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Temperature Mapping Study

The document outlines a temperature mapping study to verify an area maintains temperature within permitted limits of 2-8°C at all times by collecting temperature data over several days under different conditions and identifying hot and cold points. It also discusses maintaining humidity within 60-65% and installing dehumidifiers if needed, and testing major and minor equipment for temperature limits as part of temperature qualification and certification.

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142 views3 pages

Temperature Mapping Study

The document outlines a temperature mapping study to verify an area maintains temperature within permitted limits of 2-8°C at all times by collecting temperature data over several days under different conditions and identifying hot and cold points. It also discusses maintaining humidity within 60-65% and installing dehumidifiers if needed, and testing major and minor equipment for temperature limits as part of temperature qualification and certification.

Uploaded by

swathi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Temperature Mapping Study

To verify an area maintains temperature within permitted limits at all times (2-8 C)

Collect temperature data along the length and breadth of the room at different operating conditions for
couple of days (3-4 days per WHO protocol standards) and analyze the data

Identify hot and cold points of a room – those that are below and above the limits; isolate those
areas/not use to store medicines/resolve issues

Temperature and Humidity Mapping Study

If humidity is to be maintained within a maximum range (60-65%) or limits of 40-65% Rh. Install
dehumidifiers

Need for the study

For products which are temperature sensitive and which will get damaged if limits not maintained

To understand temperature level distribution

Test Protocol – where the test procedure is written

Place data loggers in the room – location and number depends on the number and position of the doors,
racks etc; 1 data logger for every 5 cm3 and all racks; a data logger is a temperature monitoring system

Data collection

Empty condition – to determine if temperature distribution is uniform

2 Loaded Conditions – 60% loaded and fully loaded

Power failure – to determine how long temp is maintained within limits after power failure

Door Opening test

Collected data is analyzed using special software and report generated

Temperature Qualification & Certification

In addition to temperature mapping, all installed major and minor equipment are tested for
temperature limits
CAPA – Corrective Actions Preventive Actions

Corrective Action – prevent recurrence of non-compliance

Preventive Action – prevent occurrence of non-compliance

Correction - Action taken to address particular instance of non-compliance


21 CFR Part 11 – Code of Federal Regulations, Title 21 – Food & Drugs, Part 11 – electronic records,
signatures, submissions to FDA

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