USP38-NF33_C71_无菌检查法-中英对照精读.docVIP

USP38 NF33 71 STERILITY TESTS 71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.◆ ◆本检查法已与《欧洲药典》和《日本药局方》对应部分进行了协调，不一致的部分用符号()标注。◆ These Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized. This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures. 按药典规定的无菌检验本身并不能确保一批产品无菌或已经灭菌，产品的无菌性主要通过对灭菌工艺或者无菌保障程序的验证来完成。 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. 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。 PRECAUTIONS AGAINST MICROBIAL CONTAMINATION 预防微生物污染 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. 无菌检查应在无菌条件下进行，为了达到该条件，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的控制。 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 requirements of the Growth Promotion Test of Aerobes, Anaerobes, and Fungi. 无菌检查需制备下表所述培养基，或者是能够符合需气菌、厌氧菌、真菌促生长试验要求的同等的商用培养基。 The following culture media have been found to be suitable for the test fo