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Multipurpose Pilot Plant

Acraf-Italy Acraf-Italy

Multipurpose Manufacturing Plants Italy Manufacturing Facilities in Italy Manufacturing Facilities in Fa Manufacturing Manufacturing Facilities in Italy Manufacturing Facilities in Italy Multipurpose Acraf-Italy Manufacturing Plants Multipurpose Manufacturing Plants

· 3 Manufacturing multipurpose facilities with reactors ranging from 800 to 6000 lt volume · 140,000 litres of total glass lined and stainless steel Finishing Bulk Facilities (AISI 316 and 304) reactor capacity Finishing Bulk Facilities · Operation conditions -10°C to +250°C · Solvent recovery Multipurpose Manufacturing Plants · 12 Stainless steel, glass lined or ebonised pressure filters and centrifuges

Manufacturing Facilities Acraf-Italy Acraf-Italy Acraf-Italy Capabilities Process R&D

in Italy

Manufacturing Acraf-Italy

· Chromatography (TLC, HPLC, GC) Facilities in Italy Regulatory · Capillary electrophoresis Finishing Bulk Facilities

Analytical R&D and QC Services Multipurpose Manufacturing Plants Multipurpose Manufactu Finishing Bulk Facilities · Titrimetry, potentiometry, gravimetry Multipurpose (C, H, N, S) · Elemental analysis Manufacturing Plants Multipurpose UV/VIS Finishing Bulk Facilities Pilotand FT-IR Plant · Spectrophotometry · Nuclear Magnetic Resonance for 1H Finishing Bulk Facilities and 13C

Multipurpose Pilot Plant Acraf-Italy Multipurpose Pilot Plant Multipurpose Manufacturing Plants Finishing Bulk Facilities

· Mass spectrometry (GC, LC Manufacturing Facilities in Italy electrospray interfaces coupled with APCI) and

Environmental Capabilities Multipurpose Capabilities Plant · Differential scanning calorimetry (polymorphism Process R&D PilotMultipurpose Pilot Plant and purity studies) Multipurpose Pilot Plant Mettler, Kofler) · Melting/boiling point equipment (Büchi,

· Particle size measurement (Sonic Sifter, Malvern Mastersizer) · Computerized QC Capabilities Process R&Ddata processing

· 7 fluid bed and rotative vacuum dryers; finished bulk APIs Process R&D Capabilities Process R&D Capabilities dryer in clean room · Separated finishing areas for micronising, blending and sieving Finishing BulkPilot Plant Facilities Multipurposerooms operations in clean

Work · METAMORPH® image Process R&D analyzerQC Services Manufacturing Facilities in Italy Force Capabilities conditions Process Analytical R&D and stability R&D Capabilities · Environment chambers for ICH

Multipurpose Manufacturing Plants Analytical R&D and QC Services Analytical R&D and QC Services Multipurpose Capabilities Process R&D Pilot Plant Finishing Bulk Facilities · 4 glass lined and stainless steel reactors ranging Regulatory from 250 to 1.000 Regulatory(50 lt capacity with distillation system. · 1 glass reactor lt) equipped Process R&D Capabilities · 1 glass lined Comber dryer-filter (500 lt) Analytical R&D and QC Services · Distributed process control systems (DCS) Multipurpose Pilot Plant · Operative conditions: -20°C to +250°C Environmental Capabilities Environmental Capabilities Analytical R&D and QC Services Regulatory Process R&D Capabilities Work Force · 3 organic synthesis Work Force laboratories operating up to 20 lt volume. · 1 FDA inspected Kilo Lab Regulatory · Micronisation equipment Environmental Capabilities · Auto-Mate H.E.L. (calorimeter QC Services Analytical R&D and for Hazard Evaluation)

Analytical R&D and QC Services and QC S Analytical R&D Regulatory Process Technology Services · FDA inspected R&D and Analytical since 1979 QC

· Validation master plans · Process validations Regulatory Regulatory Environmental Capabilities · ICH stability studies · DMF preparation and filing

Regulatory

Acraf-Farma Lepori

Environmental Capabilities Environmental Capabiliti Work Force · Physicochemical and Biological WW Plant Environmental Capabilities · Contract WW treatment Work Force

· 97 employees · Gases emission control system

Work Force

Work Force Process Technology

Process Technology Environmental Capabilities Process Technology Work Force

Regulatory

Acraf-Farma Lepori Acraf-Farma Lepori Work Force

Environmental Capabilities

Acraf-Farma Lepori Process Technology Process Technology Process Technology Acraf-Farma Lepori Acraf-Farma Lepori Acraf-Farma Lepori

Process Technology

Work Force Acraf-Farma Lepori Process Technology

Acraf-Farma Lepori

ACRAF SpA Via Guardapasso, Process Technology 1 - 04011 Aprilia (Latina) Italy - Tel + 39 06 920 40 210 - Fax + 39 06 920 40 252 - E-mail: [email protected] FARMA LEPORI, S.A.

Osi, 7-9 - 08034 Barcelona (Spain) - Tel + 34 932 53 45 41 - Fax + 34 932 80 31 22 - E-mail: [email protected]

Acraf-Farma Lepori

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