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

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

Planning Planning

EngineeringEngineering

Projects management Projects management

of Pharmaceutical Plantsof Pharmaceutical Plants

Chemical and Pharmaceutical Engineering

TSA is an engineering company focused in design and project

management of APIs and Drugs process plants.

Founded and formed by experts with specific skill achieved

in managing and directly operating on production

and utilities plants.

The direct experience achieved both in design and in carring on the

production plants define the quality and the extent of the services.

Professional skill and operative efficiency make TSA

reliable partner for the idealization,

the design and the realization of new plants,

as for the optimization or revamping of existing processes and

plants.

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

•• Basic and detail engineering • Project management• Process analysis for existing productions or new

formulations • Technical and organizational optimization of existing

processes• Feasibility studies for revamping and new plants• Procurement services, contract specifications and

purchasing assistance• Direction of the work • Construction management• Safety rules compliance supervision• CGMP validation protocols and activity • Commissioning and start-up assistance• Consulting about regulatory affairs

Range of processes and plants:

• Dangerous products: High Potent Drags, anticancer,• Use of toxic products• Formulations• Granulating, drying, Finishing• Extraction from natural source• Liquid and solid mixing, • Liquid and solid packing• Storing automate or not• Laboratories for chemical and biological analysis

and research• Macrolab laboratories and technological labs• Pilot plants• Building structures and working rooms • Pharmaceutical interior finishing ISO standards and steril• HVAC • Fire-fighting• Control and automation systems • Utilities

Some works by TSASome works by TSA

•• Process design of a multipurpose workshop: drying. milling, Process design of a multipurpose workshop: drying. milling, packaging of API fermentation products ( 3,5 millions )packaging of API fermentation products ( 3,5 millions )

•• New plant for production of APIs New plant for production of APIs semisyntheticsemisynthetic antibiotics antibiotics sterilsteril and and non non sterilsteril (about 150 tons/Y), in the same site a new pharmaceutical (about 150 tons/Y), in the same site a new pharmaceutical plant for formulation of about 90 tons of APIs in capsules and plant for formulation of about 90 tons of APIs in capsules and sterilsterilphials (25 millions)phials (25 millions)

•• Basic and executive engineering for new Basic and executive engineering for new farmaceuticalfarmaceutical workshop for workshop for high potency tablets drug production (1,5 million)high potency tablets drug production (1,5 million)

•• Detail design of an Detail design of an farmaceuticalfarmaceutical workshop for high potency vials workshop for high potency vials drug small production production drug small production production

•• Process and executive engineering for workshop for natural Process and executive engineering for workshop for natural extraction of drug from natural sourceextraction of drug from natural source

•• ProcessProcess, basic, , basic, detaildetail design, design, constructionconstruction management and startmanagement and start--up up of new of new ActiveActive PharmaceuticalPharmaceutical IngredientsIngredients production production plantplant in China in China forfor european company, european company, compliancecompliance internationalinternational and chinese GMP(25 and chinese GMP(25 millions)millions)

•• New New pharmaceuticalpharmaceutical plantplant forfor peptidespeptides purificationpurification of of smallsmall quantityquantityand and veryvery high high valuevalue of the of the productproduct..

•• Feasibility, basic and detail design of a new API purification iFeasibility, basic and detail design of a new API purification isolation and solation and andandfinishing workshop, including:finishing workshop, including:

–– purification and drying workshop of many APIs: 9 production linepurification and drying workshop of many APIs: 9 production lines s

–– milling and packaging systems (6 milling rooms, 2 milling and packaging systems (6 milling rooms, 2 micronizationmicronization rooms, 3 rooms, 3 packaging rooms)packaging rooms)

–– automated storehouse for finished products, 900 pallets, air conautomated storehouse for finished products, 900 pallets, air conditioned. ditioned.

•• Basic, detail design, construction management of a new plant forBasic, detail design, construction management of a new plant for API formulation API formulation and and andand packing workshop:packing workshop:

–– Formulation, solids mixing, milling, Formulation, solids mixing, milling, micronizingmicronizing dry and humid granulation, dry and humid granulation, drying of various APIsdrying of various APIs

–– tabletingtableting, , sterilsteril vials, vials, perfusionalsperfusionals, , suppositoryssuppositorys, ointments, syrups. , ointments, syrups.

