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1、GUIDETOINSPECTIONSOFHIGHPURITYWATERSYSTEMSNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmxinitiesfororonanyperson(s)>Thisguidediscusses,primarilyfromamicrobiologicalaspect,there
2、viewandevaluationofhighpuritywatersystemsthatareusedforthemanufactureofdrugproductsanddrugsubstances.Italsoincludesareviewofthedesignofthevarioustypesofsystemsandsomeoftheproblemsthathavebeenassociatedwiththesesystems.Aswithotherguides,itisnotall-inclusive,butprovidesbackgrounda
3、ndguidanceforthereviewandevaluationofhighpuritywatersystems.TheGuideToInspectionsofMicrobiologicalPharmaceuticalQualityControlLaboratories(May,1993)providesadditionalguidance.I.SYSTEMDESIGNOneofthebasicconsiderationsinthedesignofasystemisthetypeofproductthatistobemanufactured.Fo
4、rparenteralproductswherethereisaconcernforpyrogens,itisexpectedthatWaterforInjectionwillbeused.Thisappliestotheformulationofproducts,aswellastothefinalwashingofcomponentsandequipmentusedintheirmanufacture.DistillationandReverseOsmosis(RO)filtrationaretheonlyacceptablemethodslist
5、edintheUSPforproducingWaterforInjection.However,inthebulkPharmaceuticalandBiotechnologyindustriesandsomeforeigncompanies,UltraFiltration(UF)isemployedtominimizeendotoxinsinthosedrugsubstancesthatareadministeredparenterally.Forsomeophthalmicproducts,suchastheophthalmicirrigatings
6、olution,andsomeinhalationproducts,suchasSterileWaterforInhalation,wheretherearepyrogenspecifications,itisexpectedthatWaterforInjectionbeusedintheirformulation.However,formostinhalationandophthalmicproducts,purifiedwaterisusedintheirformulation.Thisalsoappliestotopicals,cosmetics
7、andoralproducts.Anotherdesignconsiderationisthetemperatureofthesystem.Itisrecognizedthathot(65-80oC)systemsareselfsanitizing.Whilethecostofothersystemsmaybelessexpensiveforacompany,thecostofmaintenance,testingandpotentialproblemsmaybegreaterthanthecostofenergysaved.Whetherasyste
8、miscirculatingorone-wayisalsoanimportantdesignc