Vaporized Hydrogen Peroxide (VHP®) Process

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An Overview of AeroClave
Vaporized Hydrogen Peroxide (VHP) Process A
Green Alternative for Large-Scale Sterilization
Hospitals/Healthcare
Public Safety/ First Responders
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AeroClaves Mission Statement
Our primary mission is to combat the spread of
infectious diseases through a family of
comprehensive, cost-effective, and
environmentally safe solutions.
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Why AeroClave?

• Founded by Dr. Ronald Brown (Medical Director
  of Seminole County FL EMS 1985-1999)
• Asked to formulate a plan to safeguard the
  community if a contaminated plane landed at the
  Orlando/Sanford Airport
• Taking care of the passengers was a complex plan
  but attainable
• The problem arose when Dr. Brown asked the
  simple question
• What about the contaminated aircraft,
  ambulances, and hospitals?
• There was no simple answer except
• Suit up and hand clean each area in which the
  infected passengers touched!
• The idea of AeroClave for aircraft, vehicles,
  and rooms was born.

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History of AeroClave

• 2003-2006
• Decontamination of large aircraft
• ACER/ECBC validation work (Air Cabin
  Environmental Research/Edgewood Chemical
  Biological Center)
• Harvard viral studies
• 2006-2007
• CAMI 747 and rail car work (Civil
  Aeronautical Medical Institute)
• 2008-2009
• AFRL/AMC TESTS (Air Force Research Lab/Air
  Mobility Command)
• Complete kill of anthrax simulant through
  entire aircraft with no damage to aircraft
• Multiple tests 0 failures
• Beat time-to-kill estimates by over 50

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History of AeroClave (cont.)

• 2008-2009
• Development of a Portable Asset
  Decontamination System (PADS) in Winter Park,
  FL
• 30, 60 or 100 chamber configuration
• EMS, fire and law enforcement use this chamber
  to sterilize their vehicles
• 2009-2010
• Development of Room Decontamination System
  (RDS)
• Sterilizes rooms up to 8,000 cubic ft.
• Simply move from room to room
• Easy to operate from computer tablet

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• The Difference Between Sanitization and
  Sterilization
• The three levels recognized by the EPA
• 1st level Sanitization (typically defined as 2
  log- 102 Kill rate)
• The process of making something clean.
• Use of retail soaps and cleaners
• 2nd level Disinfection (typically defined as 5
  log- 105 Kill rate)
• The process of eliminating pathogenic organisms
  (killing germs bacteria to make them
  harmless)
• Commercially available sprays and liquids
• 3rd level Sterilization (typically defined as 6
  log- 106 Kill rate)
• The reduction of the number of live
  organizations by 6 orders of magnitude
  surgical sterility
• Use of AeroClave equipment with VHP technology

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• Vaporized Hydrogen Peroxide (VHP)
• Background and History
• AeroClave uses a VHP process developed by
  AMSCO mid-1980s
• STERIS acquires AMSCO and patented VHP
  process in early 1990s
• Over 1,200 STERIS VHP systems sold world-wide
  in pharmaceutical labs
• 15 years of validated use in pharmaceutical
  manufacturing
• AeroClave develops the use of this technology
  for large-scale applications

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VHP the Process
Non-Toxic Residue
STERISs VHP Process
AeroClaves Destroyer Process
H2O
(water)

• 35 - 59
• Hydrogen Peroxide
• Liquid

H2O2

Vaporization
Peroxide Vapor
O2
(oxygen)
Kills all organisms at low concentrations
Non-Toxic Residue
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Why is VHP a Green Solution?

• Non-toxic by-products
• No dangerous post-decon residue wipe down

The AeroClave process safely returns hydrogen
peroxide to
O2

H2O
(oxygen)
(water)
EPA no risks to the environment are expected
from use of pesticide products containing
hydrogen peroxide because 1) the substance
readily decomposes to water and oxygen gas,
leaving no residue 2) it is effective at low
concentrations where no toxic effects are
expected www.epa.gov
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Typical AeroClave Sterilization Cycle

• Easy-to-use, intuitive operator screen
• Real-time monitoring with electrochemical sensors
• Short cycle times typically 2 hours start to
  finish
• No residual odors
• Comprehensive reporting

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Results of AeroClave / VHP
100Full-spectrum kill
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How is the Process Validated?
VHP Chemical Indicators (CI)
Biological Indicators (BI)
VHP chemical indicators are located throughout
the room to determine the VHP has filled the
room
Geobacillus stearothermophilus is used as a
biologic indicator to verify the efficacy of VHP
sterilization process
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Biological Indicator Results
Positive Growth (control)
Negative No Growth (100Kill)
After AeroClave cycle is completed, the BIs are
inserted into vials
Broth turns yellow and growth is seen
Broth remains clear salmon in color
Vials are incubated at 550C for 7 days (if you
dont see growth within the first 24 hours its
a very good indication youve had a 100 kill)
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VHP - Biological Efficacy

• Vaporized Hydrogen Peroxide (VHP) has a proven
  track record of biological efficacy
• Tested/Validated Department of Defense
• Proved to provide a 6-log reduction (clinical
  sterilization)
• Effective against viruses, mold, spores and
  bacteria
• Process validated each time with Geobacillus
  stearothermophilus (GS) biological indicators

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Why H2O2 Vapor? EPA-registered, FIFRA compliant
In compliance with Federal Insecticide, Fungicide
and Rodenticide Act, all anti-microbial agents
must be EPA registered. 35 Vaprox hydrogen
peroxide solutionEPA reg. no. 58779-4 59
Vaprox HC hydrogen peroxide solutionEPA reg. no.
1043-123
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VHP Comparison
Safety Profile Comparison To Other Technologies

