Synopsis

Fluidized bed granulation (FBG) is a commonly known and highly complex process in the pharmaceutical industry. In-line spatial filter velocimetry (SFV) analysis for particle size measurement provides a promising approach to enhance process control and efficiency. In the present study investigations of the installation height and the influence of differing process parameters on in-line SFV analysis were evaluated.

 

Materials and Methods

A blend of Cellets (Harke Pharma GmbH, Germany) was fluidized using a lab scale system (GPCG 2, Glatt GmbH, Germany). In-line SFV analysis by the Parsum IPP 70 probe (Parsum GmbH, Germany) was conducted at two different installation heights and further by variations of the in-let air volume, the in-let air temperature and the in-let air moisture. The results were compared to at-line SFV analysis as reference measurement.

 

Results

The particle size detected at the lower probe position (x50 = 400 ± 11 µm) was similar to the results measured at-line (x50 = 409 ± 4 µm). In contrast results determined at the higher probe position were clearly underestimated (x50 = 171 ± 44 µm) due to size segregation in the fluidized bed. Differing particle rates were observed between both positions (low position: ca. 200 particles/s; high position: ca. 5 particles/s). Increasing inlet air volume settings led to decreasing particle rates whereas the detected particle size was nearly unaffected and showed a high conformity compared to the reference measurement. Results generated by varying inlet air

 

Presentation of Theresa Reimers 

@Making Pharmaceuticals 2018 – April 25, 2018