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JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
Manufacturing Execution Systems for Life Sciences
andPharmaceutical Industries
Solutions for Electronic Batch Records (eBR)
(Registro electrónico de procesos por lotes)
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
Process changeProcess change
Better process Better process understandingunderstandingTechnology Technology
changechangeIntegratedIntegrated
solutionsolution
Social changeSocial change
DemographicDemographic
LifestyleLifestyle
PatientsPatients
Economical pressureEconomical pressure
Competition Competition with genericswith generics
ManufacturingManufacturing
Supply ChainSupply Chain
Market changeMarket change
New therapiesNew therapies
Delivery formDelivery form
PersonalizePersonalize
Influences on Pharmaceutical Industries
Pharmaceutical Pharmaceutical IndustryIndustry
driven by;Quality
Cost
RegulationsRegulationsRules governing
Medicinal Products and defining the Quality
Initiative»
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
MES for Life Sciences: MissionEnsure excellence in execution excellence in execution for the Life Sciences
industry
Deliver the broadest range of functionality broadest range of functionality on the MES level that Life Sciences need
Help the customer to be one step ahead of current current regulatoryregulatory and manufacturing requirements
Provide a plattform compatible with the rest of the automation and PAT technology installed in the plant.
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
Production PlantsSuppliers
Distribution Centers
MarketMarket
Headquarters
Finished
Goods
Raw and Packaging Goods
Feedbacks from markets
Recalls
Quality perceived
Orders
New products requests
Raw material
purchase
Sales Orders
Production Orders
Product specification
Feedback from production
Logistic
Stocks
Production landscape
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMSAADECA ISPE
MES systemizes and integrates the manufacturing process, including standard operating procedures, control points and business events
Operation & Execution Level
MES – Manufacturing Execution System:
Integrated production data and integrated operationsUnifying People, Systems and Practice
Interoperating with systems at different level, with different pace
Business LevelSupply Chain Management
Enterprise Resource Planning
Customer Relationship Management
Control LevelPLC, SoftLogic,
SCADA DCS, Batch Motor, Drives, CNC
Fast operations: 1 second or less
Slow operations: 1 hour or moreEnterprise Resource Planning
Manufacturing Execution
System
Automation
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
Improve overall quality and regulatory compliance
Reduced waste and rework
Higher materials yield
Increased efficiency of production equipment
Improved OEE
Reduced work-in-progress
MES has significant benefits improving operational performance in the plant and yet has a role to play in strategic initiatives
" . . . If you install SAP for traditional ERP functionality, but do not link to your plants, you leave about 40 to 60% of the benefits on the table”
Udo Edelmann, Former SAP Global Director, Chemical Pharmaceutical Industries, Frankfurt
Interoperability with Enterprise, unlocking incremental ERP benefits
Plant Execution, systemizing the execution of production, ensuring compliance with regulations
KPI & Reporting, facilitating the collection, tracking and reporting of accurate and unified manufacturing performance data
MES is focused on improvements in process KPIs at the plant level:
MES unlocks further benefits at the enterprise level:
Traditional MES benefits
Productiondata
collection
Productionexecution
Productionresource
management
Productiondispatching
Productiontracking
Detailedproductionscheduling
Productdefinition
management
Level 2 Process Control
ProductionPerformance
analysis
ISA95 model
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
TEAMCENTERSIMATIC ITIntelligence SuiteSIMATIC IT
R&D Suite
Level 4Corporate Functions
Level 3Plant MES Functions
Enterprise Integration
SIMATIC IT Process Integration
Level 1-2Plant ControlLayer SIMATIC PCS7SIMATIC BATCH SIMATIC
WINCCSIMATIC S7
PLC SIPAT3rd Party
Elan‘s XFP Weigh & Dispense
ERP Systems
Elan‘s XFP Electronic BatchRecord
DetailedSchedulingGenealogy LIMS Maintenance
SIMATIC IT Option Pack
SIMATIC IT Historian
SPC OEE Warehouse
Siemens MES Portfolio for Life Sciences
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
© Siemens AG 2009. All Rights Reserved.
Video
“¿Qué es eBR?”
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
Es una funcionalidad fundamental de los sistemas MES que permite el control y análisis del proceso de producción,
proporcionando un registro electrónico que detalla que sucedió durante la producción
Beneficios de eBR
Reducción en los tiempos de ciclo
Mejora en la Precisión y consistencia
Reducción del costo de compliance
Mejora en la productividad
Reducción de costos
MBR Diseño (Master Batch Record)
Ejecución
Revisión
Recolección de datos, realiza controlesautomáticos y minimiza errores .
Modelado gráfico/optimización de procesos.
Alerta de validaciones seguras y rápidas, revisión por excepción
© Siemens AG 2009. All Rights Reserved.
¿Qué es eBR?
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
Beneficios• Herramienta intuitiva de diseño / No se requieren
conocimientos de IT• Conversión sencilla del papel a la pantalla• Enabler de reingeniería de procesos de negocios
Funcionalidades
Modelado gráfico y definición de MBR u otroproceso de operaciónGestión avanzada de workflowInstrucciones de trabajo configurablesUser ID conforme a cGMPConforme a CFR 21 parte 11 (firma electrónica/registro de auditoría)Genealogía (hacia atrás y adelante)Conforme a ISA 88 e ISA 95
Master Batch Record Design
© Siemens AG 2009. All Rights Reserved.
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
BeneficiosProcesos libres de papelesMejora en el control de manufacturaReducción del tiempo de cicloReducción de costos: Menos scrap y downtime
FuncionalidadesRegistro electrónico de loteControl y asignación de recursosFabricación gestionada sin papelesOperaciones Manuales & AutomatizadasInstrucciones de trabajo electrónicas (WIN y SOPs)Control en tiempo realIndicadores de desviaciónGestión de equipamientoConexión OPC con los sistemas de automatizaciónDeclaración de manufactura
Ejecución de tareasde manufactura Gestión de equipamiento
© Siemens AG 2009. All Rights Reserved.
Electronic Batch Recording
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
© Siemens AG 2009. All Rights Reserved.
BeneficiosVisibilidad en tiempo real de las tareas de análisis de loteAcceso rápido a información relevante de lotePasos de validación simplificadosLiberación de lote más rápido y seguro
FuncionalidadesValidación de alertaAnálisis por excepciónGestión de camino de firmasRepositorio central de información de lote
Lista de desviaciones y sus origenesRegistros electrónicos de loteAudit trail con time-stampGenealogía de LoteDetalle de pesaje
Electronic Batch Recording Review
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
© Siemens AG 2009. All Rights Reserved.
Desea conocer mas sobre cómo Siemens desarrolla las tecnologías para ciencias biológicas ?
Conozca el portfolio de referencias y proyectos desarrollados con la integración de ELAN, en :
http://www.elansoftware.com
Revise las referencias de Siemens en lo relativo a Process Analitical Technologies (PAT) en:
http://www.siemens.com/sipat
Conozca en mayor detalle los desarrollos y expertise de Siemens en la industria farmacéutica y en biotecnología en:
http://www.automation.siemens.com/mcms/pharma-industries/en/Pages/Default.aspx
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING EXECUTION SYSTEMS
DISERTANTE: Ing.A.Gorenberg Ing.N.Giordano EMPRESA:
AADECA ISPE
© Siemens AG 2009. All Rights Reserved.
Muchas gracias por su atención
Siemens Industrial AutomationSus contactos :
Ing. Andrés Gorenberg
Andres.Gorenberg@siemens.comTe: 54 11 4738 7176
Ing. Nicolás Giordano
Nicolas.Giordano@siemens.comTe: 54 11 4346-8954