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1、USP38NF33<71>STERILITYTESTSv71>無菌檢查法?PortionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopeiaand/ortheJapanesePharmacopeia.Thoseportionsthatarenotharmonizedaremarkedwithsymbols(??)tospecifythisfact.??本檢查法已與《歐洲藥典》和《日本藥局方》對(duì)應(yīng)部分進(jìn)行了協(xié)
2、調(diào)，不一致的部分用符號(hào)(?令)標(biāo)注。?ThesePharmacopeialproceduresarenotbythemselvesdesignedtoensurethatabatchofproductissterileorhasbeensterilized.Thisisaccomplishedprimarilybyvalidationofthesterilizationprocessoroftheasepticprocessingprocedures.按藥典規(guī)定的無菌檢驗(yàn)本身并不能確保一批產(chǎn)品無菌或已經(jīng)滅菌，產(chǎn)品的無菌性主要通過對(duì)
3、滅菌工藝或者無菌保障程序的驗(yàn)證來完成。Thetestisappliedtosubstances,preparations,orarticleswhich,accordingtothePharmacopeia,arerequiredtobesterile.However,asatisfactoryresultonlyindicatesthatnocontaminatingmicroorganismhasbeenfoundinthesampleexaminedundertheconditionsofthetest.無菌檢查法系用于檢杳
4、藥典要求無菌的藥物、制劑產(chǎn)品和其他物品是否無菌的一種方法。若供試品符合無菌檢查法的規(guī)定，僅表明供試品在該檢驗(yàn)條件下未發(fā)現(xiàn)微生物污染。PRECAUTIONSAGAINSTMICROBIALCONTAMINATION預(yù)防微生物污染Thetestforsterilityiscarriedoutunderasepticconditions.Inordertoachievesuchconditions,thetestenvironmenthastobeadaptedtothewayinwhichthesterilitytestisperfo
5、rmed.Theprecautionstakentoavoidcontaminationaresuchthattheydonotaffectanymicroorganismsthataretoberevealedinthetest.Theworkingconditionsinwhichthetestsareperformedaremonitoredregularlybyappropriatesamplingoftheworkingareaandbycarryingoutappropriatecontrols.無菌檢查應(yīng)在無菌條件下
6、進(jìn)行，為了達(dá)到該條件，檢測(cè)環(huán)境應(yīng)符合無菌檢查的規(guī)定。防止污染的措施不得影響供試品中微生物的檢出。檢測(cè)環(huán)境應(yīng)定期抽樣監(jiān)測(cè)并進(jìn)行適當(dāng)?shù)目刂?。CULTUREMEDIAANDINCUBATIONTEMPERATURES培養(yǎng)基和培養(yǎng)溫度MediaforthetestmaybepreparedasdescribedbeloworequivalentcommercialmediamaybeusedprovidedthattheycomplywiththerequirementsoftheGrowthPromotionTestofAerobes,
7、Anaerobes,andFungi.無菌檢查需制備下表所述培養(yǎng)基，或者是能夠符合需氣菌、厭氧菌、真菌促牛長試驗(yàn)要求的同等的商用培養(yǎng)基。Thefollowingculturemediahavebeenfoundtobesuitableforthetestforsterility.FluidThioglycollateMediumisprimarilyintendedforthecultureofanaerobicbacteria.However,itwillalsodetectaerobicbacteria.Soybean-Cas
8、einDigestMediumissuitableforthecultureofbothfungiandaerobicbacteria.以下培養(yǎng)基已經(jīng)被證實(shí)適合用于無菌檢查，硫乙醇酸鹽流體培養(yǎng)基主要用于厭氧菌的培養(yǎng)，但其也可用于需氣菌培養(yǎng)。大豆■酪
