Nasal Spray Production Process Optimization with Final Sterilization Removal

Abstract

A non-sterile nasal spray production process is presented and examined with the aim of eliminating the gamma terminal sterilization step. Several key points, including but not limited to process design, bioburden control, and environmental monitoring (EM) are considered alongside this endeavor. By implementing the best practices dependent on these factors, sterile filtration prior to filling can be achieved.