The person-in-charge shall ensure that:
Equipment for processing drinking water is:
Maintained in a sanitary and working condition;
Provided with instrumentation to allow:
Process control; and
Monitoring;
Monitored to verify that process requirements are met; and
Durable and impervious to water;
Materials used as water contact surfaces of equipment and utensils:
Are nontoxic and inert to water under the conditions of use;
Do not migrate to or adulterate drinking water;
Are nonporous and nonabsorbent; and
Are corrosion resistant;
Water contact surfaces of equipment and utensils are:
Designed, constructed, and maintained to be:
Smooth;
Easily cleanable;
Free of difficult to clean internal surfaces;
Self-emptying or self-draining if an interior surface;
Visible for inspection or the equipment is readily disassembled for inspection;
If manually cleaned:
Readily accessible for cleaning without tools; or
If not readily accessible, readily disassembled for cleaning with the use of simple tools kept available at the equipment; and
If cleaned and sanitized by pressurized cleaning-in-place, readily accessible to the cleaning and sanitizing solutions without disassembly; and
Cleaned and sanitized:
In accordance with 21 CFR ยง129.80(c) and (d); and
As often as necessary to maintain sanitary conditions and prevent the adulteration of drinking water;
When pressurized clean-in-place is used:
A cleaning and sanitizing solution is:
Fully circulated through a fixed system to contact all interior water contact surfaces;
Effective in cleaning and sanitizing water contact surfaces;
Used in accordance with the chemical manufacturer's instructions; and
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:
Rinsing the equipment or water contact surface with drinking water that is diverted to waste until the cleaning and sanitizing solutions are evacuated; or
Other means to evacuate the cleaning and sanitizing solutions and prevent the adulteration of finished product water;
The design, construction, and maintenance of a clean-in-place piping system prevents the contamination of drinking water by cleaning and sanitizing chemicals; and
The operation of a clean-in-place system using chemicals that are potentially hazardous to public health is controlled and monitored;
A record is made that:
Documents the:
Proper cleaning and sanitizing of:
Water contact surfaces; and
Filling and dispensing machines and equipment;
Evacuation of cleaning and sanitizing solutions from equipment and water contact surfaces; and
Inspection and maintenance of equipment associated with cleaning and sanitizing water contact surfaces;
Is maintained for at least 2 years after the cleaning, sanitizing, inspection, maintenance, or monitoring activity; and
Is available for inspection by the Department; and
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.