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PharmaceuticalsActiveFactory software, InBatch software, InTouch HMI,

Laboratorios Almirall Wonderware System Platform

Automate manufacture of Products Formulated inJet Engines for the Pharmaceutical Industryby Wonderware Spain

VALUE DRIVERS

Goals

• To automate the seven new jetengines and drier filter;

• To create a new Recipe;

• Management System whilemaintaining compatibility with theexisting PLCs and SCADA that arealready in place.

Challenges

• To assure that the new system isfully ISA S88 compliant;

• The new system should becompatible with the code of theexisting PLC and SCADAprograms;

• The solution must be deployedwith minimal effect to the existingmanufacturing.

KEY METRICS

Wonderware Solutions

• ActiveFactory software;

• InBatch software;

• InTouch HMI;

• Wonderware System Platform.

Results

• The system is easily explandableand the cost is lower for theengineering required to addfeatures and functions;

• The developed system providesan easy and intuitive operation ofthe plant;

• The reporting system complieswith the requirements of FDA 21CFR part 11;

• The solution is robust thatbreakdowns are minimized.

Company Overview Laboratorios Almirall, S.A. – Barcelona,SpainAlmirall, an international pharmaceuticalcompany based on innovation andcommitted to health, headquartered inBarcelona, Spain, researches, develops,manufactures and commercialises its ownR&D and licensed drugs with the aim ofimproving people’s health and wellbeing.The therapeutic areas on which Almirallfocuses its research resources are related tothe treatment of asthma, COPD (ChronicObstructive Pulmonary Disease), psoriasis,rheumatoid arthritis and multiple sclerosis.Almirall’s medicines are currently present inover 70 countries with direct presence inEurope and Latin America in 11 countries,specifically in Germany, Austria, Belgium,France, Italy, Mexico, Poland, Portugal,Spain, the United Kingdom-Ireland andSwitzerland. Some Almirall’s propietary R&Dproducts are: almotriptan (anti-migrainedrug - 2000), aceclofenac (anti-inflam-matory - 1992), ebastine (antihistamine -1990), cinitapride (gastroprokinetic - 1990),piketoprofen (anti-inflammatory - 1985),almagate (antacid - 1984) and clebopride(gastroprocinetic - 1979).For further information please visit thewebsite at: www.almirall.com

“With the Wonderware solution,

it is possible to easily expand our

production facilities. This will

allow us to create a standard

engineering approach, and we

will be able to expand our

control system while

maintaining the robustness and

reliability of the production

system.”

Manuel Orriols, Automation Manager, Laboratorios Almirall, S.A.

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Initial situation

Laboratorios Almirall, S.A. is one of the leadingpharmaceutical laboratories in Spain and this leading positionis shared by its industrial installations, which have a high gradeof automation in their processes. When we started thisproject, Almirall wanted to automate the functioning of sevennew jet engines and a drier filter, but at the same time, wehad to substitute software of receipt manufacture, whichworked for six automate equipments with PLCs and SCADAthat were already there and that should remain there. Thenew receipt software had to be compatible with the oldcontrol system, but moreover, it had to be compliant to theprescriptions of the ISA S88 law for Batch processes.

Solution implementation

The project was assigned to EMTE Sistemas, S.A.U., ArchestrA-certified system integrator. EMTE started the project making awide analysis of requirements, functionalities, securities, etc,of the plant, together with Almirall’s technicians. Theyworked very hard in the different project’s phases like themodelling of the process, definition of steps, etc. until theyhad the total security that the defined criteria were the mostsuitable ones for this installation, and that these could beimplemented in the planned system. The installed controlsystem responds to a configuration of servers, where each ofthem is dedicated to fulfil the following functions: - Communications and objects server with WonderwareSystem Platform and Wonderware Application Server (part ofthe Wonderware System Platform software solutions’ offering).This server provides connection to the field controllers in asimple and robust way. Its function is “sharing” data and ordersby a two-way communication between the controllers and themonitoring and control system;- InTouch HMI (Human Machine Interface) implemented in aClient-Server architecture. Thanks to InTouch HMI, Almirall isable to have an interface which is needed for the operators tomonitor and control the process running in the reactor’s plant.On the operational standpoint then, the architecture requiredthe installation of 4 InTouch HMI for the operators’supervision; - Wonderware Historian (formerly known as IndustrialSQL orInSQL Server and part of Wonderware System Platformoffering) and ActiveFactory software. This server is responsiblefor achieving all data and events of interest throughout theprocess. It is possible to access information related to changingthe variables, alarms and other data that allow Almirall toidentify with precision the evolution of the process. With thisinformation, it is possible to answer all questions abouttraceability;- Batch Server with InBatch sofware. The development of theactive ingredients in reactors requires the use of a batchprocess. This is the reason why Almirall required the InBatchsoftware server release. This solution complies allrequirements and regulations needed in an pharmaenvironment and of course in this project."Now, with Wonderware architecture, it is possible to expandeasily our production facilities. This will not imply a newengineering approach, and we will be able to expand our

control system keeping the robustness and liability of theproduction system" said Manuel Orriols, Automation Manager,Laboratorios Almirall, S.A.The entire solution is based on the TPC/IP communicationbetween Server stations, clients’ stations and PLCs. EMTE hasminimized the laying of signal wires, because they used remoteentrances – exits directly installed in the classified area andconnected by means of Profibus to the PLC. The integration ofthe previous control system to the new management systemof inBatch software receipts has been developed thanks to theflexibility that has Wonderware System Platform system andthe technical capacity of EMTE Systems in the design of anefficient interface.

Architecture’s benefits

“The new control system has been validated in its differentstages DQ-IQ-OQ, and after some months working in normalconditions, we can state that thanks to Wonderwaretechnology, the project has fulfilled all its expectations that wehave formulated in its beginning. The developed system allowsus an Interface of an easy and intuitive operation, it gives uscomplete reports on how each of the manufactures have beendeveloped (Batch’s reports) and furthermore they fulfil ourrequirements according to the FDA 21 CFR part 1.1 law.” saidCarlos Gonzalez, Industrial Sales Manager, EMTE Sistemas,S.A.U. “Moreover the adopted configuration allows us to fastand securely overcome eventual breakdowns that the systemmay have. To sum up, both the Wonderware Archestratechnology and the integration that EMTE Systems has done forthis project have satisfied all our expectations” commentedOrriols.

This document was realized thanks to the support of: Laboratorios Almirall, S.A., and

EMTE Sistemas, S.A.U., ArchestrA-certified system integrator

Laboratory testing

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PharmaceuticalsActiveFactory software, InBatch software, InTouch HMI, Wonderware System Platform

Almirall.qxp:LifeScan 30-07-2008 15:31 Pagina 62