外资企业天平的校验与维护规程

文献编码Doc.No.:

颁发日期：生效日期：

原则操作程序

IssueDate:EffectiveDate:

Standard复审日期：

Operating

Procedure替代：Supersedes:ReviewDate:

页码：第1页共8页PageNc，.：1

of8

标题：分析天平日勺操作，校验和维护程序

TITLE:PROCEDUREFOROPERATION,PERFORMANCECHECK&MINTENANCEANALYTICAL

BALANCE

1.0目的Purpose:

描述了分析天平时操作与校验的程序。

TodescribetheprocedureforoperationandperformancecheckofAnalyticalBalance.

2.0范围Scope:

合用于下表所列的分析天平的操作与校验：

Thisprocedureappliestooperationandperformancecheckofanalyticalbalanceofthe

following:

生产厂家仪器编号型号序列号量程最大称样量最小称样量

MakeIDNOModelSrnoCapacityMaximumWlMinimumWt

210g±0.1mg200g10mg

41g±0.01mg

位置：检测中心天平室

Location:QualityControlDepartment(BalanceRoom)

3.()定义Definitions:无Nil

4.0责任Responsibility:

分析天平的操作与校验由检查员负责。

TheresponsibilityofoperationandtoverifytheperformancecheckofAnalyticalbalances

lieswithQC.Analyst.

5.0程序Procedure:

5.1操作Operation:

5.1.1观测水平仪的气泡与否处在中心确认天平与否处在水平。假如没有，通过调成天平

后方的地脚螺钉直至气泡处在中心位置。

Ensurethatthebalanceisleveledbyobservingtheairbubbleisinthecenteroflevelindicator.If

notadjustthelevelingbyturningfootscrewsattherearsideofthebalancehousinguntilthe

bubbleisin(hecenterofthelevelindictor.

5.1.2打开天平电源开关。

Switch'ON'themainswitchofthebalance.

5.1.3按“ON/OFF”键。

Press<tON/OFF^^key.

5.1,4等30秒天平初始化后，天平显示"000()0,g。否则按，一()一，键。

Waitforabout30secondsfortheinitializationofthebalance.Afterinitializationthebalance

displays40.00000'g.Otherwise,press0-'key

5.1.5当日平显示DOOOOO,时，可以对天平开始操作。

When'0.00000'isdisplayed,thebalanceisreadyforoperation.

5.1.6将称量纸或称量瓶置于称量盘中心，关上天平玻璃门。

Placetheemptycontainer/butterpaperonthecenterofthepanandclosetheslidingglassdoors.

5.1.7等读数稳定。

Waittillthebalanceshowsstablereading.

5.1.8按，-T-，键清零，显示变为'0.00000'go称量纸或称量瓶的重量被去皮重了。

Taretheweightbypressing*—>T*—5keybriefly.Thedisplaychangesto*0.00000*g.Nowthe

weightofthecontainer/paperistared.

5.1.9加入称量样品到达规定量。

Addweighingsampleto(hecontainer/papertilltherequiredweightisdisplayed.

5.1.10等读数稳定。记录数据为总重量g°

Waituntilthebalanceshowsstablereading.Recordtheweightas“GrossWting”.

5.1.11小心将样品移入量瓶后,将称量纸或称量瓶小心放置在称量盘中。

Transferthesamplecarefullyintotheflaskandplacethebutterpaperorweighingobjectonthe

pancarefully.

5.1.12关上天平玻璃门等读数稳定，记录数据为皮重g。

Closethedoorsandwaitti'lthebalanceshowsstablereading.Recordtheweightas“TareWtin

g”.

5.1.13称量mg样品，按天平右边的I'F键。显示变为-0.00,mg,接着按照5.1.6环节进

行称量。

Toweighthesamplein'mg',press'F'keyintherightsideofthebalance.Thedisplayconverts

into'0.00'mgandcontinuefromstep5.1.6fortoweigh.

