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SmartMES
An OEM Solution for Manufacturing Execution for a Single Use Bioprocess
Structure1. Introduction2. Industry Trends3. SmartMES4. Benefits and Taking Advantage of SmartMES5. Deployment Considerations6. Customer Example
Headquarters in St. Louis, Missouri USA
Diversified global manufacturer and technology provider
Approximately 115,000 employees worldwide
Manufacturing and/or sales presence
in more than
150 countries
220manufacturing
locationsaround the world
No. 121 on 2014 FORTUNE 500 list of America’s largest
corporations
Founded
in 1890NYSE: EMR
US $24.5 Billion in Sales
Emerson
Measure & Analyze
The broadest range of measurement and analytical technologies for process clarity and insight.
Operate & Manage
The systems and tools that provide the decision integrity to run your operation at its full potential.
Final Control & Regulate
Highly reliable final control technologies to help you regulate and isolate your process with certainty.
Solve & Support
Expertise and global resources to help you dependably define, execute and support a strategy throughout the lifecycle of your operation.Rosemount
Micro MotionDeltaVSyncade
FisherBettis
Taking on the industry’s toughest challenges, and bringing predictable success any time, any place.
DanielRoxar
AMS Suite
Emerson Process Management
ISA-S95
Manufacturing Operations Activities of a manufacturing facility that coordinate the resources in the conversion of raw materials into products.
The Life Science Industry
More Technology
Retiring Workforce
Complex Processes
Fewer Incoming Workers
Fewer Specialists
New Markets
Batch Records
Traditional MES Project
Plan Design Implement Execute
Project ManagementProject ManagementExamples:
GreenfieldBrownfield
BioAPIOSDFill/FinishR&DPD
MES for SmartFactory Market
Single Source Supply for the Entire Bioprocess
Market Opportunity to Support Smaller Biotech Companies
– Less resources– Need faster time to market– Release by exception– Electronic batch record
MES for Single Use Bioprocess
MES
Automation
Industry
...
Process
Humanus
Challenges
How to Build MES Recipe For an Unknown Product:– Bill of materials are unknown– Bill of Equipment are unknown– Process parameters are unknown– Required samples are unknown– Instructions to the users are unknown
Single Recipe Design– Make different products without having to change the MES recipe
Boundaries & IntegrationManaging Details of Operator InstructionDeploying an OEM MES Solution
How?A MES Recipe for Each UnitA Product Code for Each Produced MaterialMetadata for Each Product Code
– Bill of Materials
– Bill of Equipment
– Bill of Parameters
– Bill of Samples (Sample Plan)
– Text Resources
Bills are Editable Data Sets– End user substitutes data for non-virtual products
SmartMES Production Definition Management Environment
Configuration Tool Production Definition Object
21CFR Part 11Data Storage
Prod
uctio
n De
finiti
on M
anag
emen
t Com
pone
nts
Syncade Recipe Authoring (RA)
Syncade BOM Editor
Resource Text Tool
Resource Text Tool
Bill of Materials File
Bill of Equipment File
Bill of Parameters File
Syncade Document Control & Archiving
(DCA)Database
RA ServerDatabase
Resource Text ToolWork Instruction
Text
Resource Text ToolSample Plan
How? - BOM Editor
How? - Resource Text Tool
Edit and store recipe data parameters outside the recipe
Parameter data is called from the file into the recipe during Run Time
Recipe does not change when new product codes are created
Challenges – Boundaries & IntegrationRole of MES
– Record material usage– Record un-automated process parameters– Generate batch record– Minimize specification of detailed manual activities using recipe workflow
(depend on SOPs for this)Role of TruBio
– Control the process (Regulatory & batch)– Charge materials
Recipe Parameter Management– Defined in TruBio– Minimize recipe parameters passed between
Challenges – Boundaries & IntegrationBusiness Consideration
– SmartMES is offered as an option to SmartFactory– Need to minimize dependency of TruBio/TruPur & TruChome on Smart MES
Integration Philosophy– Strategy was for loose coupling of the system– Separate MES and automation recipes– Recipes coordinated via hand shaking with permissive defined as TruBio Unit
parameters.– Data passed between the systems using TruBio unit parameters– Unit parameters read/write between Syncade and DeltaV via OPC– Ability to call alarm data into the EBR
Challenge –Operator Instructions
SmartMES Needs to Direct Operators to Execute Manual Activities
– Different products will have different instructions– How can this be managed using a different recipe?
