Md. Code Regs. 10.15.11.08

Current through Register Vol. 52, No. 1, January 10, 2025

Section 10.15.11.08 - Equipment and Utensils

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.

Md. Code Regs. 10.15.11.08