USP-《71》-STERILITY-TESTS--中英对照-质量人文档

USP<71〉STERILITY TESTS 无菌测试

+Portions ofthis general chapter have been harmonized with the corresponding texts ofthe

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 beenfound in the sample examined under the conditions ofthe test.

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。

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 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.

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，但其也可用于需气菌培养。大豆-酪胨培养基适合于培养真菌和需气菌。

Fluid Thioglycollate Medium

硫乙醇酸盐流体培养基

L-Cystine L-胱氨酸

0.5g

Sodium Chloride氯化钠

2.5g

Dextrose Monohydrate/Anhydrous水合葡萄糖/无水葡萄糖

5.5/5.0 g

Agar琼脂

0.75g

Yeast Extract(water-soluble)酵母提取物(水溶的)

5.0g

Pancreatic Digest of Casein胰酶消化酪蛋白胨

15.0g

Sodium Thioglycollate硫乙醇酸盐

0.5g

or Thioglycolic Acid或硫乙醇酸

0.3 mL

Resazurin Sodium Solution(1 in 1000),freshly prepared新配制的刃天

青水溶液(1:1000)

1.0 mL

Purified Water纯化水

1000 mL

pH after sterilization:7.1±0.2.

灭菌后pH 值：7.1±0.2.

Mix the l-cystine,agar,sodium chloride,dextrose,yeast extract,and pancreatic digest of casein

with the purified water,and heat until solution is effected.Dissolve the sodium thioglycollate or

thioglycolic acid in the solution and,if necessary,add 1N 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 vessels 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 use the medium for a longer storage period than has 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

溶解。将硫乙醇酸钠或硫乙醇酸溶解于该溶液，如果需要可加入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。使用经过验证的工艺进行灭菌。如果器中，在2～25℃贮藏。如果超

过三需分要之贮一存的该培培养养基基已，经应呈将粉其红置色于，无可菌以、用气以密下

容方法恢复该培养基功能，但每批培养基仅能恢复一次：在水浴锅中或者自由流动蒸汽中加

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。灭菌后培养

基存放时间超过验证期限时，不得使用。

Fluid Thioglycollate Medium is to be incubated at 30°-35°.For products containing a mercurial

preservative that cannot be tested by the membrane filtration method,Fluid Thioglycollate

Mediumincubated at 20°-25°may be used instead of Soybean-Casein Digest Medium provided

that it has been validated as described in Growth Promotion Test of Aerobes,Anaerobes,and

Fungi.Where prescribed or justified and authorized,the following alternative thioglycollate

medium might be used.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

directed above.The pH after sterilization is 7.1±0.2.Heat in a water bath prior to use and

incubate at 30°-35°under anaerobic conditions.

硫乙醇酸盐流体培养基应在30～35℃条件下进行培养。含有汞制剂防腐剂的产品不能使用

膜过滤方法检测。经需气菌、厌氧菌、真菌促生长试验验证，在20～25℃培养时，大豆酪蛋

白消化培养基可以替代硫乙醇酸盐流体培养基。经合理授权，配制的与硫乙醇酸盐流体培养

基成分相同，但省略了琼脂和刃天青溶液的培养基，可以替代硫乙醇酸盐流体培养基使用。

按上述方法灭菌，灭菌后pH 值为7.1±0.2。使用前用水浴加热，置于30-35℃厌氧条件下培

养。

Soybean-Casein Digest Medium

大豆-酪胨消化物培养基

Pancreatic Digest of Casein酪蛋白胰酶消化物

17.0g

Papaic Digest of Soybean Meal大豆粉木瓜蛋白酶消化物

3.0g

Sodium Chloride氯化钠

5.0g

Dibasic Potassium Phosphate磷酸氢二钾

2.5g

Dextrose Monohydrate/Anhydrous水合葡萄糖/无水葡萄糖

2.5/2.3g

Purified Water纯化水

1000 mL

pH after sterilization:7.3±0.2.

灭菌后pH:7.3±0.2.

Dissolve the solids in the Purified Water,heating slightly to effect a solution.Cool the solution to

room temperature,and adjust the pH with 1N sodium hydroxide so that,after sterilization,it will

have a pH of 7.3±0.2.Filter,if necessary to clarify,dispense into suitable containers,and

sterilize using a validated procedure.Store at a temperature between 2°and 25°in a sterile

well-closed container,unless it is intended for immediate use.Do not use the medium for a longer

storage period than has been validated.

将固体物质置纯化水中，轻微加热使其溶解。溶液放凉至室温，并用1mol/L 氢氧化钠溶液

调整pH 值，使其灭菌后pH 值为7.1±0.2。如需要使之澄清，则过滤，分装入适合的容器，

并用经过验证的程序灭菌。如果不立刻使用，则保存在2～25℃无菌且密闭良好的容器中。

灭菌后培养基存放时间超过验证期限时，不得使用。

Soybean-Casein Digest Medium is to be incubated at 22.5±2.5°.

大豆-酪胨消化物培养基在22.5℃±2.5℃条件下培养。

Media for Penicillins or Cephalosporins

用于青霉素和头孢菌素的培养基

Where sterility test media are to be used in the Direct Inoculation of the Culture Medium method

under Testfor Sterility of the Product to be Examined,modify the preparation ofFluid

USP-《71》-STERILITY-TESTS--中英对照

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