The Mango system was evaluated by spiking Fluid A with seven different microorganisms: Clostridium sporogenes ATCC 11437, Cutibacterium acnes ATCC 6919, Staphylococcus aureus ATCC 6538, Bacillus spizizenii ATCC 6633, Aspergillus brasiliensis ATCC 16404, Pseudomonas paraeruginosa ATCC 9027, and Candida albicans ATCC 10231. For each microorganism, two replicates were prepared on spread plates, Oasis TSA cartridges, and Mango Cartridges. Each microorganism was tested three times by three different analysts. The inoculated control plates (Oasis and spread plates onto TSA medium) were incubated at 30-35°C for 24h to 7 days. The Mango test plates were incubated for 16-160h.The study provides comparative data on the time to detection and recovery rates for the tested microorganisms. The results indicated that the Mango system consistently showed faster time to detection for aerobic organisms than traditional methods, however incubation time and conditions were microorganism-dependent, particularly for anaerobic bacteria such as C. sporogenes and C. acnes. In addition, this study showed that the rates of recovery between the Mango and traditional systems were equivalent and provides data on the filterability of different matrices. The findings indicate that the Mango system has potential to rapidly and consistently recovery microorganisms from biopharmaceutical samples.
Jeffrey et al. (Thu,) studied this question.