A Framework for Evaluation of New Processing Technologies in Human Milk Banking.

The purpose of this review was to devise a framework for validation studies to test new processing technologies in human milk banking. Human milk banks are an expanding service globally. They provide donor human milk to predominantly preterm and low-birth-weight infants, who represent a vulnerable population. The most common method used by milk banks to ensure the safety of human milk is Holder pasteurization. There has been significant interest in recent years in alternative pathogen inactivation techniques for human milk banking, which may better preserve nutritional content while maintaining an appropriate safety profile. At present, there is no global standard for evaluating and validating new processing technologies for human milk. A major difficulty in developing a standard to evaluate novel processing methods for human milk is that it is not fully established which components of human milk, beyond macronutrient content, contribute to better clinical outcomes in preterm infants. A validation study should ideally address both the safety and nutritional impact of a new technology for human milk. For food safety, the main goal remains to achieve complete inactivation of relevant pathogenic bacteria and viruses. The secondary goal is to ensure adequate nutritional quality of the final product, so that infants receive nutrition that is as close as possible to mother's own milk. We have done a comprehensive narrative review of the key safety parameters, and nutritional and immune components of human milk, to suggest a novel framework for process validation studies in human milk banking, including suggestions for sample size where appropriate.