Low-Temperature Plasma Decontamination of Pharmaceutical Fill/Finish Operations

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 DESCRIPTION (provided by applicant): The goal of the proposed SBIR program is to develop an innovative, atmospheric pressure microwave microplasma technology for the generation of charge-neutral reactive oxygen and nitrogen species to replace vapor Phase hydrogen peroxide (VPHP) in parenteral drug manufacturing facilities, including barrier isolator sterilization system and lyophilizers. The proposed replacement of VPHP will eliminate the significant shortcomings associated with residual VPHP following sterilization including its deleterious effects on biotechnology drug therapies and the challenge associated with reliably monitoring part per billion (ppb) levels of VPHP in a manufacturing environment without the need for a PhD level scientist to operate the chemical detection system. This development targets the USFDA process analytical technology (PAT) initiative for building quality into pharmaceutical products, the industry Quality by Design (QbD) initiative, and Executive Order 13329 to modernize pharmaceutical manufacturing. The proposed R&D supports increasing the availability of critical drug products like vaccines and biotechnology drugs, the fastest growing segment of the industry. Improved manufacturing technologies will ultimately reduce the costs of prescription drug products.