N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 70-3.1 - Validation testing
(a) Prior
to using an autoclave to treat regulated medical waste, a facility shall
conduct validation testing under conditions, including, but not limited to load
configuration, composition and volume, that simulate conditions anticipated
during actual waste treatment. Validation testing protocols shall be included
in the facility's autoclave operation plan submitted to the department pursuant
to section
70-3.2
of this Subpart.
(b)
(1) Validation testing shall employ spores of
Geobacillus stearothermophilus at a minimum concentration of 6 log
10 spores per indicator unit placed in the center of the
load or otherwise coldest point in the autoclave chamber as identified by the
manufacturer; provided, however, the department may require alternative and/or
supplemental indicators as necessary to demonstrate effectiveness of
treatment.
(2) Effective treatment
of regulated medical waste shall be demonstrated by a 4 log
10 reduction in viable Geobacillus stearothermophilus
spore concentration, or other measure of effectiveness for alternative and/or
supplemental indicators as specified by the department.
(c) No autoclave that fails to meet the
criteria for effective treatment pursuant to subdivision (b) of this section
upon validation testing at the site of installation shall be used to treat
regulated medical waste.
(d) A
facility that seeks to operate an autoclave at other than the generally
accepted operating parameters (i.e., time, temperature and pressure) provided
in section
70-3.3(a)
and (b) of this Subpart shall request and
obtain department approval for operation of the autoclave as an alternative
treatment system pursuant to Subpart 70-5 of this Part.
Notes
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