Hydrogen Peroxide
Bio-Decontamination
Martin Orlowski
Technical Sales
BIOQUELL Inc.
www.bioquell.com
Background
Summary of Technology
Gas
phase
2H2O2
Catalytic
decomposition
2H2O +
HYDROGEN
WATER
PEROXIDE
VAPOR
Not a cleaning product
Residue Free
Safe- Non Carcinogen
Repeatable & Validatable Results
Target Specific Solutions
O2
OXYGEN
Chlorine Dioxide & Formaldehyde vs. HPV
Chlorine Dioxide
Formaldehyde
Hydrogen Peroxide
Vapor
Conditions
Requires RH above 70%
and temperature above 70
deg F to be effective
Only truly effective above
75% RH
RH not critical to the microcondensation process. 20 to
80% RH OK
Toxicity
Carcinogenic gas which
out gasses for long
periods. Requires long
contact time
Classified as a
carcinogen (WHO). Very
slow out gassing
Fast kill & short contact
time. H2O2 is less
absorbent with shorter
cycles
Powdery residue left by
sodium bisulphate used to
neutralize gas. Poor
materials compatibility
Difficult and long setup
times. Hard to control
Residue of white paraformaldehyde. Adds
cleaning time and risk of
recontamination
Poor process control.
High consumable cost
HPV micro- condensation is
invisible; residue free and
compatible with most
electronics and materials
Highly controllable. Easy to
validate. Low running costs
Post Decon
Clean Up?
Control
Isolator Sterilants
Hydrogen Peroxide Vapor (HPV)
Hydrogen Peroxide Spray
174 180
13 160
Peracetic Acid
6
Chlorine Dioxide
4
Alcohol Wipe(s)
3
Hydrogen Peroxide & Steam
1
Formaldehyde
1
Other
6
140
120
100
80
60
40
20
Other
Formaldehyde
Hydrogen Peroxide & Steam
Alcohol Wipe(s)
Chlorine Dioxide
Peracetic Acid
Hydrogen Peroxide Spray
Ref; ISPE Barrier Conference
208
(HPV)
Total
Hydrogen Peroxide Vapor
0
HPV Development
Technology
transfer
ISOLATORS
Ref: Lysford & Porter
ISPE Report
BIOMEDICAL &
BIOLOGICS
ROOMS & RABS
Pharmaceutical
Applications
HPV Applications
Decontamination Chambers
HPV Applications
Autoclave/ Cage Washer
HPV Applications
Isolators
HPV Applications
Rooms/ Facilities
Technology
HPV Bio Decontamination Process
Just 3 Stages!
Conditioning
Internal Safety Checks
System Heat Up
Typically 10 minutes
Not Environmental Conditioning!
Injection
Volume Specific Times
Aeration
System Dependent
Optimized to Client Requirements
Efficacy
Demonstrating Bio- Burden Reduction is
Crucial to a Decontamination Process
BIOQUELL uses Geobacillus stearothermophilus biological
indicators
Micro organism resistant to HPV
Same challenge as steam sterilizers (6log10)
Easy to handle
Micro Biological Efficacy Examples
“Superbugs”
Other
bacteria
1.
2.
3.
MRSA1
VRE1
Acinetobacter1
Pseudomonas3
Klebsiella1
Endospores
C. difficile1
G. stearothermophilus2
B. subtilis2
B. anthracis2
Virus
Mouse and Rat Parvo
Influenza
Fungus
Aspergillus spores
French GL, Shannon KP, Otter JA. Survival of nosocomial bacteria dried in air and killing
by hydrogen peroxide vapour. 44th ICAAC, Washington DC, 2004.
Rogers JV, Sabourin CL, Choi YW, Richter WR, Rudnicki DC, Riggs KB, Taylor ML,
Chang J. Decontamination assessment of Bacillus anthracis, Bacillus subtilis, and
Geobacillus stearothermophilus spores on indoor surfaces using a hydrogen peroxide gas
generator. J Appl Microbiol 2005;99:739-748
Cabinet bio-decontamination trial. Centre for Applied Microbiology and Research (CAMR)
(now HPA
Business Division), Porton Down. March 1995.
