ACTIVEPURE TEST RESULTS MARCH 2021 - THE BUILT ENVIRONMENT ...
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ActivePure Test Results
March 2021
ActivePure has been tested in over 100 independent laboratory
settings and different live environments. The following tests
results highlight our capabilities.
To request other test results, please contact:
medical@activepure.com
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Table of Contents
I. Aerosol Research and Engineering Laboratories
FDA 510K Class II Testing Review-Medical Guardian
II. MRI Global
ActivePure Technology in decontamination of Live SARS-CoV-2
o Hydroxyl Blaster tested
III. University of Texas Medical Branch
ActivePure Technology in Elimination of airborne live SARS-CoV-2
o Aerus Pure and Clean tested
IV. Eastern Health-Health Science Center Newfoundland, Canada
Medical Guardian pathogen reduction in Surgical Intensive Care and
Cardiovascular Intensive care units
Test results showed improvement post-implementaion of UV and HEPA filtration
V. Overview on Cleveland Clinic Two-year double-blind Study
Composite outcome of postoperative complications
o Mortality
o Major Surgical site infection
o Healing-related wound
complications
o Estimated enrollment-86,000 plus
patients
Cost of Care-2nd end point
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Efficacy of Aerus Medical Guardian Air System against
Various Bioaerosols
Jamie Balarashti a, Sylvester Marshall III a, Dan Merchant a
a
Aerosol Research and Engineering Laboratories Inc. Olathe KS
Background: This in-vitro study characterized the decontamina on e cacy of the Aerus Medical Guardian against
various aerosolized biologicals. Aerus Medical LLC’s (Bristol, VA) Medical Guardian unit is an indoor air puri on
system that is designed to neutralize airborne microorganisms. The e ec veness of the system was assessed for six
(6) aerosolized biologicals: two vegeta ve bacteria: Staphylococcus epidermidis (Gram +) and Erwinia herbicola (Gram
-); two viruses: MS2 (RNA bacteriophage) and Phi X174 (DNA bacteriophage); a bacterial endospore; Bacillus globigii,
and a mold spore; Aspergillus niger. The tes ng consisted of a single control trial plus triplicate decontamina on trials
for each organism tested.
Methods: Each of the six (6) organisms used for tes ng were nebulized into a sealed environmental bioaerosol
chamber containing the Aerus Medical Guardian air system. AGI impingers were used to capture chamber bioaerosol
concentra ons at set sampling mes. Viable cascade impactors were u lized with some organisms for higher
resolu on sample collec on. All impinger samples were serially diluted, plated and enumerated in triplicate to yield
viable bioaerosol concentra on at each sampling point and me. Chamber control trial data was subtracted from
Medical Guardian trial data to yield net LOG reduc on in the chamber for each tested bioaerosol challenge.
Results: Staph had an average Net LOG reduc on of 5.46 +/- 0.34 for the triplicate trials. Erwinia’s average Net LOG
reduc on was 5.36 +/- 0.37. The Medical Guardian’s e cacy against the MS2 virus was 5.58 +/- 0.43. The
performance against Phi X174 showed 4.05 +/- 0.27 net LOG reduc on. The endospores, Bacillus, had an average net
LOG reduc on of 4.23 +/- 0.31, and the mold spores, A. niger, had a net LOG reduc on of 4.12 +/- 0.10. The two test
viruses, MS2 and Phi X174, organisms showed no viability er t=75minute (MS2) and T=60minutes (PhiX174), in
order to calculate the net LOG kill for these organisms a ous single colony count was used to calculate the limits
of detec on for each trial and to show the minimum Net LOG reduc on achieved for the Medical Guardian.
Summary: Overall, the Medical Guardian showed an average Net LOG reduc on for all organisms tested of 4.80 +/-
0.74. The unit seemed most e ec ve at removing vegeta ve bacteria from an environment, with an average net LOG
reduc on of the two vegeta ve bacteria tested of 5.41 +/- 0.07. However both viruses were below detectable limits
due there being zero plaques observed on plates er a certain me point, meaning that the net LOG reduc on for
those organisms only represents a minimum value. Spores are known to be tough and highly resilient, and therefore
it is not unexpected that their net LOG reduc ons, average 4.18 LOG, are not quite as high as the other organisms.
Overall the Medical Guardian showed a high e cacy against of a broad range of viable bioaerosol.
This study was conducted in compliance with FDA Good Laboratory Prac ces (GLP) as de ned in 21 CFR, Part 58.
Overview
This study was conducted to evaluate the e cacy of safety level 1 (BSL1) organisms in order to evaluate the
the Aerus Medical Guardian produced by Aerus system’s Net LOG reduc n of the viable bioaerosols.
Medical LLC’s (Bristol, VA), to decontaminate viable All Bioaerosol challenge tes ng for this study used
airborne bioaerosols. Tes ng was conducted in a an Aerus Medical Guardian (Model # F170A)
controlled stainless steel aerosol chamber designed to developed by Aerus Medical LLC (Bristol, VA). A picture
simulate a small room environment. The Medical and details of the Medical Guardian air system is shown
Guardian’s e ec ness was tested against six (6) Bio- in Figure 1.