• Hydrogen Peroxide
• Skin/eye irritant
• PEL 1.0 ppm
• STEL N/A
• IDLH 75 ppm
• TDC 150-400 ppm

• Chlorine Dioxide
• Severe irritant
• PEL 0.1 ppm
• STEL 0.3 ppm
• IDLH 5.0 ppm
• TDC 500-1,500 ppm

• Formaldehyde
• Human carcinogen
• PEL 0.75 ppm
• STEL 2 ppm
• IDLH 10 ppm
• TDC 8-10,000 ppm

PEL - Personal Exposure Limit (8 hours) STEL -
Short-term Exposure Limit (15 min.) IDLH -
Immediately Dangerous to Life or Health TDC
Typical Decontamination Concentration
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VHP Material Compatibility

• Plastics
• ABS Excellent Polyacetal (Delrin) Excellent
• Aflas Excellent Polycarbonate Excellent
• CPVC (chlorinated polyvinylchloride) Excellent
• Polyetherimide (Ultem) Excellent
• Kel F Excellent
• Polymethylepentene Excellent
• Nylon Fair
• Polyphenylene oxide Excellent
• PMMA Excellent
• Polyetherketone (PEEK) Excellent
• Polyethersulfone (PES) Excellent
• Polyethylene (HDPE, LDPE UHMWPE) Excellent
• PolyethyleneTerephthalate (PET) Good

• Metals
• Aluminum Excellent
• Anodized Aluminum Good
• Steel Good
• Brass Good
• Titanium Excellent
• Copper Good
• Stainless Steel Excellent

Compatibility is defined as the materials
ability to undergo exposure to VHP with no
significant changes in physical, or chemical
properties (i.e. no changes in strength,
flexibility, chemical composition, color etc.).
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A Summary of VHP Advantages

• Rapid decontamination at ambient temperatures
  and low concentrations
• Strong history of use and efficacy data, easily
  validated with BIs
• Strong comparative safety profiledetectable
  well below IDLH
• Non-toxic by-products green solution
• Minimal aeration period
• No residue nothing to wipe down or clean up
• Strong material compatibility profile
• EPA RegisteredFIFRA compliant

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Portable Asset Decontamination System
(PADS)Reasons for development

• Epidemic rise of Multi Drug Resistant Organisms
  (MDROs) pose threat to patients and crews
• Studies show large percentage of
  ambulances/rescues have MRSA
• Current cleaning methods are ineffective and may
  actually spread organisms and/or promote
  development of new MDROs

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Portable Asset Decontamination System (PADS)

• Applications
• Hospital transportation vehicles
• Fire/Rescue vehicles
• Police/Sheriff vehicles
• Public transportation buses

AeroClaves complete vehicle sterilization
process takes less than 2 hrs!
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PADS Sterilization Process
Step 1 Place equipment inside treatment
chamber Step 2 Open all doors and
compartments Step 3 Place sensors and BIs Step
4 Secure all doors per safety plan Step 5
Authorized users log on and begin cycle Step 6
After cycle is complete data is automatically
uploaded to server and reports may either be
printed on-site or accessed via the Internet by
authorized users.
Important to follow Fumigation Management Plan
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ComprehensiveReporting
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Room Decontamination System(RDS)

• Reasons for Development
• Healthcare Associated Infections (HAIs) are the
  most preventable cause of hospital morbidity and
  mortality, kill over 100,000 patients and cost
  the US healthcare system over 45 billion each
  year.1
• Infections due to MRSA led to a 7-fold increased
  risk of death, a 35-fold increase of hospital
  readmission, more than 3 weeks of additional
  hospitalization and more than 60,000 of
  additional charges.2
• New studies have shown that using common
  disinfectants could actually promote the growth
  of antibiotic-resistant organisims.3
• The Direct Medical Costs of Healthcare-Associated
  Infections in U.S. Hospitals and the Benefits of
  Prevention. Douglas R. Scott II, Centers for
  Disease Control and Prevention, March 2009
  http//www.cdc.gov/ncidod/dhqp/pdf/Scott_CostPaper
  .pdf
• 2009 Public Library of Science Journal PLoS ONE
• Microbiology, January 2010

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Room Decontamination System (RDS)

• Applications
• Surgical suites
• Out-patient surgical centers
• Physician offices and health clinics
• Hospital rooms, diagnostic, procedural and
  operating suites
• Research facilities
• Locker rooms and gymnasiums
• Local, state, and federal assistance offices,
  SSI, unemployment, license bureaus etc
• Educational facilities from pre-school to
  college
• Veterinary hospitals and animal shelters
• Law enforcement offices, jails, holding cells
  and prisons
• Hotels

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RDS Sterilization Process
Step 1 Place RDS in center of area to be
treated Step 2 Plug in and attach water supply
and return Step 3 Place sensors and BIs in
room Step 4 Insure that pre-treatment safety
checklist is completed Step 5 Start cycle with
remote tablet computer Step 6 At completion of
cycle, harvest BIs and print report and labels
Important to follow Fumigation Management Plan
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The AeroClave Advantage

• Superior efficacy
• Fast turn-times (2 hours) with full-spectrum
  kill
• Environmentally-friendly (green) (returns to
  water oxygen)
• Cost-effective cycles
• No residues- nothing to wipe down or wipe off
• Compatible with sensitive electronics
• Broad range of materials compatibility
• Real-time monitoring with electrochemical
  sensors
• Supported by a team of professionals with over
  20 years of experience