Md. Code Regs. 10.15.11.08 - Equipment and Utensils

Current through Register Vol. 49, No. 8, April 8, 2022

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.

Notes

Md. Code Regs. 10.15.11.08

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