DOI: 10.36347/sajp

Pages: 347-350

A case of an oral antimalarial tablet was analyzed microbiologically for microbial contamination immediately on the same manufacturing day (zero time) and was found to be contaminated by an exceptionally out-of-trend (OOT) bioburden of total viable aerobic count (TVAC) equals to 1233 ± 275 colony forming unit (CFU) ± SD/g of the medicinal product. The result of the test was observed only after two days. Hence, resampling and retesting processes were conducted promptly and interestingly all culture plates showed no signs of growth even after five days of incubation. Thus, the outcome was recorded as <100 CFU/g. Thus, the logarithmic (log10) reduction (LR) within a couple of days was 1.08 ± 0.09. The test was repeated again after that 15 times from different locations from the batch and again no sign of microbial presence was detected. The contamination was from single species of Gram-negative rods which were identified using miniaturized biochemical identification kits. A bacterium was identified as Stenotrophomonas maltophilia. The case highlighted the importance of the test conduction time after manufacturing to detect the rapidly fading bioburden from the product otherwise misinterpretation of drug cleanliness and good manufacturing practice (GMP) will result. Another annoying issue also raised which is related to the possibility that the microbial cells may be still present but not able to grow. Thus, the microorganism may become viable-but-not-culturable (VBNC). This fact might allow for objectionable microbes to pass silently to the patients unnoticed