USP38-NF33_C71_无菌检查法-中英对照.doc

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1、USP38NF33<71>STERILITYTESTS<71>无菌检查法◆PortionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopeiaand/ortheJapanesePharmacopeia.Thoseportionsthatarenotharmonizedaremarkedwithsymbols(◆◆)tospecifythisfact.◆◆本检查法已与《欧洲药典》和《

2、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。◆ThesePharmacopeialproceduresarenotbythemselvesdesignedtoensurethatabatchofproductissterileorhasbeensterilized.Thisisaccomplishedprimarilybyvalidationofthesterilizationprocessoroftheasepticprocessingprocedures.按药典规定的无菌检验本身并不

3、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。Thetestisappliedtosubstances,preparations,orarticleswhich,accordingtothePharmacopeia,arerequiredtobesterile.However,asatisfactoryresultonlyindicatesthatnocontaminatingmicroorganismhasbeenfoundinthesampleexamin

4、edundertheconditionsofthetest.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。PRECAUTIONSAGAINSTMICROBIALCONTAMINATION预防微生物污染Thetestforsterilityiscarriedoutunderasepticconditions.Inordertoachievesuchconditions,thetestenvironme

5、nthastobeadaptedtothewayinwhichthesterilitytestisperformed.Theprecautionstakentoavoidcontaminationaresuchthattheydonotaffectanymicroorganismsthataretoberevealedinthetest.Theworkingconditionsinwhichthetestsareperformedaremonitoredregularlybyappropriatesam

6、plingoftheworkingareaandbycarryingoutappropriatecontrols.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。CULTUREMEDIAANDINCUBATIONTEMPERATURES培养基和培养温度Mediaforthetestmaybepreparedasdescribedbeloworequivalentcommercialmediama

7、ybeusedprovidedthattheycomplywiththerequirementsoftheGrowthPromotionTestofAerobes,Anaerobes,andFungi.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。Thefollowingculturemediahavebeenfoundtobesuitableforthetestforsterility.FluidThioglycollateMediumisprima

8、rilyintendedforthecultureofanaerobicbacteria.However,itwillalsodetectaerobicbacteria.Soybean–CaseinDigestMediumissuitableforthecultureofbothfungiandaerobicbacteria.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