Temperature Mapping

Equipment, Procedures and Compliance

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Kevin Loomis
Sr Validation Engineer
Panasonic Healthcare Corporation of NA
Temperature Mapping 101
Equipment and facilities are temperature
mapped to verify that they have the ability to
meet specified performance characteristics.
Specifications are established using URS, DS,
FS, regulatory compliance criteria and
established specifications for the products of
the application.
Planning
Step 1 – Determine Critical Mapping
Points
Step 2 – Determine Sample Rate
Step 3 – Establish Data Logger Criteria
Step 4 – Place Loggers at Pre
Determined Points
Step 5 – Capture, Retrieve and Evaluate
Logged Data
Step 6 – Document Processes (and
Repeat?)
Regulatory References and Guides
for Temperature Mapping
21 CFR Part 210 cGMPs for
Manufacturing, Processing or
Holding of Drugs
21 CFR Part 211 cGMPs for
Finished Pharmaceuticals
21 CFR Part 820 cGMPs for
Medical Devices
21 CFR Part 820.150 Storage
ICH Q10 Pharmaceutical Quality
System (2009)
ISPE Good Practice Guide –
Cold Chain Management (2011)
ISPE Controlled Temperature
Chamber Mapping (2012)
PIC/S GMP Guide Part I: Basic
Requirements for Medicinal
Program Sections 3.19 and 4.9
USP Chapter 1079 Monitoring
Devices – Good Storage and
Shipping Practices (under
revision
2011)
PDA Technical Report No. 52 –
Guidance for Good Distribution
Practices for the Pharmaceutical
Supply Chain (2011)
PIC/S GMP Guide Part II: Basic
Requirements for Active
Pharmaceutical Ingredients
Sections 7.42 and 10.1

Many guides tell you why to map, but don’t tell you how to map!
Reference ISPE doc above & IEC 60068-3-11 for methodology.
Temperature Mapping - Basic Equipment

Sensors & Systems

PRTDs, Thermocouples or Thermisters
connected to a recording device.
(NIST/ISO17025 Calibrated)

Software
for Data, Graphs and Analysis
(21 CFR Part 11 Compliant)
Differences in Equipment

• Wired and Wireless

• Loggers and Live
• Sensors
• Software
Equipment Advantages and
Disadvantages
• Wireless “loggers” are easy to set up, but
can’t be monitored live.
• Wireless “transmitters” can be monitored
live, but signal loss is a concern.
• Wired systems are robust, but often create
gaps in chamber seals. Limited to sensor
wire length.
• Integrated software may be easy to use, but
may not be regulatory compliant.
Sensors
Sensor types should be acceptable for the
accuracy and range of the device/system
being mapped.
TC Standard Standard Application
Range Tolerance
J >0 to 750C 2.2C or 0.75% OK for refrigerators, unacceptable for
incubators and not rated for freezers.
K >0 to 1250C 2.2C or 0.75% OK for refrigerators and freezers,
-200 to 0C 2.2C or 2.0% unacceptable for incubators.

T >0 to 350C 1.0C or 0.75% Good for incubators, refrigerators, and

-200 to 0C 1.0C or 1.5% freezers.

Note: A calibrated mapping system will have increased accuracy to

that of standard.
Sensor Placement
Placement should follow risk based
approach using design
considerations and expected use.

Location considerations follow the

same methodology regardless of
chamber size.
Refrigerators, Freezers and Cold Rooms
• Use forced air flow
through evaporator
and ducting to
remove heat.
• Proper air flow is
essential to
uniformity and
temperature
control.
Cold Wall Units
• Remove heat using
evaporator coils
encased in the
chamber walls.
• Not subject to air flow
issues.
• Uniformity determined
by efficiency of
refrigerant.
Incubators and Ovens

• Heating elements, and fans work together to

control temperature and achieve uniformity.
• Like refrigerators, proper air flow is essential.
 Autoclaves
• Mapping should capture temperature and pressure.
• Software may assist in determining lethality.
Warehouses, Stability and Dry Storage
Chambers
• Temperature and Humidity data
should be captured.
• Proper air flow is essential.
Uniformity Testing
• Temperature mapping data helps determine
areas in the chamber that may not meet
specification.
Dynamic Testing
• Open Door testing gives chamber characteristics
during normal use.
• Power Failure testing gives chamber characteristics
during failure and recovery conditions.
Loaded versus Empty Chambers
• Empty chambers
typically give
“Worst Case”
performance
characteristics.
• Loaded chambers
typically produce
better data as the
mass aids in
buffering
temperature
fluctuations.