cGMP API manufacture

Manufacture of API from preclinical to commercial supply.

 

At SONEAS Research, we have regulatory approval for cGMP manufacture of APIs and intermediates on lab to pilot plant scale, from preclinical through to commercial supply; meeting the needs of your development programmes.

 

We are all focused on delivering quality products and service. Site master files are available on request. Clients regularly visit our facilities for formal or informal audits, and we are happy to provide detailed information in relation to our quality systems.

 

Equipment to ensure our manufacturing meets and exceeds your expectations includes:

 

Kilo Laboratory

  • 63L SCHOTT gl reactors
  • 100L QVF gl reactor
  • 50L QVF crystallisation reactor
  • 250L QVF reactor with DN150 Sulzer graphite distillation column (20 theoretical plate numbers)
  • Glass reactors to 100L
  • 20L ss mobile hydrogenation reactor (10 bar)
  • 20L and 50L ss mobile Process filter/dryer
  • 20L rotary evaporators
  • 400mm ss Centrifuge; HEPA environment (class 100,000)
  • Mobile filters to 60L
  • Vacuum tray dryers
  • Scrubber

 

Pilot Plant

  • 250L, 500L, 1600L gl reactors
  • 1000L crystallisation reactor
  • 1000L Hastelloy C reactor with glass and gl overheads (operable down to -80°C)
  • 100L ss hydrogenation reactor (10 bar)
  • 600mm PFA coated centrifuge
  • 1,000 mm ss centrifuge (Class 100,000 HEPA environment)
  • Vacuum tray drier (Class 100,000 HEPA environment) – (capacity up to 50 kg)
  • 20L ss mobile drum blender
  • 0.6m2 QVF glass thin film evaporator
  • 35L Hastelloy C reactor (operable down to -80°C)
  • 20L Glass-top Distillation reactor
  • 20L gl reactor with DN100 distillation column
  • Huber thermostat (-80 to 200°C)
cGMP API Manufacture

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