PHARMA IN RUSSIA

PHARMAIN RUSSIA

NEW PARTNERSHIP

Thank to STI’s deep knowledge of the Russian market and Techniconsult’s experience in the pharmaceutical industry sector, a new reality is born: the best solution to satisfy customers’ needs that will be able to trust in a foreign supplier with a fixed presence in Russia, guaranteeing the time to market reduction and the quality of the services.

The decision to invest in the Russian market cames from the aim to offer specialized services for the pharmaceutical industry with local an engineering company.

PHARMACEUTICAL INDUSTRIY

RUSSIA AND CIS COUNTRIES

OVERVIEW

PHARMAIN RUSSIA

Techniconsult Firenze S.r.l:

+30 years of experience, specialises in pharmaceutical industry providing integrated engineering services: EPCM, EPC, C&Q and General Contracting

P H A R M A I N R U S S I A

STI Engineering Russia, LLC :

Russian Design Institute with +20 years of experience, specialises in building, industrial, petrolchemical, providing integrated engineering services: Design, Management, Consulting & Digital

R

US

S I A & C I S C O U N T RI E

S

P H A R M A I N R U S S I AINDUSTRY

PHARMACEUTICALS

API BULK

RESEARCH &DEVELOPMENT

BIOTECHNOLOGIES

CHEMICAL

One Russian partner for a full range of services

in pharmaceuticalindustry

P H A R M A I N R U S S I AMULTIDISCIPLINARY

Process Design

Civil

Structural

Architectural

Pharma finish

Mechanical wet

Mechanical dry

Electrical & Special Systems

Instrumentation & Automation

Logistics

PRESENCE

+30 years of experience

+500 staff

STI engineering

Techniconsult150300

50STI engineering

Russia, LLC


ProjectsSTI Engineering Russia, LLC

1980 1990 2000 2010 2020Techniconsult

STI engineeringSTI engineering

STI engineering RU

Russia DesignInstitute

NUMBERS

+1600 Completed Projects

30 Years of experience

30mln€ TurnOver

1000 Active clients

Kedrion Thyssen Helsinn Merck

ENI

Saipem Elpen ST MicroelectronicsLeonardo GSK

Pierrel PfizerCargill Chiesi Menarini Group

Halliburton Danieli

Sanofi

Abbvie Novartis

Teva

Abbott Berlin-Chemie Menarini

Eli lilly Cremonini

Brusnika Decal OrenbeefMarr Zuegg

Gazprom

Tecnimont


STRENGHTS

CUSTOMERS NEEDS: OUR PRIORITY

CONTINUOUSIMPROVEMENT

ENGINEERING PROJECT LIFE CYCLE

FLEXIBILITY TO ADAPT OUR ACTIVITIES

Good Manufacturing Practice (GMP)

compliance

Safety as a core value

Competence in cleanroom

and controlled environments

Long-term customer

relationships

Philosophy of IPD

Fast-track approach

SKILLS P H A R M A I N R U S S I A

VALUESVALUESThanks to our common values, in our daily work we leverage on the different experiences we come from to contribute building a better world.

Respect

Sustainability

Diversity

Inclusion

Passion

Innovation

Professionalism

Loyalty

Ethic


CERTIFICATIONS

Place and date: For the issuing office:Vimercate (MB), 05 August 2021 DNV - Business Assurance

Via Energy Park, 14, - 20871 Vimercate (MB) - Italy

Zeno BeltramiManagement Representative

Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.

ACCREDITED UNIT: DNV Business Assurance Italy S.r.l., Via Energy Park, 14 - 20871 Vimercate (MB) - Italy - TEL: +39 68 99 905. www.dnv.it

MANAGEMENT SYSTEM

CERTIFICATE

Certificate no.:266551-2018-AQ-ITA-ACCREDIA

Initial certification date:23 August 2018

Valid:24 August 2021 – 23 August 2024

This is to certify that the management system of

TECHNICONSULT FIRENZE S.r.l.Via Carlo Del Greco, 25/a - 50141 Firenze (FI) - Italy

has been found to conform to the Quality Management System standard:

ISO 9001:2015

This certificate is valid for the following scope:

