食品企业水处理审核检查表Word下载.docx
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食品企业水处理审核检查表Word下载.docx
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TreatedWaterSpecifications
BO-RQ-245
WaterQualityMonitoring
BO-RQ-250
WaterStorageandTransportation
BO-RQ-235
RawWaterMonitoring
ReferenceManual
RF-WA-266
TotalTrihalomethanesMonitoring
TCCQSupdatesarecapturedtillDecember15,2005
3)SpecificationsandRequirementsSummary:
Specifications/Requirements
1
Isthedesignofthewatertreatmentareaadequatetopreventcontamination(outside,inside)?
水处理设计能有效防止污染吗
DoesthewatertreatmentareameetallapprovedconditionsfortheGMPdesigncriteria?
水处理区的设计符合认可的GMP要求吗
Thelisteditemsare“approvedconditions”inordertocomplywiththegeneralrequirement“topreventcontaminationinthewatertreatmentarea”
认可条件是指水处理区不被污染.
Ifsomeoftheseapprovedconditionsarenotfulfilled,theauditorwilljudgeonthepossiblecontaminationresultingfromwatertreatmentareadesignobservedduringtheaudit.
如果一些认可条件没有得到执行,审核员要判断这种已发现的设计不足可能造成何种污染。
∙Watertreatmentareaseparatedorenclosed.
∙水处理区是单独或是附属的
∙Preventorrestricttrafficbynon-essentialpersonnel.
∙防止或是限制无关人员进入
∙Minimizenumberofdoorsandopenings.
∙最少化门窗数量
∙Non-openingwindowsinthewatertreatmentarea.
∙水处理区窗应是不可开的
∙Self-closingdoors.
∙自动式门关闭系统
∙Airventilationsysteminplace(typically6changes/hour).
∙空气换送系统每小时6次
∙Ifbulkacidisstoredinsidetheplantand/orion-exchangesystemisinuse,extraventilationneedsareinvestigated&
applied.
∙如果室内贮有大量的酸或是使用离子交换系统则要另外考虑所需的通风系统
∙Watertreatmentareatobeeasycleanable.
∙水处理区易清洁
∙Nouseofwoodenmaterialsinthewatertreatmentarea(asaconstructionmaterial,desks,chairswoodenfixtures,…)
∙水处理区不用木制品(如建筑材料、桌子、椅子)
∙Storageofliquidchlorinecylindersinaself-containedshedwithoutsideventilation.Localrequirementstobemet.
∙液氯贮存罐应在自我封闭区且有通风系统,并且符合当地法规
∙Adequatedrainingprovided(worstcasewaterload).
∙有足够的排水设施(最糟糕排水量)
∙Floorsareself-draining/drainshavewatertrapsandscreentraps.
∙地面和自排系统/拦水排水系统
2
Isthewatertreatmentareafreeofanyobvioussourcesofpotentialcontamination?
TheserequirementsareresultsfromthegeneralrequirementsinBO-RQ-200“ImplementGMPproceduresthroughouteachsection”.
这些要求都是由BO-RQ-200衍生出来的,对每个部分实施GMP要求
∙Theareaisclean,organizedandwellmaintained
∙区域清洁、有条理和易保养
∙Nopotentialcontaminationpointssuchasforinstance:
∙没在潜在污染点诸如:
-Standingwaterinthearea
-地面积水
-Wetwoodenpallets
-湿木托板
-Storageofchemicalsinthearea
-有化学品贮存
-Strongoff-odorsdetectedinthearea
-有强烈的异味
-Dirtyfloors,wall,ceiling
-地面、墙壁和天花板脏
∙SOP’savailableonthehousekeepingofthewatertreatmentarea
∙有关于水处理区清洁的SOP
∙Nouncoveredwatertanksopeningslocatedunderdirtysealing,pipeworkorlightfixtures.
∙没有无盖的水罐位于脏的焊接处、工程管道或灯具下面。
3
Doestheplantcomplywithgeneralrequirementsonwatertreatment?
Exception:
PackagedWaterwhenlegallimitationsforwatertreatmentexist;
seePackageWatermodule.
例外:
如果包装水的水处理有相关法律限定,参见包装水模块
∙Onlytreatedwatertobeusedforproductionofcarbonatedandnon-carbonatedbeverages(simple&
finalsyrup,finalproducts).
