The purpose was development of a qualitative rapid method for determining microbiological contamination in sterile pharmaceutical products. The method for determining microbiological contamination in sterile pharmaceutical products is based on the use of the instrument Celsis Accel, which achieves a high level of sensitivity through bioluminescence ATP. This enables obtaining results regarding product sterility in a shorter time compared to the standard sterility test method. By preparing dilution
series of test microorganisms, we have found high sensitivity to both bacterial and fungal cells. The instrument can detect bacterial concentrations at 480±45 CFU/ml and fungal concentrations at 35±18 CFU/ml. However, the method itself does not allow for the detection of bacterial spores nor bacterial endotoxins, which are important for a safe pharmaceutical product. The results of the analysis are influenced by the liquid growth medium used daily for the standard sterility test method. The light signal from the liquid medium can mask the light signal from the cells, resulting in a false negative result. The method in question, enables us to achive results in 6 days, which is 8 days faster than the standard method of sterility testing. This allows for a faster release of sterile pharmaceutical products to the market and thus faster delivery to patients.
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