美国药典USP31无菌检查
71 STERILITY TESTS 无菌反省法
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.
此通那么的各局部曾经与欧洲药典hooray和shlr/或日本药典的对应局部做了协调。不分歧的局部用符号〔 〕来标明。
gate valve
311什么意思The following procedures are applicable for determining whether a Pharmacopeial article purporting to be sterile complies with the requirements t 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 Examinedsimon king where the nature of the product permits. If the membrane filtration technique is unsuitable, u 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 Obrvation and Interpretation of Results.
下面这些步骤适用于测定能否某个用于无菌用途的药品能否契合其详细的各论中关于无菌反省的要求。只需其性质容许，这些药品将运用供试产品无菌反省法项下的2011四级成绩查询膜过滤法来检测。假设膜过滤技术是不适宜的，那么运用在供试产品无菌反省法项下的培育基直接接种法。除了具有标志为无菌通道的设备之外，一切的设备均须运用培育基直接接种法停止检测。在结果的观测与了解项下包括了复验的规则。
Becau sterility testing is a very exacting procedure, where apsis 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 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.
由于无菌反省法是一个十分准确的顺序，在此进程中顺序的无菌形状必需失掉确保以完成对结果的正确了解，因此人员经过适当的培训并取得资质是十分重要的。无菌反省在无菌条件下停止。为了完成这样的条件，实验环境必需调整到适宜停止无菌反省的方式。为防止污染而采取的特定预防措施应不会对任何试图在反省中发现的微生物发生影响。经过在任务区域作适当取样并停止适当控制，来活期监测停止此实验的任务条件。
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.
这些药典规则顺序自身的设计不能确保一批产品无菌或曾经灭菌。这主要是经过灭菌工艺或许无菌操作顺序的验证来完成。
When evidence of microbial contamination in the article is obtained by the appropriate Pharmacopeial method, the result so obtained is conclusive evidence of failure of the article to meet the requirements of the test for sterility, even if a different result is obtained by an alternative procedure. For additional information on sterility testing, e Sterilization and Sterility Assurance of Compendial Articles 1211 .
当经过适当的药典方法取得了某物品中微生物污染的证据，这样取得的结果是该物品未能到达无菌检验要求的结论性证据，即使运用替代顺序失掉了不同的结果也无法否认此结果。 如要取得关于无菌检验的其他信息，见药品的灭菌和无菌保证<1211>
MEDIA ten years培育基
Prepare media for the tests as described below, or dehydrated formulations may be ud provided that, when reconstituted as directed by the manufacturer or distributor, they meet the requirements of the Growth Promotion Test of Aerobes, Anaerobes, and Fungi. Media are sterilized using a validated process.
依照下面描画的方法配制实验用培育基；或许运用脱水培育基，只需依据其制造商或许分销商说明停止恢复之后，其可以契合好氧菌、厌氧菌、霉菌生长促进实验的要求即可。运用经过验证的工艺对培育基停止灭菌操作。
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 Mediumbrunt is suitable for the culture of both fungi and aerobic bacteria.
下面的培育基曾经被证明适宜停止无菌反省。巯基醋酸盐液体培育基主要用于厌氧菌的培育。但其也用于检测好氧菌。大豆酪蛋白消化物培育基适宜于培育霉菌和好氧菌。
Fluid Thioglycollate Medium 巯基醋酸盐液体培育基
L-Cystine L-胱氨酸 | 0.5 g |
Sodium Chloride氯化钠 | 2.5 g |
Dextro (C6H12O6·H2O) 葡萄糖 | 5.5/5.0 g |
Agar, granulated (moisture content not
exceeding 15%) 琼脂，呈颗粒状(水分含量不超越15%) | 0.75 g |
suffixYeast Extract (water-soluble) 酵母提取物(水溶性) | 5.0 g |
Pancreatic Digest of Cain 酪蛋白胰酶消化物 | 15.0 g |
Sodium Thioglycollate巯基乙酸钠 | 0.5 g |
or Thioglycolic Acid或许巯基乙酸 | 0.3 mL |
Resazurin Sodium Solution (1 in 1000),
freshly prepared 刃天青钠溶液(1比1000)，新配制 | 1.0 mL |
Purified Water every纯真水 | 1000 mL |
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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.