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The e ec veness of the Medical Guardian was The aerosol test chamber is constructed of 304
evaluated against vegeta ve bacterium, endospores, stainless steel and is equipped with three viewing
viruses, and mold spores. Tes ng with each of the six windows and an air- ght lockable chamber door for
dis nct organisms was completed in triplicate trials plus system setup and general ingress and egress. The test
a control trial to demonstrate the capability of reducing chamber internal dimensions are 9.1 x 9.1 x 6.8 ,
viable bioaerosol concentra ns. There were a total of with a displacement volume of 562 cubic feet, or 15,914
twenty-four (24) independent trials in this study. liters. Figure 2 shows a diagram of the tes ng chamber
con gura n. Tes ng condi ns inside the chamber
Each organism was examined during a set process were consistently 72.0 F with 50% rela ve humidity.
involving a control trial and three test trials. During the
control trials the Medical Guardian would remain inside The chamber is equipped with ltered HEPA inlets,
the tes ng chamber, but would never be ac ated. The digital internal temperature and humidity monitor,
organisms were aerosolized into the controlled external humidi ers (for humidity control), ligh ng
chamber, and air samples were collected at set me system, mul ple sampling ports, aerosol mixing fans,
points throughout each trial. Comparisons of the and a HEPA ltered exhaust system that are operated
number of living organisms between the control trials with wireless remote control. For tes ng, the chamber
and the test trials allowed for determina n of the was equipped with four 3/8 inch diameter stainless steel
Medical Guardian’s e acy at removing viable probes for aerosol sampling each sampling about 18”
bioaerosols from an enclosed room environment. from the nearest sidewall. A stainless 1 inch diameter
port was used for bio-aerosol dissemina n into the
chamber using a Collison 24-jet nebulizer for the
bacteriophages, vegeta ve cells and bacterial spores, or
Aerus Medical Guardian a dry powder eductor for the fungal spores.
Picture: A ¼ inch diameter probe was used for con nuous
aerosol par cle size monitoring via a TSI Aerodynamic
Par cle Sizer (APS) model 3321. All sample and
dissemina n ports were inserted approximately 18
inches from the interior walls of the chamber to avoid
wall e ects and at a height of approximately 40 inches
from the oor.
The aerosol sampling and aerosol dissemina n
probes are stainless steel and bulk headed through the
chamber walls to provide external remote access to the
Device Features aerosol generator and samplers during tes ng.
Manufacturer: Aerus Medical LLC
Model: F170A The test chamber is equipped with two high- ow
Notes: Ion Generator, Photocatalytic Oxidizer HEPA lters for the introduc on of filtered puri ed air
Figure 1: Aerus Medical Guardian air system into the test chamber during aerosol evacua n/purging
of the system between test trials and a HEPA ltered
exhaust blower with a 500 3/min rated ow capability
Bioaerosol Testing Chamber for rapid evacua n of remaining bioaerosols.
A magnehelic gauge with a range of 0.0 +/- 0.5 inch
A large sealed aerosol test chamber was used to
H2O (Dwyer instruments, Michigan City IN) was used to
replicate a poten ly contaminated room environment
monitor and balance the system pressure during aerosol
and to contain any poten release of aerosols into the
genera n, aerosol purge and tes ng cycles.
surrounding environment.
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Figure 2: Bio-Aerosol Test Chamber Flow Diagram.
Test Location and Conditions MN). The APS sampled for the en re dura n of all trials
(90 minutes) with 1 minute sampling intervals.
Tes ng was conducted at Aerosol Research and
Engineering labs located at 15320 S. Cornice Street in The impingers were lled with 20 mL of sterilized
Olathe, Kansas 66062. Laboratory condi ns were PBS (addi n of 0.005% v/v Tween 80) for bioaerosol
approximately 70.6 F with 36% rela humidity. collec n. The addi n of Tween 80 was shown to
increase the impinger collec n e iency and de-
Bioaerosol Sampling and Monitoring System agglomera n of all microorganisms.
Two AGI-30 impingers (Ace Glass Inc., Vineland NJ) During tes ng with some organisms, sample
were used for bio-aerosol collec of biological collec ns were also obtained using a pair of viable
aerosols to determine the chamber concentra n. cascade impactors. A viable cascade impactor (SKC Inc.,
These impingers were connected to the bioaerosol Valley View, PA) comprises an inlet cone, precision-
chamber via sample ports located at opposite corners of drilled 400-hole impactor stage, and a base that holds a
the chamber. standard-size agar plate (Figure 3). A high ow pump
pulls microorganisms in air through the holes (jets)
The AGI-30 impinger vacuum source was where they are collected on the agar surface.
maintained at a nega e pressure of 18 inches of Hg
during all characteriza n and test sampling to assure
cri cal ow condi ns. The AGI-30 sample impingers
were ow characterized using a calibrated TSI model
4040 mass ow meter.
Aerosol par cle size distribu ns and count
concentra ns were measured in real- me through the
dura n of all control and Aerus trial runs using a model Figure 3: SKC BioStage Viable Cascade Impactor.
3321 Aerodynamic Par cle Sizer (APS) (TSI Inc., St Paul,
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Target Impinger
ATCC Monodispersed Challenge Total Trial Sample Time
Trial Run Species (gram, description) Ref Particle Size Conc. (#/L) Time (min) (min) Sampling Plating and Enumeration
1 Control Stapilococcuss epidermidis
4 6 0, 15, 30, 45, 60,
2 Challenge (+, vegetative) 12228 2.5-3.0µm 10 -10 90 APS, Impingers & Viable Cascade all samples in triplicate
75, 90
3 Control Erwinia herbicola
4 6 0, 15, 30, 45, 60,
4 Challenge (-, vegetative) 27155 2.5-3.0µm 10 -10 90 APS, Impingers & Viable Cascade all samples in triplicate
75, 90
5 Control MS2 bacteriophage
4 6 0, 15, 30, 45, 60,
6 Challenge (E. coli phage) 15597-B1
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dissemina n of the bioaerosol, instead a custom dry
Vegetative Cells Culture & Preparation eductor and feeder was used dispersed into the
chamber using a ARE Labs dry powder aerosoliza n
Pure strain seed stocks were purchased from ATCC unit.
(American Type Culture Collec n, Manassas VA).
