The goal of the proposed SBIR program is to develop a pharmaceutical manufacturing decontamination system using the innovative PSI atmospheric pressure microwave microplasma technology. Commercialization of this technology is targeted to replace the use of vapor phase hydrogen peroxide (VPHP) in parenteral drug manufacturing facilities, including barrier isolator sterilization systems and lyophilizers. The replacement of VPHP in decontaminating aseptic pharmaceutical manufacturing facilities 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 manufacturing environments. This development targets the USFDA process analytical technology (PAT) initiative for building quality into pharmaceutical products, the industry Quality by Design (QbD) initiative, and the national goal 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.
The proposed project will develop a novel decontamination system that uses a low-power, microwave driven microplasma technology to produce reactive oxygen and nitrogen species for decontaminating parenteral pharmaceutical manufacturing facilities.