Conception, supervision de la construction et coordination des activités de constructioncivile et industrielle; mise en service et validation d'installations industrielles,d'équipements et de systèmes de processus(IAF 34)

CertificationISO 9001:2015(Techniconsult)

CertificationDesign & Consulting Service Russian’s Licence(STI RUSSIA)


SERVICES

DESIGN

FeasibilityStudy

Concept Design

ConstructionManager

SafetyManagement

TimeControl

CostControl

QualityControl

CONSTRUCTION

PROCUREMENT

START UP & COMMISSIONING

PROTOCOL DE VELOPMENT VALIDATION ( IQ/OQ) (PQ)

MAINTENANCE

Punch List Redaction Ready for PQ Project Completion


Stage “P” Stage “RD”

S E R V I C E S

• Project Management

• Site Evaluation & Selection

• Feasibility Study

• Site Master Plan

• Process Technology And Equipment Evaluation

• GMP Consulting

• Contamination and Biocontamination Consulting

• Energy Efficiency Audit

• Energy Managementaifa/Fda Consulting

Consulting & Planning

S E R V I C E S

• Project Review

• Concept Design

• Stage “P”

• Stage “RD”

• Local Approvals - Expertise

• Facility System Integration

• BIM - Building Information Modeling

• CFD & Process Simulation

• Procurement Assistance

• Follow Up

• Value Engineering & Cost Optimization

• Safety

Design & Engineering

S E R V I C E S

Process Team Leader with more than 20 years experience in process design and start-up of pharma plants with particular reference to

Biotechnology, Plasma Fractionation, API Bulk and Pharmaceutical facilities.

Process Design

Process experience covering a wide range of facilities:

Core Skills in Safety Process Design:

• API Bulk

• Sterile Manufacturing

• Plasma Fractionation

• Suspension Preparation

• OSD

• Cosmetics

• HAZOP

• Safety and SIL studies

Hazardous

• Area Classification Studies

• Fire Risk Analysis

• EU Product Directive Dossiers

S E R V I C E S

• Project Management

• Design Management

• Construction Management

• Contract Supervision

• Time & Cost Control

• Work Supervision

• Follow Up

• BIM - Building Information Modeling

• Start-up & Commissioning

• As- built Documentation

• Construction and / or Revamping of facilities with

the use of specialized technologies

• Sustainability Analysis - Energy Efficiency

• General Contracting

Construction

S E R V I C E S

• Construction Checklist

• Systems Assessment, SAT/FAT witnessing

• Mechanical Completion and punch list

management

• Start-Up HVAC Systems, Black & Clean Utilities

• Balancing and “troubleshooting” of new or

existing HVAC Systems, Black & Clean Utilities

• Commissioning Package issue

Commissioning

• Instruments Calibration

• Validation Master Plan and Qualification Plan Issue

• Preparation and execution of:

• DQ, IOQ, PQ and Periodic Qualification

• Computer System Validation (CSV)

• Cleaning Validation

• Data Integrity Assessment and Periodic Review

• GxP, Regulatory and EHS Risk Analysis

• SOP issuing and training

Qualification

S E R V I C E S

For strategic projects we are able to provide the following resources:

• C&Q Coordinator / Validation Manager

• QA Specialist / Deviation and Change Control

Manager

• Technology Transfer Specialist

• Supplier Auditor

Techniconsult develops, organises and conducts training courses including technical and management-based

refreshers. Depending on the specific needs of the client, training projects are made to measure and on-demand.

Training

S E R V I C E S

CATEGORIES:

• Organisation and management

• Defining the pharmaceutical layout

• CFD (Computational Fluid Dyamics)

• Plant engineering

• Process engineering and pharmaceutical

techniques

• QA/QC

• cGMP regulations

• Regulatory framework of environmental

contamination control

A value engineering tool: an opportunity to define the design according to the real exigencies.

With this technology and the knowledge of GMP compliance the tool guaranees:

• De-bottlenecking of processes• Capacity optimisation for Equipment and Clean Utilities• Schedule complex processes• Process optimisation & facility lay-out optimisation• Maximise equipment utilisation• Analyse multiple scenarios• Assess labour/resources requirements• Assess environmental emissions• Perform cost analysis

CFD studies enables simulating local internal and external fluid dynamics on several applications, including:

• Clean rooms fluid dynamics analysis;• Process machines fluid dynamics analysis;• Stirred tanks / mixing tanks fluid dynamics analysis;• Thermo-fluid dynamics analysis of temperature-controlled warehouses;• Design and optimization of air diffusers.

