Incubation Parameters and Micro-Colony Incubation Time of Used Micro-Organisms
Micro-Organism | Incubation Parameter | Micro-Colony Incubation Time |
---|---|---|
Stressed Propionibacterium acnes | 30–35 °C (anaerobic) | 5 days (i.e., at least 91 h)* |
Stressed Kocuria rhizophila | 30–35 °C (aerobic) | 45 h |
Stressed Penicillium spec. | 20–25 °C (aerobic) | 35 h |
Stressed Bacillus clausii | 30–35 °C (aerobic) | 32 h |
Stressed Acinetobacter lwoffii | 30–35 °C (aerobic) | 22 h |
Stressed Clostridium sporogenes | 30–35 °C (anaerobic) | 26 h |
↵* The standard Milliflex Rapid incubation time for rapid sterility testing was validated to be 5 days. This time is dependent on the worst-case micro-organism. The worst-case micro-organism stressed, Propionibacterium acnes, can reproducibly be found after 91 h of anaerobic incubation at 30–35 °C. These 91 h were rounded up to 4 full days and an additional day was added to account for variability in laboratory operations.