Bussey D M, Tsuji K
Appl Environ Microbiol. 1986 Feb;51(2):349-55. doi: 10.1128/aem.51.2.349-355.1986.
Bioluminescence measurement significantly improved the accuracy, sensitivity, precision, and reliability of the current visual endpoint determination for the USP sterility test and eliminated the day 7 transfer/dilution step required for testing suspension products. Thirteen strains of bacteria and fungi (representing potential contaminants in sterile products), three pharmaceutical suspension products, and four media were used in the experiment. No interference from suspension products was encountered in the detection of microbial growth by the bioluminescence measurement. The poor fungal growth encountered was attributed to insufficient diffusion of oxygen into the medium and was circumvented by use of a large tube size (38 by 200 mm) or by vortexing the medium once during the 2-week incubation period. Bioluminescence measurement would facilitate automated handling of the sterility test endpoint readout operation. The optimum parameters of bioluminescence measurement for application in sterility testing were determined.
生物发光测量显著提高了美国药典无菌试验当前视觉终点判定的准确性、灵敏度、精密度和可靠性，并省去了检测混悬液产品所需的第7天转移/稀释步骤。实验中使用了13种细菌和真菌菌株（代表无菌产品中的潜在污染物）、三种药物混悬液产品和四种培养基。在通过生物发光测量检测微生物生长时，未遇到来自混悬液产品的干扰。所遇到的真菌生长不佳归因于氧气向培养基中的扩散不足，可通过使用大尺寸试管（38×200毫米）或在2周培养期内对培养基进行一次涡旋处理来解决。生物发光测量将有助于无菌试验终点读数操作的自动化处理。确定了用于无菌检测的生物发光测量的最佳参数。
