(a) Aliquoting when using the Holder pasteurization method.

1. (1)

   1. (A) Pooled breast milk is aliquoted into clean containers.
   2. (B) Original containers may be used as long as:

(i) They have been maintained under clean conditions;

1. (ii) Manufacturers' documentation confirms that they have multiple-use approval; and

   1. (iii) They have been appropriately sanitized.
2. (2) Containers are filled leaving adequate air space in the container to allow for expansion during freezing.

3. (3)

   1. (A) All containers are filled to the same approximate level.
   2. (B) Breast milk is examined during pouring for foreign matter.
   3. (C) Breast milk is strained and visually examined before heat processing.
   4. (D) Any foreign matter should be removed, and, if not removable, the breast milk is discarded.
4. (4) All containers are tightly closed with clean caps to prevent contamination of breast milk during heat treatment.

5. (5)

   1. (A) Multiple batches may be created from one (1) pool.
   2. (B) “Batch” means the set of bottles that fit into a single pasteurizer or shaking water bath at one (1) time.

(b) Heat processing.

1. (1) When using equipment specifically designed for human breast milk pasteurization, the procedures for use of the machine are followed.

2. (2) The following guidelines refer to shaking water baths only:

   1. (A) Aliquots of breast milk are processed by completely submerging the containers in a well-agitated or shaking water bath preheated to a minimum of sixty-two and five-tenths degrees Celsius (62.5°C);

   2. (B)

      1. (i) A control bottle containing the same amount of breast milk or water as the most filled container of breast milk in the batch is fitted with a calibrated thermometer to register breast milk temperature during heat processing.
      2. (ii) The control bottle follows the same process as the rest of the batch at all times;

   3. (C)

      1. (i) The thermometer is positioned:

(b) (b) According to manufacturer's instructions.

1. (ii) Probe should not be touching the bottle in any way;

   1. (D) The monitored aliquot is placed into the water bath with all other aliquots and is either positioned at the coldest area of the water bath, as identified during calibration checks, or positioned according to the manufacturer's instructions;

   2. (E)

      1. (i) After the temperature of the monitored control bottle has reached sixty-two and five-tenths degrees Celsius (62.5°C), the heat treatment continues for thirty (30) minutes, maintaining the temperature, and then ends immediately.
      2. (ii) Fluctuation during the heating process may be seen for short periods of adjustment, where heat may briefly fluctuate between sixty-two to sixty-four and five-tenths degrees Celsius (62°C – 64.5°C);
   3. (F) Breast milk temperature and bath temperature are monitored and recorded; and

   4. (G)

      1. (i) Air bubbles released from breast milk containers indicate insecure caps.
      2. (ii) Such bottles are discarded.
      3. (c) Chilling and storage. When using equipment specifically designed for human breast milk pasteurization, the procedures for use of the machine are as follows:

2. (1)

   1. (A) Following heat processing, the breast milk is rapidly cooled to four degrees Celsius (4°C) (thirty-nine degrees Fahrenheit (39°F)) using either the processing equipment manufactured to cool breast milk or ice baths.

   2. (B) If using ice baths for cooling:

      1. (i) Water source must be of adequate sanitary quality; and
      2. (ii) The ice-creating equipment must be maintained per manufacturer's instructions.
   3. (C) Note. Unless using caps and equipment designed for submersion, caps need to remain above water level to prevent possible contamination from water seepage;
3. (2) An aliquot of processed breast milk from each batch is cultured for bacteria count;
4. (3) Breast milk is promptly labeled and frozen for storage; and

5. (4)

   1. (A) Cooled, heat-processed breast milk can be stored and sealed for up to seventy-two (72) hours at four degrees Celsius (4°C) for dispensing without freezing once bacteriological culture procedures and standards are met.

   2. (B) Breast milk can then be frozen for later use if not needed immediately.

      1. (d) Labeling of breast milk.
6. (1) Containers are labeled with batch number and expiration date of not more than one (1) year from earliest pumping date of breast milk in pool.
7. (2) Containers are labeled with the name of the breast milk bank where the processing occurred.

(e) Bar-coding of breast milk.

1. (1) Barcode or other automatic tracking systems are not included as a minimum requirement for breast milk banks.

2. (2) If a breast milk bank chooses to use an automatic tracking system, it is used within the following parameters:

   1. (A) The tracking/coding system is maintained following manufacturer's directions;
   2. (B) The breast milk bank reports annually to receipt hospitals about what system is being used for tracking; and
   3. (C) The system would ideally be used by the recipient hospital also, but this is not required.

(f) Bacteriological testing.

1. (1)

   1. (A) Any bacteriological growth is unacceptable for heat-processed breast milk.
   2. (B) Individual milk banks have the microbiology standards of practice available in their banks, distributed by Human Milk Bank Association of North America or the Food and Drug Administration’s Bacteriological Analytical Manual.
   3. (C) Individual breast milk banks ensure that the microbiology lab performing the testing is in compliance with the procedures.

2. (2)

   1. (A) Breast milk that does not meet acceptable bacteriological standards is not distributed to a recipient but may be used for research.
   2. (B) If not used for research, the contaminated breast milk is discarded.

3. (3)

   1. (A) The bottle of breast milk for the microbiological sample is:

      1. (i) Chosen randomly from each batch of breast milk; and
      2. (ii) Discarded once the sample is taken.
   2. (B) It is not resealed and dispensed, and it does not need to be stored for further testing.

(g) Shipping.

1. (1)

   1. (A) Breast milk banks follow the standard guidelines of the shipper for ensuring that breast milk arrives at the destination intact and in a frozen state.
   2. (B) Dry ice or blue ice may be used if sufficient in weight or size to keep breast milk frozen.

2. (2)

   1. (A) Cold-chain verification may be required in your state or province.
   2. (B) A number of technologies exist to verify temperature.