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Practical Guide to Autoclave Validation by

by Raymond G. Lewis, PE In addition to potential business liabilities, there can be significant costs associated with an autoclave validation process. The practical experience that this article is based on may provide assistance in ensuring an effective, efficient validation process for steam sterilization. Introduction This article is based on practical experiences gained by the author while conducting hundreds of validation test runs on dozens of autoclaves of varied manufacture. It is primarily intended that personnel who perform validation testing on autoclaves may benefit from these experiences, and that it will assist in ensuring a high level of compliance in the validation process. The article also may be of benefit in selecting an appropriate validation strategy and/or cycle. Personnel unfamiliar with steam sterilization principles or autoclave validation could use the material as a basic training tool and it may be a good refresher for more experienced personnel. A list of definitions and references are provided at the end of the article.