At the Rogers Hixon Ontario Human Milk Bank, we follow a careful process to keep donor human milk safe for vulnerable infants in the Neonatal Intensive Care Unit (NICU).
We follow strict safety protocols from the first donor screening to the delivery of pasteurized donor milk. These steps help us ensure that potentially harmful bacteria are removed while essential nutrients are retained.
Safety and quality
Research shows that donor human milk helps protect preterm and medically fragile infants from serious health complications. Making sure donor human milk is safe and high-quality is our top priority. Milk donors go through a thorough screening process, and we test and pasteurize the milk to make sure it’s safe for hospitals to use.
The Milk Bank adheres to all federal, provincial and local government guidelines, including those from Health Canada External Link, the Canadian Food Inspection Agency External Link and Toronto Public Health External Link. We adhere to standards set by the Human Milk Banking Association of North America External Link to ensure donor human milk is handled safely.
Donor screening
People who want to donate milk go through a screening process similar to the one used for blood donors.
First, they complete a questionnaire about their health and lifestyle. Then they have a blood test to confirm they don’t have any infectious diseases.
Physicians for the donor parent must sign a form stating that the parent is healthy and has enough milk to donate.
Pasteurization
We mix milk from three to five donors, then bottle and pasteurize it using the Holder technique. This method heats the milk to 62.5 C for 30 minutes. After pasteurization, donor human milk is quickly cooled and then frozen at –20 C. This process is similar to how the dairy industry treats cow’s milk, but it uses lower temperature and a longer time. This helps better protect important milk components.
The Holder technique is effective at inactivating potential bacteria, viruses and other microorganisms. We test all donor human milk before and after pasteurization to make sure it is safe and ready for hospital use. Pasteurized donor milk can be kept frozen for up to six months. To learn more, read the research on pasteurized and unpasteurized donor human milk from the Canadian Paediatric Society External Link.
Nutrition
Most of the nutrients and antibodies in donor human milk remain intact after pasteurization and during frozen storage. Although some nutrients may decrease, all infants in the NICU are closely monitored to make sure they receive proper nutrition and grow well.
Processing stages
Donor screening: A lactation coordinator from the Milk Bank does a health and lifestyle screening interview.
Milk collection: Once approved, the donor collects at least five to 10 litres (165 to 330 ounces) of milk in food-grade, BPA-free hard plastic containers or milk freezer storage bags. Donors can store their milk in a freezer for up to two and a half months or in a deep freezer for up to five and a half months.
Zip-lock bags, sandwich bags and glass bottles are not acceptable storage containers.
Shipping: The Milk Bank provides a thermal-lined cardboard shipping kit for frozen milk. The Milk Bank team assists the donor to have their milk couriered.
Receipt and freezing: When the frozen milk arrives at the Milk Bank, it is frozen at a temperature of –20 C.
Testing: We test all donor milk for bacterial levels before further processing.
Pooling: Our team thaws three to five donor deposits overnight and then pools them in 20-litre glass beakers.
Pasteurization: Pooled milk is poured into plastic bottles and sealed for pasteurization. Each bottle is heated to 62.5 C for 30 minutes and then rapidly cooled to 4 C.
Post-pasteurization testing: We perform a bacterial culture test on one bottle from each batch.
Approval: If no bacterial growth is found, the batch is approved for use by our medical director or nurse practitioner. A batch is disqualified if any of the following happen:
- There is a positive post-pasteurization bacterial culture
- Any Bacillus bacteria are present
- The critical limits for pasteurization are not met (62.5 C for 30 minutes)
Storage and distribution: Pasteurized donor milk is kept in freezers at –20 C for long-term storage. Hospitals can use donor milk for up to six months after it has been pasteurized.
Distribution: Donor milk is picked up and delivered to hospitals by courier.
