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From Monitoring to Controlling with Vaporized H2O2Sensors– Why, How & Case Study

Webinar 18 June 2019Vaisala & Cleamix

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Meet the Presenters

2019-06-18From Monitoring to Controlling with Vaporized H2O2 Sensors - Why, How and Case Study 2

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

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

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Meet the Presenters


Cleamix: Hanna-Kaisa KyyrönenHanna-Kaisa Kyyrönen has over 10 years of experience in decontamination and sterilization processes having worked in different sales and product management positions in health technology.

Cleamix: Panu Wilska With over 25 years of international work experience ranging from nuclear physics to managing hi-tech start-ups, Wilska joined Cleamix 2016 to assist in investor relations and commercial operations. He has served as Chairman of Board since May 2018.

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Basics of Bio-Decontamination with Vaporized H2O2

Vaisala’s patented PEROXCAP® Technology

Inline Measurements During Bio-Decontamination

- From Monitoring to Controlling

Cleamix Technology Highlights

Variables That Influence Hydrogen Peroxide Vapor Concentration

How Measurements Can Help You to Provide Efficient H2O2 Vapor Output?

Case Study: Hospital Room Bio-Decontamination

Q&A Session


Agenda

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Basics of Bio-Decontamination with Vaporized H2O2

© Vaisala2019-06-18From Monitoring to Controlling with Vaporized H2O2 Sensors - Why, How and Case Study 6

Why H2O2 for 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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Typical non-condensing bio-decontamination process in isolators


Example Bio-Decontamination Cycle

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Vaisala’s Patented PEROXCAP®

Technology

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HPP270 series Patented PEROXCAP® measurement technologyBased on capacitive thin-film polymer sensor (HUMICAP®)Measurements: Hydrogen peroxide vapor, up to 2000 ppm, not

for safety (<1ppm) Humidity, 0-100%

– Relative Saturation (%RS)– Relative Humidity (%RH)

Temperature, 5-50ºC Digital and analog outputs

9From Monitoring to Controlling with Vaporized H2O2 Sensors - Why, How and Case Study 2019-06-18

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The Difference Between Relative Humidity (%RH) and Relative Saturation (%RS)

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Relative Saturation vs. Relative Humidity


Only H2O vapor present H2O and H2O2 vapor present

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RELATIVE SATURATION %

100%

0%

Condensation

RS% value is the only parameter for controlling condensation when H2O2vapor is present. 12

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Customer Case / FDA Audit


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Relative Humidity vs. Relative Saturation

CONDENSATION

100%100%

0%

H2O

0%

H2O

H2O2

%RH %RS

2019-06-18 14From Monitoring to Controlling with Vaporized H2O2 Sensors - Why, How and Case Study

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Solution For All Bio-Decontamination Processes; Dry, Wet or Micro-condensing Relative saturation (RS) value is needed to be able to control a condensation

phenomenon.


Process type

Humidityvalues

Condensing environment

Dry < 100 % Avoided

Micro-condensing

~ 100 % Being at a sub-micron level is invisible to the naked eye

Wet ≥ 100 % Visible condensation to naked eye

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Inline Measurements During Bio-Decontamination

- From Monitoring to Controlling

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Indicators vs. Inline MeasurementsChemical indicators (CI)

Biological indicators (BI)

Enzyme indicators (EI)

Measurement sensor; Vaisala HPP272

What the product looks like?PROS Inexpensive

Easy to useQuantitative results Quantitative results

Instantaneous reactionContinuous, stable andrepeatable measurement

CONS Tells only ”±” resultNot quantitative results

Takes 7 days to get resultsNeeds qualified personnel and laboratory premises

Manual work neededDoesn’t give continuous measurement data

Doesn’t tell if micro-organisms are dead;combine with BIs/EIs

What does thisproduct measure?

Change in color; H2O2 concentration

Log reduction of micro-organisms (SAL min. 10-6)

Log reduction of micro-organisms (SAL min. 10-6)

H2O2 ppm concentration, RH/RS and temperature


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Why Inline Measurements?


