Temperature and Relative humidity validation

Temperature and relative humidity are critical aspects of pharmaceuticals USFDA(United states food and drug administration) as well as other regulatory agencies states that we must identify the environmental conditions impacting our product quality and ensure as well as demonstrate that storage conditions have met the acceptability criteria. so, Procedure of Temperature and Relative humidity Validation/Mapping is followed to ensure the safety of pharmaceutical products manufactured.

• Storage conditions depends upon the Stability study data of the products to be stored
• Data loggers with thermocouple sensors could be used but they must comply 21 CFR part 211 and software must be validated. Temperature could vary ±0.2°C and Humidity ±3% .
• Regarding number of sensors to be used most of regulatory agencies remains unclear and states sufficient number of sensors must be used. However, ISPE(International society for pharmaceutical engineering) provides some guidance it specifies 9 sensors for an area equivalent to 2m³. 15 sensors should be used for an area between 2m³ to 20m³. If area is larger than 20m³ additional sensors could be used justifying the reason . For larger areas mainly storage location of product must be monitored.
• Calibration of Sensors prior to Validation studies must be performed by NIST (National institute of standards and technology) or vendor approved by NIST.
• Worst case scenario studies should also be performed like Power failure , Door opening and closing interventions and variations of temperature at single point.
• Validation or Mapping frequency should be 48 hours for area equivalent to 2m³ . For larger areas 6 days mapping should be done on the hottest as well as coldest days of year.
• After successful mapping studies we will get Hot spot and Cold spot in an area.
• The Digital hygrometers for future recording of Temperature and Relative humidity should be placed on Hot spot as well as Cold Spot as we know that Temperature could be more at Hot spot and Relative humidity could be more at Cold spot and both of them could impact product quality.

Related Article : Effect of Hot and Cold spot on Relative humidity