Company Presentation

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EUROTHERM
Pharmaceutical Solutions Group
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overview

• 180 year heritage of BTR and Siebe
• 3 billion in annual sales
• 50,000 employees
• Innovation, quality and customer focused
• 500 offices worldwide

telligence
In ven sys
tion
In
tems Solutions
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only
can deliver leading brand solutions, from the
production line to the bottom line.
Only Invensys
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Strategic Vertical Markets
Customer Focused - What do our customers need?
OilGas
Pharma
Food
Plastic
Glass
Mfg
Product Focused - What can we build?
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Flexible Scalable Solution
Temperature and Process Controllers, Indicators
and Alarm Units
Process Control Systems
Recorders and Data Management Equipment
Engineering Services, Training
Power Controllers and Solid State Relays
I/O Signal Conditioning, Ancillary, Thermosensors
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Flexible Scalable Solution
The power and performance of a DCS . at the
price and the ease-of-use of PLC/HMI
offerings!
Start Small

• Simple loop application solutions
• Data Acquisition
• Unit application solutions
• Large process solutions
• Complete system solutions
• Information integration solutions

Grow Big
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Industry Applications
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Industry Applications
Engineering Services, Training

• Service Centre
• Commissioning
• Training
• Warranties
• Maintenance contracts
• Calibration contracts
• Spares and consumables

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Industry Applications
Pharmaceuticals Key application areas

• Reaction Vessels
• Fermentation
• Freeze Drying
• Environment Monitoring Systems
• Autoclave Control
• Spray Drier Control
• Clean Steam
• Purified Water
• Equipment Sterilisation
• Mixers and Blenders
• Pressure/pH/Temperature/Flow Control

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Industry Applications
EUROTHERM Pharmaceutical Solutions Group
Eurotherm
Customer

Master Validation Plan
User Audit

• One vendor for all the elements of the DCS
• One vendor for design, engineering, commissioning
• One vendor for development, support, service,
  value
• Support agreements available from Invensys from
  local, established field based service network
• Singular global network for multi-national
  organizations

Equipment Validation Plan Explanation to Supplier
Proposal Quality Validation Project Plan
Req
Proposal
User Requirements Specification (Living Document)
Functional Specification (traceable to URS)
P.O.
Proposal Analysis
Detailed Design Documentation (traceable to FS)
Approval
Review Functional Spec
System Acceptance Test Specs (IQ/OQ)
Review Detailed Design
Approval
Hardware Software

Review System Acceptance Test Specifications
Approval
System Acceptance Testing and Results
Integrate with Validation Dos (as appropriate)

Maintenance Support Documentation
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Industry Applications
Pharmaceuticals Some of our current Customers
Montford Inst
Cardinal Health
3M Healthcare
Nestle
CIS BIO International
Arancia
Novartis
Clarient France SA
Abbot Laboratories
OSI Pharmaceutical
Chauvin Pharmaceuticals
Accentus
Organon
CP Pharmaceuticals
Akzo
Ortho
Eli Lilly
Alpharma
Patheon
Eurand
Amersham
Pfizer
Finorga
Astrazeneca
Pharmacia
Fresenius
Astur Pharma
Proctor Gamble
Genzyme
Aventis
Roche
GSK
Biomeriux
SA
Rhodia
Institut Pastur
Baxter Healthcare
Sanofi
Ipsen biopharm

Bayer
Schering
IVAX Pharmaceutical
Plough
Biomerieux
Soldeva
SA
Johnson Johnson
Boehringer Ingelheim
Hoescht
Solvay pharma
Boots
Lonza
Biologics
Tyco
Bristol Myers Squib
MacFarlen
Smith
Unimedic
MSD
Wyeth
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Industry Applications
Pharmaceuticals Some of our Applications

• DSM Pufa 16 Fermenters and Seed Vessels
  (6xT940)

• PharmaciaUpjhon Utilities (17xT640)

• PharmaciaUpjhon Idrogenator batch pilot plant

• SORIN 7 Reactors for Cardio-Valves
  Carbonisation (7xT800)

• Chiron Inactivation exaust fluids

• Menarini CIP (T103, T800, T3500)

• Biosphere Fermenter CIP (2xT800, T3500)

• Pierrel O2/N2 Production (3xT103, 2xT3500)

• Vacsera Sterilizer CIP (T103, T3500)

• Dompè Lyophiliser (8xT640)

• Bioferma Filtration CIP (5xT800)

• Lab MAG 8 Batch Reactors (8xT640, 7xT100,
  3xT103, 2xT3500)

