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Autoclaves for the Sterilization of Compounded Parenteral Products

Author(s):  Rahe Hank

Issue:  Mar/Apr 2003 - Terrorism
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Abstract:  This article documents the results of recent testing conducted to determine whether the performance of an autoclave (Model AS12P 58939-950, Barnstead/Thermolyne, Dubuque, Iowa) matched the preset cycles, provided heating to a temperature of 121 degrees C (required for sterilization) and maintained that temperature for the required 15 minutes. When the autoclave was tested without a load, results indicated that its performance matched the respective printout data. When a load was added, measurements showed a variation between the actual temperature of the water and the temperature indicated on the printout. According to the printout, the water in the beaker did not reach 121 degrees C until the sterilization cycle was more than half complete, which indicated that the required temperature was not maintained for the 15 minutes necessary for sterilization. Previous experience with several autoclaves indicated that individual units perform differently and that a single unit cannot be used to determine sterilization cycles for other brands or types of unit. Each unit should be tested to determine the correct sterilization cycle for a specific load. Testing must be based on the characteristics of the load because different loads require different cycles. All autoclaves used for preparing sterile injectable products that are not sterile-filtered through a double 0.22-micrometer filter should be subjected to this type of testing.

Related Keywords: Autoclaves, for sterilization of parenteral products, Parenteral products, sterilization of by autoclave, Sterilization, of parenteral products, by autoclave


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