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Validation[VALHL]

Validation[VALHL]

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In every process in the food and pharma manufacturing industry, where temperature is a parameter of the process, temperature mapping is required.

The purpose of temperature mapping is to ensure that all areas of the process equipment achieve the required temperature. The outcome of the test is a temperature map defining the cold spot of the process equipment. It is necessary to perform temperature mapping in process equipment such as autoclaves (retorts), cooking/smoking chambers, dry heat sterilizers, stability chambers, EtO chambers, warehouses, etc.

Temperature mapping must be run with the process equipment both empty and fully loaded. The process equipment must be mapped annually, with every new product configuration and after every modification of the process equipment.

The typical procedure of temperature mapping starts with a pre-calibration of the measuring equipment. The measuring equipment is then set-up inside the process equipment. Then the process cycle is started and the measuring equipment logs data. A post-calibration check of the measuring equipment completes the mapping.

To conduct temperature mapping, three runs are recommended.  This includes one initial test and two replicates. If there are variations between the three tests, run a 3rd replication. For temperature mapping, at least 12 measuring points per run are recommended
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