Data Logging Solutions

for Ethylene Oxide (EtO)
Sterilization
 Table of Contents

• Company Information • How sensors measure

• Intrinsically Safe Data • How EtO affects the
Loggers sensors
• Software and EtO • Internal Verification
Processes Processes
• Maintenance
 About Us
• Global company headquartered in
Contoocook, NH
• Founded on traditional principles, customer
service, quality, and trust.
• Dedicated to providing customers with
reliable, affordable products, and excellent
service.
 What MadgeTech Does
• MadgeTech designs and • Recalibration Services
manufactures data loggers traceable to N.I.S.T.
at it’s USA headquarters – Temperature
facility. – Humidity
– Pressure
• Capable of Measuring – Voltage
– Temperature, Humidity and – Current
Pressure
– Voltage & Current
– Shock & Vibration
– Acceleration
– Strain
– pH
– And more…
Temp1000IS
• Rated as Intrinsically Safe by FM Approvals for use
in Class I, Division 1, Groups A, B, C and D and
non-incendive for Class I, Division 2, groups
A, B, C and D indoor and outdoor.
• Sensor: DS1631 Digital Semiconductor
• Accuracy: ±0.5°C
• Repeatability: ±0.1°C
RHTemp1000IS

• Rated as Intrinsically Safe by FM Approvals for use

in Class I, Division 1, Groups A, B, C and D and
non-incendive for Class I, Division 2, groups
A, B, C and D indoor and outdoor.
• Sensor: Honeywell HIH-3610, capacitive polymer
• Accuracy: ±0.5°C, ±3%RH
• Repeatability: ±0.1°C, ±.5%RH
PRTemp1000IS
• Rated as Intrinsically Safe by FM Approvals for use
in Class I, Division 1, Groups A, B, C and D and
non-incendive for Class I, Division 2, groups
A, B, C and D hazardous environments.
• Sensor: Sensym Strain Gauge Transducer
• Accuracy: ±0.5°C, ±2% Full Scale Range
– 30 PSIA Sensor accuracy: ±0.6PSIA
• Repeatability: ±0.1°C, ±0.010%FSS
Complete Data Logging System

• Data Logger
– Temp1000IS
– RHTemp1000IS
– PRTemp1000IS

• Interface Cable
• Computer & Software
– 21 CFR Part 11
MadgeTech Secure: 21 CFR part 11
 Programming Data Loggers

• Autoconfigure
• Batch Start
– Reading Rate: 5
minutes
– Delay Start

• Check Configuration
with Device Status
Deploy

• Data logger is placed wherever it is needed

– Units are placed throughout and around the
pallet or load to measure stratification
• Cycles are run
• No wires – completely self-sufficient
Retrieve or Download Data

• Download Each Device Individually

Analyze Data

• Reporting Features
– Minimum, maximum,
and delta for all data
loggers

– By individual date and

time stamp

– Immediate
identification load
parameters are met
How it Measures: Temp1000IS
• Digital IC semiconductor
temperature measurement
device.

• Uses semiconductor
junction analog and ΔΣ
ADC digital technology.

• Specific one or two point

calibration points can be
requested to improve
accuracy over limited
ranges.
How it Measures: RHTemp1000IS

• Capacitive Humidity Sensor

• A thin ≈ 1um plastic sheet with a porous platinum or gold metalization layer
on each side. Water from the environment goes into the polymer and changes
the dielectricity and thus the capacitance of the sensor. When used in an
oscillator, the presence of water will change the output-frequency.

• Output is proportional to relative humidity, rather than moisture content

How it Measures: PRTemp1000IS

• Pressure differential distorts a

membrane or expands a bellows
• Measures external force applied
to a resistive wire
• Wire lengthens and cross section
contracts which increases
resistance
• Pressure is determined by
change in resistance in a
wheatstone bridge circuit
• Temperature is compensated by
a thermistor in the bridge circuit
 EtO Effects on Sensors
Temp1000IS PRTemp1000IS
• Does not effect temperature  • Pressure sensor is sealed by 
sensor stainless steal
EtO Effects on Sensors: RHTemp1000IS
• When using resistive or capacitive RH sensors in an EtO
environment, additional error will be created by the reactive effects of the
compound. The chart below indicates the typical error induced in a
capacitive sensor by prolonged exposure to EtO. Error for resistive sensors
tends to be more non-linear.
• EtO sterilization is primarily concerned with accuracy over the 40-85%
range, where error is typically less than 5%
EtO Error curve
15

10

5
% Error

0
10 20 30 40 50 60 70 80 90 100

‐5

‐10
%RH
 Reconditioning
• EtO effect decays 1‐2 days after exposure

• Decay may be accelerated in a higher 
temperature, drier environment
– Dry Bake:
• 55C, 35%RH for 4‐24 hours

• For additional security
– Wet Bake
• 30C, 75%RH for 4 hours
 Tolerance Verification
• Verify Tolerance Values
– NIST traceable equipment
– Data logger standards (not exposed to EtO)
• Software report 
– Display Minimum and maximum values
– Verify that all are within 5% to standard
Internal Processes: Recalibration
• Collect “as found” data (optional)
– Units as received
• Replace batteries and humidity sensor
– ±6%RH from 35%RH
– Battery voltage checked when not in use
(<3.4V)
• Verify Operation
• Recalibrate at standard or custom points
 Equipment
Test Equipment Procedures
• PGC Calibration Chamber • Validating Chamber
• Rotronic hygrometer – Temperature and
• Accuracy Humidity Map
• ±1%RH • Verify equipment is
• ±0.2°C within calibration
• 6 Month Calibration
• Vaisala HMP155
• Accuracy
• ±1%RH
• ±.17°C
 Maintenance
• Recalibration
– 6 or 12 month intervals

• Humidity Sensor Replacement

– 6 or 12 month intervals

• Annual Battery Replacement

– TL-2150 battery required
Customer Support
• One year warranty
• Monday through Friday
• 8:00 am to 6:00 pm
• Phone: 603‐456‐2011
• Fax: 603‐456‐2012
• Email: support@madgetech.com