas who may be in a similar situation (out of freezer space, travelling, moving, high-lipase, NICU milk) to see what they have to say.

 

You can also ask your baby's pediatrician or your lactation consultant to review a service and their process/claims before you choose to use them.

 

What to look for:

 

👀 Communication: Since you may be shipping your breast milk, you will want a service that can communicate with you quickly and effectively in case of any type of shipping delay.

 

👀 Packaging: How your freeze-dried breast milk is packaged has a huge impact on its estimated shelf life. Are notes (pump date, diet, sickness) from your bags retained on the pouches you get back? Check out pictures from others who have used the service to see what you will actually be receiving back.

 

👀 Instructions: Are there clear instructions provided for how to use and store the breast milk powder? Accurate rehydration instructions are very important for ensuring the safety and caloric density of the rehydrated milk for your baby - adding too much or too little water to the breast milk powder can be dangerous.

 

👀 Availability / turnaround time: How long will it take the service to complete your order? If you have an expiration date coming up, make sure that the service will be able to complete your order in the timeframe that you need!

 

MILKIFY'S ANSWER:

Milkify has helped thousands of parents safely freeze-dry their stash. Their verified reviews are posted on our Google and Facebook profiles. The highlights section of our Instagram profile (@milkify.me) also has dozens of video testimonials posted by our clients, healthcare providers, and lactation experts.

Freeze-drying breast milk is an amazing option for parents and their babies. However, with the current lack of U.S. regulations in the industry, it is currently up to the service providers to ensure that they are providing a safe and thoroughly vetted process and are advertising their service transparently to clients. This is a huge responsibility, and one that should be taken very seriously. Although it may seem like a very simple process, there are many aspects to freeze-drying breast milk as a service - it takes much more than a home freeze-dryer and store bought packaging to provide a safe service. At Milkify, we worked hard to build a service that has the highest quality control processes in the industry, be transparent with each of our clients, and provide a safe, clean environment.

 

There are few wonders more precious that a mother's breast milk for her baby. If you are considering freeze-drying your breast milk, do your own research before using any service!