Temperature Mapping (WHO).pdf

Presenter:
Noor Nabi
Deputy Manager QA Compliance,
Validation & Qualification
Temperature Mapping

CONTENTS
Temperature Mapping (What and Why)
GMP Requirements
Regulations and Guidance
Stages of temperature-mapping process
Methodology
Periodic requalification

If we have knowledge about the
Normal then we can easily detect the
Abnormal

What is Temperature Mapping Study?
Temperature Mapping study is the process to identify the difference or changes
in temperature (Where applicable) that occurs within a warehouse/walk in
rooms & Chambers due to the influence of the system and / or Equipments
and by the outside environment condition.
TM identified Temperature distribution within the zone being mapped and it
locates hot and cold spots.
Why Temperature Mapping Study ?
A temperature mapping exercise is required by regulatory bodies for any space
allocated for the storage and handling of products with a specified labeled
storage temperature.
Freezer Rooms,
Cold Rooms,
Temperature-controlled Storage Areas,
Quarantine Areas ,Receiving and Loading Bays.

WHO PIC/S Health Canada ISPE FDA
TRS No. 961,
2011 –
Temperature
mapping of
storage areas
(For storage
areas)
PIC/S Guide to Good
Distribution Practice
for Medicinal Products
PE 011-1, June 2014
Health Canada
GUI-0069 –
Guidelines for
Temperature
Control of Drug
Products during
Storage and
Transportation
(2011)
ISPE Good
Practice Guide
– Cold Chain
Management
(2011)
ISPE Controlled
Temperature
Chamber
Mapping (2012)
(Environmental
chambers
and other
equipments)
21 CFR 210
Manufacturing
Processing or
Holding of
Drugs
21 CFR Part
211
cGMP for
Finished
products
References

General Consideration For TM
HVAC system /Equipments which support the area should be qualified prior
to temperature mapping study.
For new Facility study conducted on both Empty & Loaded Condition
For periodic Requalification study conducted on real time basis
If storage areas are affected by seasonal temperature variations, at least two
temperature-mapping studies may be needed. one during the warmest season
and one during the coldest season.
 Typically, two-season mapping is not necessary for cold rooms and freezer
rooms.

The Temperature-mapping process has four stages:
 Prepare a mapping protocol.
 Carry out the mapping exercise.
 Prepare a mapping report.
Implement the recommendations

Methodology
It is important to note that steps 1 to 5 must be completed before the mapping
protocol can finally be approved.
Step 1 – Select Electronic Data Logging monitor :
Sufficient memory
3-point calibration completed and valid (within the current year), and have an
error of no more than ― 0.5.
Valid calibration certificates for each of the data loggers used in the
study must be included in the mapping report.
Calibration temperature points used for the calibration of EDLMs should
cover the required temperature range
 One calibration point below the low end of the range,
 One calibration point in the middle of the range,
 One calibration point above the high end of the range.

To ensure consistency, use only one type of device per mapping study.
It may be appropriate to include an EDLM device that is able to monitor
door openings, programmed so that the readings on the temperature monitoring
devices can be aligned with door opening times.
Step 2 – Designate the mapping team:
Identify and list the team members.
Record their signatures and initials so that signed records can be traced back to the
person who prepared the document.
Ensure that all team members receive the training needed to perform their assigned
tasks.

Step 3 – survey the site:
Conduct a site survey of the area(s) to be mapped. The following information
is required for each thermally separate area being mapped:
Length, width and height;
Drawing of each area, showing elements, such as shelving or pallet racking,
that may have an effect on the even heating or cooling of the space and which
may affect its temperature stability. The shelving or pallet racking will be used
to place the EDLMs, so it is important to record these components accurately;
The location of heating and cooling components, including air
distribution outlets and/or ceiling fans;
The location of existing temperature recording sensors and
temperature controlling sensors.

Step 4 – Establish acceptance criteria:
Type of TTSPPs time- and temperature-sensitive pharmaceutical product being stored.
Example: + 2.0 °C to + 8.0 °C or + 15.0 °C to + 25.0 °C.
However, some mapping studies may be performed without predefining any
acceptance criteria. This type of study can be used to establish the types of product that
can safely be stored in a specific space, and what remedial actions might have to be
taken to improve the thermal performance of the space in order to optimize its use.
If the temperature-mapping study is designed to include door opening(s), this should
be stated in the study methodology and acceptance criteria. Also the door opening
parameters (frequency and duration) should be defined. The temperature should be
maintained within the defined temperature limits except for a maximum of 30 minutes
following the door opening.

Step 5 – determine EDLM locations:
Use the site survey to mark the required locations of the EDLMs.
A risk-based approach can be applied to define these locations.
Length and width:
EDLMs should be arranged in a grid fashion along the width and length of the area so
that the area is reasonably covered, with EDLMs located
Every 5–10 meters. (In very large facilities, this can be up to 20 or 30 meters) The
chosen sensor grid should take account of:
the layout of the area (e.g. whether it is square or includes alcoves);
the degree to which shelving and products may affect airflow;

Height:
At each point on the grid, arrange EDLMs vertically as follows:
If the ceiling height is 3.6 metres or less, position EDLMs directly above one another at
high, medium and low level (e.g. one EDLM at floor level, one at 1.2 metres and one
EDLM at 3.0 metres.
If the ceiling height is greater than 3.6 metres, EDLMs can be arranged in vertical arrays
at the bottom, middle (multiple) and top of the space. For instance, for a storage area 6
metres in height, EDLMs can be positioned in each grid location at heights of 0.3 metres,
1.8 metres, 3.6 metres and 5.4 metres.

Number of sensors for Warehouse

Number of sensors for Walk in Rooms/Chambers

There is no formal time limit for a mapping study.
warehouses and other ambient storage areas,
it should be run for a minimum of seven consecutive days – including five
working days and two weekend days. (Data logging Interval 10-15 minutes)
Temperature-controlled equipment
( Freezer rooms and cold rooms), the mapping study should be run for
between 24 and 72hours, or longer if justified. (Data logging Interval 05-10
minutes)

Periodic requalification?
When any significant change in system i.e.
Performance of System change form its predetermined parameters
Modification in Area
Replacement of HVAC supporting system or Its parts
When there is no change or abrupt behavior
Study conducted after every 03 years (20 days Margin)

Cold Spot
Lowest temperature(s) recorded in the space over the study period, but these lowest
temperature(s) remain within the specified temperature range (e.g. cold spots
identified between +15.0 °C and +17.5 °C in a room with a specified temperature
range of +15.0 °C to +25.0 °C).
Hot Spot
Highest temperature(s) recorded in the area studied over the study period, but these
highest temperature(s) remain within the specified temperature range (e.g. hot spots
identified between +23.0 °C and +25.0 °C in a room with a specified temperature
range of +15.0 °C to +25.0 °C).
Mean Kinetic Temprature (MKT)
The single calculated temperature at which the total amount of degradation over a
particular period is equal to sum of the individual degradation that would occur at
various temperature

Temperature Mapping (WHO).pdf

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