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Practical Guide to Autoclave Validation

"Practical Guide to Autoclave Validation" is a reference guide written by Raymond G. Lewis, a pharmaceutical engineer. It contains information on how to obtain validation of biological sterilization equipment most efficiently.

  1. Autoclave

    • An autoclave is a device used to sterilize biological equipment by blasting it with very hot steam. Before these devices may be used in pharmaceutical engineering projects, they must be validated by an authorized autoclave validation organization.

    Issues

    • Because improper sterilization of pharmaceutical engineering equipment can have harmful repercussions, obtaining autoclave validation can remove potential business liabilities. Validation also can be extremely costly. It is important to find the most cost-effective way of obtaining validation.

    Contents

    • This guide contains information on definitions, sterility assurance levels, thermal resistance characteristics, log reduction cost reduction, the overkill approach, common misconceptions, basic validation approaches and cautions.

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