Temperature Mapping can be a very cost effective way to ensure compliance and satisfy your auditor's concerns. Whenever temperature is critical, having a detailed mapping of a chamber, vessel, or other container where products are stored or processes occur is a valuable tool in documenting the control of your storage or process.
Temperature mapping involves placing temperature probes at various locations within a chamber and documenting the temperature over a designated time period and/or during interruptions to the control of the chamber. By mapping the chamber you can determine the mean chamber temperature, the variation within the chamber, the control curve of the chamber temperature controller, determine if their are areas of poor media circulation, determine the error in the controller, and a host of other concerns. Mapping can be performed in empty chambers to qualify the equipment or with chambers containing formulated ingredients or storage materials to qualify the process.
Examples of chambers that are frequently mapped are reaction vessels, sterilization vessels, refrigerators, freezers, autoclaves, ultra-cold freezers, process vessels, bio-reactors, and freeze dryers.
Mapping autoclaves is critical to ensure the documentation chain of heat treatment. By mapping the autoclave we determine if all materials within the various locations in the autoclave meet the sterilization requirements of the process. By mapping the empty autoclave we can qualify the autoclave function. By mapping the hardest to heat items withing a autoclave load, we can determine the minimum sterilization parameters than can ensure the desired level of sterilization. The minimum and maximum lethalities can easily be calculated using the data from the temperature mapping. Biological Indicators can be located next to probes during the mapping to enhance the proof of autoclave function.
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