USP微生物限度法.pdfVIP

MICROBIAL LIMIT TESTS (微生物限度检查 USP) 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. Unless otherwise directed, where the procedure specifies simply — incubate, II 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 Iis uiaslesdeinsae shpeerecin, i.e., to designate the presence and presumed proliferation of viable microorganisms. 这一章规定，测试估计的数目可行的好氧微生物，从指定的微生物物种在制药文章的 所有 品种，从原料到成品的形式。一个自动化的方法，可取代的考验就在这里，只 要它已妥善 验证给予同等或更好的结果。在准备和在应用试验，观察无菌的预防措 施，再处理标本。 除非另有指示，凡指定的程序是简单的 “孵化” ，举行容器中的 空气是恒温的控制在温度 至 ，时间 至 小时。相对而言， “增长”是 30 35 24 48 用来在一个特殊的意义在这里， 即 指定的存在和扩散的微生物。 Preparatory Testing (筹备测试) 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 the multiplication, 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, Escherichia coli, Pseudomonas aeruginosa, and Salmonella. 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 dilutio n (in pH 7.2 Phosphate Buffer,