Powder Production from Sterile Injectables by a Fluidized Bed Granulator

摘要

Freeze dryers are widely used for drying sterile injectables due to their established acceptanceon CIP (clean in place) and SIP (sterilize in place) validations. However, it requires a longdrying time with this system, which leads to high manufacturing costs. In this study, wedeveloped a spray-dry type fluidized bed as an alternative to the freeze-drying. To meet withthe powder production requirements of drying sterile injectables and be free from thecontaminations of insoluble particles and endotoxic materials, a fluidized bed granulatorequipped with two-fluid nozzles, spiral pulse-jet nozzles, irrotational cleaning nozzles, andstar-shaped stainless steel sintered filters was developed and tested to validate its feasibilityfor CIP and SIP operations. It was found that the developed spray-dry type fluidized bedgranulator could be used to manufacture pharmaceutical powders from sterile injectables.