TITLE 35: ENVIRONMENTAL PROTECTION
SUBTITLE M: BIOLOGICAL MATERIALS
CHAPTER I: POLLUTION CONTROL BOARD
SUBCHAPTER b: POTENTIALLY INFECTIOUS MEDICAL WASTES
PART 1422 DESIGN AND OPERATION OF FACILITIES
SECTION 1422.124 INITIAL EFFICACY TEST
Section 1422.124 Initial Efficacy Test
a) The manufacturer, owner or operator of a treatment unit shall conduct an Initial Efficacy Test, pursuant to Appendix A of this Part, for each model prior to its operation. If significant mechanical changes are made to a treatment unit, the Initial Efficacy Test must be repeated. Treatment units are considered to be the same model if they:
1) Are manufactured by the same company;
2) Have the same capacity; and
3) Have no significant mechanical changes.
b) The Initial Efficacy Test must be conducted by the use of Options 1, 2 or 3 of Appendix A of this Part, and the challenge loads as described in Table C of Appendix A of this Part. If any of the challenge loads fails the Initial Efficacy Test, the operating conditions must be revised and the Initial Efficacy Test must be repeated for all challenge loads. The Initial Efficacy Test must also meet the requirements of this Section.
1) Option 1 must be used for a treatment unit that does not maintain the integrity of the container of test microorganisms (e.g., grinding followed by chemical disinfection). This option is a two phase test.
A) The first phase is to determine the dilution of each test microorganism from the operation of the treatment unit for each challenge load. The log of the number of viable test microorganisms in the processed residue must be greater than or equal to six (6).
B) The second phase is to determine the effectiveness of the treatment unit. The log kill (L) for each test microorganism after treatment must be greater than or equal to six (6).
2) Option 2 must be used for a treatment unit that maintains the integrity of the container of test microorganisms (e.g., autoclaving). The log kill (L) for each test microorganism after treatment must be greater than or equal to six (6).
3) Option 3 can only be used for a thermal treatment unit that maintains the integrity of the container of indicator microorganism spores (e.g., autoclaving, incinerating). The log kill (L) of indicator microorganism spores after treatment must be greater than or equal to six (6).
c) Composition of Challenge Loads
1) For treatment units designed to treat all types of PIMW, all three (3) types of challenge loads must be used in conducting the Initial Efficacy Test. The three (3) types of challenge loads represent PIMW with a high moisture content, low moisture content and high organic content. The quantity of each challenge load must equal 100% of the maximum capacity of the treatment unit. Each challenge load must include, at a minimum, 5% of each of the following categories: blood/broth cultures, fibers, metals, sharps, plastics, pathological waste, glass, non-woven fibers and bottles of liquids. Table C of Appendix A of this Part contains the moisture and organic content requirements that must be met in each type of challenge load.
2) For treatment units designed to treat only select categories of PIMW (e.g., a sharps treatment unit), a modification in the composition of the challenge load(s) may be used if approved by the Agency in writing.
d) The Initial Efficacy Test must be conducted under the same operating conditions under which the treatment unit operates on a day-to-day basis. The feed rate for the treatment unit must remain constant throughout the Initial Efficacy Test. This feed rate must never be exceeded during the operation of the treatment unit.
e) The Initial Efficacy Test must be performed so that:
1) Each container of test microorganisms and/or indicator microorganism spores is placed in the load to simulate the worse case scenario (i.e., that part of the load that is the most difficult to treat). For example, the worst case scenario for an autoclave would be to place the container of test microorganisms and/or indicator microorganism spores within a sharps container that must in turn be deposited in a plastic biohazard bag that is then located centrally within each of the challenge loads.
2) Test microorganisms and/or indicator microorganisms must be cultured and enumerated in accordance with instructions provided by the supplier of the microorganisms and Standard Methods for the Examination of Water and Wastewater, incorporated by reference at 35 Ill. Adm. Code 1420.103.
f) A Document of Initial Efficacy Demonstration must be retained at the treatment facility, and made available at the treatment facility during normal business hours for inspection and photocopying by the Agency. The Document of Initial Efficacy Demonstration must include, at a minimum:
1) A detailed description of the test procedures used, including all test data generated, with descriptions of data handling, and a presentation and interpretation of final test results;
2) A detailed description and verification of the operating parameters (e.g., temperatures, pressures, retention times, chemical concentrations, irradiation doses, and feed rates);
3) A description of quality assurance/quality control procedures and practices for the culture, storage and preparation of test and/or indicator microorganisms (including, but not limited to, organism history, source, stock culture maintenance and enumeration procedures). The purity of the test microorganisms and/or indicator microorganism spores must be certified by a commercial or clinical laboratory;
4) A description of microorganism preparation and packaging, challenge load weight and composition, unit testing scheme (numbers of test rows) and sampling strategy (e.g., number and weight of solid and/or liquid samples);
5) A description and demonstration of microorganism recovery including sample processing, incubation and effective neutralization, and absence of toxic compounds due to neutralization (as applicable);
6) Appendices containing raw data and assumptions in tabular form;
7) The name(s), date, signature(s) and title(s) of person(s) conducting the Initial Efficacy Test, and their qualifications; and
8) A list of references used to evaluate the data and obtain the final conclusion.