∙只用处理水对碳酸产品或非碳酸产品适用(单糖浆、终糖浆和成品
∙WatertreatmentmustbeMultipleBarrierinapproach.
∙水处理须是多级过滤
∙ProceduredevelopedandimplementedonMB-system(processinstructions,maintenance,chemicalsusage,potablere-usepractices,performancerecords).
∙对MB系统要制定程序并加以实施(工艺结构、保养、化学品的使用、饮料再使用条例、性能记录)
∙Samplinglocations,testfrequencies,proceduresandrecordsaredocumented.
∙取样点、测试频率、程序和记录都要文件化
4
Doestheplantcomplywithallrequirementsonrawwater(sourcewater)?
Iftherawwaterdoesnotmeetallcriteriaforpotablewater:
如果原水不是符合所有的饮用水标准
-formaldivisionapprovalnecessary
-必须要有公司的认可
-pre-treatthewatertobringittostandardbeforeMBsystem
-在MB系统之前,必须预处理以使其达到标准
-orensurethatMBsystemproperlytreatsthesecontaminants
-或确保MB系统可以适当处理污染
-extramonitoringinthewatertreatmentprocessfortheseparameters
-额外监测这些处理工艺参数
Rawwaternotmeetingcriteriaforpotablewaterisnormallyfromprivatesources,wellsordisruptionsinmunicipalsupplies
一般不符合标准的原水是来自于私人水源、井水或是自来水中断供应。
∙SourcewatermustmeetlocalandWHOstandardsfordrinkingwater
IntheEuropeanUnion,directive98/83/ECon“Qualityofwaterintendedforhumanconsumption”isvalid.Proofofcompliance(frequencyandscopeoftests)istobeavailable(inmostcasesthisishandled/executedbytheLocalAuthorities)
源水须符合当地和WHO饮用水标准
∙Mapthewatersourceandarea,mainusersandindicatepotentialsourcesofcontamination
∙绘制水源和水处理区图,主要使用者,并标识潜在的污染源
∙Forprivatewatersources:
∙对工厂水源
-developasourceprotectionstrategy
-制定水源保护战略
-evaluateMBsystemtoaddressemergingcontaminants
-评估MB系统以阐述出现污染
∙Formunicipalwatersources:
∙对市政水源:
-assesstheriskofpotentialwaterdisruptions
-评估水源中断的潜在风险
-buildprofessionalrelationshipwithwatersupplier
-与供水方建立职业关系
5
Doestheplantfollowtherequirementsonfullanalysisforrawwater?
∙Testonceayear,ataminimum,eachparameterspecifiedasbelow:
∙至少一年一次对以下规定的每个参数进行测试:
-Ifrawwaterend-useisforbeverages,thentreatedwaterspecsarefollowed..
-如果源水终端用于饮料则处理水标准要符合
-Ifrawwaterend-useisforpackagedwaterornaturalmineralwater,PackagedWaterSpecs.andmonitoringarefollowed.
-如果源水终端用于包装水或是矿泉水则包装水标准要符合
∙AnalyticallaboratorymustbeapprovedbyDivisionQA.
∙分析实验室须经公司认可
∙In-planttest:
∙厂内检测
Testfrequency:
weekly
每周测试频率:
-Alkalinity(M)
M碱
-pH
-TotalDissolvedSolids(TDS)
总溶解固体
-Turbidity
浊度
-Coliforms
大肠
-TotalViableCount
-平板总数
∙Fullanalysisofsourcewaterorpotabilitycertificate3timesperyear.
∙每年3次全分析报告,
6
Isthewatertreatmentsystemmulti-barrierindesign?
