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 perf
ormed. 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 gcontainer容器用法 琼脂 Sodium chloride 2.5 g 氯化钠 Glucose monohydrate/anhydrous 5.5 g/5.0 g 葡萄糖一水合物/无水葡萄糖 g/ g Yeast extract (water-soluble) 5.0 g 酵母提取物（水溶性） Pancreatic digest of casein 15.0 g 酪蛋白胰酶消化物 Sodium thioglycollate or 0.5 g 硫乙醇酸钠 Thioglycollic acid mL 硫乙醇酸 Resazurin sodium solution (1 g/L of mL sodium), freshly prepared 刃天青钠溶液（刃天青钠1 g/L），新鲜配制 Water R 1000 mL 水 R 1000ml pH after sterilisation ± 灭菌后的pH ± |
Mix the L-cystine, agar, sodium chloride, glucose, water-soluble yeast extract and pancreatic digest of casein with the water R and heat until solution is effected. Dissolve the sodium thioglycollate or thioglycollic acid in the solution and, if necessary, add 1 M sodium hydroxide so that, after sterilisation, the solution will have a pH of ±. If filtration is necessary, heat the solution again without boiling and filter while hot through moistened filter paper. Add the resazurin sodium solution, mix and place the medium in suitable vessels which provide a ratio of surface to depth of medium such that not more than the upper half of the medium has undergon e a
colour change indicative of oxygen uptake at the end of the incubation period. Sterilise using a validated process. If the medium is stored, store at a temperature between 2 °C and 25 °C in a sterile, airtight container. If more than the upper one-third of the medium has acquired a pink colour, the medium may be restored once by heating the containers in a water-bath or in free-flowing steam until the pink colour disappears and cooling quickly, taking care to prevent the introduction of non -sterile air into the container.
Do not use the medium for a longer storage period than has been validated.
将L-胱氨酸、琼脂、氯化钠、葡萄糖、水溶性酵母提取物以及酪蛋白胰酶消化物与水R混合，加热至溶解。将硫乙醇酸钠或硫乙醇酸用上述溶液溶解，必要时用1M氢氧化钠调节pH值，使灭菌后培养基溶液的pH值为±。如需要过滤处理，将溶液在此加热（加热此溶液），但不得煮到沸腾，乘热采用经润湿的滤纸进行过滤。加入刃天青钠溶液，混合均匀，将制备的培养基装入合适的容器中。在该容器中，培养基的表面和高度应具有恰当的比例，以便在灭菌结束后指示氧气摄入的颜变化不超过培养基的上半部分。采用经验证的工艺灭菌。如果需要保存，将培养基装入无菌、气密容器并在2-25°C 之间储存。如果培养基的上面超过1/3的部分已经出现粉红，将装有培养基的容器采用水浴或自由流动蒸气加热，直到粉红颜消失，之后快速冷却，注意预防非无菌的气体被引入装培养基的容器，以此进行培养基再生处理。如果培养基保存的时间超过经验证的保存期限，不得使用。（禁止使用超过验证储存期限的培养基）
Fluid thioglycollate medium is to be incubated at 30-35 °C. For products containing a mercurial preservative that cannot be tested by the membrane-filtration method, fluid thioglycollate medium incubated at 20-25 °C may be used instead of soya-bean casein digest medium provided that it has been validated as described in growth promotion test.
硫乙醇酸盐流体培养基用于（应）在30-35°C条件下培养。对于含有汞类防腐剂无法采用薄膜过滤法进行检查的产品，如果已按照生长促进试验所述方法验证，硫乙醇酸盐流体培养基可代替替代重复大豆酪蛋白消化物培养基在20-25°C条件下进行培养。
Where prescribed or justified and authorised, the following alternative thioglycollate medium may be used. Prepare a mixture having the same composition as that of the fluid thioglycollate medium, but omitting the agar and the resazurin sodium solution, sterilise as directed above. The pH after sterilisation is ± . Heat in a water-bath prior to use and incubate at 30-35 °C under anaerobic conditions.
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