§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 Appendix A, Table C.

 

b)         Place the test microorganisms and indicator microorganism spores in a sealed container that remains intact during treatment.

 

c)         Place the container 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)         Calculate the log kill of the test microorganisms compliant with Option 2 of Appendix A to determine the effectiveness of the treatment unit.  The equivalent log kill 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 Appendix A, Table C 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).

 

(Source:  Amended at 43 Ill. Reg. 10072, effective August 30, 2019)