ARE Labs was contracted by HGI industries Inc. for characterization and decontamination testing of a novel biological decontamination system the ODOROX® (MDU) for cGLP FDA 510(k) Application Requirement.  Based on the testing results FDA granted HGI industries’ claims for 4-log reduction of viable aerosolized: Bacteria (gram negative and positive), Viruses (DNA and RNA), spores (Bacillus globigi, surrogate for  Bacillus Anthrisis; Anthrax) and mold spores. 

ODOROX®  ‘s decontamination technology is based on hydroxyl radical generation via UV radiation.  The System is design for use in patient recovery rooms for the destruction of airborne biological pathogens.  This is very much an important area of development for recovery and continued well being of hospital patients and those with compromised immune systems.  With the continued emergence of biological pathogens that have therapeutic and antibiotic resistance, this technology could have broad applications for reducing or eliminating the potential transmission of infectious disease from patient to patient and to hospital staff.  The threat of aerosol transmission is of great concern due to the increased risk of infectivity via the inhalation route in relation to other transmission routes.

The testing was performed here at ARE Labs in our stainless steel biological/chemical aerosol and vapor containment chamber.  Our Aerosol Test Chamber (ATC) is designed for evaluating biological and chemical generation, sampling, detection and decontamination systems in a large scale room-like environment.  THE ATC is outfitted with multiple aerosol generators, sampling ports, mixing fans, and vaporous & aerosol hydrogen peroxide decontamination generator for testing biological and chemical decontamination efficacy.  In addition, everyday objects found a hospital or residential can also be placed in the chamber with controlled leak rates to simulate a true real-world  situations.  Surface swatches and swabs can be performed to gather surface decontamination efficacy data is so desired.

For this study we characterized the efficacy of HGI’s MDU technology against six biological pathogen surrogate aerosols that included two vegetative bacteria (Gram pos & neg), two viral (RNA & DNA) and two spore forming organism (bacteria and mold).   The system was tested in a multi-pass recirculation mode for efficacy of reducing bioaerosols in a room environment by a magnitude of 4 logs against the 6 biological aerosols in individual test trials.  Testing included baseline control test trials and three replicate MDU™ test trials for each of the biologicals.  The objective was to characterize the unit to determine capability to achieve a 4-log reduction in viable bioaerosols within 6 hour test period.

We prepared working stock cultures of the biological test organisms and generated the aerosols in the respirable mass size range with appropriate aerosol sampling and real-time particle size monitoring of the Aerosol Test Chamber.  Particle size distributions of each bioaerosol were measured throughout the duration of each trial using a TSI Aerodynamic Particle sizer.   Resultant aerosols for each biological showed ≥ 1×105 cfu or pfu/Lair viable airborne concentrations for each organism throughout the 6 hour time in conducted pilot control testing.   Concentrations were verified via impinger, filter or impactor sampling during the total trial period with triplicate plating and viable concentration emeration of the test samples.

Characterization testing showed outstanding results with a total reduction of bioaerosol viability  of 3.8-5 log (organism dependent) within a 2 hour period.   HGI was gracious in letting us post some of the results from testing their ODOROX® MDU disinfection unit.

ARE Lab’s provides the highest quality standards in the testing and development of our clients products.  From decades of experience in performing biological, chemical and environmental aerosol studies, we know the importance of designing systems, and study test plans and procedures that are customized specifically for the application of testing and evaluating our client’s products.

If you have any questions or would like to inquire on how we may support your products testing or development, please feel free to give us a call.  We look forward to talking with you.