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Temperature & Humidity Mapping For Storage Area
Choksi Laboratories Ltd. offers Temperature & Humidity mapping related services for any type of Storage Area/warehouse/production/cold room /Refrigerated Van in market. These validation services help our clients comply with pharmaceutical (USP/EP), healthcare & food regulatory requirements as well as International Standard for Temperature & Humidity mapping related.
REFERENCE DOCUMENT:
WHO Technical Report Series, No. 961, 2011 (Supplement 8, May 2015).
Purpose of Mapping
- The purpose of this mapping is to verify that the temperature and humidity in the storage area are within the specified limit with respect to seasonal variation (summer, monsoon & winter).
- This mapping activity is carried out to verify that respective facility meets the acceptance criteria required for fulfillment of the current Good Manufacturing Practice (CGMP).
- Documenting high and low temperature fluctuations caused by the environmental control systems operating at the time of the study – for example, heating, cooling and ventilation.
- Identifying potential airflow issues that may be the cause of temperature variations.
- Identifying the best places to locate temperature sensors for routine monitoring in circumstances in which a monitoring system is to be installed. If a monitoring system is already installed, identify the best places to relocate temperature sensors (if necessary).
Why Needs Temperature Mapping?
It helps identify temperature hotspots ,cold spots and any Temperature Fluctuation that may occur during Storage or transportation. By collecting accurate and comprehensive data, thermal mapping allows for informed decision-making to maintain optimal temperature conditions throughout the pharmaceutical supply chain