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STERIS

RinsesamplingforCleaningValidationStudies

清洁验证中淋洗取样法的研究

DestinA.LeBlanc

Rinse-samplingproceduresthatdrawfromthefinalrinsesolutioncanprovideupper-limitestimatesof

potentialcontaminationinsubsequentlymanufacturedproducts.Theprocesscanbeimprovedby

separatingtheprocessrinsefromthesamplingrinse.Thismayresultinmoreaccurateactualestimates,

moreflexibilityinselectinganalyticalprocedures,andmoreflexibilityinchoosingasamplingrinse

solutionthatisdifferentfromtheprocessrinsesolution.Proceduresforsuchdeterminationsdependon

adequaterinserecoverystudies.Thisarticledescribesthesestudies.

从最终淋洗溶液取样的淋洗液取样程序可以提供后续生产产品中潜在污染物的上限评估。该程序中也可将

淋洗工艺和取样工艺分开。选择不同的更加灵活分析规程、选择与淋洗工艺不同的取样淋洗溶剂，均可以

得到更准确的结果评估。这些检测程序均基于充分的淋洗回收率研究。本文即描述这些研究

Validationofcleaningprocessesusedforproductcontactsurfacesinpharmaceutical

manufacturingisrequiredbyFDA.The1993decisionofUSv.BarrLaboratoriesgave

FDAtherighttomandatethatcleaningisacriticalprocessthatmustbevalidated(1).

Althoughthisdecisionfocusedmainlyonissuesrelatedtoretestingafter

out-of-specificationresults,italsoheldthatFDAhadtherightinthiscasetomandate

validationofcleaningprocesses.InJuly1992,whilethiscasewasbeinglitigated,the

agency’sMid-AtlanticRegionstaffdevelopedaninternalinspectionguidelineforcleaning

validation(2).InJuly1993,themoreofficialandstillcurrent“GuidetoInspectionsof

ValidationofCleaningProcesses”wasissued(3)

FDA要求药品生产中对于产品直接接触的表面清洁工艺必须进行验证。199