5.2提醒Precautions:

5.2.1天平必须防止振动、风吹、高温、高

湿。

Thebalanceshouldbefreefromvibration,airthrust,strongheatandmoisture.

5.2.2AG245天平称量范围不得超过200go

Donotweighbeyond(heweighing200gonAG245balancefortheanalyticalwork.

5.2.3读数稳定后再确认数据。

Considerweightreadingsoftheobservationstillconstantreadingisdisplayed.

5.2.4称量之前保证称量盘是洁净的。用软毛刷清洁称量盘。

Ensurethepaniscleanedbeforeweighing.Cleanthepanwi:hsoftbrush.

5.3校验Perfornancecheck

5.3.1分析天平时日校

验Daily

PerformancecheckAnalyticalBalance

5.3.1.1清除称量盘负载，清洁称量盘及其周围。

Removeanyloadfromtheweighingpan,cleanthepanandarea.

5.3.1.2持续按右上角的“Cal”键至显示“CalibrationInternal”。

Press“Cal”keyattherighttopforawhiletoperform''CalibrationInternal”.

5.3.1.3天平显示自校：开始显示+200.00000g结束显示0.00000g。Balanceshows

calibrationinternal,(hen+2()0.()()(X)0gandfinally().()()()(M)g.

5.3.1.4将lOmg原则祛便置于称量盘中央,记录读数。

Place10mgstandardweightatthecenterofthepanandrecordthedisplayreading.

5.3.1.5将lOOmg原则祛码置于称量盘中央，等显示稳定记录读数。

Place100mgstandardweightatthecenterofthepanandrecordthedisplayreadingtillconstant

readingisdisplayed.

5.3.1.6将2(X)g祛码置于称量盘中央，将读数记录在天平校验记录里。

Placetheweight200gatthecenterofthepanandrecordtheobservedreadinginPerformance

checkRecordofAnalyticalBalance.

5.3.1.7将校验细节记录在如附录I所示分析天平校验记录里。

RecordthePerformancecheckdetailsinthePerformancecheckRecordofAnalyticalBalanceas

showninAnncxurc-1.

5.3.2月校验(多种原则诙

码)

Monthlyperformancecheck(withmultiplestandardweights)

精确度Accuracy:

5.3.2.1用原则祛码校验天平。

Cheektheperformancecheckofthebalancebyusingstandard

weights.

532.2将200mg,500mg,lg,2g,5g,10g,20g,50g,100g,200g原则祛码置于称量盘中

央，记录读数。并奖成果记录在附录H所示的表格里。

Place200mg,500mg,lg,2g,5g,10g,20g,50g,100g,200g,standardweightsatthe

centerofthepanandrecordtheobservedreadings.TabulatetheresultsinMonthlyPerformance

checkrecordofAnalyticalbalanceasshowninAnnexure-II.

5.3.3原则程度AcceptanceCriteria:

原则硅码重量Standard程度范围AcceptanceUSP等级Class

WeightRangeasperUSP

10mg+0.05mg1

100mg+0.10mg1

200mg+0.12mg4

500mg+0.10mg1

1g+0.20mg4

2g+0.20mg4

5g+0.30mg4

10g+0.50mg4

20g+0.70mg4

50g+1.20mg4

100g+2.0mg4

200g+4.0mg4

5.3.4反复性试验MeasurementofRepeatability:

5.3.4.1保证原则祛码使用前己校验合格。

Ensurethatthestandardweightsarecalibratedpriortotheiruse.

5.342保证天平做反复性试验前已校验合格。

Ensurethatthebalanceischeckedforperformancecheckpriortotherepeatabilitystudy.

5.3.4.3将lOOmg原则稚码置于分析天平称量盘中央。Take

the1(X)mgstandardweightandplaceitatthecenterofthepanoftheanalyticalbalance.