Working stock cultures were prepared using sterile Plating and Enumeration
techniques in a class 2 biological safety cabinet and
followed standard prepara n methodologies. Impinger and stock biological cultures were serially
Approximately 100ml of Staph and Erwinia Herbicola diluted and plated in triplicate (mul ple serial dilu ns)
stock was prepared in tryp c soy liquid broth media, and using a standard spread plate assay technique onto
incubated for 24 hours with oxygen infusion (1cc/min) at tryp c soy agar plates. The plated cultures were
37°C. Biological stock concentra ns were greater than incubated for 24-48 hours (species dependent) and
1 x 109 cfu/ml for Staph and Erwinia using this method. enumerated and recorded.
Stock cultures were centrifuged for 12 minutes at Inert Particle Characterization
4000 rpm in sterile 50mL conical tubes, growth media
was decanted, and the cells re-suspended in sterile PBS In order to calculate the dissemina n e iency,
bu er for aerosoliza n. Aliquots of these suspensions stability and to pinpoint impinger/viable cascade sample
were enumerated on tryp c soy agar plates (Hardy mes pre-tes ng was conducted using polystyrene latex
Diagnos cs, Cincinna OH) for viable counts and stock beads (PSL miscrospheres) prior to bioaerosol tes ng.
concentra n calcula s. For each organism, test PSL microspheres were used to characterize the various
working stocks were grown in su ient volume to aspects of the chamber and Aerus system.
sa use quan es for all tests conducted using the
same culture stock material. Polydispersed PSL beads with aerodynamic
diameters of 1.0 m were nebulized and chamber
Viral Culture & Preparation concentra ns were recorded using the APS. The
control trials were used to calculate nebuliza n
Pure strain viral seed stock and host bacterium e ciencies, par cle stability and AGI-30 collec n
were obtained from ATCC. Host bacterium was grown in e ciencies were used to es mate genera n
a similar fashion to the vegeta ve cells in an appropriate e ciencies, dissemina n mes, sample mes and
liquid media. The liquid media was infected during the aerosol persistence prior to bioaerosol tes ng. Live
logarithmic growth cycle with the speci c trials with the Medical Guardian system were also
bacteriophage. A er an appropriate incuba n me the performed to measure par cle removal rates of the
cells were lysed and the cellular debris discharged by system.
centrifuga n. MS2 stock yields were greater than 1 x
109 plaque forming units per milliliter (pfu/ml) with a
single ampli ca n procedure. Phi X174 stock yields
were less than MS2 yields, and ranged between 1 x 108
to 1 x 109 pfu/ml a er two ampli ca ns.
Endospore Culture & Preparation
Bacillus globigii spores were growth, sporelated,
spray dried and stored in a pure dry powder (2.41 x 1011
cfu/gr.) form ahead of me. Master stocks were
prepared using the pure spore and were kept stored in a
30% ethanol : 70% PBS + tween solu n to maintain
their endospore state and to prevent contamina n by
other vegeta cells. Nebuliza n proceed directly
using this master stock.
Figure 4: LOG Reduction of 1.0um PSL Beads
Aspergillus niger fungal spores were also cultured,
Figure 4 shows the LOG reduc n of 1.0um PSL
puri ed and stored in puri ed bulk powder form with a
beads both with the Medical Guardian unit on (Test
concentra n of 3.4 x 109 cfu/gr. Due to the size of the
Trial) and o (Control Trial). The gure shows the
spore (5µm diameter) nebuliza n was not used for
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General Timeline for Bioaerosol Chamber Testing
Purge Nebulization Hold Hold Hold Hold Hold Hold Evac Decon
Impinger Sampling Medical Guardian Turn on,
Impinger Sampling and Possible Medical Guardian Turn off,
Viable Cascade Sampling
Table 2: General Trial Timeline for Aerus Medical Guardian Decontamination Trials.
comparison between the reduc n with and without the 20 mL of sterilized PBS (addi on of 0.005% v/v Tween
Medical Guardian. When the Guardian is turned on the 80) for bioaerosol collec n. The addi n of Tween 80
LOG reduc n of 1.0um PSL beads follows a precise was shown to increase the impinger collec n e iency
logarithmic func . It is notable that this size (1um) is and de-agglomera n of all microorganisms.
smaller than the vegeta ve bacteria, bacterial
endospores, and mold spores, but larger than the two The chamber mixing fan was turned on during
viruses. bioaerosol dissemina n to assure a homogeneous
bioaerosol concentra n in the test chamber prior to
the rst impinger sample.
Control Testing
Following bioaerosol genera n, baseline
To accurately assess the Aerus Medical Guardian bioaerosol concentra ns were established for each
unit, test chamber pilot control trials were performed pilot control and Guardian test by sampling
with all Bioaerosols from 90 to 120 minute periods simultaneously with two AGI-30 impingers located at
without the Medical Guardian in opera n to opposite corners of the chamber. AGI samples were
characterize the biological challenge aerosol for par cle collected for 2, 5, or 10 minutes (organism dependent)
size distribu n, aerosol delivery/collec n e iency, at intervals of 15 minutes throughout the en re period.
decay rate and viable concentra n over me. Control Table 2 above shows the general meline for each
tes ng was performed to provide baseline compara e Medical Guardian live bioaerosol challenge trial.
data in order to assess the actual reduc n from Medical
Guardian challenge tes ng and verify that viable Collected impinger chamber samples were pooled
bioaerosol concentra ns persisted above the required and mixed at each sample interval for each test. Aliquots
concentra ns over the en re pilot control test period. of impinger samples were collected and then used for
pla ng. Impingers were rinsed 6x with sterile ltered
During control runs, a single low velocity fan located water between each sampling interval, and re- lled with
in the corner of the bioaerosol test chamber was turned sterile PBS using sterile graduated pipe es for sample
on for the dura n of trial to ensure a homogenous collec n.
