【横河电机株式会社】2024智能制造评估引领制药制造商迈向智能工厂的数字化转型之路白皮书

YOKOGAWA

Co-nnovatingtomorrowTM

SMARTMANUFACTURINGAssessment

GuidingPharmaceuticalManufacturersinthe

DigitalTransformationJourneyTowardsSmartFactory

Bulletin80A0108-01EN

FutureofPharmaceuticalmanufacturers

Environment

Theworldisrapidlyandcontinuouslychanging,andpharmaceuticalmanufacturersfacenew

Developmentsinbiotechnology

Newinfectiousdiseasethreats

Demographicchanges

issueseveryday.Theindustryhasamissionofachievingpersonalwell-beingwhilerespondingtoanever-changingenvironmenttodeliver

Universalization

ofadvanced

pharmaceuticals

Acceleratingdevelopment

Increaseddemandforpharmaceuticals

safeandsecuremedicinestosociety,butitisbecomingincreasinglychallenging.

Demandforpharmaceuticalsissteadily

increasingasglobalpopulationgrowsand

developedcountriesage.Thereisincreasingpressurefromthenationalgovernmentsto

holddowndrugpricesandkeepmedicalcostsdowninordertoreducethegovernment’s

IndustryKSF

socialsecurityburden.Atthesametime,theindustrymustrespondtostricterregulationsandhigherqualityassurancelevels.

Cost-optimizedproduction

Newproduction

(Responsetonewmodalities)

Reduceddevelopmentleadtime

Inadditiontoconventionalsmallmolecules,avarietyofnewmodalities,suchasantibodydrugs,nucleicacidandpeptidedrugs,andcelltherapy,willbeputintopracticaluseatan

acceleratedpace.

Tobesuccessfulinthisenvironment,companiesmustemploynewtechnologiessuchasAI

andITtocontinuouslydrivebusinesswhile

navigatingtheseknownorsuddenchallenges.

SMARTMANUFACTURINGAssessment2

AcceleratingDXinPharmaceuticalManufacturing

Forpharmamanufacturers,meetingcost,productivity,andstablesupplyisessential,butatthesametime,ensuringthequality,safety,andefficacyofmedicine.

TherealizationoftheseseeminglyconflictinggoalsisembodiedintheconceptofPharma4.0,aroadmapdevelopedbyISPEforthepharmaindustrytointroduceIndustry4.0,wheretheuseofITtechnology

becomesindispensable.

Althoughtherehavebeenchallengesinthepast,theevolutionofITtechnologyhasnow

madenewsolutionspossible.DXentailsashiftfromconventionalmethods,andduringthisprocess,itiscrucialtobalanceinnovationwithcompliancewithexistingregulations.

MovingPharmaceuticalManufacturingtoPharma4.0andBeyond

AchievingPharma4.0willestablishmanufacturingcapabilitiesthatcatertodiverse

modalitieswhileensuringthequality,safety,andefficacyofmedicine.Thiswillmake

thesepharmaceuticals,whicharecurrentlychallengingtomass-produceandcostly,moreaccessibletoalargerpopulation.

Torealizethis,itiscrucialtoadvancedigitalizationincompliancewithpharmaceutical

regulatoryrequirementsandintegrateequipmentwithvariousprotocolsintoonesystem.Designingsystemconnectionsisessential,requiringathoroughunderstandingof

productionprocesses,facilities,andthelocationofrelevantinformation.

Attemptingtoachievethisinoneleapischallenging,soaphasedapproachwithacarefullydevisedroadmapisnecessarytosteadilyprogresstowardsimplementationwhilealigningwithvariousnationalregulatoryrequirementsandguidelinessuchasPIC/SandICH.

SMARTMANUFACTURINGAssessment3

DigitaltransformationinPharmaceuticalindustry

SourceIndustrialTransformation

Figure1showsthestudydonebyInternationalCentreforIndustrialTransformationtodemonstratethedigitalmaturitylevelsof12

manufacturingindustrygroups.