Multiplebarrierdesignconsistsof:
∙Enhancedfiltration
∙加强过滤
-Coagulation/Flocculation(conventional;
FeorAlcoagulant)
凝结/絮凝(一般Fe或是Al胶体
-InLineFlocculation(directfiltration;
在线絮凝(直接过滤,Fe或是Al胶体)
-Ultra-Filtration(UF);
min.20,000molecularweightcutoff
Ultra过滤,至少能过滤20,000个分子重
-Nano-Filtration(NF)
纳米过滤
-ReverseOsmosis(RO)
反渗透
∙AlkalinityReduction(ifneeded=ifalkalinity>
85mg/l)
-Conventional(withlime;
Ca(OH)2)
一般碱石灰
-Ionexchange
离子交换
-Electrodialysis
电解
-ReverseOsmosis/Nano-Filtration
-反渗透/纳米过滤
∙Disinfection消毒
-Chlorine(minimum1ppm)
至少1PPM的氯
-UV(assupplementarydisinfectionaftermembranefiltration)
-UV灯(膜滤后的一个消毒补充)
∙Carbonpurification
∙碳滤
∙PolishingFiltration(5–20microns)
∙精滤(5–20microns的微生物)
7
Arespecificrequirementsfulfilledforthewatertreatmentsystem?
∙In-lineflocculation(directfiltration):
useonlyifrawwatermeetsfollowingrecommendedqualitycriteria.
∙在线絮凝(直接过滤)仅适用于当原水符合以下标准要求时:
-Turbidity:
<
5NTU
-KMnO4:
<
5ppm
高锰酸钾
-Iron:
0.3ppm
铁
-Manganese:
0.05ppm
镁
-TOC:
3ppm(totalorganiccarbon)
总有机碳
∙Chlorination:
Minimumcontacttimeis30minutes(bydesign!
)
∙氯化:
至少接触30minutes
∙UVtreatment:
(assuppldisinfaftermembranefiltrationonly):
∙UV灯处理:
(只是膜滤后的一个消毒补充)
-minimum40.000µ
Ws/cm2on254nmattheendoflamp’slife
-至少40.000µ
Ws/cm2,使用终结时波长254nm
∙Carbonpurification:
∙碳过滤
-beddepth>
=1.5m
床深
-50%freeboard
-stainlesssteeltype316
316型不锈钢
-flowrate:
max.140liters/minute/m3carbon
-流速:
最大140升每分钟每立方米碳
8
Arethechemicals/contactmaterialsusedinthewatertreatmentauthorizedforcontactwithdrinkingwater?
Approvedchemicalsare:
认可的化学品
Coagulants:
Aluminumsulfate,Ferricsulfate,Ferricchloride,Ferricsulfite,Polyaluminumchloride,
絮凝剂:
硫酸铝、氯化亚铁、亚硫酸铁、三氯化铝
Alkal.Red.:
Calciumchloride,Calciumsulfate,Calciumhydroxide,
红碱:
氯化钙、硫酸钙、氢氧化钙
Disinf.:
Calciumhypochlorite,Sodiumhypochlorite,Chlorinegas
消毒:
次氯酸钙、次氯酸钠、氯气
∙Listofapprovedmaterialsavailableonsite
∙有认可的物料清单
∙Allchemicals,filteraids,contactmaterialsusedarelisted
∙所有化学品、过滤助剂、接触的物料都已列举
9
Areallrequiredtestsperformedattherequiredfrequency?
ThepresenceofcalibratedIn-linemonitorscanreducetherequiredfrequencyforspecificparameters.
Specificwatertreatmentsystemsmightallowmodificationstotheserequirements.
特殊的水处理系统允许修改以符合这些要求。
Thesandfiltereffluenttestsaretheoperationalteststocontrolthewatertreatmentprocess
沙滤测试是操作性测试,为的是控制水处理工艺.
Malkalinity:
onlywhenalkalinityneedsreduction.
M碱:
仅当碱需降低时
Palkalinity:
onlywhenhydratedlimetreatmentused.
P碱:
仅当用碱石灰处理时
pH:
onlyforflocculation/coagulation,notforUF,NF,RO.
pH:
仅适用于絮凝/絮凝剂,但不适于UF,NF,RO.
Thetreatedwatertestsarethefinalingredient(water)tests.
处理水测试是最后的主剂测试
Note:
DivisionQAmaymodifytestfrequencybasedonprocessperformanceandthetypeofthewatertreatmentsystem,exceptforplantsusingcoagulation/flocculation,whichisrequiredeveryfourhours.Supportingdatamustbeavailableuponrequest.
公司QA部修改测试频率的依据是工艺表现、水处理系统的类型,除非工厂用絮凝剂,要求每4小时
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