ABB Automation

ABB in the Pharmaceutical Industry

DNA - Definitive New Approach to AutomationSolutions for the Pharmaceutical Industry

ABB Automation

DNA - Definitive New Approach to Automation

The Vision Behind the NameABB is the leading automation solution supplierto major pharmaceutical manufacturers worldwide.Our experienced technical professionals providean extensive range of knowledge solutions andsupport services that extend our Open ControlSystems to support your automation philosophyacross your enterprise.

ABBs field-accepted automation solutionsenhance your operations in many ways, frombasic utilities management and complex bulkproduct manufacturing to final product packag-ing via robotics and materials management.Our total life cycle support services, includingValidation AssuranceSM, Project Managementand Production Management, complementthese solutions.

As a pharmaceutical manufacturer, yourprofitability and growth are directly linked tocreating new products and reducing time tomarket. ABB is dedicated to providingsolutions that help you maintain the flexibilityyou need to make and deliver new productssooner, to guarantee quality, and to meetgovernmental and environmental regulations.

Validation AssuranceCurrent Good Manufacturing Practices (cGMP)and Good Automated Manufacturing Practice(GAMP) drive pharmaceutical companies toimprove process design and operations whilemeeting regulatory standards. ABB providesfield-proven solutions to help you meet industryobjectives in a variety of areas, including hiringand training, in accordance with industrybenchmarks such as ANSI, IEEE, IEC and SEI.

ABBs Validation Assurance integratesvalidation activities throughout the systemdevelopment life cycle. As an ISO 9000certified company, we are committed to theprinciples of Six Sigma, cGMP and GAMP. Webuild System and Installation Qualificationinto our products and applications during thedesign and development phases.

Security, integrity, version control anddocumentation are part of all ABB systems.Additionally, we use standards and methodswith history-of-use to ease on-site installation

and operations qualification. ABB has optimizeda suite of deliverables and services to meet thephases of validation: definition, design, implemen-tation, acceptance, installation and qualification.For existing systems, we offer RetrospectiveValidation services.

Project ManagementEffective project management reflecting theunique forces driving the pharmaceuticalindustry, e.g., time-to-market reduction andregulatory compliance, is critical to the successof all pharmaceutical projects.

To meet this need, ABB has Project Managementteams dedicated to the pharmaceutical industry.We have broadened the scope of traditionalproject management and redefined it as abusiness management function. Involved fromthe bid and proposal stage, the team is comprisedof experienced business managers, applicationconsultants and systems engineers knowledge-able in compliance requirements, electronicrecording standards, and batch processing.

We have shifted the business managementfunction to an earlier point in the value chainso business managers can work with you tobuild a good relationship and gain understandingof your expectations right from the start. Thisknowledge, combined with industry experience,will help minimize critical situations during thelife cycle of your project.

Guided by our own successful global businessand feedback from our pharmaceuticalindustry partners, ABB has received highrankings for our customer-focused businessmanagement solution. We have not only met,but have exceeded, our customers expectations.

ABB Automation

Production ManagementABBs suite of products spans the range ofapplications the pharmaceutical industryrequires. Our evolutionary, scalable OpenControl System platform builds on intelligentinstrumentation and analyzers, I/O andcontroller subsystems that support all fieldbustechnologies and IEC-1131 standards. Thisenables the automation user to leveragecurrent industry standards. Incorporatinga browser-based, web-enabled HumanSystems Interface, the traditional operatorconsole becomes the platform for theenterprise window.

ABBs MES solution bridges the gap betweenprocess control and enterprise functions. Thebackbone of this solution is ABBs EnterpriseHistorian (EH), a powerful historical enginewith a desktop graphical user interface. EHleverages the power of information frommultiple sources on a scalable, secure,redundant, and distributed architecture.

Collecting both continuous and batch datafrom the automation layer, EH generatesreports and Production Data Logs (PDLs)to facilitate data analysis comparisons acrossbatches. It is interfaced to ERP systems,making available plant and process informationessential to enterprise resource planning andmanagement.

ABBs Electronic Batch Record (EBR) andBatch Manager, developed with guidancefrom major pharmaceutical companies, haveevolved to encompass ISA S88.01 batchstandards and the 21CFR Part 11 regulations.EBR is applicable to manual batch processes,sequencing the operator and records actionson portable terminals and bar code readers.

The powerful EBR provides for looping andbranching in the sequence, management ofseveral batches simultaneously and password/signature authorization for critical steps andrecipe exceptions. It produces an auditable,archivable report with exception listings thatreduce validation time.

Batch Manager automates and controls batchprocesses. With a flow chart interface, itcomplies with current S88.01 terminology andstate definitions, incorporating the addedfunctionality of exception recipes and manualbatch actions.

Support Services SolutionPost-shipment service is essential to thepharmaceutical industry, where survivaldepends on remaining current withevolving standards and regulations.ABBs support solution meets thischallenge with Productivity Services,Availability Services, and PerformanceServices.

ABBs Productivity Services portfolio buildsupon clearly defined service products thatcan be delivered anywhere in the world.

ABBs Availability Services, comprised ofCustomer Support and Parts and LogisticsServices, ensures maximization of ourcustomers investments in ABB products.

