Current through Register Vol. 56, No. 18, September 16, 2024
(a) Mechanical
bottle washers shall be provided when multi-use containers are used. In
addition, mechanical washers shall be designed and maintained to thoroughly
wash and sanitize all surfaces of containers prior to filling.
(b) Multi-use bottles shall be checked prior
to washing by a method acceptable to the Department to assure that containers
that may have been used for other purposes are not reused for bottled water.
Such containers shall be rendered unusable for rebottling.
(c) Before filling, all multi-use containers
shall be thoroughly washed in an effective cleansing agent and water solution,
having a temperature not less than 120 degrees Fahrenheit, followed by
application of a bactericidal solution, and the inside rinsed with product
water to remove traces of sanitizing agents.
(d) The bactericidal procedure as a minimum,
shall be one of the following:
1. Sanitize
with 100 parts per million chlorine water solution at 75 degrees Fahrenheit for
not less than 30 seconds;
2.
Sanitize with a 2 1/2 percent caustic solution at a minimum temperature of 120
degrees Fahrenheit followed by a rinse containing not less than 10 parts per
million free chlorine. (Note: When caustic is discharged by means of
high-velocity jets, this procedure shall be considered to satisfy both cleaning
and bactericidal requirements);
3.
Sanitize with water at an inside bottle temperature not less than 170 degrees
Fahrenheit for not less than 15 seconds;
4. Sanitize by exposing all surfaces to a
three percent caustic solution at a minimum temperature of 120 degrees
Fahrenheit for five minutes by means of automatic bottle washers utilizing
high-velocity jets (hydro type) or by means of soaker washers, followed by a
rinse containing not less than 10 parts per million free chlorine;
5. As an alternative to the use of a caustic
alkali solution, multi-use containers may be cleaned and sanitized prior to
refilling by the use of an alkaline detergent cleaner containing a minimum of
0.35 percent active alkalinity at a minimum temperature of 130 degrees
Fahrenheit for not less than one minute (if high velocity jets are used), or
for not less than three minutes (if a soaker type washer is used), followed by
a rinse of at least one minute with a sanitizing solution containing at least
25 parts per million chlorine or 10 parts per million iodine. All bottles and
carboys shall be rinsed until free of any detergent or sanitizing solution
residue with product water; or
6.
Other methods equally protective of public health as the above, when approved
by the Department, may be used.
(e) Only sanitizers listed in
21 CFR
178.1010 shall be acceptable.
