Equipment

Introduction to the facilities and equipment that form SPERA PHARMA’s technology.

Equipment suitable for all stages of CMC research is in place. If a special machine or apparatus etc is required, please do not hesitate to inquire using the inquiry page.

Main owned equipment of SPERA

Chemical R&D Division

  • Drug substance synthesis and process design research facilities: Research and testing facilities for drug substance synthesis studies, facilities for studying the application of asymmetric synthesis technology, solid form screening facilities
  • Facility for scale-up simulation studies
  • Production facilities for investigational drug substances (GLP and GMP)
  • Raw materials, investigational drug substance storage facilities etc.

Pharmaceutical Technology R&D Division

  • Solid investigational drug manufacturing facility:
    Small to medium scale GMP investigational drug manufacturing facilities
    Representative equipment: Agitation granulation device, dry granulation device, granule coating device, tablet coating device, capsule filling machine, extruder, wet grinding device, etc.
  • Solid investigational drug primary & secondary packaging facilities (GMP):
    Blister line (PVC, PP, Aclar, Al/Al film), bottle filling line, separate packaging line, bulk packaging line, etc.
  • Storage room for raw and other materials, etc.
  • Injectable formulation secondary packaging equipment

Analytical R&D Division

  • Physical and chemical test facility, raw material testing facility: analysis equipment room, HPLC room, chemical hazard room
    Representative equipment: LC/MS, LC/MS/MS, GC, GC/MS, Imaging System (NIR, Raman), Zeta Potometer, Particle Size Distribution measuring apparatus, Thermal Analysis apparatus (DSC, TG, XRD/DSC ), Automatic moisture absorption equilibrium equipment, Powder X-ray diffractometer, Dissolution tester (including reciprocating flow-through cell) etc.
  • Microorganism related test facility: biochemical laboratory, endotoxin test room, culture preparation room
    Representative equipment: MALDI Bio-Typer, Toxinometer, Endotoxin measuring apparatus, etc.
  • Storage facilities for stability tests: stability sample storage room, stability sample storage cabinet monitoring system, light stability test device
  • Process analysis equipment
    Representative equipment: LC/MS, LC/MS/MS, GC/MS, NMR, Particle distribution analyzer, ICP–AES, ICP–MS, Thermal analyzer (TG/DTA, DSC), Powder X-ray diffractometer, HPLC detectors (ELSD, Corona CAD) etc.

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