Title: Section 70-3.1 - Validation testing

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 log10 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 log10 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.