# COMAR Title 10 — Maryland Department of Health

## Subtitle 15 — Food

### Chapter 11 — Bottled Water

#### Regulation .08 Equipment and Utensils.

*COMAR 10.15.11.08*

The person-in-charge shall ensure that:

A. Equipment for processing drinking water is:

  (1) Maintained in a sanitary and working condition;

  (2) Provided with instrumentation to allow:

    (a) Process control; and

    (b) Monitoring;

  (3) Monitored to verify that process requirements are met; and

  (4) Durable and impervious to water;

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

  (1) Are nontoxic and inert to water under the conditions of use;

  (2) Do not migrate to or adulterate drinking water;

  (3) Are nonporous and nonabsorbent; and

  (4) Are corrosion resistant;

C. Water contact surfaces of equipment and utensils are:

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

    (a) Smooth;

    (b) Easily cleanable;

    (c) Free of difficult to clean internal surfaces;

    (d) Self-emptying or self-draining if an interior surface;

    (e) Visible for inspection or the equipment is readily disassembled for inspection;

    (f) If manually cleaned:

      (i) Readily accessible for cleaning without tools; or

      (ii) If not readily accessible, readily disassembled for cleaning with the use of simple tools kept available at the equipment; and

    (g) If cleaned and sanitized by pressurized cleaning-in-place, readily accessible to the cleaning and sanitizing solutions without disassembly; and

  (2) Cleaned and sanitized:

    (a) In accordance with 21 CFR §129.80(c) and (d); and

    (b) As often as necessary to maintain sanitary conditions and prevent the adulteration of drinking water;

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

  (1) A cleaning and sanitizing solution is:

    (a) Fully circulated through a fixed system to contact all interior water contact surfaces;

    (b) Effective in cleaning and sanitizing water contact surfaces;

    (c) Used in accordance with the chemical manufacturer's instructions; and

    (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:

      (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

      (ii) Other means to evacuate the cleaning and sanitizing solutions and prevent the adulteration of finished product water;

  (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) The operation of a clean-in-place system using chemicals that are potentially hazardous to public health is controlled and monitored;

E. A record is made that:

  (1) Documents the:

    (a) Proper cleaning and sanitizing of:

      (i) Water contact surfaces; and

      (ii) Filling and dispensing machines and equipment;

    (b) Evacuation of cleaning and sanitizing solutions from equipment and water contact surfaces; and

    (c) Inspection and maintenance of equipment associated with cleaning and sanitizing water contact surfaces;

  (2) Is maintained for at least 2 years after the cleaning, sanitizing, inspection, maintenance, or monitoring activity; and

  (3) Is available for inspection by the Department; and

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.