欧洲药典EP8.02.6.1无菌检验sterility中英文翻译程序.docVIP

2.6.1. STERILITY 2.6.1 无菌检查法 The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test. 本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。 PRECAUTIONS AGAINST MICROBIAL CONTAMINATION 微生物污染防范 The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls. 无菌检测试验应在无菌的条件下进行。为了达到这样的条件，检测环境应当与无菌检测的操作要求相适应。避免污染的防范措施应当不对本检查方法进行检测的微生物造成影响（应并不影响用本检查法检测的微生物）。通过对工作区域的适当取样以及进行适当的控制来对无菌检查的工作环境进行例行监测。 CULTURE MEDIA AND INCUBATION TEMPERATURES 培养基和培养温度 Media for the test may be prepared as described below, or equivalent commercial media may be used provided that they comply with the growth promotion test. 应按下面描述的方法制备无菌检查的培养介质，如果满足生长促进试验要求，与本处所述培养基相当的商业化培养基也可以采用（也可采用与本处……）。 The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium is primarily intended for the culture of anaerobic bacteria; however, it will also detect aerobic bacteria. Soya -bean casein digest medium is suitable for the culture of both fungi and aerobic bacteria. 下述的培养基已被证明（经证明）适用于无菌检查。硫乙醇酸盐流体培养基主要用于厌氧菌培养，但是，也适用于需氧菌检测。大豆酪蛋白消化物培养基适用于真菌和需氧菌培养。 Fluid thioglycollate medium 硫乙醇酸盐流体培养基 L-Cystine 0.5 g L-胱氨酸 0.5g Agar 0.75 g 琼脂 0.75g Sodium chloride 2.5 g 氯化钠 2.5g Glucose monohydrate/anhydrous 5.5 g/5.0 g 葡萄糖一水合物/无水葡萄糖5.5 g/5.0 g Yeast extract (water-soluble) 5.0 g 酵母提取物（水溶性） 5.0g Pancreatic d