5.3.4.4记录读数。用同一原则祛码反复称10次，计算原则偏差值。Recordthe

readingonthedisplay.Repeatthestepfortentimeswiththesamestandardweightandcalculate

thestandarddeviationofthedisplayweights.

5.3.4.5用1g和100g原则祛码反复5.3.43和5.3.4.4股I环节，计算原则偏差

值。Repeat5.3.43and53.4.4with

1gand100gofthestandardweights,calculatethestandarddeviationoftheweights.

534.6将反复性数据记录在附录III所示的表格里。

RecordtheRepeatabilitydatainthePerformancecheckrecordasshowninAnncxure-III.

5.3.4.7假如反复性试验中出现任何偏差，必须对偏差进行调查，并且必须进行内部或代埋

商的J校正。

IncaseofanydeviationfoundduringRepeatability,deviationshouldbeinvestigatedandshould

becorrectedbyin-houseorbyexternalagency.

5.3.4.8校正后，天平必须进行机能检查和反当性试验。Aftercorrecting,the

balanceshouldbetestedforPerformancecheckandtestedforrepeatability.

5.3.5置.信度Uncertainty,precision(repeatability):

5.3.5.1用100mg、1gand100gm的反复性数据计算不可信度

Calculatetheuncertaintyvaluefor100mg、1gand100gmstandard

weightsundermeasurementofrepeatability.

3x原则偏差

计算公式：

原则祛码重

3xStandardDeviation

Calculation:

StandardWeight

535.2程度范围：＜0.001

AcceptanceCriteria:Shouldnotbemorethan0.001.

5.4校验周期FrequencyforCalibration:

5.4.1用指定原则祛码进行每日校验。

Dailyperformancechecktobedonebyusingspecifiedstandardweights.

5.4.2多原则祛码校验周期：一•种月+2天。

Performancecheckwithmultiplestandardweightsshallbecarriedoutonceinamonth+2days.

5.4.3反复性试验周期：一种月+2天。

Repeatabilityshallbedoneonceinamonth+2days.

5.5维护计划MaintenanceProgram:

5.5.1当口平观测到需要维修/未通过校验时，应贴上“维谬，标签(附件V),同步向QC经理

汇报。

Pul“UNDERMAINTENANCEMlabel(Annexure-V)ontheinstrumentwhenitwasobserved

breakdown/oroutofcalibration,intimatetoQ.C.Manager.

5.5.2QC经理告知仪器售后服务工程师，经修理后需校验仪器，检查与否正常工作并记录。

（注意：本次校验为额外校验，应按照校验日程计划照常进行每月的校验）。

Q.C.ManagerinformstotheInstrumentserviceengineer.Aftermaintenance,calibratethe

instrumenttocheckitssatisfactoryfunctioningandrecordthereadings.(Note:Calibratethe

instrumentasperthemonthlycalibrationschedule,thiscalibrationisanadditional)

5.5.3将仪器维修汇报附在仪器维护历史文献中，按照附件VI的格式填写仪器故障的详细

状况。

RetainservicereportcopyattachedintheInstrumentMaintenanceHistoryFileandenterthe

breakdowndetailsintheenclosedformatasAnnexure-VL

6.0有关文献RelatedDocuments:

6.1分析天平Fl校验记录(附录

Dailycalibrationrecordofanalyticalbalance(AnnexureI)

6.2分析天平月校验记录[附录-n)

MonthlycalibrationofrecordofAnalyticalBalance(Annexure-II)

6.3分析天平反复性试验记录(附录-IH)

Precision(repeatability)ofanalyticalbalance(Annexure-III)

6.4校验状态标签(附录-[V)

Calibrationstatuslabel(Annexurc-IV)

6.5“维修标签(附录-V)

“UNDERMAINTENANCE^^label(Annexure-V)

6.6仪器维修记录(附录-VI)

MaintenanceRecord(Anne\ure-VI)

