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Hydrogen Peroxide VaporTechnology & Applications
© Bioquell Inc (2010). All rights reserved.
Martin Orlowski
2H2O2 2H2O + O2
Gas phase
HYDROGEN
PEROXIDE
WATER
VAPOR
OXYGEN
Catalyticdecomposition
Summary of Technology
© Bioquell Inc (2010). All rights reserved.
� Not a cleaning product� Repeatable & validatable process � No pre/ de- humidification � Residue free � Safe- non carcinogenic� Target specific solutions
� First used in 1990’s for
pharmaceutical industry aseptic
process isolators
� Isolators use HEPA filters at inlet &
outlet for protection
History of Hydrogen Peroxide Vapor
© Bioquell Inc (2010). All rights reserved.
� Presently, 95% of aseptic process
isolators use HPV for
decontamination
� Demonstrates great material
compatibility
60
80
100
120
140
160
180Hydrogen Peroxide Vapor (HPV) 174
Hydrogen Peroxide Spray 13
Peracetic Acid 6
Chlorine Dioxide 4
Alcohol Wipe(s) 3
Hydrogen Peroxide & Steam 1
Formaldehyde 1
Other 6
Isolator Sterilants
© Bioquell Inc (2010). All rights reserved.
0
20
40
Hydrogen Peroxide Vapor
(HPV)
Hydrogen Peroxide Spray
Peracetic Acid
Chlorine Dioxide
Alcohol Wipes
HP & Steam
Formaldehyde
Other
Other 6
Total 208
Ref; ISPE Barrier Conference
Technology Development
Technology transfer
© Bioquell Inc (2010). All rights reserved.
ROOMS, RABSBIOMEDICAL &BIOLOGICS
ISOLATORS
Decontamination Chambers
© Bioquell Inc (2010). All rights reserved.
Rooms, Facilities
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�Geobacillus stearothermophilus biological indicators� Micro organism resistant to HPV
Demonstrating Bio- Burden Reduction is Crucial to a Decontamination Process
Micro-biological Efficacy
© Bioquell Inc (2010). All rights reserved.
� Micro organism resistant to HPV� Same challenge as steam sterilizers (6log10)� Easy to handle
“Superbugs”
MRSA1
VRE1 Endospores
C. difficile1
G. stearothermophilus2
B. subtilis2
B. anthracis2
Micro-biological Efficacy
© Bioquell Inc (2010). All rights reserved.
Otherbacteria
Acinetobacter1
Pseudomonas3
Klebsiella1
Virus
Fungus
Mouse and Rat ParvoInfluenza
Aspergillus spores
1. French GL, Shannon KP, Otter JA. Survival of nosocomial bacteria dried in air and killing by hydrogen peroxide vapour. 44th ICAAC, Washington DC, 2004.
2. 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
3. Cabinet bio-decontamination trial. Centre for Applied Microbiology and Research (CAMR) (now HPA Business Division), Porton Down. March 1995.
Hydrogen Peroxide Vapor is compatible with most materials and is used for decontamination of:
� Rooms
� Isolators
� RABS
Material Compatibility
© Bioquell Inc (2010). All rights reserved.
� 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
� Conditioning� Internal Safety Checks
� System Heat Up� Typically 10 minutes
Just 3 Stages!
Bio Decontamination Process
© Bioquell Inc (2010). All rights reserved.
� Typically 10 minutesNo pre/de- humidification required
� Injection� Volume Specific Times
� Aeration� System Dependent� Optimized to Client Requirements
Concentration / time graph H
PV
con
cent
ratio
n
Inflection point (dewpoint implied)- onset of rapid kill
Plateau: more HPV is added, but gas concentration no longer increases, hence must be laying down condensate
Dwell starts System reaches equilibrium (no further HPV added)
Aeration starts
Rapid decline in HPV
Inactivation of micro-organisms
© Bioquell Inc (2010). All rights reserved.
HP
V c
once
ntra
tion
TIMEt=0* GASSING DWELL AERATION
Gas concentration initially rises fast
Rapid decline in HPV concentration initially (from catalytic conversion)
Starts to slow
Gassing stops
Aeration starts
* Conditioning phase not shown(Vaporiser reaches temperature)
Schematic of dewpoint and kill dynamics
Onset of rapid kill
Bio
logi
cal I
ndic
ator
* (“
BI”
) sur
vivo
rs
Th
ick
ness o
f con
dens
ate
Only slight decline in BI population prior to dewpoint (D value: c. 2 hours)
6 log
© Bioquell Inc (2010). All rights reserved.
Onset of dewpoint /micro-condensation
Bio
logi
cal I
ndic
ator
* (“
BI”
) sur
vivo
rs
Th
ick
ness o
f c
Rapid inactivation of BIs (D value: c. 2 minutes)
TIME
Injection of HPV into the enclosure starts (t=0)
Importance of micro- condensation
© Bioquell Inc (2010). All rights reserved.
Ref: JPI Published ISPE 2008
� Inject H202 through inlet
HEPA fliter and into the
chamber while then
pulling H202 back through
exhaust HEPA
Gas in
Valve Valve
Gas out
Conventional Isolator Decontamination
© Bioquell Inc (2010). All rights reserved.
� Proven effective
� Watch gas distribution, and
if necessary, aid with
circulating fans
� Measure and control
critical parameters
HPV
Unit
� Inject gas directly into
work area and pull back
through HEPA filters
� Distribute the gas while
still hot
Gas in
Gas out
HEPA
Direct Injection Decontamination
© Bioquell Inc (2010). All rights reserved.
� Uniform gas
Distribution
� Decreased cycle times
� Measure and control
critical parameters
Rotating Nozzle
HPV
Unit
Isolator/ Chamber Injection Nozzles
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Fixed Injection Nozzle Rotating Injection Nozzle
� Inject H202 from generator through
ports designed into chamber
� Exhaust is recommended to speed
up aeration cycle
Decontamination Chamber
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up aeration cycle
Rotating Gas Distribution Nozzle c/w sealed enclosure and access panel
Supply hose trace heated &
insulated
Trace heated return line
Room Bio- Decontamination: Fixed Installation
© Bioquell Inc (2010). All rights reserved.
Gas generator placed external to room under bio-decontamination
Mobile Solution
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� Generators are placed
in strategic locations
throughout facility for
gas distribution
� Monitor Temp, RH, and
Facility Decontamination
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�
H202 concentration at
multiple locations
� Used for outbreaks,
pre-commissioning, etc.
� Containment
� Vapor not gas
� Easy to seal
� During Cycle
�
Safety!
© Bioquell Inc (2010). All rights reserved.
� Sensors inside target area
� Highly sensitive sensors outside area
� Post Decontamination
� Two sensors used to confirm
area safe for re-entry� No dangerous residue
Two Key Exposure Limits
�P.E.LPermissible Exposure Limit: parts per million parts of air as an 8 hour time weighted average
� IDLHImmediately Dangerous to Life & Health:
Safety!
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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
Formaldehyde Chlorine
Dioxide
Exposure
Level
Exposure Limits
HPV
Safety
© Bioquell Inc (2010). All rights reserved.
0.5
20
0.1
5.0
PEL
IDLH
1.0
75
Source: www.osha.gov
Thank You, Questions?
© Bioquell Inc (2010). All rights reserved.