71 STERILITY TESTS 无菌检测
Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japane Pharmacopeia. Tho 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 Pharmacopeial procedures are not by themlves 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 aptic processing procedures.
这些药典规定程序自身的设计不能确保一批产品无菌或已经灭菌。这主要是通过灭菌工艺或者无菌操作程序的验证来完成。
The test is applied to substance, 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.
检测应用于根据药典要求无菌的如物质、药剂或商品。而令人满意的结果只包括在这样的检测条件下被测样品的完全无微生物污染。
Precautions against microbial contamination微生物污染的预防
The test for sterility is carried out under aptic 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.
无菌测试要在无菌条件下进行。为了达到这样的条件，测试环境要适应于无菌测试的要求。为了避免微生物污染而采取的预防措施不能有可检出的微生物污染。进行测试的环境要进行定期的取样检测并采取适宜的控制措施。
Culture media and incubation temperature培养基和培养温度
肝不好会有哪些症状
Media for the test may be prepared as described below or equivalent commercial media may be ud provided that comply with the requirements of the Growth Promotion Test of Aerobes, Anaerobes, and Fungi.
用于无菌测试的培养基可以按下述方法配制或采用满足好氧菌，厌氧菌和真菌促生长要求的物质的等效商业培养基。
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–Cain Digest Medium is suitable for the culture of both fungi and aerobic bacteria.
下面的培养基已经被证实适合进行无菌检测。巯基醋酸盐液体培养基主要用于厌氧菌的培养。但其也用于检测好氧菌。大豆酪蛋白消化物培养基适合于培养霉菌和好氧菌。
Fluid Thioglycollate Medium 巯基醋酸盐液体培养基
L-Cystine L-胱氨酸 | 0.5g周记初中生 |
| 鳝鱼的家常做法 Sodium Chloride氯化钠 | 2.5g |
Dextro Monohydrate/Anhydrous葡萄糖水化物/无水葡萄糖 | 5.5/5.0g |
橡皮擦英文Agar 琼脂 | 0.75g |
Yeast Extract (water-soluble) 酵母提取物(水溶性) | 5.0g |
Pancreatic Digest of Cain 酪蛋白胰酶消化物 | 15.0g 丧事 |
单杠4练习Sodium Thioglycollate巯基乙酸钠 | 0.5g |
or Thioglycolic Acid或者巯基乙酸 | 0.3ml |
Resazurin Sodium Solution (1 in 1000), freshly prepared 刃天青钠溶液(1比1000)，新配制 | 1.0ml |
Purified Water 纯化水 | 1000ml |
| |
pH after sterilization:7.1±0.2 灭菌后pH：7.1±0.2
Mix the L-cystine, sodium chloride, dextro, yeast extract, and pancreatic digest of cain with the purified water, and heat until solution is effected. Dissolve the sodium thioglycollate or thioglycolic acid in the solution and, if necessary, add 1 N sodium hydroxide so that, after sterilization, the solution will have a pH of 7.1 ± 0.2. 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 vesls that provide a ratio of surface to depth of medium such that not more than the upper half of the medium has undergone a color change indicative of oxygen uptake at the end of the incubation period. Sterilize using a validated process. If the medium is stored, store at a temperature between 2 and 25 in a sterile, airtight container. If more than the upper one-third of the medium has acquired a pink color, the medium may be restored once by heating the containers in a water-bath or in free-flowing steam until the pink color disappears and by cooling quickly, taking care to prevent the introduction of nonsterile air into the container. Do not u the medium for a longer storage period than h
as been validated.
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，并加热至实现溶解。将巯基乙酸钠或者巯基乙酸溶解于该溶液，如果需要可再加入1N氢氧化钠，以便在灭菌后该溶液呈pH值7.1 ± 0.2。如需要则过滤，再次加热该溶液但不得煮沸，并趁热以湿润滤纸将该溶液过滤。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，以使在培养期末表明氧气摄入的变色部分不超过培养基的上半部分。使用经过验证的工艺进行灭菌。如果需要储存该培养基，将其置于无菌、气密容器中，在2°至25°之间储藏。如果超过上部三分之一的培养基已经呈粉色，可以用以下方法恢复该培养基一次：在水浴锅中或者自由流动蒸气中加热该容器，直至粉色消失，并迅速放凉，须小心防止非无菌空气进入到容器中。我不相信禁止使用超过验证储存期限的培养基。
Fluid Thioglycollate Medium is to be incubated at描写雨的诗30°-35°.For products containing a mercurial prervative that cannot be tested by the membrane filtration method, Fluid Thioglycollate Medium incubated at 20-25°may be ud instead of Soybean-Cain Dige
st Medium provided that it has been validated in Growth Promotion Test of Aerobes, Anaerobes, and Fungi. Where prescribed or justified and authorized, the following alternative thioglycollate medium might be ud. Prepare a mixture having the same composition as that of the Fluid Thioglycollate Medium, but omitting the agar and the resazurin sodium solution. Sterilize as described above. The pH after sterilization is 7.1±0.2. Heat in a water bath prior to u and incubate at 30-35°under anaerobic conditions.
