Low-temperataure plasma decontamination of pharmaceutical manufacturing fill/finish operations

Project Summary AbstractThe goal of the proposed SBIR program is to develop a pharmaceutical manufacturing decontamination system using the innovative PSI atmospheric pressure microwave microplasma technologyCommercialization of this technology is targeted to replace the use of vapor phase hydrogen peroxideVPHPin parenteral drug manufacturing facilitiesincluding barrier isolator sterilization systems and lyophilizersThe replacement of VPHP in decontaminating aseptic pharmaceutical manufacturing facilities will eliminate the significant shortcomings associated with residual VPHP following sterilizationincluding its deleterious effects on biotechnology drug therapies and the challenge associated with reliably monitoring part per billionppblevels of VPHP in manufacturing environmentsThis development targets the USFDA process analytical technologyPATinitiative for building quality into pharmaceutical productsthe industry Quality by DesignQbDinitiativeand the national goal to modernize pharmaceutical manufacturingThe proposed Randamp D supports increasing the availability of critical drug products like vaccines and biotechnology drugsthe fastest growing segment of the industryImproved manufacturing technologies will ultimately reduce the costs of prescription drug productsProject NarrativeThe proposed project will develop a novel decontamination system that uses a low powermicrowave driven microplasma technology to produce reactive oxygen and nitrogen species for decontaminating parenteral pharmaceutical manufacturing facilities