We describe the development of a portable, fully automated, user friendly, cost-effective HBM that uses modern technology, requires less space, no special plumbing, and can recycle water. Digital screens display time and temperature in real time. Heating or cooling is controlled by intelligent microcontrollers ensuring temperature accuracy. The device is capable of pasteurizing 10-500 ml of EBM. It has been used successfully in four hospital-installed DBMB in India for more than a year and a half and at Centinela Hospital Medical Centre, Inglewood, California for more than wo months.
In the food industry worldwide, regulating agencies prefer to use stainless steel for heating, cooling or drying food because it prevents any chemical reaction between the food and the container (24). The Food and Drug Association’s rule states that materials used in the construction of utensils and food contact surfaces may not allow the migration of deleterious substances or impart color, odor, or tastes to food. Such material needs to be safe, durable, corrosion-resistant to many chemicals, non-absorbent, sufficient in weight and thickness to withstand repeated washing, have a smooth, easy-to-clean surface, resistant to pitting, chipping, crazing, scratching and scoring. Therefore, we chose stainless-steel grade 304 rather than plastic bottles. This type of stainless steel is most commonly used as an alloy in a variety of industries since it can resist corrosion caused by several chemicals and can be electropolished to a smooth, shiny and easy-to-clean surface.
In this device, the water level during heating or cooling mode is above the milk level, ensuring that the BM is evenly treated with the provided energy. During heating or cooling, it is an unsteady state of energy transfer, meaning the temperature difference between the DBM and water is high. However, as the temperature difference between the water and DBM decreases, the energy transfer is slow. Therefore, as per the law of thermodynamics, it is called an unsteady state. We conducted several experiments to determine the optimum rate of heat transfer so that the desired milk temperature can be reached in the shortest time, which will be cost effective regarding power consumption and time. To accomplish this goal, we varied the flow of water entering the pasteurization chamber, its effects on warming and cooling and the time taken. Then, we varied the heater wattage and heater output power via microcontrollers to achieve fast warming without overshooting it. In these trials, we ensured that the milk temperature never exceeded 63 °C. Lastly, we invented a sandwich heating mechanism that ensures that each drop of water entering the heating body is evenly heated to the same temperature during the entire travel time. We manufactured the heater body in stainless steel for better heat transfer compared to aluminium.
There is always a gap between the milk and the lid of the milk container. During the heating process, heat transfer will only occur when there is a temperature difference between milk and air. As the milk temperature starts rising, the air temperature will also start rising due to convective heat transfer. As the temperature difference is high, the rate of heat transfer will also be very high, but as the temperature difference between air and milk decreases, there will be no heat transfer to the air. This state is defined as equilibrium.
We measured the milk and air temperature using two different probes, and the temperature difference was recorded. When the milk temperature was 62.7 0 C, the air temperature was 62.3 0 C. This did not change even when we increased the time of heating because the system reached the stage of equilibrium. In the heating mode, equilibrium is achieved in 25 minutes.
There are concerns with fully submerging plastic bottle containers under water during heating. As used in other pasteurizers. plastic is an insulation material; therefore, heat conduction is poor. As a result, it is necessary to stir the water for better heat transfer. In Kimie, stirring milk is not necessary because the conductive property of steel is 100 times faster than that of plastic (24). Submerging the plastic bottles under water increases the time for heating, consumes more energy and needs more water and is not eco-friendly. Even if recycled, plastic bottles will need to be discarded after a few cycles. Stainless-steel containers can be reused indefinitely.
Debate continues regarding early postnatal readiness for enteral feeding in premature appropriate for gestational age (AGA) or intrauterine growth restricted (IUGR) neonates (25-38). Early enteral feeding has been associated with improved survival and postnatal growth, decreased incidence of sepsis and necrotizing enterocolitis (NEC) and fewer days of total parenteral nutrition (25, 26, 29, 34-36). Therefore, there is an increasing trend to initiate at least minimal enteral nutrition (trophic feedings) as early as 6 hours of life and for early aggresive enteral nutrition (25-29). A baby’s own mother’s expressed breast milk (EBM), including colostrum, is the best feeding option. The overarching goal is to reach full enteral EBM feeding in the shortest possible time (25-38). However, when mother’s EBM milk is not available, insufficient or not suitable, supplementation with PDBM or specially designed preterm formulas is a common practice (1-6). PDBM is considered to be a better option than the preterm formula (1-6).
The detailed operation of traditional DBMBs has been described (15-17, 39-49). These banks rely on a donor breast-feeding population to ensure an adequate supply of DBM (15-17, 39-45). In general, donor mothers have delivered a baby at full-term gestation and have been lactating for several weeks or months (15-17, 36-39). These women, under prescription from a physician, donate their extra BM for vulnerable babies (15-17). These mothers are screened for medical and lifestyle risk factors, serum for syphilis, HIV, hepatitis B and C, and human T-cell leukemia virus (HTLV) (15-17). Staff members of the traditional DBMB instruct women to properly collect and store milk at home in hygienic conditions (15-17). Subsequently, they are instructed to transfer stored frozen DBM to the DBMB in a suitable insulated container on ice or ice packs. In this model, it is assumed that the donor mother has a refrigerator at home that they may not. At these banks, collected DBM milk is stored frozen until pasteurized and then frozen again until shipped to the regional NICU. DBM is frozen and thawed up to three times before it is consumed by the baby. In general, DBM from four to six mothers is pooled for pasteurization. On the other hand, in the in-hospital installed DBMB setting, a physician, nurse or both approach all mothers who deliver premature babies in the immediate postpartum period. Information regarding their medical and lifestyle risk factors and prenatal serum syphilis, HIV, hepatitis B and C, and HTLV is readily available from prenatal records, even in developing countries such as India. No additional testing or an order for donation by a physician is needed. The NICU staff educate these women regarding the need for expressing milk, the importance of breast hygiene, and the proper collection and storage of EBM. Several times BM is expressed in the hospital under supervision of a nurse or a lactation specialist. These mothers are requested, when needed, to express milk more than what their baby requires. The extra fresh EBM can be easily pasteurized shortly and stored at 40 °C in small aliquots to be used within the next 24 hours or stored frozen at -180 °C for use after 24 hours.
In any NICU, the following is a common scenario: A premature baby gets admitted to the NICU, needing assisted ventilation or not, and is ready for enteral feedings as early as 6 hours of age. It is common that the baby’s natural mother is unable to produce enough colostrum or BM for at least 2-3 days or even longer. During the interim, the baby receives TPN, premature formula, DBM obtained from the traditional DBMB or a combination of these. With the availability of Kimie, it will be easy to give PDBM obtained from another mother who had a premature baby a few days or weeks ago and is now able to produce extra milk than what her baby requires. The DBM from the preterm mother can be collected, pasteurized and stored frozen or pasteurized soon after expressing and used immediately. In the later scenario, PDBM can be stored at 40°C in small aliquots to be used within the next 24 hours. This approach will decrease the need for TPN and eliminate the use of premature formula or DBM obtained from mothers who had a baby at full-term gestation. The use of preterm milk is better since it has a higher content of protein, fat, amino acids, lysozymes, calcium and sodium (50-53). Clinical studies to establish the validity of the above stated approach using Kimie seem warranted.
In summary, we have developed a human breast milk pasteurizer better suited for in-hospital installed DBMB that should help improve the health of premature babies worldwide.