Digital Solutions for the Life Sciences Industry - ISPE · Digital Solutions for the Life Sciences...
Transcript of Digital Solutions for the Life Sciences Industry - ISPE · Digital Solutions for the Life Sciences...
Digital Solutions for the LifeSciences IndustryThe connected product and manufacturing concept
Realize innovation.Unrestricted © Siemens AG 2017
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Andrew Whytock
Global Business Development, Life SciencesPharma Business Support for UK & Ireland
MES & Digitalization
Vertical Pharma Competence CenterKarlsruhe, Germany
An introduction
Frank Faurholt
Sales DirectorAutomation & Industrial Communication
Digitalization
Siemens A/[email protected]
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Digitalizationchanges
everything
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New business models in the Internet age
From record storeto streaming
From taxito ride-sharing
From yellow pagesto marketplace
From bookstoreto e-book
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The Digital (r)Evolution
Water & SteamElectrification
Automation
Digitalization
Digitalizationis still beingdefined…
4th Industrial(r)Evolution3rd Industrial
Revolution2nd IndustrialRevolution1st Industrial
Revolution
Siemens has been at the forefront since the beginning of the Industrial Revolution
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The (same old) business drivers
Reducingthe time tomarket
• Individualization: highproduct variety, smallcampaigns
• Seasonal demand
Enhancingflexibility
• Energy efficiency andresource efficiencyas key competitivefactors
Increasingefficiency
IncreasingQuality
• Closed loop qualityprocesses
• Traceability andintegrated genealogy
• Shorterinnovation cycles
• More complex products• Wider product portfolios
Product and productionintegrated
Flexibleproduction
Full processtransparency
Optimizedproduction resources
Security
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Integrating and digitalizing the entire value chainis key to staying competitive in the future
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Creating a Digital Twin of the entire value chainIntegrating and digitalizing the entire value chainis key to staying competitive in the future
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The Digital Twin in detailIntegrating technical domains into ONE data model
Digital Twin of theproduct
Digital Twin of theproduction process
Digital Twin of theequipment
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Publishing the optimized Digital Twin to all stakeholders,including suppliers, with the collaboration platform
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Smarter products andexperiences are changing thePharma Industry too…
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"Every time you talk to Siri, or use GoogleMaps, you are using a form of artificial
intelligence. The same technology could beused in many healthcare applications, such
as analyzing cancer patient data andrecommending more effective treatments,”
Google Ventures President, Bill Maris
ArtificialIntelligence
Understandingof the brain
ReinventingAntibiotics Battling Cancer
Gene editing &gene therapies Microbiome Organ
regenerationStem cellresearch
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Pharmaceutical plant of the futureIncreasing flexibility, faster market readiness and improved productivity
• From idea to production• Continuous Manufacturing• Smart Modular Standards
Time tomarket
• Right first time production• Data integrity• Data consistency
Quality /Regulations
• Personalized medicine• Data integrity from lab to
patient
Flexibility • Operational excellence• Resources• International collaboration
Efficiency
Engineering &Commissioning Operation ServicesProduct
designProcess &Plant design
Integrated EngineeringIntegrated Operations
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Use Simulation to achieveforesight in the Virtual World
Summary – The Vision Comes to LifeKey Advantages of Digitalization
Use Big DataAnalytics to gaininsight and drive
continuousimprovement
Drive intra-company and
suppliercollaboration viadata integration
Productionengineering
Productionexecution
Services3 4 5Productdesign
Process &plant design1 2
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Innovative concepts to support digitalization initiatives inthe pharmaceutical industry
PLM for vaccines production Manufacturing of the Future Integrated secondary lines
Paperless Production Continuous Production
Personalized Medicines
Integrated Engineering Flexible Bio Production
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Innovative concepts to support digitalization initiatives inthe pharmaceutical industry
PLM for vaccines production Manufacturing of the Future Integrated secondary lines
Paperless Production Continuous Production
Personalized Medicines
Integrated Engineering Flexible Bio Production
Innovative ManufacturingConcepts for Life
Sciences
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PAT enabled CENTRALCONTROL SYSTEM:
• SIMATIC SIPAT
• SIMATIC PCS 7
RawMaterial 1
RawMaterial 2
RawMaterial 3
RawMaterial 4
Lubricant
Endproduct
Coatingsolution Coating pan
Tablet pressSort gate
Reject
NIRBlender
Mill
Volumetric feeder
Gravimetric feeder
Hopper with load cell
Sieve
Platform scale
Continuous Oral Solid Dosage (OSD) line with direct compression isleading reference for continuous manufacturing at Janssen
Initial situation Actual status
Value Proposition• Realize continuous quality
verification• Enable real time product release• Shorten time to market for existing
products• Right first time production• Smaller footprint and reduced waste
Use Case à Real Time Product Release: J&J, Puerto Rico
Challenges• Continuous manufacturing
for the first time• Coordination of assembled
unit operations into continuoussetup
