23.1 Aliquoting when using the Holder Pasteurization Method

23.1.1 Pooled milk is aliquoted into clean containers. Original containers may be used as long as they have been maintained under clean conditions, manufacturers' documentation confirms that they have multiple-use approval, and they have been appropriately sanitized.

23.1.2 Containers are filled leaving adequate air space in the container to allow for expansion during freezing.

23.1.3 All containers are filled to the same approximate level. Milk is examined during pouring for foreign matter. Milk is strained and visually examined before heat processing. Any foreign matter should be removed, and, if not removable, the milk is discarded.

23.1.4 All containers are tightly closed with clean caps to prevent contamination of milk during heat treatment.

23.1.5 Multiple batches may be created from one pool. A “batch” is the set of bottles that fit into a single pasteurizer or shaking water bath at one time.

23.2 Heat Processing

23.2.1 When using equipment specifically designed for human milk pasteurization, the procedures for use of the machine are followed.

23.2.2 The following guidelines refer to shaking water baths only:

23.2.2.1 Aliquots of milk are processed by completely submerging the containers in a well-agitated or shaking water bath preheated to a minimum of 62.5°C.

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

23.2.2.3 The thermometer is positioned such that approximately 25% of the milk volume is below the measuring point of the thermometer, or according to manufacturer's instructions. Probe should not be touching the bottle in any way.

23.2.2.4 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.

23.2.2.5 After the temperature of the monitored control bottle has reached 62.5°C, the heat treatment continues for 30 minutes, maintaining the temperature, and then ends immediately. Fluctuation during the heating process may be seen for short periods of adjustment, where heat may briefly fluctuate between 62° and 64.5°C.

23.2.2.6 Milk temperature and bath temperature are monitored and recorded.

23.2.2.7 Air bubbles released from milk containers indicate insecure caps -- such bottles are discarded.

23.3 Chilling and Storage

23.3.1 When using equipment specifically designed for human milk pasteurization, the procedures for use of the machine are as follows.

23.3.2 Following heat processing, the milk is rapidly cooled to 4°C (39°F) using either the processing equipment manufactured to cool milk, or ice baths. If using ice baths for cooling, water source must be of adequate sanitary quality and the ice-creating equipment must be maintained per manufacturer's instructions. (NOTE: Unless using caps and equipment designed for submersion, caps need to remain above water level to prevent possible contamination from water seepage.)

23.3.3 An aliquot of processed milk from each batch is cultured for bacteria count.

23.3.4 Milk is promptly labeled and frozen for storage.

23.3.5 Cooled, heat-processed milk can be stored, sealed, for up to 72 hours at 4°C for dispensing without freezing once bacteriological culture procedures and standards are met. Milk can then be frozen for later use if not needed immediately.

23.4 Labeling of Milk

23.4.1 Containers are labeled with batch number and expiration date of not more than 1 year from earliest pumping date of milk in pool.

23.4.2 Containers are labeled with the name of the milk bank where the processing occurred.

23.5 Bar-coding of Milk

23.5.1 Barcode or other automatic tracking systems are not included as a minimum requirement for milk banks.

23.5.2 If a milk bank chooses to use an automatic tracking system, it is used within the following parameters:

23.5.2.1 The tracking/coding system is maintained following manufacturer's directions.

23.5.2.2 The milk bank reports annually to receipt hospitals about what system is being used for tracking.

23.5.2.3 The system would ideally be used by the recipient hospital also, but this is not required.

23.6 Bacteriological Testing

23.6.1 Any bacteriological growth in unacceptable for heat-processed milk. Individual milk banks have the microbiology Standards of Practice (SOP) available in their banks, distributed by Human Milk Bank Association of North America (HMBANA). Individual milk banks ensure that the microbiology lab performing the testing is in compliance with the procedures.

23.6.2 Milk that does not meet acceptable bacteriological standards is not distributed to a recipient but may be used for research. If not used for research, the contaminated milk is discarded.

23.6.3 The bottle of milk for the microbiological sample is chosen randomly from each batch of milk and discarded once the sample is taken. It is not resealed and dispensed, and it does not need to be stored for further testing.

23.7 Shipping

23.7.1 Milk banks follow the standard guidelines of the shipper for ensuring that milk arrives at the destination intact and in a frozen state. Dry ice or blue ice may be used if sufficient in weight or size to keep milk frozen.

23.7.2 Cold-chain verification may be required in your state or province. A number of technologies exist to verify temperature.