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

Area of Science:

• Human milk banking
• Infant nutrition
• Food safety engineering

Background:

• Human milk banks globally serve vulnerable preterm and low-birth-weight infants.
• Holder pasteurization is the standard safety method, but alternatives are sought to preserve nutritional content.
• No global standard exists for validating new human milk processing technologies.

Purpose of the Study:

• To propose a framework for validation studies of novel processing technologies in human milk banking.
• To address both safety and nutritional impacts of new technologies.
• To guide the evaluation of methods that may better preserve human milk's benefits.

Main Methods:

• Comprehensive narrative review of safety parameters, nutritional, and immune components of human milk.
• Analysis of challenges in evaluating novel processing methods.
• Development of a framework for process validation studies.

Main Results:

• Identified key safety parameters for pathogen inactivation.
• Highlighted the importance of preserving nutritional and immune factors.
• Proposed a framework for validation studies, including sample size considerations.

Conclusions:

• A standardized validation framework is needed for new human milk processing technologies.
• Validation must encompass pathogen inactivation and nutritional/immune component preservation.
• The proposed framework aims to ensure safe and nutritionally superior donor human milk for infants.