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Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can
degrade at higher temperature therefore it important to validate the storage area for temperature.
Limits of the temperature and humidity depend upon the material to be stored in the area.
These should be defined according to the recommendation of the manufacturer. We can
tighten the limits but it should be justified when we use the wider limits.
Number of sensors used in temperature and humidity mapping is a confusing topic of the pharmaceutical professionals because most
of the regulatory guidelines do not say about the number of sensors to be used in mapping. According to USP a suitable number of
thermometers of other temperature recording instruments should be used for temperature mapping.
But International Society for Pharmaceutical Engineering (ISPE) says to use 9 sensors for the area less than 2 m3 in volume.
These sensors should be placed in all corners and one in the center. If volume of area is between 2 m3 to 20 m3, 15 sensors should be
used for mapping. Placement of 9 sensors should be done as 9 sensor configuration and addition sensors should be place at the
center of the floor, ceiling and four walls. If area is larger than 20 m3, additional sensors should be used by understanding the criticality
of the area. Some distance should be maintained between wall and the sensors. All sensors must be calibrated before starting the
mapping and should be traceable to NIST.
Mapping should be done twice in year in coldest and hottest days of the year. Hotspot should find after the mapping and routine
temperature mapping should be done at this point.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-
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