Hydrogen Peroxide Vapor Technology & Applications

Hydrogen Peroxide Vapor Technology & Applications Martin Orlowski © Bioquell Inc (2010). All rights reserved. Summary of Technology 2H2O2 Gas ph...
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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

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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

© Bioquell Inc (2010). All rights reserved.

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

© 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

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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 © 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

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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

© 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

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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.

© 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

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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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