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Vaisala On-Demand Webinar:

Room Bio-Decontamination with


Vaporized Hydrogen Peroxide
Listen to the Recording at www.vaisala.com/webinars

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Content by:

Sanna Lehtinen
Product Manager at Vaisala with 20 years of
experience in life science applications and
wide product management experience from
leading international high tech companies.

Piritta Maunu
Life Science Regulatory and Industry Expert
at Vaisala with over 15 years of experience in
biotechnology and life science applications.

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What Drives Us?
Sustainability Awareness, Urbanization, Energy and Resource Efficiency, Well-
Being & Health, Climate Change, Circular Economy, Digitalization & Big Data,...

Observations for a Better World


Better Informed Societies through Industrial & Weather Measurements

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How Vaisala Helps the Life Science
Industry
Our Offering
Measurement instrumentation, continuous
monitoring systems and validation for regulated or
highly controlled life science environments.

Our Goal is to Help Customers


• Reduce their risk of lost or
adulterated product
• Reduce their risk of failing to
meet GxP regulations and/or
guidelines

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Room Bio-Decontamination Webinar

1. History of H2O2
2. Why Vaporized H2O2
3. Industries & Applications
4. Regulations and Guidance
5. Typical Process Conditions
6. Benefits of Repeatable Online Measurements
7. Technology Comparison
8. New PEROXCAP® 3-in-1 Probe

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1. History of H2O2
From Cancer Treatment to Antiseptic
and Bio-Decontamination with H2O2
 Found by Louis-Jacques Thenard (1777-1857)
 First used as an intravenous infusion in 1920
 In the 1920s tried as a treatment for cancer
 Familiar to most people as an antiseptic for
cleansing minor cuts
 Has been used over 20 years in bio-
decontamination isolators, process equipment
and more in pharmaceutical industry

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2. Why Vaporized H2O2?
Why Vaporized H2O2?
Agent State Residue Validation Safety Occupational
quality (PEL) challenge
Formaldehyde, Gaseous Powder Poor 0.5 ppm Carcinogenic
CH2O
Ethylene Gaseous Yes Good + 1.0 ppm Toxic, flammable,
Oxide, EtO carcinogenic
Chlorine Gaseous None Good 0.1 ppm Severe respiratory
Dioxide, ClO2 irritant
Peracetic acid Vaporized Variable Good 0.17 ppm Very irritant to
or blends (AEGL-1) skin, eyes,
(liquid) lungs...
Ozone Gaseous None Moderate 0.1 ppm Toxic, air
pollutant,
genotoxic...
H2O2 (liquid) Vaporized None Good + 1.0 ppm Skin / eye irritant

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Why Vaporized H2O2?
Agent State Residue Validation Safety Occupational
quality (PEL) challenge
Formaldehyde, Gaseous Powder Poor 0.5 ppm Carcinogenic
CH2O
Ethylene Gaseous Yes Good + 1.0 ppm Toxic, flammable,
Oxide, EtO carcinogenic
Chlorine Gaseous None Good 0.1 ppm Severe respiratory
Dioxide, ClO2 irritant
Peracetic acid Vaporized Variable Good 0.17 ppm Very irritant to
or blends (AEGL-1) skin, eyes,
(liquid) lungs...
Ozone Gaseous None Moderate 0.1 ppm Toxic, air
pollutant,
genotoxic...
H2O2 (liquid) Vaporized None Good + 1.0 ppm Skin / eye irritant

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Benefits of H2O2 Bio-Decontamination

 Easy to use
 Destroys all biological contaminants
 Works in low temperature processes
 Processes can be validated
 Compatible with a wide variety of materials
 Environmentally friendly process
 Leaves no real residues – only water vapor and oxygen

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3. Industries & Applications
Used in Many Different Industries

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Typical H2O2 Applications

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H2O2 Measurement Markets in 2015 and
in 2024

Reference: Transparency Market Research: Hydrogen Peroxide (H2O2) Measurement Market

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4. Regulations and Guidance
Regulations and Guidance

 Lots of documents guiding vaporized H2O2 use in:


 H2O2 as a sterilizing agent (a chemical)
– Including country specific health and safety regulations (e.g. OSHAs
and limit values like PEL, REL, IDLH, STEL..)
– Including EPA documents
 Sterilization machine/equipment (sterilizers)
 Isolators
 Manufacture of sterile products, aseptic fillings and sterility tests
 Use of BIs (Biological Indicators) and CIs (Chemical Indicators)

 Not many guidance documents for room bio-decontamination


applications.

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Regulations and Guidance for
Room Bio-Decontamination

 ANSI/AAMI ST58:2013. Chemical Sterilization and


High Level Disinfection in Health Care Facilities

 CDC, Guideline for Disinfection and Sterilization in Healthcare


facilities, 2008

 AAMI TIR17:2008 Technical Information Report.


