The person-in-charge shall ensure that:

1. A. Equipment for processing drinking water is:

   1. (1) Maintained in a sanitary and working condition;

   2. (2) Provided with instrumentation to allow:

      1. (a) Process control; and
      2. (b) Monitoring;
   3. (3) Monitored to verify that process requirements are met; and
   4. (4) Durable and impervious to water;

2. B. Materials used as water contact surfaces of equipment and utensils:

   1. (1) Are nontoxic and inert to water under the conditions of use;
   2. (2) Do not migrate to or adulterate drinking water;
   3. (3) Are nonporous and nonabsorbent; and
   4. (4) Are corrosion resistant;

3. C. Water contact surfaces of equipment and utensils are:

   1. (1) Designed, constructed, and maintained to be:

      1. (a) Smooth;
      2. (b) Easily cleanable;
      3. (c) Free of difficult to clean internal surfaces;
      4. (d) Self-emptying or self-draining if an interior surface;
      5. (e) Visible for inspection or the equipment is readily disassembled for inspection;

      6. (f) If manually cleaned:

         1. (i) Readily accessible for cleaning without tools; or
         2. (ii) If not readily accessible, readily disassembled for cleaning with the use of simple tools kept available at the equipment; and
      7. (g) If cleaned and sanitized by pressurized cleaning-in-place, readily accessible to the cleaning and sanitizing solutions without disassembly; and

   2. (2) Cleaned and sanitized:

      1. (a) In accordance with 21 CFR §129.80(c) and (d); and
      2. (b) As often as necessary to maintain sanitary conditions and prevent the adulteration of drinking water;

4. D. When pressurized clean-in-place is used:

   1. (1) A cleaning and sanitizing solution is:

      1. (a) Fully circulated through a fixed system to contact all interior water contact surfaces;
      2. (b) Effective in cleaning and sanitizing water contact surfaces;
      3. (c) Used in accordance with the chemical manufacturer's instructions; and

      4. (d) Removed from equipment and water contact surfaces prior to drinking water for bottling or dispensing coming into contact with the equipment or water contact surface by:

         1. (i) Rinsing the equipment or water contact surface with drinking water that is diverted to waste until the cleaning and sanitizing solutions are evacuated; or
         2. (ii) Other means to evacuate the cleaning and sanitizing solutions and prevent the adulteration of finished product water;
   2. (2) The design, construction, and maintenance of a clean-in-place piping system prevents the contamination of drinking water by cleaning and sanitizing chemicals; and
   3. (3) The operation of a clean-in-place system using chemicals that are potentially hazardous to public health is controlled and monitored;

5. E. A record is made that:

   1. (1) Documents the:

      1. (a) Proper cleaning and sanitizing of:

         1. (i) Water contact surfaces; and
         2. (ii) Filling and dispensing machines and equipment;
      2. (b) Evacuation of cleaning and sanitizing solutions from equipment and water contact surfaces; and
      3. (c) Inspection and maintenance of equipment associated with cleaning and sanitizing water contact surfaces;
   2. (2) Is maintained for at least 2 years after the cleaning, sanitizing, inspection, maintenance, or monitoring activity; and
   3. (3) Is available for inspection by the Department; and
6. F. Before new or remodeled bottling equipment is used to produce finished product water, a plan for the equipment design, construction, installation, and maintenance of the equipment is submitted to and approved by the Department.

Authority: Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-305, 21-306, 21-334, 21-336, and 21-336.1, Annotated Code of Maryland

Effective date: March 23, 2009 (36:6 Md. R. 491)