USP71-无菌检查法Sterility-Tests完整版.docxVIP

PAGE19 / NUMPAGES20 PAGE1 / NUMPAGES20 USP71 无菌检查法Sterility Tests 无菌检查法系用于检查药典要求无菌的药物、制剂产品和其他物品是否无菌的一种方法。若供试品符合无菌检查法的规定，仅表明供试品在该检验条件下未发现微生物污染。 The test is applied to substances, preparations, or articles which, according to the Pharmacopeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test. 1 预防微生物污染 Precaotions Against Microbial Contamination 无菌检查应在无菌条件下进行，为了达到条件，检测环境应符合无菌检查的规定。防止污染的措施不得影响供试品中微生物的检出。检测环境应定期抽样监测并进行适当控制。 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 microorganisms that 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. 2 培养基和培养温度 Culture Media and Incubation 无菌检查需制备下表所述培养基，或者是能够符合需氧菌、厌氧菌、真菌促生长试验要求的同等的商用培养基。 Media for the test may be prepared as described below or equivalent commercial media may be used provided that they comply with the requirements of the Growth Promotion Test of Aerobes, Anaerobes, and Fungi. 以下培养基已经被证实适合用于无菌检查。硫乙醇酸盐流体培养基主要用于厌氧菌的培养，但其也可用于需氧菌培养。大豆酪蛋白培养基适合于培养真菌和需氧菌。 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. Soybean–Casein Digest Medium is suitable for the culture of both fungi and aerobic bacteria. 将L-胱氨酸、氯化钠、葡萄糖、酵母提取物、酪蛋白胰酶消化物与纯化水混合，并加热至溶解。将硫乙醇酸钠或硫乙醇酸溶解于该溶液，如果需要可再加入1mol/L氢氧化钠溶液，以便在灭菌后该溶液呈pH值7.1±0.2。如需要过滤，再次加热该溶液但不得煮沸，并趁热以润湿滤纸将该溶液过滤。加入刃天青钠溶液，混匀，并将该培养基置于适当容器中，该容器应为培养基提供特定的面积/深度比，以使在培养期结束后能明确显示氧气摄入的变色部分不超过培养基的上半部分二分之一。使用经过验证的工艺进行灭菌。如果需要贮存该培养基，应将其置于无菌、气密容器中，在2