The ingredients in the oil and water phases are blended together in a concentrated mixture, heated, and the pH adjusted to stabilize the protein (Fig. 2). This mixture is subjected to a combination of processes which are similar to typical dairy processes: homogenization, pasteurization, UHTST (ultrahigh-temperature short-time sterilization), HTST (high temperature short time sterilization), de-aeration, and clarification. Heat-labile nutrients and flavors are added after these processing steps. Samples are taken for measurement of pH and total solids at this point, and the mix is adjusted to final total solids and pH.

Shelf-stable, liquid enteral products are commercially sterilized using either retort or aseptic processes. In the retort process, the final product is filled in either metal, glass, or plastic containers and sealed, normally under a slight vacuum. The filled containers are subjected to rapid heating with superheated steam. In most cases, the containers are rotated or shaken to assure even distribution of heat throughout the product. In the aseptic filling process, the product undergoes a UHTST treatment just prior to filling. The containers and lids are independently treated with a sterilant (eg, hydrogen peroxide) to assure sterility. The product is filled in the package in a sterile filling zone in the filler. Aseptic packages include plastic, glass, aluminum, steel, and fiberboard containers.

In the case of both retort and aseptic sterilization processes, the manufacturer must establish that the product and package receive treatment that is adequate to reduce pathogenic microorganisms in the finished product to a nonviable level for the shelf life of the product. Typically, the manufacturer subjects the product and package to testing protocols to assure sterilization processes are adequate. Before commercial release, the product is incubated at typical storage temperatures to assure that no microbial contamination occurs postprocess.

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