美国药典USP31无菌检查VIP专享VIP免费

美国药典 USP31-NF26 无菌检查法《71》.doc71 STERILITY TESTS 无菌检查法Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols ( ) to specify this fact. 此通则的各部分已经与欧洲药典和/或日本药典的对应部分做了协调。不一致的部分用符号（ ）来标明。 The following procedures are applicable for determining whether a Pharmacopeial article purporting to be sterile complies with the requirements set forth in the individual monograph with respect to the test for sterility. Pharmacopeial articles are to be tested by the Membrane Filtration method under Test for Sterility of the Product to be Examined where the nature of the product permits. If the membrane filtration technique is unsuitable, use the Direct Inoculation of the Culture Medium method under Test for Sterility of the Product to be Examined. All devices, with the exception of Devices with Pathways Labeled Sterile, are tested using the Direct Inoculation of the Culture Medium method. Provisions for retesting are included under Observation and Interpretation of Results.下面这些步骤适用于测定是否某个用于无菌用途的药品是否符合其具体的各论中关于无菌检查的要求。只要其性质许可，这些药品将使用供试产品无菌检查法项下的膜过滤法来检测。如果膜过滤技术是不适合的，则使用在供试产品无菌检查法项下的培养基直接接种法。除了具有标记为无菌通道的设备之外，所有的设备均须使用培养基直接接种法进行检测。在结果的观测与理解项下包含了复验的规定。 Because sterility testing is a very exacting procedure, where asepsis of the procedure must be ensured for a correct interpretation of results, it is important that personnel be properly trained and qualified. The test for sterility is carried out under ase...