JETTBlende URS.docx

JETTBlende URS.docx

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JETTBlendeURS

UserRequirementsTemplate

fora

BLENDER

forPharmaceuticalproducts

NOTESforuseoftheUserRequirementsTemplate:

Uponcompletionofthetemplate,deletethispagepriortoupdatingtheTableofContentsandprinting.

1.Manyareasofthistemplatehaveselectionsortablesthathavebeenpreparedforguidanceandeaseoftemplatecompletion.TextinitalicsisintendedtobeusedasnotestotheUserandshouldbedeletedpriortoprinting.Anyoptionsand/orexamplesthatarenotapplicabletothespecificdocumentbeingcreatedshouldbedeletedaswell.

2.ToupdatethefinalTableofContents,placethecursorinsidetheshadedarea,presstheRightmousekey,andselectUpdateField.

3.Wherepossible,theUsershouldidentifythesource（e.g.studies,standards,etc.）fortheacceptablerangesofvariablesorothercriticalrequirementsthathavebeenderived.

REVISIONHISTORY

Rev.

Date

Approval

RevisionSummary

0

July27,2003

VinceMiller（JETT）

Approvedforinitial,formalrelease.

TableofContents

1.0Introduction5

2.0Overview5

2.1Use:

5

2.2Capacity:

5

3.0OperationalRequirements6

3.1Capacity6

3.2ProcessRequirements6

3.3ProcessControl7

3.4Functions7

3.5DataandSecurity13

3.6Environment17

4.0Constraints20

4.1MilestonesandTimelines20

4.2EquipmentConstraints21

4.3CompatibilityandSupport21

4.4Availability23

4.5ProceduralConstraints23

4.6Maintenance25

5.0Life-Cycle25

5.1Development25

5.2Testing25

5.3Delivery26

5.4Support27

6.0Glossary28

7.0References29

8.0Approval30

ProjectNo.:

InserttheuniqueprojectnumberassociatedwiththisparticularURS.

DocumentNo.:

InserttheDocumentIdentificationNumberandRevision.

DocumentDescription:

Insertdescriptionofdocument,e.g.BLENDERUserRequirementsTemplate,JETTExampleUserRequirementsSpecification.

1.0Introduction

Thisdocumentwasgeneratedundertheauthorityofthe___________________Companyforthepurposeofspecifyingtheuserrequirementsforanautomatedblendingsystem.Thesystemshallbeusedtoperformadiffusionblendingstepinwhichanactivepharmaceuticalingredientiscombinedwithinertdryingredientstoformauniformmixture.

1.1Thisuserrequirementspecificationwillberecognizedasanintegralpartoftheprocurementagreementwiththeselectedequipmentvendor.Theequipmentsupplierorvendorwillabidebytheinformationandconditionssetforthbythisdocumentaswellasthestandardpurchasingtermandconditionsofthe____________________Company.

1.2Theblendingsystemwillbeoperatedindependentlyofotherequipmentandsystemsandwillbelocatedinadesignatedoperatingarea.

1.3Anequipmentvalidationplanhasbeendevelopedtooutlinetheplannedtasksandexpectationsforvalidationoftheblendingsystem.ThisplanhasbeenincludedasAttachment_____.TheequipmentsupplierorvendorhasspecificresponsibilitiesasoutlinedbytheValidationPlanandthisdocument.

2.0Overview

2.1Use:

TheBlendershallbeusedtocombineadrybulkactivepharmaceuticalingredient（mediumactive）withtwoinertdrycompoundstoproduceauniformblendtomeetformulationrequirements.

2.2Capacity:

Theblendershallbecapableofhandling500cu.Ft.ofdryproductperbatch.

3.0OperationalRequirements

Therearemanytypesofblenders,eachprovidingcertainfeaturesthatmightbeapplicabletoagivenprocessorproductneed.Thissectionshoulddescribethespecifictechnologywhichwillbeutilizedforaspecificprocessrequirement.Themajorblendertypesare:

1.Ribbon

2.V-ConeorV-Shell

3.Y-Cone

4.DoubleCone

5.Fossberg,highspeedblender

6.Verticalconescrewblender/Conicalorbitalscrewmixer

7.Ribbonblender

8.Zig-ZagBlender

9.IBCBlender

Eachtypehasuniquefeaturesandcapabilitiestofitaparticularprocessneed.Thissectionshouldprovideanoverviewoftheuniquefeaturesrequiredforthespecificprocessapplication.Theusershoulddescribethebasicoperatingprinciplesrequiredbytheproductformulationspecifications,suchasdiffusionblending,convectionmixing,orpneumaticmixing.

3.1Capacity

Describethebatchsizeandthroughputrequirements.（Batchesperday,poundsperhour）.Itisimportanttoclarifyboththeminimumandmaximumbatchsizes.Someblenderswillhaveaminimumpercentfullloadrequirementforaneffectiveblendingaction.

∙Maximumvolume/capacityrequired.

∙Minimumvolume/capacityrequired.

∙Rangeofproducts（i.e.density,moisturecontent,viscosity,etc.）

∙Commoditiestobeused（i.e.typesofcontainers,ormethods,usedtochargeanddischargematerialstobeblended.）

∙ProcessedMaterialstobeusedorinvolved

∙Productionrates

3.2ProcessRequirements

∙Qualityofproductsandconcentrations

∙Productlimitations（i.e.temperature,humidity,pH,etc.）

∙Blendingtime

∙Blendingspeed

3.3ProcessControl

Note:

Ataminimum,listthecriticalprocessparameters.Considerdocumentinghoweachoftheparameterrequirementswasdetermined.

