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USP30--1231WATERFORPHARMACEUTICALPURPOSESUSP301231制药用水（节选饮用水部分）SOURCEORFEEDWATERCONSIDERATIONS水源或供水系统Toensureadherencetocertainminimalchemicalandmicrobiologicalqualitystandards,waterusedintheproductionofdrugsubstancesorassourceorfeedwaterforthepreparationofthevarioustypesofpurifiedwatersmustmeettherequirementsoftheNationalPrimaryDrinkingWaterRegulations(NPDWR)(40CFR141)issuedbytheU.S.EnvironmentalProtectionAgency(EPA)orthedrinkingwaterregulationsoftheEuropeanUnionorJapan,ortheWHOdrinkingwaterguidelines.为了保证能达到某些化学和微生物的最低质量标准，用于药品生产的水或者是用于制备各种纯化水的水源必须要符合美国环境保护局（EPA）发布的国家基本饮用水规定（NPDWR）(40CFR141)。欧盟、日本或WHO的有关饮用水规定也可适用。Limitsonthetypesandquantitiesofcertainorganicandinorganiccontaminantsensurethatthewaterwillcontainonlysmall,safequantitiesofpotentiallyobjectionablechemicalspecies.Therefore,waterpretreatmentsystemswillonlybechallengedtoremovesmallquantitiesofthesepotentiallydifficult-to-removechemicals.Also,controlofobjectionablechemicalcontaminantsatthesource-waterstageeliminatestheneedtospecificallytestforsomeofthem(e.g.,trihalomethanesandheavymetals)afterthewaterhasbeenfurtherpurified.对某些有机和无机污染物的种类和数量进行限定可以保证水中只含有微小的，可靠数量的潜在的化学物质。因此水的预处理系统只需除掉这些少量的、难以去除的化学物质。而且，从水源开始对这些令人讨厌的化学污染物进行控制就可以免去在后续纯化过程中对这些化学物质（如：三卤代甲烷和重金属）的检验。Microbiologicalrequirementsofdrinkingwaterensuretheabsenceofcoliforms,which,ifdeterminedtobeoffecalorigin,mayindicatethepotentialpresenceofotherpotentiallypathogenicmicroorganismsandvirusesoffecalorigin.饮用水规定中的微生物标准保证了水中不存在大肠菌群。如经确定该菌来自粪便，则预示可能有来自粪便的其他病原微生物和病毒。Meetingthesemicrobiologicalrequirementsdoesnotruleoutthepresenceofothermicroorganisms,whichcouldbeconsideredundesirableiffoundinadrugsubstanceorformulatedproduct.符合国家饮用水的微生物标准并不排除有其他微生物的存在。同时人们也不希望这些微生物出现在基质药物和配方产品中。Toaccomplishmicrobialcontrol,MunicipalWaterAuthoritiesadddisinfectantstodrinkingwater.Chlorine-containingandotheroxidizingsubstanceshavebeenusedformanydecadesforthispurposeandhavegenerallybeenconsideredtoberelativelyinnocuoustohumans.为控制微生物，地方水务局在饮用水中加入消毒剂。公认的对人体无害的含氯消毒剂和其它氧化性消毒剂被用了数十年。However,theseoxidantscaninteractwithnaturallyoccurringorganicmattertoproducedisinfectionby-products(DBPs),suchastrihalomethanes(THMs,includingchloroform,bromodichloromethane,anddibromochloromethane)andhaloaceticacids(HAAs,includingdichloroaceticacidandtrichloroaceticacid).ThelevelsofDBPsproducedvarywiththelevelandtypeofdisinfectantusedandthelevelsandtypesoforganicmaterialsfoundinthewater,whichcanvaryseasonally.但是，这些氧化剂能跟自然存在的有机物反应，产生消毒副产品（DBPs），如：三卤代甲烷（THMs，包括氯仿，溴代二氯甲烷和二溴代一氯甲烷），卤乙酸（HAAs，包括二氯乙酸和三氯乙酸）。