Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at a 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.
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.
The number of sensors used in temperature and humidity mapping is a confusing topic for 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 or 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 the volume of the 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 placed at the center of the floor, ceiling and four walls.
If the area is larger than 20 m3, additional sensors should be used by understanding the criticality of the area. Some distance should be maintained between the 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 a year in coldest and hottest days of the year in any GMP storage facility. Hotspot should find the mapping and routine temperature mapping should be done at this point.
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Nice and very useful topic to each and every pharmaceutical industry.It is better if the time interval is provided to record temperature and humidity for hot spot in routine.
ReplyDeleteSee the new proposed WHO Guideline for more detailed requirements
ReplyDeleteHi, how is temperature mapping of Raw material Storage areas done. And how do we evaluate the storage condition for a particular Raw material if its supplier suggests storage in cool and dry place and not exact temperature of storage or humidity requirement.
ReplyDeleteVery good effort
ReplyDeleteThanks for sharing such an amazing blog, This post is really informative and right to the point. Lots of useful info in this blog.
ReplyDeleteGood work sharing for gk..
ReplyDelete