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| Multipurpose Manufacturing Plants |
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- 3 Manufacturing multipurpose facilities with reactors ranging from 800 to 6000 lt volume
- 140,000 litres of total glass lined and stainless steel(AISI 316 and 304) reactor capacity
- Operation conditions -10°C to
+ 250°C
- Solvent recovery
- 12 Stainless steel, glass lined or ebonised pressure filters and centrifuges
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| Finishing Bulk Facilities |
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- 7 fluid bed and rotative vacuum dryers; finished bulk APIs dryer in clean room
- Separated finishing areas for micronising, blending and sieving operations in clean rooms
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| Multipurpose Pilot Plant |
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- 4 glass lined and stainless steel reactors ranging from 250 to 1000 lt capacity
- 1 glass reactor (50 lt) equipped with distillation system.
- 1 glass lined Comber dryer-filter (500 lt)
- Distributed process control systems (DCS)
- Operative conditions: -20°C to + 250°C
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| Process R&D Capabilities |
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- 3 organic synthesis laboratories operating up to 20 lt volume.
- 1 FDA
inspected Kilo Lab
- Micronisation equipment
- Auto-Mate H.E.L. (calorimeter for Hazard Evaluation)
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| Analytical R&D and QC Services |
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- Titrimetry, potentiometry, gravimetry
- Elemental analysis (C, H, N, S)
- Chromatography (TLC, HPLC, GC)
- Capillary electrophoresis
- Spectrophotometry UV/VIS and FT-IR
- Nuclear Magnetic Resonance for 1H and 13C
- Mass spectrometry (GC, LC coupled with APCI) and electrospray interfaces
- Differential scanning calorimetry (polymorphism and purity studies)
- Melting/boiling point equipment (Büchi, Mettler, Kofler)
- Particle size measurement (Sonic Sifter, Malvern Mastersizer)
- METAMORPH® image analyzer
- Environment chambers for ICH stability conditions
- Computerized QC data processin
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| Regulatory |
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- FDA
inspected
since 1979
- Validation master plans
- Process validations
- ICH stability studies
- DMF preparation and filing
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| Environmental Capabilities |
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- Physicochemical and Biological WW Plant
- Contract WW treatment
- Gases emission control system
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| Work Force |
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