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

Unrestricted / © Siemens AG 2017 All Rights Reserved.

Andrew Whytock

Global Business Development, Life SciencesPharma Business Support for UK & Ireland

MES & Digitalization

Vertical Pharma Competence CenterKarlsruhe, Germany

[email protected]

An introduction

Frank Faurholt

Sales DirectorAutomation & Industrial Communication

Digitalization

Siemens A/[email protected]


Digitalizationchanges

everything

Unrestricted / © Siemens AG 2017. All Rights Reserved.


New business models in the Internet age

From record storeto streaming

From taxito ride-sharing

From yellow pagesto marketplace

From bookstoreto e-book


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


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


The Digital Enterprise / The Digital Plant


Integrating and digitalizing the entire value chainis key to staying competitive in the future


Creating a Digital Twin of the entire value chainIntegrating and digitalizing the entire value chainis key to staying competitive in the future


The Digital Twin in detailIntegrating technical domains into ONE data model

Digital Twin of theproduct

Digital Twin of theproduction process

Digital Twin of theequipment


Publishing the optimized Digital Twin to all stakeholders,including suppliers, with the collaboration platform


Smarter products andexperiences are changing thePharma Industry too…


"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


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


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


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 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


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)

https://workspace.automation.siemens.com/content/10003424/Image%20Database/SIE_130625_0763-2_sRGB.JPG


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(*)


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


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


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


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


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


Realization of the Digital Enterprisethrough Integrated Engineering and Integrated Operations

Integrated Engineering optimizes engineering and lifecycle management …

Integrated Operationsimproves productivityand flexibility


www.siemens.com/digitalizationwww.siemens.com/digital-enterprisehttp://www.siemens.com/global/en/home/company/topic-areas/digital-plant.htmlwww.siemens.com/pharmawww.siemens.com/mindsphere

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digital solutions for the life sciences industry - ispe · digital solutions for the life sciences...

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