Contrà S. ANNA 1/5 35012 CAMPOSAMPIERO (PD)

www.tsaonline.it tel. 0039-0495792435 – fax 0039-0499306065

Design EngineeringDesign Engineering

Project management Project management

Construction managementConstruction management

Equipment supplyEquipment supply

of API & DRUG PRODUCTION PLANTSof API & DRUG PRODUCTION PLANTS

TechnologyTechnology

TecnologiaTecnologia

SafetySafety

SicurezzaSicurezza

EnvironmentEnvironment

AmbienteAmbiente

T.S.A. – Bulk and Pharmaceutical EngineeringT.S.A. T.S.A. –– Bulk and Pharmaceutical EngineeringBulk and Pharmaceutical Engineering

TSA is an engineering company focused on the design and the realization

of APIs bulk and pharmaceutical plants founded by established experts

with specific skills achieved in managing and directly operating on

production and utilities plants.

The direct experience, achieved both in planning and in running of

production plants, defines especially the quality and the extent of our

services.

Professional skills and operative flexibility and efficiency make TSA a

reliable partner for study, design and realization of new plants, as well as

for the optimization or revamping of existing processes in APIs and

pharmaceuticals productions.

Range of products and services:Range of products and services:Range of products and services:

•• Process analysis for existing or new productionProcess analysis for existing or new production

•• Technical and organizational optimization of existing processeTechnical and organizational optimization of existing processess

•• Feasibility studies and business analysis for new projectsFeasibility studies and business analysis for new projects

and revamping of existing plantsand revamping of existing plants

•• ProcessProcess, , Basic and detail engineering Basic and detail engineering

•• Project management, Construction managementProject management, Construction management

•• Plants or key Equipment design and supply Plants or key Equipment design and supply

•• Procurement services, contract specifications and Procurement services, contract specifications and

purchasing assistancepurchasing assistance

•• Work supervision Work supervision

•• Commissioning and startCommissioning and start--up assistanceup assistance

•• Turn Turn keykey plantsplants

•• Safety analysis and safety rules compliance supervisionSafety analysis and safety rules compliance supervision

•• Consulting about regulatory affairs and cGMP standardsConsulting about regulatory affairs and cGMP standards

•• Validation activities and protocols for cGMP compliance Validation activities and protocols for cGMP compliance

TSA OrganizationTSA OrganizationTSA OrganizationGeneral Manager

FRANCESCO PINTON

Process Engineering

Project Manager

Mechanical-Structural

Project Manager

Air treatment

Project Manager

Secretary

Process Engineer Mechanical EngineerCAD OPERATORS

(Internal / external)

Wiring & automation

Quality, documentation & safety

CAD OPERATORS

(internal / external)Civil and hydraulic Engineering

CAD OPERATORS

(internal / external)

CAD OPERATORS

(Internal / external)

Several external specialists can be involved if necessary

Range of processes and plants:Range of processes and plants:Range of processes and plants:

• Batch or continuous synthesis• Extraction and transformation of chemical compounds

from natural sources• Powders filtering from liquids, drying, micronizing, sieving, sizing• Liquid and solid mixing, moving, packing, storing • Pharmaceutical production processes:

- tablets, capsules, film coated specialties, suppository, injectable vials, packaged in blisters, bags or jars, perfusionals, syrups, drops, ointments,

• Chemical and biological laboratories, Macrolab, Pilot plants• Biotech production plants• Pharmaceutical interior finishing, controlled contamination

areas, clean rooms, sterilized rooms • Sterile Manufacturing Plant• High potent API bulk production and drug formulation plants• Citotoxic drug bulk production and drug formulation plants • HVAC systems for clean room • Fire-fighting• Control and automation systems • Utilities, building structures and industrial infrastructures

TSA tools:TSA tools:TSA tools:

TSA offices in TSA offices in CamposampieroCamposampiero--PadovaPadova--ItalyItaly are equipped with workstations and are equipped with workstations and

laptops and server with double backlaptops and server with double back--up of the data.up of the data.

TSA can liaise with external partners in order to meet our custoTSA can liaise with external partners in order to meet our customersmers’’ special special

requirements. requirements.

All the computers are equipped with CPU and video cards accreditAll the computers are equipped with CPU and video cards accredited by Autodesk. ed by Autodesk.

The ram are of 4 The ram are of 4 GbGb with screen 19 or 21 inches with screen 19 or 21 inches

All the computers are equipped with operating system Windows XP,All the computers are equipped with operating system Windows XP, office 2007.office 2007.

