M+W Group

Enabling New Horizons

M+W Central Europe GmbH

Company Presentation

M+W Central Europe GmbH
A Company of the M+W Group
www.ce.mwgroup.net

Agenda

 Overview
 M+W Central Europe
 Introduction of Technical Facilities EE
 Services
 References

2 May 2015 Source: M+W Group

Enabling New Horizons

Overview

M+W Group
Organization

Board Dr. Herbert Demel M+W Group Wolfgang Homey

CEO Dr. Friedrich Schneider CFO

COO

Corporate Strategy and Environment, Engineering Project Risk Accounting & Information
Functions M&A Health & Safety Efficiency Management Treasury Technology

Public Relations Human Internal Audit Procurement Controlling Tax
Resources

Compliance Contract Legal & Administration
Management Insurance

AMER EMEA APAC

Regions Advanced Technology Facilities
Global Business Units Life Sciences & Chemicals
Energy
High Tech Infrastructure

Cleanroom Technologies & Controlled Environments

4 May 2015 Source: M+W Group

M+W Group
Global business units and markets

Advanced Technology Life Science & Energy High Tech
Facilities Chemicals Infrastructure

 Semiconductor  Pharmaceutical &  Solar  Science & research
 Photovoltaics health  Waste-to-energy  Data centers
 Displays  Conventional power  Space & security
 Batteries  Food & nutrition
 Consumer goods plants
 Chemicals  Nuclear systems

Cleanroom Technology
& Controlled Environments

 Cleanroom products  Critical subsystems
 Air handling units  Analytical laboratories

5 May 2015 Source: M+W Group

M+W Group
At a glance

 Leading global engineering and construction company

 Unique skillset in the delivery of complex

technology-intensive factories and facility

 Special expertise in cleanroom technology

and controlled environments

 Established in Germany in 1912 – over 100 years of history

 Figures 2015

Order Intake: € 3.0 bn

Sales: € 3.0 bn

Employees: 7,050

MMiissssiioonn SSttaatteemmeenntt:

“M+W creates customer value through a unique combination of
lean and sustainable, high-technology engineering and

project management solutions in an injury-free environment.”

6 May 2015 Source: M+W Group

M+W Group EMEA APAC
Global footprint 2,350 employees 2,500 employees

AMERICAS
2,200 employees

Headquarters Offices

7 May 2015 Source: M+W Group

Safety and quality management – first target

Comply with Comply with
Client’s EHS Protocol Legal Requirements

GOAL : Zero EHS Incident

Comply with SCC P Comply with
Corporate EHS Policy ISO 9001 certified Project EHS Plan/
Requirements/ Manual Programs

8 May 2015 Source: M+W Group

9 May 2015 Source: M+W Group

10 May 2015 Source: M+W Group

Enabling New Horizons

M+W Central Europe

M+W Central Europe at a Glance

Company data

Headquarters Stuttgart, Germany

Founded 1995

Managing directors Andreas Wortmann

Josef Kriegl
Gerald Schneider

Employees 650

Turnover 2014 180 Mio. €

Corporate M+W Group

Locations 12 offices in Germany

10 offices in further European countries

12 May 2015 Source: M+W Group

M+W Group Locations Europe

Locations M+W Central Europe GmbH

Germany Belgium
Melsele
Stuttgart (Hauptsitz)
Berlin Poland
Biberach Gdansk
Dresden Wroclaw
Leverkusen Warsaw
Ludwigshafen
Marburg Russia
Nürnberg St. Petersburg
Penzberg Moscow
Schkeuditz / Leipzig
Schwarzheide Serbia
Schwedt Belgrade

Austria sales representatives

Wien Source: M+W Group

Switzerland

Allschwil / Basel
Schlieren / Zürich

13 May 2015

Field of Experiences M+W Central Europe

Pharmaceutical Biotechnology Chemicals and Medical Devices Consumer and Food
Industry Fine Chemicals Beauty Care
• Up-stream- • Stents • Beverages
• Solid dosages processing • Fine chemicals • Surgery devices • Beauty care • Nutrition
• Parenterals • API synthesis • Implants • Baby care • Chocolate
• Injectables • Down-stream • Refineries • Tissue • Personal paper • Culinary
• Lyophyllisation processing • Power • Household care • Dairy
engineering • Cereals
technology • Vaccines • Ice cream
• Ointments • Blood plasma
• High potent APIs • Advanced
• Clean utilities
• Technical facility therapy
• Disposable
management
technology