• Material tracking to link inputmaterials to end products
Janssen’s leading reference for continuous manufacturing:Continuous solid dosage manufacturing area(Janssen, Puerto Rico)
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Innovation Project at Siemens Austria (CT)
Initial situation Actual status
Value Proposition
Use Case à Siemens Corporate Technology Lab Showcase for Biotechnological Processes
Challenges• Modular Equipment• Parallelization and Multiplexing of
Sensors• Inline and Online Measurement• Real-time Monitoring and Analysis• Advanced Process Control
1 large scale fermentor… 1 million doses
1,000 small scale fermentors,each producing 1,000 doses… 1 million doses
• Improved Production Processes Know-How• Embedding into Plant Environment• Smooth Interplay and Connection on all Manufacturing
Layers• Integration into complete Manufacturing LifeCycle:• From Suppliers & Materials to Production to Logistics
• Broad Range of ProcessOrganisms
• High Variability of ProcessDesigns
• High Flexibility in ProcessExecutions
Included:- COMOS- SIMATIC PCS7- SIMATIC IT eBR- SIMATIC SIPAT- SIMIT- RAPIDLab(*)
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Paperless manufacturing based on SIMATIC IT eBRreduces cycle time and discards and ensures 99% right at first time
Initial situation Offering: Improved compliance
Value Proposition• Enhanced quota of
“right at first time”• Increased manufacturing flexibility• Reduced discards
• Improved compliance andtraceability
Use Case à Paperless Manufacturing: Baxter Healthcare, Ireland
Challenges• Products need to be
manufactured right first time– no remanufacturing possible
• Verification at the point of entryand review by exception
• Reengineer the recording andreview process
Customer Benefits• Right First Time (RFT) ratio: > 99%• Production schedule: reduced to 30 min• Batch-release cycle time: from days to hours• Improved compliance• Large savings due to reduced discards
Baxter Healthcare, Ireland:
• Intravenous (IV) solutions andadministration sets, premixeddrugs and drug reconstitutionsystems
• First site in a multi-site rolloutacross Europe and US
ShippingRelease byExceptionLabellingPacking
Removalfrom Trucks
SteamSterilization
Placement onTrucks
Pouching
MicroLaboratory
ChemistryLaboratory
FillingWeighing &Dispense
Water forInjection
SolutionManufacture
Covered by eBR
Assembly &Printing
Not covered by eBR
Project Scope• In production since 2007• 800 trained users• 54 000 tasks per day• 150 concurrent users
Simatic IT eBR• Weigh and Dispense• Work Instructions• Electronic Batch Record• Quality Control• Review by Exception
eBR: Electronic Batch Recoding
Source: Baxter
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Five key steps towards an integrated MES and AutomationReducing cost and risk during engineering, review and operations
StandardizedS88 model for
Automatedand ManualOperations
IntegratedRecipe
IntegratedRecipe
IntegratedHMI
IntegratedHMI
IntegratedWorkflowIntegratedWorkflow
IntegratedDeviations
IntegratedDeviations
Less cost,less riskduring
engineering& config
Less cost,less riskduring
operations& review
IntegratedAppendices
IntegratedAppendices
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Siemens has different tools that allow manufacturers to simulate product,process and production flow
Product and Material Simulation
• Accurately predict effects ofdesign changes
• Earlier in the design phases• Simulate complex designs
with complex physics in real-world environment
• More timely and affordable thanphysical prototyping and testing
• Common plant model andintegration
Process and Equipment Flow
Virtual Process CommissioningTest the original automationsoftware using a simulation model
Operator training (OTS):Train the interaction with theoriginal automation software bythe use of a simulation model
Product and Production Flow
Virtual Plant SimulationSimulation of entire secondaryproduction plant
…to discover betterdesigns, faster.
…. to ensure efficient productionand cope with increasedcomplexity plants.
Processdevices
Processunits
Bus.process
Process
Engineering Operations
Fielddevices
Buscomms Signals
SIMIT
Tecnomatix
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Proof of Concept for the Factory of the Future – Continuous Tableting
Pharmaceutical future factory - The Art of the Possible
• Novel technologies in existing and new IT systems
• Process robustness and visibility of process data
• Continuous tableting process
ü User centered design and operation
ü Demonstrate innovative and immersive operator experience
ü Siemens automation as a cornerstone to a real industrial context
ü Technology incubation and deployment
ü Optimized operations and visibility
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Paperless manufacturing helps to create a digital plantfor personalized immunotherapies
Paperless manufacturing helps to create a digital plantfor personalized immunotherapies
• Central access point for data
• Avoid manual data transfer
• Enable fast scale up
• Eliminate paper-based batch reports and release by exception
• Provide intelligent guidance and planning throughout the process
ü Considerable reduction in manufacturing cost
ü Approaching individualized mass production
ü Higher throughput without compromise on quality“We are pleased to partner with Siemens on automatinga specialized, proprietary manufacturing process fortruly personalized medicine.” Ugur Sahin, CEO BioNTtech
Business
Systems
AdvancedScheduling
Labo
rato
ryM
anag
emen
t
AutomationSystem
ManufacturingSystem
Central access point:All process and
quality data
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Realization of the Digital Enterprisethrough Integrated Engineering and Integrated Operations
Integrated Engineering optimizes engineering and lifecycle management …
Integrated Operationsimproves productivityand flexibility