USP38-NF33_C71_无菌检查法-中英对照

《USP38-NF33_C71_无菌检查法-中英对照》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。

1、USP38NF33<71>STERILITYTESTSv71>无菌检查法♦PortionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopeiaand/ortheJapanesePharmacopeia.Thoseportionsthatarenotharmonizedaremarkedwithsymbols(♦♦)tospecifythisfact.♦♦本检查法已与《欧洲药典》和《日本药局方》对应部分进行了协

2、调，不一致的部分用符号(♦令)标注。♦ThesePharmacopeialproceduresarenotbythemselvesdesignedtoensurethatabatchofproductissterileorhasbeensterilized.Thisisaccomplishedprimarilybyvalidationofthesterilizationprocessoroftheasepticprocessingprocedures.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

3、灭菌工艺或者无菌保障程序的验证來完成。Thetestisappliedtosubstances,preparations,orarticleswhich,accordingtothePharmacopeia,arerequiredtobesterile.However,asatisfactoryresultonlyindicatesthatnocontaminatingmicroorganismhasbeenfoundinthesampleexaminedundertheconditionsofthetest.无菌检查法系用于检杳

4、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,thetestenvironmenthastobeadaptedtothewayinwhichthesterilitytestisperfo

5、rmed.Theprecautionstakentoavoidcontaminationaresuchthattheydonotaffectanymicroorganismsthataretoberevealedinthetest.Theworkingconditionsinwhichthetestsareperformedaremonitoredregularlybyappropriatesamplingoftheworkingareaandbycarryingoutappropriatecontrols.无菌检查应在无菌条件下

6、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MediaforthetestmaybepreparedasdescribedbeloworequivalentcommercialmediamaybeusedprovidedthattheycomplywiththerequirementsoftheGrowthPromotionTestofAerobes,

7、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、真菌促牛长试验要求的同等的商用培养基。Thefollowingculturemediahavebeenfoundtobesuitableforthetestforsterility.FluidThioglycollateMediumisprimarilyintendedforthecultureofanaerobicbacteria.However,itwillalsodetectaerobicbacteria.Soybean-Cas

8、einDigestMediumissuitableforthecultureofbothfungiandaerobicbacteria.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