【橫河電機株式會社】2024智能制造評估引領制藥制造商邁向智能工廠的數(shù)字化轉(zhuǎn)型之路白皮書

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