ABB in the Pharmaceutical Industry

DNA - Definitive New Approach to Automation

Solutions for the Pharmaceutical Industry

ABB Automation

DNA - Definitive New Approach to Automation

The Vision Behind the Name
ABB is the leading automation solution supplier
to major pharmaceutical manufacturers worldwide.
Our experienced technical professionals provide
an extensive range of knowledge solutions and
support services that extend our Open Control
Systems to support your automation philosophy
across your enterprise.

and operations qualification. ABB has optimized

a suite of deliverables and services to meet the
phases of validation: definition, design, implementation, acceptance, installation and qualification.
For existing systems, we offer Retrospective
Validation services.

ABBs field-accepted automation solutions

enhance your operations in many ways, from
basic utilities management and complex bulk
product manufacturing to final product packaging via robotics and materials management.
Our total life cycle support services, including
Validation AssuranceSM, Project Management
and Production Management, complement
these solutions.
As a pharmaceutical manufacturer, your
profitability and growth are directly linked to
creating new products and reducing time to
market. ABB is dedicated to providing
solutions that help you maintain the flexibility
you need to make and deliver new products
sooner, to guarantee quality, and to meet
governmental and environmental regulations.

Validation Assurance
Current Good Manufacturing Practices (cGMP)
and Good Automated Manufacturing Practice
(GAMP) drive pharmaceutical companies to
improve process design and operations while
meeting regulatory standards. ABB provides
field-proven solutions to help you meet industry
objectives in a variety of areas, including hiring
and training, in accordance with industry
benchmarks such as ANSI, IEEE, IEC and SEI.
ABBs Validation Assurance integrates
validation activities throughout the system
development life cycle. As an ISO 9000
certified company, we are committed to the
principles of Six Sigma, cGMP and GAMP. We
build System and Installation Qualification
into our products and applications during the
design and development phases.
Security, integrity, version control and
documentation are part of all ABB systems.
Additionally, we use standards and methods
with history-of-use to ease on-site installation

Project Management
Effective project management reflecting the
unique forces driving the pharmaceutical
industry, e.g., time-to-market reduction and
regulatory compliance, is critical to the success
of all pharmaceutical projects.
To meet this need, ABB has Project Management
teams dedicated to the pharmaceutical industry.
We have broadened the scope of traditional
project management and redefined it as a
business management function. Involved from
the bid and proposal stage, the team is comprised
of experienced business managers, application
consultants and systems engineers knowledgeable in compliance requirements, electronic
recording standards, and batch processing.
We have shifted the business management
function to an earlier point in the value chain
so business managers can work with you to
build a good relationship and gain understanding
of your expectations right from the start. This
knowledge, combined with industry experience,
will help minimize critical situations during the
life cycle of your project.
Guided by our own successful global business
and feedback from our pharmaceutical
industry partners, ABB has received high
rankings for our customer-focused business
management solution. We have not only met,
but have exceeded, our customers expectations.
ABB Automation

Solutions for the Pharmaceutical Industry

The powerful EBR provides for looping and
branching in the sequence, management of
several batches simultaneously and password/
signature authorization for critical steps and
recipe exceptions. It produces an auditable,
archivable report with exception listings that
reduce validation time.

Production Management
ABBs suite of products spans the range of
applications the pharmaceutical industry
requires. Our evolutionary, scalable Open
Control System platform builds on intelligent
instrumentation and analyzers, I/O and
controller subsystems that support all fieldbus
technologies and IEC-1131 standards. This
enables the automation user to leverage
current industry standards. Incorporating
a browser-based, web-enabled Human
Systems Interface, the traditional operator
console becomes the platform for the
enterprise window.
ABBs MES solution bridges the gap between
process control and enterprise functions. The
backbone of this solution is ABBs Enterprise
Historian (EH), a powerful historical engine
with a desktop graphical user interface. EH
leverages the power of information from
multiple sources on a scalable, secure,
redundant, and distributed architecture.
Collecting both continuous and batch data
from the automation layer, EH generates
reports and Production Data Logs (PDLs)
to facilitate data analysis comparisons across
batches. It is interfaced to ERP systems,
making available plant and process information
essential to enterprise resource planning and
management.
ABBs Electronic Batch Record (EBR) and
Batch Manager, developed with guidance
from major pharmaceutical companies, have
evolved to encompass ISA S88.01 batch
standards and the 21CFR Part 11 regulations.
EBR is applicable to manual batch processes,
sequencing the operator and records actions
on portable terminals and bar code readers.
ABB Automation

Batch Manager automates and controls batch

processes. With a flow chart interface, it
complies with current S88.01 terminology and
state definitions, incorporating the added
functionality of exception recipes and manual
batch actions.

Support Services Solution

Post-shipment service is essential to the
pharmaceutical industry, where survival
depends on remaining current with
evolving standards and regulations.
ABBs support solution meets this
challenge with Productivity Services,
Availability Services, and Performance
Services.
ABBs Productivity Services portfolio builds
upon clearly defined service products that
can be delivered anywhere in the world.
ABBs Availability Services, comprised of
Customer Support and Parts and Logistics
Services, ensures maximization of our
customers investments in ABB products.
ABBs Performance Services, comprised of
Process, Application, Consulting and Education
Services, optimizes both system and personnel
performance. For example, Consulting Services
offers on-line and on-demand industry-specific
solutions for application implementation and
optimization. ABBs Automation University
delivers over 210,000 student days per year
in over 100 local centers, providing standard
and customized courses on both ABB and
non-ABB products.

