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Study Title: EFFICACY OF THE PURIFI LABS™ IAI-100 AGAINST AEROSOLIZED SARS-COV-2 DELTA VARIANT
Sponsor: PuriFi Labs™
Test Facility: Innovative Bioanalysis, Inc. 3188 Airway Ave Suite D, Costa Mesa CA, 92626
Device Testing: PLASMAGUARD PRO by PURIFI LABS
Report Date: 08/09/2021
Experimental State Date: 07/17/2021
Experimental End Date: 07/17/2021 Study Completion Date: 08/09/2021
Study Objective: An ionization device, PLASMAGUARD PRO, was provided by PuriFi Labs™ for testing to evaluate the efficacy of the device against an aerosolized virus, SARS-CoV-2 Delta variant.
Test Method: Bioaerosol Generation: The nebulizer was filled with a (1.24 x 107 TCID50 per mL) FBS-based viral media of SARS-CoV-2 Delta variant and nebulized at a flow rate of 1mL/min with untreated local atmospheric air. For this experiment, fans were used to thoroughly mix 15 mL of aerosolized viral media into the environment to replicate a room containing a high viral load. Bioaerosol procedures for the controls and viral challenges were performed in the same manner with corresponding time points and collection rates.
Bioaerosol Sampling: Four probes connected to a calibrated Gilian 10i vacuum device set at a standard flow of 5.02L/min with a 0.20% tolerance were inspected for functionality before being used. Sample collection volumes were set to 10-minute draws per time point. The air sampler operated in conjunction with a removable sealed cassette and manually removed after each sampling time point. Cassettes had a delicate internal filtration disc to collect viral samples, which was moistened with a viral suspension media to aid in the collection. Filtration discs from Zefon International, Lot# 24320, were used for testing.
Test System Strains: SARS-CoV-2 Delta Variant
Equipment Overview: The equipment arrived at the laboratory pre-packaged from the manufacturer and was inspected for damage upon arrival. Before starting the challenge, the PLASMAGUARD PRO, powered by PuriFi Labs™ unit, was operated for 1 hour in a dry run to confirm correct operations. Positive and negative ion levels were measured using two Alpha Labs AIC2 devices with an average generation of 2,200 ± 500 ions per cubic centimeter.
MANUFACTURER: PuriFi Labs™
MODEL: PLASMAGUARD PRO
DIMENSIONS: 12” x 8.5” x 14” (with antenna)
MAKE: PLASMAGUARD PRO Generator
SERIAL #: 9454935D9913
Testing Layout: Testing was conducted in a 20'x8'x8' sealed chamber per Biosafety Level 3 (BSL3) standards. The overall dimensions of the test chamber provided a displacement volume of 1,280 cubic feet and approximately 36,245.56 liters of air. At each chamber corner, low-volume mixing fans were positioned at 45-degree angles to ensure homogenous mixing of bioaerosol concentrations when nebulized into the chamber. The room was equipped with four probes for air sampling positioned along the centerline of the room and protruded down from the ceiling 24". A nebulizing port connected to a programmable compressor system was located in the center of the 20' wall protruding 24" from the wall. The chamber was visually inspected, pressure tested, and all internal lab systems and equipment were reviewed before testing.
A modified HVAC system with an air handler box housing the PuriFi Labs™ IAI-100 device was used. The air handling box was located downstream from a fan unit and was situated in one corner of the room with a vertical stack of ducting. The duct traveled along the ceiling of the chamber creating an internal duct line with two diffusers in the room's centerline, as shown in Figure 1. The modified HVAC system made an airflow of approximately eight air changes per hour through the circular ducting.
Test Method:
Exposure Conditions:
1. The temperature during all test runs was approximately 77 ±2F with a relative humidity of 41%. Testing conditions were taken in two sections of the chamber to confirm a deviation of less than ±3%.
2. Testing time points were as follows, with T equal to minutes: T-0, T-14, T-29, and T-59.
Experimental Procedures:
1. Before the initial control test and following each trial run, the testing area was decontaminated and prepped per internal procedures.
2. Test conditions were a "Hot Start" scenario where the ion and modified internal HVAC system were turned on 15 minutes before the introduction of the pathogen.
3. A SARS-CoV-2 Delta variant stock of 1.24 x 107 TCID50/mL in FBS media was nebulized into the sealed environment via the dissemination port.
4. Air sampling collection occurred after nebulization ceased for the challenges and control test.
5. After each run, sample cassettes were manually removed from the collection system and taken to an adjacent biosafety cabinet to be pooled.
Post Decontamination:
After each viral challenge test, the UV system inside the testing chamber was activated for 30 minutes. After 30 minutes of UV exposure, there was a 30-minute air purge through the air filtration system. All test equipment was cleaned at the end of each day with a 70% alcohol solution. Collection lines were soaked in a bleach bath mixture for 30 minutes then rinsed repeatedly with DI water. The nebulizer and vacuum collection pumps were decontaminated with hydrogen peroxide mixtures.
Control Protocol
To accurately assess the IAI-100, a static decay control and an airflow control were conducted without the device operating in the testing chamber. The static decay control was performed to simulate an HVAC system in standby mode, and the airflow control acts as an active HVAC system without an air purification device. The collection was taken at corresponding time points used for the challenge trial, in the same manner, to serve as a comparative baseline to assess aerosolized viral reduction when the device was operating.
Conclusion: The PLASMAGUARD PRO, powered by PuriFi Labs™ device, performed to manufacturer specifications and demonstrated a consistent progressive reduction of the active virus at 14 minutes, 29 minutes, and 59 minutes of exposure in aerosol form. The amount of active SARS-CoV-2 Delta variant in the atmosphere was reduced over the control samples by approximately 99.998% vs the static control and 99.997% vs the airflow control, with a total reduction of 99.999%. When aerosolizing pathogens and collecting said pathogens, some variables cannot be fully accounted for, namely, placement of pathogen, collection volume, collection points, drop rate, surface saturation, viral destruction on collection, viral destruction on aerosolization, and possibly others. Every effort was made to address these constraints with the design and execution of the trials. And these efforts are reflected in the meaningful recovery of virus in the control test. Considering the variables, there was a measurable amount of reduction achieved by the PuriFi Labs™ IAI-100 device at each of the T-14, T-29, and T-59 time points. The decline in air was consistent with the manufacturer's claims that the device can decrease the concentration of active pathogens in the air. Overall, the PLASMAGUARD PRO, powered by PuriFi Labs™ device, showed efficacy in reducing SARS-CoV-2 from the air samples collected.
Disclaimer: The Innovative Bioanalysis, Inc., LLC. ("Innovative Bioanalysis") laboratory is not certified or licensed by the United States Environmental Protection Agency and makes no equipment emissions claims pertaining to ozone, hydrogen peroxide gas, reactive oxygen species, volatile organic compounds, or byproduct of any GPS FC48™ device. Innovative Bioanalysis, Inc. makes no claims to the overall efficacy of any GPS FC48™. The experiment results are solely applicable to the device used in the trial. The results are only representative of the experiment design described in this report. Innovative Bioanalysis, Inc. makes no claims as to the reproducibility of the experiment results given the possible variation of experiment results even with an identical test environment, viral strain, collection method, ion concentration, inoculation, viral media, cell type, and culture procedure. Innovative Bioanalysis, Inc. makes no claims to third parties and takes no responsibility for any consequences arising out of the use of, or reliance on, the experiment results by third parties.