14 May 2015 Source: M+W Group

M+W Central Europe at a Glance

M+W CEE is an Integrated Engineering Contractor

Industry Competences Technical
Facility
 Pharmaceutical Industry Management
 Biotechnology Industry Validation
 Chemical and Fine Chemical Industry
 Medical Devices Construction
 Consumer and Beauty Care
 Food Industry Design

Our Services for Investment Projects Consulting

 Engineering services Source: M+W Group
 General planning services (EPCMV)
 General contractor for turnkey or EPC
 Compliance and validation

15 May 2015

Competence Spectrum M+W CE

PROCESS BUILDING SERVICE
TECHNOLOGY SYSTEMS

Process equipment, Cleanroom technology,
process infrastructure (clean ventilation, utilities,
utilities, CIP-/SIP-systems, fire protection installation,
chemical supply), building automation,
piping technology, electrical and
emission control, communication systems
waste water treatment,
waste handling PROCESS CONTROL
ENGINEERING
CIVIL, ARCHITECTURE
Instrumentation, process
Structural works (concrete, automation, manufacturing
steel), civil construction, execution system (MES),
finishes, cladding, vertical integration
site development
LAB FACILITIES
LOGISTICS
Equipment and furniture
Warehouse- and storage-
management and -control,
transportation systems

M+W has in-house capabilities for all critical disciplines !

16 May 2015 Source: M+W Group

Quality Management System

 Certified ISO 9001 TÜV Rheinland Cert GmbH
 SGU-management-system according to SCC
 Targets and Indicators

17 May 2015 Source: M+W Group

18 May 2015 Source: M+W Group

Enabling New Horizons

Introduction of
Technical Facilities Eastern Europe

M+W Eastern Europe
A Company of the M+W Group
6 October 2016

Introduction - EE

20 May 2015 M+W EE as Part of the M+W Group is
bundling the strength and experiences
to focus on the Central East European
Market with an high priority on Russia.
Our target is to provide efficient services
with an extended local & international
Know How and expertise including
successful local “Authority Handling” for
our clients

Source: M+W Group

Introduction M+W Technical Facilities EE

M+W EE - Locations
• 1x Austria, Vienna (Headquarter)
• 3x Poland, Warsaw Gdansk, Wroclaw
• 2x Russia, Moscow & St. Petersburg
• 1x Serbia, Beograd

Service Area:
• Eastern Europe & Russia
• Saudi Arabia
• Africa

21 May 2015 Source: M+W Group

Introduction M+W Technical Facilities EE

Team of 180 Diversified Expert
with Global Experiences in the
fields of

• Life Science
• Food
• Semiconductor
• High Tech Facilities

22 May 2015 Advantage:

• Transfer of Know How between
Different Industry Segments

• Flexibility

Source: M+W Group

Introduction M+W Technical Facilities EE

Life Science Responsibility

Employee overview for

- Vienna (Austria)
- Gdansk, Warsaw, Breslau (Poland)
- Belgrade (Serbia)
- Sankt Petersburg, Moscow (Russia)

Discipline Total Employees 180

Management 3
Finance 18
Business Development 5
Human Resources 4
Administration 14
Engineering 84
Project Management 14
Procurement / Commercial Project Management
13
23 QuMaayl2i0t15y Assurance
3 Source: M+W Group

Office in Serbia

Team of 60 experienced, motivated and high qualified
engineers
Located in Belgrade, capitol of Serbia
Successfully completed dozens of projects in central,
eastern Europe and Middle east
Projects that have been done are listed in reference list

24 May 2015 Source: M+W Group

Philosophy of M+W Technical Facilities EE

Ensuring Costumer Satisfaction and Success in Russian Projects Trough:

Quality

• Mix of international and local specialists
• Long time experience in pharmaceutical design and construction works
• All required licenses and certificates in house
• No internal intercommunication, responsibility and interest gaps (in one hand)
• Established procedures for quality check of materials and equipment's
• Established time and cost management procedures

Fixed Project Timeline
• Strong back up of personal resources
• Local established brand and reputation (preferred customer)
• Experienced in local authority engineering and communication
• We are not reinventing the wheel but we customize and improve it.

Cost certainty for our clients & value added

• Intelligent sourcing - local sourcing
- International sourcing (pooling, ….)

