ABB - Page 1

Overall enterprise
integration in a
validated
environment

Solution scenario
Validated
Pharmaceutical plant

Issues: Enterprise Integration and validation

Industry: Pharmaceuticals

Overall enterprise integration

ABB - Page 2

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

Additional requirements

ABB - Page 3

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

ABB Solution: Enterprise Integration

ABB - Page 4

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

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

ABB - Page 5

Data is collected into the Enterprise Historian

ABB application consolidates the batch record and
forwards it to SAP

ABB Solution: architectural view

Barcode
system
Enterprise
Historian

Mixing system

Process
management

SAP
Production
scheduling,
orders,
final batch
records
Production
supervision
& accounting

Production lines
Product Routing

ABB - Page 6

Building control system

ABB Solution: Enterprise Integration

ERP system interface via SAP certified software

(Verano Enterprise Link)

ABB - Page 7

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

Industrial IT solution: validation and security

Data source uniqueness is

preserved

ABB - Page 8

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.