Comparison of the bioluminescence technology to the sterility test of the hospital preparations

Objective

The hospital preparations sterility test described by the European Pharmacopeia needs 14 days of incubation. Rapid microbiological based on detection of microbiological growth are marketed alternate sterility methods. Bioluminescence rely upon the measurement of ATP that reflect microbiological growth. The aim is to compare a French commercially bioluminescence technology to the sterility test of the hospital preparations on 3 parameters: positivity delay, positivity rate and limit of detection.

MethodFor each microorganism (C.albicans, B.subtilis, S.aureus, P.aeruginosa, Cl.perfringens et Salmonella sp) serial 10 fold dilutions from 10 to 1000 CFU are inoculated in sterile preparation of Cefotamime and Phenylephrine. Solutions were observed at day 2 and day 3 for microbiological technique and day 0 and day 2 for bioluminescence technology

Results

Limits of detection of microbiological technique are 10 CFU for B.subtilis, S.aureus, P.aeruginosa, Salmonella sp, Cl.perfringens and 100 CFU for C.albicans.
Limits of detection of bioluminescence technology are higher than 1000 CFU.
Positivity delays is 2 to 3 days for microbiological technique and longer for bioluminescence.

Positivity rates are higher and present less variability for the microbiological technique than for bioluminescence whatever the microorganism or the preparation.

Conclusion

This bioluminescence technology is not suited for the early detection of microorganism in the sterile hospital preparations because of the variability of the results and high detection limit.