Galenic Development Laboratory
•Development of oral solids: ERWEKA LK-5, high-speed Lleal MGR5 granulation, mixture, Bonals compression, coating
•Development of liquids and semi-solid formulations: preparation of solutions, suspensions, syrups, creams and gels
•Development of injections: preparation of vials, Telstar Cryodos Freeze Dryer.
•Development of transdermal patches: Elcometer 3580 Film Applicator
•Biological safety cabins for handling high activity substances
• Galenic control equipment: weight, Erweka TBH30 durometer, Erweka TA10 friability tester, Erweka ZT71 disgregation, Brookfield DV-II + Pro Viscosimeter, Dr. Schleuniger JV2000 Volumeter, RETSCH AS200 Sieve
Analytical Development and Quality Control Laboratory
• Agilent 1100 and 1200 HPLCs with Diode Array detection, fluorescence, refractive index
• Agilent 1200 UPLC
• Agilent 6890 gas chromatography with Head Space
• Dionex ion chromatography
• Erweka Dt800 and Sotax AT7 dissolution tests in line with UV/Visible spectrophotometer with automated sample-taking and fraction collector
• UV/visible Agilent 8453 spectrophotometry
• Mettler Toledo DL 38 moisture analyzer by Karl Fischer
• Mettler Toledo DL50 titrator
• Mettler Toledo 822E/200 DSC
• Moisture analyzer (HB43) and analytical scales by Mettler Toledo
• Climatic chambers (Binder KBF720) for ICH stability and photo-stability studies
• Climate Room for ICH stability studies
• Biological safety cabins for handling high activity substances
• Microbiological control laboratory. Sterility control.
Pilot Plant in cGMP conditions
•Pilotmix L and Oystar Hüttlin 75 L high shear mixer-granulator
• Container and 60 L container mixer
• Fette compressor model 1200 iC, fully equipped for galenic development and manufacturing
• Manesty XLab and Oystar Manesty coating equipment
• CLINIPACK blister machine
•Process control laboratory: Dr. Schleuniger durometer, Erweka disgregator, Erweka friabilometer, moisture tester
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