CFD studies, have become a great tool as a guide to the design phase and a troubleshooting tool for finding and solving existing systems

problems.

SimulationComputational Fluid Dynamics (CFD)

Process simulation

S E R V I C E S

P H A R M A I N R U S S I AASSOCIATIONSWe as companiesand through our teams are members of:

ASCCA (Italian Association for Contamination Control and Clean Room Technology)

ASHRAE (American Society of Heating, Refrigerating ,Air Conditioning Engineers)

AICARR (Associazione Italiana Condizionamento dell’Aria, Riscaldamento e Refrigerazione)

ISPE (International Society of Pharmaceutical Engineers)

AFI (Associazione Farmaceutici Industria)

UNI working group on Clean Room Technology

PHSS (The Pharmaceutical & Healthcare Sciences Society)

ISO (ISO TC 209 Working Group)

P H A R M A I N R U S S I AAWARDS

2020 Facility of the Year Award Winner for Social Impact

The Attachment Inhibitor Project of GSK has been awarded by ISPE for the Facility of the Year Awards (FOYA) for the Social Impact Category.

Techniconsult was responsible for designing the new building and the construction management(including Start-Up & Commissioning)

2020 International property Awards winner

Kandinskiy Haus - Residential High Rise Development Urals, Russia

The awards celebrate the highest levels of achievement by companies operating in all sectors of the property & real estate industry.

An International Property Award is a world-renowned mark of excellence.

This achievement has been obtained thanks to the commitment of STI in the Multidisciplinary Detail Design and the Construction Management.

CASE HISTORIES

GREENFIELDNEW OSD PLANT

Location: ItalyClient: Confidential -Pharmaceutical Company TYPE OF WORK• Construction of a new OSD plant

SECTOR• Pharmaceutical

PROJECT STATUS• 2019 - 2021

SCOPE OF WORK• Feasibility Study, Concept Design & Light Basic Design

PROJECT SIZE• Total Investment Cost: € 123M

MAIN DATA• Product: oral solid dosage

FACILITY DATA• Construction of a new manufacturing plant of an approximate footprint

of 60.000 sq m.• Total Land Size 100.000 sq m.

NEW MANUFACTURING PLANT

NEW TR&D LABORATORIES

Location: ItalyClient: Confidential - Pharmaceutical Company TYPE OF WORK• Revamping of the existing building in order to

accommodate all TRD department, and expansion of the existing building as offices area for labs staff.

SECTOR• Pharmaceutical, Laboratories & Offices

PROJECT STATUS• 2019 – 2021

SCOPE OF WORK• EPCM Services

PROJECT SIZE• Total Investment Cost: € 16M• Overall footprint: 4.100 sqm

TRD LABORATORIES AND OFFICES IN ONE BUILDING IN COMPLIANCE WITH SMARTLAB REQUIREMENTS.

NEW HIGH CONTAINMENT SOLID DEPARTMENT

Location: Parma - ItalyClient: GSK Manufacturing TYPE OF WORK• Construction of a new building and revamping of the

production and warehouse areas of the existing building in order to create a new high-containment solid department.

SECTOR• Pharmaceutical, High containment, solids

PROJECT STATUS• Completed: 2017 - 2019

SCOPE OF WORK• EPCM Services - Fast-track project


MAIN DATA• Product: Solids • Total surface: 1.500 sq m.

NEW FACILITY AND REVAMPING OF THE EXISTING BUILDING

NEW FILL-FINISH LINEFOR INJECTABLES

Location: EnglandClient: Confidential – Pharmaceutical Company TYPE OF WORK• Revamping of existing technical/ manufacturing areas• Construction of new manufacturing facility within existing

building in the revamped areas• Construction of new auxiliary plant building

SECTOR• Pharmaceutical, Sterile powders

PROJECT STATUS• Completed: 2011 – 2013

SCOPE OF WORK• EPCM Services


REVAMPING & EXTENSION OF THE EXISTING BUILDING.

