Evaluation of validation of a fully instrumented Hüttlin HKC 05-TJ laboratory-scale fluidized bed granulator.
The instrumentation and validation of a laboratory-scale fluidized bed apparatus is described. For continuous control of the process, the apparatus is instrumented with sensors for temperature, relative humidity (RH), and air velocity. Conditions of inlet air, fluidizing air, product, and exhaust air were determined. The temperature sensors were calibrated at temperatures of 0.0 degree C and 99.9 degrees C. The calibration of the humidity sensors covered the range from 12% RH to 98% RH using saturated electrolyte solutions. The calibration of the anemometer took place in a wind tunnel at defined air velocities. The calibrations led to satisfying results concerning sensitivity and precision. To evaluate the reproducibility of the process, 15 granules were prepared under identical conditions. The influence of the type of pump used for delivering the granulating liquid was investigated. Particle size distribution, bulk density, and tapped density were determined. Granules were tableted on a rotary press at four different compression force levels, followed by determination of tablet properties such as weight, crushing strength, and disintegration time. The apparatus was found to produce granules with good reproducibility concerning the granule and tablet properties.
Wöstheinrich
K
K
University of Tübingen, Department of Pharmaceutical Technology, Germany.
Schmidt
P C
PC
D002138:Calibration; D002626:Chemistry, Pharmaceutical; D019245:Compressive Strength; D004339:Drug Compounding / Q000295:instrumentation* / Q000379:methods; D005069:Evaluation Studies as Topic; D010316:Particle Size; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry
D013607:Tablets