Granulation

General Description

This operation is used for drying and granulation of a mixture containing dissolved solids, for example active pharmaceutical ingredients and excipients. It is a common processing step in the pharmaceutical industry for dosage formulation when the final product is in tablet or capsule form. The advantage of this operation over the tray drying operation is that the drying, homogenizing and storing steps in a vessel are combined in one method (instead of using a dryer and silo), reducing labor requirement and contamination risks. In addition the simultaneous stirring / agitation can reduce the drying batch time.

Unit Procedure Availability

      Drying-Granulation Procedure

Granulation: Modeling Calculations

Material and Energy Balances

The material balances are done based on the evaporation percentage of the solvent components. The specific heating requirement along with the amount of solvents that evaporate are used to calculate the total heating requirement. The specific power requirement is used to calculate the overall power requirement. The Drying Gas requirement along with the amount of solvents that evaporate is used to calculate and adjust the flowrate of the drying gas.

Equipment Sizing

The equipment is sized based on its volume. In Design Mode, the user specifies the maximum equipment volume and the maximum allowable working to vessel volume. The user specified Final Solids Bulk Density is used to calculate the dried solids volume (working volume). If calculated volume exceeds the maximum allowable per unit, the program assumes multiple identical units operating in parallel with a total tray area equal to the calculated. In Rating Mode, the user specifies the number of parallel units their volume, and the maximum allowable working to vessel volume. If the calculated working volume exceeds the maximum allowable value, the user is warned.

Granulation Time

The drying time is either specified by the user or calculated based on the spaying rate (in kg evap./h), that is the feed rate of the main input, the liquid solution that contains the active ingredient.

Vacuum Pump Power Consumption

See Vacuum Pump Auxiliary Equipment Calculations.

Granulation: Interface

The interface of this operation has the following tabs:

      Oper. Cond’s, see Granulation: Oper. Conds Tab

      Volumes, see Mixing & Drying Operations: Volumes Tab

      Utility Data, see Granulation: Utility Data Tab

      Labor, etc, see Operations Dialog: Labor etc. Tab

      Description, see Operations Dialog: Description Tab

      Batch Sheet, see Operations Dialog: Batch Sheet Tab

      Scheduling, see Operations Dialog: Scheduling Tab