USP微生物限度检查.doc

?61?MICROBIAL LIMIT TESTS 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,” hold the container in air that is thermostatically controlled at a temperature between 30and 35,for a period of 24to 48hours.The term “growth” is used in a special sense herein, i.e., to designate the presence and presumed proliferation of viable microorganisms. Preparatory Testing 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 1mLof not less than 10?3dilution of a 24-hour broth culture of the microorganism to the first dilution (in pH7.2Phosphate Buffer, Fluid Soybean–Casein Digest Medium, or Fluid Lactose Medium)of the test material and following the test procedure. Failure of the organism(s)to grow in the relevant medium invalidates that portion of the examination and necessitates a modification of the procedure by (1)an increase in the volume of diluent, the quantity of test material remaining the same, or by (2)the incorporation of a sufficient quant