Theverticalaxis(S.I.R.IMaturity)showshowcompanieswithinanindustry

sectorhavebeencollectivelyadvancedindigitaltransformationascomparedtoothersectors.Ahigherrankingindicatesthattheindustryislikelytobe

furtheraheadandmorematureinitsindustrialtransformationjourney.Thehorizontalaxis(S.I.R.IVariance)showsthedegreeofdispersionamongdigitalmaturitylevelsofcompanieswithinagivenindustrysector.Thelowerthe

S.I.R.IVariance,themoreuniformthepaceofindustrialtransformationinthesector.

Pharmamanufacturingindustryhasmanypotentialareastoimproveandestablishthemselvesasleadersinthedigitaleconomy.

Therearevariationsinthedegreeofdigitaltransformation(DX)withinthe

industry.Thepotentialforawideninggapinthefutureexistsbetweenthosewhoareprogressingandthosewhoarenot.ItwouldbeessentialtoconsiderstartingearlywithDXinitiativestosecureastrongpositionwithinthe

industryandadapttofuturetrends.

SMARTMANUFACTURINGAssessment4

YokogawaSmartManufacturing(SM)Assessmentandvalue-ledIndustry4.0implementation

Didyouknowthatonly30%ofdigitaltransformationissuccessful*?Akeydeterminantofsuccessiseffectiveprogressmonitoring

towarddefinedoutcomes.EffectivetrackingstartswithhavingaclearvisionandaroadmapofyourDigitalTransformation(DX)

journey,includingmilestones.

YokogawawilltakeyouthroughasystematicmethodologytofindyourwayinDigitalTransformationwithYokogawaSmart

Manufacturing(SM)Assessment.ItbuildsontheprinciplesoftheSmartIndustryReadinessIndex(S.I.R.I.)-aglobalmeasurefor

Industry4.0transformationmaturitydevelopedbytheSingaporeEconomicDevelopmentBoard(EDB).

*Source:BCGanalysis,2020

03

FunctionalAreaAssessment&IT/OTConvergence

02

DigitalMaturityAssessment

Drilldowntoreviewandidentify

DigitalPriorityAssessment

01

Gapanalysisandcomparisonto

improvementareasofkeyfunctionalareasandIT/OToperatingmodel.

Identifybiggestimpactareaswithbestfinancialreturnthatmeetsthebusinessgoals.

industrypeerswithdevelopmentofDXroadmap.

SMARTMANUFACTURINGAssessment5

01DigitalPriorityAssessment

TIER:AHolisticFrameworkforPrioritization

Whereshouldyoufocusyourdigitalizationeffortsandinvestmenton?

Digitaltransformationisnotaone-sizefitsall

solution.Theprioritiesforaregionalmid-size

manufacturersdiffersfromalargerscaleglobal

manufacturerwithmorediversifiedproductlines–forexampleprocessefficiencyfortheformerversusenergymanagementforthelatter.

Foracompanytoseearealbusinessimpactfromtheirdigitaltransformation,itneedstoidentifyandprioritizethefocusareasthatgeneratethegreatestvalueforthecompany.

YokogawaguidescompaniesthroughasystematicprioritizationapproachbasedontheTIERframeworkwiththeobjectiveof:

1.Understandingshort-termfocus(costdriversandkeychallenges)and

2.Aligningwithlong-termgoals(businesstargets).

T

TODAY’SSTATE

Developanin-depth

understandingof

thecompany’s

currentIndustry4.0

maturitylevel

.$

IMPACTTO

BOTTOMLINE

Analysehowdistinct

Industry4.0areasaffect

profitsandidentifythose

thatcangeneratethe

greatestfinancialreturn

E

ESSENTIALBUSINESSOBJECTIVES

Determinethemost

criticalbusiness

objectivestoguidethe

selectionofrelevant

Industry4.0areas

R

REFERENCESTOTHE

BROADERCOMMUNITY

Emulatethesuccessesof

thebroadermanufacturing

community,andlearnfrom

theirmistakesaswell

TIERprovidesaquantitativemethodologytoenableanpharmaceuticalmanufacturertoobjectively

identifyfocusareasaroundthesefourprinciples.

