Optimization of a freeze-drying cycle of a viral vaccine based on changes in temperature, time and geometry of the vials.

ABSTRACT

The freeze-drying process is used in pharmaceutical industry, however in terms of process management, the process must be avoided at all cost because it has several disadvantages such as high equipment investment, high energy demand, a process that requires long times and products easily to moisturize and fragile and needs to be carefully packed and stored. This work aims at reducing the freeze-drying cycle time of a viral product and consider loading this product at subzero temperatures to increase productivity of this product. Experiments were carried out with freeze-drying cycles with less 15 and 20h in comparison to the original cycle. The experiments were performed with the same formulation of the commercial batch and using a pilot freeze dryer. Modifications were made in the physical properties of the current freeze-drying cycle (temperature, pressure and time) and the loading temperature of the product, without changing the formulation of the vaccine or primary loading. Samples of the lyophilized product trial were analyzed for their appearance, performance, residual moisture, strength and accelerated thermostability in the amount currently used by the company quality control. All the results were within the specifications of the company were close to or better when compared to commercial batches.