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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
Decontamination Chambers
© Bioquell Inc (2010). All rights reserved.
Rooms, Facilities
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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 © Bioquell Inc (2010). All rights reserved.
Thickness of c condensate
Biological Indicator* (“BI”) survivors
6 log
Importance of micro- condensation
Ref: JPI Published ISPE 2008 © Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
Isolator/ Chamber Injection Nozzles
Fixed Injection Nozzle
Rotating Injection Nozzle
© Bioquell Inc (2010). All rights reserved.
Decontamination Chamber
Inject H202 from generator through ports designed into chamber Exhaust is recommended to speed up aeration cycle
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
Mobile Solution
© Bioquell Inc (2010). All rights reserved.
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.
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
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
© Bioquell Inc (2010). All rights reserved.
Thank You, Questions?
© Bioquell Inc (2010). All rights reserved.