随着所用消毒剂种类、用量的变化和水中有机物的种类的季节性变化，DBPs的量也有所不同。BecausehighlevelsofDBPsareconsideredahealthhazardindrinkingwater,DrinkingWaterRegulationsmandatetheircontroltogenerallyacceptednonhazardouslevels.However,dependingontheunitoperationsusedforfurtherwaterpurification,asmallfractionoftheDBPsinthestartingwatermaycarryovertothefinishedwater.Therefore,theimportanceofhavingminimallevelsofDBPsinthestartingwater,whileachievingeffectivedisinfection,isimportant.由于饮用水中高含量的DBPs被认为有害健康，饮用水规定中要求把DBPs控制在可接受的无危害水平。但是从水的后续纯化中使用的单元操作来看，源水中很少量的DBPs都能被带到纯化的最终阶段。因此，在达到消毒效果的同时，保证饮用水中含有最小程度的DBPs是很重要的。DBPlevelsindrinkingwatercanbeminimizedbyusingdisinfectantssuchasozone,chloramines,orchlorinedioxide.Likechlorine,theiroxidativepropertiesaresufficienttodamagesomepretreatmentunitoperationsandmustberemovedearlyinthepretreatmentprocess.Thecompleteremovalofsomeofthesedisinfectantscanbeproblematic.Forexample,chloraminesmaydegradeduringthedisinfectionprocessorduringpretreatmentremoval,therebyreleasingammonia,whichinturncancarryovertothefinishedwater.可以用臭氧，氯胺或者二氧化氯这些消毒剂来减少水中的DBPs含量。比如氯，它们的氧化能力足以破坏一些预处理单元操作，必须在预处理程序中尽早除去。要完全除去其中一些消毒剂会有些困难。例如，氯胺在消毒过程或预处理过程中会发生降解，释放出氨，而这些氨又能被带入成品水中。Pretreatmentunitoperationsmustbedesignedandoperatedtoadequatelyremovethedisinfectant,drinkingwaterDBPs,andobjectionabledisinfectantdegradants.Aseriousproblemcanoccurifunitoperationsdesignedtoremovechlorinewere,withoutwarning,challengedwithchloramine-containingdrinkingwaterfromamunicipalitythathadbeenmandatedtoceaseuseofchlorinedisinfectiontocomplywithevertighteningEPADrinkingWaterTHMspecifications.预处理单元操作必须经过合理的设计和运行，以便充分地去除消毒剂、饮用水DBPs和令人讨厌的消毒剂降解物。为遵守更严格的EPA饮用水THM规定，市局会被要求停止使用含氯消毒剂而改用氯胺消毒剂。如果设计为用来除氯的单元操作毫无预兆地被用于这些含氯胺的城市饮用水，就会出现一系列的问题。Thedechlorinationprocessmightincompletelyremovethechloramine,whichcouldirreparablydamagedownstreamunitoperations,butalsothereleaseofammoniaduringthisprocessmightcarrythroughpretreatmentandpreventthefinishedwaterfrompassingcompendialconductivityspecifications.Thepurificationprocessmustbereassessedifthedrinkingwaterdisinfectantischanged,emphasizingtheneedforagoodworkingrelationshipbetweenthepharmaceuticalwatermanufacturerandthedrinkingwaterprovider.这个除氯过程可能会不完全地除去一些氯胺，从而不可逆地破坏下游单元操作，在此过程中释放的氨会被带入预处理程序，使得成品水的电导率无法达标。如果饮用水的消毒剂发生变化，则必须对纯化过程进行再评价，这一过程强调了制药用水厂商和饮用水供应者之间良好协作的必要性。DrinkingWater—ThistypeofwatercanbereferredtoasPotableWater(meaningdrinkableorfittodrink),NationalPrimaryDrinkingWater,PrimaryDrinkingWater,orNationalDrinkingWater.Exceptwhereasingulardrinkingwaterspecificationisstate