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TheLongArmofS88

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Home/Articles/2004/TheLongArmofS88

The Long Arm of S88

Batchautomationstandardsarehavinganimpactfarfromthecontrolroom,changingapproachestoplantdesign,
specification,andvalidation
Dec15,2004
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ByNickBasta,ContributingEditor
Economicpressuresandregulatoryuncertaintiesareforcingmanydrugmanufacturerstodaytooperateinhurryupandwaitmode.Capital
expenditureshavetobemadeaslateaspossibleinthedrugmanufacturingprocess,yetcompaniesmustbereadytoimplementthemonce
drugsmeetregulatoryapproval,saysLouPillai,ITteamleaderatPfizer,Inc.(NewYork,N.Y.).

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Processdesignandspecificationusedtobeasomewhatunstructuredprocessnowtheresalanguageandamethodologythatallows
everyoneinvolvedindesignandprocesscontroltocommunicatewitheachother.
Modularconstruction(seePharmaceuticalManufacturing,September2004,p.36)ishelpingdrugmakersmanagethesepressuresinnew
plantconstruction.Butforplantdesign,specificationandvalidation,standardsdevelopedintheprocesscontrolfieldarehavingafarreaching
impactondrugmanufacturing.S88(seesidebar,below),whichoriginatedasawaytowritecontrollogicforbatchprocesses,hasbecomea
preferredroutefordesigningandspecifyingalltheproductionequipmentinapharmaceuticalplant.
Thestandard,firstestablishedinthe1990sbytheWorldBatchForumundertheimprimaturofISAInternational(Raleigh,N.C.),beganasan
approachtoprocesscontrolforbatchmanufacturing.Ithasalsoinfluencedabroader,parallelprogram,S95,EnterpriseControlSystem
Integration,designedtorationalizehowinformationleavestheplantfloorandistransferredtoenterpriseITsystems.
Simplestructure,significantbenefits
S88isgroundedonthreeprinciples:
Batchfunctionsshouldbemodularsequencesofsuchactionsasfilling,heatingordrying
Therecipe,orproceduralsteps,shouldbewrittenindependentlyoftheequipmentinwhichtheactionsareperformed
Thelogic,orcapabilities,oftheequipmentshouldbecapturedinadatafile.
Astherequirementsofarecipearematchedupwiththeequipmentlogic,anoverallproductionprocesscanbespecified,andfromthis,the
actualcontrollogiccanbecoded.Multipurposeplants,withanarrayofrecipes,canberunondifferingsetsofequipment,andtheoverall
automationsystemcankeeptrackofitall.
S88ssuccessincodifyinghowprocessesareanalyzedhasmadeabigdifferenceinprocessdesignandconstruction.Thestandardis
providingsomecompanieswithafoundationforSixSigmaprograms,connectingmanufacturingexecutionsystems(MES)toERPandother
platforms,andlinkingbatchcontrolwithothereffortssuchaspackagingautomation.Italsopromisestohelpmanufacturersdealmore
effectivelywithFDAselectronicrecordkeepingrequirementsunder21CFRPart11,andinhandlingdatafromprocessanalyticaltechnologies
(PAT)programs.
S88isplayingakeyroleinhowthepharmaceuticalindustryspecifies,designsandbuildsitsfacilities,saysPfizersPillai,headofthe
educationcommitteeofWorldBatchForum.Ithelpsusspeeduptheprocessofvalidatingsystemsitiskeytodesigningmultipurposeplants
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itprovideswaystoapproachrevalidatingorrepurposingprocesslines.
Alotofsmart,farsightedpeoplegotthiseffortgoingyearsago,andwereenjoyingthebenefitsofitnow,saysDennisBrandl,presidentof
BR&LConsulting(Cary,N.C.),andeditoroftheS95standardcommittee.Processdesignandspecificationusedtobeasomewhat
unstructuredprocessnowtheresalanguageandamethodologythatallowseveryoneinvolvedindesignandprocesscontrolto
communicatewitheachother.
Olderfacilitiesstilltraditionbound
MostcurrentornewcapitalprojectsandcontrolsysteminstallationsuseS88methodology,accordingtoBrandl,andotherindustrysources
agree.However,theindustryistraditionboundwhenitcomestoindustrialautomationcurrently,only30%ofexistingpharmaceuticalfacilities
useS88,Brandlnotes.
Astimegoeson,Brandlfeels,thestandardsimpactwillonlybroaden.S95isexpectedtohaveasimilarimpactatthisfallsannualISA
meeting(Houston,Oct.57),Part3ofthestandardwasratifiedandwillnowgoouttoISAmembershipforapproval.
