Temperature and Humidity Validation/Mapping in Storage Area
Learn about the temperature mapping including the location and number of sensors to be placed in the area.
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.
In pharmaceuticals refrigerators, incubators, stability chambers, controlled sample rooms and raw material storage areas are need to be validated. These areas are monitored for 24 hours for three consecutive days.
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.
Measurement of temperature and humidity should be accurate. Error in temperature and humidity should not be more than ±0.2°C and ±3% respectively. Thermocouples or data logger can be used for the monitoring of the area. If any software is used for the collection of data then it must be validated and comply 21 CFR Part 11 guidelines.
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.
Related: Principle of Hygrometer and Its Use in Pharmaceuticals
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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