title: Analysing drying unit performance in a continuous pharmaceutical manufacturing line by means of mass--energy balances.
abstract: The current trend in the pharmaceutical industry to move from batch-wise to continuous production processes strengthens the need for monitoring and controlling the process in-line. The ConsiGma™ continuous tableting line collects data of the different subunits in real-time, but these are not really used. In this paper the data of the six-segmented fluidized bed dryer in the line are used for the development and evaluation of a mass and energy balance. The objectives are multiple: (1) prediction of the moisture content of the granules leaving the dryer solely based on the currently logged data and (2) prediction of the gas outlet temperature to check the mass balances. Once a validated system is established the gas temperature in different horizontal sections of the drying unit can be predicted. Calculations are also used to identify errors in the system and to propose alternative sensor locations. A calibration is performed in order to predict the evaporation rate. The balances were able to predict both the moisture content of the granules at the end of the drying process and the gas outlet temperature quite accurately. Combining the gathered information with the height of the bed in the fluidized bed can be used to predict the gas temperature in different horizontal sections of the dryer. An extra sensor measuring the gas temperature and the humidity at the wet transfer line would increase the accuracy of the calculations. An extra gas velocity sensor at the outlet would be useful to incorporate an extra supervision of the calculations.
authors.affiliation: Department of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Ghent, Belgium; Department of Pharmaceutical Analysis, Ghent University, Ghent, Belgium. Electronic address: severine.mortier@ugent.be.
authors.forename: Séverine Thérèse F C
authors.initials: ST
authors.lastname: Mortier
authors.affiliation: Department of Chemical and Biochemical Engineering, Technical University of Denmark, Kgs. Lyngby, Denmark. Electronic address: KVG@kt.dtu.dk.
authors.forename: Krist V
authors.initials: KV
authors.lastname: Gernaey
authors.affiliation: Department of Pharmaceutical Analysis, Ghent University, Ghent, Belgium. Electronic address: thomas.debeer@ugent.be.
authors.forename: Thomas
authors.initials: T
authors.lastname: De Beer
authors.affiliation: Department of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Ghent, Belgium. Electronic address: ingmar.nopens@ugent.be.
authors.forename: Ingmar
authors.initials: I
authors.lastname: Nopens
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D016208:Databases, Factual; D003890:Desiccation / Q000379:methods*; D006813:Humidity / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000737:chemistry*; D013696:Temperature
chemical_list: D004364:Pharmaceutical Preparations
keywords: Drying process; Energy balance; In-line univariate measurements; Mass balance; Pharmaceutical engineering; Process monitoring