- Creative scouring (via Serbia, customs benefits)

• Integration of value engineering and efficient CM sources e.g. (Serbia)

25 May 2015 Source: M+W Group

26 May 2015 Source: M+W Group

Enabling New Horizons

Services

Scope of Services

Consulting Engineering Construction Qualification Technical
& Facility

Validation Management

 Feasibility studies  General planning or  Interdisciplinary  DQ / IQ / OQ  Maintenance /
 Risk analysis acc.
 Conceptual design single discipline construction and customer services
 Process simulation engineering project to FMEA or HACCP
 Process technology management  Requalification
and optimizing  Computer system  Recalibration
 Site management  cleanroom
 Site selection studies - Logistics  Authority validation (CSV)
measurement
 Benchmarking - Process automation engineering  Cleaning validation
 Support services for  Contract
 EU-GMP / FDA - Building service  Procurement
consulting systems, HVAC  Turnkey project process validation management for

 Support authority - cleanroom execution as maintenance
general contractor
inspections and technology services
 Design + build on
demands - Civil & architecture
open book or
 Relocation planning GmaxP-contracts

 Integration planning

M+W Eastern Europe offers complete solutions from the one source !

28 May 2015 Source: M+W Group

Our service offering: General
Multiple contract scenarios Contractor

M+W Central Europe as your
partner takes on several
responsibilities:

Engineering
Partner

Subcontractor

Services

Consultant’s Responsibility Design Turnkey

responsibility for supplies responsibility responsibility

29 May 2015 Source: M+W Group

Our service offering:
Project management

 Scope, time, cost, and quality management Project
 Risk management data
 Procurement management
 Project management by modern operation tools Source: M+W Group

 Project-flow model (PFM)
 Web based collaboration tool with access for

clients
 Progress reporting

Abläufe Basic Engineering

Auftraggeber Freigegebene Konzeptstudie F1 F2 Enddokumentation Auftraggeber

Projektleitung Projektterminplan Vorgabe Kostenstruktur Gesamttermin / Kostenplan Projektleitung
Resourcenplan
Prozeßtechnik
Prozeßtechnik Detaillierung Detaillierung BFD Detailliertes Equipmentlisten Wärmelasten ELT-Verbrauch stat. Lasten P&ID Endgültige Bilanzen Dimensionierung Equipment Datenblätter Ausrüstung P&ID Spezifikation Listen aus P&ID 50% P&ID 100% Angebot auswerten Listen aus P&ID Abgleich BFD, PFD, P&ID,
Verfahrensbeschreibung Verfahrensfließbild Wärmelasten stat. Lasten 10% Medien/ELT und RL 50% Spezialausrüstung Vefahrensbeschreibung Handling
Wärmelasten stat. Lasten Logistik
Disciplines Handling Materiallisten Beschreibung Handling/ Handlingschema (BFD) Auslegung Lagerbereiche ELT-Verbrauch endgültige Materialbilanzen Spezifikation Angebot auswerten
Logistik Lagerlisten Logistik Equipmentlisten Spezialausrüstung Utilities
Wiegematrizen

Utilities Detaillierung Utilities Utilities PFD Equipmentlisten ELT-Verbrauch Abgleich Auslegung P&ID Dimensionierung Equipment Datenblätter Ausrüstung P&ID Spezifikation Angebot auswerten Überprüfung Auslegung Abgleich BFD, PFD, P&ID,
10% und RL 50% Spezialausrüstung Vefahrensbeschreibung

Ausrüstung Spezifikation Ausrüstung Anfrage Ausrüstung Angebot auswerten Ausrüstung
Plant Design
HVAC/RRT Trassenkoordinierung und Detaillierte 3D-Studie kritischer Bereiche Stahlbau Konzept Prozeß Rohrtrassenbedarf Integrierter Aufstellungsplan GMP-Pläne Rohrklassenübersicht vorläufiges Mengengerüst Anfrage RL/Armaturen Stahlbau Spezifikation Massenschätzung Stahlbau Anfrage Stahlbau Rohrtrassen Prozess/Utilities endgültig integrierter Design Review endgültiges Mengengerüst Auswertung Angebote RL/ Plant Design
Vorgaben Aufstellungsplanung RL/Armaturen Aufstellungsplan RL/ Armaturen Armaturen/Stahlbau
PLT Prozeß/Hdl./Util. Utilities Aufstellungsplan HVAC/RRT
Auslegung HVAC ELT-Lasten Trassenplan stat. Lasten Systembeschreibung Vorläufiges Mengengerüst Anfrage kritischer endgültiges Layout Auswertung Angebote
Detaillierung HVAC-Konzept Komponenten Technikzentrale PLT

