Quality control

Quality control

Quality is considered the fundamental objective in the Bioindustria L.I.M. strategy

A chemical quality control laboratory and a microbiological quality control laboratory allow to carry out all the necessary analyses, from analytical controls on raw materials and excipients to process controls, to controls on the finished product and to analyses for stability studies.

Our laboratory has all the tools needed to perform all release and stability analyses.

Equipment:

  • High pressure liquid chromatograph (HPLC)
  • Gas chromatograph (GC)
  • Ion chromatograph
  • Atomic Absorption Spectrometer (AAS)
  • NIR spectrophotometer
  • Ft-IR infrared spectrophotometer
  • UV-VIS spectrophotometer
  • Osmometer
Bioindustria L.I.M. has on-site stability chambers in order to perform all stability tests prescribed by the ICH guidelines, including those representing of the conditions in the IVB zone and the refrigeration conditions (2 to 8°C).