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.APPENDIX A INITIAL EFFICACY TEST PROCEDURES



Section 1422.APPENDIX A   Initial Efficacy Test Procedures

 

All PIMW treatment units must demonstrate that the infectious potential has been eliminated by using an Initial Efficacy Test in accordance with this Appendix. This Option 1 is for a treatment unit that compromises the integrity of the container of test microorganisms (e.g., grinding followed by chemical disinfection). The purpose of this Phase 1 is to determine the dilution of each test microorganism from the treatment unit for each challenge load (Types A through C) identified in Table C of this Appendix.

 

a)         Prepare and sterilize by autoclaving, two (2) challenge loads of Type A as identified in Table C of this Appendix.  Reserve one (1) challenge load for Phase 2.

 

b)         Each test microorganism must be processed in separate runs through the treatment unit.  Prior to each run, the number of viable test microorganisms in each container must be determined in accordance with applicable manufacturer's recommendations, and Standard Methods for the Examination of Water and Wastewater, incorporated by reference at 35 Ill. Adm. Code 1420.103.

 

c)         Processing of the PIMW must occur within thirty (30) minutes after introducing the container of test microorganisms into the treatment unit.

 

d)         The container of test microorganisms and challenge loads must be processed together without the physical and/or chemical agents designed to kill the test microorganisms.  For example, in treatment units that use chemical disinfectant(s), an equal volume of liquid (e.g., sterile saline solution (0.9%, volume/volume), phosphate buffer solution, tap water) must be substituted in place of the chemical disinfectant(s).

 

e)         A minimum of five (5) representative grab samples must be taken from the processed residue of each challenge load in accordance with Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (SW-846), incorporated by reference at 35 Ill. Adm. Code 1420.103.  The number of viable test microorganisms in each grab sample must be determined in accordance with applicable manufacturer's recommendations, and Standard Methods for the Examination of Water and Wastewater, incorporated by reference at 35 Ill. Adm. Code 1420.103.

 

f)         Calculate the effect of dilution for the treatment unit as follows:

 

            SA = Log NoA - Log N1A; where Log N1A  ≥ 6

 

where:             SA is the log of the number of viable test microorganisms (CFU/gram of waste solids and PFU/gram of waste solids) that were not recovered after processing challenge load Type A.

 

                       

 

NoA is the number of viable test microorganisms (CFU/gram of waste solids and PFU/gram of waste solids) introduced into the treatment unit for challenge load Type A.

                       

 

N1A is the number of viable test microorganisms (CFU/gram of waste solids and PFU/gram of waste solids) remaining in the processed residue for challenge load Type A.

 

            If Log N1A is less than 6, then the number of viable test microorganisms introduced into the treatment unit must be increased and steps (a) through (f) in Phase 1 must be repeated until Log N1A is ≥ 6.  NoA is the inoculum size for challenge load Type A in Phase 2 below.

 

g)         Repeat steps (a) through (f) in Phase 1 for challenge loads of PIMW for Types B and C identified in Table C of this Appendix to determine the effect of dilution (SB and SC, respectively).

 

The purpose of this Phase 2 is to determine the log kill of each test microorganism in each challenge load (Types A through C) identified in Table C of this Appendix.

 

a)         Using the inoculum size (NoA) determined in Phase 1 above, repeat Phase 1 steps (a) through (e) under the same operating parameters, except that the physical and/or chemical agents designed to kill the test microorganisms must be used.

 

b)         Calculate the effectiveness of the treatment unit by subtracting the log of viable cells after treatment from the log of viable cells introduced into the treatment unit as the inoculum, as follows:

 

            LA = Log NoA - SA - Log N2A ≥ 6

 

where:             LA is the log kill of the test microorganisms (CFU/gram of waste solids and PFU/gram of waste solids) after treatment in the challenge load Type A.

 

NoA is the number of viable test microorganisms (CFU/gram of waste solids and PFU/gram of waste solids) introduced into the treatment unit as the inoculum for challenge load Type A as determined in Phase 1 above.

 

SA is the log of the number of viable test microorganisms (CFU/gram of waste solids and PFU/gram of waste solids) that were not recovered after processing the challenge load Type A in Phase 1 above.

 

N2A is the number of viable test microorganisms (CFU/gram of waste solids and PFU/gram of waste solids) remaining in the treated residue for challenge load Type A.

 

c)         Repeat steps (a) through (b) in Phase 2 for challenge loads Types B and C identified in Table C of this Appendix to determine the effectiveness of the treatment unit (LB and LC, respectively).

 

This Option 2 is for a treatment unit that maintains the integrity of the container of test microorganisms (e.g., autoclaves).

 

a)         One microbiological indicator assay containing one of the test microorganisms at numbers greater than one million (1,000,000) must be placed in a sealed container that remains intact during treatment.  The inside diameter of the container must be no larger than required to contain the assay vial(s).  The vial(s) must only contain the test microorganisms.

 

b)         The container of test microorganisms must be placed within a Type A challenge load as identified in Table C of this Appendix.

 

c)         Calculate the effectiveness of the treatment unit by subtracting the log of viable cells after treatment from the log of viable cells introduced into the treatment unit as the inoculum, as follows:

 

            LA = Log No -  Log N2A ≥ 6

 

where:             LA is the log kill of the test microorganisms (CFU and PFU) after treatment in challenge load Type A.

 

                       

 

No is the number of viable test microorganisms (CFU and PFU) introduced into the treatment unit as the inoculum.

                       

 

N2A is the number of viable test microorganisms (CFU and PFU) remaining after treatment in challenge load Type A.

 

d)         Repeat steps (a) through (c) in this option for challenge loads Types B and C identified in Table C of this Appendix to determine the effectiveness of the treatment unit (LB and LC, respectively).

 

This Option 3 is for a treatment unit that uses thermal treatment and maintains the integrity of the container of indicator microorganism spores (e.g., autoclaves and incinerators).

 

a)         One microbiological indicator assay containing at least one million (1,000,000) spores of one of the indicator microorganisms listed in Table B of this Appendix must be placed in a sealed container that remains intact during treatment.  The inside diameter of the container must be no larger than required to contain the assay vial(s).  The vial must contain only the indicator microorganism vial.

 

b)         The container of indicator microorganisms must be placed within a Type A challenge load as identified in Table C of this Appendix.

 

c)         Calculate the effectiveness of the treatment unit by subtracting the log of viable cells after treatment from the log of viable cells introduced into the treatment unit as the inoculum, as follows:

 

            LA = Log No -  Log N2A ≥ 6

 

where:             LA is the log kill of the viable indicator microorganisms (CFU) after treatment in challenge load Type A.

 

No is the number of viable indicator microorganisms (CFU) introduced into the treatment unit as the inoculum.

 

N2A is the number of viable indicator microorganisms (CFU) remaining after treatment in challenge load Type A.

 

d)                  Repeat steps (a) through (c) in this option for challenge loads Types B and C identified in Table C of this Appendix to determine the effectiveness of the treatment unit (LB and LC, respectively).