USP-55生物指示剂-抗性测试.pdfVIP

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USP55BIOLOGICALINDICATORS—RESISTANCEPERFORMANCETESTS

生物指示剂－抗性测试

TOTALVIABLESPORECOUNT

活孢子数总数计数

Removethreespecimensoftherelevantbiologicalindicatorfromtheiroriginalindividual

containers.Dispersethepaperintocomponentfibersbyplacingthetestspecimensina

sterile250-mLcupofasuitableblendercontaining100mLofchilled,sterilizedPurified

Waterandblendingfor3to5minutestoachieveahomogeneoussuspension.Transfer

a10-mLaliquotofthesuspensiontoasterile,screw-capped16-×125-mmtube.

从生物指示剂的原包装袋中取出3支作为样本。把待测样品放入一个已灭菌的250mL有

搅拌器的杯子里，杯子内装100mL放冷的灭菌纯化水。把杯子里的纸片磨碎成纤维状，

并混合3～5min使之成为均一的悬浮液。转移10ml的整数倍的悬浮液至一个已灭菌的16

×125mm的螺盖管中。

ForBiologicalIndicatorforSteamSterilization,PaperCarrier,heatthetubecontaining

thesuspensioninawaterbathat95to100for15minutes(heatshock),startingthe

timingwhenthetemperaturereaches95.

如果是纸载的蒸汽灭菌生物指示剂，则把装有悬浮液的管放入95℃～100℃水浴15min

（热休克），在悬浮液温度达到95℃时开始计时。

ForBiologicalIndicatorforDry-HeatSterilization,PaperCarrier,andforBiological

IndicatorforEthyleneOxideSterilization,PaperCarrier,heatthetubecontainingthe

suspensioninawaterbathat80to85for10minutes,startingthetimingwhenthe

temperaturereaches80.Coolrapidlyinanicewaterbathat0to4.

如果是纸载的干热灭菌生物指示剂及环氧乙烷灭菌生物指示剂，则把装有悬浮液的管放入

80℃～85℃水浴10min，在悬浮液温度达到80℃时开始计时。在0℃～4℃冰浴中迅速冷

却。

Transfertwo1-mLaliquotstosuitabletubes,andmakeappropriateserialdilutionsin

sterilizedPurifiedWater,thedilutionsbeingselectedascalculatedtoyieldpreferably30

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