MES Workflow Wording Variability– Can be managed on product basis using the resource text tool
Procedural Variability– Can be managed with recipe parameters (example – the need for a pre-use
FIT)
Metadata Storage
Metadata Files are Managed in SmartMES
– Version controlled– Change request
process supported– Merged with the
control recipe at run time
Introducing SmartMES
Finesse Branded MES Solution for Single Use Bioprocess• Built on Emerson’s Syncade platform
Designed for use with SmartFactory• Flexible unit based recipes
• Single recipe produces several products
Pre-configured solution for single-use bioprocess
Decrease Deviations
Reduction in Inventory
and Storage
Overall increase in
Product Quality
More time for Process
Improvement
Reduction in Batch
Record review time
SmartMESTruBioTruPur
TruChrom
W. Edwards Deming
SmartMES – Knowing What to DoSmartFactory with SmartMES is Pre-validated skidded solution that is production ready and ERP capable1. Stop deviations before they occur2. Ensure correct resources are involved:
• People• Equipment• Equipment Status• Material• Documents• Work Instructions
3. Electronic Batch Record4. Implement release by exception
Decrease Deviations
Reduction in Inventory
and Storage
Overall increase in
Product Quality
More time for Process
Improvement
Reduction in Batch
Record review time
SmartMESTruBioTruPur
TruChrom
What is SmartMES?
Pre-Configured MES Solution • Recipes
• Equipment Model
• Security Model
• Training Management Model
SmartMES Pre-Configured Recipes
Thaw & InoculationSolutions (Media & Buffer)Bioreactor (Seed & Production)HarvestChromatography (Protein A, Cation Exchange, Anion Exchange)Viral InactivationViral FiltrationTangential Flow Filtration (UFDF)
Right First Time
Reduce Complexity
Embed Knowledge
Eliminate Unnecessary
Work
Security & Audit
Materials Management
Document Management• Recipes • Bach Records• Mfg. SOP’s
Training & Development
Weigh & Dispense
Manufacturing Portal (Partial)• Support Deployed Modules
Batch Workflow / Recipe Authoring
Procedure Workflow
Equipment Tracking Order Management (Partial)• Scheduling and running of batch• Batch Workflow
• Media Prep batch• Fermentation (Bioreactor)
Federated Search
Process Miner
Message Broker
Batch Production Records - EBR
Green = These modules are fully implemented and pre-configured to be used within the SmartMES offering.Gray = These modules are NOT implemented within the SmartMES offering and are NOT part of the SmartMES default or base system offerings.Blue = These modules are only partially implemented or pre-configured in the default or base SmartMES offering. The SmartMES Overview Specification describes what that module supports - "Out of the Box“.Red = These modules are included as the default offering within SmartMES licensing, but there is no pre-configuration.
SmartMES
SmartMESht
tp:/
/
User Data
Adjacent System
User Data
DV Integration
Web ServicesSyncade
SOA Platform
Internal Batch Reporting
Raw Batch Data
Message Broker (XML)
The preferred integration option(s).
A “custom or standardized Interface” to an any adjacent system: Unchanging set of tags, records ect...
External system interface which is out of scope.
External Batch Reporting
WMSWarehouse Management System
ERPEnterprise Resource Planning
BMSBuilding Management System
LIMSLaboratory information management system
Barcoding
Syncade Standard User http:// interface. TruBioTruPur
TruChrom
SmartMES Architecture
Benefits of SmartMES
• Reduces the Total Installed Cost of MES for Single Use Bio-Process
• Accelerated Deployment for GMP Manufacturing
• Reduces the Expertise Required to Deploy MES
• Enables Smaller Companies to Implement Electronic Batch Records
• Pre-configured Integration with TruBio
Single MES recipe for many different products
• Process Equipment, Automation, & MES from a Single Supplier
Deploying an OEM MES SolutionRequired Data Definition
– Material master data– Equipment instances– Inventory locations– Inventory receiving (On-site activity)– Recipe data configuration
Optional Data definition– Recipe customizations– Nomenclature & language customizations– Label customizations– Security model customizations
Taking Advantage of SmartMESRun Sheets are developed by end user
Example templates are provided
SmartMES makes assumptions where:– End users will develop run sheets for each product– Run sheets are stored in DCA– Recipe metadata file (text) are edited to reference owner
provided run sheet– SmartMES may be configured to reference SOP’s and/or
Run Sheet’s
Summary
SmartMES is the First MES System Pre-Configured for the Entire Bioprocess Train
– Reduce cost of deployment– Reduce calendar time for deployment
SmartMES Offers a Flexible Recipe Architecture to Allow a Single Recipe to be applied to Produce Many Different Products
SmartMES Makes MES Available to Small to Mid-Size Biotech CompaniesSmartMES is Provided by Finesse & Supported by Emerson Globally
Proprietary and Confidential © Finesse Solutions Inc., 2015
SmartFactory: SmartMES Example
Alvotech Production FacilityRejkjavik, Iceland (Q1 2016)
2 x 8,000L single-use/hybrid
Two bio-similar drug products
Four products in pipe-line
Full automation + MES
Full validation
Thank You for Attending!
Shawn OpatkaEmerson Process [email protected]
Questions?
Enjoy the rest of the conference.
