The paper explores the use of environmental isolated bacteria in drug microbiological testing.By consulting relevant information on drug microbiological testing at home and abroad,this paper explores the existing problems and briefly elaborates on its applicable fields.At present,pharmacopoeias and industry guidelines in various countries have clearly stipulated the validation of disinfectant efficacy,antibacterial efficacy testing,and suitability of culture medium methods,requiring the use of environmental isolated bacteria in these processes.Compared to standard strains,environmental isolated bacteria can more accurately reflect the true state of microorganisms in the sample or environment.Using them for drug microbiological testing can provide a more objective and scientific evaluation.At the same time,risk assessments can be conducted by combining the testing items,drug production technology,and drug characteristics in the study to determine the environmental isolation bacteria suitable for drug microbiological testing.
关键词
环境分离菌/药品/微生物检验/质量控制
Key words
environmental isolated bacteria/pharmaceuticals/microbiological testing/quality control
维普
万方数据