Hydrogen Peroxide Vapor
Technology & Applications
Martin Orlowski
© Bioquell Inc (2010). All rights reserved.
Summary of Technology
2H2O2
Gas
phase
Catalytic
decomposition
2H2O
HYDROGEN
WATER
PEROXIDE
VAPOR
+
O2
OXYGEN
Not a cleaning product
Repeatable & validatable process
No pre/ de- humidification
Residue free
Safe- non carcinogenic
Target specific solutions
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History of Hydrogen Peroxide Vapor
First used in 1990’s for
pharmaceutical industry aseptic
process isolators
Isolators use HEPA filters at inlet &
outlet for protection
Presently, 95% of aseptic process
isolators use HPV for
decontamination
Demonstrates great material
compatibility
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Isolator Sterilants
174
180
13
160
Peracetic Acid
6
140
Chlorine Dioxide
4
120
Alcohol Wipe(s)
3
100
Hydrogen Peroxide & Steam
1
80
Formaldehyde
1
Other
6
Hydrogen Peroxide Vapor (HPV)
Hydrogen Peroxide Spray
60
40
20
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Other
Formaldehyde
HP & Steam
Alcohol Wipes
Chlorine Dioxide
Peracetic Acid
0
Hydrogen Peroxide Spray
Ref; ISPE Barrier Conference
208
Hydrogen Peroxide Vapor
(HPV)
Total
Technology Development
Technology
transfer
ISOLATORS
BIOMEDICAL &
BIOLOGICS
ROOMS, RABS
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Decontamination Chambers
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Rooms, Facilities
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Micro-biological Efficacy
Demonstrating Bio- Burden Reduction is
Crucial to a Decontamination Process
Geobacillus stearothermophilus biological indicators
Micro organism resistant to HPV
Same challenge as steam sterilizers (6log10)
Easy to handle
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Micro-biological Efficacy
“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.
© Bioquell Inc (2010). All rights reserved.
Material Compatibility
Hydrogen Peroxide Vapor is compatible with most materials and is
used for decontamination of:
Rooms
Isolators
RABS
Computers
Microscopes and precise laboratory equipment
The following materials should be avoided (if possible) :
Soft, absorbent materials which will absorb chemical and
reduce overall efficacy
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Bio Decontamination Process
Just 3 Stages!
Conditioning
Internal Safety Checks
System Heat Up
Typically 10 minutes
No pre/de- humidification required
Injection
Volume Specific Times
Aeration
System Dependent
Optimized to Client Requirements
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Concentration / time graph
Plateau: more HPV is added, but gas concentration no
longer increases, hence must be laying down condensate
HPV concentration
Inflection point
(dewpoint implied)
- onset of rapid kill
Dwell starts
System reaches equilibrium
(no further HPV added)
Aeration starts
Inactivation of micro-organisms
Rapid decline in HPV
concentration initially (from
catalytic conversion)
Gas concentration
initially rises fast
t=0*
GASSING
* Conditioning phase not shown
(Vaporiser reaches temperature)
Starts to slow
Gassing DWELL Aeration
stops
starts
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AERATION
TIME
Schematic of dewpoint and kill dynamics
Onset of
rapid kill
Only slight decline in BI
population prior to dewpoint
(D value: c. 2 hours)
Rapid inactivation of BIs
(D value: c. 2 minutes)
Onset of dewpoint /
micro-condensation
Injection of HPV into the
enclosure starts (t=0)
TIME
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Thickness of c
condensate
Biological Indicator* (“BI”) survivors
6 log
Importance of micro- condensation
Ref: JPI Published ISPE 2008
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Conventional Isolator Decontamination
Valve
Gas out
Gas in
Valve
Inject H202 through inlet
HEPA fliter and into the
chamber while then
pulling H202 back through
exhaust HEPA
Proven effective
HPV
Unit
Watch gas distribution, and
if necessary, aid with
circulating fans
Measure and control
critical parameters
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Direct Injection Decontamination
Inject gas directly into
work area and pull back
through HEPA filters
Gas out
HEPA
Distribute the gas while
still hot
Gas in
Rotating
Nozzle
Uniform gas
Distribution
HPV
Unit
Decreased cycle times
Measure and control
critical parameters
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Isolator/ Chamber Injection Nozzles
Fixed Injection Nozzle
Rotating Injection Nozzle
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Decontamination Chamber
Inject H202 from generator through
ports designed into chamber
Exhaust is recommended to speed
up aeration cycle
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Room Bio- Decontamination: Fixed Installation
Rotating Gas
Distribution Nozzle c/w
sealed enclosure and
access panel
Supply hose
trace heated &
insulated
Trace heated return
line
Gas generator placed
external to room under
bio-decontamination
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Mobile Solution
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Facility Decontamination
Generators are placed
in strategic locations
throughout facility for
gas distribution
Monitor Temp, RH, and
H202 concentration at
multiple locations
Used for outbreaks,
pre-commissioning, etc.
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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
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Safety!
Two Key Exposure Limits
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 © Bioquell Inc (2010). All rights reserved.
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
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Thank You, Questions?
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