aerosol concentra n within the aerosol chamber. The
mixing fan was used for all control runs and was turned For Medical Guardian biological tes ng, the unit
o during Medical Guardian decontamina n trials. The was turned on immediately following a me 0 baseline
two impingers used for bacteriophage, vegeta , sample and operated for the en rety of the test (up to
fungal and bacterial endospore test sampling were 90 minutes). Subsequent impinger samples were taken
pooled and mixed prior to pla ng and enumera n. at intervals of 15 minutes and samples enumerated for
viable concentra n to measure the e ec viable
bioaerosol reduc n during opera n of the Medical
Medical Guardian Testing Guardian system over me. Table 2 outlines the general
meline for the tes ng procedure with the Medical
For each control and challenge test, the Collison Guardian.
nebulizer was lled with approximately 50 mL of
biological stock and operated at 50 psi for a period of 20 Test chamber temperature and humidity were
or 25 minutes (organism dependent). For control and recorded at the ini n and comple n of each test.
Medical Guardian trials, the impingers were lled with
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All samples were plated in triplicate on tryp c soy agar tes ng chamber. The control trial experienced only a
media over a minimum of a 2 log dilu n range. 0.62 LOG reduc n of Staph a er 90 minutes of sample
collec ns using the AGI-30 impingers.
Plates were incubated for viable plaque forming
units (pfu) formation for the viral phase of the study, and
colony forming units (cfu) for fungal spore, and bacterial
endospore phases of the study. Plates were incubated
and enumerated for viable counts to calculate aerosol
challenge concentra ns in the chamber and reduc n
of viable microorganisms.
Post-Testing Decontamination and Prep
Following each test, the chamber was air ow
evacuated/purged for a minimum of twenty minutes
between tests and analyzed with the APS for par cle
concentra n decrease to baseline levels between each
test. The chamber was decontaminated between live
microorganism trials with aerosol/vaporous hydrogen
Figure 5: LOG Reduc n of S. epidermidis in control and
peroxide (35%). The Collison nebulizer and impingers
Medical Guardian test trials.
were cleaned at the conclusion of each day of tes ng by
soaking in a 5% bleach bath for 20 minutes. The
The Medical Guardian trials saw a dras c increase
nebulizer and impingers were then submerged in a DI
in reduc n with the unit ac ated. In 15 minutes, over
water bath, removed, and spray rinsed 6x with ltered
the three test trials, an average of only 1.183% of the
DI water un l use.
viable Staph s ll remained inside the tes ng chamber.
Figure 5 shows the LOG reduc n of Staph for the
control and test trials over the 90 minute tes ng periods.
Data Analysis
At 60 minutes there was an average net LOG reduc n
of Staph of 5.95 +/- 0.34 with a limit of detec n of 8.15.
Shows the results of the quadruplicate trials for
Figure 6 shows the LOG reduc ns for each Staph trial
each biological tested for this study. All results indicate
and their average +/- standard devia n.
the calculated viable bioaerosol concentra n both
upstream and downstream of the Clean Air System and
the Net LOG reduc n provided by the system.
All trials show individual and group average +/-
standard devia ns for Net LOG reduc n on a per
challenge organism basis.
Results by Organism
Staphylococcus epidermidis
The S. epidermidis are a gram posi aerobic
bacteria that grow in tryp case soy at 37°C and were
chosen to act as surrogates for Staph aurus. Infec ns Figure 6 Net LOG Reduc n of Staphylococcus
from S. aurus are a leading cause of hospital-acquired epidermidis
infec ns and are linked to 50,000 deaths in the USA per
year. Erwinia herbicola
Staph cultures were ini ted the day prior to their The black plague surrogate, Erwinia herbicola, was
tes ng, and grew to a concentra n greater than 1e 10 the second and nal vegeta e bacterium tested in this
cfu/ml. A er nebuliza n, ini concentra ns of study. The gram-nega bacterium were grown
Staph averaged 2.6e5 cfu/L of atmosphere inside the overnight to an average concentra n of 8.4e9 cfu/ml,
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and a er nebuliza n had an average concentra n of
1.9e5 cfu/L of atmosphere inside the tes ng chamber.
The Erwinia control trial saw a 0.70 LOG reduc n
a er 90 minutes of sample collec n. A er 15 minutes
of being ac ated, the Medical Guardian removed an
average of 99.992% of the viable Erwinia from the
chamber atmosphere. The average net LOG reduc n
of Erwinia by the Medical Guardian at 75 minutes was
5.36 +/- 0.37 with a limits of detec n of 7.64.
Figure 9: LOG Reduc n of MS2 bacteriophage in
control and Medical Guardian test trials.
The single control trial saw a slightly increased
reduc n in viable organisms over me compared with the
vegeta bacterium, reaching a LOG reduc n of 0.94 in
90 minutes. With the Medical Guardian ac ated, an
average of 99.999% of the virus had been removed from the
chambers atmosphere in 15 minutes. At 60 minutes, there
was an average net LOG reduc n of MS2 of 5.58 +/- 0.43
Figure 7: LOG Reduc n of Erwinia herbicola in control with a limits of detec n of 6.37. The Net LOG reduc n is
and Medical Guardian test trials. considered a minimum value because a single pfu was
ar cially added at 60 minutes in order to show detec n
limits. There were in reality, no observed viable growth
collected at 60 minutes. However, if zeros were to be
marked for the plates the logarithmic math does not
calculate.
Figure 8: Net LOG Reduc on of Erwinia herbicola.
