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Late last month the FDA CBER (Consumer Affairs Branch) issued an advisor notice to interested persons containing information related to the storage and use of temperature sensitive biological products that have been involved in a temporary electrical power failure, or flood conditions.

It states: "While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product".

It continues: "Vials of Biological products in contact with flood waters should be discarded given the possibility of contamination and the likelihood of significant exposure to temperatures outside of those recommended for cold chain storage".

The CDC and the FDA both recommend that any refrigerated storage unit that stores biological products and/or vaccines has a back-up power source and a temperature recording device that will provide a record of any temperature excursions that may have occurred due to severe weather power losses, or power losses caused by an equipment failure. Using suitable temperature monitoring devices will add a level of risk aversion, plus provide actual condition reassurance as it will be possible to see if any of the stored, or exposed, products have experienced any excursions outside of the recommended limits.

A general rule in any cold chain logistics operation is that it is far more cost effective and safer to include a temperature monitoring device with each cold chain shipment rather than face the cost of a shipment that needs to scrapped, or to run the added risk of potentially impacting a patient's health.

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

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