title: Gaining fluid bed process understanding by in-line particle size analysis.
abstract: 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.
authors.affiliation: Orion Corporation Orion Pharma, Orionintie 1, P.O. Box 65, FIN-02101 Espoo, Finland. tero.narvanen@orionpharma.com
authors.forename: Tero
authors.initials: T
authors.lastname: Närvänen
authors.forename: Tanja
authors.initials: T
authors.lastname: Lipsanen
authors.forename: Osmo
authors.initials: O
authors.lastname: Antikainen
authors.forename: Heikki
authors.initials: H
authors.lastname: Räikkönen
authors.forename: Jyrki
authors.initials: J
authors.lastname: Heinämäki
authors.forename: Jouko
authors.initials: J
authors.lastname: Yliruusi
mesh_terms: D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D005374:Filtration / Q000379:methods*; D010316:Particle Size