Del. Admin. Code tit. 7, 1000, 1300, 1301, app B

Current through Reigster Vol. 28, No. 6, December 1, 2024
Appendix B - Section 11, Part 1, APPENDIX B Correlating Periodic Verification Procedures

1. Use a certified microbiological indicator assay containing the test microorganisms and indicator microorganism spores.

2. Place the test microorganisms and indicator microorganism spores into sealed containers that remain intact during treatment.

3. Place a container of the test microorganisms and indicator microorganism spores in each challenge load (as described in Appendix A, Table C) to simulate the worst case scenario (i.e., that part of 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 indicator microorganism spores within a sharp container that must in turn be deposited in a plastic biohazard bag that is then located centrally within the treatment unit.

4. Determine the effectiveness of the treatment unit by calculating the log kill (L) of the test microorganisms in accordance with Option 2 of Appendix A. The equivalent 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 inoculum as follows:

TA = Log N 0 - Log N2A >=3

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

N 0 is the number of viable indicator microorganism spores (CFU/gram of waste solids) introduced into the treatment unit as the inoculum (>=6).

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

5. Repeat steps 1 through 4 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 equivalent kill of the indicator microorganism spores (LB and LC, respectively).

Del. Admin. Code tit. 7, 1000, 1300, 1301, app B

11 DE Reg. 807 (12/01/07)
21 DE Reg. 893 (5/1/2018) (Final)