Regulation .08 Equipment and Utensils.
Regulation .08 Equipment and Utensils.LinkCopy Citation
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.