6.7仪器使用记录(附录-vn)

INSTRUMENTUSAGELOGBOOK(Annexure-VII)

7.0修订记录RevisionRecord:

序号版本号修订内容备注

SLNoRevisionStatusDetailsofRevisionRemarks

******文献终止符ENDOFDOCUMENT

附录I

ANNEXURE-I

分析天平每日校验记录

DAILYPERFORMANCECHECKRECORDOFANALYTICALBALANCE

参照文献编码Doc.Ref.No.:表

格号FormNo.:

生效日期EffectiveDate:

第1页共1页Page1ofI

仪器编号ID.No.序列号S/N:生产厂家型号

Model:MAX：200gMIN：lOmg

水平内校硅玛重量也数误差程度范围备注校验人复核人

日期SpiritInternalStandardDisplayDifferenceAcceptanceRemarksCalibratedChecked

DateLevelCalibrationWeightReadingcriteriabyby

10.00mg0.05mg

100.00

0.10mg

□♦mg

200.0000

4.0mg

g

10.0()mg().05mg

100.00

0.10mg

□□mg

200.0000

4.0mg

g

10.00mg0.05mg

100.00

0.10mg

□□mg

200.0000

4.0mg

g

附录II

ANNEXURE-II

分析天平每月校验记录

MONTHLYPERFORMANCECHECKRECORDOFANALYTICALBALANCE

参照文献编码Doc.Ref.

No.:表格号Form

No.:

生效日期EffectiveDate:

第1页共1页Page1of1

仪器编号序列号S/N:生产厂家

Make:

型号Model:MAX：200gMIN：

IOmg精确度Accuracy

日期水平内校原则祛码读数误差程度范围备注校验人复核人

DateSpiritInternal重量DisplayDifferenceAcceptanceRemarksCalibratedChecked

LevelCalibrationStandardReadingCriteriabyby

weight

200.00

0.12mg

mg

5OO.(X)

0.10nig

mg

1.00000g0.20mg

□□

2.00(X)0g0.20mg

5.00000g0.30mg

K).O(XXX)

0.50mg

g

20.000000.70mg

g

50.0000g1.20mg

100.0000

2.0mg

g

200.0000

4.0mg

g

下次校验日期NextCalibrationduedate:

附录HI

ANNEXURE-III

分析天平反复性（精密度）每月试验记录

PRECISION(REPEATABILITY)OFANALYTICALBALANCE

参照文献编码Doc.Ref.No.:表格号Form

No.:

生效日期EffectiveDate:

第1页共I页Page1of1

校验日期calibrationon:仪器编号

ID.No.序列号S/N:

生产家型号

Model:MAX：200g

MIN：lOmg精密度(BalanceUncertainty)

水平内校读嗷程度范围备注校验人复核人

SpiritInternal原则祛Displa)niadings3xSDAcceptanceRemarksCalibratedChecked

LevelCalibration码重量12345678910stdCriteriabyby

Standardstndrdthththththththwt

weight

根据精确度和精密度来确认上述天平性能与否合格。

Remarks:Theperformanceoftheabovebalanceissatisfactorj//NotSatisfactoryinterm

ofAccuracyandPrecisionarewithintheLimit

下次校验日期NextCalibrationduedate:

附件IV

ANNEXUREIV

校准状态标签

CLIBRATIONSTATUSTAG

参照文献编码Doc.Ref.No.:标签号LabelNo.:

生效日期EffectiveDate:

第1页共1页pagelof1

校准状态标签

CALIBRATIONSTATUSTAG

名称INSTRUMENT/EQUIPMENT:

编码I.DNO.:

校验日期CALIBRATEDON:

下次校验日期CALIBRATIONDUE:

校验人/口期CALIBRATEDBY/DATE:

复核人/日期CHECKEDBY/DATE:

附件VANNEXUREV

附录-V

ANNEXURE-V

分析天平维修标签

ANA