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© ABB - Page 1 Solution scenario Validated Pharmaceutical plant Overall enterprise integration in a validated environment

© ABB - Page 1 Solution scenario Validated Pharmaceutical plant Overall enterprise integration in a validated environment

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Page 1: © ABB - Page 1 Solution scenario Validated Pharmaceutical plant Overall enterprise integration in a validated environment

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Solution scenarioValidated Pharmaceutical plant

Overall enterprise integration in a

validated environment

Page 2: © ABB - Page 1 Solution scenario Validated Pharmaceutical plant Overall enterprise integration in a validated environment

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Industry: Pharmaceuticals

Issues: Enterprise Integration and validation

Overall enterprise integration SAP integration for scheduling and

master recipes Enterprise connection to diverse

systems including: HVAC, mixing, maintenance management product routing and water systems

Total plant pharmaceutical industry validation This large pharmaceutical

manufacturing facility produces over 3 billion tablets annually

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Additional requirements

Regulatory compliance in the design and deployment of products and systems from the plant floor to the ERP level

Process, raw material, and product tracking and control

High level of operator interaction Automated sampling data entry

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ABB Solution: Enterprise Integration

System integration services were provided by ABB

Inform IT Enterprise Historian selected as the heart of the ERP/MES/Plant Floor for production related activities

Planning functions are logically and physically separated from production. In the event of a network failure, the MES system continues production for days based upon previously downloaded SAP production orders

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ABB Solution: Enterprise Integration

SAP system selected as the basis for recipe development, production planning and material movement and permanent batch records

ABB handled distribution and synchronization of recipes across multiple, independently controlled process areas

ABB is responsible for the electronic batch record keeping Data is collected into the Enterprise Historian ABB application consolidates the batch record and

forwards it to SAP

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ABB Solution: architectural view

Enterprise Historian

Building control system

Product Routing

Mixing system

SAPProduction scheduling,

orders,final batch

records

Production supervision

& accounting

Processmanagement

Barcodesystem

Production lines

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ERP system interface via SAP certified software (Verano Enterprise Link) Production orders Quality data Batch records (schedule)

Material short-term tracking Operator interface Automation system interface Peripherals interface Maintenance system (CMMS) interface Historical process recording

ABB Solution: Enterprise Integration

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Industrial IT solution: validation and security

Data source uniqueness is preserved Data can only be entered at one place

All operator and maintenance personnel entries recorded (by an electronic batch recording system)

Project documentation is available at the Enterprise Historian served up by Netscape Fasttrack web server. Goal is to become paperless.