Gaining fluid bed process understanding by in-line particle size analysis.
Different process phenomena and process failure modes could be monitored using the in-line particle size data measured by spatial filtering technique (SFT). In addition to the real-time granule growth monitoring, other events, such as the blocking of filter bags and the distributor plate, could be observed. SFT was used off-line, at-line and in-line in 14 differently manufactured granulation batches. No significant fouling occurred during the manufacturing due to the appropriate positioning of the probe. The off-line SFT results correlated well (R(2) = 0.97) with the sieve analysis results. It was also found that size segregation influenced both the in-line and at-line particle size results during the fluidization: in-line method underestimated and at-line method overestimated the final particle size.
Närvänen
Tero
T
Orion Corporation Orion Pharma, Orionintie 1, P.O. Box 65, FIN-02101 Espoo, Finland. tero.narvanen@orionpharma.com
Lipsanen
Tanja
T
Antikainen
Osmo
O
Räikkönen
Heikki
H
Heinämäki
Jyrki
J
Yliruusi
Jouko
J
D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D005374:Filtration / Q000379:methods*; D010316:Particle Size