设备清洁取样方法的研究_靳献蕊

121.0500412.050000。“”。2。TQ051.8+4B2095-5979201404-0130-03StudyonCleaningSamplingMethodsforEquipmentsJINXian-rui1,DONGRong-mei2(1.Zhongrunsite,CSPCZhongruoPharmaceutical(Shijiazhuang)CorporationLtd.,Shijiazhuang050041,China;2.HebeiHuarongPharmaceuticalCorporationLtd.,Shijiazhuang050000,China)Thechoosingofsamplingmethodsandsamplingpointswerestudiedinequipmentcleaningvalidation.Thesamplingpointsshouldstandforthedirtiestpointoftheequipment.Themostdifficultcleaningsiteshouldbefirstlyconsideredwhenlookingfortherepresentativesamplingpoint.Thetwosamplingmethodswereintroducedthatthesurfaceswabbingmethodandelutionmethod.Accordingtotheroutinecleaningvalidationofcompany,differentcleaningvalidationprotocolsweresetupforonekeyequipment,basedonthecomparisonandanalysisofvalidationresults,thereasonableapplicationofsurfaceswabbingmethodandelutionmethodwereelaborated.equipmentsampling;cleaningvalidation;samplingmethodandsamplingpoint;validationprotocol;surfaceswabbing;elutionmethod;placebosamplingmethod2014-01-091971—。[e-mail].[J].2014374130-132.“”。。。。。1CoalandChemicalIndustry37420144Vol.37No.4Apr.2014130201441。。PIC/SPIC/SPI006。。25cm2。。。。2.1.1。≥70%≤20%、。APIAPI。、。。。。。2.1.2316L100mm×100mm5。100mm×100mm3。5mLRSD。2。2.2.11。。。21S1S2S3S4S5S6S7S8S9S10S1S2S3S4S5S6S9S7S8S101312014437≥95%2.2.2。1。2。3。VV/3~V/2。1.2.3。。1。2。3。。。。。“”。。、。。。3。。。。、。。“”。。。。。2。＜10-510-5。31234567891011123×10-64×10-610-51.2×10-57×10-68×10-69×10-6149132201442.5mmol/L95%。、pHNO2-、NO3-N2。A/SBR1。1A/SBRCOD。225%。95%20%~30%20%~30%1/3。350%。。490%40%~50%。[1].[M].2009.[2].SBR[M].2011.32。。。。。123。FDA。、、、、。、2。[1].[J].20095.[2].[J].20085.[3].[M].2003.CIP、CIPCIPCIP////(t·h-1)/(mg·L-1)COD/(mg·L-1)pH/t/t/(mg·L-1)COD/(mg·L-1)pHNO2--N/(mg·L-1)NO3--N/(mg·L-1)/%2012-0963.432001108.705.437.088.0011.406.9000962012-1051.062851708.702.7016.753.4811.746.9000992012-1149.371201907.800.758.235.407.246.9000962012-1273.11922157.2005.104.9210.066.9200952013-0178.031021656.9009.254.6310.086.860095132!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!A/SBR149