BecauseS88doesnotspecifycontrolmethodsorcommunicationprotocols,thestandardwaseasyforautomationvendorstoembrace,and
severalofthemhaveactivelyparticipatedinitsdevelopment.AndthesameprinciplesofmodelingprocessesandproceduresofS88have
beencarriedintoS95.Today,mostoftheleadingautomationvendorsservingthepharmaceuticalindustryhavecontroldesignsoftwareor
relatedITtoolstohelpclientsspecifyandcodetheircontrolsystemsbyS88/S95standards:
RockwellSoftware(Milwaukee,Wis.)employsS88methodsinRSBatch,fordevelopingcontrolprograms,andRSView,itshuman
machineinterface(HMI)softwarefordisplayingproductionactivities.WithoutS88,thecompanysays,writingbatchcodeforits
programmablelogiccontrollerscanconsume5060%ofanautomationprojectstimeS88basedsoftwareallowsthistimetobecutto
15%.
Honeywell(Phoenix,Ariz.)offersitsPOMSmanufacturingexecutionsoftwarewithS95compliantfeatures.
Invensys(London)WonderwaresubsidiaryfeaturesInBatchsoftwareformanufacturingexecution.
ABBs(Zurich)IndustrialITdivisionoffersProduceIT,claimingasmuchasa50%reductioninimplementationcoststhroughS88
methods.
SiemensEnergyandAutomation(Alpharetta,Ga.)deploysbothitsAPACS+batchcontrolsoftwareandSIMATICITmanufacturing
executiontechnologywithS88/95.Thecompanyclaimsthatthelargestpaperlessbiotechplantintheworld,GenentechsVacaville,
Calif.,facility,savednearly$5millioninimplementationcostsbygoingthisroute.
EmersonProcessManagement(Austin,Tex.)incorporatesS88standardsintoitsDeltaVautomationsoftwareinaddition,itsproject
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servicesorganizationhasaProjectBuilderLibraryofpredefinedmodelsthatareusedtodefinecontrolsystemstructuresand
componentsaccordingtoS88definitions.
Duetotheheavyvalidationprocedurespriortocommercialproduction,andthebatchrecordresponsibilitiesduringproduction,pharmaplant
operatorsarefindingthattheycanspeedupthevalidationprocess,andheadoffrecordkeepingburdens,byadoptingS88methodsearlyin
theprocess.S88isgeneralenough,itsadvocatessay,thatitcanbeusedtodesignandorganizeevenmanualbatchoperations.
Insteadofbuildingonevessel15times,whynotbuildaclassofvesseloraclassofsoftwareonceandvalidatethat,saysPhillipMaderia,
associatedirectorofautomationengineeringatGenzymeCorp.(Cambridge,Mass.).GenzymeandEmersonProcessManagementworked
togetherrecentlyonaprogramtoreconfigureallprocessandequipmentdescriptionsinthismodular,classbasedapproach.Maderiasays
thecompanyisseeingbenefitsinslicingsixto12monthsoutofcommissioningandvalidationschedulesfornewfacilitiesandcutting
documentationcostsbynearlyhalf.
Atleastonesoftwarevendor,SpecSoftPFS(TelAviv,Israel)hasjumpedonthisideaasawaytoproducedesignandcontrolsystem
requirementsdocumentsthatareeasilyvalidated.Thecompanyoffersasuiteofproducts,includingPFSDefinition,thatfollowS88methods
closely.Userscanpullrelevantdatafrompipingandinstrumentationdiagrams(P&IDs)automaticallytobuildthecontrolsystemandcontrol
logic.Thecompanycountsseveralpharmaceuticalandchemicalcompaniesamongitsclients,andhasreceivedbackingfromABBVentures.
Insynchwithmodularconstruction
TherearesignificantadvantagestodesigningpharmaceuticalfacilitieswithmodularunitsthatmoreorlessfollowS88sprocesscell
definition,accordingtoLarsPeterson,managerofautomationatNovoNordisk(Bagsvaerd,Denmark),whodiscussedthepossibilitiesatlast
yearsWBFmeetinginapaperprovocativelytitled,Isitpossibletobuildapharmaceuticalplantin18(oreven12)monthswithS88?
Usingthisapproach,multipleequipmentvendorsorengineeringandconstructionfirmscouldbuildmodulesinparallel,witheverythingcoming
together(includingthecontrolscheme)asthemodulesareassembledattheplantsite.Automationistimeconsuming,Petersonsaid,
especiallywhenqualifying[theequipment]anddocumentingthetest.S88canbeimplementedwithoutmodularizationatalllevels,butthe
realsavingsoccurwhenthisisdone,hesaid.
PfizersPillaiseessignificantbenefitstothepharmaceuticalindustryifthismodularizationtrendgrows,bothforspeedinguptheconstruction
andvalidationprocess,andformakingmultipurposeplantseasiertodesignandoperate.Theideaisthatplantdesignproceedsasa
