Qualification of Steam Sterilizer
1)Heat Distribution Studies
📌The intent of this study is to demonstrate the temperature uniformity and stability of the sterilizing medium throughout the sterilizer. Temperature distribution studies should be conducted on both empty and loaded chambers with maximum and minimum load configurations. Temperature uniformity may be influenced by the type, size, design, and installation of the sterilizer. The manufacturer of the vessel, based on the variables mentioned, should determine a satisfactory empty chamber temperature uniformity.
📌A narrow range is required and is generally acceptable if the variation is less than ±10°C (±2°F) of the mean chamber temperature. Significant temperature deviations greater than ±2.5°C (~±4.5°F) of the mean chamber temperature may indicate equipment malfunction. Stratified or entrapped air may also cause significant temperature variations within the sterilizer chamber. Initially, a temperature distribution profile should be established from studies conducted on the empty chamber. Confidence may be gained through repetition, and therefore empty chamber studies should be conducted in triplicate in order to obtain satisfactory assurance of consistent results.
📌Subsequent to the empty chamber studies, maximum load temperature distribution studies should be conducted to determine if the load configuration influences the temperature distribution profile obtained from the empty chamber studies. The thermocouples utilized in the heat distribution studies are distributed geometrically in representative horizontal and vertical planes throughout the sterilizer. The geometric center and corners of the sterilizer should also be represented. An additional thermocouple should be placed in the exhaust drain adjacent to the sensor that controls vessel temperature, if possible.
📌The number of thermocouples utilized in the heat distribution study will be dependent on sterilizer size. In a production-size sterilizer, 15 to 20 thermocouples should be adequate. The thermocouples utilized for loaded chamber heat distribution studies should be positioned in the same locations used for empty chamber heat distribution studies. The uniformity and stability of the sterilizing medium are monitored in the distribution studies; consequently, the temperature probes should be suspended to avoid contacting solid surfaces and should not be placed within any containers. Temperatures must be obtained at regular intervals (e.g., each minute) throughout the time duration specified for a normal production cycle.
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#pharmaceutical
