HACCP Cold Chain

The new EC food directive EC 852/2004

Since January 2006 the member states of the European Union have a common food law.

Among other directives EC 852/2004 describes the food-safety and HACCP principles. The food business operator has to take care, that the cold chain of temperature sensitive products is maintained. Temperature values have to measured with suitable instruments and documented for inspection of the authorities.

Cold chain

A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range.

Uses

Cold chains are common in the food and pharmaceutical industries and also some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C. but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped.

This is important in the supply of vaccines to distant clinics in hot climates served by poorly developed transport networks. Disruption of a cold chain due to war may produce consequences similar to the Smallpox outbreaks in the Philippines during the Spanish-American war.

Traditionally all historical stability data developed for vaccines was based on the temperature range of 2-8 °C. With recent development of biological products by former vaccine developers, biologics has fallen into the same category of storage at 2-8 °C due to the nature of the products and the lack of testing these products at wider storage conditions.

Validation

A cold chain can be managed by a quality management system: it can be analyzed, measured, controlled, documented, and validated. The food industry uses the process of Hazard Analysis and Critical Control Point, HACCP, as a useful tool. Its usage continues into other fields. PDA (Parenteral Drug Association) Technical Report # 39 gives a rough summary of how the cold chain can be validated.

temperatures have to be monitored :

in storage
in transport
in process
in the incoming goods department
in the store
during preparation work
in the hot and cold food kitchen
when dishing out food
in deep freeze cabinets

Deep freeze cabinet stipulation

Since 1.1.97, deep freeze cabinets with more than 10m3 should be equipped with the appropriate thermometers. Continuous logging of the air temperature and proof of the data for at least 1 year is required.

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