Provides continuous measurement data

Guarantees that a process works as planned

May decrease a number of biological, chemical or enzymatic indicators

Monitoring processes also between validations enables you to see changes in the environment (°C, %RH)Enables good documentation practicesFrom monitoring to controlling

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Why from Monitoring to Controlling?

From H2O2 liquid injection rate to real in-line controlling with H2O2 concentration measurement From high batch variability to more controlled processes Reduces your validation efforts Follows PAT (Process Analytical Technology) ideology


0

100

200

300

400

500

600

H2O

2C

once

ntra

tion

(ppm

)

Time

With Controlling Systems; Target = 400 ppm

0

100

200

300

400

500

600

H2O

2C

once

ntra

tion

(ppm

)

Time

Without Controlling Systems; Target = 400 ppm

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Measurement Used for Process Controlling Should

Be repeatable

Be stable

Withstand condensing environments

Be accurate

Not absorb, desorb nor catalyze H2O2 vapor

Have digital signal

Have long calibration intervals

Have fast response time


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PEROXCAP Technology Supports Controlling Activities

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PEROXCAP® H2O2, Measurement Repeatability

2019-06-18From Monitoring to Controlling with Vaporized H2O2 Sensors - Why, How and Case Study

-15

-10

-5

0

5

10

15

0 1 2 3 4 5 6 7 8 9 10

Diff

eren

ce to

ave

rage

[H2O

2] er

ror

(ppm

)

Cycle number

P2230776 P2230779 P2230780 P2230782 P2230784P2430885 P2430886 P2430887 P2430888 P2430889

HPP272 at 500 ppm & 40 %RS

22

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PEROXCAP® %RS, Measurement Repeatability


-0.6

-0.4

-0.2

0

0.2

0.4

0.6

0 1 2 3 4 5 6 7 8 9 10

Diff

eren

ce to

ave

rage

[RS]

erro

r (%

RS)

Cycle number

P2230776 P2230779 P2230780 P2230782 P2230784P2430885 P2430886 P2430887 P2430888 P2430889

HPP272 at 500 ppm & 40 %RS

23

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‐50

‐30

‐10

10

30

50

70

90

110

130

0 50 100 150 200 250 300 350 400 450 500

d [H2O

2] (p

pm)

ref [H2O2] (ppm)

H2O2 measurement drift after different exposure times

4 h 16 h 30 h 76 h 140 h 218 h

PEROXCAP®, HPP272, Long Term Stability, H2O2 ppm


218h at 460 ppm= e.g. 436 times at 460 ppm for 30 minutes→ drift only ~ +10 ppm

24

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Reliable Measurements Also Under Condensing Environments

0

0.05

0.1

0.15

0.2

0.25

0.3

0.35

0.4

0.45

0.5

0 10 20 30 40 50 60 70 80 90 100

Mea

sure

men

t erro

r [%

RH

/ %

RS]

Relative humidity [%RH]

HPP272 stability after 200 times at H2O2 cycles (400-500 ppm, RS~100%RS)

RH RS


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Accurate H2O2 and Humidity Measurements

Traceable factory calibration Traceable to the international system of units (SI)

through national metrology institutes

Quality of probe materials Limited absorption, desorption and catalyzing of H2O2

Materials selected according to the rigorous and wide material test results


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Cleamix Technology Highlights

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Cleamix VCS Series: A New Method for Generating Vaporized H2O2

A powerful, portable bio-decontamination unithaving the size of a briefcase. Performance experiments conducted in 3

different enclosures:

One litre bottle is sufficient for significant decontamination volumes.


Size of enclosure/ m3

ppm/H2O2 vapor time/min

10 > 800 1536 > 600 3068 > 500 50

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Variables That Influence Hydrogen Peroxide VaporConcentration

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Measurable Variables That Impact H2O2 Vapor Concentration

Humidity

Temperature


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Other Enclosure Variables That Impact H2O2 Vapor Concentration Total surface area of the space or

room to be decontaminated

Properties of the surface materials: Porosity Tendency to break down

hydrogen peroxide molecules

Temperature variations of the surfaces The cooler the surface than the

air temperature, the earlier the condensation.


