TABLE IX

Minimum Detectable Levels by the BacT/ALERT 3D in Biopharmaceutical Samples Inoculated with Different Dilutions of Microorganisms

MicroorganismColony-Forming Units against Time to Detection
Microbial InoculumTime to Detection
CFU(Days)
C. sporogenes220.84
C. sporogenes30.94
C. sporogenes10.98
C. albicans491.26
C. albicans71.47
C. albicans21.55
Bacillus subtilis340.63
Bacillus subtilis30.73
Bacillus subtilis10.73
Pseudomonas aeruginosa230.76
Pseudomonas aeruginosa20.88
Pseudomonas aeruginosa10.87
Staphylococcus aureus290.83
Staphylococcus aureus10.85
Aspergillus niger301.31
Aspergillus niger31.63
Aspergillus niger22.23
Methylobacterium radiotolerans126.49
Methylobacterium radiotolerans26.80
Burkholderia cepacia610.94
Burkholderia cepacia181.07
Burkholderia cepacia21.15

  • N=2.