MS2 Virus
The bacteriophage MS2 is a single stranded RNA virus
that o en serves as a surrogate for noroviruses in studies of Figure 10: Net LOG Reduc n of MS2 bacteriophage
disease transmission. MS2 infects E. coli, which was used
as its mechanism of reproduc n for this study. Average
concentra ns of MS2 reached 5.4e9 pfu/mL in culture pre Bacillus globigii endospores
tes ng, and chamber concentra ns a er nebuliza n
averaged 8.1e5 pfu/L of atmosphere. Endospores are an extremely resilient structure
formed by some bacteria under unfavorable condi ns
that are resistant to UV radia n, desicca n, chemical
disinfectants and severe temperatures. The Bacillus
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globigii spores tested served as surrogates for a similar
species that causes Anthrax. Aspergillus niger, the second spore based organism
tested is a fungus rather than bacterial species. It is
Unlike the vegeta e bacterium and viruses, the known for causing black mold disease in fruits and
spores did not need to be cultured before tes ng. Large vegetables and is closely related to Aspergillus
quan es of spores stored in alcohol can be purchased fumigatus, the most common airborne fungal pathogen.
and are ready for immediate tes ng. Pre nebuliza n Like B. globigii, the A. niger spores did not require
stock of B. globigii was at a concentra n of 2.7e9 cul a n, but were commercially acquired ready for
cfu/mL, and chamber concentra n post nebuliza n tes ng.
had an average concentra n of 7.95e5 cfu/L.
Figure 13: LOG Reduc n of Aspergillus niger spores in
control and Medical Guardian test trials.
Figure 11: LOG Reduc n of Bacillus globigii
endospores in control and Medical Guardian test trials. Concentra ns of A. niger inside the chamber a er
With the Medical Guardian o the control trial saw nebuliza n was less than previous organisms, with an
a LOG reduc n a er 90 minutes of 0.49. A er 15 average of 2.61e4 cfu/L. The control trial revealed a LOG
minutes with the Medical Guardian ac ated during the reduc n a er 90 minutes of 1.77, which was higher
test trials, 1.09% of the spores remained in the chambers than had been observed previously. With the Medical
atmosphere. A er 90 minutes there was a net LOG Guardian ac ated for 15 minutes during tes ng trials,
reduc n of 4.23 +/- 0.31 with a limits of detec n of an average of only 0.29% of A. niger remained inside the
5.70. chamber. A er 60 minutes there was an average net
LOG reduc n of 4.12 +/- 0.10 with a limits of detec n
of 5.59.
Figure 12: Net LOG Reduc on of Bacillus globigii
endospores
Figure 14: Net LOG Reduc on of Aspergillus niger
Aspergillus niger Mold Spores spores.
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Phi X174 Virus
The Phi X174 bacteriophage tes ng was planned
immediately following MS2 tes ng, however obstacles
arose with culturing the virus to desirable
concentra ns. The tes ng was pushed back to the end
of the study to give me to develop slight altera ns to
the growth protocols. Like MS2, Phi X174 infects E. coli,
however it is a DNA virus with a small genome.
Figure 16: Net LOG Reduc n of Phi X174
bacteriophage.
Figure 15: LOG Reduc n of Phi X174
bacteriophage in control and Medical Guardian test
trials.
Pre-tes ng cultures of Phi X174 had an average
concentra n of 4.4e8 pfu/mL, which was signi cantly
lower than any other organisms tested. Once nebulized,
the concentra n of the atmosphere inside the tes ng
chamber averaged 7.63e3 pfu/L. There was a LOG
reduc n of Phi X174 of 0.89 at 90 minutes during the
control trial, and an average net LOG reduc n of 4.05
+/- 0.27 with limits of detec on of 4.73 during tes ng
trials. There were no plaques observed beyond 30
minutes and a single pfu was added to determine
detec n limits.
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Aerus Medical Guardian Bioaerosol Challenge Summary Net LOG Reduction Results
Limits of
Time Avg Net LOG Standard
Challenge Organism Surrogate for ATCC # Gram T1 T2 T3 Detec on
(min) Reduc on Devia on
Methicillin Resistant Staph
1 Staphylococcus epidermidis 12228 pos 60 5.72 6.35 5.79 5.95 0.34 8.15
aureus (MRSA)
2 Erwinia herbicola Yersinia pes s (Black Plague) 27155 neg 75 5.12 5.79 5.17 5.36 0.37 7.64
3 MS2 virus In uenza, Norovirus 15597-B1 NA 60 5.44 6.06 5.25 5.58 0.43 6.37
4 Phi X174 virus HCV, HBV, HIV 13706-B1 NA 60 4.18 4.22 3.74 4.05 0.27 4.73
C. di cile (spore) & Anthrax
5 Bacillus globigii endospore 16404 pos 90 3.99 4.12 4.58 4.23 0.31 5.70
(spore)
6 Aspergillis niger mold spore Black Mold 13835 NA 60 4.01 4.20 4.14 4.12 0.10 5.59
*Red text = at detec on limits, Calculated LOG Reduc on values represent a minimum
Table 3: Net LOG reduc on summary for the Medical Guardian air system.
Summary of Results be tough and highly resilient, and therefore it is not
unexpected that their net LOG reduc ns are not quite
Overall, the Medical Guardian’s showed an average as high as the other organisms.
Net LOG reduc n for all organisms tested of 4.80 +/-
0.74. The unit was more e ec at removing The Figure 17 below shows each average net LOG
vegeta bacterium from the tes ng chambers reduc n for the organisms tested +/- their standard
atmosphere than either the viruses or spores, with an devia ns. Table 3 shows a nal summary table of the
average net LOG reduc n for just the two vegeta e net LOG reduc n results for each organism tested in
bacteria of 5.41 +/- 0.07. However tes ng of both this study.
viruses were below detectable limits due there being
zero plaques observed on plates a er a certain point, The Medical Guardian had an overall Clean Air
meaning that the net LOG reduc n for those organisms Delivery Rate of 94.63 cubic feet per minute (cfm), which
only represents a minimum value. Spores are known to is explained in detail in Appendix A.
