ENHANCED DEVELOPMENT CAPABILITIES

R&D LABORATORY

• Building expansion to make segregated area for small-scale cGMP synthesis
• Four new fumehoods & workstations

LABORATORY INSTRUMENTS

• Bruker 300 MHz multi-probe NMR
• Agilent G6420 Triple Quadruple LC/Mass Spectrometer
• Agilent 1290 Infinity UPLC (2)
• Agilent 720 ICP-OES
• Agilent 7890A Ion Trap GC/Mass Spectrometer
• OptiMax (Semi-automated Reactor System with Heat Flow Calorimetry)
• Chemglass Jacketed filtration set up
• Open Lab^® software in place
• Uninterrupted Power Supply for laboratory instruments

cGMP KILO LAB

• New building constructed for the kilo lab
• 7 walk-in fume hoods
• Buchi 30 L ChemReactor train
• Buchi 20 bar 20 L Type 4 stainless steel KiloClave high pressure reactor
• Buchi 10 L triple jacket reactor
• Buchi 30 L high containment glass Nutsche filter
• Heidolph 20 L Rotavapor
• Binder vacuum dryer 4.1 cu ft.
• Huber -60°C to 250°C heating/cooling system
• Inline scrubber

UPGRADED MANUFACTURING OPERATIONS

PILOT PLANT

• Addition of one – 750 L Hastelloy C^® reactor with charging containment device
• Addition of one – 250 L glass-lined reactor
• Addition of two – 630 L glass-lined reactors
• Addition of a 0.5 m² Hastelloy C^® filter dryer with discharging containment device and continuous liner system
• Upgrade to silicon carbide condensers
• Connection of reactors to a new mono-fluid system with DCS
• Addition of two high-efficiency dry vacuum pumps
• All reactors and filter/dryer connected to a scrubber venting system

COMMERCIAL MANUFACTURING

• Construction of new building for the new mono-fluid system with DCS
• Upgrade to silicon carbide condensers
• Addition of one – 4,000 litre cryogenic reactor
• Replacement of two – 4,000 L glass lined reactors
• Replacement of two – 6,600 L stainless steel reactors
• Replacement of two – 2,500 L glass lined vessels
• Replacement of three – 1,500 L glass lined vessels
• Addition of two – 4,000 L stainless steel crystallizers
• Addition of two inverted basket centrifuges with continuous liner systems
• Addition of one Hastelloy C^® filter dryer – 2 m² with continuous liner system
• All reactors connected to a venting treatment system to minimize solvent release into atmosphere

EH&S IMPROVEMENTS

• Sampling booths with HEPA filtration and laminar flow
• Fully isolated charging stations in the pilot plant and commercial areas
• Continuous liner systems in the pilot plant and commercial areas for isolation and packaging of APIs
• Addition of seven high-efficiency dry vacuum pumps
• Addition of a distillation column for solvent recovery