Porous
Non-porous
Anthrax Bio Deactivation US EPA Study
Glass
7.92 log kill (complete bio-deactivation)
Decorative laminate
7.85 log kill (complete bio-deactivation)
Painted wallboard
6.92 log kill (complete bio-deactivation)
Galvanised metal
ductwork
7.54 log kill (complete bio-deactivation)
Painted concrete
6.36 log kill
Bare wood
3.70 log kill
Carpet
3.01 log kill
Note short cycle: 20 minutes gassing; 20 minutes dwell (plus issues with limits of
detection)
Bacillus anthracis Ames bio-deactivation data – report available on EPA website (ETV
program)
Material Compatibility
Extensive Testing
Prior to technology release
Ongoing “in- the field” data collection
860 cycles and counting…
Importance of
MicroCondensation
Micro Condensation
condense (verb)
condensation (noun)
to make moisture appear on a surface
the drops of water that appear on cold surfaces
as a result of hot air or gas becoming cool
the process by which a gas or vapor changes to a
liquid, appearing as a film or drop of water
(Courtesy of Cambridge Dictionary of American English)
"45 microns, 2 times smaller than the
diameter of a human hair and close to
the limit of resolution for the human
eye"
Importance of Micro Condensation
Warm Gas
Delivered
Raised H2O2
Chamber
concentration
Formation of invisible
‘Micro-condensation’
Cold Gas
Exhausted
HPV Concentration Curve
Gas concentration
Peak gas concentration c.200-1000ppm
Gas concentration starts to plateau –
any additional peroxide added to
system effectively goes into
condensate
Gas concentration starts to climb quickly
Gassing starts – liquid peroxide injected into vaporiser
Time
Dew Point & Kill Dynamics
D value : 120 min
(pre-dew point)
D value : 2 min
post dew point
Dewpoint
25
1.00E+06
15
1.00E+03
10
5
0
1.00E+00
1
6
11
16
21
Gassing Time Minutes
26
31
Dew Point Index
Survivors
20
Isolator
Configurations
Traditional Decontamination
Valve
HPV out
HPV in
HPV
Unit
Closed loop process
Injection through HEPA filters
Valve
Direct Injection
Valve closed for
gassing
HPV out
HEPA
HPV in
Rotating
Nozzle
No fans required for mixing
Rotating nozzle eliminates ‘hot spots’ from vapor
Use with empty isolator or with load
Available for range of units
Isolator/ Chamber Injection Nozzles
Fixed Injection Nozzle
Rotating Injection Nozzle
Example – 2 Glove Soft Wall Isolator
Liquid Volume
25ml
Conditioning
10 min
Gassing
18 min
Dwell
15 min
Traditional Cycle
213 min
Direct Injection 125 min
HPV Room
Bio-decontamination
solutions
Clarus C – Fixed Installation
Rotating Gas Distribution
Nozzle c/w sealed
enclosure and access
panel
Supply hose trace
heated &
insulated
Clarus C gas generator
placed external to room
under biodecontamination
Trace heated return
line
Clarus C – Room Decontamination 1
HVAC Aeration
Clarus C
Clarus C – Room Decontamination 2
HVAC Aeration
Remote screen
UMI
Aeration Unit
(not always
required)
Clarus C
Control cable
under doorway
Room BioDecontamination
Service (RBDS)
RBDS
Room Bio- Decontamination Service
Service not Product
Volumes 1,000,000+ ft3
Fast Turnaround
Conduct in Occupied Building
Ideal for
Commissioning
Outbreak
Large volumes
Continuous Feedback Control
RBDS
Client with
contaminated
room
Site survey
by BIOQUELL
RBDS
process execution
Evaluation of
RBDS parameters
Remove RBDS
equipment
RBDS equipment/
team dispatched
BIOQUELL
confirms BIs dead
RBDS equipment
& BI set-up
Client with
Bio-decontaminated
room
RBDS
Safety
Safety
Safety!
Containment
Vapor not gas
Easy to seal
During Cycle
Sensors inside target area
Highly sensitive sensors
outside area
Post Decontamination
Two sensors used to confirm
area safe for re-entry
No dangerous residue
Safety
Exposure Limits
2 key levels
P.E.L
Permissible Exposure Limit: parts per million parts
of air as an 8 hour time weighted average
IDLH
Immediately Dangerous to Life & Health:
concentration of any toxic, corrosive or asphyxiant
substance that poses an immediate threat to life or
would cause irreversible or delayed adverse health
effects or would interfere with an individual's ability
to escape from a dangerous atmosphere
Definitions: www.cdc.gov/niosh/idlh
Safety
Exposure Limits
Exposure
Level
Formaldehyde
Chlorine
Dioxide
HPV
PEL
0.5
0.1
1.0
IDLH
20
5.0
75
Source: www.osha.gov
Case Studies
Case Study 1
Company
MD Anderson Cancer Center
Location
Houston, TX
Type of Facility
Animal Research
Description
150 animal rooms with equipment including
cage wash and autoclave area.
Approx. Volume
1,000,000 cubic feet
Reason
Pre–commissioning
Case Study 1
Client Requirements & Results
Residue-free, bio-decontamination was sought prior to animal introduction into facility
RESULT: Using Hydrogen Peroxide Vapor (HPV) the facility was decontaminated
Essential to allow sensitive electronic equipment, animal racks, and bio-safety
cabinets……etc to remain in area while bio-decontaminating
RESULT: No damage reported on any equipment
Ensure a high level of sterilization by using biological indicator - 6 log Geobacillus
stearothermophilus
RESULT: All 800 biological indicators returned negative
High emphasis on immediate and long term health & safety of employees in otherwise
occupied building
RESULT: No issues during or after decontamination
Case Study 2
Company
Confidential
Type of Facility
High Containment Area (BSL-4)
Description of Facility
BSL-4 lab that included incubators, safety
cabinets, computers, microscopes, and other
pieces of precise electronic equipment.
Approximate Volume
14,000 cubic feet
Reason
Annual bio-decontamination for preventative
maintenance to be performed on equipment
Case Study 2
Client Requirements & Results
Rapid, Residue-Free, bio-decontamination was sought so employees could perform
basis preventative maintenance on equipment after decon
RESULT: Area successfully decontaminated using HPV
A high-level disinfection was required due to the nature of the organisms researched
inside the lab (Ebola, Plague, etc.)
RESULT: 100% deactivation of all biological indicator challenges
Wanted to ensure all surfaces were bio-decontaminated (behind, under, and inside all
equipment)
RESULT: Success demonstrated through challenging indicator placement
All equipment (computers, microscopes, incubators, etc.) had to be left inside the area.
RESULT: No material compatibility issues observed
Thank You & Questions?
Available Documentation…
Case Studies
Efficacy Data
Materials Compatibility Reports
PDA Reference Paper (2003)
Technical Design Guides
EPA Report