pharmaceuticalproductisgoingthroughclinicaltrials,hesays.Iftheplantisdesignedtherightway,itscapabilitieswillbeabletohandle
revisedormodifiedrecipeswithoutrevalidating.Theseparationbetweentherecipemodelandtheequipmentmodeliskeytoaccomplishing
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this.
Fasterdesignbuildcyclesareonlyoneofthebenefitscitedbyproponentsofthenewstandards.EliLilly(Indianapolis)usedthestandardto
revampthecontrolsystemofa10yearoldfluidbeddryerandgranulator,whichhadbeenusedforproductionandprocessdevelopment.
Whilethescaleofthesystemsome250controlpointswasnotmassive,thenumberofdifferentcontrolmodules(controlroutinesfor
specificrecipes)wasgreaterthan70,in11differentclasses,resultinginthousandsofconfigurationvaluesforthecontrolsystem.
Requirementsfortheregulatedindustriesaremuchmorestringentnowcomparedtowhattheywere10yearsago,saysBrianDeHaan,a
seniorprocessautomationengineeratLilly,whopresentedresultsatthisyearsWorldBatchForummeetinginChicago."Legacy
documentationhaseitherbeennonexistent,ortoogeneraltobeuseful."
Lillysprojectwasnoteasy.Overall,moretimewasspentongatheringnecessaryinformationfromequipmentvendors,plantoperatorsand
plannersthanactuallyreengineeringthecontrolsystem,DeHaansaid.Nevertheless,thecompanyisnowbenefitingfromnewcapabilitiesin
runningtheprocesssmoothlyintransitionfromonestatetoanother,fromfewerabortedbatchesandnuisancealarms,andfrombetter
recordkeeping.
GenentechispreparingtomanufacturemultipleproductsinanS88documentedmonoclonalantibodyplantatitsVacaville,Calif.,location.
Theapproachreflectsthefactthatthecellculturingpartofthefacilitychangeslittlefromoneproductioncampaigntoanothermostofthe
changesoccurindownstreamrecovery,wheredifferentfiltration,chromatographicorotherprocessesmightbeusedtorecoverthe
antibodies,accordingtoautomationsupervisorsMahastiKheradmandandJohnOConnell.
Bothnotethatsuchaprojectposesgreatchallenges.Forexample,whenaparticularprocesschangeisconsideredforanewproduct,the
masterrecipesofmanyoftheotherproductsmustalsobechanged.However,theynote,havingtheplantautomationsystemsorganized
aroundS88standardscanspeedupthechangeoverfromonetypeofproductiontoanother.
Futuresteps
WorkonS88isnearingcompletioneffortsnowfocusoncommunicationprotocols,andwithbuildingoutadditionallibrarymodels.Meanwhile,
S88ssuccessinbatchmanufacturinghasmadeitamodelforS95.Parts1and2ofthatstandardhavebeenapprovedPart3couldmeet
ISAmembershipapprovalinthenextyear.
Part3definesapreferredmethodofdataexchange,knownbytheacronymB2MML(businesstomanufacturingmarkuplanguageaccess
attachedPDFonthisbyclickingthe"DownloadNow"buttonattheendofthisarticle).Thegoalistoprovideawaytoallowdifferentsystems
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(anMES,oranenterpriseinformationsystem,forexample)tocommunicateviaacommonstructure.IfitisbroadlyadoptedbyITvendors
andpharmacompanyclients,itwillprovideawayforthesesystemstocommunicatewithouttheneedforcustomwritteninterfaces.
Meanwhile,theS88modelisalsosettingthepatternforanothercontrolandcommunicationeffort,PackML,forvendorsandusersof
packagingmachinery.Eventhoughpackaginginvolvesdiscreteratherthanbatchcontrols,developersofautomationsystemsforpackaging
havefoundsignificantvalueintheS88model.
PackMLisasubteamoftheOMACPackagingWorkingGroup,whichinturnispartofabroadstandardizationeffort,OpenModular
ArchitectureControls(www.omac.org).IftheS88modelcanbemappedtoOMACsPackMLStateModel,thisbatchsoftwarecouldbe
extendedintopackaging,sayscommitteechairFredMarkham.Sincesomuchofpharmaceuticalproductionwindsupgoingthroughsome
typeofpackagingmachine,thiscouldbeaveryconvenientextensionofS88inpharmaceuticalproduction.
Atlastspring'sWorldBatchForummeeting,representativesofWBFandOMACdecidedtocreateajointworkinggroup,"Process2Packing,"
andtoaimfordevelopingadraftstandardcombiningtheirinterestsby2006.ThedraftwillthenbesubmittedforANSI/ISAapproval,andIEC
approvalby2008.Thejointgroupwillholdmonthlyteleconferences,andscheduleperiodicmeetingstowardthisgoalindustryparticipationis
invited.