Detaillierung PLT-Konzept Abschätzung ELT-Verbrauch PLT-Trassenbedarf stat. Lasten Pattern Spec Systembeschreibung Vorläufiges Mengengerüst Anfrage Instrumentierung/PLS Aufstellungspläne GO/GF Beschreibung endgültiges Mengengerüst Auswertung Angebote IT
Meßstellen PLS Instrumentierung Schalträume Instrumentierung / PLS
Layout Serverräume ELT
IT Detaillierung IT-Konzept Abschätzung ELT-Verbrauch IT-Trasssenbedarf Systembeschreibung IT Anfrage IT-System Aufstellungsplan Auswertung Angebote Bau/
Komponenten Architektur
ELT Detaillierung ELT-Konzept Verbrauch ELT-Gebäude Auslegung ELT Aufstellungsplanung stat. Lasten Endgültige Verbraucherliste Endgültige Auslegung ELT Sicherheits-
Trassenbedarf Entwurfsplanung Vorstatik ELT ELT-Raum Layout technik
Bau/ Mechanical Design Data Behörden-
Architektur Detailliertes Konzept Bau Vorplanung Bau Baugenehmigungsunterlagen Korrektur Entwurfsplanung Baumassen engineering
Brandabschnitte Fluchtwege Beschaffung
Sicherheits-
technik Sicherheitskonzept Vorgaben ST Layout Review Sicherheitstechnik Montage

Behörden- Bieterliste Definition Auswertung Angebote Compliance
engineering Einkaufsbedingungen Auswertung Angebote

Beschaffung

Montage Faktorenabschätzung Anfrage Montage Anfrage
Expending

Compliance Risikoanalyse Liste kritischer Parameter GMP-Review Layout GMP-Review
Ausrüstungs Specs

Version 1.0

Go Architektur
Go HVAC

Project-Time

30 May 2015

Our service offering:
Detailed process insight by advanced simulation

Weekly Consumption

Gantt chart Total Quantity

Time (h) Simulation of unit operations
 Use of advanced tools as
Batch process simulation
 General balances ChemCad and ASPEN
 Superimposed consumption  Scientific based dimensioning

curves and specification of
 Debottlenecking equipment
 Process optimization
Source: M+W Group
31 May 2015

Our service offering:
Integrated process automation

ERP i.e. Enterprise Business Systems
SAP R/3®
Amount of control levels
MES / MIS Site Operation Systems

Manufacturing
Execution / Information System

PCS Process Control System Plant Operation
or Systems

SCADA-System

SPS, Fieldbus, Remote I/O, MCC, MVI Field level
Actors, Sensors (peripheral)

Inside control level

32 May 2015 Source: M+W Group

Our service offering:
Fully integrated engineering

Piping Process Building Laserscanning Architectural /
PDS/PDMS Equipment Services Civil Steel Works

PDS/PDMS VENTURIS/ PDS/PDMS/
ACAD ADT/ACAD/…

„Intelligent“ Input Design Review
P+I-Diagrams/Lists Input
Input Check
MTO PDS-2D/ Input
Smart Plant Input
P&ID/
Comos PT

Check

PIPING CoClolillsisiioonnsCchheeccksk
Stress Calculations
Check
Caesar II/
Rohr 2 Check

Output
Output
Output
Output

Equipment Arrangement Isometrics Simulation Material
Management
PDS/PDMS/ PDS/PDMS/DXF/ INOSIM – batch
ACAD/MS DGN plant simulation – PDS/PDMS/SQL/
eM-plant ASCII/XLS

33 May 2015 Source: M+W Group

Our service offering:
Qualification and validation

Retro- and prospective

Risk analysis • Process equipment
• Utilities
Engineering VMP DQ, IQ, OQ • HVAC systems and
Planning PQ CV, PV cleanrooms
Document
preparation • Computerized systems:
Execution • PLC, PCS, MES, ERP
Production
• Manufacturing processes
• Cleaning processes

• Laboratory equipment
• Analytical methods

VMP - Validation Master Plan OQ - Operational Qualification CV - Cleaning Validation PCS - Process control system
DQ - Design Qualification PQ - Performance Qualification PLC - Programmable logic controller MES – Management execution
system ERP – Enterprise resource
IQ - Installation Qualification PV - Process Validation
Source: M+W Group
34 May 2015

Our service offering:
Manufacturing of complex process skids

35 May 2015 Source: M+W Group

Our service offering: Source: M+W Group
Prefabricated building modules

 Building element (“cell”)
including all structural elements,
building finishes and building
service installations (utilities,
HVAC, electrical systems)

 Module contains all process
installation inside the “cell”

 Fabricated and tested off-site
(at VENDORS workshop) incl.
pressure/integrity test and
cleaning/passivation

 Assembled and tested at
VENDORS premises, after
completion of tests
disassembling and shipping to
site, reassembling on site

36 May 2015

Our service offering: Advanced engineering
methods for revamp-projects

Situation on site

 Ideal tool to grasp the as-built-state of an 3D model after Post-Processing Laser-Scan-Result
installation without manual survey on site
Source: M+W Group
 Generation of a 3D-CAD-model in post-treatment,
pipe-classes and equipment parameters may be
added

