(a)

1. (1) Recording thermometers monitor freezer temperatures, or freezers are equipped with temperature-sensitive alarms.
2. (2) Two (2) distinct and appropriately calibrated thermometers, whether electronic, indwelling, or mercury, monitor freezers.
3. (3) Breast milk bank personnel investigate and resolve discrepancies in thermometer readings.

(c)

1. (1) Breast milk is stored in dedicated freezers that maintain breast milk in a frozen state.
2. (2) Freezer temperature is held no higher than negative eighteen degrees Celsius (-18°C) or zero degrees Fahrenheit (0°F), and any lower temperature is acceptable.
3. (3) Brief fluctuations in temperature secondary to opening the doors or self-defrosting cycles are acceptable as long as breast milk remains frozen.

(e) Storage and processing equipment are calibrated:

1. (1) Every six (6) months; or
2. (2) According to manufacturers' instructions.

(h)

1. (1) Processed breast milk is stored in glass or food-grade plastic that meets Food and Drug Administration requirements for both freezing and heating temperatures used in processing.
2. (2) Documentation of such is maintained in the breast milk bank.

(i) All equipment used in the breast milk bank is cleaned and maintained according manufacturer's instructions, including but not limited to:

1. (1) Freezers;
2. (2) Refrigerators;
3. (3) Pasteurizers;
4. (4) Shaking water baths;
5. (5) Dishwashers;
6. (6) Thermometers;
7. (7) Alarms; and
8. (8) Breast milk composition analysis equipment.

(j)

1. (1) All breast milk bank equipment and utensils are designed and made from material that can be adequately cleaned and maintained.

2. (2) The design, construction, and use of equipment and utensils do not result in the adulteration of breast milk with:

   1. (A) Lubricants;
   2. (B) Fuel;
   3. (C) Metal fragments;
   4. (D) Contaminated water; or
   5. (E) Any other contaminants.
3. (3) All equipment should be installed and maintained to facilitate the cleaning of the equipment and of all adjacent spaces.
4. (4) Breast milk contact surfaces are corrosion­resistant when in contact with breast milk.

5. (5) They are:

   1. (A) Made of nontoxic materials; and
   2. (B) Designed to withstand:

(i) The environment of their intended use;

1. (ii) The action of breast milk; and

   1. (iii) If applicable, cleaning compounds and sanitizing agents.
2. (6) Breast milk contact surfaces are maintained to protect breast milk from being contaminated by any source, including unlawful indirect breast milk additives.

(k) Seams on breast 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.

1. (l) Equipment that is in the manufacturing or breast milk handling area and that does not come into contact with breast milk is constructed so that it can be kept in a clean condition.

   1. (m) 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.