7-冗余过滤

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1、RedundantFiltrationLine冗余过滤ManyexamplesofredundantsterilefiltrationexistRedundantfiltrationcurrentlyinuseinawiderangeofprocessesWhatisredundantfiltration?PDATechnicalReport26rev2008Onefiltercouldfail….P1P2F1F2Twofiltersshouldbeintegral串联过滤和冗余过滤有什么区别？IsthisaRedundantFilt

2、rationSystem?IsthisaRedundantFiltrationSystem?ThoughtleadersandcontrollingdocumentsPDATR266.11FiltersinSeriesNote:Twoormorefiltersinaseriesmaybeusedtoensurethefollowing:•Iftwofiltersareneededtoensurethattheeffluentissterilethenitis•effluentissterileSERIALfiltrationbutno

3、tREDUNDANT•atleastonefilterpassesintegritytesting•thefinalfilterreceivesnomorethan10cfu/100mL•IftwofiltersareusedinseriestoensurethatatleastonefilterpassesSerialfiltrationmayalsobeusedwherebacterialpenetrationofintegritytesting,thenthefiltrationcanbedeclaredREDUNDANTste

4、rilizing-gradefiltersissuspected.•Iftwofiltersareneededtoensurethatthefinalfilterreceivesnoundertheseprocessconditions,bothfilterswouldneedtomeetpre-andmorethan10cfu/mLthanitisSERIALfiltrationbutnotpost-filtrationintegrityREDUNDANTtestingacceptancecriteria.Sterilizinggr

5、adefilteridentificationBioburdenreductionSterilizingfiltrationP1PP11PP1P12RedundantAsrequiredNMT10cfu/100mlP1P1P2InseriesAsrequiredThoughtLeadersandControllingDocuments-PDATR26“Defines”thesecondfilteras‘primarysterilizing’filter&firstfilteras‘redundant’filterThoughtlead

6、ersandcontrollingdocumentsUSFDAGMPFDA对于冗余过滤的建议UseofRedundantsterilizingfiltersshouldbeconsideredinmanycasesThoughtleadersandcontrollingdocumentsEUGMPAnnex1欧盟GMP则没有明确定义..Asecondfiltrationviaasterilizedmicroorganismretainingfilter,immediatelypriortofilling,maybeadvisable.

7、.111.Duetothepotentialadditionalrisksofthefiltrationmethodascomparedwithothersterilizationprocesses,asecondfiltrationviaafurthersterilisedmicro-organismretainingfilter,immediatelypriortofilling,maybeadvisable.Thefinalsterilefiltrationshouldbecarriedoutascloseaspossiblet

8、othefillingpoint.NewGMPAnnex1fromSFDASFDAhasissuedthefollowingdraftguidanceregardingredundantfiltrationDuetoth