Temperature & RH Mapping
We offer services for Temperature & R.Humidity Mapping for Warehouse, Cold Room and Staging Room.
Temperature sensitive materials can degrade at higher temperature therefore it is important to validate 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.
Temperature and Humidity are important factors in the stability of the pharmaceutical ingredients.Limits of the temperature and humidity should be accurate. Error in temperature e and humidity should not be more than +/- 0.2º C and +/- 3% respectively. Thermocouples or data logger can be used for monitoring of the area.
Number of sensors used in temperature and humidity mapping is 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.
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.
ISO 8573 STANDARD
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