(b) The building and facilities:

1. (1) Provide sufficient space for placement of equipment and storage materials to permit sanitary operations and production of donor human breast milk;

2. (2) Permit the use of proper precautions to reduce the potential for contamination of:

   1. (A) Breast milk;
   2. (B) Breast milk contact surfaces; or
   3. (C) Breast milk packaging materials;

3. (3)

   1. (A) Are constructed in such a manner that floors, walls, and ceilings may be adequately kept clean and in good repair.
   2. (B) Any droplets or condensates from fixtures, ducts, and pipes do not contaminate:

(i) Breast milk;

1. (ii) Breast milk contact surfaces; or

   1. (iii) Breast milk packaging materials.

   2. (C) Aisles or working spaces are:

      1. (i) Provided between equipment and walls; and
      2. (ii) Adequately unobstructed and of adequate width to:

(b) (b) Protect against contaminating:

1. (1) (1) Breast milk or breast milk contact surfaces; and
2. (2) (2) Breast milk packaging materials;

3. (4)

   1. (A) Allow no pests in any area of the breast milk bank.

   2. (B) Effective measures are taken to:

      1. (i) Exclude pests from the processing areas; and
      2. (ii) Protect against the contamination of breast milk on the premises by pests.

   3. (C) The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of:

      1. (i) Breast milk;
      2. (ii) Breast milk contact surfaces; and
      3. (iii) Breast milk packaging materials;
4. (5) Do not allow persons unnecessary to breast milk processing into the breast milk preparation area while open containers of breast milk are being processed;

5. (6) Properly identify cleaners and sanitizers, which are:

   1. (A) Stored in dedicated containers; and
   2. (B) Kept away from the breast milk in processing;

6. (7) Provide adequate hand washing facilities, including a lavatory fixture (sink) with:

   1. (A) Either hot/cold or warm running water;
   2. (B) Soap or detergent; and
   3. (C) Individual sanitary towels;
7. (8) Provide that pasteurizing, pouring, cooling, and labeling of breast milk occur in one (1) room with a separate door, which is closed whenever breast milk containers are open;

8. (9)

   1. (A) Provide a separate room for the cleaning of equipment and containers.
   2. (B) In the absence of separate rooms, the cleaning of equipment is done after breast milk processing is complete;

9. (10)

   1. (A) Provide designated areas or rooms for the receiving, handling, and storage of returned (recalled) breast milk and breast milk products.
   2. (B) Freezer space for the returned product must not be commingled with raw-frozen or pasteurized breast milk, although both raw and processed breast milk can be in different sections of the same freezer;

10. (11)

    1. (A) Provide separate freezers to store incoming raw-frozen donor breast milk and pasteurized breast milk.
    2. (B) Minimally, breast milk can be stored in the same freezer but must be clearly separated, labelled, and identifiable in the same freezer;

11. (12)

    1. (A) Provide toilet facilities that do not open directly into any room in which breast milk and/or breast milk products are processed.

    2. (B) Restrooms must:

       1. (i) Be completely enclosed, with the door kept closed; and
       2. (ii) Include signage for hand washing.
    3. (C) Lab staff must scrub back into lab after use of the restroom; and
12. (13) Provide a water supply in compliance with city, state, or township ordinances for potable water.