NEW STERILE AREA

Location: ItalyClient: Confidential - Pharmaceutical Company TYPE OF WORK• Design and revamping of an existing building to

create a new aseptic and containment department.

SECTOR• Pharmaceutical, Suspension solution

PROJECT STATUS• Completed: 2016 - 2018

SCOPE OF WORK• Basic Design Consolidation, Detail Design,

Procurement Assistance, Follow Up and Final Documentation.


REVAMPING OF THE EXISTING BUILDING TO PRODUCE SUSPENSION SOLUTION

NEW API PRODUCTION BUILDING

Location: SwitzerlandClient: Confidential –Pharmaceutical Company

TYPE OF WORK• Construction of a new facility for the production of Active

Pharmaceutical Ingredients (API), including changing rooms, offices, warehouse, washing room, sampling etc.

SECTOR• API Bulk

PROJECT STATUS• Completed: 2021

SCOPE OF WORK• Basic Design


NEW ACTIVE PHARMACEUTICAL INGREDIENTS (API), PRODUCTION FACILITY .

NEW INHALERS FACILITY

Location: RussiaClient: Confidential –Pharmaceutical Company

TYPE OF WORK• New department in a green field area in the existing site, including

definition of containment strategy, market investigation for filling and assembly, layout study for all support functions areas.

SECTOR• Pharmaceutical, inhalers


SCOPE OF WORK• Concept Design


NEW FACILITY IN THE EXISTING SITE.

NEW PHARMACEUTICAL PLANT

Location: TurkeyClient: Confidential –Pharmaceutical Company

TYPE OF WORK• The scope of the project was to analyze the different option for

the construction of new plant of; • Oral Solids• Injectable cephalosporins• Ampoules • Eye drops• Oral Penicillin’s• Oral Cephalosporins

SECTOR• Pharmaceutical, Solids, Injectables, Liquids


SCOPE OF WORK• Concept Design


NEW MANUFACTURING PLANT.

CENTRAL REFERENCE LABORATORY (BSL-3)

Location: Almaty, KazakhstanClient: Undisclosed

TYPE OF WORK• Bio-safety laboratory

SECTOR• High containment, diagnostic

PROJECT STATUS• Built.• Project and consulting : 2010-2011

SCOPE OF WORK• MEP Design

PROJECT SIZE• 100 MIO $

MAIN DATA• Central Asia’s First Biothreat Research Lab

FACILITY DATA:• Overall area: 8,000 m²• Research area: 550,000 m²

BIO-SAFETY LABORATORY LEVEL 3

GAZPROM / NIPIGAZ «AMURSKY»GAS PROCESSING PLANT

Location: Svobodny, Amur Region, RussiaClient: Tecnimont SpA TYPE OF PROJECT• New construction, Gas processing plant

SECTOR• O&G, Down Stream, Gas Refining

PROJECT STATUS• Under construction • Phase 1: completed (2018 – 2020)

SCOPE OF WORK • MEP Detail Design

PROJECT SIZE• Confidential

MAIN DATA• Confidential

UTILITIES, OFFSITES AND INFRASTRUCTURES FOR GAS PROCESSING PLANT

ZUEGG RUSSIA

TYPE OF PROJECT• New construction, industrial plant

SECTOR• Industrial, Food & Beverage, Fruit & Vegetables processing

PROJECT STATUS• Built.• Project and consulting : 2012 – 2013

SCOPE OF WORK • Multidisciplinary Design and Construction Supervision

PROJECT SIZE• 45 MIO Eur (incl. equipment)

MAIN DATA• Processing capacity: 20.000 Tons / Year • Products: Fruit jams and juices

FACILITY DATA: • Overall area: 60.000 m²• Covered area: 10.000 m²• Electrical Power: 254,52 kW / t • Gas Consumption : 65,25 m3/ t • Water: 5,64 m3 / t

