F J BENJAMIN HOLDINGS LTD Characterization of a
Natural Convection Thermal
Flow-Through (TSS Technology)
Air Purification Device in
Deactivation of Aerosolized
SARS-CoV-2
Final Report
FOR
Airfree - Produtos Electronicos SA
Julieta Ferrão no.10, 9 piso, Fracção A 1600-131 Lisbon, PORTUGAL
MRIGlobal Project No. 311744.01.001
May 28, 2021
Preface
This final report was prepared at MRIGlobal for the work performed under MRIGlobal Task No. 311744.01.001, "Characterization of a Natural Convection Thermal Flow-Through (TSS Technology) Air Purification Device in Deactivation of Aerosolized SARS-CoV-2."
The experimental phase of this task was initiated by MRIGlobal on April 15, 2021 and ended on April 21, 2021.
The test was performed by Rick Tuttle and Kristy Solocinski, Ph.D. They were assisted by Jacob Wilkinson. The project was managed by William Sosna.
The study was not performed in compliance with the FDA Good Laboratory Practice Regulations (21 CFR 58). All operations pertaining to this study, unless specifically defined in this protocol, were performed according to the Standard Operating Procedures or approved Laboratory Procedures of MRIGlobal. All technical procedures were overseen by a second person and data was quality checked and peer reviewed.
All study records are stored at MRIGlobal.
Sincerely,
MRIGLOBAL
Rick Tuttle
Principal Scientist
Approved:
Claire R. Croutch, Ph.D.
Portfolio Director
Medical Research
May 28, 2021
MRIGlobal-HCG311744-01-001_R | ii |
Contents
Preface............................................................................................................................................. | ii | ||
Executive Summary....................................................................................................................... | iv | ||
Section 1. | Objective ........................................................................................................................ | 1 | |
Section 2. | Sponsor, Testing Laboratory, and Personnel Responsibilities....................................... | 2 | |
2.1 | Sponsor's Representative ...................................................................................... | 2 | |
2.2 | Testing Laboratories.............................................................................................. | 2 | |
2.3 | Personnel Responsibilities..................................................................................... | 2 | |
Section 3. | Test Materials................................................................................................................. | 3 | |
3.1 | Test Product........................................................................................................... | 3 | |
3.2 | Test Components................................................................................................... | 3 | |
Section 4. | Test Systems and Methods............................................................................................. | 4 | |
4.1 | Test Device............................................................................................................ | 4 | |
4.2 | Methods................................................................................................................. | 4 | |
Section 5. | Analysis of Data............................................................................................................. | 9 | |
Section 6. | Results.......................................................................................................................... | 10 | |
Section 7. | Results and Conclusions .............................................................................................. | 14 | |
Figures | |||
Figure 1. | SARS-CoV-2 Aerosol Test System ............................................................................... | 5 | |
Figure 2. | Test Device Temperature Profile ................................................................................... | 6 | |
Figure 3. | Aerodynamic Particle Sizer (APS) Aerosol Particle Count vs Sample Time Plot ...... | 12 | |
Figure 4. | Aerodynamic Particle Sizer (APS) Aerosol Particle Size Distribution Plot................ | 13 | |
Tables | |||
Table 1. | Test Matrix..................................................................................................................... | 7 | |
Table 2. | TCID50/ml Calculations for Aerosol Testing of the Airfree® Onix 3000 .................... | 10 |
MRIGlobal-HCG311744-01-001_R | iii |
Executive Summary
Objective:
The objective of this project was to determine if the Airfree® Onix 3000 (sold in Asia and Europe as P150) Air Purifier ("Test Device") can deactivate airborne SARS-CoV-2 in controlled tests conducted at MRIGlobal. The Test Device incorporates a ceramic core, which heats up to temperatures in the range of 80° to 210°C. Airflow through the unit is obtained through natural convection, which pulls in room air for recirculation and sterilization of bio-aerosols. As air exits the thermal air purification heat core, it enters a cooling chamber in the unit which cools the air to near room air temperature conditions before release back into the room. This thermal flow through air recirculation design provides maintenance free operation without the use of fans or filter units, and uses the thermal heat core for the deactivation of biological aerosols.
Study Design:
The Airfree® Onix 3000 (sold in Asia and Europe as P150) air purifier was evaluated at MRIGlobal under controlled conditions in a biological level 3 ("BSL-3") laboratory. Testing was conducted using an aerosol containment system housed in a biological class 3 safety cabinet. All testing was conducted using a common stock of SARS-CoV-2 prepared in suspension at a concentration of 1.47E+07 TCID50 / ml. MRIGlobal utilized the USA-WA1/2020 (Washington State 1 isolate) strain of the virus, acquired from BEI Resources (NR-52281). The virus was propagated in Vero E6 cells (ATCC CRL-1586).Vero E6 cells were cultured in growth media consisting of Dulbecco's Modified Eagle Medium with Nutrient Mixture F-12 (DMEM/F12) supplemented with 5% FBS (Fetal Bovine Serum), and PSN (penicillin, streptomycin, and neomycin). MRIGlobal designed and fabricated the SARS-CoV-2 aerosol test system for the evaluation of multi pass air recirculation purifiers.
The aerosol system is equipped with aerosol generation and sampling systems and calibrated digital flow controllers and meters. Pre - device test characterization of the viral aerosol delivery efficiency and time weighted viable aerosol concentration testing was performed to establish baseline (standard) results for subsequent thermal viral deactivation efficacy testing comparison. The Test Device was placed in the center bottom of the test system with only a low flow test chamber recirculation fan operational (Test Device off) for providing uniform mixing and a homogeneous concentration of generated aerosols. Aerosol samples were collected Midget Impingers (Midget, model 7531, Ace Glass Inc.) filled with 10 ml DMEM/F12 to assess the efficacy of the device. Collected Impinger samples were diluted 1:10 down a 96 deep well plate in DMEM/F12. These dilutions were transferred to a plate of Vero E6 cells with media removed. After approximately 45 minutes, DMEM/F12 supplemented with 5% Fetal Bovine Serum (FBS) was added to cells to feed them for the next four to five days. The inoculated plates were then read for cytopathic effects (CPE). Additionally, an APS 3321 aerosol particle sizer ("APS") was used for sequential real time sampling for aerosol particle size and concentration measurements.
MRIGlobal-HCG311744-01-001_R | iv |
Section 1.
Objective
The objective of this project was to determine if the Airfree® Onix 3000 (sold in Asia and Europe as P150) Air Purifier (Test Device) can deactivate airborne SARS-CoV-2 in controlled lab tests.
MRIGlobal-HCG311744-01-001_R | 1 |
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F J Benjamin Holdings Ltd. published this content on 15 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 June 2021 13:51:04 UTC.
