Current through Register Vol. 48, No. 38, September 20, 2024
a) The
manufacturer, owner, or operator of a treatment unit must conduct an Initial
Efficacy Test, under Appendix A, 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 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 using Option 1, 2, or 3 (see
Appendix A), and the challenge loads as described in Appendix A, Table C. 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.
1) A treatment unit that
does not maintain the integrity of the container of test microorganisms (e.g.,
grinding followed by chemical disinfection) must use Option 1. 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.
B) The second phase is to
determine the effectiveness of the treatment unit. The log kill for each test
microorganism after treatment must be greater than or equal to six.
2) A treatment unit that maintains
the integrity of the container of test microorganisms (e.g., autoclaving) must
use Option 2. The log kill for each test microorganism after treatment must be
greater than or equal to six.
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 of indicator microorganism spores
after treatment must be greater than or equal to six.
c) Composition of Challenge Loads.
1) For treatment units designed to treat all
types of PIMW:
A) Conduct the Initial
Efficacy Test using all three types of challenge loads in Appendix A, Table C.
The three types of challenge loads represent PIMW with a high moisture content,
low moisture content, and high organic content. Appendix A, Table C contains
the moisture and organic content requirements that must be met in each type of
challenge load.
B) The quantity of
each challenge load must equal 100% of the maximum capacity of the treatment
unit.
C) Each challenge load must
include 5% of each of the following categories: blood/broth cultures, fibers,
metals, sharps, plastics, pathological waste, glass, non-woven fibers, and
bottles of liquids.
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
loads may be used if approved by the Agency in writing.
d) The Initial Efficacy Test must be
conducted under the same operating conditions 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 or indicator microorganism spores is placed in the load to
simulate the worst 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 or indicator
microorganism spores within a sharps container that is deposited in a plastic
biohazard bag that is then located centrally within each of the challenge
loads.
2) Test microorganisms or
indicator microorganisms must be cultured and enumerated following instructions
provided by the supplier of the microorganisms and Standard Methods for the
Examination of Water and Wastewater (see 35 Ill. Adm. Code
1420.103
).
f) A Document of
Initial Efficacy Demonstration must be kept 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:
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 and quality control procedures and practices for the culture,
storage, and preparation of test or indicator microorganisms (including
organism history, source, stock culture maintenance, and enumeration
procedures). The purity of the test microorganisms 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 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, date, signature, title, and qualifications of the person or persons
conducting the Initial Efficacy Test; and
8) A list of references used to evaluate the
data and obtain the conclusion.