Planning Engineering Projects management of Pharmaceutical Plants

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1 Planning Engineering Projects management of Pharmaceutical Plants Contrà S. ANNA 1/ CAMPOSAMPIERO (PD) tel fax

2

3 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.

4 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

5 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

6 Some works by TSA Process design of a multipurpose workshop: drying. milling, packaging of API fermentation products ( 3,5 millions ) New plant for production of APIs semisynthetic antibiotics steril and non steril (about 150 tons/y), in the same site a new pharmaceutical plant for formulation of about 90 tons of APIs in capsules and steril phials (25 millions) Basic and executive engineering for new farmaceutical workshop for high potency tablets drug production (1,5 million) Detail design of an farmaceutical workshop for high potency vials drug small production production Process and executive engineering for workshop for natural extraction of drug from natural source Process,, basic, detail design, construction management and start-up of new Active Pharmaceutical Ingredients production plant in China for european company, compliance international and chinese GMP(25 millions) New pharmaceutical plant for peptides purification of small quantity and very high value of the product.

7 Some works by TSA Feasibility, basic and detail design of a new API purification isolation i and and finishing workshop, including: purification and drying workshop of many APIs: 9 production lines milling and packaging systems (6 milling rooms, 2 micronization rooms, 3 packaging rooms) automated storehouse for finished products, 900 pallets, air conditioned. Basic, detail design, construction management of a new plant for API formulation and and packing workshop: Formulation, solids mixing, milling, micronizing dry and humid granulation, drying of various APIs tableting, steril vials, perfusionals, suppositorys,, ointments, syrups. packaging systems and warehouses for row and finished products,. HVAC plant and of pharmaceutical decoration (Sterile, ISO 7 and ISO 8 areas), utilities area Total project amount 18 millions General audit on facilities and GMP management checking the compliance level of the Italian factory of a foreign company. Formulation of a general plan of adjustment, timing and cost evaluation. Final inspection of FDA and no 483 as result

8 TSA TOOLS The TSA offices in Camposampiero(PD) are equipped with: 12 workstations, all the computers are equipped of cpu and cards video accredited from Autodesk the ram are of 2-42 gb with screen d inches All the computers are equipped with operating system Windows XP, office package Structural design: Modest,, Strauss, Rendering: rhinoceros technical design 2D and 3D: Autocad 2008 of Autodesk with all the applicativi packages EsaPro printing plotter for great formats till A0 Two printing laser brother copy-fax fax-scanner Konica Minolta A3 colors

9 Architettural & Civil Design

10 T.S.A. srl 3D VIEW Production & Warehouse Industrial buildings

11 T.S.A. srl 3D VIEW - Services Industrial buildings

12 T.S.A. srl 3D VIEW - Offices Industrial buildings

13 Air Treatment

14 Process design

15 Atex Classification

16 Fire Proof

17 Eletric Design&Power Supply

18 Mechanical Design&Piping

19 Some Installation

20 Here some companies with wich TSA keeps continuous and profitable work relationship : 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)

21 Contacts: Head office and operations site T.S.A. srl Contrà S. Anna 1/5 I CAMPOSAMPIERO (PD) Tel: Fax: Dr. Francesco Pinton Tel:

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