T:AssessmentMatrixScoreI:CostProfile

E:KeyPerformanceIndicators

R:Best-in-ClassBenchmark

Source：InternationalCentreforIndustrialTransformation(INCIT)

Figure

SMARTMANUFACTURINGAssessment6

02DigitalMaturityAssessment

ManufacturingSectorComparison

◀16dimensions

Source：InternationalCentreforIndustrialTransformation

Figure3

OneofthekeyquestionsthatcompaniesaskYokogawaconsultantsis“wheretostartourDX”?TheSmartIndustryReadinessIndex(S.I.R.I.)breaksdowntheabstractconceptinto16dimensionsmakingiteasierforcompaniestounderstand,visualize,andcontextualizetheirdigitalmaturity.

Source：InternationalCentreforIndustrialTransformation

S.I.R.I.isadigitalmaturityassessmentframeworkdevelopedbytheSingaporeEconomicDevelopmentBoard(EDB)toassessandguidecompaniesintheirdigitaltransformationjourneywithinthemanufacturingand

Figure4

relatedsectors.Itisdesignedtohelporganizationsevaluatetheirreadinessandidentifyareasforimprovementinadoptingadvancedtechnologiesand“Pharma4.0”.

Yokogawa'sCertifiedS.I.R.I.Assessors(CSAs)willevaluateacompany'sthreebuildingblocks–Process,Technology,andOrganization–whiletappingintodecadesofexperienceworkingwithpharmaceuticalmanufacturerstoachievefactoryefficiencythroughourmeasurement,control,informationtechnologies,andinformationtechnology(IT)andoperationaltechnology(OT)systemsconvergencecapabilities.

First,thecurrentdigitalmaturitylevelisassessedbasedon16dimensionsintheSmartIndustryReadinessIndex(Figure3).ThenwiththeManufacturingSectorComparison(Figure4),comparethecurrentstateofdigitalreadinesswiththeindustrypeersandprocessindustriestoidentifygapstobeaddressedtoachieveacompany'sIndustry4.0goals.

YokogawaanalyzeshowdistinctDXareasaffectthecompany'sprofitsandidentifiesthosethatcangeneratethegreatestfinancialreturn.ThisanalysisisusedtodevelopacustomizedDXroadmapwithshort-termwinsandlong-termgoals.

SMARTMANUFACTURINGAssessment7

03

Roadmap

Developa

Basedonthebusinessgoal,currentstateofdigitalmaturitylevelandthegapanalysis,YokogawaCSAswillidentifythepriorityareasfor

improvementswithourcustomers.Asaleadingautomationcompanywithabroadrangeofdigitalenterprisesolutions/products,ourexpertisewithyearsofexperienceinpharmaceuticalmanufacturingindustrywilldevelopaPhase-wiseDigitalTransformationRoadmapthatisbestfitto

achievecustomers'businessgoal.

Wesupportourcustomersintheireffortstosolvechallengesandrealizetheirgoals.

EnterpriseResourcePlanning

MainpackagedproductsthatbuildupYokogawa'stotalsolutions

MicrosoftDynamics365Finance&SCM

Productionmanagement

Productionmanagementpackageforpharmaceuticalindustry“PIMS”

Productionscheduling

FLEXSCHE

Qualitycontrol

LaboratoryinformationmanagementsystemforpharmaceuticalindustryOpreXLIMS

Environmentalmonitoring

EnvironmentalmonitoringsystemOpreXEMS

Equipmentmaintenanceandmanagement

ComputerizedmaintenancemanagementsystemeServ

Processdatabase

PlatformforAdvancedControlandEstimation

Real-timeplantinformationmanagementpackagePISystem

PlantinformationmanagementsystemExaquantum

Proceduralautomation

OperationefficiencyimprovementpackageExapilot

Productionprocessmonitoringandcontrol

CENTUMVP

CollaborativeinformationserverCIServer

VisiblestructurebatchsystemVizBatch

Fieldinstruments

After-salesservicebusinesssupport

After-salesserviceenterpriseresourceplanningsystemServAir

Integratedinformationmanagementsystem

Multifunctionelectroniclabnotebook,OpreXInformaticsManager

Others

FlowimagingmicroscopyFlowCam

DigitaltwinforcellcultureprocessesInsilicoDigitalTwinFactory

Biologicalcontaminationmanagement*Underdevelopment

SmartManufacturingAssessment

SMARTMANUFACTURINGAssessment8

Customervoice

YokogawahasbeenofferingSMARTMANUFACTURINGAssessmentstodiverseindustriesworldwide,employingthestructuredthree-stepprocess.Thisinitiativecontributestotheglobaldigitaltransformation,fosteringthecreationofmorevalueforsocieties.

