Sterility testing as described in the pharmacopoeia compendia requires a 14-day incubation period to obtain an analytical result. Alternative methods that could be applied to evaluating product sterility are especially interesting due to the possibility of reducing this incubation period and thus the associated costs. The aims of this study were to evaluate the performance of the BacT/ALERTR 3D system in detecting microorganisms in large-volume parenteral solutions that were intentionally contaminated and to compare this system to pharmacopoeia sterility testing using the membrane filtration method. The results indicated that there were no significant differences between the methods regarding the ability to detect microbial contamination; however, detection with the BacT/ALERTR 3D system was faster compared to the pharmacopoeia method. Therefore, the BacT/ALERTR 3D system is a viable alternative for assessing the sterility of injectable products.

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test. There was no significant difference between the ability of the culture media to allow detection of microbial contamination. However, the rapid sterility testing method allowed a more rapid detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.

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The mean final results (45 minutes) were equivalent to 107.73 % (RSD = 2.98 %) and 108.58 % (RSD = 1.44 %), respectively, independently of the changes on the compression machine used in the manufacturing line. The statistical analysis was used to evaluate result variability and to determine the similarity factor among the different batches of drugs tested (f2 = 57.64), what allowed to conclude that the drugs tested showed similar dissolution profile. The results of dissolution efficiency calculation are: 83.14 % (RSD = 1.89) to dissolution profiles obtained to the cyproterone tablets manufactured with compression machine 1 and 79.83 % (RSD = 1.93) to the cyproterone tablets manufactured with compression machine 2. Statistical analysis showed that the differences observed between the results. The results based on the statistical calculations of f2 showed equivalence in the dissolution profile, and different performances based on calculation of the dissolution efficiency (D.E.). However, the dissolution method could be reevaluated to analyze properly the product in study, fast dissolving formulation, using discriminative conditions.