A SIMULATION-MODEL FOR THE PRIMARY DRYING PHASE OF THE FREEZE-DRYING CYCLE

A lyophilization process model was adapted to fit experimental data fr om product vials processed using a development scale dryer. The model was evaluated with regard to how well it simulated the primary drying time and temperature conditions for product vials during the primary d rying phase of the cycle. The results indicated the predicted drying t ime was very close to the actual drying time observed for the product. The simulated product temperature profile also compared well with the actual product temperature profile. The simulation results are presen ted as well as the coefficients used to fit the data,