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第11楼2009/06/18
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 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.
此章节提供了检验方法，以便在所有种类的药用物品——从原料到成品中，估计其中存在的各种好氧微生物的数量，并确保其不含有指定种类的微生物。只要已经通过验证证明自动方法能够产生相等或更好的结果，即可用其代替在此呈现的方法。在准备和实施此试验的过程中，注意处理样品时的无菌预防措施。除另有规定，当操作步骤仅要求“培养”，将该溶液置于恒温控制在30 与35 之间的空气中24至48小时。名词“生长”在此用于特殊的含义，例如指明各种微生物的存在与推测的增殖。
只要已经通过验证证明自动方法能够产生相等或更好的结果，即可用其代替在此呈现的方法是否可改为“如果经过验证确认可以得到相同或更好的检测结果，也可以采用自动化的检测方法代替本方法”？
除另有规定，当操作步骤仅要求“培养”，将该溶液置于恒温控制在30与35之间的空气中24至48小时。是否可改为“除另有说明外，培养一词是指在30-35°C的培养箱中恒温培养24-48小时”？
