Temperature Mapping

Equipment, Procedures and Compliance

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

ICH Q10 Pharmaceutical Quality

System (2009)

USP Chapter 1079 Monitoring

Devices Good Storage and
Shipping Practices (under
revision
2011)

21 CFR Part 211 cGMPs for

Finished Pharmaceuticals

ISPE Good Practice Guide

Cold Chain Management (2011)

PDA Technical Report No. 52

Guidance for Good Distribution
Practices for the Pharmaceutical
Supply Chain (2011)

ISPE Controlled Temperature

Chamber Mapping (2012)
21 CFR Part 820 cGMPs for
Medical Devices
21 CFR Part 820.150 Storage

PIC/S GMP Guide Part I: Basic

Requirements for Medicinal
Program Sections 3.19 and 4.9

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 dont 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
cant 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
Range

Standard
Tolerance

Application

>0 to 750C

2.2C or 0.75%

OK for refrigerators, unacceptable for

incubators and not rated for freezers.

>0 to 1250C
-200 to 0C

2.2C or 0.75%
2.2C or 2.0%

OK for refrigerators and freezers,

unacceptable for incubators.

>0 to 350C
-200 to 0C

1.0C or 0.75%
1.0C or 1.5%

Good for incubators, refrigerators, and

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.