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Importance of Procurement.
August 10, 2014

Cold Chain Compliance.


Cold Chain Validation

Cold Chain Validation requires the verification that the internal temperature throughout any transportation container, used to distribute temperature sensitive cGMP regulated product; is maintained within the acceptable temperature range mandated for the product being transported. Further to this; documented evidence of such conformance must be produced. Documented proof of conformance may be produced using two sampling data loggers to record actual container temperatures at predetermined intervals. Both the actual location of the loggers and sampling time intervals must be established through trials and then validated. Uniformity of temperature throughout the container and the location of the history generating loggers must be both established and documented during the execution of a temperature mapping exercise. The number and location of single channel data loggers required for successful temperature mapping of a cold chain warehouse is dictated by several factors. Disruptive air flows entering or leaving the storage area, distribution of conditioned air inlet and exhausts, open doors and or windows and generally the environmental insulation of the ceiling and walls.
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