Validating autoclaves

15-Jul-2020 15:40

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For information on how to safely operate an autoclave see Autoclave Safety and Operation.

Although minimum autoclave parameters of 15 minutes (excluding exhaust time) at 121°C/250°F at 15 psi may achieve sterilization, it is recommended that biological waste run times are extended to at least 60 minutes to assure that the waste has been appropriately decontaminated.

Of all these sterilants, autoclaving is the fastest and most reliable, which is why the regulators always scrutinize autoclave validation / Qualification activities.

Here are 10 items to consider when qualifying autoclaves.

Special emphasis should be on equilibration time and temperature because it is a requirement for a good Fo.

Deviations cannot be forgotten as they may be encountered regularly throughout the qualification process.

Although sometimes this may seem trite the differences in the temperature profiles of the solution and air filters can be great.

Pay special attention to the worst case loads and explain the rationale (mostly filter and silicone hose).

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A good description of the system in a protocol shows that you understand how the process works and which critical points you need to keep under control.

The principal physical means is autoclaving; other physical methods include boiling and dry heat.

Chemicals used for sterilization include the gases ethylene oxide and formaldehyde, and liquids such asglutaraldehyde .

Operating Instructions must include parameters of sterilization, the scheme item and position of the control probes in the chamber.

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The emphasis is on the calibration of instruments because small errors in temperature can affect the Fo value to a great extent.A robust deviation management process should exist as they may impact the quality of the product.

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