–– packaging systems and warehouses for row and finished products,packaging systems and warehouses for row and finished products,. .

–– HVAC plant and of pharmaceutical decoration (Sterile, ISO 7 and HVAC plant and of pharmaceutical decoration (Sterile, ISO 7 and ISO 8 areas), ISO 8 areas), utilities area utilities area

–– Total project amount 18 millions Total project amount 18 millions €€

•• General audit on facilities and GMP management checking the compGeneral audit on facilities and GMP management checking the compliance level of liance level of the Italian factory of a foreign company. Formulation of a generthe Italian factory of a foreign company. Formulation of a general plan of al plan of adjustment, timing and costadjustment, timing and cost evaluation. Final inspection of FDA and no 483 as evaluation. Final inspection of FDA and no 483 as resultresult

Some works by TSA Some works by TSA

The TSA The TSA officesoffices in in CamposampieroCamposampiero(PD) are (PD) are equippedequipped withwith::

••12 12 workstationsworkstations, ,

allall the the computerscomputers are are equippedequipped of cpu and of cpu and cardscards video video accreditedaccredited fromfrom Autodesk the ram are of 2Autodesk the ram are of 2--4 4 gbgb withwithscreenscreen d 19 0 23 d 19 0 23 inchesinches

••AllAll the the computerscomputers are are equippedequipped withwith operatingoperating system Windows system Windows XP, office package 2003. XP, office package 2003.

••StructuralStructural design: design: ModestModest, Strauss, , Strauss,

••RenderingRendering: : rhinocerosrhinoceros

••technicaltechnical design 2D and 3D: Autocad 2008 of Autodesk design 2D and 3D: Autocad 2008 of Autodesk withwith allallthe applicativi the applicativi packagespackages EsaProEsaPro

••printingprinting plotter plotter forfor greatgreat formatsformats tilltill A0A0

••TwoTwo printingprinting laser laser brotherbrother

•• copycopy--faxfax--scannerscanner Konica Minolta A3 Konica Minolta A3 colorscolors

TSA TOOLS TSA TOOLS

Architettural & Civil DesignArchitettural & Civil Design

T.S.A. srl 3D VIEW 3D VIEW –– Production & WarehouseProduction & Warehouse

IndustrialIndustrial buildingsbuildings

3D VIEW 3D VIEW -- ServicesServicesT.S.A. srl

IndustrialIndustrial buildingsbuildings

3D VIEW 3D VIEW -- OfficesOfficesT.S.A. srl

IndustrialIndustrial buildingsbuildings

Air TreatmentAir Treatment

ProcessProcess designdesign

Atex Classification

Fire ProofFire Proof

Eletric Design&Power Supply

Mechanical Design&Piping

Some Installation

•Amsa – Como

•City of Bikaner - Rajastan (India)

•Biofer – Medolla (Modena)

•Cambrex – Paullo (Milano)

•Chemi – Patrica (Frosinone)

•Chemo iberica - Madrid (Spagna)

•Fidia – Abano Terme (Padova)

•Gold pharma ltd - Sanmen - Zhejiang (Cina)

•Quimica Sintetica – Alcalà (Spagna)

•Aqua solution – Delhi (India)

•Icrom – Concorezzo (Milano)

•Industriale Chimica - Saronno

•Lamberti – Albizzate (Varese)

•Lundbeck – Padova

•Sifavitor – Mairano (Lodi)

•Pdp – Montegalda (Vicenza)

•Pyros – P. Marghera (Venezia)

•Profarma – Tirana (Albania)

•Sabo – Levate (Bergamo)

•Uquifa – Agrate brianza (Milano)

•Gruppo Italfarmaco – Cinisello B. (Milano)

•Zambon group spa – Lonigo(Vicenza)

•Università di Alicante – Alicante (Spagna)

•Itf Chemical – Camacari (Brasil)

Here some companies with wich TSA keepscontinuous and profitable work relationship :

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

Dr. Francesco Pinton

Email: f.pinton@tsaonline.it

Tel: 0039-3343388063