MICROBIAL LIMIT TESTS微生物限度测试.docVIP

MICROBIAL LIMIT TESTS 微生物限度测试 This chapter provides tests for the estimation of the number of viable aerobic microorganisms present and for freedom from designated microbial species in pharmaceutical articles of all kinds, from raw materials to the finished forms. An automated method may be substituted for the tests presented here, provided it has been properly validated as giving equivalent or better results. In preparing for and in applying the tests, observe aseptic precautions in handling the specimens. 本章提供了评估各类药物（从原料到制剂）中需气性微生物存在数量及是否存在某些特定微生物的方法。在已得到验证表明具有同等或更好的结果的情况下，可用一种自动化的方法代替本章阐述的方法。在准备及使用这些方法时，应注意采取无菌措施处理样品。 Unless otherwise directed, where the procedure specifies simply incubate ,hold the container in air that is thermostatically controlled at a temperature between 30℃ and 35℃ for a period of 24 to 48 hours. The term growth is used in a special sense herein, i.e., to designate the presence and presumed proliferation of viable microorganisms. 除非另有说明，在注明直接培养的方法中，将容器置于温度稳定控制在30℃和35℃范围内的空气中24小时至48小时。Growth这个术语在这里具有特定的含义，即指有需气性微生物存在且在繁殖。 Preparatory Testing 准备性试验 The validity of the results of the tests set forth in this chapter rests largely upon the adequacy of a demonstration that the test specimens to which they are applied do not, of themselves, inhibit themultiplication, under the test conditions, of microorganisms that may be present. Therefore,preparatory to conducting the tests on a regular basis and as circumstances require subsequently,inoculate diluted specimens of the material to be tested with separate viable cultures of Staphylococcus aureus（金黄色葡萄球菌）, Escherichia coli（大肠杆菌）, Pseudomonas aeruginosa（假单胞铜绿菌, and Salmonella（沙门氏菌. This can be done by adding 1 ml of not less than 10-3 dilution of a 24-hour broth culture of the microorganism to the first dilution (in pH 7.2 Phosphate Buffer, Fluid Soybean-Casein Digest Medium（液体胰酶大豆培养基）, or Fluid Lactose Medium（液体乳糖培养基）) of the test material and following the test procedure. Failure of the organism