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
- 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.
- 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
- 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.