Quality

Quality
 

Process development from lab to pilot scale

  • Experienced team of chemists focus on process development and scale up, aligned with customers’ requirements.
  • Development is carried out in close collaboration with the plant chemist, analytical laboratory, pilot plant, process engineer, and safety manager.

Analytical methods development

Development and validation of analytical methods supports various activities carried out by:

  • R&D
  • Plant chemist – Manufacturing operation
  • Raw materials and suppliers qualification
  • Waste, effluents and emissions
  • Stability and shelf life

QC Laboratory

Data acquisition/ management
The QC tests results are stored in StarLims ® system which controls batch release for shipments and allow for statistical data analysis.

Equipment
HPLC and GC equipped with auto samplers, UV-VIS spectrophotometer, conductivitymeter, Karl Fischer titrators (volumetric and coulometric), automatic titrators (potentiometric), densimeter, USP Pharmacopeia automated melting point system, Analytical balances, LOD balance.