Structural design and stress analysis: Modest, Straus7, Caesar IStructural design and stress analysis: Modest, Straus7, Caesar III

3D Rendering: Rhino3D Rendering: Rhino

Technical design 2D and 3D: Technical design 2D and 3D:

CatiaCatia V5, Solid Works 2010 for solids studyV5, Solid Works 2010 for solids study

Fluent for CFD simulationFluent for CFD simulation

AutocadAutocad 20082008--2011 Autodesk packages 2011 Autodesk packages EsaProEsaPro

For process simulations TSA engineers have a privileged access tFor process simulations TSA engineers have a privileged access to ASPEN o ASPEN

Printing plotter for great formats till A0Printing plotter for great formats till A0

Printers laser and ink jet A4Printers laser and ink jet A4--A3A3

CopyCopy--faxfax--scanner A3 coloursscanner A3 colours

Only few of the works by TSA :Only few of the works by TSAOnly few of the works by TSA ::

•• General audit of facilities and management regarding the GMP comGeneral audit of facilities and management regarding the GMP compliance level of the Italian factory of pliance level of the Italian factory of a foreign company. Drawing up and management of a general plan oa foreign company. Drawing up and management of a general plan of adjustment. Final inspection of f adjustment. Final inspection of FDA and no 483 as resultFDA and no 483 as result

•• Design and construction management of a new pharmaceutical plantDesign and construction management of a new pharmaceutical plant in Eastern Europe producing: in Eastern Europe producing: tablets, tablets, injectableinjectable vials, vials, perfusionalsperfusionals, syrup, ointments, suppository, drops etc, syrup, ointments, suppository, drops etc……), compliance with ), compliance with international international cGMP(projectcGMP(project amount 18 millionsamount 18 millions€€) including:) including:–– Basic and detail design for production equipment, Processes orgaBasic and detail design for production equipment, Processes organization, Industrial nization, Industrial

building(10.000 mbuilding(10.000 m22))–– Pharmaceutical finishing, Sterile rooms, HVAC, Warehouses, UtiliPharmaceutical finishing, Sterile rooms, HVAC, Warehouses, Utilitiesties–– Commissioning, startCommissioning, start--up and validationup and validation

•• Design of a multipurpose workshop: drying, milling, packaging oDesign of a multipurpose workshop: drying, milling, packaging of API fermentation products f API fermentation products (investment amount 5,5 millions(investment amount 5,5 millions€€ ))

•• Design and construction management of a new API production plantDesign and construction management of a new API production plant in China for a European in China for a European company, compliance international cGMP (total project amount 28 company, compliance international cGMP (total project amount 28 millions millions €€) including:) including:–– Basic and detail design for production equipment, Processes orgaBasic and detail design for production equipment, Processes organization, Industrial buildings, nization, Industrial buildings,

wastes treatments (13.000 mwastes treatments (13.000 m22))–– Construction management, commissioning, validation, startConstruction management, commissioning, validation, start--up, people training, engineering up, people training, engineering

department organizationdepartment organization–– Synthesis, drying, finishing, packing workshopsSynthesis, drying, finishing, packing workshops–– Utilities production and distribution, WarehousesUtilities production and distribution, Warehouses–– HVAC for controlled areasHVAC for controlled areas

•• Basic and detail design of production plant of sterile antibiotiBasic and detail design of production plant of sterile antibiotic, sterilization, isolation, drying, powder c, sterilization, isolation, drying, powder sizing, sterilized packing in different packaging. (Total projecsizing, sterilized packing in different packaging. (Total project amount 2.2 millionst amount 2.2 millions€€) )

•• Feasibility, basic and detail design of a new API purification aFeasibility, basic and detail design of a new API purification and packing workshop:nd packing workshop:

–– 9 purifications and drying lines9 purifications and drying lines

–– milling and packaging systems (6 milling rooms, 3 milling and packaging systems (6 milling rooms, 3 micronizationmicronization rooms, 5 packaging rooms)rooms, 5 packaging rooms)

–– Automated storehouse for finished products, 900 pallets, air conAutomated storehouse for finished products, 900 pallets, air conditioned. ditioned.

