Types of analyzes:
- Chemical/physicochemical analysis (qualitative and quantitative) of medicinal products according to approved and validated/transferred in the laboratory analytical methods for the purpose of incoming control or analysis upon import into the European Union (EU-retest); chemical/physicochemical control of purified water according to pharmacopoeial monographs.
- Microbiological analyzes of non-sterile medicinal products and food supplements according to approved and validated/verified in the laboratory microbiological methods; microbiological monitoring of clean rooms, production equipment, personnel, and water.
- AQL tests on tablets and capsules
- Incoming control of primary and secondary packaging materials
- Stability testing of finished medicinal products under storage conditions 25°C / 60% RH
Equipment in the analytical laboratory:
- UV-Vis spectrometers
- FTIR spectrometers
- HPLC and UHPLC systems with UV-Vis, PDA, and RI detectors
- Gas chromatography system (GC) with flame ionization detector (FID) for headspace analyzes and liquid samples’ analyzes
- Karl Fischer titrators for determining the water content
- Testers for pharmaceutical tests of medicinal forms - disintegration, friability, hardness, and dissolution
- Vacuum dryer
- Dryer at normal pressure
- Muffle furnace
- Other ancillary equipment
Equipment in a microbiological laboratory:
- Incubators that maintain different temperature regimes - respectively for incubation of molds and yeasts, aerobic microorganisms, and E. coli
- Autoclaves
- Dry sterilizer
- Water bath
- Laminar boxes class A according to clean room classification
- Colony counter
- KRUSS microscope
- Vitek 2 – system for microbiological identification