INDUSTRIAL FRUIT PROCESSING PLANT FOR JAM AND JUICES PRODUCTION

Location: Afanasovo, Kaluga Region, RussiaClient: Zuegg SpA

KANDINSKY HOUSERESIDENTIAL BUILDING

Location: Yekaterinburg, RussiaClient: Brusnika LLC

TYPE OF PROJECT• New construction, city plant and masterplan

SECTOR• Residential, Urban Landscapes

WE WORKED WITH• AEDAS (Concept Design)• Martin Hyamo - AHR Architects (General Architecture e Façade)• Christian Lundwall - Lundwall Architects (Interior design)• Yonas Egger - Greenhance (External areas)

PROJECT STATUS• Built (2014 – 2018)

SCOPE OF WORK• Multidisciplinary Detail Design, Construction Management

PROJECT SIZE• 25 MIO Eur

FACILITY DATA• Surface: 22 000 mq• Residential units: 88 apartments• Total floors : 16• - P -3/-1 : parking lots• - P 0-6: offices• - P 7: panoramic terrace with garden• - P 8-16 residential (last 2 VIP floors)

MARR RUSSIALOGISTIC PLATFORM

Location: Odintsovo (Moscow), Russia Client: Marr Russia LLC (OOO Kaskad)/ Cremonini Group TYPE OF PROJECT• New construction, meat processing plant

SECTOR• Industrial, Food & Beverage, Meat Processing


SCOPE OF WORK • Multidisciplinary Design (Preliminary, Tender, Construction, As-built), • Project and construction Management


MAIN DATA• Processing capacity: 50.000 Tons / Year • Products: burger patties, bacon

FACILITY DATA: • Surface : 26.000 m²• Electrical Power: 7,5 MW• Refrigeration Power: 4,5 MW• Heating Capacity: 12 MW• Storage Capacity: 10.000 pallet

LOGISTIC PLATFORM & MEAT PROCESSING PLANT

SHISHIMSKAYA-GORKA (Uktus Alfa)

Location: Yekaterinburg, RussiaClient: Brusnika LLC TYPE OF PROJECT• New construction, masterplan

SECTOR• Residential, Urban Landscapes

WE WORKED WITH• ARC concept: KCAP Architects&Planners

PROJECT STATUS• Built (Start: 2015 – End: 2017)

SCOPE OF WORK • Multidisciplinary Preliminary and Detail Design


MAIN DATA• Building 18 : GFA 46.000 m² - 516 housing units of various sizes• Building 19: GFA 32.000 m² - 338 housing units of various sizes

RESIDENTIAL COMPLEX, BUILDINGS 18 AND 19

ORENBEEF

Location: Orenburg, Russia Client: ORENBEEF / CREMONINI GROUP TYPE OF PROJECT• New construction, meat processing plant

SECTOR• Industrial, Food & Beverage, Meat Processing


SCOPE OF WORK • Multidisciplinary Design (Preliminary, Tender, Construction, As-built), • Project Management and Manpower Technical Coordination,

Procurement, Site Management, Commissioning


MAIN DATA• Processing capacity: 20.000-22.000 Tons / Year • Products: Fresh/frozen beaf

FACILITY DATA: • Covered area: 11.000 m²• Electrical Power: 2,5 MW• Refrigeration Power: 2,8 MW• Water: 600 m3/day

CATTLE SLAUGHTERHOUSE & MEAT PROCESSING PLANT

MAIN REFERENCES

RUSSIA MARKET PHARMACEUTICAL REFERENCES

Amursky GCCSvobodny – RU

Dynamo villageSakhalin – RU

Kandinsky houseEkaterinburg – RU

Food Logistic Platform Odinzovo – RU

Slaughtering & Meat Processing – Orenburg – RU

Benzine & Oil terminalRostov – RU

Park of ParksKaluga region- RU

WorkshopOkelbo – SWE

Odoptu phase IIOdoptu – RU

New production area for liquid & lyophilized bio-tech

products - IT

2 new production Suites in the existing CPD1 production

building - IT

Process simulation for insulin downstream purification - RU

New Production Process, Ansamitocin P3 (AP3) - IT

New Dispensing area - IT New production facility ( vials, ampoules, eye drops) - EG

New automatized warehouse - GE

New OSD manufacturing plant in Azerbaijan - AZR

New up&down stream facilities - IT

Thanks

Documents

PHARMA IN RUSSIA