At the Aerosol Research & Engineering Laboratories (ARE Labs), a U.S. laboratory specializing in the study of aerosolized microorganisms, PYURE conducted an evaluation of the kill rate on several pathogens, including viruses, bacteria and mold. The Odorox® MDU/Rx™ device demonstrated a kill rate of between 99.9% and 99.99% within an hour.
Two viruses were selected to evaluate performance against RNA and DNA based viruses:
• MS2 bacteriophage is a positive sense, single-stranded RNA virus that infects the bacterium Escherichia coli. MS2 is routinely used as a simulant for pathogenic RNA viruses such as SARS.
• Phi-X174 bacteriophage is a circular single stranded DNA based virus that infects the bacterium Escherichia coli. Phi-X174 is routinely used as a simulant for DNA viruses such as smallpox.
Two vegetative bacteria were selected as simulants for a broad range of pathogenic bacteria:
• Staphylococcus epidermidis, a Gram-positive bacterium and simulant for a range of medically significant pathogens such as Staphylococcus aureus (“staph” infections).
• Erwinia herbicola, renamed Pantoea agglomerans, is a Gram-negative bacterium commonly used as a simulant for Francisella tularensis and Yersinia pestis (bubonic plague).
One species of black mold
• Aspergillus niger was selected because it is a pernicious black mold that has been attributed to many respiratory problems for infants, the elderly and immunocompromised individuals. It is particularly difficult to kill in air and on surfaces.
For copies of reports testing PYURE devices on other surface bound pathogens, please contact PYURE.
Comparative Biosciences, Inc. in compliance with the US Food & Drug Administration GLP regulations (21 CFR Part 58), conducted a 13-week toxicology study on the effects of elevated PYURE output levels on a statistically significant population of rats. Rat exposure levels were 2 to 3 times higher than the maximum levels recommended by PYURE. The results showed no adverse effects on treated animals vs. control animals after continuous exposure for 13 weeks, neither at the gross or cellular level.
This toxicology study, along with the mechanism of action and pathogen destruction studies, were submitted to the FDA as part of the 510k registration and listing for the Odorox® MDU/Rx™ unit. As part of the FDA submission, a review of NIH, CDC and other relevant government databases was conducted. The review did not reveal any data or evidence that natural natural or artificial hydroxyls are in any way toxic to humans, animals or plants.
A study conducted at the Lovelace Respiratory and Research Institute (LRRI), in an ultra-clean environmental chamber demonstrated that:
• Hydroxyl production levels of an Odorox® Boss ™ unit are similar to the hydroxyl concentrations produced by sunlight outdoors
• Hydroxyls react within 20-40 milliseconds with volatile organic compounds (VOC) and generate powerful organic oxidants stable enough to circulate throughout the treatment space and sanitize air and surfaces
• The reaction rate of hydroxyls with VOC is a million times faster than ozone
• A very small quantity of ozone is produced as a byproduct of hydroxyl production, but the concentrations produced stay well within safe limits for occupied spaces
These results were subsequently published in a peer reviewed scientific journal. (David R. Crosley, Connie J. Araps, Melanie Doyle-Eisele & Jacob D. McDonald (2017) Gas-phase photolytic production of hydroxyl radicals in an ultraviolet purifier for air and surfaces, Journal of the Air & Waste Management Association, 67:2, 231-240, DOI: 10.1080/10962247.2016.1229236).
A study of PYURE Technology’s impact on indoor air quality was conducted by Columbia Analytical Services. The study examined the chemistry that resulted from hydroxyl decomposition of volatile organic compounds (VOC). The study revealed that operating a PYURE device significantly reduced total VOC levels, resulting in better indoor air quality. The VOC were rapidly decomposed and the steady state amounts of intermediate organic compounds, including formaldehyde, other aldehydes, ketones and alcohols did not accumulate while the PYURE device was running. The study detected very low levels of ozone (less than 15 parts per billion), far below the 50 part-per-billion maximum established by the FDA for continuous exposure. The study confirmed that PYURE Technology improves indoor air quality.