–– HVAC plant and pharmaceutical finishing (ISO5, ISO 7 and ISO 8 HVAC plant and pharmaceutical finishing (ISO5, ISO 7 and ISO 8 areas)areas)

–– utilities area utilities area

–– (Total project amount 16 millions (Total project amount 16 millions €€) )

•• Basic design of a new synthesis pilot plant in classified area IBasic design of a new synthesis pilot plant in classified area ISO 7 SO 7

•• Process and detail engineering for the installation of 4 filter Process and detail engineering for the installation of 4 filter dryers (from 2 mdryers (from 2 m22 to 8 mto 8 m22) for API, in ) for API, in controlled area (ISO 8) (project amount 5,5 millions controlled area (ISO 8) (project amount 5,5 millions €€))

•• High Potent Drug production plant design and realization for a BHigh Potent Drug production plant design and realization for a Brazilian company (3.9 million razilian company (3.9 million €€))

•• Industrial application, technical and economical evaluation of cIndustrial application, technical and economical evaluation of continuous microontinuous micro--reactors to transform reactors to transform chemical processes from batch to continuous plant.chemical processes from batch to continuous plant.

•• Basic and Detail design, construction management and supply of tBasic and Detail design, construction management and supply of the most critical equipments of new he most critical equipments of new factory in Eastern Europe for APIs productions compliance the infactory in Eastern Europe for APIs productions compliance the internationals GMP rules (3,7 millions ternationals GMP rules (3,7 millions €€))

•• Basic and detail design for revamping of an oil tanks area for Basic and detail design for revamping of an oil tanks area for refinery: crude oil, gasoline, refinery: crude oil, gasoline, benzinebenzine, , diesel oil and others 25 tanks for a total 800.000 mdiesel oil and others 25 tanks for a total 800.000 m33..

•• Process and detail engineering, construction management of new pProcess and detail engineering, construction management of new plant for peptide purification in clean lant for peptide purification in clean room (ISO 8, ISO 7, ISO 5, ISO 3) with innovative technologies (room (ISO 8, ISO 7, ISO 5, ISO 3) with innovative technologies (project amount 6.5 millions project amount 6.5 millions €€) )

Only few of the works by TSA :Only few of the works by TSAOnly few of the works by TSA ::

Architectural & Civil DesignArchitectural & Civil DesignArchitectural & Civil Design

Industrial BuildingsIndustrial BuildingsIndustrial Buildings

Air TreatmentAir TreatmentAir Treatment

Process DesignProcess DesignProcess Design

Pharmaceutical PlantsPharmaceutical PlantsPharmaceutical Plants

Some DRUG Production PlantsSome DRUG Production PlantsSome DRUG Production Plants

Mechanical Design & PipingMechanical Design & PipingMechanical Design & Piping

Same API Production PlantSame API Production PlantSame API Production Plant

Equipment SupplyEquipment SupplyEquipment Supply

FireproofFireproofFireproof

Here some companies with wich TSA keeps

continuous and profitable work relationships:

Here some companies with Here some companies with wichwich TSA keepsTSA keeps

continuous and profitable work relationships:continuous and profitable work relationships:

•Lundbeck – Padova (Italy)

•Sifavitor – Lodi (Italy)

•Pyros – Venezia (Italy)

•Profarma – Tirana (Albania)

•Uquifa – Milano (Italy)

•Italfarmaco – Milano (Italy)

•Zambon Group – Vicenza (Italy)

•Sabo – Bergamo (Italy)

•University of Alicante – (Spain)

•Itf Chemical – Salvador (Brazil)

•Corning – Avon (France)

•A. Rabahi – Algiers (Algeria)

•Cosma – Bergamo (Italy)

•Zetafarmaceutici – Vicenza (Italy)

•Amsa – Como (Italy)

•City of Bikaner – Rajastan (India)

•Biofer – Modena (Italy)

•Cambrex – Milano (Italy)

•Chemi – Frosinone (Italy)

•Chemo Iberica – Madrid (Spain)

•Fidia Farmaceutici – Padova (Italy)

•GP Pharma ltd – Sanmen (China)

•Quimica Sintetica – Alcalà (Spain)

•Aqua solution – Delhi (India)

•Icrom – Milano (Italy)

•HengKang Ph LTD – Sanmen (China)

•Basf – Bologna (Italy)

•Chemessentia – Novara (Italy)

Contacts:

Head office and operations site T.S.A. srl

Contrà S. Anna 1/5 I-35012 CAMPOSAMPIERO (PD)

Tel: 0039-0495792435 Fax: 0039-0499306065

Email: info@tsaonline.it www.tsaonline.it

GM Francesco Pinton

Email: f.pinton@tsaonline.it

Tel: 0039-3343388063