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Last Modified: Thursday, September 19, 2019

Autoclave Validation

The process of sterilization within an autoclave chamber is a critical process!

There is a regulatory requirement for autoclave validation in most countries. Although autoclave validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

Thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process. Process sterilization temperatures can vary from 121°C for a fluid sterilization to over 300°C for dry heat sterilization processes. The autoclave is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility. The confidence of degree of sterility can then be expressed by a lethality formula or ‘thermal death time’. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

For more information please visit our Thermal Validation Systems page.

The TQSoft™ thermal validation system is used by most leading autoclave validation companies, and at leading training establishments in the UK for HTM2010 HTM01-01 and EN554 and EN285 compliance.

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