• Miteni Large Scale Pilot Plant

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Industry Applications
Pharmaceuticals Some of our Applications

• AstraZeneca 18 Reactors (18xT800, T940,
  5xEurothermSuite)

• Lonza 11 Fermenters (11xT800,
  1xEurothermSuite)

• Novartis 3 Tablet coating (3xT800, 1x
  EurothermSuite

• Severn Science Freeze dryer OEM (1xT800 per
  unit)

• AMC Steriliser OEM (1xT800 per unit)

• Merck Sharp Dohme Stability room monitoring
  (InSQL, T3500, T103s)

• Eli Lilly Utilities monitoring

• Eli Lilly Spray Drier

• Eli Lilly Stability rooms monitoring

• Macfarlen Smith Multi product batch plant
  (T103, T3500)

• Loctite Indermil(EurothermSuite, T103)

• Ethypharm Purified Water (2xT800)

• Servier Laboratories 4 Intermediate Batch
  Reactors

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Industry Applications
Pharmaceuticals 21 CFR Part 11 made easy

• Data management at every level Recorders,
  Unit solutions, Plant solutions
• Configurable 21 CFR Part 11 features Make
  ERES to match your production
• and validation needs
• Designed to be 21CFR part 11 compliant Reduce
  SOP's
• In-built protection Alarm in the event of any
  interruption of data collection
• Central password management Change in one
  place and deploy to many
• AUDIT trail at every level. Available locally
  or across the network for central collection
• Support for most common field busses
• Provide ONE Audit trail and Data Repository
  for the entire system.
• Innovative "WRAP EMBRACE" program
• Remediation solutions for compliance

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Industry Applications
Pharmaceuticals Validation Solutions

• Innovative WRAP EMBRACE solutions
• Achieve compliance for legacy systems
• AUDIT by our experts
• provide an Action" report on Validation,
  Support, 21CRF part 11, Networks, Expansion...
• GAP analysis by our experts
• provide an Action report on Risk management,
  documentation, implementation risks and options
  and recommend a strategy
• Scalable, flexible solution
• Added to your existing system to expand your
  capabilities.
• Support for most common field busses
• allow integration to your existing systems.

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Industry Applications
Pharmaceuticals Full Cycle support
Business Analysis

• Your engineering partner, full life-cycle
  support
• Training with bespoke courses for all levels
  of your organisation
• Global network of trained and audited
  "Development Partners" to provide local support
  and service 24/7
• Work closely with your preferred SI
• All firmware and hardware changes are
  comprehensively tested,
• documented and tracked.
• Minimise production interruption with optional
  redundancy and hot swapping.
• Future proof by scalable, and Modular
  construction and high level of granularity
• Not only offering the best equipment but
  always offering a simple migration path to our
  latest technology
• Migration and backward compatibility always
  in our focus
• Object oriented methodology dramatically
  reduces the pain of migration.
• Published obsolescence policy ensures
  continuity of supply for the life of
• your plant.

Design
Build Test
Operate Maintain
Improve
Retire
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Industry Applications
Pharmaceuticals Global Implementation Solution

• Our object oriented tools and methodology
  ensures standardisation
• and reusability
• Speed up project completion reduces errors
  and
• accelerates Time to Market.
• Documented Objects and SW modules that make
  easier to
• make changes with minimum re-validation.
• Global network of trained and audited
  "Development Partners"
• providing local support and service
• We have regular customer / engineering
  meetings to disseminate good practice,
  application knowledge and future direction.
• We have training programs to bring your
  preferred System
• Integrator up to speed with our tools
  products and methodologies

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Industry Applications
Pharmaceuticals Manufacturing Strategy Solution

• Redundant solutions with both high MTBF and
  availability figures
• Minimise production interruption and waste with
  optional redundancy
• and hot swapping modules.
• By automating your production processes
  semplifying SOPs significantly.
• Carefully specifying and implementing
  automation will improve both
• efficiency and quality for example
  achieving tighter tolerances
• Making data available improving visibility
  enables easy optimisation of the processes
• and the ability to preempt problems
• Total local and remote control whilst still
  maintaining a "closed system" via a VPN
• Both our modular and stand-alone controllers
  are designed to became integral part
• of an overall system
• We can supply solutions small enough to be cost
  effective in a lab which are expandable
• to full production size, and which use the
  same object based programming code.
• Our scalable solutions can be cost effectively
  expanded as required
• Modular cost effective easily scalable
  solutions enable a distributed
• architecture which suits Lean manufacturing
  philosophies.