“

Yokogawahadbeenanimportantandvaluablepartnerinourjourneytodigitalization.The

workshopandsolutionsprovidedwererelevant

”

andanenablingfactorforourstepstowardIndustry4.0.

“

Implementingsmartmanufacturingatproductionsitesisanimportantsteptoimproveprecision

andproductivitysothatwecandelivertherightqualityproductstoourcustomersontime.Itisalongjourneyforus,andwecan’tsucceedinthis

journeywithoutthesupportofYokogawa.”

SMARTMANUFACTURINGAssessment9

YokogawaisyourtrustedpartnerforyourDXjourney

✓Yearsofexperiencewithpharmaceuticalmanufacturers

Basedonourexperienceinimplementingmorethan1,000systemsforAPIs,drugformulations,andbiotechnology,Yokogawasupportsallphasesfromconceptionto

implementationofatotalsystem.

$

Alignwithcorporategoalsandstrategy

✓CertifiedS.I.R.I.assessors

Ourtrainedassessorsprovideservicesacross

variousgeographicalregionstohelptosharetheconceptsandbenefitsofdigitaltransformationwithmanufacturersinternationally.

Assess

readiness

Maturitymodel

Breakorganizationalsilostocollaborate

organizeprocessesaroundcustomers

Identify

quickwinsand

estimatebenefits

Buildatechnologyfoundation

organizetechnologyarounddata

✓Digitalsavvy

Wehaveabroadrangeportfolioofdigital

enterprisesolutionswithIT/OTconvergence.

✓Aleadingautomationcompany

Weareagloballyleadingindustrialautomationcompanythatsupportsmanufacturersworldwideinthedigitalizationoftheirproductionfacilities.AutomationisinourDNA.

SMARTMANUFACTURINGAssessment10

WhatYokogawaforeseesasthetransitiontowardsfutureofmanufacturing

Asystemofsystems(SoS)isoneinwhicheachcomponentisintricatelyconnected,andeachistreatedasasystem.Thecomponentsystemsworktogetherwhilemaintainingoperationalandmanagementindependence,andrealizingobjectivesasawholesystemthatcannotberealizedalone.Yokogawa

believesthatSoScanberealizedthroughthematurationoftwoelements–IA2IAandSmartManufacturing.

IndustrialAutomationtoIndustrialAutonomy(IA2IA)

Symbioticautonomy

Autonomous

operations

Automateddecision-making

throughAIenablesoptimal

productionacrossmultiple

linesanddifferentitems.

Movingfromautomationtoautonomyofoperations.Thedegreetowhichvariousproductionfacilities,companies,andentireindustriesoperateautonomouslyis

Autonomous

directlyrelatedtotheprogressofdataintegrationandAIlearningfunctions.

orchestration

Overallproductionautonomy

Semi-autonomous

andoptimalproductionfor

TheuseofAIenablespartial

eachitemarerealizedaccording

automaticparameteradjustments,

toproductionplansand

makingmanufacturingpartially

shippingoperations.

Automated

Processesareautomatedaccordingtopredefinedlogic,andthecoordinationofpre-andpost-workisautomated.

autonomous.Asystemfor

predictingandpreventing

frequentproblemsisestablished.

Semi-automated

Individualoperationsineach

processareautomated.

IA2IA

SmartManufacturing

Supplychain

Consistentinformationthatencompasses

thesupplychainbeyondproduction

reduceslossesandshortensleadtimes.

Societyasawhole

Solvingsocialissuesthrough

collaborationacrossindustries

andregions.

Inacompany

Theentireproductionprocess,including

qualitycontrolisoptimizedfroma

company-widemanagementperspective.

In-plant

Bothqualityimprovementsandcostreductions

areachievedwhileincreasingmanufacturing

efficiencyinplants.

SmartManufacturing

Expandingthescopeofcontrol.

Smartmanufacturingshouldbeginwiththecontrolofproductionfacilitiessuchasplantsthenexpandtohigher-levelsystems.

Theentirecompanyshouldbeoptimize