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Figure 17: Average net LOG reduc on for each bioaerosol organism tested, average +/- standard devia on for the
triplicate trials.
References
T. Reponen, K. Willeke, V. Ulevicius et al. Techniques of Dispersion of Microorganisms in Air. Aerosol Science and
TechnoLOGy. 27: 1997. pp. 405-421.
Ding and Wing. Effects of Sampling Time on the Total Recovery rate of AGI-30 Impingers for E. coli. Aerosol and Air Quality
Research, Vol. 1, No. 1, 2001, pp. 31-36.
J.F. Heildelberg et al. Effects of Aerosolization on Culturabilty and Viability of Gram-Negative Bacteria. Applied and
Environmental Microbiology. Sept 1997, p 3585-3588.
P Hyman et al. Practical Methods for Determining Phage Growth Parameters. Bacteriophages: Methods and Protocols, Vol. 1:
Isolation, Characterization and Interactions. vol. 501. 2009. pp. 175-201.
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Analytical Testing Facility
Aerosol Research and Engineering Labs, Inc.
15320 S. Cornice Street
Olathe, KS 66062
Study Director
Jamie Balarashti
Aerosol Research and Engineering Laboratories
GLP Statement
We, the undersigned, herby certify that the work described herein was conducted by
Aerosol Research and Engineering Laboratories in compliance with FDA Good Laboratory
Practices (GLP) as defined in 21 CFR, Part 58.
Study Director: 3/1/2019
Date
_________________________ 3/21/2018
Jamie D. Balarashti Date Date
Study Director
ARE Labs, Inc.
Principal Investigator: 3/1/2019
1/14/2019
Date
Date
_________________________ 03/21/2018
Richard S. Tuttle Date
Principal Investigator
ARE Labs, Inc.
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Virus
Plaque assay
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Aerus devices
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HOSPITAL SURGICAL AND CARDIO ICU S
TESTING REPORT
EFFICACY OF BEYOND MEDICAL GUARDIAN AIR WITH AERUS ACTIVEPURE TECHNOLOGY
IN CANADIAN MEDICAL ICU SETTINGS
AUGUST 2, 2019
© 2020 Beyond by Aerus
CONFIDENTIAL PROPRIETARY INFORMATION OF AERUS MEDICAL LLC – NOT FOR REDISTRIBUTIONTesting of contaminants in the air and on surfaces
inside ICUs at Canadian Hospital
Date of Report August 2, 2019
Contents
Executive Summary ............................................................................................................................... 3
Materials and Methods ..................................................................................................................... 4 - 6
Results and Graphs
Total Bacteria and Fungi; Results (Swab) ........................................................................................ 7 - 8
Methicillin Resistant Staphylococcus (MRSA) (Swab).................................................................. 9 - 10
Blood and Potato Agar Plate Results (Air) ................................................................................... 11 - 12
Airborne Particulates .................................................................................................................... 13 - 14
Noteworthy Unusual Observations ...................................................................................................... 15
Conclusion ........................................................................................................................................... 16
Contact Information ............................................................................................................................. 17
CONFIDENTIAL PROPRIETARY INFORMATION OF AERUS MEDICAL LLC – NOT FOR REDISTRIBUTIONEXECUTIVE S UMMARY
Post-Surgical Site Infections (SSI) and Healthcare-Acquired Infections (HAI) are of major concern to hospitals, doctors
and patients across North America.
The Public Health Agency of Canada reported a 17-fold increase in MRSA rates in Canadian hospitals between 1995 and
2010. 1 In a study published in 2003, "an estimated one in nine Canadian patients develops a healthcare-associated
infection during his or her hospital stay — a total of 220,000 patients per year. Further, an estimated 8,000 Canadians will
lose their lives from these infections every year.” 2 Often, treatment is more costly than prevention: estimated costs in
2004 were $82 million. In 2010, costs were estimated at $129 million.3
In Canada, health spending was projected to reach $253.5 billion in 2018 (versus $207 billion in 2012). Statistics show
that from 2017-2018, the average cost of a bed in Canada for acute care is $6,137/day.4 A 2014 article in The Canadian
Journal of Infectious Diseases & Medical Microbiology noted that “approximately 60% of total health spending is
directed to hospitals and although it’s difficult to estimate, the proportion of this spending attributed to the management
of nosocomial infections, overuse and/or misuse of antimicrobials, and infections due to multidrug-resistant bacteria is
significant.”5
Statistics as somber as these make it clear that even a small reduction in SSI/HAI occurrences can translate into
significantly improved overall patient care as well as lower medical costs for health providers.
This study was conducted to determine whether the Beyond by Aerus ActivePure® Technology could materially reduce
or eliminate microorganisms and particulate matter from the air and on surfaces in an active hospital Surgical Intensive
Care Unit (SICU) and a Cardiovascular Intensive Care Unit (CV-ICU) environment. Surface and airborne
microorganisms are a major contributor of SSIs/HAIs, with bacteria Staphylococcus and Methicillin Resistant
Staphylococcus as the most common. Specific analysis of bacteria (including MRSA, fungi and airborne particles) was
performed before and after the installation of the Beyond Medical Guardian Air units.
The study results show material reduction in bacteria, MRSA, fungi and airborne particles after the installation of the
Beyond Medical Guardian Air units – significantly reducing the exposure to infection from pathogens to those patients
and healthcare providers in the SICU and CV-ICU environment.
Bacteria and fungi reduction ranged from 73% to 94%.
Methicillin-resistant Staphylococcus aureus (MRSA) was generally below detection levels (BDL) when first
tested, but in one instance, it was very high and post installation showed a 100% reduction.
Staphylococcus Aureus was reduced by 97%.