ABBs Performance Services, comprised ofProcess, Application, Consulting and EducationServices, optimizes both system and personnelperformance. For example, Consulting Servicesoffers on-line and on-demand industry-specificsolutions for application implementation andoptimization. ABBs Automation Universitydelivers over 210,000 student days per yearin over 100 local centers, providing standardand customized courses on both ABB andnon-ABB products.

Solutions for the Pharmaceutical Industry

ABB Automation

ABB has over 140 years of on-site experience. We havebuilt excellent relationships with major pharmaceuticalmanufacturers worldwide. Our multi-faceted solutionsare total life cycle solutions that meet every automationrequirement of the pharmaceutical industry.

ABB puts customer satisfaction first, offering solutionsthat are engineered to successfully meet and exceed todaysrequirements while finding ways to incorporate tomorrowstechnologies. We have emerged as todays multi-dimensionalleader, redefining yesterdays one-stop-process-automation-shopas tomorrows solution-centric enterprise partner.

ABB Multi-faceted Solutionsfrom a Multi-dimensional Company

Fieldbus

Project Management

Project Financing

Migration Strategies

Analyzers

Measurement andControl Instrumentation

Asset Optimization

Intrinsically Safe I/O

ABB Automation

HardwareSolutionsWorld-class productionrequires superior control.At the heart of every process automationsolution are field devices and control systems.ABB constantly interacts with plant operators,process engineers and plant safety personnel,and participates in organizations that guidenew technologies.

As a result, we offer the most ergonomicallydesigned range of field instruments, analyzersand Open Control Systems available. Capitalizingon current industry standards and technologiessuch as fieldbus connectivity, OPC and webbrowsing, these user-friendly, evolutionarysystems provide the platform for enterprisemanagement, today and into the future.

KnowledgeSolutions

ABBs knowledge solutionsportfolio is based on the power of S88.01compatible Batch Management, ElectronicBatch Records that fully meet the 21 CFRPart 11 regulations, Asset Optimization andValidation Assurance, tied together withEnterprise Historian. Our project managers,systems engineers and application consultantssuperior FDA-regulated industrial plant andprocess experience, combined with ABBsknowledge solutions, effectively bridges thegap between our hardware and businesssolutions to provide an integrated offeringfrom a single company.

ElectronicBatch Records

Construction andProduction Support

Batch Control

Business SystemsConnectivity

Warehouse Management Systems

Start-up andCommissioning Assistance

ABB Automation

BusinessSolutionsInformation is the keyto effective enterprisemanagement. From the field to the controlroom to the boardroom, ABBs businesssolutions make information availableseamlessly. Our MES solutions allow enterprisesystems to leverage plant and processinformation for optimized resource planningand management. Additionally, our enterprisepartnering, e-business and financing solutionsenable pharmaceutical manufacturers to sharerisks and experiences with ABB to increase therewards for both organizations.

SupportSolutionsService solutions meritthe same meticulousdevelopment, delivery and support processesthat have traditionally been applied to hardwareand software solutions. For this reason, ABBhas organized to support the pharmaceuticalindustry, focusing on three key areas ofproductivity improvement: process consulting,applications consulting and personnel knowledgeenhancement. Each of our advanced serviceofferings has been specifically designed toachieve documented improvements for thepharmaceutical industry.

Enterprise Historian

Training Simulators

Switchgear andDistribution Equipment

Robotics for MaterialHandling and Packaging

Consulting andBenefit Analysis

AC Drives, DriveStarters and Motors

ABB Automation

Liquid, Gas andFlow Flowmeters

Validation Assurance

Maintenance Supportand Parts Logistics

Loop Optimizationand Auditing

Open Control Systems

Total Life Cycle Support

Automation University

e-Business

3BUS092056R0001Copyright 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 donot represent product configurations or functionality. User documentation accompanying the product is the exclusive source for functionality descriptions.

The Bottom LineABB is a $30 billion, multinational companyand a global leader in providing state-of-the-art technology solutions to the pharmaceuticalindustry. With access to the best technologyfrom anywhere in the world, we can providecomplete support through the life cycle ofyour project. From engineering, training andcommissioning to service and round-the-clocksupport every day of the year, ABB does it all.

Let ABB deliver a Definitive New Approach toyour businesss evolution. Our objective istotal customer satisfaction. Our goals are to:

optimize your automation solution

improve your personnelsperformance

build an ongoing and mutuallybeneficial business partnership

with you.

For additional information, visit uson the Internet at www.abb.com/pharmaceuticals

ABB Automation Inc.29801 Euclid AvenueWickliffe, Ohio USA 44092Tel: +1 440 585 8500Fax: +1 440 585 8756

ABB Automation Ltd.Gunnels Wood RoadsStevenage, HertfordshireSG1 2EL UKTel +44 (0) 1438-742366Fax +44 (0) 1438-742367

ABB Automation GmbHIndustriestrasse 28DE-65760 EschbornGermanyTel +49 (0) 6196 800-1280Fax +49 (0) 6196 800-1282

ABB Instrumentation S.p.A.Via Sempione 2431-20016 Pero, ItalyTel +39 (02) 3392-8432Fax +39 (02) 3392-8542