(163b) Powder Production for Sterile Injectables by a Fluidized Bed Granulator

Freeze dryers are widely used for drying sterile injectables due to their established acceptance on CIP and SIP validations. However, it requires a long drying time with this system, which leads to high manufacturing costs. In this study, we developed a spray-dry type fluidized bed granulator as an alternative to the freeze dryer. To meet with the powder production requirements of drying sterile injectables and free from contaminations of insoluble particles and endotoxic materials, a fluidized bed granulator equipped with two-fluid nozzles, spiral air jet nozzles, rotational cleaning nozzles, and star-shaped stainless steel sintered filters were developed and tested for its feasibility in CIP and SIP validations. It was found that the developed spray-dry type fluidized bed granulator could be used to manufacture pharmaceutical powders for sterile injectables.