14.1 Recording thermometers monitor freezer temperatures, or freezers are equipped with temperature-sensitive alarms. Two distinct and appropriately calibrated thermometers -- whether electronic, indwelling, or mercury -- monitor freezers. Milk bank personnel investigate and resolve discrepancies in thermometer readings.

14.2 Freezers are locked or in a secured area.

14.3 Milk is stored in dedicated freezers that maintain milk in a frozen state. Freezer temperature is held no higher than -18°C (or 0°F) and any lower temperature is acceptable. Brief fluctuations in temperature secondary to opening the doors or self-defrosting cycles are acceptable as long as milk remains frozen.

14.4 Refrigerators used for storing thawed or processed milk are held no higher than 4°C (or 40°F).

14.5 Storage and processing equipment are calibrated every six (6) months, or according to manufacturers' instructions.

14.6 All equipment manuals are available to milk bank personnel at all times.

14.7 Equipment intended for human milk banking -- processing or storing -- is used only for milk banking purposes.

14.8 Processed milk is stored in glass or food-grade plastic that meets FDA requirements for both freezing and heating temperatures used in processing. Documentation of such is maintained in the milk bank.

14.9 All equipment used in the milk bank is cleaned and maintained according manufacturer's instructions, including, but not limited to, freezers, refrigerators, pasteurizers, shaking water baths, dishwashers, thermometers, alarms, and milk composition analysis equipment.

14.10 All milk bank equipment and utensils are designed and made from material that can be adequately cleaned and maintained. The design, construction, and use of equipment and utensils do not result in the adulteration of milk with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be installed and maintained to facilitate the cleaning of the equipment and of all adjacent spaces. Milk-contact surfaces are corrosion-resistant when in contact with milk. They are made of nontoxic materials and designed to withstand the environment of their intended use and the action of milk, and, if applicable, cleaning compounds and sanitizing agents. Milk-contact surfaces are maintained to protect milk from being contaminated by any source, including unlawful indirect milk additives.

14.11 Seams on milk-contact surfaces are smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter, and thus minimize the opportunity for growth of microorganisms.

14.12 Equipment that is in the manufacturing or milk-handling area and that does not come into contact with milk is constructed so that it can be kept in a clean condition.

14.13 Holding, conveying, and manufacturing systems -- including gravimetric, pneumatic, closed, and automated systems -- are of a design and construction that enables them to be maintained in an appropriate sanitary condition.