Migration Strategies

ABB Multi-faceted Solutions

from a Multi-dimensional Company
ABB has over 140 years of on-site experience. We have
built excellent relationships with major pharmaceutical
manufacturers worldwide. Our multi-faceted solutions
are total life cycle solutions that meet every automation
requirement of the pharmaceutical industry.
ABB puts customer satisfaction first, offering solutions
that are engineered to successfully meet and exceed todays
requirements while finding ways to incorporate tomorrows
technologies. We have emerged as todays multi-dimensional
leader, redefining yesterdays one-stop-process-automation-shop
as tomorrows solution-centric enterprise partner.
Measurement and
Control Instrumentation

Project Management
Analyzers

Intrinsically Safe I/O

Project Financing

Fieldbus

Asset Optimization
ABB Automation

Electronic
Batch Records

Hardware
Solutions

Knowledge
Solutions

World-class production
requires superior control.
At the heart of every process automation
solution are field devices and control systems.
ABB constantly interacts with plant operators,
process engineers and plant safety personnel,
and participates in organizations that guide
new technologies.
Construction and
Production Support

As a result, we offer the most ergonomically

designed range of field instruments, analyzers
and Open Control Systems available. Capitalizing
on current industry standards and technologies
such as fieldbus connectivity, OPC and web
browsing, these user-friendly, evolutionary
systems provide the platform for enterprise
management, today and into the future.

ABBs knowledge solutions

portfolio is based on the power of S88.01
compatible Batch Management, Electronic
Batch Records that fully meet the 21 CFR
Part 11 regulations, Asset Optimization and
Validation Assurance, tied together with
Enterprise Historian. Our project managers,
systems engineers and application consultants
superior FDA-regulated industrial plant and
process experience, combined with ABBs
knowledge solutions, effectively bridges the
gap between our hardware and business
solutions to provide an integrated offering
from a single company.

Batch Control

Start-up and
Commissioning Assistance

ABB Automation

Warehouse Management Systems

Business Systems
Connectivity

Business
Solutions

Support
Solutions

Information is the key

to effective enterprise
management. From the field to the control
room to the boardroom, ABBs business
solutions make information available
seamlessly. Our MES solutions allow enterprise
systems to leverage plant and process
information for optimized resource planning
and management. Additionally, our enterprise
partnering, e-business and financing solutions
enable pharmaceutical manufacturers to share
risks and experiences with ABB to increase the
rewards for both organizations.

Service solutions merit

the same meticulous
development, delivery and support processes
that have traditionally been applied to hardware
and software solutions. For this reason, ABB
has organized to support the pharmaceutical
industry, focusing on three key areas of
productivity improvement: process consulting,
applications consulting and personnel knowledge
enhancement. Each of our advanced service
offerings has been specifically designed to
achieve documented improvements for the
pharmaceutical industry.

Switchgear and
Distribution Equipment

Training Simulators

Enterprise Historian

AC Drives, Drive
Starters and Motors

Consulting and
Benefit Analysis

Robotics for Material

Handling and Packaging

ABB Automation

Total Life Cycle Support

Validation Assurance

Loop Optimization
and Auditing

Open Control Systems

Liquid, Gas and

Flow Flowmeters

e-Business
Maintenance Support
and Parts Logistics
Automation University

ABB Automation

The Bottom Line

ABB is a $30 billion, multinational company
and a global leader in providing state-of-theart technology solutions to the pharmaceutical
industry. With access to the best technology
from anywhere in the world, we can provide
complete support through the life cycle of
your project. From engineering, training and
commissioning to service and round-the-clock
support every day of the year, ABB does it all.
Let ABB deliver a Definitive New Approach to
your businesss evolution. Our objective is
total customer satisfaction. Our goals are to:
optimize your automation solution
improve your personnels
performance
build an ongoing and mutually
beneficial business partnership
with you.

For additional information, visit us

on the Internet at www.abb.com/pharmaceuticals

ABB Automation Inc.

29801 Euclid Avenue
Wickliffe, Ohio USA 44092
Tel: +1 440 585 8500
Fax: +1 440 585 8756

ABB Automation Ltd.

Gunnels Wood Roads
Stevenage, Hertfordshire
SG1 2EL UK
Tel +44 (0) 1438-742366
Fax +44 (0) 1438-742367

ABB Automation GmbH

Industriestrasse 28
DE-65760 Eschborn
Germany
Tel +49 (0) 6196 800-1280
Fax +49 (0) 6196 800-1282

ABB Instrumentation S.p.A.

Via Sempione 243
1-20016 Pero, Italy
Tel +39 (02) 3392-8432
Fax +39 (02) 3392-8542

3BUS092056R0001
Copyright 2000 by ABB Automation Inc. All rights to trademarks reside with their respective owners.
Specifications subject to change without notice. Pictures, schematics and other graphics contained herein are published for illustration purposes only and do
not represent product configurations or functionality. User documentation accompanying the product is the exclusive source for functionality descriptions.