145°C Heated Decontamination Cycle Validation
NuAire hired a third party, Pace Analytical, to validate the effectiveness of 145°C Heated Decontamination Cycle. Pace Analytical is a full services sampling and analytical services firm operating a network of 18, NELAC accredited, 14 laboratories nationwide.
Test Procedure Summary
- Prior to placement of Biological Indications (BI), the interior surfaces of the incubator were wiped with sterile 70% Isopropyl alcohol wipes
- Bls were placed by the client in the locations defined by the client protocol and secured in place with aluminum foil tape.
- The Dry Heat Decontamination Cycle was run.
- The following day, after the cycle was complete, the BIs were removed and aseptically transferred to Tryptic Soy Broth (TSB) tubes that were provided by the client. LM 140 includes instructions to ensure aseptic processing of BIs as well as instructions for performance of in process environmental monitoring controls.
- The TSB tubes were incubated at 30-35°C for seven days per the manufacturer's instructions. Tubes were evaluated daily for Growth/No Growth.
Log reduction is a term (as is "log increase") used to show the relative number of live microbes eliminated from a surface by cleaning. For example, a "5-log reduction" means lowering the number of microorganisms by 100,000-fold. If an incubator surface contains 100,000 pathogenic microbes, a 5-log reduction would reduce the number of microorganisms to one.
Total inactivation of a biological indicator with a log10 population of 6.6 was observed.