Table II

Incubation Parameters and Micro-Colony Incubation Time of Used Micro-Organisms

Micro-OrganismIncubation ParameterMicro-Colony Incubation Time
Stressed Propionibacterium acnes30–35 °C (anaerobic)5 days (i.e., at least 91 h)*
Stressed Kocuria rhizophila30–35 °C (aerobic)45 h
Stressed Penicillium spec.20–25 °C (aerobic)35 h
Stressed Bacillus clausii30–35 °C (aerobic)32 h
Stressed Acinetobacter lwoffii30–35 °C (aerobic)22 h
Stressed Clostridium sporogenes30–35 °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.