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How Measurements Can Help You to Provide Efficient H2O2Vapor Output?

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Sensor to PLC Connection for Control

Sensor must be rugged enough to maintain accuracy through multiple processes.

Testing determined that available sensing technologies were unsatisfactory.

EXCEPT with Vaisala’s HPP272 probe…


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Why We Selected Vaisala's Technology?

The probe provides all the parameters you need: Hydrogen peroxide vapour Temperature Humidity as both relative saturation and relative humidity Options for dew point and vapor pressure

The HPP270 probe with digital output signal Analog signals are subject to deterioration by noise during transmission and write

or read cycles Communication achieved via Modbus RTU– HPP272 and Portable vaporizer use RS-485 allowing the communication in a

local area network, nearly resistant to electromagnetic interference

Calibration only once a year


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Things to Consider When Planning Bio-Decontamination Processes Evaluate applicable process parameters H2O2 vapor concentration and exposure

time, required to eliminate contamination from surfaces

Consider environmental factors Relative saturation limit value is the

dominant variable Hydrogen peroxide and water vapor

levels are maintained below saturationpoint Ignore if condensation is acceptable

according to material properties


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Controlling Condensation

Real time monitoring of relative saturation is needed to maintain dry conditions with minimum condensation

Challenges:

Optimizing the hydrogen peroxide vapour generation rate to fit small decontaminationvolumes

– Difficulties in controlling the hysteresis

Condensation is more likely to occur if any of the exposed surfaces are cooler than the air


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Validation of Decontamination Cycles

In order to validate a process, accurate, real time information on cycle parameters is necessary

When a desired H2O2 ppm level is easily attained, the total treatment time can be relatively short and the time needed for aeration is propably short as well

When a desired H2O2 ppm level is difficult to reach, the cycle time gets much longer and so does the time for aeration


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Challenges in Infection Prevention


Suboptimal cleaning practises

Important pathogens not eliminated fromsurfaces:

Clostridium Difficile (C.diff)

Methicillin-resistant Staphylococcusaureus (MRSA)

Vancomycin-resistant Enterococcus(VRE)

Multidrug-resistant Acinetobacter

Risk of infections transmitting from patientto another

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No Touch Decontamination Solution

Automated technology – exceeds humanperformance More intensive decontamination Reliable process monitoring and control


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Monitoring of the Decontamination Cycles

Control: Via cable or WiFi– Touch screen and computer– Tablet– Phone

Accurate Real time Documented


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Safety Concerns


Post warning signs around perimeter to restrict access to H2O2 exposed area

In the event you must enter the process area, wear appropriate protective clothing and mask

Use handheld meter to detect any leaks of H2O2

Wait until proper aeration to enter area

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By moving from monitoring to controlling you can Control the process based on real results Reduce batch variability Reduce validation efforts

Repeatable, stable and accurate PEROXCAP technology provides easy way to Keep the H2O2 ppm value at a desired level Control the process humidity and condensation with %RS Control %RH between bio-decontamination cycles

Without understanding the effect of enclosure variables, it’s difficult to validate bio-decontamination cycles


Conclusion

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Would you like a Sales Engineer to Contact You?

Yes, Vaisala Sales Engineer (HPP271, HPP272, PEROXCAP®) Yes, Cleamix Sales Engineer (VCS-100 vapor generators)


https://www.vaisala.com/en/lp/contact-form/contact-us

http://cleamix.com/?page_id=5

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Thank You for Attending!Vaisala:

HPP270 Series data sheet

Learn more about Bio-decontamination

– Blogs, Videos, Application Notes

More information about HPP270 series products

Cleamix:

Video of VCS100


https://www.youtube.com/watch?v=v5ilfzxCFNM

https://www.vaisala.com/en/bio-decontamination

https://www.vaisala.com/sites/default/files/documents/HPP270-Series-Datasheet-B211644EN.pdf

https://www.vaisala.com/en/products/instruments-sensors-and-other-measurement-devices/instruments-industrial-measurements/hpp272

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