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Cold Chain Compliance.
April 19, 2014
Good day

Cold Chain Compliance.

Cold Chain Validation suddenly became a hot topic when the results of a government investigation into Cold Chain distribution compliance were published.
The facts release indicated that nearly a quarter (23%) of all drugs distributed in the USA, are of unknown efficacy. The distribution of these temperature sensitive products in vehicle containers that lacked validated methods of maintaining the correct internal temperature or even the ability to produce a validated history of what the actual conditions were; has rendered these products 'adultered', i.e. of unknown efficacy or safety. Vehicle body internal temperatures; with seasonal variations, can range from a high of 50 to a low of -40 (degrees centigrade). In contrast the mandated internal temperature for distribution containers for standard drugs and medical products is 2 to 8 (degrees centigrade), with much lower temperatures specified for some drugs.

This shocking news has certainly guaranteed that Cold Chain Validation compliance will be top of everyone's audit list, specifically when drug interactions with the end user are considered as critical. The implications of products being damaged and out of specification may induce many companies to replace doubtful goods or even trigger the regulators into initiating product recalls. This problem is expected to create a veritable stampede as distributors scramble to ensure that all the vehicles and containers they used in this essential everyday service, are rendered Cold Chain compliant, as soon as is possible.

Any vaccine that has not been stored at a temperature of 2-8ÂșC as per its licensing conditions is no longer a licensed product

The Problem Requires Immediate Attention

The Regulators Are adamant Compliance is Essential.

The Patient Must Come First.

Where there is any doubt that cold chain has not been maintained, medications should not be used.

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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