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 B CORRELATING PERIODIC VERIFICATION TEST PROCEDURES



Section 1422.APPENDIX B   Correlating Periodic Verification Test Procedures

 

a)         A certified microbiological indicator assay containing the test microorganisms and indicator microorganism spores is introduced into each challenge load as identified in Table C of Appendix A.

 

b)         The test microorganisms and indicator microorganism spores must be placed in a sealed container that remains intact during treatment.

 

c)         The container must be placed in each challenge 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 test microorganisms and indicator microorganism spores container within a sharps container that must in turn be deposited in a plastic biohazard bag that is then located centrally within the treatment unit.

 

d)         The effectiveness of the treatment unit is demonstrated by calculating the log kill (L) of the test microorganisms in accordance with Option 2 of Appendix A of this Part.  The equivalent log kill (T) of the indicator microorganism spores is calculated 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:

 

            TA = Log No - Log N2A ≥  3

 

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

 

                        No is the number of viable indicator microorganism spores (CFU) introduced into the treatment unit as the inoculum (≥  6)

 

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

 

e)         Repeat steps (a) through (d) for challenge loads Types B and C identified in Table C of Appendix A to determine the correlation between the log kill of the test microorganisms and the equivalent kill of the indicator microorganism spores (LB and LC, respectively).