Blood and potato agar plate samples showed reductions of 64% to 85% in bacteria, mold and yeast.
Airborne particle reduction ranged from 41% to 95%.
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Sampling locations selected in the Surgical Intensive Care Unit (SICU) and the Cardiovascular Intensive Care Unit (CV-
ICU) focused on areas most likely to have routine exposure or physical contact. These areas were active spaces, where
cleaners are applied on a routine basis, which helps lower additional bacteria counts. In addition to surface testing, blood
and potato agar plates were used to collect ambient air samples using a BioStage collection device attached to a vacuum
pump. A laser particle counter was used to independently measure total airborne particulates 1.0 micron and smaller.
Pre-Treatment (Before) Protocols
On May 30, 2019, surface and air samples were collected in the Surgical Intensive Care Unit (SICU) and the
Cardiovascular Intensive Care Unit (CV-ICU) of a Canadian hospital. Samples were taken to determine if and to what
degree bacteria (including MRSA) and fungi exist within that environment, to establish a baseline for comparison.
Normal ICU operating conditions were in place as were all other hospital protocols relating to the control of airborne and
surface pathogens.
To determine levels of contaminants, five individual surface locations inside the SICU and CV-ICU areas were selected
for sample collection. These areas were;
patient monitor handle
patient bed rail
light switch in the patient area
nurse’s station work surface
medical equipment cart drawer handles.
Surface samples were collected using the sampling methodology established by the Antimicrobial Testing Laboratory to
ensure consistent sampling and prevent contamination during collection and handling. The Antimicrobial Testing
Laboratory located in Round Rock, Texas is an independent and accredited FDA, EPA third-party test laboratory.
Each individual surface location was sampled using the 3M pre-moistened biocide-free cellulose sponge swab with a 10
mL neutralizing buffer. The swab was moved in an overlapping pattern over the surface area to fully expose the swab to
any possible pathogens. The exposed swab was then placed in its sample container and sealed for transit to the lab. This
process was performed for each of the selected surface sampling locations. The collected samples were packaged in
containers with cold packs to keep the samples cool during transit to the Round Rock, Texas lab. Upon receipt to the lab,
microbiologists unpacked and prepared the samples for plating. The prepared plates were then incubated at a temperature
of 30°-36°±C for 2 – 5 days. Fully incubated plates were removed and the Colony Forming Unit (CFU) count was
determined and recorded.
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Air samples were collected in real time at two locations within the SICU and two locations within CV-ICU areas. The air
sample counts were collected using a laser particle counter specifically designed for counting airborne particles. The laser
particle counter device is calibrated and NIST traceable. The laser counter measured in real time the number of total
particles 1.0 micron and smaller per cubic meter of air. The particle counter does not differentiate the type of
contaminants counted, only the number of particles.
Agar plates were used in the same locations the airborne particle counts were taken to collect air samples for specific
analysis of bacteria, molds and yeast. Blood agar plates were used to collect air sample for analysis of bacteria while
potato agar plates were used for the analysis of molds and yeast. Each agar plate was exposed to the air using a BioStage
collection device attached to a vacuum pump, with an airflow rate of 30 liters per minute. Collected plates were sealed
and shipped to the independent lab where they were incubated from 2 – 5 days at a temperature of 30°-36°±C.
Treatment (After) Protocols
Upon completion of the May 30, 2019 air and surface sampling, Beyond Medical Guardian Air units were placed into the
SICU and CV-ICU areas. These units utilize several technologies, most notably our ActivePure Technology – which
creates powerful and safe hydroxyls and super ions that travel through the air and onto surfaces remediating pathogens –
and a better-than-HEPA filter media. ActivePure is in the Space Technology Hall of Fame and is the only technology in
its class certified as Space Technology by the NASA sponsored Space Foundation. ActivePure is derived from
technology initially developed for and used on the International Space Station. The Beyond Medical Guardian units were
turned on and allowed to operate continuously for seven days while normal hospital protocols for control of air and
surface pathogens also continued. The Beyond Medical Guardian Air Units were also used in conjunction with a few
additional purification units engineered with the same, but a smaller version of, ActivePure Technology used in the
Beyond Medical Guardian Air Units.
On June 5, 2019 surface and air samples were again collected in the Surgical Intensive Care Unit (SICU) and the
Cardiovascular Intensive Care Unit (CV-ICU) following the same protocols established and used in before treatment.
Samples and measurements were collected and analyzed to determine whether and to what degree use of the Beyond
Medical Guardian Air units reduced bacteria (including MRSA) and fungi (mold, yeast and air particles) within the SICU
and CV-ICU environment.
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ActivePure Technology utilizes a proprietary hydrophilic photo catalytic coating consisting of non-Nano titanium dioxide
with a proprietary combination of additional transition elements to enhance efficacy. Activated by a specific wavelength
of ultraviolet light, oxygen and humidity are extracted from the air to create powerful oxidizers that target air and surface
pathogens. These oxidizers are extremely effective at destroying bacteria, viruses, fungi, volatile organic compounds
(VOCs) and other environmental contaminants. Most significantly, they are not harmful to humans, pets or plants and are
completely safe for indoor use in occupied spaces.
The difference between the before samples and the samples after running the Beyond Medical Guardian Air units for
seven days was very substantial and significant.
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During the surface sampling periods on May 30, 2019, a combined total of 15,430 Colony Forming Units (CFUs) of
bacteria were discovered in the Surgical Intensive Care Unit (SICU) and 2,956 CFUs of bacteria were measured in the
Cardiovascular Intensive Care Unit (CV-ICU) as a result of the surface sampling. Testing results for Fungi (molds and
yeast) in these same areas were 2,812 CFUs in the SICU and 480 CFUs in the CV-ICU.
