13.1 Milk processing buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for milk-processing purposes. The building and facilities:

13.1.1 Provide sufficient space for placement of equipment and storage materials to permit sanitary operations and production of donor human milk.

13.1.2 Permit the use of proper precautions to reduce the potential for contamination of milk, milk-contact surfaces, or milk-packaging materials.

13.1.3 Are constructed in such a manner that floors, walls, and ceilings may be adequately kept clean and in good repair. Any droplets or condensates from fixtures, ducts, and pipes do not contaminate milk, milk-contact surfaces, or milk-packaging materials. Aisles or working spaces are provided between equipment and walls, and are adequately unobstructed and of adequate width to permit employees to perform duties and to protect against contaminating milk or milk-contact surfaces, and milk-packaging materials.

13.1.4 Allow no pests in any area of the milk bank. Effective measures are taken to exclude pests from the processing areas and to protect against the contamination of milk on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of milk, milk-contact surfaces, and milk-packaging materials.

13.1.5 Do not allow persons unnecessary to milk processing into the milk preparation area while open containers of milk are being processed.

13.1.6 Properly identify cleaners and sanitizers, which are stored in dedicated containers and kept away from the milk in processing.

13.1.7 Provide adequate hand-washing facilities, including a lavatory fixture (sink) with either hot/cold or warm running water, soap, or detergent and individual sanitary towels.

13.1.8 Provide that pasteurizing, pouring, cooling, and labeling of milk occur in one room with a separate door, which is closed whenever milk containers are open.

13.1.9 Provide a separate room for the cleaning of equipment and containers. In the absence of separate rooms, the cleaning of equipment is done after milk processing is complete.

13.1.10 Provide designated areas or rooms for the receiving, handling, and storage of returned (recalled) milk and milk products. Freezer space for the returned product must not be comingled with raw frozen or pasteurized milk, although both raw and processed milk can be in different sections of the same freezer.

13.1.11 Provide separate freezers to store incoming raw-frozen donor milk and pasteurized milk. Minimally, milk can be stored in the same freezer but must be clearly separated, labelled, and identifiable in the same freezer.

13.1.12 Provide toilet facilities that do not open directly into any room in which milk and/or milk products are processed. Restrooms must be completely enclosed, with the door kept closed, and include signage for handwashing. Lab staff must scrub back into lab after use of the restroom.

13.1.13 Provide a water supply in compliance with city, state, or township ordinances for potable water.