Validate the Proper Functioning of Retorts
Heat and Temperature Distribution Studies in Autoclaves
Temperature Distribution Studies
This study is performed to assess the proper functioning of the equipment, determine its come-up time, and evaluate stability during the holding phase. It allows identification of slow-heating zones within the sterilization chamber. Temperature-measuring devices are placed throughout all spatial zones of the autoclave to establish a reliable programmed cycle that ensures all containers processed in the retort receive the same thermal treatment.
With this, operational procedures for the autoclave can be established for use by the operations area—procedures that are essential to guarantee product safety. Temperature distribution data can provide valuable information about the impact of changes made to the processing equipment, utilities, and other factors such as packaging load, rack design, and more.
The study is conducted using the plant’s worst-case scenario: smallest container, maximum equipment load, low steam or water flow rates, etc. These parameters are defined by the technical specialist and the Process Authority.
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Heat Distribution Studies (Heat Transfer Distribution)
This study is exclusive to Steam-Air mixture autoclaves. It is conducted under the worst-case conditions identified in the temperature distribution study and evaluates the lethal effect imparted by the autoclave to the containers, ensuring it is equivalent across all spatial zones of the sterilization chamber. A 5% Bentonite solution is typically used for this study, or another solution recommended by the technical specialist on-site.
Measuring instruments are placed inside containers filled with the bentonite solution and distributed across all spatial zones of the autoclave to determine the lethal effect. The result is expressed as a coefficient of variation, which must be less than 5% to ensure that all containers receive an equivalent thermal treatment
