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ServicesGMP

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Intermediate and cGMP API manufacture

The lllatos Site undertakes cGMP manufacture of APls and intermediates from laboratory to pilot plant scale and is approved by the regulatory authorities for the manufacture of API from preclinical to commercial supply, supported by a fully qualified, well equipped analytical laboratories and comprehensive SOPs. Site Master Files ore 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.

Soneas OGYÉI Certificate
Soneas EMA Certificate
KILO LABORATORY
  • Glass reactors: up to 100L
  • QVF glass lined reactor: 100L
  • QVF crystallization reactor: 50L
  • QVF reactor with DNISO Sulzer graphite distillation column: 250L, theoretical plate number 20
  • SCHOTT gloss lined reactors: 63L
  • Stainless steel mobile hydrogenation reactor: 20L,10bar
  • Rotary evaporators: 20L
  • Filters and driers:
    • Stainless steel mobile process filter/dryer: 20L and 50L
    • Mobile filters: to 60L
    • Vacuum troy driers
  • Centrifuge
  • Stainless steel centrifuge (HEPA cl 100,000)
  • Scrubber
PILOT PLANT UNIT-1
  • Crystallization reactor: 1,000L
  • Glass lined reactors: 250L; 500L; 1,600L
  • Thin evaporator: QVF glass; 0.6m2
  • Vacuum troy dryer: up to 50kg (HEPA cl 100,000)
  • Centrifuge: stainless steel;1,000mm (HEPA cl 100,000)
  • Mobile drum blender: stainless steel; 20L
PILOT PLANT UNIT-2
  • Glass lined reactor with DN100 distillation column
  • Glass top distillation reactor: 20L
  • Hastelloy C reactor with glass, glass lined overheads: 1,000L; 35L; down to -80°C
  • Stainless steel hydrogenation reactor: 100L;10bar
  • Centrifuge: PFA coated; 600mm
  • Huber Thermostat: -80 to 200°C
PILOT PLANT UNIT-3
    • DeDietrich glass lined reactors: 1,600L; 2×1,000L
    • HEPA environment (cl 100,000) on demand
    • Filter/dryer: Rosenmund stainless steel: 2×0.4 m2
    • HEPA environment cl 100,000
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