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Validating an autoclave

Commonly used standards and guidelines are ISO EN 285, ISO EN 17665, ISO EN 11138, HTM 2010 and PDA Technical Report No.

Bottles and ampoules are typically sterilized in smaller autoclaves.Every laboratory strives for consistency and repeatability in its sterilization processes. In order to ensure your autoclave operates efficiently it’s critical that you validate the sterilization process and verify that the equipment is working safely and properly.This is known as Operational Qualification (OQ), and it’s one of the most important validation tests you can run on your steam sterilizer.Whatever the nature of the load, the product is loaded on trays or in cages to optimize the distribution of the load.For validation purposes it is important that the load is standardized, therefore full loads are usually used.Autoclaves can be used for sterilization of liquids in various containers such as bottles, vials, ampoules, bags and medical equipment.In most cases it is necessary to monitor the temperature of the product and the pressure of the autoclave during sterilization.Guidelines state that 11 temperature-measuring points are needed when performing a heat distribution study of an autoclave that is from 1.5 to 2.5 m3.This number is reached by placing one sensor in each of the eight corners in the autoclave, one in the center, one close to the drain and one next to the autoclave’s temperature sensor.To document the validation adequately a diagram must be made that shows all the sensors´ ID numbers related to their exact position in the autoclave.This is easily done in Val Suite™ Pro by integrating the data session with predefined schematics, pictures and Word documents.

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