∙MeasurementRange

∙SetpointRange

∙ParameterControlTolerance

3.4Functions

3.4.1Operation

Theoperationalrequirementsforablendercanincludeoneormoreofthefollowing:

▪Evendistributionofcomponents

▪Wetgranulation

▪Agglomeration

▪Drying

▪Temperaturecontrol

▪Variablespeeddrive

▪Softstart

▪Highspeedchopper

▪Spraynozzles

▪Describeanyconstraintsrequiredbytheprocessapplication,suchasmaximumtipspeedand/orRPMlimitations.

▪Describeanyportabilityrequirementssuchascasters,utilityconnections,etc.

▪Describedrivelocationoracclimationrequirements.

▪Describeanyplatformheightrequirements.

▪Describethenumberofrecipesandrecipeparametersthatwillberequired.

▪Describethemethodofdefiningrecipeparameters.

▪Ifthemachinewillbemonitoredand/orcontrolledbyaSCADAorMESsystem,describethedatainterfacerequirements.Seesection3.2.3.

Enteryourspecificoperationalrequirementshere.

∙Cyclesexpectedthesystemwilloperateatare…

∙Recipesthesystemwillcontainare…

∙Operatorinteractionwiththesystemwillinclude…

Thefollowingisanexample:

Thesystemshalloperatewithaminimumofoperatorinvolvement.Operationshallbesafefromanoperatorandenvironmentalstandpoint.

Thesystemshallbeoperatedlocallyattheequipmentitself.

Controlsystemrequirements:

∙Manualonly

∙Manual/automatic

Operationalparameterscanbedefinedinnarrativeorinatable,asillustratedbelow:

Parameter

IndicatedonLocalHMI

Monitoredremotely

Operatoradjustable

Determinedbyrecipe

Datastored/trended

Rotationspeed

#ofrotations

Blendtime

Producttemperature

Vaporoutlettemperature

Shellin/outtemperature

Drivetorque

Vacuumlevel

Intensifierspeed

Intensifierpower

Intensifierflowrate

Agglomerationtime

Blenderloadweight

FinalBlendYield

3.4.1.1Loading

Describehowtheblenderwillbeloaded.Specifyasepticornon-aseptic

3.4.1.2Unloading

Describehowtheblenderwillbeunloaded.Specifyasepticornon-aseptic

3.4.1.3Cleaning

Describethecleaningrequirementsfortheunit.Willanautomatedclean-in-placesystembeused?

Willtheunitbeusedformorethanoneproduct?

3.4.1.4Sanitization

Describeanysanitizationrequirementsfortheunit.

3.4.1.5Otherrequirements.

∙Alpha-Betavalve–forsanitaryunloading

∙Johnsonjoint–forprocessconnectionstorotatingparts

∙encloseddrivesystem

∙remotedrivesystem

∙listanysterilityorcontainmentrequirements

∙ASMEVacuum/pressurerating

∙Describeoperatoraccesspointsandthemethodofoperatoraccess,i.e.platformheightandalignment.

∙Dustcollectionsystems

∙Safetyfeaturessuchas:

oE-Stop

oPhotoeyesorlightcurtaintodisabledriveoperationwhenoperatorispresent.

oDoorinterlocks

oNoauto-restartafterfailure

oFailsafedesignonvalveactuators.Considerdouble-acting（failinlastposition）vs.springreturn（failclosed）actuatorswherehazardtooperatorexists.

oLockoutfeaturesonallenergysources

oRoompressurizationinterlock

3.4.2Powerfailure/Recovery

PowerFailure:

Onpowerfailure,thesystemshallfailintoa“safestate.”Onpowerrestoration,thesystemshallnotrestartwithoutoperatororcommunication-linkinput.Insertyourspecificpowerfailure/recoveryschemehere.

Forexample:

Intheeventofapowerfailure,thesystemshallprotectinthefollowingpriority:

∙Personnel

∙Equipment

∙Product

A“safestate”shallbedefinedas:

∙Allmotionstoppedonthemachine

∙Resetrequiredbeforemachinecanberestarted

∙Nodamagetomachinewilloccurasaresultofgoingtothesafestate.

∙Valvesandactuatingdevicesgotosafestate（define）.

∙Noproductloss.

∙BatchcanberestartedwithoutlossofbatchIDorbatchstatusdata.

∙Listeachsequenceorprocessstepandthedesiredfailstateforeach.

∙Listanyautomatedremedialactiontobetakenintheeventofsensororinstrumentfailure.

RecoveryMethods:

Insertyourspecificrecoveryschemehere.

Forexample:

∙Manuallyre-startbasedonoperatorinputs（Operatorinitiatespowerrecoverysequence）.

∙Re-startbasedonlaststatebeforelossofpower.（Systemrunsthroughpowerrecoverysequencewhenoperatorstartsignalisgiven）

∙AllequipmentshallbedesignedtoretainthePLCprogramincaseofpowerloss,andbeabletorecoverwithminimaloperatoractions.

∙Ifthereisanautomaticbatchreportingsystem,theinformationshallberetainedintheeventofapowerfailure（AUPSisrequir