During the same test period time on June 5, 2019, seven days after installing the Beyond Medical Guardian Air units, the
combined total bacteria count was reduced to 867 CFUs of bacteria in the SICU and 784 CFUs of bacteria in the CV-ICU.
Testing results for Fungi in these same areas were 313 CFUs in the SICU and 70 CFUs in the CV-ICU.
This equates to a reduction in total bacteria by 94% in the SICU and 73% in the CV-ICU and a total reduction in Fungi by
89% in the SICU and 85% in the CV-ICU.
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METHICILLIN RESISTANT STAPHYLOCOCCUS (MRSA)
(SWAB)
During the surface sampling periods on May 30, 2019, a total of 31 CFUs of Methicillin Resistant Staphylococcus Aureus
(MRSA) were discovered in the Surgical Intensive Care Unit (SICU) and 0 CFUs of Methicillin Resistant Staphylococcus
Aureus (MRSA) were found in the Cardiovascular Intensive Care Unit (CV-ICU) as a result of the surface sampling.
Testing results for Staphylococcus, Aureus in these same areas were 6,314 CFUs in the SICU and 1,779 CFUs in the CV-
ICU.
During the same test period time on June 5, 2019, seven days after installing the Beyond Medical Guardian Air units, the
combined MRSA count was reduced to 0 in the SICU and 1 CFU was present in the CV-ICU. This equates to a reduction
in MRSA bacteria in the SICU to 100% and the level in the CV-ICU was below detection limits (BDL).
Testing results for Staphylococcus Aureus in these same areas were 186 CFUs in the SICU and 57 CFUs in the CV-ICU.
This equates to a reduction in Staphylococcus Aureus in the SICU by 97% and 97% in the CV-ICU.
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BLOOD AND POTATO AGAR PLATE RESULTS ( AI R)
Agar plate samples collected on May 30, 2019 had a combined total bacteria count of 104 CFUs with blood agar and
total fungi of 17 CFUs with potato agar in the Surgical Intensive Care Unit (SICU) and a total bacteria count of 24 CFUs
with blood agar and total fungi of 7 CFUs with potato agar in the Cardiovascular Intensive Care Unit (CV-ICU), as a
result of the sampling.
Agar plates collected on June 5, 2019, seven days after installing the Beyond Medical Guardian Air units, had a combined
total bacteria count of 16 CFUs with blood agar and total fungi of 6 CFUs with potato agar in the SICU, and a total
bacteria count of 11 CFUs with blood agar and a total fungi of 4 CFUs with potato agar in the CV-ICU as a result of the
sampling.
This equates to a reduction in total bacteria CFUs of 85% in the SICU and 72% in the CV-ICU. Total fungi CFUs were
reduced by 64% in the SICU and 68% in the CV-ICU. The results indicate that the air was materially less contaminated
with bacteria and fungi as a result of the Beyond Medical Guardian Air units.
All agar plate samples were collected using a BioStage Single-stage Impactor, coupled to a vacuum pump with an airflow
rate of 30 liters per minute.
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AIRBORN E PARTIC UL ATE S
Prior to installing the Beyond Medical Guardian Air units, particle counts were collected three different times on May 30,
2019. The combined average particle counts measured 485,395 particles per cubic meter at 1.0 um and 958,580 particles
per cubic meter at .5 um in the Surgical Intensive Care Unit (SICU). They measured 1,711,928 particles per cubic meter
at 1.0 um and 12,145,965 particles per cubic meter at .5 um in the Cardiovascular Intensive Care Unit (CV-ICU).
During the same three test periods time on June 5, 2019, seven days after installing the Beyond Medical Guardian Air
units, the combined average particle counts were reduced to 269,432 particles per cubic meter at 1.0 um and 569,315
particles per cubic meter at .5 um in the SICU and 269,061 particles per cubic meter at 1.0 um and 562,097 particles per
cubic meter at .5 um in the CV-ICU. This equates to an overall reduction in airborne particulates in the SICU by 44% and
in the CV-ICU by 84%.
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NOT E W OR T HY UN US U A L OB S E R VA T I ONS
None observed.
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Testing results indicate that the Beyond Medical Guardian Air with Aerus ActivePure Technology materially reduces or
eliminates microorganisms and particulate matter from the air and on surfaces in the Surgical ICU (SICU) and
Cardiovascular ICU (CV-ICU) environments. Results showed that: Surface Bacteria counts were reduced over an
average of 83%; Surface Fungi were reduced by 87%; Surface Methicillin Resistant Staphylococcus (MRSA) were (BDL)
below detection levels with the exception of a single instance where it was reduced 100%; Surface Staphylococcus
Aureus was reduced by 97% and Airborne Particulates were reduced over an average of 64% during the seven-day test
period.
The Beyond Medical Guardian Air with Aerus ActivePure Technology was very effective in eliminating bacteria
(including MRSA) and fungi on all surfaces, as well as providing ongoing protection of the surfaces and air against future
contamination.
FOOTNOTES
1.https://sunnybrook.ca/media/item.asp?c=2&i=401&page=185
2.https://www.patientsafetyinstitute.ca/en/Topic/Pages/Healthcare-Associated-Infections-(HAI).aspx
3.Ibid
4. https://yourhealthsystem.cihi.ca/hsp/inbrief?lang=en#!/indicators/015/cost-of-a-standard-hospital-stay
5.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4028670/
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Joseph P. Urso Beyond by Aerus Chairman and CEO
14841 Dallas Parkway – Suite #500
The Aberdeen Building
Dallas, TX 75254
214 .378 .4001
jurso@aerusonline.com
Andrew Eide Beyond by Aerus Vice President
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The Aberdeen Building
Dallas, TX 75254
214 .378 .4090
aeide@aerusonline.com
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T ial eco d 1 1 fo : NCT04610294
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