The 411 on S88


Historically,batchprocessinghassufferedfromawidedivergenceinhowcontrolengineersdealtwiththeirtasks.Designingacontrol
systemforabatchprocesscouldrangefromscribblinginstructionsonasheetofpapertoletanoperatorknowwhichstatuslightstowatch,
toimplementingelaboratecontrolprocessesoftenrunbyprogrammablelogiccontrollers.Batchautomationsystemsfromcontrolvendors
cantiethesedisparateelementstogether,buttherealityhasalwaysbeenthatother,separateprocessunitshadtobetiedtothebatch
systeminsomefashion.
Thebatchautomationmovement,ifthattermcanbeused,aimedtosetsomestandards.ItkickedoffwiththeformationoftheWorld
BatchForum(www.wbf.orgPhoenix,Ariz.)intheearly1990s.Theforumbroughttogethercontrolengineersinbatchintensiveindustries,
equipmentvendors,andsoftwaredeveloperswhowereexploitingthenewcapabilitiesofPCbasedcontrol.Membersbeganamultiyear
efforttoestablishanewstandard,nowknownasANSI/ISAS88(andIEC615121intheinternationalarena).MuchofForumsworkwasto
defineacommonlanguageconceptsthatmeantthesamethingfromprojecttoproject,orcontrolsystemtocontrolsystem.
S88requirestheuseofobjectorientedprogrammingtoconceptualizebatchcontrol,andspecifiesthattherecipebeseparatedfromthe
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processunitorcontrolsystemwherethatrecipewouldbeexecuted.Itthenshowshowtodothisinsuchawaythatthesamerecipecould
berunondifferentprocessunits,aslongasthoseprocessunitshadcomparableprocessingcapabilities.Thereusabilityalsomeansthat
oncealibraryofprocessandrecipemodelswasdefined,writingtheactualcontrolcodecouldproceedrapidlyfromthosegenericmodels.
Althoughtherearenumeroussubclassifications,thebasicelementsofS88areasfollows:
aphysicalmodelofamanufacturingprocess,whichisadescriptionofwhattheprocessdoes,andwhatitscapabilitiesare.
arecipe,whichdescribestheformula(thephysicalingredientsofabatch)andwhatactionsaretobetakeninwhatorder.Therecipeis
writtenasaproceduralmodel,whichcanbesubdividedintounitprocedures,theunitproceduresintooperations,andtheoperations
intophases.
theequipmentlogic,whichisthedescriptionofhowtheprocedureisimplemented.
Byproceedinginastepbystepmanner,sothateachstepisdefinedbeforethenextonebegins,thecontrolengineerthenhasarelatively
easiertaskofwritingthecontrolcodethatmatchestheequipmentlogicwiththedesiredphasesoftheprocedure.
Whendoneright,thesestepsallowthesameproceduralmodeltobeappliedtodifferentequipment(i.e.,thesameendproductbeing
manufacturedattwodissimilarsites),andthesameequipmentlogictobeusedforotherunits,savingdesignandspecificationtime.Other
definitions,suchasprocesscellorprocessmodel,describethefinishedcombinationofprocedureandequipmentinsomecases,these
canbereusedorduplicatedaswell.
ThesimplicityandefficiencyofS88modelswasaninfluenceonthedevelopmentofS95,EnterpriseControlSystemIntegration.This
standardisastronginfluenceonhowmanufacturingexecutionsystems(MESs)aredesignedandoperated,sincetheMESisthegateway
throughwhichinformationaboutproductdemand,oringredientinventories,filtersthroughtotheproductionfloor.
MESandenterpriseinformationsystemsdealwithanevenmorediverseandheterogeneousenvironmentthantheproductionfloor.The
modelsofmanufacturingprocesses,andthedistinctionsbetweenwhatbusinessgoalsaretobeaccomplished,andhowtheywillbe
accomplished,arecorrespondinglymorevaluable.

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