QbD-PAT MatrixRS

Quality by Design * Design Space * Process Analytical Technology * NIR – spectroscopy * Chemometry * Multivariate data analysis

Reserch Infrastructure

Two fully equipped research laboratories: one for drug pre-formulation, formulation and preparation (Galenic Laboratory) and one for drug analysis/characterization (Drug Analysis Laboratory) are available for the research team

A. Galenic Laboratory

– analytical balances (Sartorius, Germany)

– technical balances (Ohaus, SUA)

– eccentric tablet press (Korsch, Germany)

– drum hoop mixer (Erweka, Germany)

– laboratory kneader (Erweka Germany)

– laboratory wet granulator (Erweka, Germany)

– laboratory fluid bed system for powder /granules drying, granulation (GEA-Aeromatic, Switzerland)

– laboratory Wurster fluid bed

– ultra-turax homogenizer (Ika, Germany)

– DSC832e – Differential Scanning Calorimeter  (Mettler Toledo, Switzerland)

– TGA – Thermogravimetric Analyzer (Mettler Toledo, Switzerland)

– climatic chambers for stability studies (Binder, Germany

– climatic chambers with forced air convenction –  VENTICELL 55 (BMT, Czechia)

– vertical discs mill, vibrating balls mill

– laser particle size analyzer  (Fritsch, Germany)

 

 

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B. Drug Analysis Laboratory

– MicroNIR™ PAT-U Spectrometer (VIAVI,  Italy)

– FT-NIR spectrometer MPA (Bruker,  Germany)

– 2 dissolution testers (PharmaTest, Germany)

– UV-Vis spectrophotometer (Jasco, Germany)

– HPLC (Agilent, SUA)

– disintegration tester (Erweka, Germany)

– tablets hardness tester (Schleunige, Germany)

– tablets friability tester (Erweka, Germany)

– powder tappet/bulk density tester (Erweka)

– powder flow tester (Copley Scientific, UK)

– sieve analysis tester (Retsch, Germany)

– pH-meter (Mettler Toledo, Switzerland)

– centrifuge Sigma 2-16 (Sigma, Germany)

– automate pipettes (Biohit, Finland)

– ultrasonic bath

– moisture analyzer (Ohaus, Germany)

– titrator karl-fischer  TitroLine® 7500 KF trace (SI Analytics, Germany)

– optical microscope with video camera and software for image analysis (Optika, Italy)

Computers, software for data processing infrastructure

– DoE software: Modde 11.0 (Umetrics, Sweden), Unscrambler X (Camo, Norway);

– multivariate data analysis and chemometric software: SIMCA-P 14.0 (Umetrics, Sweden), Unscrambler X (Camo, Norway), Opus Quant (Bruker, Germany);

Details about the available research infrastructure are presented on ERRIS platform to the following address: https://erris.gov.ro/Laboratory-of-Pharmaceutical

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https://erris.gov.ro/Laboratory-of-Pharmaceutical