 In a minimum the scan data may be used as
“background” for the design of new systems,
ensuring a clash free design

37 May 2015

Our service offering: Source: M+W Group
Comprehensive sustainability

Environment

 CO2 footprints (analyses, balances,
optimizing, solutions)

 Green building (preparation of the certificate)
 Leed / DGNB certification
 Water- and wastewater management
 Waste management

Energy

 Power plants
 Alternative energy production solutions (solar

/ biomass)
 Energy optimization (balances, block-type

thermal power station)
 Heat recovery

38 May 2015

39 May 2015 Source: M+W Group

40 May 2015 Source: M+W Group

Enabling New Horizons

Pharmaceutical references

Projects overview

Pharmaswiss

Belgrade, Serbia

New Production Facility

Specifications Solid dosage forms
Product 20 000 m²
Total Building Area

2012 - 2013 Key Features
 Production and packaging, warehouse and distribution

centre, laboratory, administration
 15,000 m² + 5,000 m² extension

M+W Group Scope
Cleanroom construction

42 May 2015 Source: M+W Group

Projects overview

Novartis Neva

Sankt Petersburg, Russia

New pharmaceutical production of solid forms

Specifications Pharmaceuticals
Product 28 000 m²
Total Building Area

2012 - 2014 Key Features
 Ventilation System
M+W Group Scope  Heating System
Design & Construction Management for MEP  Cooling System
Qualification/Validation  Compressed Air
 Aqua Purificata
 Cleanroom Wall/Ceiling/Floor
 BMS / EMS System
 Electrical

43 May 2015 Source: M+W Group

Projects overview

Rosta

Sankt Petersburg, Russia

New pharmaceutical production of solid forms Phase 1
& Phase 2

Specifications Pharmaceuticals
Product 3 800 m²
Total Building Area

2012 - 2015 Key Features
 Ventilation System
M+W Group Scope  Heating System
Design of Black Utilities and Q/V  Cooling System
Troubleshooting in Commissioning phase  Compressed Air
 Aqua Purificata
44 May 2015  Cleanroom Wall/Ceiling/Floor
 BMS / EMS System
 Electrical

Source: M+W Group

Projects overview

Pharmathen

Sapes, Greece

Pharma Production Plant

Specifications Pharmaceutical
Product 7 000 m²
Production Area

2015 Key Features
 New API and Fill and Finish Facility

M+W Group Scope
100% Qualification / Validation

45 May 2015 Source: M+W Group

Projects overview

Spimaco PDTSC

Buraydah, Saudi Arabia

New Laboratory and Solid Production Support
Plant

Specifications Pharma Products developmentl
Specification 5.000 m²
Production area

2014 Key features
 Solid dosage development center
 Laboratories

M+W Group Scope
Engineering
Procurement
Construction Management

46 May 2015 Source: M+W Group

Projects overview

Spimaco Dammam

Dammam, Saudi Arabia

New Oral Solid Dosage Production Plant

Specifications Solid Dosage Forms
Product 10.000 m²
Production area

2013 - 2014 Key Features
 Reconstruction of complete facility
M+W Group Scope
Detail Design of HVAC & Black utilities

47 May 2015 Source: M+W Group

Projects overview

Zdravlje Actavis

Leskovac, Serbia

Trimazolin Production Plant

Specifications API synthezis production
Product 300 m²
Production area

2014

M+W Group Scope Key Features
Basic Design  Reconstruction of old closed facility to accomodate new
Detail Design
production process

48 May 2015 Source: M+W Group

Projects overview

Actavis Balkanpharma

Troyan, Bulgaria

Liquid forms Production Plant

Specifications API synthezis production
Product 2000 m²
Production area

2015

M+W Group Scope Key Features
Basic Design  Process equipment
Detail Design  Clean utilities
 Black utilities related to process

49 May 2015 Source: M+W Group

Projects overview

Imunoloski Zavod

Zagreb, Croatia

New Production Site

Specifications Biotechnology
Product

2006 - 2008 Key Features
 Bulk production of viral and bacterial vaccines, tetanus
M+W Group Scope
Design vaccine, blood plasma fractionations and filling facilities
Conceptual and Basic Design for liquid and freeze-dried products in vials, ampoules
and syringes
 Process and clean utilities, warehouse, central weighing
and dispensing, bulk production of viral vaccines (MMR),
facility for formulation, filling and freeze drying,
secondary packaging, layouts and GMP requirements,
VMP

50 May 2015 Source: M+W Group