There is a persistent problem running through every NICU that uses donor human milk (DHM). It happens when a nurse or milk room tech has to discard milk that was thawed but never used. It happens when a care plan changes and the milk that was pulled from the freezer last night no longer matches today’s feeding orders.
Waste is so built into the current DHM system that most NICUs just absorb it as an operational cost.
LactaLogics’ Gentle-UHT™ pasteurization makes human milk shelf-stable. This closes a longstanding safety gap that costs milk rooms millions of milliliters of discarded milk each year and it removes the thaw-and-clock constraints that drive so much milk room and bedside waste in the NICU.
The Bacillus cereus Problem
Holder pasteurization (HP) has done its job for decades. It inactivates the viruses, gram-negative bacteria, and non-spore-forming organisms that can make milk sharing unsafe. But there is one organism it cannot inactivate: Bacillus cereus.
B. cereus is an environmental spore-former found in a wide range of foods and surfaces. Its spores tolerate the 62.5°C heat of HP, and in some cases the elimination of competing organisms during the pasteurization process actually gives surviving spores more room to germinate and grow once the milk is thawed and warmed for feeding.
Studies have found B. cereus in up to 7% of Holder-pasteurized donor milk samples. At some milk banks, contamination by B. cereus and other heat-resistant spore-formers contributes to discard rates of 15 to 30% of total milk donations. This is milk that was collected, screened, pooled, and pasteurized that has to be discarded because a safety test came back positive after processing.
For a supply that is already stretched thin, this is a significant and solvable problem.
LactaLogics addresses it in two stages.
First, bactofugation: a clarification method borrowed from the bovine dairy industry that physically spins bacterial particles, including spores, out of DHM before the milk is ever heated. The milk entering the pasteurizer has already had its microbial load substantially reduced. Then, Gentle-UHT™ applies indirect steam heat at approximately 285°F for less than 10 seconds. That combination of rapid, high heat is what standard HP cannot achieve. Bacillus cereus spores that survive lower-temperature methods do not survive Gentle-UHT™.
It is worth noting that Gentle-UHT™ eliminates the direct contact with heat used in traditional UHT by running the DHM through a small tube encapsulated in a larger tube of steam traveling in the opposite direction. This allows LactaLogics to produce DHM in which any remaining B. cereus that survived centrifuge removal is inactivated without the nutrient degradation that comes from lengthy-pasteurization times or direct contact with heat.
The result is milk that passes post-processing safety testing at rates that Holder-pasteurized products cannot match—virtually eliminating wasted milk. Less contamination at the processing stage means more milk reaching the babies who need it.
The Thaw Clock
Under current standard practice, DHM arrives frozen. Before it can be used, it has to be thawed, usually in a warmer, and must be used immediately or discarded after one hour. It cannot be refrozen.
In a population as medically dynamic as NICU patients, this creates a structural problem. Feeding volumes change. Infants are intubated, extubated, and sometimes intubated again. Procedures are scheduled and rescheduled. A baby’s condition at 11am. may look entirely different by noon.
When that happens, the milk that was thawed in anticipation of a feeding order that has since changed becomes waste. This is the predictable consequence of a frozen product being managed in an unpredictable clinical environment.
Shelf-stable DHM removes the thaw clock entirely.
LactaLogics’ Gentle-UHT™ process, combined with aseptic packaging, produces DHM that is stable at room temperature until it is opened. There is no freezer storage required. There is no thaw window to calculate. Milk is drawn from the shelf when it is needed. That means the decision to prepare a feed can be made at the time of the feeding.
Once a carton of milk is opened, LactaLogics DHM remains usable for two weeks.
The Broader Picture
Waste in the donor human milk supply happens at processing facilities dealing with contamination rates that are partly an artifact of an aging pasteurization method. It also happens downstream, in NICUs managing a frozen product against a clinical reality that doesn’t hold still.
LactaLogics’ Gentle-UHT™ process addresses both. By inactivating Bacillus cereus and other heat-resistant organisms and producing a shelf-stable product that is opened only when it is needed and remains usable for two weeks after opening, it preserves more milk at the bedside.
Donor human milk is still a finite resource. The goal of any processing advance should not just be what it does to the milk. It should also be measured by how much more of the milk makes it to the patients who need it.
LactaLogics does not make claims about its products prior to regulatory clearance. Clinical references cite peer-reviewed literature.