From Monitoring to Controlling with Vaporized H O Sensors · From Monitoring to Controlling with...
Transcript of From Monitoring to Controlling with Vaporized H O Sensors · From Monitoring to Controlling with...
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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
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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
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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
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Agenda
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Basics of Bio-Decontamination with Vaporized H2O2
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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
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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
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The Difference Between Relative Humidity (%RH) and Relative Saturation (%RS)
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Relative Saturation vs. Relative Humidity
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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
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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.
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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?
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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
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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
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-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
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PEROXCAP® %RS, Measurement Repeatability
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-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
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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
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218h at 460 ppm= e.g. 436 times at 460 ppm for 30 minutes→ drift only ~ +10 ppm
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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.
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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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Case Study: Hospital Room Bio-Decontamination
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Challenges in Infection Prevention
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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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Hospital Room Decontamination
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OPENREMOVE REMOVE
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Hospital Room Decontamination
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Cleamix H2O2vapor generator HPP272 PROBE
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Hospital Room Decontamination
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Cleamix H2O2vapor generator HPP272 PROBE
Oscillating fans
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Hospital Room Decontamination
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Cleamix H2O2vapor generator HPP272 PROBE
Oscillating fans
BIs and CIs
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Hospital Room Decontamination
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Cleamix H2O2vapor generator HPP272 PROBE
Oscillating fans
BIs and CIs
Catalyticconverter
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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
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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
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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)
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Q&A Session
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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
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