ispe cc chapter_martinorlowskipres

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


� 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


� 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


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


ROOMS, RABSBIOMEDICAL &BIOLOGICS

ISOLATORS

Decontamination Chambers


Rooms, Facilities


�Geobacillus stearothermophilus biological indicators� Micro organism resistant to HPV

Demonstrating Bio- Burden Reduction is Crucial to a Decontamination Process

Micro-biological Efficacy


� 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


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


� 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


� 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


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


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


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


� 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


� Uniform gas

Distribution

� Decreased cycle times

� Measure and control

critical parameters

Rotating Nozzle

HPV

Unit

Isolator/ Chamber Injection Nozzles


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


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


Gas generator placed external to room under bio-decontamination

Mobile Solution


� Generators are placed

in strategic locations

throughout facility for

gas distribution

� Monitor Temp, RH, and

Facility Decontamination


�

H202 concentration at

multiple locations

� Used for outbreaks,

pre-commissioning, etc.

� Containment

� Vapor not gas

� Easy to seal

� During Cycle

�

Safety!


� 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!


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


0.5

20

0.1

5.0

PEL

IDLH

1.0

75

Source: www.osha.gov

Thank You, Questions?


ispe cc chapter_martinorlowskipres

Healthcare