Combatibility of materials subject to sterilization

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5. Typical Process Conditions
H2O2 Vaporization Process in Rooms

Typically
400-500 ppm

2H2O2 2H2O + O2

6-59% Vaporization Low Ventilators No residues


liquid e.g. heat temperature
H2O2 plate, process, Aeration
typically often in room
around temperature
100°C

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H2O2 Liquid Concentration Affects on
Vapour Concentration (ppm)

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Typical Process Values in Rooms

Parameter Phase Values


H2O2 Bio-Decontamination 400 – 500 ppm

Humidity After dehumidification phase, if 5 – 35 %


included

Humidity At the end of bio-decontamination 60 – 100 %

Temperature Throughout the process 18 – 40°C

Time Total bio-decontamination cycle Varies, from 4 to 24


time hours

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Control of Condensation is Needed

When used in wet processes

H2O2 condenses on walls and surfaces

Corrosion risk to different materials like metals

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Control of Condensation is Needed

Relative saturation (RS) value is needed to be able to control


a condensation phenomenon.

Process type Humidity Condensing environment


values

Dry < 100 % Avoided

Micro- ~ 100 % Being at a sub-micron level is


condensing invisible to the naked eye

Wet ≥ 100 % Visible condensation to naked eye

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6. Benefits of Repeatable
Online Measurements
Bio-Decontamination Measurements

 H2O2, ppm
 Humidity Our topics today
 Temperature

Potential other parameters:


 Time
 Pressure (P) and differential pressure (dP)
 Airflow and velocity
 Airborne particles

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Why Repeatable Online H2O2
Measurement?

 Provides continuous measurement data


 Guarantees that a process works as planned
 Can decrease a number of biological, chemical or
enzymatic indicators
 From monitoring to controlling

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7. Technology Comparison
Different Measurement Technologies
Technology Benefits Challenges Measurement
parameters
Electrochemical cells Sensor cell easy Short lifespan, ppm (H2O2)
to change repeatability
NIR (near infrared Stable, for R&D Expensive, big size, ppm (H2O2/H2O), a
technologies) not for low (H2O2, µg/), a (H2O,
measurements g/m3)
Gas analyzers (laser High selectivity, Expensive, big size, ppb, only low level
technology) detection limit, heavy, measurements
low noncontinuous
measurements measurement
Vaisala capacitive Several Vaisala HPP272 not RH%, RS%, °C,
thin-film polymer measurement for safety ppm (H2O2),
sensors parameters, applications absolute H2O2,
stable, (≤1 ppm) absolute H2O, H2O
repeatability, ppm by volume,
small size saturation vapor
pressure
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Capasitive Thin-Film Polymer Sensor

A = Sensor with
catalytic layer
B = Sensor without
catalytic layer

1 = Catalytic layer
2 = Thin film polymer
between two electrodes
3 = Alumina substrate

Difference between Sensor measures:


sensors B and A ppm, RS, RH, ˚C +
gives ppm result many other calculated
Vaisala PEROXCAP® HPP272 probe parameters

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Relative Saturation vs. Relative Humidity

Only H2O vapor present H2O and H2O2 vapor present

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Maximum Achievable Relative Humidity, %RH

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Maximum Achievable Relative Humidity, %RH at 20ºC

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H2O2 ppm as a Function of RS/RH Sensor Readings at 20.0˚C

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H2O2 ppm as a Function of RS/RH Sensor Readings at 20.0˚C

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H2O2 ppm as a Function of RS/RH Sensor Readings at 20.0˚C

%RH
~ 53%

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H2O2 ppm as a Function of RS/RH Sensor Readings at 20.0˚C

%RH
~ 53%

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H2O2 ppm as a Function of RS/RH Sensor Readings at 20.0˚C

%RH
~ 53%

%RS
~ 100%

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Bio-Decontamination Example;
RH vs. RS Difference

RH RS T ppm

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How Temperature Affects %RS?

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8. New PEROXCAP® 3-in-1 Probe
HPP272 for Vaporized H2O2, Humidity
and Temperature Measurements

Capacitive thin-film polymer


sensor

PEROXCAP® measurement
technology

Based on the Vaisala world


leading humidity
measurement technology
(HUMICAP®)

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Vaisala HPP272 Highlights

 3 in one with a display (˚C, RH/RS, ppm)


 Repeatable
 Stable
 Traceable calibration certificate
 Withstands highly condensing H2O2 environments (IP65)

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HPP272 Measurement Stability

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Things to Remember

1. H2O2 has been used decades for bio-decontamination


2. H2O2 is effective and safe to use
3. From healthcare to transportation and food production
4. Three guidelines for room bio-decontamination
5. Main parameters to monitor & control are temperature,
humidity and H2O2 vapor concentration (ppm)
6. Online measurements streamline processes
7. Measurement technology matters
8. New PEROXCAP® technology

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Q&A Session
 Visit the product page at www.vaisala.com/HPP272 for
datasheet, technology description, video, user guide, etc.

Validating H2O2 Bio-Decontamination – the Easy Way


P.S. Our previous webinar on vaporized hydrogen peroxide bio-decontamination in
isolators and transfer hatches was recorded in October and can be found in Vaisala
webinar portal: www.vaisala.com/webinars.

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